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THE CHOLESTEROL TIME BOMB Stephen Holt, M.D. Detailed Contents Chapter 1: The Bomb 17 What is the Cholesterol Time Bomb? 18 The Bouquet of Barbed Wire 20 Synergy of Risk Factors 21 A Sure Detonation of the Bomb! 22 Spotting the Risks 24 Slow Suicide by Continued Adverse Lifestyles 26 The Folly of Just Lowering Cholesterol 27 Failure of Focused Interventions 28 Negative Aspects of Lowering Cholesterol 30 Reduction of Cholesterol Levels to Improve Total Mortality 31 Agencies Differ in Approaches to Cholesterol 35 Who Owns the Risk Factors? 38 Defusing the Bomb 39 Chapter 2: The Cholesterol Issue 42 Don’t Just Lower Cholesterol 43 Tiresome Advice But Scared Patients 45 Conventional Versus Alternative Approaches 46 Never Too Late: Never Too Early 49 Overlooking Nutrition as the Key 49 The Natural Way 51 The Implications of High Blood Lipids 52 Types and Amounts of Blood Lipids 53 Bad Cholesterol 58 Good Cholesterol 59 Ratios of HDL to LDL 60 A High HDL and a Low for the Rest 61 Optimal Blood Lipid Levels 63 Ethnic and Socioeconomic Status Determines Outcome 65 More Complex Lipids Play a Role to be Defined 69 Obsession With Blood Cholesterol Numbers 71 Cholesterol Targets Defined 75 How Does Atheroma Form in Blood Vessels? 77 Summing Up 84 1 Chapter 3: Addressing the Principal Issues Is Cholesterol Theory of Cardiovascular Disease Correct? Pivotal Studies Linking Cholesterol and Coronary Artery Disease 75 Challenging the Cholesterol Hypothesis Beyond Cholesterol as the Cause Oxidative Injury & Coronary Artery Disease Facts About Heart Attack The Scary Environments of Hospitals What Kinds of Risks Lurk in the CCU Expensive and Dangerous Urination in the Acute Care Setting Tubes and Needles Cost-Effective Cardiac Testing and Treatment Escape From the Coronary Care Unit Returning to Normal Life Following a Heart Attack Sex After Heart Attack Do Not Forget the Mind The Benefits of Bypass Surgery: Unresolved What Happens to Patients Undergoing Bypass Surgery Avoiding Revascularization (Bypass and Angioplasty) Procedures A Word About Chelation Therapy Doctor Watchers: A Necessary Evil Sudden Cardiac Death CPR: A Practical Skill The Dangers of Diabetes Mellitus Exercise & Coronary Risks An Aspirin a Day Keeps the Heart Attack Away 134 Radical Arguments From Free-Radical Proponents Smoker’s Heart Attack Risk Factors for Hypertension The Silent Killer is Often Mild Good Trends Hide Bad Situations Lowering Blood Pressure Without Drugs Evidence That Good Habits Lower Blood Pressure Substance Abuse and High Blood Pressure Simple Dietary Switches With Big Effects Miscellaneous Natural Options Dietary Supplements Emerge as an Option 2 71 72 76 83 85 88 90 93 94 96 97 100 104 109 110 112 119 121 123 124 127 130 132 133 135 136 137 139 143 151 155 158 161 162 162 Summarizing Natural Approaches to Blood Pressure Reduction 163 Chapter 4: Lifestyle Approaches Lifestyle Change: Plans Not Diets Smoking Stress 169 The Lifestyle Concept The Ten Lifestyle Commandments Self-Identification and Self-Intervention Changing Behavior Excessive Drinking What is Sensible Drinking? Prevention of Alcohol Problems Alcohol and Heart Disease Drinking Doctors and Cardiovascular Risks Substance Abuse Smoking Prescription Drug Abuse Exercise Psychological Well-Being Depression Self-Help Techniques for Elevating Mood Behavior That Will Get You in the End Type A Behavior and Cardiovascular Disease The Irritable Bowel Syndrome The Mind Minds the Heart The Body’s Innate Ability to Heal Spiritual Connection Mind Body Prescription for the Heart Social Aspects of Cardiovascular Wellness 218 Stress Reduction and Relaxation Programs Remember the Bouquet of Barbed Wire Chapter 5: Dietary Adjustments Reversing Atheroma? Drs. Pritikin and Ornish Speak! Who Missed the Boat? Dr. Fredericks Got it Right! Diets at the Crossroads The Missing Links are Discovered? 3 166 167 168 172 175 176 181 183 186 188 190 191 194 195 196 198 201 201 203 203 204 207 209 211 212 214 219 223 224 225 228 234 235 237 238 Soy Essential Fatty Acids and Fiber Prevail Chapter 6: Nutritional Influences on Cardiovascular Disease Nutritional Therapy of Lower Lipid: The Dietary Supplement 243 Some Important Dietary Details Fussing About Fat Bad Eggs, Good Eggs? Rotten Egg Ratios Selecting Foods Dietary Fiber Focus on Fiber The Fiber Hypothesis Irritable Bowel Syndrome Increasing Dietary Fiber Intake Fiber in Soya Fiber and Longevity Benefits of Eating Fiber How Much Fiber? Different Fibers Cause Much Confusion Soya Fiber Lowers Cholesterol Diabetes mellitus a Cardiovascular Killer Get the Right Type of Carbohydrates Alcohol and Coffee Consumption Vitamins Minerals Miscellaneous Nutritional Factors Chapter 7: Soy and Cardiovascular Health Overlooking Diet as the Key to Cardiovascular Health Premature Prescription Practice? Soya Protein Isolates are Effective at Lowering Cholesterol Is Soy Rabbit Food? How Does Soy Lower Cholesterol? How Does Soy Promote Cardiovascular Wellness? What is in a Soyabean? What Other Cardiovascular Benefits are Present in Soy? Summing Up on Soy Can Soy Milk Replace Cow’s Milk Is Soy Milk Dangerous in Infancy? Chapter 8: The Omega Factors Do Not Skip This Chapter! 4 241 242 244 246 247 248 249 251 253 254 256 257 258 263 264 265 266 267 269 270 271 273 274 277 279 280 280 282 287 288 293 295 295 300 303 306 307 308 Not All Fats are Bad Understanding the Chemistry of Essential Fatty Acids Oils Produced by Bad Processes What do Fatty Acids Do? The Essential Nature of the Essential Fatty Acids Sources of Essential Fatty Acids Tracing the Origin of the Health Benefits of Fish Oils The Health Benefits of Fish Oil The Importance of EPA & DHA A Brief Overview of Essential Fatty Acids Putting Essential Fatty Acids in Pathways Good and Bad Oils from Fish How Much Fish Oil per Day? Essential Fatty Acids Need Co-Factors Ideal Intakes? Delayed-Release Fish Oil Supplements Are Desirable A Word of Caution Frying or Heating Dietary Fat 346 Fish Oil is Essential The Omega 6 and 3 Balance Visiting the Omega 3 Factor Essential Fatty Acids and Prostaglandins: The Important Health Link Fish Oil Shifts Away From Leukotrienes Fish Oil and the Generation of Prostaglandins Series 1 Prostaglandins Type 3 Prostaglandins Preferred Over Type 2 Retiring Type 2 and Emerging Type 1 and 3 Type 1, 2, and 3 Prostaglandins Understood by Remembering 3 361 Dangerous Animal Protein Diets and Prostaglandins Fish Oil Lowers Cholesterol Dr. Phillipson’s Pivotal Study on Fish Oil The Eskimo Research Project Both levels of Blood Cholesterol and Amounts of Fish Oil are Important Preventing Atheroma and thrombosis Lowering Blood Pressure Fish Oil for Bypass Surgery 5 309 311 313 315 316 319 321 322 325 327 331 337 339 340 341 343 345 348 348 350 353 357 358 359 360 360 362 364 364 366 368 369 370 371 Fish Oil and Angina Eicosopentanoic Acid in Focus Fish Oil Supplements Conclusion Chapter 9: Botanical Influences on Cardiovascular Disease Botanical Influences or Cardiovascular Diseases A Warning About Botanicals Garlic Versatile Effects of Garlic Focus on Garlic and Cardiovascular health Garlic: How Much? What Type? Procyanidolic Oligomers Plant Constituents: Polyphenols & Bioflavonoids 396 Free-Radical Damage to the Cardiovascular System Antioxidant Effects of Co-Enzyme Q10 Ginger Ginseng Guggul Fo-ti Some Natural Blood Pressure Lowering Agents “Salt” by Other Names and Types A “Salty” Education Celery May Lower Blood Pressure Combination Remedies in Dietary Supplements: Mixed Blessing Chapter 10: General Dietary Factors Optimal Nutrition 436 A Reasonable Composite Diet A Primer of Digestion and Nutrition 439 From Mouth to Anus Main Dietary Constituents in Simple Focus Understanding Vitamins Some Alarming Facts About Children Dr. Attwood’s Twelve Common Myths Special Consideration: The Young and The Elderly Examining Aspects of Popular Childhood Diets Childhood Nutrition and Cardiovascular Risk 6 372 372 376 379 380 381 383 386 386 393 393 396 413 415 417 418 424 425 426 426 428 431 432 435 437 442 446 447 451 453 459 463 464 Dietary Supplements Present Options Diet in the Mature Female Simple Facts About Menopause Difficult Decisions for the Mature Female Simple Observations in the Climacteric Biopharmaceutical Complexity of Isoflavones Where Do Isoflavones Act in the Body? Estrogenic Activities of Isoflavones The Potential Significance of the Estrogenic Effect of Soy Isoflavones 484 A Miracle of Menopause The Downside of Female Maternity Soy Isoflavones and Menopausal Symptoms Double-Blind Controlled Trials Show the Benefit of Soy Isoflavones in Menopausal Women Can Soy Isoflavones by Used as Natural HRT? Words of Caution About Isoflavone Dosage Doses of Isoflavones for Health Benefits? Focus on Soy and Cardiovascular Disease in the Mature Female Other Benefits of Soy in the Post-Menopausal State Are Phytoestrogens Safe? Summing Up Soy Isoflavones Carnitine: Not Just for the Body-Builder Chromium Cardiovascular Function Fights Father Time Diets for the Elderly at Risk of Cardiovascular Disease Looking at Food: How to Eat? Chapter 11: Weight Control Caution for the Dieter Eating Disorders May be Forgotten Dispelling the Fads: Looking at Diets Chapter 12: Obesity Overview of Obesity Measuring Weight Status The Confused Healthcare Giver The Importance of Body Fat Distribution Killer Types of Obesity Population Studies Define Risks “Tailor Made” Diets 7 469 470 471 472 473 475 481 482 485 486 487 488 491 493 494 495 497 498 499 501 503 505 507 509 516 517 517 520 527 528 530 533 533 534 535 537 Critical Elements of Diets Different Direction With Diets Obesity Defined and Re-Defined The Significance of Being Fat What Causes Obesity? Chapter 13: Making Recommendations Pulling it All Together The Author’s Recommendation on Diet Plans Special Diets for Special People Natural Substances for the CardioPlan Appendix A: Dietary Supplement Health & Education Act 8 539 540 541 544 544 549 550 551 557 561 565-584 FORWARD Stephen Holt, M.D. has produced a unique, scholarly work in “The Cholesterol Time Bomb”. This book draws upon Dr. Holt’s encyclopedic knowledge of conventional and natural medicine to present solid advice on how to achieve cardiovascular health. To overcome the complacency that exists in trying to get people to correct adverse lifestyle, Dr. Holt has used a touch of humor which helps impact on the serious nature of the health issues that are discussed in this book. It appears that many healthcare professionals may have forgotten several natural options to combat cardiovascular disease. Dr. Holt discusses the importance of the incorporation of soy in the diet, the cardiovascular benefits of fish oil and the application of a holistic healthcare approach in cardiovascular disease management. This book covers these and other natural options in enough detail to place their importance in a clear perspective. The concepts that Dr. Holt presents as “The Cholesterol Time Bomb” subscribe to the notion that cardiovascular risk factors are interwoven to form a pernicious web of danger. Although the evidence for the role of cholesterol and blood lipid abnormalities as a pivotal cause of atheriosclerosis is unquestionable, Dr. Holt points out that they are only part of the overall puzzle of cardiovascular disorders. Dr. Holt goes beyond our knowledge of the pathophysiology of atherosclerotic cardiovascular disease and discusses the poorly applied link of psychosocial factors and 9 cardiovascular wellness. The most striking feature of this book is the validity of its discussion about natural medicine. This discussion is supported by an expert appraisal of contemporary scientific literature. Dr. Holt has produced a readable book that will not bore even the most informed. Individuals interested in cardiovascular health from a personal or professional basis stand to gain much applicable knowledge from this work. There is an up to date account of the scientific basis or rationale for the use of several macro- or micronutrients to promote cardiac health. This book proposes non-invasive and potentially cost-effective approach to cardiovascular wellness in a commendable manner and it is recommended as timely in the face of escalating costs of healthcare. Not only does this book examine natural options for the person with established coronary heart disease, it provides common-sense tactics for cardiovascular disease prevention. The concept of combining diet and lifestyle with the appropriate selection of conventional or alternative medical options makes this book a unique contribution to healthcare. Dr. Holt pioneers the expansion of pluralistic medicine in tackling atherosclerosis which is humankind’s number one killer disorder. The contribution of this book in the war against cardiovascular disease will be easily recognized. 10 PREFACE This is just another book about lowering blood cholesterol! It is written for everyone - it will inform the layperson and enhance, and to the healthcare professional. It integrates natural and conventional medicine in the quest for cardiovascular health. This is not alternative, conventional or complementary medicine, it is medicine, period - the best of both worlds. As we approach the new millennium, medical breakthroughs lie at the intersection of healthcare disciplines. It is not one choice or the other for caregivers. The age of integrated medicine is upon us. It is our right as care receivers to have it all. Promoting cardiovascular wellness is my answer to the devastating effects of cardiac disease on my family and friends. We share our disappointment with results of the current treatment and attempted prevention of coronary heart disease. The story of the causes heart disease and what constitutes effective prevention of this life-robbing process, needs to be told. There is power in the telling when the story is correct, complete and really told from the heart. Many books on cardiovascular health make false promises or adopt a narrow focus on the problem. Others sell a product or a service and several offer misguided or even dangerous advice. This book will give you a hearthealthy lifestyle that you can really live with. Medicine is at a crossroads in its approach to cardiovascular health. Conventional medicine beats a high-technology drum while some alternative 11 practitioners hype poorly-researched natural remedies. We must demand quality from both disciplines. We want the best of both worlds. An integrated medical approach may risk rejection by both conventional and alternative healthcare givers. I believe that this is a chance worth taking. Real progress most often occurs at that cutting edge that separate disciplines. Many people are disenchanted with both conventional and alternative medicine. The constant dog-fights between the conventional and alternative practitioners of medicine leave us wondering about the competence of both. Every healthcare consumer should have the right to receive the best treatment and the best preventive care. Anyone who truly needs cardiac bypass surgery should have it and not have to resort to untried or tested interventions. However, if the best approach may is to put the cardiac surgeon out of business by preventing coronary atherosclerosis through an alternative approach, then this option should be available. During my work with the Institute of Medicine Task Force in Washington D.C. in the late 1980’s, the importance of lifestyle change as a key to health was embraced by all assembled health experts. The concept of disease prevention by lifestyle adjustment was not a new idea. The conclusions of the Task Force were accepted by the U.S. Congress but not completely enacted. Innovative scientists, politicians, and physicians have the benefits of correcting adverse lifestyles for over 30 years. Theologians have recommended this approach from time immemorial. But as we approach the end of the second millennium, lifestyle plans are still not part of mainstream healthcare. Several European countries have taken a lead in preventive health strategies but the U.S.A. lags far behind. It’s time for the 12 American public to have equal opportunities for optimal healthcare. The “Cholesterol Time Bomb” is meant to overcome the complacent attitude that exists in the healthcare and general population toward enacting beneficial lifestyle adjustments for the promotion of cardiovascular and general health. This work is more complete than many other attempts at enhancing health, especially in the presentation of the information on natural health options. I have examined and utilized credible scientific information about natural medicines to support my recommendations and conclusions about its integration into current medical practice. I strongly believe it is about time to get past caring about whether a therapy is considered alternative or conventional and go with what works! It is my ambition to motivate healthcare givers to embrace obvious but overlooked solutions to cardiovascular wellness. Because it helps the “medicine go down”, this book if often humorous. The “Cholesterol Time Bomb” is serious, however, in presenting the intertwined risks of cardiovascular disability and death. It is a marriage of conventional medicine and effective natural options for cardiovascular health. When healthcare givers and patients read this book with optimism, they will gain a new perspective on the use of combined approaches to tackle humankind’s number one enemy - cardiovascular disease. Stephen Holt, M.D. January 1, 1997 13 CHAPTER 1 THE BOMB 14 What is the Cholesterol Time Bomb? At this stage, anyone who questions the role of hypercholesterolemia in the causation of coronary heart should probably join “the flat earth society”. However, high blood cholesterol is not the only issue relevant to cardiovascular wellness, and this is why the author has coined the collective term “Cholesterol Time Bomb”. Time bombs usually tick and provide some warning before they go off. Unfortunately, the “Cholesterol Time Bomb” has no tick, but it can be spotted before detonation. The “Cholesterol Time Bomb” is a description of the most important factors that determine the risks of atherosclerosis and coronary artery disease. Elevated blood cholesterol is one major factor that is inextricably linked to other cardiovascular disease risk factors. Medical research has shown that stress, obesity, cigarette smoking and genetic predispositions are often linked to high blood cholesterol and the risk of coronary heart disease (Table 1). These factors operate together in compounding the risk of heart attack and ischemic heart disease. Everyone must know that coronary heart disease remains the number one killer in Western Society. Factor Significance Diet artery A high lipid content of diet may potentiate coronary disease. Saturated fat is bad, essential fatty acids are good Blood Lipids Risk of atheroma is directly proportionate to the increase in concentration of total cholesterol and of low density lipoprotein (LDL) and inversely proportionate to concentration of high density lipoprotein (HDL). 15 Blood Pressure Risk is directly proportionate to the increase of systolic or diastolic blood pressure. Cigarette Risk is proportionate to the number of cigarettes smoked Smoking per day (risk is 3 times control at a pack or more of cigarettes per day). Personality Type A competitive, driving person (so-called Type A personality) is more prone to coronary artery disease. The aggressive, conversation-interrupting male is a great risk. Sedentary Living Individuals who do not exercise regularly may have a greater risk of myocardial infarction than do individuals who exercise regularly. Diabetes Mellitus Risk is two times control in diabetic men, three times control in diabetic women. Obesity Fat people have more coronary artery disease than those of normal body habitus. Table 1: Risk Factors for Coronary Artery Disease. Although alcohol and caffeine have been claimed by some to be independent risk factors, they have not been established to be clear risks. However, obesity acts by increasing the severity of hypertension, hyperlipidemia, and diabetes mellitus and it has an important influence on the development of coronary artery disease. The concept of time for the bomb to detonate is important. Cardiovascular risks compound over time. If the bomb is to be prevented from exploding, an early intervention to correct adverse lifestyle is required. It has been often overlooked that high blood cholesterol affects our children and atherosclerosis has its early manifestations in teenagers. Risks of cigarette smoking and excessive alcohol intake are directly related to quantity, frequency and particularly duration of consumption. The duration 16 of the adverse lifestyle often determines the risk. The earlier the intervention, the better the prognosis in most disease states. “The Bouquet of Barbed Wire” Risk factors for cardiovascular disease are tangled together in a way that they are interdependent and difficult to separate, and recent scientific research continues to provide evidence of close linkage among cardiovascular disease risk factors. Many studies show that hypercholesterolemia (elevated blood cholesterol) goes hand in hand with stress, smoking and obesity. Obesity is linked with hypertension and sedentary occupations. Smoking causes heart disease and may precipitate heart attack. The permutation of associations of health risk factors are variable and often complex. The common thread that aids in the understanding of the causes of coronary artery disease is the recognition that the overall risk is related to adverse lifestyle. Adverse lifestyle creates domains of risk behavior that form a complex “bouquet of barbed wire” within the “Cholesterol Time Bomb”. Most individuals can spot if they are too fat, smoke too much or engage in risky behavior. Many such individuals, however, continue to maintain their risks in an unimpeded manner. This book will visit the mechanisms of unentanglement of cardiovascular risk factors. Synergy of Risk Factors The incorporation of TNT into a bomb will give a “big bang”, but the addition of plastic explosive and atomic fission will result in a devastating explosion. In the same way, multiple cardiovascular risk factors add up to more serious cardiovascular risks and consequences. It is recognized that 17 the dangers of coronary heart disease and heart attack increase as the number of risk factors increase. The synergy of risk factors was clearly demonstrated in the Framingham Heart Study which contributed greatly to our knowledge about the importance of several risk factors. The recognition and correction of risk factors is at the “heart” of the prevention program of the American Heart Association. A Sure Detonation of the Bomb! (Not to be read by the foolhardy) Most popular books on weight reduction or cardiovascular wellness stress the changes that are necessary to promote well-being. This approach may not be quite as effective as pointing out the ways to ensure ill health (Table 2). Why? The major reason is that adverse lifestyle is pleasurable for many and it is often subject to denial, projection or rationalization: “If my friends did not smoke, I would not smoke.” “The occasional six pack of beer (on a daily basis) does not hurt. Did you know they brew the beer with spring water and organic hops……?” There is a large body of scientific evidence to support the notion that most people minimize their indulgence in adverse lifestyles. The person who has an eating disorder at the root of his or her problem of obesity and hypercholesterolemia is highly likely to underestimate the quantity and quality of food consumed on a daily basis. Fast food has become a staple diet for many but it is often loaded with unhealthy types of fat and it is cholesterol rich. It is a normal human reaction to suppress the significance of a risk, especially if maintaining the risk is pleasurable. 18 Lifestyle Approach to Poor Health Smoke Heavily Comments Safe levels of smoking defy clear definition. Drink Alcohol to Excessively If you do not die of liver disease you will succumb trauma usually after very painful social isolation. Stay Fat disease Significant obesity is clearly associated with chronic and early death. Do Not Exercise being. This assures many health problems and a lack of well- Stress Yourself Constantly You may become distraught, mentally or physically ill and persecute others. Eat a Lousy Diet A good way to make almost every organ in the body fail. Distain Conventional Medical Practitioners He or she could save your life. Distain Nutritionally Orientated Physicians He or she has a lot to offer and can enhance the quality of your life. Do Not Have Periodic Health Checks You will never know much about your risks of illness or death. You will suffer or die in ignorance. Self-Medicate With to Pharmaceuticals Over-the-counter medications are freely available for you Take Excessive Quantities of “Health Foods”, Dietary Supplements or “way-out” Herbal Cures You can ruin your health with excessive vitamin intake. Many dietary supplements have “purposely” misleading health claims. Some herbs are great poisons. abuse and some are lethal when misused. Make Your Own Diagnosis There are many serious diseases that can kill you slowly. and Ignore Prolonged or Several are amenable to cure. Self-medication or diagnosis Serious Symptoms is a great way of denying yourself a good health outcome. Engage in Risk Lifestyles to die prematurely. 19 It may be pleasurable to put your life at risk and it is easy Table 2: Some sure tactics for poor health. NOTE: These are not recommendations for anyone to follow. They are written and expressed in a manner that is designed to stimulate thoughts about lifestyle change that could accrue to an individual’s benefit. Other factors reinforce the perpetuation of adverse lifestyle. Excessive drinking, overeating and smoking have powerful social endorsement. If the Food and Drug Administration had to approve the free use of cigarettes, there would be no smokers, except in closets! Excess intake of the wrong type of dietary fat is a major factor in the causation of coronary heart disease. Scientific studies show that dietary fat intake is closely related to obesity and overeating. It has been estimated that the average daily intake of fat has increased up to about 83 grams per day over the last decade. Fats are very efficient sources of unwanted calories. Who can really discuss the nutritional value of fast-food and keep a straight face when examining its caloric and fat content? (Table 3) Spotting The Risks The medical profession has gone far down the path of technology and the idea of disease prevention by simple intervention is often overlooked. Such interventions are often not reinforced with quick results. Furthermore, simple preventive medicine strategies are rarely perceived as effective, even though in the long-term they are very effective. Teaching an individual the art of “self-watching” for adverse lifestyle is very important. An intervention Popular Fast Food Items 20 Grams of Fat Per Average Serving Whopper Burger 36 Burrito Supreme 22 Deluxe Hamburger 21 Sausage Biscuit with Egg 33 Popcorn Chicken 45 Quarter Pounder with Cheese 28 Table 3: The approximate fat content of single servings of some of the most popular fast food items. The fat is largely of the saturated type and the food contains a relatively large amount of trans-fatty acids that may be dangerous to health. These fast food items are not much different than many processed animal protein products that are found in all stores. Compositions of food vary with time and salad bars have emerged in fast food restaurants as this industry responds to demands for better nutrition. cannot occur unless the problem is clearly identified or recognized by both the caregiver and the individual engaged in the risks. Slow Suicide by Continued Adverse Lifestyle The “old style” family doctor is an iron of the past and the applied concepts of community medicine have been replaced by managed care. Managed care organizations engage in long discussions about preventive medicine strategies which are touted extensively in their advertising 21 campaigns to attract clients. However, very few managed care organizations will foot the bill or pay directly for preventive medicine. The “new” physician may often have a “no talk, hands off, investigational-intense” attitude. This attitude is often combined with a quick reach for a prescription pad. When did a physician in the United States last make a “house call”? It is understood that Dr. Jack Kevorkian makes regular house calls in Michigan and his practices reflect our general social endorsement of slow suicide by continued adverse lifestyle. The sardonic nature of this dialogue is to reinforce the complacency that exists. This complacency is difficult to overcome. In order to assist in countering the very powerful mental dynamics that an individual can use to deny a risk or reject a corrective lifestyle intervention, the author has summarized several ways of almost ensuring cardiovascular disease or premature death (Table 2). The keen eye will see that a cardiovascular risk is often equally a risk for other common killer diseases. These concepts lie at the basis of the definition of the “Cholesterol Time Bomb”. Many readers may question; Why the focus on cholesterol? The answer is simple. Dietary and lifestyle interventions to control cholesterol are among the most readily applicable adjustments that can be made by an individual. Indeed, most roads of cardiovascular risk lead to aspects of the traditional concepts that surround the “Cholesterol Theory” of cardiovascular disease. The author subscribes to the cholesterol theory in association with clear recognition of the other adjunctive risks of cardiovascular disease. 22 The Folly of Just Lowering Cholesterol Some physicians and scientists have rejected the notion that low cholesterol diets reduce the risk of atheroma. There are clinical trials that have failed to show a clear connection between dietary saturated fat and cholesterol intake in the development of coronary artery disease or atheroma. On the other hand, there are many studies that have indicated that a clear connection exists. This situation is at least very confusing! One of the problems in interpretation of these studies is that some research protocols have included several beneficial lifestyle interventions in addition to taking a low cholesterol diet. If multiple beneficial interventions are studied together in one clinical trial, then it is difficult to factor out the significance of one intervention, such as a low cholesterol diet alone. The author believes that there is good reason to question the efficacy of a focus on cholesterol reduction in the diet alone as an effective strategy for reducing the risk of coronary artery disease and other types of arteriosclerosis. Failure of Focused Interventions A good example of a failure of a focused intervention to reduce cholesterol alone is the Multiple Risk Factor Intervention Trial (MRFT) was performed in the mid-1970’s. This trial examined the role of reducing dietary cholesterol and saturated fats as a means of preventing heart disease and found this intervention to be less successful than may have been initially anticipated. The MRFT involved the study of 12,000 men who were considered at risk from cardiovascular disease. This group of men were 23 divided into two groups where one group was advised to take a diet designed to reduce blood cholesterol levels and the other group were given no advice about specific dietary interventions. In both groups normal supportive medical care occurred, such as the prescription of medication to reduce blood pressure. This prospective (forward, ongoing) study showed that the group who were advised to take a low cholesterol diet were able to achieve overall lower serum cholesterol values and lower blood pressure recordings than the group who did not receive a specific dietary intervention. However, no improvement in death rate from cardiovascular disease was noted as a consequence of the dietary intervention to lower cholesterol. Some researchers have gone further in their criticism of medical interventions to lower cholesterol. These individuals have questioned the use of drugs to lower serum cholesterol and some more nutritionally orientated physicians have described the practice of lower cholesterol with drug therapy as perhaps worthless and quite dangerous! The issue of the failure of blood cholesterol lowering alone to reduce cardiovascular mortality underscores the importance of the concept of the “Cholesterol Time Bomb”. The concept of the “Bomb” focuses on the issue that there are several risk factors that are inextricably linked in the causation of atherosclerosis and coronary artery disease. Attempting to focus on one risk factor alone at the expense of considering the synergistic, adverse health effects of all risk factors, is a common mistake in medical practice. The author would like to emphasize that he does not believe that the lowering of blood cholesterol is an unnecessary pastime, however, this intervention must be undertaken with that a multi-pronged approach to 24 disease prevention by addressing all risk factors in a simultaneous manner. Opinions that blood cholesterol are not part of the cause of cardiovascular problems should be rejected with the added caveat that it is only one of several major components of cardiovascular risk factors. Negative Aspects of Lowering Cholesterol There is no reason to doubt the clear relationship between abnormal blood lipids and coronary artery disease. However, it has been conceded that coronary artery disease is a multifactorial disorder (a condition with many causes). There has been much debate about the potential negative health benefit of low blood cholesterol levels. Studies that have examined data derived from several sources indicate that individuals with blood cholesterol levels below 160 mg% have an increased risk of death from diseases other than myocardial infarction. Detailed analysis of some of these data show that increased risk of death from non-coronary events was measurable for more than five years following the initial documentation of a low blood cholesterol. There are a number of proposed explanations for this increased death rate from non-cardiovascular events in individuals with low blood cholesterol. It has been suggested that a status of low blood cholesterol in itself may be unhealthy. On the other hand, it may be that serious conditions that predisposed to a low blood cholesterol may have been present in individuals at the time of the study and these conditions were undetectable. This means that individuals could have had disorders or illnesses that caused low blood cholesterol and these underlying disorders may have been responsible for subsequent deaths. A good example may be to look at deaths 25 from the acquired immunodeficiency syndrome (AIDS). How many people died from AIDS before we knew anything about this disease? Reduction of Cholesterol Levels to Improve Total Mortality When one examines primary prevention trials to reduce overall death rate from coronary artery disease, these trials may often fail to show that lowering cholesterol has a material benefit. Primary prevention involves the removal of factors at an early stage that may contribute to the causation of a disease process. The reason for this circumstance is that the reduction in death rate as a consequence of reducing coronary mortality (death due to coronary artery disease) is counterbalanced by some increase in the number of deaths due to causes other than heart disease. This failure of primary prevention studies to improve total overall mortality rates has been used as a reason to criticize cholesterol lowering strategies. In contrast, if one looks at secondary preventive strategies then the benefit of reducing blood cholesterol in patients who have hypercholesterolemia and established heart disease is quite apparent. This is an example of secondary prevention. Secondary prevention differs from primary prevention. Secondary prevention involves the early diagnosis of a disorder and intervention at a stage when treatment makes a difference to overall outcome or prognosis. Secondary prevention strategies involve the early diagnosis of coronary artery disease and the prompt lowering of blood cholesterol which can be shown to lower deaths from coronary artery disease. The benefit in this circumstance is clear and readily explained. If there were any minor increases in the death rate due to causes other than coronary events then any such increase in non-coronary death rate is 26 completely offset by the advantage of reducing cholesterol in lowering death due coronary artery disease. The medical algorithm (intervention plans) for secondary prevention in patients with coronary artery disease is shown in Table 4. These concepts are somewhat difficult to understand and individuals should not be mislead into thinking that lowering blood cholesterol levels in the presence of coronary artery disease is not worthwhile. However, these data do support the hypothesis that attempts to just lower cholesterol alone are quite misguided. Examination of the results of primary and secondary preventive measures indicate with clarity that the benefits, or lack thereof, of reduction of total blood cholesterol are quite dependent on the overall risk that the individual has for the development of coronary artery disease and its sequelae (consequences). In simple terms, this means that the higher the overall risk that an individual has for the development of coronary artery disease, the greater the benefit that will accrue to an individual who reduces their blood cholesterol levels. Lipoprotein Analysis* After Fasting for 9 to 12 Hours. Average of Two Measurements 1 to 8 Weeks Apart** ↓ Optimal LDL Cholesterol Diet and ≥100 mg/dL (2.6 mmol/L) → -Individualize Instruction on Physical Activity Level -Repeat Lipoprotein Analysis annually ↓ Higher Than Optimal LDL 27 → - Do Clinical Evaluation (History, Cholesterol >100 mg/dL (2.6 mmol/L) - Evaluate for Secondary Causes Physical Examination, and Laboratory Tests) (When Indicated) - Evaluate for Familial Disorders (When Indicated) - Consider Influences of Age, Sex, and Other CHD Risk Factors ↓ Initiate Therapy (*) Lipoprotein analysis should be performed when the patient is not in the recovery phase from an acute coronary or other medical event that would lower the usual LDL-cholesterol level. (**) If the first two LDL-cholesterol test results differ by more than 30 mg/dL (0.7 mmol/L), a third test result should be obtained within 1 to 8 weeks and the average value of the three tests used. Table 4: Secondary prevention in adults with evidence of coronary artery disease. This algorithm is based on low-density lipoportein (LDL) cholesterol level and it was proposed in the second report of the National Cholesterol Education Program (NCEP) expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). This was published in JAMA, 1993; 269:3020. Agencies Differ in Approaches to Cholesterol The debate that surrounds the potential dangers of lowering blood cholesterol has led to some differences in recommendations for the screening and treatment of abnormal blood lipids. In the United States, the Adult Treatment Panel of the National Cholesterol Education Program have proposed more assertive screening and treatment strategies than Canadian authorities who function through the Department of Health and Welfare of Canada. 28 The recommendations of the second report of the National Cholesterol Education Program expert panel to treat blood lipids abnormalities are summarized in Table 5. These recommendations were published in the Journal of the American Medical Association in 1993 and have been considered by some individuals to be quite aggressive in their approach. The recommendations are somewhat incomplete because they do not include any recognition of the many options to lower blood cholesterol other than specific dietary or drug therapy. The recommendations have a surprisingly low threshold for recommending the prescription of lipid lowering drugs, probably because of the political lobby of the multinational pharmaceutical industry. Treating Low-Density Lipoprotein Cholesterol Levels Dietary Therapy Initiation Level Goal Drug Therapy Initiation Level Goal ≥160 mg/dL <160 mg/dL (4.1 mmol/L) (4.1 mmol/L) ≥190 mg/dL (4.9 mmol/L) <160 mg/dL (4.1mmol/L) Without ≥130 mg/dL <130 mg/dL Coronary (3.4 mmol/L) (3.4 mmol/L) Disease and ≥2 Risk Factors ≥160 mg/dL (4.1 mmol/L) <130 mg/dL (3.4 mmol/L) Without ≥100 mg/dL <100 mg/dL Coronary (2.6 mmol/L) (2.6 mmol/L) Disease and <2 Risk Factors ≥130 mg/dL (3.4 mmol/L) <100 mg/dL (2.6 mmol/L) With Coronary Disease 29 Treating High-Density Lipoprotein Cholesterol (Less Than 35 mg%) With Associated LDL and/or Triglyceride Abnormalities Diet, Risk Factor Modification, Consider Drug Therapy With Other Associated Lipid Abnormalities Diet and Risk Factor Modification Table 5: The recommendations for treating LDL cholesterol and low HDL cholesterol, a set forth by the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). These data were published in JAMA, 1993; 269:30189. NOTE the aggressive advice on the cholesterol lowering drugs. Although one could not argue with the advisability of the thresholds of blood cholesterol levels that have been chosen to initiate treatment, there is a risk that these recommendations may tend to spur healthcare givers into a premature prescription of lipid lowering drug therapy (Table 5). The “expert panel” in the United States indicated that consideration should be given to the treatment of individuals with low HDL cholesterol levels in their blood (Table 5). These recommendation for the treatment of individuals with HDL levels less than 35 mg/dL include the application of specific diet and modification of overall risk factors for coronary artery disease, providing that other blood lipid abnormalities are not present. In the presence of a blood HDL level of less than 35 mg/dL, with associated increases in LDL cholesterol or triglyceride levels, recommendations have been made for the diet combined with risk factor modification and the consideration of drug therapy. Again, these recommendations seem to be deficient in discussions about natural options to elevate HDL cholesterol 30 levels without resorting to drug therapy. Indeed, the role of lipid lowering drugs in the induction of favorable changes in blood HDL concentrations is quite questionable! Who Owns the Risk Factors? To perceive that an individual is not the owner of his or her own cardiovascular risk factors is a common self-styled deception. Whilst there are risk factors, such as genetic “gifts” or gender that are unchangeable, most cardiovascular risk factors are changeable. Even if an individual has atherosclerosis, there are many contributing factors to advancing disease that are readily controllable. It may come as a surprise that advancing age, in and of itself, is not to be considered an independent risk factor. Few people would argue with the statistical observation that the older one becomes, the greater the risk of coronary artery disease. However, scientific studies have hinted that lowering cholesterol in the mature adult can lower the risk of coronary heart disease. This reinforces the importance of the time factor within the “Cholesterol Time Bomb”. Chronological age does not always coincide with biological age. We are all aware of the 40-year-old man or woman in the 70-year-old body! There are several readily identifiable risk factors that can be changed and most bear some relationship to cholesterol (Table 6). Equally, there are several simple goals that underlie such changes (Table 6). Do not feel unique in facing the challenges presented by Table 6, you have many peers in the same boat! 31 Defusing the Bomb This book promises nothing and it is not written primarily to proffer medical advice. Your healthcare giver is the person with whom you should consult in a quest for health. The author trusts that the content of this book will stimulate lifestyle change that will promote cardiovascular wellness. Its purpose is to provide a summary of contemporary thought on more natural ways to achieve cardiovascular health. Understanding the principles of a natural path to health may permit an individual to make a wiser consumer choice of healthcare services. The term healthcare services is used to embrace everything from the use of a slimming clinic to the receipt of advanced cardiac life support. If this book pushes the “at risk” individual towards a healthcare giver who can steer the person away from risk, it will have achieved its objective. Cardiovascular Risk Factors Amenable to Change: High blood cholesterol Smoking Physical inertia High blood pressure Low levels of high density lipoprotein Aims of a Simple Risk Factor Reduction Program: Decrease saturated fat intake Achieve and or maintain ideal body weight Reduce sodium intake 32 Stop smoking Table 6: Cardiovascular risk factors that are readily changed and simple approaches to reducing risks. There is no attempt in this book to reject conventional medicine, since the author regards himself as largely of the conventional medical persuasion. Several aspects of this book attempt to look at a well-defined role of nutritional products (dietary supplements) in the promotion of cardiovascular wellness. The author hopes that the concepts embraced in the Cholesterol Time Bomb will stimulate thought for new directions by patients and healthcare givers alike. 33 CHAPTER 2 THE CHOLESTEROL ISSUE AND CARDIAC CONSEQUENCES 34 Don’t Just Lower Cholesterol Targeted therapy to just lower blood cholesterol in isolation may be short-sighted or even foolish medicine. Cholesterol reduction that is induced by the dietary exclusion of cholesterol and synthetic lipid lowering drugs, in the absence of a nutritional program to improve general health, is not always safe and it is not cost-effective. The ability of cholesterol lowering drugs to reduce cholesterol the “easy way” has overshadowed the importance of their side effect profile. Side effects of some of these lipid lowering drugs are sometimes serious and such drugs are expensive (Table 7). These are overriding reasons to seek safer, natural options to lower cholesterol, normalize blood lipids and promote general wellness. In many cases the long-term effects of drug therapy to reduce cholesterol is unknown. Although recent studies claim a reduction in heart attacks with the use of certain cholesterol lowering drugs, there is not much evidence that the overall death rate from heart attacks can be substantially reduced by this limited pharmacological approach. Cholesterol reductions by drug therapy have been associated with an increase in suicide rate or cancer Drugs to Lower Lipids Drugs Sometimes Used for Obesity Probucol Benzphetamine * Fibric Acids Clofibrate Dextroamphetamine * 35 Gemfibrizol Diethylprotion HMG CoA Reductase Inhibitors Lovastatin Pravastatin Simvastatin D,L-enfluramine Mazindol Methamphetamine * Bile Acid Sequestrants Cholestyramine Colestipol Phendimetrazine Phenmetrazine Phenylpropanolamine Table 7: Drugs that are commonly used to lower cholesterol and treat obesity. The asterisks (*) denote amphetamine-like compounds which should not, in the author’s opinion, be used for obesity management. Many of the drugs listed for obesity management are controlled substances and they have adverse effects on cardiovascular function. incidence in some circumstances, even though the significance of these statistical associations is arguable. In contrast, a nutritional program that can effectively reduce cholesterol may have many other associated health benefits. In addition, nutritional programs are generally safe and often cheaper than drug therapy. With nutritional programs, overall promotion of wellness may occur. Many therapeutic programs for cardiovascular wellness use options to treat obesity and lower lipids. Drugs for obesity 36 treatment are often ineffective, frequently addictive and, overall, are to be avoided (Table 7). Tiresome Advice But Scared Patients Most individuals are tired of being told that the road to low blood cholesterol is an ideal pathway to cardiovascular health. However, concerns about high blood cholesterol create niggling doubts in many people’s minds. Increasingly, few middle-aged individuals get the reassurance of a low blood cholesterol result during periodic health examination. The healthcare giver has been programmed to create anxiety in patients about high blood cholesterol but his or her approach is often limited to dietary advice about reducing cholesterol intake, sometimes combined with a premature prescription or recommendation of a lipid-lowering drug. There is an enthusiastic willingness of a physician to adopt a pharmacological approach to the therapy of high blood cholesterol and an equal willingness for the hyper-cholestrolemic individual to take this apparent easy way out. Lowering cholesterol and simultaneous enhancement of general health by good nutrition is an ideal approach. This therapeutic approach is drug free and frequently highly effective. It is a preferable first line-option for the health-conscious individual who wants to control cholesterol and promote more general health through natural and nutritional means. Conventional Versus Alternative Approaches Several best selling books have focused on programs to lower cholesterol. One common thread among these books is the recommendation 37 of lifestyle change but they tend to select a fairly simple focus on cholesterol lowering and cardiovascular health. In many cases, such books do not provide a comprehensive review of natural options or they focus on a single natural option, sometimes in a self-serving manner. Whilst one may be critical of conventional medicine with its bent toward a pharmacological approach to lower cholesterol, even more criticism may be made of the alternative medicine practitioner who does not consider the entire array of available natural options to promote cardiovascular wellness. Like it or not, the conventional medical practitioner is armed with the convincing double blind controlled trial. The alternative medical practitioner should cast off the self-chosen label of “oppressed” and start to search more for a scientific basis for his or her treatment recommendations. In the early part of the 1980s a considerable amount of research was performed on the role of cholesterol as a key factor in the causation of coronary artery disease. Many leading healthcare institutions and the Federal Government of the United States endorsed the cholesterol and heart disease link, and cholesterol reduction had become a prime health objective by the latter part of the 1980s. Coincidental with this, multinational pharmaceutical companies invested millions of dollars into the research and development of synthetic cholesterol-lowering drugs. Although the role of dietary and lifestyle adjustment in lowering cholesterol has been apparent from the start of the cycle of interest, the anticipation of lack of compliance with lifestyle change fueled the quantum leap from appropriate, non-invasive, first-line options for cholesterol reduction to the ubiquitous application of drug therapy to lower cholesterol. 38 This situation occurred at the expense of considering lifestyle change as a key to cardiovascular health, general health and longevity. At the same time that the public awareness was increasing in blood cholesterol elevations and heart disease, a few farsighted individuals attempted to promote what they termed life extension programs. The idea of life extension is neither novel nor new, since it has been an unfulfilled ambition of humankind from early civilizations to the present. However, the real importance of life extension philosophies is that they broaden ideas to the concept of general wellness promotion rather than a fixation on only one part of the health puzzle. It is the author’s thesis that the focus on cholesterol and cardiovascular risk has led to an unhealthy preoccupation of reducing one risk factor for premature mortality at the expense of the individual’s consideration of more general health promotion. Approaches to cardiovascular health have ranged from short-term methods, such as the “8-Week Cholesterol Cure” (Kowalski, 1989) or Lower Your Cholesterol in 30 Days (Cheraskin, Orenstein and Miner, 1986), to the “forever recommendations” of “Life Extension” (Pearson and Shaw, 1983, Kent, 1985). Short-term approaches to cholesterol lowering are not worthy goals and life extension methods are often fraught by the promotion of specific dietary supplements without knowledge of the long-term consequences of their use. Never Too Late: Never Too Early The enticement of the “fountain of youth” plagues the elderly rather than the young. This enigma is unfortunate, since the commonest killer 39 disease is cardiovascular disease that has its roots and prevention in early life. However, it is never too late and much encouragement comes from the ever-increasing number of observations that established arteriosclerosis is reversible to some degree. Lifestyle intervention in the mature adult and the elderly has been shown conclusively to result in benefit in many recent scientific studies (Hodgson and Miller, 1982). Overlooking Nutrition as the Key One pivotal factor in prevention of atheroma (ateriosclerosis, coronary heart disease, etc.) is a well-balanced diet that provides an optimal array of nutrients. Unfortunately, the average Western diet is not well-balanced and rarely, if ever, provides an optimal amount of necessary nutrients. A reasonable approach to solving this problem is the use of dietary supplements, but there is probably as much misuse of dietary supplements as there is of prescription or over-the-counter drugs. In some circumstances, excesses of some unregulated dietary supplements may be more dangerous than the adverse effects of prescription drugs! If it is not already clear, personal health is owned by the person. The person has to be educated to become a safe, self-medicator. Confusion may prevail in the reader’s mind. On the one hand, a warning sounds against prescription drugs, whereas on the other, some dietary supplements require caution when used. The answer to the confusion rests in the fact that the self-medicators should take the time to be certain that they have educated themselves in the judicious use of dietary supplements or other natural medical options. A couple of authors have toiled with searching the literature for credible scientific information to 40 support an array of alternative medicine practices (Werbach, 1993, FughBerman, 1996). Perhaps a more effective strategy is to seek the services of a qualified healthcare giver with a well-balanced and pluralistic approach. This kind of healthcare practitioner is open-minded about options and less willing to “reach for the prescription pad”. All healthcare givers have much to offer in separate domains. Naturopaths, osteopaths, podiatrists, chiropractors and nutritionists sometimes have much more to offer than a physician, in some specific instances. The Natural Way? Many individuals have questioned the approach of conventional medicine to a variety of disease states. This questioning has emanated from a disenchantment with the limitation of conventional therapy for a variety of diseases, or the lack of acceptance of the side effect profile of many synthetic drugs. Many healthcare consumers have turned to natural medicine but they have faced a dilemma that many “conventional” physicians may reject dietary supplements or natural medicine, out of hand. This rejection by some physicians is rooted in part in their ignorance of the value of natural medicine. Very few medical school curriculae teach nutrition to a level that would permit an average physician to provide informed judgments about many of the proposed nutritional options that are available to combat disease. Add to the dilemma the fact that many theories or applications of natural medicine are flawed, or are empiric. Alternative medicine suffers from a chronic lack of controlled clinical studies that demonstrate safety or efficacy of the intervention (Fugh-Berman, 1996). Miracle cures may exist but few, if any, have been presented in this century. Alternatively speaking, “pigs can fly but they are rare birds”. 41 Achieving an optimal diet is one of the most overlooked paths to cardiovascular health. The objectives of the present author’s approach are to achieve a reduction in cholesterol, weight control, general well-being and make a contribution to longevity. This book stresses the importance of the normalization of blood lipids as a primary target of programs for cardiovascular wellness. There are many other health benefits that can accrue from the selection of “natural” cholesterol-lowering options that are discussed in later chapters of this book. These natural options are versatile because they possess significant ancillary wellness benefits. The Implications of High Blood Lipids At the outset it must be recognized that lowering blood cholesterol is advantageous for most people but lowering cholesterol alone without consideration of other lifestyle or health concerns is not a worthy objective. In this context the cholesterol theory of disease causation should be examined in some detail. Medical science has focused on high blood cholesterol as a principal contributing factor to a variety of diseases. The focus has rested most notably on a variety of cardiovascular diseases including: heart attack, stroke, peripheral vascular disease, arteriosclerosis and vascular causes of dementia. Other common and serious diseases may be associated with hypercholesterolemia (high blood cholesterol) including prostatic disease, renal diseases, pancreatic disease and certain cancers. Focused cholesterol-lowering therapies tend to limit the health benefits of the intervention to removal of only one of several cardiovascular or disease risk factors. This type of intervention is not a cost-effective healthcare strategy. 42 Types and Amounts of Blood Lipids The importance of hypercholesterolemia in the causation of coronary artery disease, peripheral vascular disease, and cerebrovascular disease is well documented. Abnormalities in blood lipids (fats), including high blood cholesterol levels, are determined by complex factors, but diet frequently makes the most significant contribution to this problem. This has led to recommendations by leading authorities (American Heart Association and the National Cholesterol Education Program) that dietary fat be reduced to 30 percent of the total daily intake of calories and fat of animal origin (saturated fat) should be limited. The main types of lipids found in the blood are summarized in Table 8. The latter half of the 20th century has seen an ever-increasing number of scientific articles that clearly document the relationship between high blood cholesterol and heart disease, and contemporary research has shown that cholesterol is not the only blood lipid to consider. There are many lipoprotein fractions in the blood as summarized in Table 9. Prevention of coronary artery disease is possible with interventions that lower blood lipids. Overall, it is believed that a high total blood cholesterol, a high low-density lipoprotein (LDL), a high very low-density lipoprotein level (VLDL), a high triglyceride level (TG), and a low high-density cholesterol level (HDL) are all deleterious to health. In simple terms, low-density cholesterol (LDL) is the “bad type” of cholesterol and high-density cholesterol (HDL) is the “good type” of cholesterol. Varying abnormalities in total cholesterol, LDL, VLDL and HDL can 43 be classified into certain types of high blood lipid, or hyperlipoproteinemia (Table 10). The lay reader should not be overwhelmed by this classification, since physicians often forget this classification and refer to it frequently in Lipoprotein Major Lipid Origin Function Chylomicrons Triglycerides Intestine Transport of dietary fat “Bad Cholesterol” Very low-density lipoprotein (VLDL) Triglycerides Liver Transport of endogenous fat “Bad Cholesterol” Low-density lipoprotein (LDL) tissue Cholesterol VLDL Transport of cholesterol to peripheral “Good Cholesterol” High-density lipoprotein (HDL) Cholesterol Table 8: Major Serum Lipoproteins 44 Liver, Gut Reverse cholesterol transport Lipoprotein Fractions Chylomicron Very low density lipoprotein (VLDL) -very low density lipoprotein ( -VLDL or VLDL2) Intermediate density or remnant lipoprotein (IDL) Low density lipoprotein (LDL) High density (HDL) Table 9: A list of plasma lipoproteins which have varying functions and occur in varying concentrations in the blood. Alterations of the amount and pattern of these lipids occurs in abnormal circumstances of lipoprotein metabolism resulting in hyperlipoproteinemia. Changes in Blood Levels Abnormalities Hypercholesterolemia II Mild Problem Moderate Problem 45 Characteristics Type of Disorder High cholesterol High LDL cholesterol Type 200-239 mg/dl 240-300 mg/dl 130-159 mg/dl 160-210 mg/dl Severe Problem ≥300 mg/dl ≥210 mg/dl Hypertriglyceridemia Moderate Problem Severe Problem High triglycerides 250-500 mg/dl High VLDL Type IV >500 mg/dl High VLDL + Type V High Chylomicrons Mixed Hyperlipidemia High cholesterol (>240 mg/dl) High triglycerides (>250 mg/dl) Combined hyperlipidemia Dysbetalipoproteinemia Chylomicronemia Low HDL High LDL + high VLDL Type IIB High -VLDL Type III High VLDL + high chylomicrons Type V None Low HDL (<35 mg/dl) Table 10: The Main Groups of Lipoprotein Disorders practice. This classification is important because it has implications concerning the selection of therapy. However, the implications of this classification are more relevant when considering drug therapy because tailored nutritional interventions are often portable to all common types of hyperlipoproteinemia. At the risk of over-simplification of the issues, the reader can conveniently remember that high density lipoprotein (HDL) is the 46 only “good type of cholesterol”, the rest are bad! Bad Cholesterol Cholesterol is only one of several lipids with variable functions that are found in the blood and tissues. Some understanding of the components of blood lipids is required in order to interpret abnormalities. Low density lipoproteins (LDL) are believed to be the major problem in determining atheroma (a process of blocking and “hardening” of the arteries) and, in particular, coronary artery disease. In general, the higher the LDL the greater the risk of occurrence of coronary artery disease. Low density lipoproteins carry cholesterol in the bloodstream. When LDL is oxidized, it is more likely to be deposited in the lining of arterial vessels leading to atheroma. Both oxidized LDL and peroxidated polyunsaturated fats enhance atheroma formation. These substances are atherogenic, in part by inhibiting the synthesis of one of the many prostaglandins known as prostacyclin (PGI2). Prostacyclin is an example of the prostaglandin series of compounds which play a major role in the promotion of health. Prostacyclin functions as an antithrombotic by inhibiting platelet aggregation. Very low density lipoproteins (VLDL) are substances that are utilized by the liver to produce LDL. Thus, VLDL are important precursors of LDL, and higher levels of VLDL will tend to leave more available substrate for LDL production by the liver. Good Cholesterol In contrast to the characterization of LDL and VLDL as “bad types” 47 of cholesterol, high density lipoprotein cholesterol (HDL) is considered a “good type” of cholesterol. In simple terms, HDL exerts an effect of drawing cholesterol into the circulating blood away from its site of deposition in arterial blood vessel walls (anti-atherogenic). High density lipoprotein has a complex function. It is responsible to some degree for returning cholesterol to the liver and it directly protects the lining of blood vessels from smaller remnants of fat that have been enzymatically digested in the blood stream. Ratios of HDL to LDL The ratio of the amounts of HDL to LDL is a reasonable measure of coronary artery disease risk. In addition, ratio between HDL and total cholesterol is an important measure of the risk of heart diseases. The most desirable ratio of HDL to LDL is a ratio that favors a preponderance of HDL. Ratios can be confusing. For example, looking at ratios of total cholesterol to HDL leads to a desirable ratio of less than 4.5. This ratio can be altered by raising LDL or lowering HDL, tending to push the ratio higher. In contrast, lowering LDL and raising HDL, tends to push the ratio lower. There are still no generally agreed optimum circumstances in terms of a total blood cholesterol level. Less than 200 mg/dl, or a ratio of total cholesterol to HDL cholesterol of less than 4.5 are probably generous allowances given current knowledge. The acceptable level of total blood cholesterol tends to be revised downwards these days. Most healthcare givers recommend all methods of elevating HDL to improve cardiovascular health. Exercise and moderate drinking of alcohol are associated with modest elevations of HDL. However, the 48 recommendation of ethanol intake even in modest amounts is not often volunteered by the healthcare giver. The author believes that moderate alcohol intake is safe, even accepting the oxidant and free-radical producing effects of ethanol. Several other conditions or factors affect blood HDL levels (Table 11). A High HDL and a Low For the Rest In summary, the aims of altering blood lipids to promote cardiovascular health are to achieve a low LDL, a low VLDL, low triglycerides, a high HDL, a low total cholesterol and low cholesterol ratios. Cardiovascular disease caused by atheroma (a buildup of fat and cholesterol in arterial blood vessels) is at the root of the number one cause of death in Western society. Several factors are known to play a role in determining cardiovascular risks, especially for heart attacks. These factors include high blood cholesterol, obesity, cigarette smoking, stress, high blood pressure, diabetes mellitus and genetic (hereditary, familial) influences. Tackling a high blood cholesterol in the absence of addressing other potentially correctable risk factors is an incomplete approach. The isolated control of blood cholesterol may be a principal reason for the continuing failure of primary care medical practice to materially decrease death rates from cardiovascular disease. Decrease HDL Increase HDL Vegetarian Diet Oral Estrogens (Female sex) 49 Cigarettes Sedentary Lifestyle Exercise Alcohol (moderate intake) Obesity Lean Body Mass Menopause Androgens Progestogens Insulin Table 11: Conditions or agents that alter high density lipoprotein (HDL) Cholesterol Levels (good cholesterol). Note low overall fat intake as occurs in the presence of a strict vegan diet lowers all types of blood lipids, including HDL. This has been used as an argument against the proposed healthfulness of the strict vegan diet. Optimal Blood Lipid Levels? The levels of blood cholesterol and other lipids that can be considered healthy for an individual cannot be determined precisely. A good guide to the levels of blood lipids that can be considered healthy is shown in Table 12. On occasion, individuals with high blood cholesterol may live to a ripe old age without cardiovascular problems. Conversely, some with low blood cholesterol may die prematurely. The cholesterol theory is not foolproof 50 because factors other than cholesterol play a pivotal role in causing heart disease and other cardiovascular problems. It has been argued that cholesterol exclusions in the diet and drug therapy have not been shown conclusively to reverse atherosclerosis. However, evidence has emerged that some nutritionally based interventions may reverse established arteriosclerotic disease. It is known that the overall average range of total blood cholesterol levels of adult Americans and Western Europeans is 210 - 225 mg/dL, and statistical studies demonstrate with clarity that the death rate from coronary artery disease increases with increasing blood cholesterol levels. When the Total Cholesterol……………… less than 200 mg/dl LDL Cholesterol……………… less than 130 mg/dl HDL Cholesterol……………… greater than 35 mg/dl LDL to HDL Ratio.…………… less than 4:5 Triglycerides………………….. 50 to 150 mg/dl 51 Table 12: A Guide to the Levels of Blood Lipids blood cholesterol level is 240 mg/dL, the mortality from cardiovascular diseases increases four-fold above the average rate and at 260 mg/dL, the risk of death is about six-fold, or greater. (It is not just the total blood cholesterol that determines risk, it is the lipid profile and, in particular, levels of LDL are important, Table 13.) Blood cholesterol levels in affluent countries are higher than those in third world countries. It should be noted that in affluent societies it is the lower socioeconomic groups that may be particularly at risk because high cholesterol, high fat, low fiber, high sugar containing food is relatively cheap and abundant; largely with thanks to the fast food industry. To be fair, the fast food industry is making some token gestures to improve general nutrition by looking at more incorporation of vegetables into their menus. Ethnic and Socioeconomic Status Determines Outcome Throughout this book, it has been recognized that there are certain risk factors for coronary artery disease that cannot be readily abolished. Advancing age and male gender are obvious encumbrances that are not Total Cholesterol 52 LDL Cholesterol Desirable: Borderline High Risk: Less than 200 mg/dl Less than 130 mg/dl 200 - 239 mg/dl 130 - 159 mg/dl High Risk: Greater than 240 mg/dl Greater than 160 mg/dl Table 13: This simple classification of risk based on blood cholesterol levels was proposed by the adult treatment panel of the National Cholesterol Education Program. amenable to correction or intervention. The fixed risks and modifable risks are shown in Table 14. However, females have cause for concern. The lower prevalence of heart disease in premenopausal women is quite striking and the incidence of coronary artery disease in women who are premenopausal is approximately equivalent to that found in men who are about 15 years younger. However, it is sometimes forgotten that coronary artery disease is the most common cause of death in women, as it is in men. 53 There is much concern about the management of coronary artery disease in women because evidence has emerged that it may be often under-diagnosed in the female and managed in a much less assertive manner, than it may be managed in a male. Contrary to popular belief, risk factors for coronary artery disease in the U.S. appear to be almost the same in African Americans, Hispanics and Caucasians. However, it is apparent that coronary artery disease deaths have not declined to the same degree in African Americans as they have in Caucasians. The author believes that this is largely due to circumstance where African Americans have much less access to intervention strategies to reduce the risks of cardiovascular disease. In addition, it is well known that Amenable to Modification Smoking Elevated Blood Pressure Blood Lipid Disorders Diabetes Mellitus Clotting Disorders Behavioral Issues Lack of Exercise Being Fat Deficiency of Essential Fatty Acids Lack of Other Nutrients? 54 Fixed Risk Age Male Sex Family History * Post-menopausal Female Table 14: An expanded list of ‘risk’ factors for coronary heart disease. Arguments prevail about the true role of some of these items in the risk of cardiovascular disease. * The post-menopausal risk is forgotten by many but it may be amenable to modification by isoflavones or hormone replacement therapy. African Americans in the United States have a frequent non-medical insurance status and they do not have ready access to modern treatment facilities, as do many Caucasians. This problem is overlooked in the American healthcare system. It has been perceived, like it or not, as an unfortunate discrimination against ethnic groups, even though it is unintentioned. It is not suggested that there is any conspiracy in any healthcare system to discriminate against certain ethnic or lower socioeconomic groups but even recipients of government funded healthcare, such as Medicaid patients, cannot get access to all practitioners because of the perception by some practitioners of poor reimbursement levels by Medicaid. There are other complex issues that affect the portability of health care in the United States. More Complex Lipids Play a Role to be Defined Much concern has been expressed in the literature about the relative importance of a low LDL or a high HDL. Part of modern scientific evidence seems to imply that the ratio of LDL:HDL cholesterol appears to be more important than a consideration of either LDL or HDL alone. Controversy 55 continues about the risk of hypertriglyceridemia alone as an independent risk factor for coronary artery disease. The author believes that hypertriglyceridemia alone is a risk factor, but most current treatment recommendations suggest to manage this condition specifically only if there is a marked elevation of triglycerides to levels of greater than 500 mg/dL or higher. Recent research has focused on the importance of lipoprotein(A) as an independent risk factor for coronary artery disease. Lipoprotein(A) is very similar to LDL and it has quite marked effects on the inhibition of thrombolytic substances that activate dissolution of clots (dissolution of blood clots) activity that may be provided by tissue plasminogen activators. Tissue plasminogen activators are compounds that the body releases to promote the dissolving of clots that may form in the body. Some interest is focused on the importance of apoproteins. Apoproteins are basically the structural components of circulating lipoproteins. These proteins come in various types, including apoprotein A, B and E. Apoprotein(E) is synthesized primarily in the liver and is found in HDL, VLDL and chylomicrons. It is believed that genetic factors may determine apoprotein(E) levels and such factors could account for around a 10% variation in LDL and total cholesterol levels. Apoprotein(A), like apoprotein(E), and a variety of its subtypes, provide the major protein support for HDL. In contrast, apoprotein(B) occur in two forms as the predominant protein structure for LDL. Much discussion has occurred in newer medical literature about the significance of apoproteins. However, there is no substantial evidence to-date that the measurement of apoprotein 56 levels in the blood result in a better prediction of the risks of coronary artery disease. Measurements of LDL and HDL and their ratio appear to be the most accurate way of determining a cardiovascular risk due to abnormal blood lipids. Obsession with Blood Cholesterol Numbers It is easy to become obsessed by cholesterol numbers. In the author’s clinical experience, patients place too much emphasis on the apparent “magic numbers” of blood tests. A healthy adult would ideally have a blood cholesterol in the range of 120 - 180 mg/dL, but under 200 is often regarded as quite acceptable. However, there is little point in having a blood cholesterol of 120 mg/dL and continuing to smoke or drink excessively. Several studies have confirmed that excessive dietary cholesterol intake and salt intake are among the commonest threats to health in Western Society. Excessive salt intake is a significant health problem in some Asian societies, especially Japan, and this factor may be linked to the high stroke mortality that is observed among the Japanese. In addition, high salt intake may play a role in the high incidence of gastric cancer that is seen in Southeast Asia. Overall, about 60% of all Americans may have high blood cholesterol, 80% eat too much fat and/or protein and 50% take too much salt in their diet. The modern concepts of “What constitutes a high blood cholesterol” level emanate from epidemiological data on blood lipids that were collected from more than 60,000 individuals in 10 different population groups in the United States (Rifkind and Segal, 1983). Kowalski (1989) has summarized data on blood lipid levels and shown the relevance of considering age and sex in the interpretation of normality (Table 15 and Table 16). Many 57 scientists have scrutinized safe levels of cholesterol and other blood lipids, and various interpretations of safe levels exist. In general, the incidence of coronary artery disease starts to climb with blood cholesterol levels greater than 200 mg/dL. It has been accepted overall that 200 mg/dL is the maximum acceptable “normal” total cholesterol level regardless of age or sex (Table 12). Other Total Cholesterol: Male Female LDL: Male Female 58 Age(Yrs.) Average 5% 95% 0-19 20-24 25-29 30-34 35-39 40-44 45-69 70+ 0-19 20-24 25-34 35-39 40-44 45-49 50-54 55+ 155 165 180 190 200 205 215 205 160 170 175 185 195 205 220 230 115 125 135 140 145 150 160 150 120 125 130 140 145 150 165 170 200 220 245 255 270 270 275 270 200 230 235 245 255 270 285 295 5-19 20-24 25-29 30-34 35-39 40-44 45-69 70+ 5-19 95 105 115 125 135 135 145 145 100 65 65 70 80 80 85 90 90 65 130 145 165 185 190 185 205 185 140 20-24 25-34 35-39 40-44 45-49 50-54 55+ 105 110 120 125 130 140 150 55 70 75 75 80 90 95 160 160 170 175 185 200 215 Table 15: Total Blood Cholesterol and LDL vary by age and sex (modified from Kowalski, 1989). 5% and 95% are percentiles. The risk of heart disease relates to values above the 50th percentile. Age Average 5% 95% HDL: Male 5-14 55 35 75 15-19 45 30 65 20-24 45 30 65 25-29 45 30 65 30-34 45 30 65 35-39 45 30 60 40-44 45 25 65 45-69 50 30 70 70+ 50 30 75 Female 5-19 55 25 70 20-24 55 35 80 25-34 55 35 80 35-39 55 35 80 40-44 60 35 90 45-49 60 35 85 50-54 60 35 90 55+ 60 35 95 Triglyceride: Male 0-9 55 30 100 10-14 65 30 125 15-19 80 35 150 20-24 100 45 200 25-29 115 45 250 30-34 130 50 265 35-39 145 55 320 40-54 150 55 320 55-64 140 60 290 65+ 135 55 260 Female 0-9 60 35 110 59 10-19 75 40 130 20-34 90 40 170 35-39 95 40 195 40-44 105 45 210 45-49 110 45 230 50-54 120 55 240 55-64 125 55 250 65+ 130 60 240 Table 16: Blood HDL and Triglycerides vary by age and sex (modified from Kowalski, 1989). 5% and 95% are percentiles. more stringent definitions of normality stem from observations that the relationship between cholesterol levels and coronary vascular disease is a continuous graded risk rather than an artificial threshold at 200 mg/dL. Some authorities have placed the maximum acceptable total blood cholesterol level at 180 mg/dL for adults. The significance of looking at cholesterol numbers relates to their use as a measure of risk. It has been estimated that for each one percent of reduction in blood cholesterol levels, there is a two percent reduction in coronary heart disease. Cholesterol Targets Defined: The Role of Combined Risk There has been continuing argument as to the optimal levels of blood cholesterol that are desirable for good health. Higher blood cholesterol levels can be tolerated in individuals who have no other significant risk factors. Currently, it is acceptable following standard guidelines for an individual to have a blood cholesterol level of up to 165 mg/dL, in the absence of any other cardiovascular risk factors. When multiple risk factors are present, it is advised that the target blood cholesterol level be less than 130 mg/dL. A large portion of individuals fall into this category and the 60 achievement of a blood cholesterol of this level is often quite difficult for individuals in Western society. The author does not believe that there is clear cut evidence that reduction of blood cholesterol to this level is necessarily advisable but would recommend that blood cholesterol be lowered to less than 160 mg/dL in the presence of cardiovascular risk factors in addition to elevated blood cholesterol. The authors advice is contrary to some accepted guidelines and may be regarded by some as too lax. The benefits of aggressive lowering of blood cholesterol in patients with coronary artery disease are much clearer than in the healthy person. It is advisable for a person with established coronary artery disease to “shoot” for the lowest cholesterol level possible and the optimal target may be less than 100 mg/dL. The person with established coronary artery disease should be quite diligent about strategies to elevate blood HDL levels but this situation can be very difficult. The problem is that lowering cholesterol in the diet tends to result in the lowering of both LDL and HDL cholesterol. This situation could be amenable to the incorporation of soy protein into the diet because some elevation of HDL is recorded in patients taking soy protein diets. Overall the elevation of HDL seen in these individuals on soy diets may not always be statistically significant in trials of soy protein diets in normalization of blood lipids. The person with coronary artery disease is advised to try and get their blood HDL level to above 35 mg/dL. How Does Atheroma Form in Blood Vessels? The hallmark of atheroma is the development of cholesterol containing plaque in the lining and wall of the blood vessels. It appears that injury to the lining of the blood vessel and excesses of circulating LDL play 61 a major role in the causation of the atheromatous plaque. Injury to the lining of the blood vessel may occur as a consequence of several factors, including diabetes mellitus, high blood pressure, smoking, immune mechanisms. Lipids (fats and cholesterol) are transported through the body in several formats. It is the deposition of these lipids from the LDL and VLDL packages that leads to arterial blockage. Arteries throughout the body have many branches with decreasing diameters. For example, the internal diameter of a major human coronary artery is about 2-3 millimeters (1/12 of an inch). The mechanisms whereby lipids are deposited in arteries to cause atheroma have been increasingly understood in the past decade. It appears that lesions in the lining of arteries (intima) form foci for the deposition of cholesterol from LDL. Repair proteins, platelet aggregation, calcium deposition and additional fats can be deposited over a long period of time to cause a buildup leading to arterial blockage. This “damming up” of arteries can occur over a long period of time without symptoms. The first manifestation of its presence can be an acute heart attack with sudden death with or without prior symptoms. The blockage of the blood vessels supplying the heart (coronary arteries) results in a starvation of oxygen and nutrients to the heart muscle. Rapid occlusion of the vessel is the cause of a classic heart attack, whereas, a more slow process may lead to angina pectoris. Angina: The Heart Screams in Pain There are many manifestations of coronary artery disease resulting in 62 the causation of an array of symptoms and signs. These manifestations are correlated to some degree with the blockage of blood vessels, especially the coronary arteries. Table 17 summarizes the clinical manifestations of coronary artery disease in relationship to the underlying structural changes in arteries (the pathology). Angina pectoris is chest pain derived from lack of blood supply to the heart. The heart essentially “screams out” in pain in this situation, especially if exercise or physiological stresses place a demand for increased blood supply to the heart which cannot occur because of the reduction of diameter and relaxability of the arteries that is caused by atheroma. Angina can be stable or unstable when the risk of heart attack may be imminent (Table 17). Angina pectoris is a term that has been carefully defined as chest discomfort due to transient lack of blood supply to the heart muscle. The term angina is derived from the Greek work which means strangulation or choking. Angina can present itself in a variety of ways. Most frequently, angina is felt as a left sided or central chest pain that is precipitated by circumstances that stress the heart resulting in increased demands for oxygen (Table 18). Many individuals with angina describe a sensation of tightness in the chest of varying severity. The pain is of a constricting type and sometimes likened to the sensation of a bank-like compression of the chest. There are several circumstances that may commonly precipitate in anginal episode. Some of these circumstances can be inferred by understanding the mechanisms whereby the heart is stimulated to cause an 63 increased demand for oxygen by increasing its blood flow. Table 19 summarizes some circumstances that can trigger an episode of angina. In a Disorder Anatomic Change Sudden Death Abnormal heart rhythm or heart attack Heart Failure Myocardial compromise due to infarction (heart attack due to lack of blood supply) or ischaemia Arrhythmias due Altered electrical conduction in the heart to ischaemia or infarction Myocardial Infarction Sudden occlusion due to coronary thrombosis Unstable Angina “One and off” obstruction due to plaque rupture with arteries spasm and clotting Stable Angina Fixed atheromatous narrowing of coronary arteries Table 17: Coronary heart disease: clinical manifestations are related to the anatomical changes that occur in arteries that supply the heart. 64 Stressors That Determine Oxygen Demand of the Heart - Increased Cardiac Work vessels - Increased Heart Rate - Blood Pressure Changes - Heart Muscle Contraction Regulators of Oxygen Supply to Heart - Blood flow through coronary - Blood flow occurs during diastole of the heart (relaxation phase) which can be of variable duration - Coronary Artery Tone - Hemoglobin saturation with oxygen Table 18: Factors that stress the heart and result in increased oxygen demand can precipitate angina. Several factors regulate oxygen supply to the heart, including flow of blood through the coronary arteries and the status of oxygenation of the blood. For example, cigarette smoking may decrease blood oxygenation and precipitate angina in the susceptible individual with narrowing of the coronary arteries by atheroma. Intense emotions Physical exertion, especially if “unconditioned” 65 Exposure to excessive cold or heat Vivid dreams (nocturnal angina) Lying flat (decubitus angina) Exaggerated “fright and flight” reactions Heavy metal exposures Smoking cigarette or marijuana Stimulant drugs Concomitant illness, e.g., retching, vomiting, excessive defecation Table 19: Circumstances that can cause the onset of angina pectoris or precipitate a heart attack. person coronary artery disease these circumstances can herald the onset of a heart attack (acute myocardial infarction, coronary thrombosis). People with angina learn to avoid events that cause angina and this results in a crippling existence for some individuals. The pain of angina comes in many guises and breathlessness is commonly associated. Anginal pain moves sometimes down the arms, causing dead feelings in upper extremities and it can be felt in more remote body locations than the chest. Some individuals experience shoulder aches, arm aches or pain in the middle of the shoulder blades. Sometimes angina may occur at the start of exercise only and it goes away with more strenuous 66 exercise. This has been called “start up” angina and it may give an individual a false reassurance that initial niggling chest pains during exercise are not coming from the heart. The reader may be puzzled about the need to describe the manifestations of angina in such great detail. The importance of the dialogue is that it is a careful history that results in a diagnosis of angina. A careful analysis of a patient’s symptoms is the most important way to make a correct diagnosis. In the days of high technology medicine where speaking to patients has been superseded by testing procedures, an early diagnosis of mild angina can be overlooked. Early diagnosis of angina may be more important that hitherto supposed because effective interventions to reverse atheroma have become available. It should not be forgotten that early diagnosis with early and effective intervention results in an improved prognosis. To wait for intervention while angina ad blockage of the coronary arteries progress is a crime. Summing Up Understanding the importance of the effects of various risk factors on the genesis of coronary artery disease is very important for the individual who is determined to lower their risk of cardiovascular illness. The simplest advice to enhance cardiovascular well-being include: smoking cessation, regular exercise, weight control, good nutrition without more than 30% of the energy derived in the diet from fat. Sounds simple but the “plot thickens”. 67 68 CHAPTER 3 ADDRESSING THE PRINCIPAL ISSUES 69 Is The Cholesterol Theory of Cardiovascular Disease Correct? Several, well-ontrolled, scientific studies demonstrate unequivocally that individuals who are able to reduce blood cholesterol levels experience less heart disease. In addition, the converse is true! Individuals who do not lower their blood cholesterol will tend overall to have more heart disease. The data derived from such studies show that reducing total blood cholesterol levels by a factor of one-third, or more, reduces the risk of coronary artery disease by about 50%. Animal experiments indicate that atherosclerosis will not occur in the absence of high blood cholesterol. Extensive studies, such as the Lipid Research Clinics Coronary Primary Prevention Trial, have indicated that males who lower blood cholesterol with diet and cholesterol-lowering drugs suffer fewer heart attacks than those in whom blood cholesterol remains elevated. Moved by these kind of data, the American Heart Association recommended the reduction of fat intake in the diet to less than 30% of the total calories. The author does not doubt that the American Heart Association was correct in its assertions about cholesterol lowering at the time of this early recommendation in the mid-1980s, but the reader will see that this is not the whole story. These recommendations, and those of several dietary enthusiasts have lost sight of the importance of good fats in the form of essential fatty acids. There has been a pernicious outcome of the studies that showed that lowering cholesterol with synthetic drugs reduced cardiovascular risk. The pernicious outcome is the premature prescription of the lipid-lowering drug. 70 The effectiveness of these drugs led several authors to recommend diet with cholesterol-lowering drugs as the secondary (but early) intervention to normalize blood lipids. These recommendations of adjunctive drug therapy have become engraved in the memory of the medical profession because very few natural options were tried prior to drug intervention. Furthermore, much, if not most, of the research on blood lipids and cardiovascular research has been funded by multinational pharmaceutical companies who are in the business of the purveyance of the synthetic, pharmaceutical approach. The Cholesterol Theory of Cardiovascular Disease seems plausible but perhaps somewhat incomplete. Prevailing controversies tend to examine the incompleteness of the theory rather than the fundamental construct of the theory. The author agrees with and subscribes to the Cholesterol Theory but considers it to be incomplete in its description and application in medicine. Elevated cholesterol is a major determinant of coronary artery disease due to atheroma, but it is not the only miscreant. There is a body of opinion that the levels of cholesterol and blood lipids that are accepted traditionally as normal are, in fact, too high. An opinion expressed by some is that the so-called “normal” range of blood lipids has been a passport to disability and death for many people. The construct of many “heart smart” diets is to attempt to lower cholesterol levels to the “normal range”. However, the concept of normality in range for cholesterol still defies accurate definition. To reduce blood lipids into what some consider a ‘safe’ range may mean lowering cholesterol levels below 160 mg% and triglyceride levels to below 80 mg%. Dr. William P. 71 Castelli, who was the principal research force behind the famous Framingham Study of risks of coronary heart disease, was recorded to have said that he had never encountered a case of coronary artery disease in a subject with a cholesterol level below 150 mg%. There is some fallacy in the reasoning that it is just cholesterol or lipid fractions alone that may determine excess cardiovascular morbidity and mortality. For this reason, an intervention for cardiovascular health should not be overly preoccupied with lowering cholesterol or lipids in isolation of more general health strategies. Pivotal Studies Linking Cholesterol and Coronary Artery Disease Coincidental with the political statements in the early 1950s that Western populations “had never had it so good” was the initiation of the Framingham Study by the National Institute of Health. It is ironic that “never having it so good” was linked clearly with coronary heart disease in the Framingham Study. The era of “celebrations” in Western Europe and the U.S. following the second world war may have been responsible for much of the recent excess morbidity and mortality from cardiovascular disease. So strong was the association of high blood cholesterol and coronary artery disease in the Framingham Study, that Dr. W.P. Castelli and his associates were able to publish a classic paper in 1983 titled “Summary Estimates of Cholesterol Used to Predict Coronary Heart Disease”. The Framingham Study is an example of one of the most complete and longest prospective studies of lifestyle as a cause of coronary heart disease, and stroke. The data from this study characterized the heart attack victim to 72 have an average blood cholesterol of 244 mg% with a range of 220-260 mg%. Several other studies clearly relate high blood cholesterol to coronary artery disease. More important may be the Oslo Study and the Zutphen Study that provide evidence that coronary artery disease can be prevented to some degree by lowering a high blood cholesterol. The Oslo Study, in Norway, examined 1,234 mature males who were split into two groups. One group modified its diet and adverse lifestyle with an emphasis on lowering blood cholesterol, whereas the other group formed a control group and received no such interventions. After five years, the incidence of heart attacks was 47% lower in the group with the lifestyle and dietary interventions compared with the control group. The Zutphen Study, in Holland, lasted 20 years during which 852 middle-aged males had their diets and lifestyles assessed prior to prospective study for the development of coronary artery disease. This study showed a cardio-protective effect from the incorporation of fish in the diet and further defined adverse lifestyle as a determinant of coronary deaths and disability. A consideration of the Framingham, Oslo, and Zutphen studies underscores the importance of blood cholesterol reduction and correction of adverse lifestyle in the prevention of coronary artery disease. There are some individuals at risk where the writing is one the wall. Table 12 summarizes the characteristics of individuals who are best advised to take immediate corrective action to reduce their risk of coronary heart disease. 73 Challenging the Cholesterol Hypothesis Any hypothesis in medicine can be doubted and there is a small body of opinion that has rejected the “cholesterol theory”. It has been argued that cholesterol consumption in Western society has remained reasonably constant for much of this century but cardiovascular death rates have skyrocketed. In the past decade, cholesterol consumption has risen in children quite significantly with the sale of billions of meat and dairy items in fast food restaurants. What will happen to these children in 30 or 40 years’ time? In general, a diet that is low in saturated fat, high in fiber, high in fruits and vegetables, low in refined carbohydrates and abundant in vitamins, minerals and micronutrients is considered ideal for lowering blood cholesterol. This dietary adjustment has the advantage of providing a host of Adult smokers Women experiencing the climacteric (menopause) Hypertensive females or males, especially over the age of 30 (BP > 140/80mmHg) Mature men and women over the age of 50 years Individuals who are more than fifteen pounds above average body weight Hypercholesterolemia in the adult, especially if greater than 180 mg% over the age of 35 years 74 Table 14: Characteristics of individuals who are advised to consider early measures to reduce cardiovascular risks. This list is not complete. other health benefits. However, before any decision can be made on the selection of a nutritional program, other theories of the links between cardiovascular disease and diet require exploration. The principal hypotheses of the nutritional causes of cardiovascular disease are summarized in Table 15. Triglycerides may be as important as cholesterol in determining the risk of cardiovascular disease; a strong relationship exists between blood triglyceride levels and cardiovascular disease. It has been indicated that the increased incorporation of foods that cause a rise in blood triglyceride levels during this century coincides with the increase in cardiovascular mortality. Foods that cause a rise in triglycerides include refined carbohydrates (sugars and starches) and saturated or hardened, non-essential fats. In addition, an overall increase in caloric intake in the diet, obesity and lack of exercise, all cause a rise in blood triglycerides. The role of refined sugar consumption in the causation of cardiovascular disease has received considerable attention in the scientific and lay press. Refined sugar (sucrose) exerts a number of undesirable effects 75 Theory Comments Cholesterol Theory Convincing evidence implicates hypercholesterolemia as a major risk for cardiac disease. However, it is incomplete and when applied alone as the treatment objective, it may be ineffective. Triglyceride Theory A good correlation exists between blood triglyceride levels and coronary heart disease. Triglycerides increase with high saturated fat and refined carbohydrate diets. Sugar Theory oxidative Simple sugars raise triglycerides, increase damage and have other adverse metabolic effects. Oxidation Theory Oxidized cholesterol and triglycerides damage arterial blood vessels. Deficiency Theory Deficiency of one or more essential nutrients, e.g. vitamins, minerals, essential fatty acids, may raise cholesterol, cause oxidative stress and heart disease. Vitamin Theory Linus Pauling proposed a unified theory to explain the cause and cure of cardiovascular disease with vitamin C. The deficiency of vitamin C may result in the deposition of repair proteins in arteries. “Wacko” Theory There is a dietary supplement or natural treatment that has panacea benefit in curing cardiovascular disease. Table 15: The principle nutritional theories of the causation of coronary artery disease are listed with relevant comments. The Cholesterol Theory is not the whole story and each other theory is somewhat incomplete. on the body’s metabolism, including: increased tissue damage by oxidative 76 mechanisms, inhibition of immune function and interference with vitamin C transport. Prompt increases in blood triglycerides occur following a sugarladen meal. Several arguments have surfaced that dietary elimination of refined sugar and incorporation of essential fatty acids and micronutrients in the diet may prevent or reverse cardiovascular and other degenerative diseases. Cardiovascular disease can not be shown clearly to be a dietary deficiency disease but lack of essential nutrients may play a major role in its causation. Increased intake of vitamins, minerals, essential fatty acids and dietary fiber have been shown in some circumstances to assist in blood cholesterol and triglyceride reduction. The omega-3 fatty acids that are found in fish oil have a particular and favorable role in lowering blood lipids. There are variable estimates of vitamin deficiencies in Western communities but as much as 85% of the population may not have a consistent, optimal intake of vitamins, minerals, essential fatty acids or fiber. If an individual is not conscientious about his or her diet, the chance of deficiency of one or more of these nutrients is 100%! Vitamin C deficiency has gained momentum as a theory of pathogenesis that may explain cardiovascular disease. Many scientific studies provide information to corroborate the importance of vitamin C and compounds that facilitate the action of vitamin C, such as bioflavonoids, in the promotion of cardiovascular wellness. It has been proposed that vitamin C deficiency leads to the deposition of repair proteins in arteries and it facilitates the oxidation of cholesterol and other lipoproteins. In support of the importance of vitamin C in the maintenance of cardiovascular health are 77 observations that this protective role of vitamin C fits the theory of elevated cholesterol and triglycerides as major factors in the causation of cardiovascular disease. Reduction in cardiovascular mortality has been ascribed in some research to an enhanced intake of vitamin C. Of considerable importance is the role of oxidation of fats in the genesis of atherosclerosis. It appears that oxidation of cholesterol and triglycerides is an important prerequisite and promoter of “fat” and cholesterol deposition in arteries. This oxidation can be prevented by nutrients that are antioxidants (notably vitamins C, E and carotene, selenium, zinc and sulfur). The correct selection of food is important because oxidized fat is abundant in aged foods or meat, especially if they are poorly manufactured or stored. Refined sugar plays a role in this oxidative process of fats, at least by its interference with the actions of vitamin C. In addition, certain phytochemicals are powerful antioxidants. Examples of such phytochemicals with this effect are soya isoflavones, such as genistein and daidzein, or bioflavanoids such as those derived from pine bark. The cholesterol theory for the causation of cardiovascular disease has validity but obviously, other nutritional factors play a major role. The overriding importance of considering the multiple theories or factors that determine disorders of nutrition as a basis of cardiovascular disease is to highlight the need for a comprehensive nutritional approach to promote cardiovascular wellness, rather than reinforce the current, prevalent obsession with cholesterol alone as the dietary culprit that causes cardiovascular impairment. 78 Beyond Cholesterol as the Cause Information that questions a conventional interpretation of the Cholesterol Theory emerges from certain epidemiological studies that look at ethnic and/or geographic differences in the incidence of coronary artery disease. The prevalence of observations coronary artery disease is lower in Japan than in the United States or Western Europe. Studies of Seventh Day Adventists show lower cardiovascular mortality among this religious group. Multiple observations of the cardiovascular disease profile of the Inuit or Eskimo, who eat a traditional diet, show a lower incidence of arteriosclerotic disease than that encountered in Westerners. These observations of a reduced prevalence of cardiovascular disease in the Japanese, Seventh Day Adventist or the Eskimo are not explained by differences in dietary intake of cholesterol. The Japanese may eat greater than 30% of total calories from fat but this is usually fat of fish origin, and the Japanese diet also is high is soy protein. Omega 3 fatty acids in the fat of fish and soy protein both lower cholesterol. Similar principles apply to the Eskimo where the diet is very high in saturated fat intake but the fish or marine mammal origin of the fat is high in omega 3 fatty acids. These essential fatty acids are known to be associated with reduced cardiovascular mortality by mechanisms that include, but are not limited to, lowering blood cholesterol. The Seventh Day Adventist has a vegetarian diet that is not strictly vegan. These individuals are lacto-vegetarians and they may relatively ingest relatively large amounts of cholesterol-containing dairy products, such as milk and cheese. In this religious group, a higher dietary quantity of 79 essential fatty acids of the omega 3 and the omega 6 series of vegetable origin may be protecting against cardiovascular disease. Whilst genetic predisposition may play a role in the lower incidence of cardiovascular disease in some ethnic groups, it is dietary complexities that most likely account for many of the observed differences in disease profile. These dietary differences include well-defined roles for essential fatty acids and soy protein. These nutritionals exert effects on cardiovascular wellness dependent or independent of a cholesterol-lowering ability. Soy protein and essential fatty acid supplementation of the diet are among the most important natural options that have emerged recently as prime candidates for dietary adjustments to promote cardiovascular health. Oxidative Injury and Coronary Artery Disease The protagonists of the free-radical theory of many chronic diseases have within their midst a few radical thinkers. This type of lateral thought is to be commended and not dismissed lightly. Increasing evidence has emerged that accelerated oxidative injury is very important in the pathogenesis of arteriosclerosis. The appeal of these theories is that oxidative damage is amenable to antioxidant therapy which is presumed to have reversible activity. The biochemistry that underlies the pathways of free-radical damage to tissues is highly complex, but the principles of oxidative theories are relatively simple. A free radical is a highly reactive but incomplete molecule that is a natural end result of energy-producing reactions in the body. Some of these free radicals are able to destroy important chemical 80 compounds in the body such as enzymes and proteins. Extensive damage to cells can occur by the generation of a chain of chemical events by free radicals. Several types of damage can be ascribed to free radicals, as summarized in Table 16. Antioxidants are a diverse collection of nutrients that can stop free-radical damage. Antioxidants, such as vitamin A, beta-carotene, vitamin C, vitamin E, selenium, pine bark extract, coenzyme Q-10 and bioflavanoids can all interfere with free radicalgeneration and the effects of free radicals. Damage to cellular membranes which protect all cellular functions Cross-linking of protein or DNA molecules. Genes are comprised of DNA which can result in mutations Lipid peroxidation where fat is attacked resulting in further free radical release Damage to cellular lysosomes which contain damaging enzymes that are released inside cells Free radicals cause lippfuscin (age pigment) deposition in cells Table 16: A summary of the types of damages to cells and molecules that 81 can be produced by free radicals. Oxidized LDL tend to be deposited in arterial vessels and antioxidants assist in mitigating this event. However, antioxidants can also act to prevent the occurrence of thrombosis (blood clots) that superimpose themselves on atheroma in the coronary arteries and cause heart attacks. Modern theories of the causation of atherosclerosis imply that the cholesterol-containing plaques in this disorder start among mutated smooth muscle cells in the middle layers of the arterial wall. It is proposed by some that this mutation of the muscle cell occurs as a result of free-radical injury. There are many potential sources of free radicals to cause this injury, including components of cigarette smoke or environmental pollutants. These explanations form the rationale for the use of vitamin E and selenium in heart disease as discussed in later chapters of this book. Facts About Heart Attack There are more than 7.5 millions survivors of heart attack in the United States at any point in time. It is fortunate that more than two-thirds of these individuals have uncomplicated heart attacks and the majority have a good, overall, long-term prognosis. One of the important issues for these individuals is that they maintain good health. Modern medical practice has concentrated increasingly on the applications of methodology that will maintain good health in survivors of myocardial infarction. There are, however, some important facts to consider. Seventy-five percent of all deaths that occur as a result of coronary 82 artery disease will occur outside a healthcare setting and it would appear that males are at much greater risk than females of death from coronary artery disease in the United States. Recent statistics showed that over the past fifteen years the number of individuals dying from coronary arteriosclerosis has decreased significantly in several western communities. The reasons for this decrease are not entirely understood but seem to be related to the application of strategies to reduce coronary artery disease risk factors and medical advances in the emergency care and follow-up treatment of patients who have a heart attack. Alternative healthcare practitioners have on occasion, inappropriately criticized acute medical interventions for myocardial infarction but it should be recognized that the early use of thrombolytic agents in the management of acute myocardial infarction has resulted in a significant improvement in the hospital death rate of patients who received these drugs. Unfortunately, not all individuals who could benefit from thrombolytic therapy receive it, even in large community hospital settings. This process is rapidly being rectified by medical education. The Scary Environments of Hospitals During my years as a medical student, I was never more nervous in a hospital setting than I felt in a coronary care unit where one is surrounded by “gadgets” and electronic instruments. In my last year of study at medical school, I became aware of a paper that was published in the British medical literature in 1971 by Drs. H.G. Mather, N.G. Pearson, K.L.Q. Reed, and their colleagues. This paper was entitled “Acute Myocardial Iinfarction: Home and Hospital Treatment” and it appeared in the British Medical 83 Journal, Vol 1, Page 334 in 1971. This controlled clinical trial showed that for patients who had undergone an uncomplicated heart attack, the morbidity and mortality was similar regardless of whether the patient was cared for at home or in an intensive care unit. Although the conclusions of this paper have been questioned frequently, it did lead to a suggestion by some that it may be ethically acceptable for some patients to be managed with a heart attack at home. In the face of increasing litigation in the United States and the lawyers concepts of usual and customary medical practice, the idea of having a heart attack cared for at home would not be acceptable in the United States. However, it does raise issues about the setting of a coronary care unit in terms of its ability to precipitate anxiety in some patients and even worsen or exaggerate cardiovascular responses in the presence of cardiovascular compromise. The author is not necessarily supportive of heart attack of being managed at home but feels that there may be a specific group of patients for which this may be most appropriate. Such patients may include the elderly who are stable following an acute myocardial infarction, especially since this group of individuals may react adversely to the tense environment of the coronary care unit. This is particularly the case in elderly individuals who have dementia or any form of cerebral impairment and it is a common medical experiences that these patients do not adjust well to the setting of a coronary care unit. There are elaborate plans that have been presented in the medical literature that provide advice for managing the patient with a myocardial 84 infarction at home. These plans usually focus upon issues such as cardiovascular conditioning, planned medical interventions with drugs and supervised exercise programs. It may be considered inappropriate by some to suggest the unconventional but it may be worth of noting one of the author’s early experiences in clinical practice. The author had the opportunity of being involved in the care of one of the most famous physicians of the twentieth century during when he was an intern (house officer). The distinguished physician in question was quite elderly and had already sustained one heart attack. This famous medical practitioner, when brought to the hospital, refused to accept the assistance of a wheelchair and climbed two flights of stairs to his hospital room. When he was placed in bed and attached to a heart monitor, the first thing he did was disconnect himself from the machine. This kind of disruptive behavior by patients is not encouraged generally in a hospital. However, it was hard under the circumstances to argue with the individual who opted to defy recommended treatment approaches. There is no doubt that modern technology has improved greatly the chances of survival of people with acute cardiovascular illness and things have changed since the early 1970’s. One may pause and consider that there may well be circumstances where high technology interventions do not “out weight” the need for tranquillity and the application of more natural healing processes. What Kinds of Risks Lurk in the CCU? Much of the criticism of the CCU as a sub-optimal healing environment for the cardiac patient are only subjective opinions. In contrast, 85 few definitive studies show material benefit of the CCU in overall reductions in morbidity and mortality. However, it is possible that an individual can be in a CCU and not receive the correct interventions. These dilemmas are examined by assessing some of the problems that may occur in an intensive care setting. First, coronary care units are not generally staffed on a continuing basis by experts. Attending or senior physicians perform short-lived rounds on the coronary care unit and much of the monitoring and treatment decisions are left up to specially training nursing staff. Whilst the quality of such staff in centers of medical excellence are not in question, there are many small community hospitals that have set aside two or three bedded areas in the hospital that are “termed” coronary care units. In this situation, there is some question, on occasion, of the level of education or skill of the nursing staff that are available to staff these units and they may be supported by rather junior medical staff who have powerful interventions available for use at their discretion. There is no argument that there are many effective courses of action available to assist in reversing circumstances that can cause morbidity and mortality in the patient who has had a heart attack, but it must be stressed that these interventions may have inherent risks in their use. Further, medications used in treating conditions such as cardiac arrhythmia have a small window between optimal therapeutic effects and toxicity. Presented differently, powerful and effective interventions often carry powerful and troublesome implications if not applied appropriately. This dialogue is by no means a criticism of the medical profession or the nursing profession but 86 it is a reality of placing high technology interventions, in some circumstances, in hands that may not have adequate experience of their effective use. Expensive and Dangerous Urination in the Acute Care Setting In a coronary care unit there is a common desire to keep an intravenous line open so that emergency administration of anti-arrhythmic drugs can occur. Fluid balance problems can be created by the maintenance of such intravenous lines and this has been shown in some studies to be a particular problem in intensive care unit settings where excessive amounts of salt or other intravenous solutions can be inadvertently delivered. Maintenance of normal fluid intake and output is a very important issue which can be readily overlooked. Some investigations of deaths in elderly people admitted to the hospital have indicated that the gross weight of lungs of such individuals may be higher on average than normal. These studies point to the fact that fluid overload may be responsible, in part, for morbidity and in some cases mortality in patients at special risk, especially the elderly. In the author’s experience, one common observation in body fluid assessments in an intensive care unit setting is the injudicious concomitant use of intravenous saline and diuretics. In simple terms, salt is introduced intravenously into the body and then cleared by the intravenous administration of diuretic drugs (water pills or injections) that cause urinary flow and salt excretion. This process of pouring fluid into one end of the body and removing it at the other cannot be perceived as materially beneficial and, fortunately, whilst it may not be a daily occurrence, it may occur with an alarming frequency. 87 Tubes and Needles There is also a common tendency in a CCU to be quite invasive with monitoring methods to assess cardiac and vascular functions. There has been some criticism of the overuse of intravenous catheters which are used to monitor physiologic functions in the heart. Such catheters are sometimes placed through the blood vessels and located in and around the chambers of the heart so that pressures can be monitored in various parts of the heart. There is no question that such measurements can be useful in selecting appropriate drug therapies to support cardiac function. However, the costeffectiveness of use of these types of monitoring devices remains in question. It is an often overlooked principle in medicine that an investigation is only effective if it changes patient management and contributes materially to the health of the patient. The routine placement of catheters to monitor heart function in intensive care units is perhaps one of the most cost-ineffective practices in the management of patients with acute myocardial events. Furthermore, information received from such monitoring interventions is only useful if it is interpreted by individuals with knowledge of the use of such information to change treatment strategy. The author would be more accepting of a cardiac catheter placed in an intensive care setting where there were staff with special expertise to interpret the results of the monitoring. However, the author may be disinclined in accept the introduction of a monitoring catheter in a small community hospital with staff that may not have the availability, experience 88 or background to utilize information derived from the process of catheterization. The issue become particularly important when one recognizes that the placement of the cardiac catheter and its continuing indwelling presents significant risks to the patient. Line item analyses of hospital bills indicate that monitoring functions performed during coronary care unit activity may contribute to be the “lion’s share” of the cost of the hospital care of a patient in a CCU. Cost-Effective Cardiac Testing and Treatment? Arguments about the appropriateness or effectiveness of cardiac investigations extend to testing that occurs outside an intensive medical care setting. Dr. Robin quotes the example of the exercise radionuclide ventriculogram in its use for screening patients for coronary artery studies as quite problematic. The radionuclide test has been shown in studies to be quite specific in detecting coronary artery disease. Specificity measures the number of patients in a test who are truly positive. This means that a positive result means the presence of disease. However, the specificity of the test was assumed to be great because studies were made of patients at diametrically opposite points on the spectrum of severity of heart disease. This situation occurs in many examples of developments of tests and their assessment of their accuracy, where healthy individuals are chosen with very unhealthy individuals to study the test accuracy. This is an example of a test being highly specific but does not give an indication of its overall diagnostic usefulness. Indeed, some studies of the use of exercise radionuclide ventriculography screening for a coronary artery disease show that the test is not very specific when applied to individuals who have mild 89 or moderate disease. Dr. Robin has pointed out that there are a large number of patients who fall between the extremes of normality and abnormality but such patients are often committed to coronary angiography and occasionally bypass surgery without complete regard to the significance of the results of preoperative testing. The author wishes to stress that problems of test specificity are not only encountered in cardiac investigations. The same problems apply with tests performed in the investigation of many different types of diseases affecting many different organs in the body. Of course, all tests must have some drawbacks and these limitations or disadvantages are overcome with advances in knowledge of the sensitivity and specificity of diagnostic tests or the development of new tests or new technology to enhance the accuracy of diagnosis. It is easy to be smug and wise in retrospect because the nature of medicine is that medical advances will point to the limitations of different interventions that may have been widely applied. This is regarded by many as the price one may pay for progress. This situation is acceptable if medicine learns from its mistakes. A classic example of a useless cardiovascular intervention is the application of internal mammary artery ligation for coronary artery disease. This technique was formerly extensively practiced until it was realized that not only did the surgery not protect patients from heart attacks, but a large number of patients had this unnecessary operation performed with a significant occurrence of complications and occasional death. 90 Escape From the Coronary Care Unit? The first time that most individuals will experience coronary care unit is when they get “wheeled through the door” following a heart attack. The human body has ways of responding and adapting to the external pressures placed upon it. This is the root of stress. Coronary care unit has certain characteristics that place significant demands on a patient who is already stressed as a consequence of a serious illness. Dr. Eugene D. Robin, M.D. highlights the drawback of the coronary care unit as a healing environment in his book entitled “Medical Care Can Be Dangerous to Your Health” (1986). Dr. Robin’s book was based on a reprint of an originally published series of articles that appeared under the title of “Matter of Life and Death”. Dr. Robin points to the specific designation and graphic geographic location of the coronary care unit in a hospital. Coronary care units were first developed in the 1950’s in Western Europe. They were introduced slightly later into hospital practice in the United States. Coronary care units, rather like emergency medical service units, were developed because of recognition that early death following a heart attack may be prevented by certain interventions. Extensions of the use of coronary care units involved the ability to continuously monitor an individual at risk following a heart attack for extended periods of time so that early medical interventions could improve prognosis and recovery of heart attack victims. Some of the strongest arguments against coronary care unit is that it produces an ideal environment where over-treatment or over-investigation of a patient may occur. The coronary care unit is one hospital location that has been associated with a 91 poorly described but common syndrome which is labeled by the author as “grandfather came into hospital for a few tests and died syndrome”. Several studies have indicated that most of the abnormal rhythms that are precipitated by acute myocardial infarction are benign and subject to self-correction. However, this finding is diminished by recent research that shows that specific types of cardiac arrhythmia with serious important are amenable to correction with appropriate drug selection. The occurrence of life threatening cardiac arrhythmias may be unpredictable. Some of the most conflicting data about the benefits, or lack thereof, of coronary care units in cardiovascular treatment come from studies that are quite contradictory in their outcome. Some early studies of mortality and effectiveness of coronary care units were performed in England in the 1960’s. Such studies included triage of patients to a coronary care unit or to ordinary wards of the hospital and in one study patients were triaged to stay at home. It is striking that in this particular study discussed by Dr. Robin, in his book, the patients that were triaged to stay at home had the lowest death rates. A reason proposed for this observation is that over-diagnosis and over-treatment with its attendant risks is more likely in a coronary care unit. Perhaps more important is the stress produced by the environment of the coronary care unit. Dr. Robin points out that few, if any, studies have satisfactorily answered questions concerning the benefit of placement of patients with acute myocardial infarction that have been placed in a coronary care unit. The author can recall one vivid description of a patient who was 92 removed from the coronary care unit following a period of stability and was then returned to the setting after minor complications had developed whilst he was in a general hospital ward. This patient’s fear of re-entry into the coronary care unit was striking. He indicated, somewhat jokingly, that he had “seen the flapping of the wings of the angel of death” as he entered the high technology environment of the coronary care unit. It is clear that physicians have perceptions, sometime impervious to reason, that patients should be placed in an intensive medical care setting simply because they believe that it is the optimal environment for caring for certain disorders, without really knowing if the environment is as optimal as they think! Dr. Robin and others have indicated that an individual who has a suspicion of having had a myocardial infarction should attempt to limit the amount of time that he or she may spend in a coronary care unit. The argument has been progressed further by some that recommend this option even in the presence of definite evidence of a heart attack. Whilst it is true that the overall cost-effectiveness and risk benefit of placement in the coronary care unit remains the subject of medical debate, most healthcare givers believe that patients particularly at risk are those that are severely ill are best placed in an environment where there is a comprehensive range of interventions available that could be lifesaving. There may be considerable benefit in avoiding some of the iatrogenic disorders that emanate from some technological interventions. Some physicians, usually the most mature, subscribe to a notion that intensive medical care may create many medical complications for a group of patients who would be better managed in more tranquil sites in a hospital 93 environment. Dr. Robin summarizes some of his conclusions about intensive care units and coronary care units in the following manner: “To summarize, the high-risk groups needlessly in the ICU are the dying, who suffer a loss of dignity and excess discomfort as a result of treatment, and the not-socritically ill, who are exposed to the extra risks of ICU care with little possibility of benefit”. The author does not reject the judicious use of the coronary care unit and recognizes that more technological advances will occur that can be applied in this setting to reduce the mortality following a heart attack. Returning to Normal Life Following a Heart Attack It is recognized that most people who are discharged from the hospital following a heart attack can be anticipated to resume normal life activities with some minor restrictions. Most restrictions are placed upon an individual over a period of one to six months of convalescence following the cardiac event. There is an unfortunate but small group of patients who remain cardiac cripples following a myocardial infarction. The important features of a management plan for a patient who has had a heart attack include detailed education of the patient and his or her family in cardiovascular health. This education permits the change of lifestyle that will promote and maintain health and it assists in the engagement of the person in effective processes of rehabilitation. The importance of education of patients in cardiovascular health has been grossly underestimated. It is hoped that several aspects of this book 94 will assist individuals in this education process and help them in their quest for improved cardiovascular well-being. There are a number of special healthcare facilities with staffs who are skilled in cardiac rehabilitation. The patient must assume the responsibility of understanding the nature of their disease, its presentation and the management strategies that are required for moving forward. Of great importance is education in the need for cardiac medication and its advantages and limitations. Table 17 summarizes some important objectives of an optimal plan of care for individuals who have survived a myocardial infarction. It is recognized that patients during the immediate recovery phase from a heart attack may not be receptive to educational material but the educational INSERT TABLE 17 (SEE REFERENCE ABOVE) 95 process should be established prior to hospital discharge. However, the process must continue in the early convalescent phase. Specific counseling may be required and management plans for the survivor of a heart attack should be tailored to the individual patient. The patient must be knowledgeable about any further medical appointments or specific testing that may be required to assess prognosis, further change of treatment or other medical intervention. One important issue for the convalescent patient is to construct an ideal activity schedule. There is great variation in recommendations for activity in different age groups and factors such as age, co-existing illness, residual cardiac disability and other matters may determine recommendations for activity. Overall, in the first month following a heart attack the average patient is expected to take regular exercise in the form of walking for five minutes or so on a level surface on a daily basis. It is advisable for the convalescing patient who has had a heart attack to occupy their time with enjoyable activity that does not involve intensive physical exertion. In the early phase following a heart attack many people feel lethargic and sometimes quite weak. They can tire easy and they should be encouraged to take frequent rest periods within the first week. In the second week of convalescence, a gradual increase in regular exercise is required with an average recommendation that an individual can walk for five to ten minutes twice a day with some relaxation of activities around the home. By weeks three and four following a heart attack, average people are encouraged to walk for ten or fifteen minutes two or three times a day. Thereafter, gradual increase in physical activity is recommended. 96 There are some fairly complicated ways of calculating energy output of exercise that permits a fairly specific prescription of activity for the person involved in cardiac rehabilitation. In this regard, there are tables that describe the energy requirements of certain activities that can be expressed as MET’s. One unit of MET is defined as the resting energy requirement. Certain activities, be them light to moderate or heavy, have MET’s up to a factor of nine MET’s. Examples of very light activity requiring less than three MET’s include: washing, dressing or activity performed while sitting, such as writing. In contrast, very heavy activity with nine MET’s includes: carrying loads upstairs, climbing stairs quickly and using a spade to dig for ten minutes or more. Sex After Heart Attacks There are some very specific social events that are important to consider because they represent issues that may control feelings of wellbeing. Sexual activity is an important event to consider for many people following a myocardial infarction but it is usually appropriate for most individuals to resume sexual intercourse about one month following a heart attack. There are studies on the number of MET’s that occur during foreplay and active sexual intercourse but these kinds of calculations may be slightly “off-putting”. There is a popular notion that people can drop dead during sexual intercourse. Fortunately, this common fear is not justified. Studies of the influence of sexual intercourse on sudden cardiac death seem to imply that less than one percent of all such deaths occur during sexual intercourse and 97 when they do occur they most often occur as a consequence of extra-martial affairs in which the male partner is usually a lot older than the female partner. A light note could be applied to a serious circumstance by saying that “sudden death during sexual intercourse is often a wage of sin”. Do Not Forget the Mind A very overlooked area in cardiac rehabilitation is consideration of psychological well-being. A myocardial infarction can have a dramatic effect on the confidence and mood of a young person who is suddenly stricken with a serious illness in circumstances where they may have had no preceding symptoms of note. Anxiety and depression is quite common following a heart attack. It is particularly troublesome during the first few weeks following the event where it may interfere with the important early process of cardiac rehabilitation. Some physicians resort to the prescription of tranquilizing drugs but some of these drugs may have adverse cardiovascular effect and are probably best avoided if anxiety and depression can be managed by counseling and supporting psychotherapy. Coronary care units are noticeably devoid of counselors and psychologists. This is a major oversight in cardiovascular care. It is very common for individuals to have a morbid fear of physical activity following their heart attack that is quite inappropriate. Much patience is required on the part of a healthcare giver and family members to reassure an individual that early, careful and steadily increasing physical activity is to be encouraged. There is much to be said for exercise in the promotion of well-being and no more is this more apparent than if it is used appropriately in the patient who is undergoing cardiac rehabilitation. 98 The author has one very important concern to express about the lack of psychological or psychiatric counseling that occurs following myocardial infarction. Many cardiac rehabilitation programs concentrate on exercise and conventional medical interventions as the mainstay of cardiac rehabilitation with the recognition that this difficult period in any individual’s life is very amenable to appropriate counseling. Unfortunately, many healthcare plans have disqualified the use of psychiatric and psychological counseling in disease rehabilitation in general. This is one of the biggest inequities of modern managed health care. We are quite aware of the influence of personality type on cardiovascular well-being and although it is a later stage of intervention, the identification of type A behavior or so called “coronary-prone behavior” in the convalescent individual following a heart attack is a very important process. Individuals who are left unencumbered to proceed with their concerns of time urgency and early return to work are those who may well find themselves with the least favorable outcome following their heart attack. Contemporary, well-controlled, scientific studies have shown that coronary-prone behavior can be modified by appropriate counseling strategies and the application of these counseling strategies has been shown unequivocally to result in significant reductions in cardiovascular mortality and morbidity. Dr. M. Friedman has highlighted the importance of the diagnosis and treatment of type A behavior in the person who is convalescing from a heart attack. Healthcare givers are advised to engage in 99 the application of conventional, alternative or natural options to promote cardiovascular wellness in the absence of considering emotional well-being which is a principle determinant of cardiovascular wellness. The Benefits of Bypass Surgery: Unresolved Controversies Opinion remains divided on the benefits of cardiac bypass surgery to effectively treat angina, prevent further cardiac ischemic episodes and enhance longevity. The technique of coronary artery bypass grafting is based on simple principles. It is known that blockage of coronary arteries results in failure of optimal blood supply to the heart muscle. The identification of occlusions or obstructions of portions of the arteries that supply the heart muscle (coronary arteries) can result in surgical procedures where these blockages or narrowings (stenoses) can be bypassed with grafts. Blood vessel grafts are often taken from peripheral veins in the body and used to bypass blockages in the coronary arteries. The procedure of bypass grafting became quite popular in the early 1960’s and it has gained increasing popularity in recent times. In fact, coronary artery bypass surgery is one of the most common surgical operations performed on a daily basis in the United States. The use of this surgery has steadily escalated to the point of an annual cost of several billion dollars per year. Bypass surgery has been heavily criticized in terms of its cost-effectiveness. Furthermore, there have been major concerns of the necessity of the procedure on many patients who have undergone the procedure. Conventional medical opinion, supported by the author, believes that 100 patients with recalcitrant angina pectoris who still have reasonable muscle function in the left ventricle of the heart are optimal candidates for coronary arteriography and coronary artery bypass grafting. Coronary arteriography involves the introduction of radio-opaque dyes into the coronary arteries which can then result in imaging studies with x-rays in sequence (or video format) that can locate blockages in the coronary circulation. Coronary arteriography is very useful in locating blockages of coronary artery, thereby defining in individuals that are most amenable to the benefit of coronary artery bypass surgery. Narrowing (stenosis) of the left main coronary artery or other specific types of blockages are believed to form a circumstance where bypass surgery can increase an individual’s survival and materially reduce morbidity from cardiac disease. There are several variations on cardiac bypass surgery. Some interventions make use of veins grafts, whereas others involve the implantation of adjacent arteries into the branches of the coronary circulation. The application of specific types of surgery and the decision to undertake surgery for coronary artery disease are highly specialized medical interventions. Several of the technical considerations that are important to reach a decision concerning bypass surgery or attempts at revascularization of the heart are shown in Table X. For more detailed further discussions about indications for coronary artery surgery, the reader is referred to standard classical textbooks on cardiovascular therapeutics. Despite the common occurrence of cardiac surgery or interventions to revascularize the heart, the indications for such procedures remain somewhat 101 debatable. After a recognition of the importance of assessing the costeffectiveness and potential health benefits of bypass surgery or coronary angioplasty, several organizations have produced working documents on their interpretation of the risk benefits of these types of interventions for cardiovascular disease. Coronary angioplasty represents one of several alternatives to improve blood supply to the heart. Angioplasty is sometimes referred to as percutaneous transluminal coronary angioplasty. It has been popularly termed “balloon angioplasty”, which describes the technique. A catheter (a thin tube) with a tiny inflatable balloon at its tip can be passed retrogradely (backwards) into vessels and lodged in locations such as the coronary artery. A well defined blockage can be located by x-rays. When the uninflated balloon is placed into the site of narrowing, the balloon can be inflated and the area of the blockage dilated. This technique can be controlled by watching the progression of the catheter by x-ray screening. Coronary angioplasty has replaced coronary artery bypass grafting in some patients. Influential healthcare organizations, such as the World Health Organization and the American Heart Association, have developed guidelines and information resources on the use of coronary angioplasty. The WHO commissioned a task force to look at recommendations for coronary angioplasty and concluded that this technique may be useful in the treatment of chronic stable angina that is not responsive to medical therapy. This technique has also been applied successfully to the treatment of unstable angina with the primary objective of overcoming blockages in coronary arteries that cause myocardial ischemia. This procedure is 102 considered by many to be contraindicated if the individual has no anginal chest pain or only mild symptoms in the absence of any evidence of ischemia (lack of blood supply) to the myocardium (heart muscle). A detailed discussion of the advantages or disadvantages of coronary artery bypass surgery and coronary angioplasty are beyond the remit of this book. However, these procedures are performed so frequently that the main implications of their use are addressed in some detail by the author. An understanding of some of the development of coronary artery bypass surgery is readily apparent when one considers all techniques that led up to the development of current coronary artery surgery. Dr. Elmer M. Cranton, M.D., and his co-author Arlene Brecher have produced an interesting analyses of the development of bypass surgery in their book entitled “Bypassing Bypass” (1984). These authors point out the misdirected enthusiasm that the medical profession had for ligating (occluding) the internal mammary artery as a means permitting blood to be diverted to the coronary circulation. This procedure of internal mammary artery ligation was popular in the 1950’s and it resulted in early claims that 9 out of 10 patients who had undergone this procedure may have experienced total relief of anginal pain or at least dramatic symptom improvement. Controlled clinical observations of the benefit of internal mammary artery legation showed that much of the effect of this operation may have been a placebo effect. In interesting surgical experiments where sham surgery was performed, it was shown in some studies that individuals undergoing sham surgery in these studies may have had, on occasion, a 103 better outcome than those who had undergone the legation surgery itself! Following the increasing popularity of cardiac bypass grafting in the 1970’s, several articles appeared in the medical literature in the early 1980’s indicating that bypass surgery resulted in beneficial symptom outcome in at least three-quarter of patients undergoing this surgery. However, several problems did emerge, not the least of which deaths from surgery were reported in a range of one to forty in 100 people who underwent the surgery. Obviously the chance of dying from this type of surgery is related strongly to the operative risk factors and the general health of the patient undergoing the surgery, but the “talent” of the surgeon performing the operation may have had significant influence on recorded mortality from the surgery. Anyone considering cardiac bypass surgery is advised to elect to have the operation performed at a center of excellence. The reader should note that statistics on mortality and morbidity from surgery can sometimes be related to the criteria that were used to select the individuals who undergo the surgery. In some studies, people with less severe forms of heart disease who are younger and in more robust health will tend to have a better outcome than those with more severe disease. Furthermore, there have been some frightening allegations that there have been a substantial number of cardiac bypass operations performed that are unnecessary. The author has a strong opinion that coronary bypass surgery or coronary angioplasty, where appropriately indicated, has many significant benefits to offer patients with coronary artery disease. Healthcare givers 104 who reject coronary artery surgery or angioplasty as unnecessary interventions do not fully understand contemporary literature that has shown increasing evidence that these interventions are effective when used appropriately. These considerations justify a global analysis of some of the outcomes of bypass grafting for coronary artery disease. What Happens to Patients Undergoing Bypass Surgery? If coronary bypass surgery is performed with skill and the patients undergoing the surgery have reasonable general health and good pumping function left in the ventricles of the heart, then about one or two in 100 patients are expected to die from the surgery itself. Unfortunately, up to one in 20 patients undergoing the surgery may develop some evidence of ischemic damage to the heart during the period of the operation. It is generally recognized that poor outcomes are usually to be expected in more elderly people undergoing this surgery and in those people who have widespread disease within the coronary arteries. A very unfortunate potential complication of coronary bypass surgery is the development of a stroke which is much more common in elderly patients undergoing this procedure. The beneficial outcome of coronary artery surgery is that about twothirds of appropriately selected individuals who undergo bypass surgery have relief of angina pectoris and about one-fifth will have considerable relief in anginal pain. Overall, about three-quarters of all people undergoing this form of cardiac surgery can expect to have improvements in their ability to exercise following the surgery. The ability of cardiac bypass surgery to prolong life has been readily apparent in some groups of patients and the 105 ability of this surgery to rehabilitate individuals in their working environment has been well documented. The performance of coronary bypass surgery in elderly people has become less controversial in recent times. Both bypass and angioplasty are an increasingly common interventions in patients older than 70 years. However, the benefits of intervention in older patients is not quite as clear as they are in the younger age groups. Avoiding Revascularization (Bypass and Angioplasty) Procedures? The first reaction that any patient may have when faced with the option of elective surgery for any condition is to look for other options. On the one hand, there have been misconceptions that bypass surgery is a panacea treatment (or even cure) for the person with coronary artery disease, whereas, on the other hand, opinions have been expressed that bypass surgery quite unnecessary and of questionable benefit. Neither of these extreme viewpoints are true and, of course, the situation is not so simple. Many people have become increasingly aware of the possible use of chelation therapy in the treatment of coronary artery disease. However, the “jury remains out” concerning a decision on its real benefits. Conventional medical opinion has failed to acknowledge any real measurable benefits from chelation therapy and few, if any, controlled clinical studies have demonstrated clear responsiveness of angina or related cardiovascular symptoms to chelation therapy. Some physicians have described chelation therapy as injurious, second-rate, expensive and lacking in any scientific basis. The author believes that sufficient evidence does not exist to recommend chelation therapy for the treatment of atherosclerosis or 106 coronary artery disease, but anecdotal studies and promising reports make this technique worthy of much further study. Zealots who push chelation therapy with overrated promises and “knockers” who reject chelation therapy out of hand for cardiovascular disease should not be encouraged to continue their bantering. Chelation therapy is certainly worthy of much further exploration as a possible treatment option for coronary heart disease. It has some rational basis for its potential use but its safety and efficacy require confirmation. There are a subgroup of individuals who may benefit from cardiac surgery but who reject the intervention. The patient is the ultimate decision maker but there may be a reluctance of a physician to offer an alternative if his or her opinion for surgery has been rejected. What should this individual do? The obvious advice is to request that the individual who rejects appropriately indicated surgery reconsider their decision. The author would advise that the individual at least seek a second opinion on the decision for cardiac surgery. Other treatments are emerging, such as laser surgery, but the safety and efficacy of these newer modalities has not been established. The remaining option for the self-reliant individual who rejects surgery is to engage in rigorous lifestyle adjustments and pharmacological and or nutritional approaches to reversing coronary artery disease. Whilst there are some reports of the success of these non-invasive approaches to coronary artery disease, the individual who stands to benefit from bypass surgery or angioplasty should take the “leap” after understanding the risks and benefits. 107 A Word About Chelation Therapy One of the most widespread techniques of chelation therapy is the intravenous administration of a synthetic amino acid known as ethylenediamine-tetra-acetic acid (EDTA). This amino acid is capable of reacting with a variety of elements or compounds to produce complexes. Chelation therapists propose that certain toxic metals can be removed from the circulation to improve some metabolic functions in the body. Some people undergoing chelation therapy are “bamboozled” into believing that they are undergoing some type of “roto-rooter” therapy, rather like the process of a plumber unblocking a drain. Of course, this is a ridiculous notion and the idea that there is some way of applying therapy in a way that drain opener chemicals are applied to drain pipes is patent nonsense. Chelation therapy does tend to link itself somewhat with oxidant theories of the causation of cardiovascular disease and many chelation therapy regimes include the administration of antioxidants, such a vitamins and botanicals by oral or systemic (intravenous) administration. Chelation therapy has some clear uses in medicine, such as the treatment of heavy metal toxicity but its role in the treatment of cardiovascular disease, in the author’s opinion, is not established and must still be considered experimental at the time of writing. At the risk of loosing some valued friends who practice nutritionally oriented medicine, the author is rejecting use of chelation therapy for cardiovascular disease as unproven at present. Doctor Watchers: A Necessary Evil? There is an emergence of so called “quality of care” issues in medical 108 practice, especially in managed care settings. Quality of care has been extended conveniently to include healthcare costs. Some discussions of quality of care make an inappropriate assumption that many physicians are engaged knowingly in the inappropriate application of unnecessary diagnostic testing or treatments. This cynical opinion is encouraged by some managed care organizations and it is increasingly apparent in organizations that regulate the practice of medicine in Western communities. Of major concern is the suggestion that licensing authorities are immediately classifying lateral thinking doctors who may engage in nutritional or alternative healthcare practice maybe a special target for the process of license suspension or revocation. The ethics of medical practice and the operation of physician review organizations and regulatory bureaus are outside the remit of this discussion. However, it is apparent that quality of care is taken to be synonymous in many circumstances with cost of care and recently there are ever increasing numbers of examples of disciplinary actions against physicians for medical practices that are open to question or debate. The author does not deny the need for systems that police professional activity but the practice of making healthcare givers paranoid to the point that they cannot exercise reasonable discretion on offering intensive investigation or treatment options that do not conform to some prearranged recipe of medical care is quite outrageous. This situation could result in interfering with medical progress and reducing standards of care to levels of mediocrity. This circumstance is counterproductive to the original intent of physician review procedures that 109 were designed, quite appropriately, to improve quality and standards of care amongst healthcare giving professions. One of the biggest disincentives to research and empiric improvements in diagnostic intervention strategies and treatment strategies is the bureaucrat who wants to question an intervention because they have some notion that there is a standard algorithm for the investigation of a disease state. It is very dangerous when bureaucrats without medical training have sweeping powers in the regulation of the medical profession. The same argument could be made about the practice of law but it would appear that there has been an attempt to systematically undermine the medical profession in several Western countries. Let the practicing physician be aware of the risk but let the patient also be aware that many healthcare givers act in good faith and the healthcare options that they are able provide to their clients are governed often by what third party reimbursement schemes will pay for. At time of writing, only a few insurance companies would even consider reimbursing physicians or healthcare givers for many natural treatment options that are known to be efficacious. Cost containment in medicine is a very important social and political initiative but if not addressed correctly, it will have a very negative effect on medical advances and the well-being of patients and their healthcare givers. Physicians who have fought “city hall” or questioned regulatory organizations that deal with “quality of care” issues usually come to a “sticky end” one way or another. Sudden Cardiac Death 110 This section is not written in an attempt to frighten individuals, but it should be recognized that sudden death is relatively common presentation of coronary artery disease. Some individuals consider sudden cardiac death as a disease entity alone. It is apparent that the risk factors of sudden cardiac death are almost identical to those that determine the causation of coronary artery disease. Risk factors for sudden death include smoking, high blood pressure and abnormal blood lipids. The incidence of sudden death increases dramatically with age and male gender exerts a major effect on prevalence of sudden death. Females do have a risk of sudden death, but their risk of this catastrophic event lags behind that of men by at least two or three decades. Individuals with a particularly high risk of sudden cardiac death are those who have already survived a cardiac arrest. In addition, anyone who has had a heart attack has a increased incidence of sudden death. Following a heart attack, the incidence of sudden death increases at a rate of about 10% per year. Aside from an assessment of known risk factors of sudden cardiac death, it is useful to attempt to characterize further the features of an individual who may be most likely to suffer this fate. This may assist in prevention. Sudden cardiac death is most common between the ages of 55 and 60 years and it predominantly effects males. The most common reason for cardiac arrest in this situation is ventricular fibrillation where the heart does not beat effectively. Significant coronary artery disease is present in at least 80% of the victims of sudden cardiac death and the event most frequently occurs without warning while the individual is outside a healthcare setting. 111 The concepts of silent heart disease and risks of impending sudden death have prompted several organization to examine efforts of improving survival in this patient group. The American Heart Association has introduced a concept called “the chain of survival”. This concept presents strategies for reducing mortality in patients at risk for sudden cardiac death or those who have sudden cardiac arrest. The approach of the American heart Association assumes that people can survive sudden cardiac arrest if certain sequences of events are in place. The first event in the “chain of survival” is that people should be aware of early warning signs of sudden cardiac death. The early access link in the “chain of survival” involves instructions about contacting emergency services which can provide personnel that can engage in effective cardiopulmonary resuscitation (CPR). One very important issue is the early application of this type of resuscitation and the individual who has suffered an episode of cardiac arrest is with a greater chance of survival if there is an individual at hand who understands the technique of CPR. The effective, early application of CPR by healthcare professionals or personnel who have training in CPR is underestimated in terms of its importance in reducing cardiac death. Survival rates from cardiac arrest are often doubled if there are bystanders available who can offer emergency CPR. For early CPR to be effective, it should be applied within a couple of minutes of the cardiac arrest, preferably in less than 4 minutes. The author believes that this is a very important strategy for reducing cardiac deaths and recommends that family members of individuals with significant coronary 112 artery disease should make it their business to learn the basis principles of CPR. A number of scientific studies have indicated that lay persons do not retains the skills for performing CPR once they have been learned and it is important for the spouse or close family member of a cardiac patient to continue revise their skills for performing CPR. Learning CPR can be a great gift of love to an individual who is at risk of sudden cardiac death. There are several CPR training programs in the community. The American Heart Association produces educational material and classes in the learning of basic CPR. These are highly recommended. CPR: A Practical Skill Cardiopulmonary resuscitation must not be practiced on healthy people. However, it is not possible to effectively teach CPR without some form of practical demonstration, but the basic maneuvers of CPR are worthy of some review. It is best to remember the approach to CPR by remembering the first three letters of the alphabet, A, B and C. A stands for airway. The person should be laid on a firm surface and the airway should be cleared so that the chance of normal resumption of breathing can occur. B stands for breathing. Sometimes simple stimulation of a person who has undergone cardiac arrest may be enough to precipitate restoration of cardiac function and respiration. The initial event in CPR is usually to strike the sternum (breast bone) with moderate force and to apply mouth-to-mouth or mouth-to-nose assisted breathing. The final component of the initial stages of CPR involves the establishment of some form of circulation in the individual by the intermittent application of mouth-to-mouth or mouth-to-nose breathing with 113 repetitive pressure on the front of the chest wall to apply a pumping force to the heart. Therefore, the principles of CPR can be reviewed quite simply as A establishment of an airway; B - establishment of breathing or respiration; and C - establishment of some form of circulatory support. The author cautions people against practicing these maneuvers on a live subject because CPR even when applied appropriately by expert healthcare professionals can result in significant injuries. Education about CPR can only come from practical demonstration and not merely from reading about the process. The reader should be encouraged that learning the principles of CPR is quite an easy process and it is very worthwhile. It should be recognized that the best treatment for cardiac arrest is administered by well trained teams of emergency medical staff. Advanced training in CPR is a common feature of modern day hospital practice and most doctors and nurses have compulsory training and re-certification requirements to maintain their skills in these valuable lifesaving procedures. The Dangers of Diabetes Mellitus The individual with maturity onset diabetes is often overweight and invariably has abnormal blood lipids. Weight loss alone can ameliorate diabetes mellitus and strict lifestyle changes with diet can be adequate and complete treatment for some people with maturity onset diabetes. In the past decade much evidence has emerged that the careful control of high blood glucose levels in diabetes will result in the reduction of diseases of blood vessels which commonly effect the eyes and kidneys. This disorder of blood 114 vessels in diabetes mellitus is due to abnormalities of the small blood vessels (microvasculature) and its causes retinopathy and diseases of the glomeurlus of the kidneys. On the other hand, high levels of circulating insulin may tend to cause atheroma in blood vessels. The benefit of precise control of blood glucose in the reduction of arteriosclerosis effecting large arterial vessels, such as the aorta, is not clear. The diabetic individual usually has multiple risk factors, including abnormalities of blood lipids and high blood pressure. Aggressive control of all risk factors is very important in the management of diabetes mellitus because patients are at special risk of cardiovascular disease. Exercise and Coronary Risks Exercise has measurable benefit in diabetes mellitus. It is well documented that individuals who have a sedentary lifestyle have a predisposition to coronary artery disease. This is related to the fact that people who do not engage in physical activity tend to be over-weight, have high blood pressure, develop diabetes mellitus more often and have abnormal blood lipids more frequently. Thus, enhancement of physical activity has been demonstrated in some studies to reduce the risk of coronary artery disease and this reduction of risk is readily demonstrable. Exercise programs that can be undertaken in patients who have survived a heart attack have been shown to improve prognosis. The more, physical training techniques in subjects with established coronary artery disease can be shown to reduce the incidence of death due to coronary artery disease by about 20%. 115 It seems likely that physical activity will exert a beneficial effect on all risk factors for coronary artery disease, including obesity, high blood pressure and abnormal blood lipids. However, it is surprising that relatively few controlled clinical studies have been performed in these areas of intervention. Circumstance contrasts with the thousands of clinical trials that have been undertaken to show the efficacy of lipid-lowering drugs. An Aspirin a Day Keeps the Heart Attack Away Aspirin has emerged as a very important prophylactic agent in coronary artery disease. Aspirin and other non-steroidal anti-inflammatory drugs interfere with platelet function and can prevent thrombosis. This effect on platelet function is observed with aspirin in a daily dose of 80 mg/day which has resulted in a recommendation for the use of “baby aspirin” for the prevention of coronary events. Several studies have shown that a daily dose of aspirin of between 160 and 325 mg can result in a reduction in the rate of heart attack in people with or without a previous history of heart attack. Aspirin is not without side effects and even in small doses it can cause gastrointestinal irritation and occasionally bleeding from the gastrointestinal tract. The evidence that aspirin can result in a lower death rate from coronary artery disease is not clear in all studies and there are some indications that aspirin ingestion may contribute to stroke due to hemorrhage into the brain. However, this observed increase in stroke rate appears to be quite small. Overall, low dose aspirin appears to be very beneficial in most males over the age of 50 years who have coronary artery disease. Some 116 healthcare givers have even extended the recommendation to take aspirin if an individual over the age of 50 has multiple cardiovascular risk factors. Aspirin is to be avoided by persons with bleeding tendencies or those who have known gastrointestinal disease that may bleed as a consequence of the administration of aspirin. Radical Arguments From Free-Radical Proponents Support for the free-radical theory of the causation of coronary artery disease has led to the increasing rejection of cholesterol-lowering drugs and other cardiac interventions by some healthcare givers. Some supporters of oxidative theories have stressed the inability of cholesterol-lowering drugs, coronary angioplasty and bypass surgery to reverse coronary artery disease. Such individuals have moved more towards dietary interventions with antioxidant use in a program that is often holistic in its approach. Free-radical hypothesizers have ventured into chelation therapy with agents such as EDTA (ethylene diamine tetracetic acid) and the intravenous administration of other chelating compounds or key minerals and/or amino acids. It has been proposed that these chelation programs may reverse arteriosclerosis and assist in normalizing the cell membranes of cardiac muscle. However, controlled clinical observations of this technique are still relatively few and reports of benefit remain anecdotal. Reports of striking improvements in coronary artery disease using chelation therapy have appeared but the jury remains out on the clear-cut benefit of this therapeutic option. Smoker’s Heart Attack 117 Smoking is associated with an increased prevalence of coronary artery disease but emerges as a very significant risk factor in the precipitation of acute heart attack (myocardial infarction). It has been argued, inappropriately, by some individuals that smoking cessation in later life is not associated with much benefit. Recent studies have shown this not to be the case. Clinical studies show that people who quite smoking in adult life have a measurable reduction in the risk of coronary artery disease after about two years. Furthermore, smoking cessation in individuals who are in mid life results in an overall improvement in life expectancy of at least two years. There is much benefit to be obtained by stopping smoking but conventional medical interventions for smoking cessation are notoriously unsuccessful. There have been questions about the cost-effectiveness of medical treatment for smoking cessation because many treatments are effective only in between one in twenty and one in five individuals. However, the benefits that accrue from the discontinuation of cigarette smoking are so significant that medical interventions for smoking cessation are perceived as cost-effective despite their low success rate. Risk Factors for Hypertension The concept of the “bouquet of barbed wire” presents itself within the single risk factor of high blood pressure in a similar manner to risks that cause cardiovascular disease. The causes of sustained raises in blood pressure overlap with many of the risk factors of cardiovascular disease. Individuals who are obese, do not exercise, consume excessive salt in their diet and drink alcohol excessively are likely to develop sustained 118 hypertension. Genetic tendencies seem to play a major role in the causation of hypertension and the African American or individuals with a strong family history of hypertension are of particular risk. The evidence that such factors promote sustained hypertension is clear in scientific studies that have shown that weight loss, exercise and reductions in salt or alcohol intake can all prevent the development of high blood pressure. There are other lifestyle changes which may influence the development or presence of hypertension. Conventional medical accounts may often question the role of stress or poor nutrition in the causation of hypertension. These accounts tend to classify these factors as inconsistent in their effect or of doubtful benefit when reversed. However, the author believes strongly that stress reduction and nutritional interventions may benefit both the prevention and treatment of high blood pressure. These important potential interventions include stress reduction and increased dietary intake of potassium, calcium, magnesium, dietary fiber, fish oil and perhaps selected dietary supplements. The Silent Killer is Often Mild Almost two million adults in North America will develop high blood pressure on an annual basis and hypertension increases with age. There have been problems of definition of hypertension because a single or isolated blood pressure recording cannot be taken as evidence of high blood pressure. It is generally accepted that high blood pressure exists if there is a recording of a systolic blood pressure of greater than 140 millimeters of mercury (mmHg) or a diastolic blood pressure of greater than 90 mmHg. However, blood pressure does change in response to various stimuli and surges of increase in blood pressure are normal during physical activity. 119 An important issue is that before hypertension is diagnosed the elevation of blood pressure should be demonstrated to be sustained. It is well recognized that an individual who may be anxious during clinical examination may have an initial elevation of the blood pressure on a first recording. Therefore, many clinicians have a patient at rest in a lying position prior to measurements of blood pressure. To be certain that high blood pressure is present it is advisable to take blood pressure on more than one occasion. It is possible for the systolic blood pressure to be elevated alone and this is termed isolated systolic hypertension. There is a risk to health with isolated systolic hypertension but it seems to be less than the cardiovascular risks associated with occurrences of both systolic and diastolic elevations of blood pressure. Table 18 lists groups of individuals in whom elevated blood pressure is more common. Several large organizations have provided statistics on the incidence and prevalence of high blood pressure. Some of this information is summarized in Table 19. It is apparent that of all subjects with high blood pressure, at least three-quarters have what might be considered mild hypertension (stage 1 hypertension). Hypertension is generally accepted to be blood pressure readings with a systolic measurement of 140 to 159 mmHg together diastolic blood pressure readings of 90 to 99 mmHg. These simple statistics are important because they indicate that the vast majority of treatment decisions that are made by healthcare givers involve the treatment of mild hypertension. In simple terms, the chances are that an individual 120 with newly-diagnosed high blood pressure has often got mild disease. It is important to note that it is mild disease that most amenable to correction by natural measures or lifestyle changes. Males Below the Age of 55 Years: - African Americans (all age groups) Males Over the Age of 55 Years: - Individuals from lower socioeconomic groups. Table 18: Systolic and Diastolic elevations of blood pressure are more common in the groups listed above. INSERT TABLE 19: (SEE REFERENCE PREVIOUS PAGE???) 121 The author believes that overall, there has been a tendency in medical practice to use drug therapy to treat mild hypertension at the expense of considering more natural options to control blood pressure. It is recognized that about 60 million Americans may have hypertension of variable severity. As a consequence, many healthcare agencies and government institutions have promoted programs for screening for high blood pressure and political initiatives have proposed projects such as the National High Blood Pressure Education Program. This widespread level of interest has resulted in improvements in the management of hypertension but it may have also resulted in the widespread use of drug therapy to lower blood pressure when more natural methods of blood pressure reduction may have been equally effective. Good Trends Hide Bad Situations Evidence has emerged that the overall prevalence of high blood pressure in adults has been reduced in the past ten years. This is attributed largely to public awareness and appropriate lifestyle modification. This reduction in blood pressure cannot be solely attributed to any specific medical advances and it is certainly not a direct consequence of the prescription of blood pressure lowering medication. Surveys have shown that there is an increasing level of awareness about the consequences of high blood pressure and people are becoming increasingly educated in methods to lower blood pressure. The level of awareness of high blood pressure has been estimated over the past twenty years to have improved from a level of about 50% to a level of about 80%. However, coincidental with this increasing level of awareness and resulting 122 increasing control on blood pressure in an enormous increase in the number of individuals receiving drug treatment for blood pressure. People on treatment for blood pressure have increased over the past 20 years from about 35% to about 75%. The author is not rejecting the opinion that many of these people with high blood pressure require medical treatment but he does question whether or not there exists among these people a large group of individuals who are receiving drug therapy for hypertension who could have managed their disease by more natural options. The application of natural options could potentially obviate the need for the prescription of blood pressure medicines in some individuals. These observations of improvements in blood pressure control have been linked to the knowledge that has been about a 50% decline in death rate from strokes and a 35 to 40% reduction in deaths from coronary artery disease over the past 20 years. Statistics sound reassuring but it should be recognized that cardiovascular deaths are still so common that they account for a number of deaths that remains equal to the sum total of all other causes of death. Thus, over-optimistic assessments of these trends could be used to conceal a situation for which there is great residual concern. Whatever the advances in the management of hypertension have been over the past two decades, there still remains a lot of ground to be made up in controlling this important cardiovascular risk factor. Lowering Blood Pressure Has Benefits There is no question that elevated arterial blood pressure is a principle 123 risk factor for both coronary artery disease and cerebrovascular accident (stroke). In early hypertension studies, there was some difficulty in demonstrating that lowering blood pressure had any real benefit in reducing the prevalence of coronary artery disease. However, these preventive trials did show clear benefits in the reduction of stroke and renal disease. More recent studies have indicated that reductions in blood pressure reduce the incidence of coronary artery disease, especially in elderly individuals. The principle reason for a failure of some of the earlier preventive trials to show benefits in the reduction of coronary artery disease may have been due to some of the adverse effects of the blood pressure lowering medications used in the clinical trials. The use of thiazide diuretics has been examined in this respect. Thiazide diuretics may have a number of adverse effects including alterations of body chemicals with a resulting low serum potassium and magnesium. In addition, these diuretics (water pills) may contribute to abnormalities of blood lipids and glucose metabolism. On occasion, thiazide diuretics have been associated with the precipitation of cardiac arrhythmias. There is continuing argument about the safety of some antihypertensive drugs (blood pressure lowering medication) and this has resulted in a tendency for physicians to use blood pressure lowering medication with safer profiles. However, blood pressure lowering medication is limited in its use by side effects in general, and these factors should encourage the use of more natural approaches to blood pressure reduction. The advantages of reducing mild elevations of blood pressure are not quite as obvious as the advantages that accrue from the reduction of 124 moderate or severe hypertension. By taking information from multiple clinical trials of blood pressure lowering for moderate hypertension, it has been demonstrated that there is an overall reduction of 10% in death rate from coronary artery disease by effective treatment of moderate hypertension. People Giving Receiving Anti-Hypertensive Therapy The focus of advice given to individuals who are receiving antihypertensive medications should include a reinforcement for these persons educate themselves in the use of the drug therapy that they are taking and understand the side effect profile of the drugs. The healthcare giver who has prescribed drug therapy is under an obligation to impart to the patient information about the risks and benefits of anti-hypertensive treatment. Patients believe, inappropriately, that high blood pressure produces symptoms. When high blood pressure does produce symptoms it is usually at pressure that is at dangerous and life threatening levels. Healthcare givers should try and select drug therapy that can be given daily to improve patient compliance and convenience of administration. An efficient medical practitioners will always question an individual about the timing of taking of anti-hypertensive drugs. He or she is well advised to ask the patient to bring their medications with them to the clinic visit, especially if multiple drug therapy is present. Polypharmacy (multiple medications in one person) spells more potential for problems. In cases of treatment failure, the healthcare giver should become a detective. Collateral sources of information from family members about 125 lifestyle habits and compliance with medication is useful in the management of patients with uncontrolled hypertension. There are convenient and cheap blood pressure monitoring devices that can be used by a patient at home to monitor their own blood pressure throughout the day. It is this kind of simple advice that can make all the difference to the day-to-day control of blood pressure. To discuss all the adverse effects of blood pressure medication is not possible because of the number of potential side effects of these medications. It would be possible to write a very long a boring account of every side effect of every blood pressure lowering drug but, if an uninformed individual were to read this information, they would probably never take an antihypertensive medication. Anti-hypertensive drugs tend to be expensive and evidence exists that more than one-third of all people taking blood pressure medication experience difficulty in paying for the medication. The situation can be overcome to some degree by selecting generic drugs, providing such drugs are known to have equivalence in their therapeutic effect to “standard” brands of drugs. Using a generic drug rather than a branded drug, sometimes reduces the cost of therapy of hypertension by 75%. Anyone who is taking multiple drug therapy may want to educate themselves more about the value of combination therapy. Such individuals are advised to seek more than one medical opinion, if necessary. The effective healthcare giver will discuss freely any side effects that an individual is having to an anti-hypertensive remedy. It is alarming to note that up to one in five people receiving anti-hypertensive therapy may well cease taking medication because of side effects. One important issue is 126 that lowering blood pressure should not significantly interfere with quality of life and, fortunately, newer drugs have been developed with more acceptable side effect profiles. Despite this, some physicians are still using obsolete and in some circumstances dangerous anti-hypertensive medications. Anti-hypertensive drugs which have acceptable side effect profiles include several gentle acting diuretics, a class of compounds called angiotensin converting enzyme inhibitors, known commonly as ACE inhibitors, drugs that block calcium channels and perhaps beta-blocking drugs. Anti-hypertensive drugs that tend to result in orthostatic hypotension (profound fall in blood pressure when changing posture) are best avoided, especially in the elderly. Aside from the unpleasant physical effects of the inappropriate lowering of blood pressure to subnormal levels, anti-hypertensive drugs are very common causes of mood disturbance, impairment of sexual activity, and a decrease in psycho-motor function. Unfortunately these drugs smay often interfere with an individual’s ability to undertake an exercise program. There is one big problem that faces the physician engaged in the treatment of hypertension which is related to the asymptomatic nature of the disease. When a physician tries to treat an asymptomatic disease with drugs that cause unpleasant symptoms, there will always be a tendency for people to consider the therapy worse than the disease! This is a major challenge for the healthcare giver. However, it is a further reason for the healthcare giver to try and adopt more acceptable, gentler and more natural solutions to the therapy of high blood pressure; without resorting to drug treatment and its frequent association with onerous side effects. 127 An important consideration in the assessment of the efficacy of any intervention for the treatment of high blood pressure is the recognition that there are many circumstances that can interfere with the many interventions that are used to lower blood pressure. An individual with high blood pressure that wishes to self-medicate should be aware of drug interactions with blood pressure. There are many over-the-counter medications or dietary supplements that should be avoided in the person with elevated blood pressure because these agents may promote high blood pressure or can interfere with anti-hypertensive drugs. Table 20 gives a list of circumstances that may interfere with interventions, natural or otherwise, to lower blood pressure. Lowering of Blood Pressure Without Drugs Many practitioners of medicine may have prescribed antihypertensive medication prematurely without the application of nonpharmacologic approaches. Why? These practitioners are encouraged to apply treatment methods for which there is very hard and fast evidence of a benefit as shown by the performance of controlled clinical trials. The problem is that the pharmaceutical industry will spend enormous amounts of money on the Lack of compliance with treatment Weight gain Salt excess in client Excessive stress Substance abuse (or its withdrawal) 128 Medication that increases blood pressure, e.g. non-steroidal antiinflammatory drugs, steroids, hormonal replacement therapy, salt containing anti-acids, decongestant remedies and other commonly used drugs. Use of some dangerous dietary supplements, e.g., those containing ephedra or botanicals that are known to cause significant raises in blood pressure. Table 20: Circumstances that may interfere with natural options or drug therapy to control blood pressure. Note some of the problems occur as a result of the injudicious use of natural options. research and development of synthetic pharmaceuticals to show their effect but there is not a corresponding industry that will spend money on the research of non-proprietary medical options, such as natural remedies. It is often considered the responsibility of government agencies or charitable foundations to fund natural options or lifestyle research. The amount of money available through this source is much less than that through pharmaceutical industry funding. Table 21 summarizes some of the more important non-drug options available to reduce blood pressure. Most non-drug options for controlling high blood pressure include significant changes in lifestyle and many of these options are common to the interventions that will decrease risks of cardiovascular disease. It has been suggested that non-pharmacologic therapies are difficult for a medical practitioner to include in the treatment of mild hypertension because of 129 compliance problems. Part of the therapy of mild hypertension should be an attempt to motivate a patient to engage in lifestyle change and encourage the belief that it is possible to use multiple natural options simultaneously as a first-line management strategy for mild hypertension. Weight reduction Restriction of sodium in the diet Physical exercise Stress reduction Dietary modification and use of dietary supplements Specific pharmaceutical options, e.g., calcium, fish oil, magnesium and potassium intake Table 21: Lifestyle or natural options available to reduce blood pressure that, in the author’s options, should be considered among first line therapy for high blood pressure. Evidence That Good Habits Lower Blood Pressure On the one hand some medical practitioners question the lack of clear evidence that measures the benefit of lifestyle correction on blood pressure 130 control but on the other hand much evidence is available that natural options are quite effective. The treatment of obesity with even modest weight loss can result in quite significant reductions in blood pressure. In the author’s experience, weight loss in some individuals of even ten pounds, or less, may make a difference in blood pressure control. One important issue is that blood pressure recordings need to be corrected for arm circumference. This leads to a circumstances where a blood pressure recordings in obese individuals can be considered to be spuriously high or on occasion low due to the incorrect selection of the correct cuff to measure blood pressure. The issue of salt restriction in the diet in the control of hypertension is very significant. Many people are prescribed diuretic drugs (water pills) in order to have the body excrete a salt load. The number of times that a person may be prescribed a diuretic without even simple advice about restriction of sodium intake is very troubling. A recommendation to lower the daily intake of sodium to about 1.5 to 2 grams of elemental sodium is good advice for the individual with elevated blood pressure. There is confusion about advice given for salt restriction because sometimes diets are expressed in milli-equivalents of sodium, amount of elemental sodium or amounts of salt. To restrict the discussion to readily understandable, patients should be advised not to exceed 4 to 6 grams of table salt per day. There are studies that have shown that the restriction of salt alone can reduce blood pressure. Fortunately, regulatory agencies are demanding increasingly that food or health supplement manufacturers list the salt content of prepared foods or dietary supplements. An individual can now select from a number of “—substitute” types of salt condiments that can 131 make food quite tasty without the need to lace it with table salt. However, there are some unforeseen problems with salt substitutes. Some allegedly “low salt” or “no salt” products are made from combinations of sodium and potassium. This can be quite misleading because these products are not free of salt and excessive use of condiments that are presumed to be low in sodium can still deliver a significant sodium intake. These products contain about half the amount of salt as regular table salt and using twice as much is obviously the same as using too much salt. A word of caution is required in the use of low sodium salt substitutes that are made with potassium because some of them have quite high contents of potassium. Potassium exerts a very potent effect on cardiac function and when taken in excess it may precipitate dangerous changes in heart rhythm. Potassium overdose can be a life threatening situation. Appendix B provides important information for patients who are living with high blood pressure in relationship to their day-to-day activity. Type in here - provide a couple of reference sources in this. One is a table in a book on ambulatory care I have and one is a book called Living With High Blood Pressure. We need to given an Appendix B on day-to-day activity with high blood pressure. The claims by some physicians that there is not good evidence to promote lifestyle change for blood pressure control should be revised. Scrutiny of a very important study performed by the Joint National 132 Committee on Detection, Evaluation and Treatment of High Blood Pressure (JNC) can provoke this revision of ideas. In 1993, an important report was made in the medical journal Archives of Internal Medicine (The Fifth Report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure). This document recommended that all patients with high blood pressure be recommended to engage in regular physical exercise. Indeed, evidence has been produced that exercise may in itself control hypertension and it has the added advantage of permitting a reduction in the amount of drug therapy that may be required to control blood pressure. It is apparent that all types of physical exercise may be beneficial, including simple activity, such as cleaning or house chores. Of course, cardiovascular conditioning occurs usually as a result of more strenuous types of exercise which should be undertaken with the supervision of healthcare givers. Substance Abuse and High Blood Pressure The role of substance abuse in the cause of hypertension has been understated and it deserves careful consideration. Smoking cigarettes, a pipe or cigars can result in a nicotine load which significantly effects cardiovascular reflects and can produce elevations of blood pressure. The carbon-monoxide content of cigarette smoke is directly injurious to the lining of blood vessels and decreases oxygen availability in the body. There are patients with angina who can have an anginal attack precipitated merely by smoking or by being in an environment where they are inhaling second hand smoke. Caffeine contained within several beverages including coffee, tea and cola can exerts significant effects on blood pressure and caffeine reduction is highly recommended by the author for people with hypertension and heart disease. Furthermore, caffeine may exert quite significant effects 133 on cardiac function and it is known to be implicated in the generation of abnormal heart rhythms. A considerable body of evidence exists that excessive drinking of alcohol is highly correlated with high blood pressure. Population surveys have shown that ethanol (alcohol) intake contributes to high blood pressure in the population. There are two principle approaches to this situation which include either moderation or discontinuation of the drinking of alcohol. So powerful is this evidence that there are studies in the literature that show that limitation of alcohol intake or cessation of drinking can be shown to be effective as the only intervention used in lowering blood pressure in some individuals. Useful or acceptable guidelines are not available for controlled drinking strategies but alcohol intake should be limited to a maximum of one or two drinks per day. In the author’s experience, many people with alcohol problems can be noted to be hypertension on initial examination and after successful treatment of their alcohol problem, their blood pressure returns to normal. It is recognized that excessive alcohol intake often passes unrecognized in clinical practice. Excessive drinking in itself can alter the composition of body chemicals and alcoholics may have gross abnormalities of sodium regulation in the body. In addition, excessive drinkers often lose potassium and magnesium in their urine which are elements that play a major role in normal heart function. Prescribing drugs that alter body chemicals, such as water pills, to an alcoholic with mild hypertension can precipitate serious iatrogenic disease by aggravating potassium or sodium loss in the urine. 134 Medical practitioners are increasingly cautious about alcohol problems presenting with hypertension but many individuals with alcohol abuse or dependence fall through the net. The nature of alcohol dependence is that relapses are common if an individual with a drinking problem tries to engage in activity that results in moderation of alcohol intake without abstinence as the goal. In the face of established alcohol problems and hypertension, the cessation of alcohol intake completely (abstinence) is the best advice. Simple Dietary Switches With Big Effects Although it is recognized that certain elements, such as potassium and calcium, can lower blood pressure, few attempts are made to alter diets to offer optimal intakes of these elements. The mere act of switching to a low sodium diet often results in an increase in potassium intake in the diet. The change from a typical Western diet to a more vegetarian diet involves the consumption of fruits and vegetables which are rich sources of dietary potassium. The author believes that calcium supplementation is something that should be considered by every mature female and some mature males to reduce their risk of osteoporosis in later life. Calcium intake may affect blood pressure beneficially, but the control of blood potassium levels is probably more important in blood pressure regulation than optimal calcium intake. It is ideal to maintain a blood potassium level of around 3.5 milliequivalents per liter (mEq/l). Potassium is often lost when water pills are taken to control blood pressure. This has resulted in the use of water pills 135 that spare potassium excretion from the body or extra potassium supplements are recommended. The role of maintaining a normal blood potassium is very important in achieving the optimal effect of a prescription of a diuretic (water pill) and this issue is frequently forgotten by both patient and healthcare giver. Miscellaneous Natural Options Stress reduction techniques have been shown in well controlled clinical trials to put beneficial effects on the reduction of cardiovascular risk factors but their use as a primary method for controlling blood pressure has remained somewhat in question by physicians. The failure of the demonstration of stress reduction or behavioral techniques to reducing blood pressure should not prevent a healthcare giver from recommending this type of intervention. There is much to be gained in terms of improving a patient’s well-being and decreasing cardiovascular risk overall. Dietary Supplements Emerge as an Option The role of nutritional interventions to lower blood pressure continues to be questioned by many medical practitioners. However, few of these people who share this disbelief of the benefit of a nutritional approach may take the trouble to examine the evidence for their benefit. Dietary supplements such as fish oil preparations, garlic and mineral supplements are known to lower blood pressure. It is argued that the potential side effects of fish oil intake in the diet may counteract the overall benefit of this intervention. However, in the commonplace situation of omega-3 fatty acid deficiency, this argument is not tenable. Garlic 136 supplementation of the diet is not associated with significant adverse effects in the vast majority of people who adopt this approach. Arguments that low caffeine diets cannot be shown to control hypertension are not to be used as reasons for caffeine inclusion in the diet because caffeine is known in many physiological settings to cause elevations in blood pressure. It is suggested that elevations of blood pressure due to caffeine are short-lived or quite transient but the ingestion of caffeine is frequently continuous in the dependent individual. Summarizing Natural Approaches to Blood Pressure Reduction The idea that has been propagated in this book that just lowering cholesterol is not a worthy objective in decreasing cardiovascular risk applies in the management of hypertension. Just lowering blood pressure may be equally as misguided as just lowering cholesterol. Interventions to reduce cardiovascular risks should occur together and these risks often go hand-in-hand. The author is not rejecting conventional medical approaches to the treatment of hypertension where appropriately indicated but is pointing out that a number medical practitioners may opt to a drug treatment approach at the expense of considering more gentle options. Table 22 summarizes an important potential treatment approach to hypertension. 137 LIFESTYLE MODIFICATIONS: Control weight Elimination of substance abuse Exercise Dietary change Smoking cessation _ _ No Response Good response requires program and followup to reinforce the change in behaviors ↓ Assess whether or not there has been a change in lifestyle and compliance with advice. _ _ No compliance Repeat lifestyle advice and intervention ↓ Go do drugs Instructions about arrows and directions or placement of arrows was too ambiguous and confusing. (Can I see table from original book reference?) Compliance has occurred, continue lifestyle advice. ↓ Follow a pathway of recommended drug intervention for prescription of increasing complexity after careful ____ checks of response to each intervention strategy. ↓ Simple prescriptions cause multiple risks, lack of compliance and increasing side effect profiles. Table 22: This table summarizes a treatment approach to hypertension. Most cases of newly diagnosed hypertension are mild and the emphasis is placed upon natural options. Drug therapy of increasing intensity and variety is to be reserved for more severe forms of hypertension that are recalcitrant to simple interventions. 138 CHAPTER 4 LIFESTYLE APPROACHES 139 Lifestyle Change: Plans Not Diets The reader may be becoming receptive to the notion that the solution to promoting cardiovascular wellness rests with interventions that involve more than lowering blood cholesterol in isolation. The risk factors of cardiovascular disease seldom occur in isolation and need to be tackled together. Such risk factors include: obesity, high blood pressure, smoking, lack of exercise, poor diet and stress, together with complex behavioral issues. The bouquet of barbed wire needs work in many directions before it will disentangle. Whilst the reader may be saying to herself or himself, “It’s easier said than done,” it is possible to tackle each problem in a systematic manner. The logical approach is to take the easiest risk factor to change, or the risk factor that when changed gives the most benefit to the individual. The author accepts that the degree of difficulty encountered in changing each risk factor may be different from one person to the other, but a common thread of difficulty is shared by all. Individuals with cardiovascular risk do not walk alone. Smoking The cardiovascular risk factor that stands out above the rest is cigarette smoking. Smokers should be counseled that the primary issue is to quit smoking. The health benefits of smoking cessation require no discussion. Quitting smoking is very tough and only possible with intense willpower and behavior modification. Adjuncts to smoking cessation are “Band-Aids”, just like slimming drugs are “short-term crutches” for weight loss. Short-term smoking cessation is one thing but relapse is another. The 140 YoYo phenomenon operates with greater speed in the smoker than in the would-be slimmer, because of the power of the smoking addiction. In addition to commitment to quit, a plan of action is required. It is not possible for the author to advise extensively on smoking cessation methods within the remit of this book. The author emphasizes that there are no magical methods. The strength of the smoking addiction in enormous. During the author’s work with heroin addicts, he became aware that their addiction to cigarette smoking was most often stronger than their addiction to heroin. If cessation is not possible, a reduction in cigarette consumption to about five cigarette per day is desirable. At least at this level there is not much statistical evidence of a major health risk. Remember, though, statistics can lie. Stress Stress and lack of exercise are two important factors that are frequently underestimated in terms of their importance as cardiovascular risk factors. Both factors can independently cause a rise in blood pressure or blood lipids or both, to some degree. Relaxation, positive thinking and varying degrees of well-planned aerobic exercise may go a long way to the promotion of general well-being. However, anyone who is completely free from anxiety, worry and periodic blues is not alive, or may be psychopathic. Stress has been associated with heart disease. Stress is a nebulous term that refers to unpleasant or painful emotions, such as anxiety, worry, hostility, anger and the like. Interestingly, reception to and manifestations of 141 stress have been hypothesized to correlate with two groups of individuals. Drs. Friedman and Rosenman are credited with the recognition of the negative effects of the assertive, time-dependent personality that they termed the Type A personality. It was their assertion that this Type A individual would be prone to coronary artery disease, hypertension, heart attacks and even strokes. In contrast, the labeled Type B individual is “laid back” and more “in control”, with an alleged reduction in a tendency to develop cardiovascular disease. This relationship between personality and cardiovascular risk is far from clear in some studies. For example, it has been shown that the Type A person may recover better from a heart attack and some studies have shown that the Type A personality is a risk factor in younger age groups, but this risk factor does not operate to the same degree in the more mature male. The “stress of life” is a misleading concept since much stress is selfgenerated. However, there are many novel examples of the effect of stress on cardiovascular function. Cardiovascular physiologists have measured the negative effects of stress on blood pressure, heart rhythm and other parameters, thereby showing a clear cause and effect relationship in some circumstances. One of the most interesting effects of stress is its demonstrated negative effect on blood cholesterol. Common examples of elevation of cholesterol with stress include observed elevations of blood lipids in students undergoing prolonged periods of examinations and accountants whose cholesterol level can be seen to rise in the pre-tax filing period leading up to the end of the taxation year. The proof of the stressrelated rise in cholesterol levels is the tendency toward normalization of 142 blood lipids after removal of the stressful influences. There are many ways in which stress can be reduced. An exercise program will help and it has intrinsic benefits for cardiovascular health. Some individuals employ sophisticated relaxation methods, such as yoga, transcendental meditation and even self-hypnosis. The simple answer to the problem is probably more related to an attempt at behavior modification. Drs. Friedman and Rosenman allege that the Type A individual can transition to the Type B. In practical terms, the stressed individual should attempt to reduce the number and severity of stressful incidents in his or her life, which usually means merely a simplification of life and an appreciation of life’s enjoyable activities. If an individual is a Type A personality, his or her cardiovascular risk may probably be more related to cigarette smoking, uncontrolled hypertension and high blood cholesterol rather than his or her behavioral traits! The behavioral scientists may not agree with the author. The Lifestyle Concept Lifestyle has a direct influence on health. This situation is easily overlooked because the effects of adverse or poor lifestyle on an individual may not be immediate. In addition, positive action to change adverse lifestyle for the better does not often produce rapid results. Physical and mental well-being are regarded as the greatest treasures of life. Considerable evidence indicates that lifestyle is a major determinant of health, and an individual can exert complete control over his or her lifestyle. Since adverse lifestyle is the commonest course of preventable disease, it is of utmost importance that harmful lifestyle is identified and intervention 143 should occur early with simple and effective corrective actions. Lifestyle is a general concept that encompasses psychological, physical and social functioning. Each person’s lifestyle is different and several domains exist which are illustrated in Table 23. All the domains that are contained within a lifestyle assessment have a bearing on physical and mental health, e.g., substance abuse, drug abuse, nutrition, exercise, etc. These domains are interrelated and in many cases interdependent. Many attempts have been made to measure or check lifestyle but the best method involves the comparison of an individual’s components of life with those of the general population. This measurement technique has the advantage of showing us that there are degrees of poor lifestyle. This process of comparison should not be perceived as an “all or nothing” phenomenon. Clearly, the more areas of an individual’s lifestyle that are under the influence of positive action, the better off an individual will be or feel! The assessment of adverse lifestyle such as smoking or excessive drinking is often applied routinely in a medical clinic by a doctor or a nurse. However, the best method of assessment is probably self-identification of a problem followed by self-intervention. Assessment research has shown that standardized questions with feedback are known to be the preferred way of assessment. In fact, it is possible to have questions written into a computer software program where the computer interrogates the patient. The computer is capable of monotonous questioning about lifestyle in a precise manner. The author and his colleagues have developed a computer-assisted 144 lifestyle testing program that has been shown to be useful in assessing lifestyle in clinic patients. Most patients rated the experience as acceptable and some Alcohol Consumption Psychological Well-Being Substance Abuse Nutrition/Eating Sexual Activity Physical Activity/Exercise Table 23: The Principle Lifestyle Domains evidence suggested that a patient may tell more to a computer than to a doctor! The use of the computer-assisted testing of lifestyle resulted in prompting patients to discuss concerns with their doctors that they may otherwise have failed to bring up in a routine visit. 145 The 10 Lifestyle Commandments An enormous amount of epidemiological research has linked a wide variety of behaviors, addictions or compulsions with the causation of chronic degenerative disease. This realization has underscored the importance of advances in experimental and clinical psychology that permit a process of behavioral change by providing practical help. Any attempts to change ingrained habits requires great commitment and motivation. However, it is now recognized that commitment is not enough, the clear plans of action are required to enact corrections of adverse lifestyle. The author has prepared a list of lifestyle commandments which were developed from a consideration of all adverse lifestyle domains that are known to be harmful to health. At first sight these lifestyle commandments may be perceived to be general recommendations for health. The well kept secret is that general health recommendations cross over completely to cardiovascular wellness. The 10 lifestyle commandments are summarized in Table 24. Self-Identification and Self-Intervention Hodgson and Miller (1982) have written an excellent account of the art of self-watching and self-help. In the introduction to their book they discuss the inscriptions on the shrine of the oracle at Delphi. This inscription reads “Know Thyself” with the added caveat, “Nothing to Excess”. Perhaps these are pivotal issues. Benjamin Franklin is one of the earliest recorded self-watchers 146 (Hodgson and Miller, 1982). It is reported that Franklin created a detailed plan for self- observation and monitoring of the behaviors that he had idealized. This is an early example of current recommendations to keep a “self-watching diary”. Hodgen and Miller (1982) have summarized target behaviors for self-observation with a view to the identification of damaging lifestyle activity (Table 25). Control your drinking of alcohol or abstain if you have recognized a problem. Avoid substance abuse, e.g., excesses of caffeine-containing beverages, unnecessary use of over-the-counter or prescription medications, etc. Stop smoking. Exercise regularly and consistently. Be in touch with your moods and levels of “stress”. Simplify your life if you can. Eat because you are hungry and eat only to satisfy your appetite. Eat a healthy balanced diet in high fiber, low sodium and low cholesterol. Subject yourself to a periodic health examination, e.g., an annual physical. Practice monogamy or safe sex. Never “do” drugs. Table 24: The 10 Lifestyle Commandments 147 Lifestyle Problem Alcohol Misuse Sample of Behavior Quantity, Frequency, Duration and Selection of Alcoholic Beverage Smoking Number of cigarette per day, number of puffs and nicotine consumption Overweight Number of calories per day, number of meals or snacks, types of foods and duration or type of exercise Workaholism Amount of time working or in leisure activities Drug Abuse Types and number of pills per day Table 25: Sample targets for self-observation proposed by Hodgson and Miller (1982). This table is modified from the book “Self-Watching” by Hodgson and Miller, 1982. The identification of adverse lifestyle is an important prerequisite to the application of methods of modifying habits or dependent behavior. Recent advances in behavioral sciences have shed light on how habits are developed and propagated. Hodgen and Miller (1982) have coined the expression the “ABC approach” to understanding the formation and reinforcement of human habits. This mnemonic breaks down the pattern of behavior into 148 three areas, including: A, which stands for Antecedent Cues, B, which focuses on the Behavior itself, and C, which are the Consequences of the habit or behavior that may diminish or enhance the behavior. Antecedent cues that trigger habits may be physiological or social. For example, an urge to smoke can emanate from nicotine craving or from a social interaction, or provides maximum pleasure. Antecedent cues can be identified for most types of adverse lifestyle, such as drinking excessively, taking drugs, or even working too hard. The antecedent cues to bad habits tend to give signals, warnings or promises of consequences that can result from the behavior that underlies the habit. For example, sitting in a bar is a setting loaded with antecedent cues to drink or smoke. The consequences could be good feelings, better social intercourse or just suppression of unpleasant physical withdrawal from substance abuse, such as smoking, drinking or even coffee consumption. One attempt to break this example of an ABC cycle may be to just stay away from bars. Behavioral scientists have wrestled with their understanding above the persistence of adverse lifestyle in the face of the individual’s knowledge that the consequences of the behavior can be catastrophic. Alcohol abusers may lose their jobs and family and smoker may get heart disease and lung cancer. The answer to this enigma may lie in an understanding of the temporal relationship between the habit and the reward. Understanding the processes of reinforcement of adverse lifestyle can 149 assist an individual in his or her own intervention for better health. Immediate pleasure from an adverse lifestyle, such as smoking, may far outweigh any considerations of harm in the long-term. Thus, short-term gratification is a powerful reinforcer of adverse lifestyle. Eating fast food today that is loaded with saturated fat leads to obesity that is apparent only over a period of days or weeks. Other examples of reinforcement include the relativity or intermittency of reinforcement. The serious drinker of alcohol may drink in the face of criticism because he may believe he is ‘better’ after drinking. The same serious drinker may not get the desired feelings or outcome each time he or she drinks but keeps drinking to hit the high spot or get the desired buzz. Hodgson and Miller (1982) refer to these three kinds of reinforcement in terms of their consequences. They use the terms reward now, reward sometimes and rewards of avoiding discomfort to match the concepts of short-term gratification, intermittent reinforcement and relativity or reinforcement, respectively (Table 26). Changing Behavior The mechanism of habit reinforcement permits the development of an action plan to fight the habit, compulsion, dependent behavior or frank addiction. Action plans have to be tailored to an understanding of the cues that precipitate the behavior that results in the consequence. This process is designed to allow self-intervention after self-identification of a problem with a logical improvement in an individual’s self-control. 150 The ABC Approach Reinforcement of Behavior Antecedent Cues Short-term gratification - Reward now Behavior Intermittent Reinforcement - Reward sometimes Consequences Relative Reinforcement - Reward of discomfort avoidance Table 26: Hodgson and Miller (1982) propose that cues lead to behavior with consequences (ABC Approach) and that the behavior is reinforced by short-term, intermittent or relative elements. The five key recommendations for changing behavior and exerting self-control are summarized in Table 27. The components of a potential action plan to confront adverse lifestyle are proposed. At the end of the day, the individual must want to change the lifestyle and the motivation should come from an education about the favorable outcome of rejecting dangerous habits or compulsions. It is not possible to engage in detailed dialogue about 151 correcting lifestyle domains but the ones that impact very specifically on cardiovascular wellness will be addressed. Excessive Drinking Most people assume that they would know if they are drinking hazardous amounts of alcohol. However, this is a big misconception! As with all forms of adverse lifestyle, drinking occurs in degrees of severity. The chronic “alcoholic” is at one end of the drinking spectrum and the abstainer or “teetotaller” is at the other. Like other lifestyle domains, one cannot use the “all or nothing” approach when considering drinking habits. There is a spectrum of drinking habits, i.e., shades of grey occur. First, we need to examine the spectrum of alcohol drinking habits and see where we fit in Component of Changing Behavior Comments Self-Identification One has to catch oneself in the act. (Self-Watching) A diary of events help unravel the A.C.B.s. Attacking Antecedent circumCues The individual understands the Substituting Alternative Rewarding Behavior instead Early in the withdrawal phase a prop can be used, e.g., nicotine gum stances that precipitates the behavior or adverse lifestyle and takes evasive action, e.g., the overeater should stay out of fast food restaurants. of smoking. The obese individual could join Weight Watchers, etc. 152 Prevent Relapse tempta- The individual must anticipate tion and develop coping techniques. Exposure to the Temptation A dangerous but effective activity where the individual tempts fate but applies resistance. Table 27: Some components of plans to change adverse lifestyle with examples of the activities in an action plan. (Figure 1). This will help us with the first key step of IDENTIFICATION of a drinking problem. The vast majority of drinkers use alcohol in moderation. Alcohol can be used in modest quantities to enhance social interaction or please the palate. About 5-10% of the population are frank alcohol abusers and they are experiencing some of the medical, psychological or social consequences of excessive drinking (Figure 1). Several specialized treatment resources are available for individuals with overt or serious drinking problems and a healthcare giver may have to be consulted to match the intervention to the severity of the level of alcohol dependence. Individuals who are “alcoholic” may often reveal their identity by their behavior or by organic illness. However, there are many problem drinkers who are often hidden from society. Medical literature is full of 153 descriptions of “hidden alcoholics” who pass unrecognized through the workplace, social circles and even hospitals. Recent evidence suggests that about 20% of the population may be problem drinkers. This means that at least twice as many problem drinkers exist for every frank “alcoholic”. Studies of young males between the ages of 18-35 years indicate that excessive drinking is occurring in epidemic proportions. It has been estimated that about 30 or 40% of all young males are “problem drinkers”. A lot of these “problem drinkers” may go on to develop frank “alcoholism”, or continue to be problem drinkers. It is therefore important to identify these individuals in the hope that something can be done to halt the progression of their disease. What is Sensible Drinking? Some would argue strongly that never drinking alcohol is the most sensible decision. Such decisions are personal and it would be unreasonable in modern day society not to be tolerant of “sensible” drinking. Most adults understand and have experienced the pleasures of drinking alcohol. The situation in which drinking occurs is also very important to many individuals. Drinking can often be fun when it is done with friends in social places in “sociable” amounts. “Serious drinkers” or alcohol abusers may drink alone. It is also important to acknowledge that drinking a small amount of alcohol is unlikely to harm an individual. From time to time all individuals who consume alcohol should take a close look at their drinking habits. It is not possible to set rigid guidelines as to what constitutes “sensible drinking” versus “risk drinking”. Tolerance to alcohol varies and it is recognized that females may be more vulnerable to 154 develop some of the alcohol-related illnesses, such as liver disease, compared with men for the same amount of alcohol intake. This known increase in susceptibility of women to the adverse effects of drinking compared with men has been ascribed in part to the amount of a protective enzyme (gastric alcohol dehydrogenase, gastric ADH) present in the stomach wall. There is a wide variability in people’s tendency to develop drinking-related illnesses and this variability is not well understood. The author proposes the following information as useful guidelines against which an individual can assess drinking habits. Some estimate of the amount of alcohol intake and the frequency of alcohol intake is a useful framework for an individual to start deciding whether or not he or she has a drinking problem. This is a key to the IDENTIFICATION of problem drinking. For men of about average weight and height, sensible drinking would be no more than four average drinks at a time and no more than 12 drinks a week. these are good approximate rules. Recommendations for sensible drinking in females are lower than those for males. For women of average height and weight, no more than 2 drinks at a time or no more than 10 drinks a week are recommended. It is obviously important to define what constitutes “a drink” because one drink to one person and one drink to another are often very different. Using generally accepted guidelines, one drink refers to one 12-oz. bottle of beer, or a 1½-oz. shot of liquor, or a 5-oz. glass of wine, or a 3-oz. glass of fortified wine such as sherry, port or vermouth. It should be remembered that safety and drinking are very dependent on what the individual may be doing at the time of alcohol intake. One drink can be too much if an 155 individual is driving or operating machinery. It is a healthy objective to set aside days during a week when no drinking occurs. Interactions between alcohol and a wide range of medications or drugs is possible and this can lead to circumstances that endanger health or well-being. Prevention of Alcohol Problems Prevention of any public health concern, such as drug abuse or excessive drinking can occur at several different levels or stages of the disease or disorder in question. To date, most attempts to prevent alcohol problems have met with limited or no success. Preventive methods which limit the availability of alcohol by prohibition or taxation have not been regarded as socially or politically acceptable in many Western societies. The medical profession has tended to concentrate its preventive efforts at a late stage in the development of alcohol abuse. The traditional medical approach has been to treat the long-standing illnesses that result from excessive drinking. Examples of such illnesses include inflammation, cirrhosis of the liver or peptic ulcers. When these late-stage problems develop from long-term excessive drinking, only some form of rehabilitation is possible and the outlook is not favorable for a cure for the individual. Indeed, medical illness resulting from alcohol costs many nations a great deal of money. It is important, however, to realize that a cure at the advanced stage of illness is not often achieved. In the past, early- or latestage activity to prevent alcohol problems has achieved only limited success. This poor outcome of early- or late-stage preventive methods has led to the “in between” concept of intermediate-stage prevention. This type of 156 preventive approach is sometimes called secondary prevention. This concept involves the identification of a drinking problem at an early stage of excessive drinking when the outlook for recovery may still be quite good. This is in contrast to treating chronic or late-stage “alcoholics” where the chances of a cure are much less. The individual with late stages of problem drinking may already have irreversible medical illness or gross disruption of his or her social circumstances. Social disruption tends to be associated with poor or bad outcome. These concepts sound interesting but many of these problem drinkers remain “hidden” from society and even from the trained healthcare professional. There is a frequent tendency of alcohol abusers to deny their problem or minimize the situation concerning their drinking habits. In addition, these individuals rationalize the circumstances of their drinking. These people are often very good at “conning” themselves into drinking by using distorted positive thoughts. It should be recognized that the problem drinker can be identified by a friend or a caring family member, or even by himself! Several simple techniques are available to IDENTIFY the problem so that INTERVENTION can be undertaken. Alcohol and Heart Disease There are many medical reasons to avoid excessive drinking in the presence of heart disease or in the presence of risk factors for cardiovascular disorders. Excessive drinking is strongly correlated with excessive smoking and alcohol is toxic to cardiac muscle. Elegant clinical experiments show that acute alcohol intake can have profound effects on cardiovascular responses by dilating blood vessels and depressing myocardial performance. 157 On occasion, alcohol can trigger abnormal heart rhythm and the psychological effects of alcohol can unleash behavioral activity that places a susceptible individual at acute risk of a heart attack. Much has been made of the potential beneficial effects of alcohol on cardiac function and blood lipids. These benefits are unfortunately easily outweighed by the deleterious effects of alcohol on cardiovascular wellbeing. Reports that red wine contain biological fractions with cardiovascular benefit is not an excuse to gulp a bottle of wine with each meal. Studies, including the author’s, have shown that modest alcohol intake raise HDL but it does not normalize blood lipids and, therefore, the evidence for benefit is arguable. The author does not reject drinking at social levels. Drinking Doctors and Cardiovascular Risks In a very important study published in the Annals of Internal Medicine on March 1, 1997, Dr. Carlos A. Camargo, Jr., M.D., and his colleagues quoted the outcome of studies of moderate alcohol consumption and the risks of myocardial infarction and angina pectoris in male physicians in the United States. Several clinical studies, prior to the performance of this study in male physicians in the US, had shown that the moderate consumption of alcohol may be protective against the risk of heart attack and the development of coronary artery disease. Dr. Camargo and his colleagues were able to report that in the “on-going” Physicians’ Health Study, moderate alcohol intake decreased the risk for angina pectoris and myocardial infarction in this apparently healthy group of men. This study examined 22,071 apparently healthy male physicians who 158 were between 40 and 84 years of age and it focused on, in the years between 1981 and 1984. These physicians responded to a very detailed annual questionnaire. Follow-up in this study through until 1994 indicated that there were 1,368 cases of new-onset of angina pectoris and 690 cases of heart attack. Very elaborate statistical analyses of the data collected in this survey showed that alcohol intake at moderate levels was strongly protective against the risk of angina and myocardial infarction. It was found that male physicians who consumed less than one drink per week were at greater risk of coronary artery disease than those who consumed alcohol in moderation. The importance in this study rests in attempt to analyze why this beneficial effect of moderate alcohol intake is apparent? It is believed that alcohol consumption may exert some anti-thrombotic effects on the body. The finding that alcohol is protective against both the development of coronary artery disease and the occurrence of heart attack indicates that alcohol may be protective against the development of atherosclerosis. It has been noted that moderate alcohol intake increases HDL levels and it is believed to be one of the major mechanisms for the observed reduction in risk of cardiovascular events that are attributed to moderate alcohol consumption. Advice to ask individuals to drink at moderate levels is quite problematic because it is known that there is an increased risk of death from cancer among people who drink moderately or abuse alcohol. Overall, the cardiovascular benefit of moderate alcohol intake appears to be clear. Drinking two or six drinks per week appears to decrease the risk of myocardial infarction and coronary artery disease, at least in males. 159 However, it would not seem prudent to advise life-long abstainers from ethanol to start drinking in order to exert a beneficial risk reduction for cardiovascular disease. Nevertheless, the protective effect of alcohol appears to be quite well defined. Substance Abuse Is it legal or illegal? Legalities and morals may matter less than slow death or serious impairment of day-to-day life. Everybody has the potential to become addicted to a drug. Any kind of addiction is self-defeating and dangerous to well-being and happiness. Drug addiction is one of the biggest problems facing mankind and it is responsible for much privation, premature death and social misery. The term “addiction” has been superseded in many sociobehavioral fields by the kinder term “dependence”. Addiction is a better term for most purposes because it reinforces the recognition that something nefarious has gained a strong, habitual and enduring hold - the hold is STRONG, it is a HABIT and it is ENDURING. Counter-activity must, therefore, be as strong as the habit. A commitment to stop substance abuse needs to be applied repeatedly without relent if an individual is to be successful in breaking the “addiction”. Smoking If you ask a heroin addict what he or she would take to the moon if only one choice was available, he or she would answer cigarettes before answering heroin. Smoking cigarettes is a very powerful and very unhealthy addiction. There is perhaps little one needs to know about the adverse 160 consequences of smoking because the advertising media now has to disclose health problems related to smoking as a means of promoting tobacco products. Why do we not think about this modern day insanity? The advertisement that lures an individual to smoke carries a clear message that he or she may die or suffer a damnable consequence. This is the strength of this enduring habit. There are many incentives for giving up smoking, such as saving money, better health, better breath, whiter teeth, etc., but very few disincentives except the power of the addiction. Remember, it is apparent that the smokers may be doing as much harm to the health of other people in the environment as they are to their own health. It’s becoming much harder these days to be a smoker. Public places are protected by law, there is no smoking on public transportation and perhaps worse, the world is full of reformed smokers. The reformed smoker is likely to be the most critical of all, try to avoid retaliating to the victimization of the ardent non-smoker or the reformed smoker. This interaction is like telling oneself “you MUST or SHOULD give up smoking”, it makes one more rebellious and unfortunately all the more likely to smoke. An individual may have already made progress along the way of quitting the smoking habit by reading this far into the chapter. There is a great deal of argument whether or not gradual withdrawal is better than quitting “cold turkey” - all at once! The author has the preference for advising others, including himself, to quit “cold turkey”. Gradual withdrawal may just prolong the agony and, let’s face it, withdrawal is not giving up, it represents a situation where one is still “giving in” to the strong, 161 enduring habit. It takes a while to get into the pleasures of smoking, so miracle cures don’t exist. It takes longer to stop the habit or the craving than it took to experience the pleasure. Prescription Drug Abuse The frank abuse of misuse of prescription drugs is alarming. Identifying this problem is very difficult for the taker and sometimes the prescriber. Government agencies have assisted by classifying certain drugs as controlled substances but abuse continues. The problem is such that the physician and patient may be blind to the circumstances. This point is very important, since identification is always necessary for any interventions. The prescription drugs that are most likely to be abused are those that have psychoactive properties (effects on the mind) such as sleeping tablets (hypnotics) and tranquilizers. So-called minor tranquilizers are among the most abused of all drugs. Such drugs include a group referred to as benzodiazepines of which diazepam (Valium), chlordiazepoxide (Librium) and lorezepam (Ativan) are common examples. Although these tranquilizers are safe and effective in short-term treatment, they have a propensity for being drugs of dependence. Dependence (addiction or habituation) probably has at least two components. The first is the psychological component where the individual becomes addicted to the complex effect of the drug on the mind. This can range from a sensation experienced as a consequence of the active tranquilizing effect or a more nebulous dependence, such as the mere act of taking the drug. The second component of dependence (or addiction) is the physical (or pharmacological) component which is a result of chemical changes that occur in body tissue, such that they almost need the 162 drug before they function. Scientists are only just beginning to understand the complex components of addiction, habituation or dependence. Exercise Exercise can make important contributions to physical and mental well-being. Before commencing an exercise program, it is important that the individual checks with his or her physician. A physician will be able to give some advice about the type and amount of exercise that is ideal. There are some misconceptions about the role of exercise in lifestyle. An individual may set an expectation that is too great and it is known that an individual’s ability to undertake an exercise depends on his or her physical condition, age and general health. Unlike sportsmen or women who need to train very arduously, most individuals will not have to prepare themselves for competitive events. Exercise has a very beneficial direct effect on the heart, lungs, muscles, joints and bones. Exercise is a very important adjunct to diet in a weight loss program because calories are expended and fat accumulation will not tend to occur or may diminish. In addition, exercise is an important aid to rehabilitation following any illness and in general terms if exercise is sustained for at least 15 minutes it results in improvements in cardiovascular and respiratory function of the body. In addition, exercise helps lower blood sugar. Routine daily exercise or workouts have a preventative benefit in terms of respiratory and circulatory diseases. Exercise increases circulation and improves muscle tone and strength. It is possible to benefit from exercise in many different forms, including walking, housework, jogging, biking, swimming or doing a series of stretching exercises. 163 It is important that exercise occurs within the limitations that have been set by a healthcare giver. People who are disabled can undertake exercise. For example, “jarming” can be used by people in a wheelchair or people with sedentary occupations. Jarming means jogging with the arms alone. The most important aspect of exercise is that it be undertaken regularly. In this regard, exercise is much more beneficial when it is undertaken several times a week instead of sporadically or only once in a while. Exercise is like every other attempt that an individual can make to change lifestyle, it does not result in immediate benefits. Building up exercise routines over a period of time will not result in quick improvements. Improvements in well-being occur gradually. It is important not to overdo exercise at the outset because this leads to soreness, injury and discouragement. It is useful to select a type of exercise that is enjoyable because there is more change of compliance. Regular exercise, even if it is not strenuous, will help burn calories and plays an important adjunctive role in dieting and the management of obesity. There is a common misconception that a workout has to be strenuous in order to burn calories but this is not the case. It is important to note that if an individual is ill, then exercise should not be undertaken. It is quite useful to keep a daily log of exercise activity and certain goals can be set to achieve over a period of time. A daily activity diary is very useful when it contains information on the date, time at which exercise occurs, description of the exercise or activity, a note of the number of times that 164 exercise occurs and a comment as to whether or not the exercise was easy or difficult. It is possible to calculate the number of calories that are burned with exercise from the activity chart (Table 28). Form of exercise undertaken and an examination of Table 28 will given an individual some indication of how many calories are being burned in a person of average height and weight (160-170 lbs). Psychological Well-Being The mind controls the body. In fact, the mind can make the body do almost anything. Psychological well-being for most people implies a state of happiness and moderate contentment. However, much of the time life is not perfect. It is normal to perceive life as experiencing some ups and downs. The negative effect of anxiety, stress and depression has become clear. The idea of the broken heart as a consequence of emotional or psychological problems transmits into a break in a cardiac health. Depression Although depression has been regarded as the “common cold” of psychiatry, it is often vicious in its effects. Depression can cause unlimited human suffering. Many sufferers are fooled by depression. An individual may not be in touch with his or her mood and it may cause a spectrum of problems from mild unhappiness to complete immobilization associated with an overwhelming sense of despair. Understanding depression is a good way to battle against it. Unlike stressful and upsetting life experiences, such as loss of a person or love, depression is always unreal, miserable, persistent and frequently incapacitating. The author believes that depression is a clear 165 risk factor in cardiovascular disease. Activity Calories Burned/Hr. Light Lying down or sleeping Sitting Driving an automobile Standing 50-200 Vigorous 80 Table tennis 100 Wood chopping 120 Ice skating 140 Tennis Calisthenics 200-350 Bicycling (10 mph) 200 Water skiing 320 Rope skipping 256 Skiing (10 mph) 220 Squash & handball 236 Bicycling (13 mph) 250 Running (7 mph) 280 Running (10 mph) 284 300 316 316 350 350 350 350 Moderate Walking, 2 mph Walking, 3 mph Bicycling 5 ½ mph Gardening Raking leaves & dirt Golf Housework, heavy Lawn mowing (power) Swimming Fishing (wading) Tennis (doubles) Square dancing Volleyball Roller skating Badminton Activity Calories Burned/Hr. Over 350 360 400 400 420 440 440 480 540 600 600 660 740 900 You could select a specific exercise and see how long you need to do the exercise to burn off certain items of food. Exercise/Time 16 minutes of jogging (10 mph) 5 minutes of jogging (10 mph) 3 hours of sitting 48 minutes of sitting 1 hr. 11 min. walking (3 ¾ mph) 17 min. walking (3 ¾ mph) 31 min. bicycling (5 ½ mph) 9 min. bicycling (5 ½ mph) 90 min. housework 38 min. housework Food item 1 piece chocolate cake 1 medium apple a 3 oz. hamburger on bun one hard-cooked egg a chocolate milk shake 8 oz. skim milk 10 french fries 1 cup green beans 1 cup ice cream 1 oz. cheddar cheese Table 28: Exercise Table. Duration of exercise required to burn off each food item. 166 Self-Help Techniques for Elevating Mood People have vastly different coping techniques. There may be a precipitating event that sends you into a tailspin, such as a death in the family, a major financial loss, or loss of a job. In contrast, an individual may not be able to easily identify a casual event. Some people may be so depressed that they think they can never feel any other way or they may have already decided to give up because they are so consumed and preoccupied with sadness, worry or grief. Behavior that Will Get You in the End In order to change your thoughts and, therefore, feelings, an individual may have to change his or her environment in a radical manner. There are some simple facts about living a happy life with contentment. Tips on happiness are an important component of cardiovascular wellness. An individual does well to adopt the no complaining stance. It is easy to complain. Complaints are much easier than positive attitudes in the face of disappointment. The gift of pleasure is usually returned. Self-discipline is required by individuals to put themselves into action in the face of depression. Action will always elevate mood. Substituting some new habits for old ones is effective and life should not be lived by the clock. Periods should occur in the day where time is unimportant. Activity is the antidote to all bad feelings. An individual who can take control of his or her life, thoughts and, therefore, feelings will not be depressed. The role of aggression and the 167 Type A personality in the causation of cardiac disease or the precipitation of heart attack is well-charted territory. Type A Behavior and Cardiovascular Disease Friedman and Rosenman (1974) paved the way to an understanding of the importance of Type A behavior in the causation of coronary heart disease. These cardiologists were so convinced that cardiovascular disease had its roots in aggressive impatient temperaments, that they proposed the following in the preface of their classic book titled, “Type A Behavior and Your Heart”. Friedman and Rosenman (1974) state “In the absence of Type A Behavior Pattern, coronary heart disease almost never occurs before seventy years of age, regardless of the fatty foods eaten, the cigarettes smoked, or the lack of exercise. But when this behavior pattern is present, coronary heart disease can easily erupt in one’s thirties or forties.” The main features of Type A behavior are summarized in Table 29. A study of this table highlights the complexity of Type A behavior which has been termed an action-emotion complex (Friedman and Rosenman, 1974). An important component of the behavior pattern is that minor challenges in the environment may provoke explosive reactions. In the same way that the author attempted to point out the sure ways of detonation of the Cholesterol Time Bomb in Chapter 1, a study of the opposite type of behavior to Type A behavior may be a good way of identifying and correcting the adverse traits. The opposite type of behavior has been termed Type B and it has been recognized that Type B personality is 168 much less likely to get coronary heat disease than the Type A individual even in the face of similar risk factors. The Type B person is not necessarily outwardly docile. Indeed, this person may have greater ambition than the Type A individual but he or she is Feature Time urgency Comment This is regarded as the key aspect of Type A Accentuation of words in speaking behavior. Not enough seconds in a minute! Typically hurries to finish a sentence Rapid eating, walking and movement Easy to spot in the Type A Overt impatience Want people to get on with what they are saying or doing Doing or thinking more than one thing at once The individual contaminates leisure time with thoughts of work or problems. Conversation focusing The individual brings the theme of a conversation to egocentric topics Inappropriate guilt Cannot rest without discomfort Cannot smell the “roses” The individual must have things here and now Creating tight schedules More and more appointments in less time. The face that makes people feel like punching it! The Type A person is challenging and does not engender sympathy for his or her own affliction Tics and Gestures Finger pointing, table thumping and jaw protrusion are examples of the innate aggression Belief that speed gives anyone an edge 169 The Type A person has to move quicker than Measuring others deeds or actions The Type A person may apply numbers to activities, thoughts or deeds Type A plus Type A make sparks The Type A is rapidly engaged by his fellow Type A Table 29: Main features of Type A behavior that are modified from Friedman and Rosenman (1974). The comments provide examples of the behavior. not obsessed with the “here and now” and does not engage in the activity of doing ever-increasing numbers of things in ever-decreasing amounts of time. Switching from Type A to Type B behavior is the ideal but taking the edge off the Type A tendency is probably all that is required. Friedman and Rosenman (1974) have aided in the understanding of the desirable Type B personality that is summarized in Table 30. Which type are you? - bearing in mind that 10-20% of the population have an intricate mixture of Type A and Type B tendencies and neither pattern may breed true entirely. The Irritable Heart Syndrome? Conventional medicine has failed often to acknowledge the role of the mind in cardiovascular wellness but recognizes with clarity the phenomenon of psychosomatic illness. The irritable bowel syndrome is a classic example of a common gastrointestinal disorder that is amenable to behavioral interventions. This disorder is difficult to manage with synthetic pharmaceuticals and conventional therapy frequently fails. Medical textbooks set aside much space to discuss its pathogenesis and management, however, one cannot find a mention of the irritable heart syndrome. 170 The Type B trait is free of Type A habits and activities No sense of time urgency Does not experience free floating hostility Does not need to keep discussing victories or topics of self-interest No need to portray themselves as superior Relaxes without guilt Works efficiently but steadily Not necessarily docile or “brain dead” Table 30: The Type B behavior pattern as modified from Freidman and Rosenman (1974). Does such a disease entity exist? The heart has an autonomic nervous system that is even more well developed than that supplying the gut. Cardiac symptoms can occur in the absence of organic heart disease which is the hallmark of the presence of functional disease. The irritable heart syndrome is a likely entity which may occur with a heterogeneous symptom expression in isolation or in association with underlying cardiovascular disease. The author proposes this new syndrome to highlight the importance of behavioral interventions in the promotion of cardiovascular wellness. The Mind Minds the Heart 171 Dr. Deepak Chopra, M.D., is commended with his popularization of Ayurvedic medicine which stresses the importance of emotional factors, thought and awareness in general health. In his classic book titled, “Ageless Body, Timeless Mind…”, Dr. Chopra teaches much about awareness as a secret to longevity. The assertion of control over body processes is believed to exert a holistic and positive influence on health. The notion that the mind-body system reacts with generalization to even simple stimulus has become increasingly accepted. A good example of a single stimulus with general health benefit is exercise. Lack of exercise or even simple mobility can have a devastating effect on the body. The mature individual that sits in a chair with no stimuli will develop a decreasing awareness and deterioration of physical health. The term “disuse syndrome” has been coined by several leading gerontologists. Dr. Chopra (1993) credits Dr. Walter Boritz with the creation of this concept of “disuse” where lack of attention paid to the physical needs of the body leads to poor health and premature demise. The individual with cardiovascular disease and the mature person at risk of coronary heart disease may rapidly go “downhill” if physical activity ceases. The effects of lack of activity produces several predictable consequences, including obesity, lack of psychological well-being, muscular-skeletal disorders and premature aging. Physical activity is used as an example of one simple stimulus since the outcome of its absence is readily identifiable. Of equal, if not more importance, could be lack of psychological well-being itself due to limited social interaction, or other factors. The circumstances become even more 172 complex when lack of psychological well-being is perceived as endogenous. The reader will recall that the principal antidote to depression is activity. Mind-body interactions form an intricate web inside the bouquet of barbed wire of the “Cholesterol Time Bomb.” Inactivity, be it emotional or physical, will lead to reductions in mental or physical well-being. Above all, the mind is the minder of the body. The Body’s Innate Ability to Heal Andrew Weil, M.D. has led contemporary thought on holistic methods to enhance the body’s intrinsic ability to maintain health and heal disease. Dr. Weil has drawn from the experience of several ancient health philosophies to promote the concept that spontaneous healing of disease may occur by fostering the body’s mechanisms of homeostasis, self-correction or regenerative powers. In his book titled, “Spontaneous Healing”, Dr. Weil does not reject the value of conventional medical intervention and he highlights the importance of pluralistic medical approaches in the prevention and correction of disease. Dr. Weil shares the opinion of many antecedent researchers about the importance of self-identification and self-intervention but extends these to self-healing. There appears to be seven distinct strategies that an individual can apply to promote self-healing (Table 31). Spiritual Connection The role of love and prayer in healing and wellness is a developing 173 science. According to Dr. Larry Dossey, “Love makes it possible for the mind to transcend the limitations of the body.” Dr. Dossey is the author of the book titled, “The Power of Prayer and the Practice of Medicine” (1993) and was the Chairman of the National Institutes of Health Office Panel on Mind-Body Interventions. Dr. Dossey believes in the power of love to create health. He draws attention to the finding that in a study of 10,000 males with cardiac disease there was a 50 percent observed reduction in the frequency of anginal chest pain in men who recognized their spouses as loving and supportive. The importance of this observation is well illustrated in the book titled, “Heartmates, A Survival Guide for the Cardiac Spouse” by Rhoda F. Levin. There have been several contemporary studies that have drawn attention to the ability of prayer to exert a healing or healthful influence. The Strategy Not taking “No” for an answer Comment When a patient is told or feels that nothing can be done for his or her disease, he or she should not give up Help seeking An individual is advised to keep seeking for a treatment option that works Find others who have healed The interaction of individuals with others who have had success in overcoming a similar disease may have a positive outcome Form good part- This is limited to finding the right healthcare professional nerships with to work with. For example, a psychiatrist who possesses healthcare givers moral judgment can rarely provide the right support 174 Make life changes Changing adverse lifestyle is the key Regard illness as a gift The individual who perceives illness as a positive stimulus to change may do well Engage in selfacceptance The ability of an individual to accept his or her own imperfections can move on to renewed health Table 31: These strategies are proposed by Andrew Weil, M.D. in his book titled “Spontaneous Healing” as a route to increase spontaneous healing events. philosophical underpinning of prayer in healing or wellness rests in a belief that prayer may serve as a mechanism to connect an individual to the absolute (Dossey, 1993). Prayer is believed by the believers to be consistently effective. Prayer may conjure up the notion that this intervention is only available to the individual with religious inclination. The involvement of religion reinforces belief in prayer and must make it more effective. However, the atheist will probably find comfort in wishful hoping and positive requests from high forces. The atheist can gain comfort from not labeling the act of prayer with religious connotation but he or she probably gains from requests for health and well-being even the act of self-request. Mind/Body Prescriptions for the Heart The concept that the mind exerts a powerful control over body 175 function and well-being has been accepted for several centuries. The notion that there are approaches to healing that involve bioenergetic techniques has gained increasing popularity in recent times. Several scientific studies have shown the benefit of psychotherapeutic intevention, meditation, prayer and spirituality in the promotion of healing a variety of disease states. In his excellent book titled, “Heartbreak and Heart Disease”, Dr. Stephen Sinatra draws on his extensive experience as a cardiologist and psychotherapist to point to convincing beneficial effects of mind/body medicine in the management of cardiovascular disease. Dr. Sinatra has explored the health effects of love and intimacy on well-being with a focus on heart disease. This consideration has stimulated several questions that he has attempted to answer (Table 32). This work is important in our attempts to understand the many ways in which mind, body and spirit work together to prevent or promote coronary heart disease. Dr. Sinatra subscribes to the hypothesis that “heartbreak” of many kinds, involving disappointments, bereavements, and other negative emotional circumstances, can result in heart disease. The concept that detachment or loss can precipitate heart disease or sudden death from a cardiac cause is well illustrated in the theories of mind-body medicine. With this in mind, the understanding of irritable heart syndrome becomes clearer, and easier to mind. To what extent do emotional factors and one’s own intrinsic personality play a part in heart disease? 176 Are suppressed feelings and emotions significant? Do negative feelings such as abandonment, heartbreak, betrayal or humiliation create conditions that invite death? What part do positive emotions such as love, faith and good humor play in the process of healing and staying well? What is the significance of the way we breathe? Table 32: These are questions generated by Dr. Stephen T. Sinatra exploring the health effects of love and intimacy. (Stephen T. Sinatra, “Heartbreak and Heart Disease”, 1996). One major feature and advantage of this approach is that it is truly holistic. It does not deny the role of organic factors in the promotion of heart disease and it takes account of the need to place mind, body and spirit in harmony. There are many approaches to mind/body therapy but the overall goal is to use psychotherapy, relaxation, counseling and spiritual methods to protect the heart by releasing repressed emotions and resolving conflict. The use of psychospiritual interventions, breathing exercises, sharing, love, intimacy, prayer, visualization and meditation are all examples of techniques that may exert powerful “healing” effects on the heart. This exciting and 177 novel approach to cardiovascular wellness can be considered a sophisticated extension of stress reduction and behavioral therapy but it is in itself a complete treatment approach. One of the perceived revolutionary aspects of the Ornish program for cardiovascular wellness applies some principles of mind-body medicine. At the very least, it provides an excellent adjunct to conventional or alternative medical practices. Social Aspects of Cardiovascular Wellness Heart disease and its prevention presents a multitude of social consequences for individuals and their loved ones. The social consequences of cardiac disease are often overlooked in the healthcare environment, where cardiac patients are surrounded by technology and “high tech” personnel. One of the most frightening environments for a cardiac patient may be the coronary intensive care unit with its tubes, monitors, bells and whistles. A jump of the heartbeat causes a jump in the medical attendants. Staff on a coronary care unit are often candidates for coronary artery disease. In her book titled, “Heartmates”, Rhoda F. Levin provides very practical advice on dealing with healthcare facilities, family consequences of cardiovascular disease and marital intimacy in the victims of coronary heart disease. The book highlights several practical techniques for change in lifestyle and focuses on the special role that a spouse can play in contributing to the well-being of the cardiac victim. Rhoda Levin is to be highly commended for bringing the importance of social interventions to the forefront in facing the consequences of cardiovascular disability. Stress Reduction and Relaxation Programs 178 There is an infinite number of aids to stress reduction and relaxation and many programs that are presented as ideal to achieve restful well-being. One of the most important works in this area is found in a book by Dr. Jon Kabat-Zinn Ph.D. entitled, “Full Catastrophic Living: using the wisdom of your body and mind to face stress, pain and illness.” This book gives insight into the techniques of stress reduction and relaxation that have been used successfully at the University of Massachusetts Medical Center. The work is split into five sections that are summarized in Table 33. The practice of mindfulness is apparent in many ancient healing philosophies and arts. This process is at the root of Buddhist meditation and has become very popular among several religious sects, social groups and some contemporary healthcare settings. Mindfulness is an extreme example of “self-watching”, it involves a specific way of paying attention by a process of self-inquiry and self-comprehension. Few people doubt the power of this approach to healing because the basis of mindful meditation is to relieve pain, illness, and lack of emotional The practice of mindfulness: paying attention The paradigm: a new way of thinking about health and illness Stress 179 The applications: taking on the full catastrophe The way of awareness Table 33: The five sections of the program for stress reduction and relaxation proposed by Dr. Jon Kabat-Zinn. well-being. By this means the organism is pointed in the direction of healing. One could consider the modern day suggestions of Stephen Sinatra, M.D., Andrew Weil, M.D., and Deepak Chopra, M.D., as more complete extensions of concepts of “paying attention”. Dr. Dean Ornish, M.D. has recognized the importance of this process in his suggested stress reduction techniques. Dr. Jon Kabat-Zinn refers to the paradigm as an understanding how mindfulness can contribute in a positive way to physical and mental health. This paradigm is the interface of science and medicine with the connection between the body and mind in psychosomatic or somatopsychic domains of illness. Stress is dealt with, in part, by having an understanding of its generation and effect on body functions. This understanding permits the application of timely interventions to cope with or reverse stress (Table 34). 180 Dr. Kabat-Zinn and his colleagues describe methods of nurturing meditation and awareness by applying guidance for using mindfulness to deal with the symptoms as medical consequences of stress-related illness. Stress (External Perceptions Internalized) ↓ Fright and Flight ↓ Neurohormonal Effects ↓ Cardiovascular Response: Sleep Disorders Headache Tachycardia Emotional Problems, Etc. ↓ Self-Destruction: Adverse Lifestyle Substance Abuse ↓ Breakdown of Biological Systems ↓ Illness: e.g., exhaustion, depression, coronary heart disease, cancer, bone and joint disease, etc. Table 34: A pathway of stress from external events (acute or chronic) through which illness occurs. Mindfulness through meditation is proposed as an ideal intervention in this process. Remember the Bouquet of Barbed Wire Obesity, high cholesterol and, surprising to some, malnutrition go 181 hand in hand. The interesting thing that emerges from a consideration of the reversal of cardiovascular risk factors is that their reduction all function in a beneficial but interdependent manner. For example, exercise burns calories and assists in weight reduction, stopping smoking improves exercise tolerance, and reduction of caloric intake causes weight loss and lowers cholesterol. All of this sounds simple but several traps exist. Quitting smoking often leads to weight gain. Exercise increases appetite and some diets that are designed for weight loss result in rebound weight gain. Unfortunately, as mentioned earlier, smoking with excessive coffee consumption is a popular, quite pleasurable, but very unhealthy way to lose weight. The author believes that the overall answer rests primarily in a carefully planned nutritional program and lifestyle program. Good nutrition assists in the fight against flab, the smoothing of temperament, the struggle with substance abuse and the promotion of a general feeling of well-being. Because of the importance of optimal nutrition for optimum health, this area is reserved for further detailed discussion. 182 CHAPTER 5 DIETARY ADJUSTMENTS 183 Reversing Atheroma? Preventive healthcare strategies are difficult to enact and most healthcare interventions occur at the tertiary level when disease states are manifest. An individual may shop for a cure for established cardiovascular disease with a self-reliance that is driven by the fear of continuing ill health or death. These circumstances lead to situations where compliance with treatment for established disease is always more apparent than compliance with preventive strategies. Desperation prevails if an individual develops a disease that is considered progressive or incurable. The good healthcare giver channels this desperation into positive activity that improves both the quality and duration of the life of the victim of disease. The new hope is that much evidence indicates that established atheroma and coronary artery disease may be amenable to variable degrees of reversal. Even if reversal of coronary heart disease is not possible in some individuals, halting progression and general enhancement of wellness are very worthy and achievable goals. The recognition that established atheroma is reversible comes from many sources. Some animal experiments have shown that dietary interventions and/or lipid lowering drug interventions result in variable regression of arteriosclerosis. For example, studies in primates who are fed high fat, cholesterol rich diets show regression of atheroma when fat and cholesterol are removed from the diet. Several human studies show similar effects. Some of the most convincing evidence of the reversal of atheroma emanates from the Framingham Study in Massachusetts. Epidemiological 184 studies of the prevalence of heart disease during World War II linked a lower incidence of heart attacks in the United States to a reduction in the dietary intake of high saturated fat and cholesterol containing foods. Contemporary evidence about the reversal of coronary heart disease comes from studies by Dr. Dean Ornish who has stressed the role of major lifestyle change for heart disease. There are several sources of evidence that dietary and other lifestyle changes can certainly stop the progression of coronary heart disease and reverse the process of atheroma in some cases. The benefit of lifestyle change in improving or reversing arteriosclerotic heart disease comes from the many studies of Ornish (1982). The idea that heart disease due to atheroma can be reversed has been around for about a century but it took 50 years to be registered as a credible treatment approach. Drug therapy has been credited with an ever-increasing role in preventing or ameliorating the consequences of ateriosclerosis. Such drugs include calcium channel blockers, an ever increasing selection of lipid lowering drugs and beta-blocker drugs. In some instances, drug therapy is very necessary but where possible, it seems reasonable to apply natural options as first-line interventions in order to moderate disease, such options should not be forgotten as adjunctive measures in more severe types of atheromatous cardiovascular disease. In any discussion of attempts to rejuvenate the cardiovascular system, the role of chelation therapy deserves special consideration. It has been proposed, largely by the alternative healthcare practitioner, that chelation 185 therapy can reverse atheroma. Chelation therapy in its simplest application involves the intravenous injection of solutions that bind with (chelate) minerals present in the bloodstream. Accounts of chelation therapy, such as “The Chelation Answer” by Drs. Morton Walker and Gary Gordon (M. Evans and Co., 1982), are, in the author’s opinion, unduly optimistic about the outcome of chelation therapy for cardiovascular disease. Chelation therapy for cardiovascular disease due to atheroma is practiced on an everincreasing basis. It is not entirely safe in all hands and should be sought only from the expert facility. It is fair to say that promising evidence is emerging about its potential efficacy but the “jury remains out” on its demonstrated efficacy. Controlled observations of any benefits of chelation therapy remain decidedly lacking. The idea of the “low fat way to a healthy heart” has its roots at the start of the Framingham Study in 1948. The low fat route to health became most popular as a result of more contemporary champions such as Dean Ornish and Nathan Pritikin. The approach of Ornish served to duplicate many of the suggestions of Dr. Nathan Pritikin. The recognition of the work of Ornish and Pritikin is so important and widespread that their methodology deserves careful consideration. Drs. Pritikin and Ornish Speak! Dr. Dean Ornish followed rapidly in the footsteps of Dr. Nathan Pritikin, M.D. in his presentation of the benefits of dramatic lifestyle change for the promotion of cardiovascular health. The work of Ornish has concentrated on stress reduction and diet as an adjunct to conventional medical interventions for the treatment and prevention of coronary artery 186 disease. In controlled clinical research, Ornish and his colleagues showed that stress management training combined with a diet low in animal fat, cholesterol and salt resulted in improvements in several assessment in patients with ischemic heart disease. In these studies, reduction in the frequency of symptoms of coronary heart disease occurred. Most notable were improvements in symptom reduction, total duration of exercise, total work performed and enhanced ability of the heart to pump blood in response to exercise (improved global left ventricular ejection fraction). During these short-term clinical investigations, Ornish and his colleagues noted beneficial changes in the patients’ cardiovascular risk profiles. This was characterized by reductions in total blood cholesterol, plasma triglyceride levels and measures of blood pressure regulation and control. These early observations of Ornish and his colleagues were extremely promising but the extent and intensity of the interventions applied to achieve the cardiovascular improvements were gauged as enormous. Compliance with the kind of interventions used in the important research by Ornish and his colleagues may be quite difficult to achieve. Although beneficial effects of interventions described by Ornish and his colleagues have been noticed in out-patient programs, the degree of self-discipline, personal cost and dedication required has been seen by many as impractical. However, with more contemporary reports of benefit of the Ornish program and an increased recognition of the importance of lifestyle adjustments, the recommendations by Ornish and his colleagues have been applied increasingly by many healthcare givers. 187 Table 35 summarizes the interventions applied by Ornish and his colleagues in order to achieve the beneficial outcomes on cardiovascular health. When the interventions are reduced to the daily timetable (Table 36), the intensity of the interventions that are required to produce a benefit become readily apparent. Ornish maintains, however, that the performance of the interventions for “only a few minutes per day” will result in benefit. The evidence for this conjecture is somewhat lacking. Ornish’s schedule is tough, but worthwhile! The successful interventions and lifestyle adjustments for the promotion of cardiovascular health described by Nathan Pritikin are to be Intervention Stress Management Training: Summary 5 Hours Daily of Each of: 1. Stretching/Relaxation Exercise is non-aerobic, breathing exercises, progressive muscle tensing and relaxing. 2. Meditation Focused attention on breathing. 3. Visualization (Applied Meditation) Thinking focused on heart and its structure and function. Wishing the heart well, or fantasizing exercise tolerance. 4. Environmental Change Subjects were housed in a rural environment with a variable reporting of stress reduction from this environment. 188 Diet: Daily Composition of Diet: 1. Vegan (No Animal Products) 1400 Calories 2. No Salt, Sugar, Alcohol or Caffeine 325 mg Sodium 3. Fruits, Vegetables and Soy Foods 5.2 mg Cholesterol Well Presented Food Table 35: Interventions that have been applied by Ornish and his colleagues. These interventions resulted in objective improvement in cardiovascular health in patients with ischemic heart disease. INSERT Table 36 (See Dr. Holt for table per his note) 189 considered by the author to be the classic basis of current work on the promotion of cardiovascular health by natural means. In a foreward to Pritikin’s book (“The Pritikin Program for Diet and Exercise”), the renowned physician Dr. Dennis P. Burkitt likened Pritikin’s recommendations on lifestyle to the style of life encountered in third-world countries. In third-world countries, there is a much lower prevalence of cardiovascular and other degenerative disease that afflict more affluent Western societies. Dr. Dennis P. Burkitt received more than unjustified “flak” for his proposals than any other contemporary physician but he has achieved complete exoneration in recent years. Of course, Dr. Burkitt admits to an appropriate preoccupation with the beneficial effects of dietary fiber, but his thoughts summarize the principal components of the Pritikin Program. These components include the recognition of the advantages of a switch from refined carbohydrates to complex polysaccharides in the diet. Pritikin stated, “the switch from fats and proteins to carbohydrates comes with enlightenment”. Although Pritikin’s diet stressed that low fat, low protein and high carbohydrates had some implications for cardiovascular health, it was incomplete in its understanding of the beneficial role of essential fatty acids in the promotion of cardiovascular health. Perhaps the “misrepresentation”, or misunderstanding that created concern among healthcare givers was the claim by Pritikin, “Not only is the Pritikin Diet safe and healthy, but it maintains your ideal weight - without any restrictions on food quantity.” To accept this is to deny the role of calories in weight control and to reject the fact that excess carbohydrate is 190 stored as hard, unhealthy fat in the body. It is surprising to the author that Pritikin would get behind this “eat as much as you want” notion. This notion is propagated in some modern day diets and it has little support in science. Who Missed the Boat? Diets that use a relatively high-fat, low-carbohydrate regimen to cause ketosis and rapid weight loss have met with some commercial success. Such diets include the Atkin’s Diet or modifications of the Stillman diets. Pritikin was particularly critical of this approach to weight loss and he indicated that such diets may promote cardiovascular disease. Equally, the proponents of the fat induced ketosis regimens for dieting, such as Dr. Robert Atkins, have been very critical of the Pritikin Diet. The author believes that both sides have missed the boat. In the author’s opinion, success in dieting is calorie counting with a balanced diet that leans toward a ‘vegan component’ not ketosis-induction with its negative metabolic effects (Atkins Diet) or carbohydrate loading (Pritikin Diet). To be entirely fair, Pritikin did stress the preference for complex carbohydrates, as indeed does Atkins, but Pritikin failed to appreciate the intricacies of the effects of fatty acid metabolism on cardiac health which have been addressed to some degree by Robert Atkins, M.D. The author believes that the Atkins Diet and the Pritikin Diet do have some merits, but the ideal is achieved by neither, especially in relationship to the promotion of cardiovascular health. Dr. Fredericks Got It Right! In a most eloquent statement, Dr. Carlton Fredericks and Dr. Herbert Bailey in their book “Food Facts and Fallacies” (1971), indicate “there is no 191 such thing as a calorie that confines itself to the production of energy. Excess calories will usually be stored - alas! - where they can be seen.” Fredericks (1971) reviews the issues surrounding the types of diets that were subsequently proposed and popularized by Atkins and Stillman in recent times where “the calories don’t count” theory abounds. In the author’s opinion, there is a misdirected notion in that a dietary regimen relatively devoid of carbohydrates and high in fat and protein produces effective, rapid weight loss. Overall, this notion of “high or liberal fat” diets is, in the author’s opinion, neither novel nor new, it is partially invalid, perhaps dangerous. It has been considered by some as an example of a food fad and it has found little support among conventional medical practitioners. It is not the author’s intent to be unduly critical of anyone else’s conceived dietary intervention but the “high or liberal fat” diet may do a lot to destroy cardiovascular health, especially if it is misunderstood or misused. The history of the relatively high-fat diet has been traced by Fredericks and Bailey. Several centuries ago, a layman called Banting (cited by Fredericks and Bailey, 1971) proposed the dietary-fat-preponderance-weight loss regimen. This regimen formed the basis of the Salisbury diets which were prepared by the rotund Earl of Salisbury. Pennington (cited by Fredericks and Bailey, 1971) experimented with Salisbury diets and a Dr. Taller (cited by Fredericks and Bailey, 1971) proposed the outcomes of such diets in his book “Calories Don’t Count”. Fredericks appears to be very “down” on the Salisbury, Pennington, Taller and somewhat in anticipation, the modern day Atkin’s approach. This is perhaps a great surprise, since Atkin’s was exposed to Fredericks as a 192 mentor. Taller and Atkins have been roasted by the American Medical Association, who seemingly rejected the “liberal fat” approach. This occurred against a background of the publication by the American Medical Association of the Gordon Diet in 1963. This was a carbohydrate exclusion diet which seemed to share much of the rationale proposed by the “liberal fat”, “calories don’t count” crowd. Diets at the Crossroads Fredericks and Bailey (1971) ascribe this incongruity in the behavior of the American Medical Association to membership of “the club” of conventional medicine. They state “There are two bodies of truth in science today: the total truth, …and the partial truth, defined as the ‘authorities’ decide to define it.” This is a recurring example of the crossroads between conventional and alternative medicine, where no “yield sign” exists. Healthcare givers drive down the opposing pathways to the crossroads without courtesy or recognition of each other. “Knocking” conventional medicine is as futile as “knocking” alternative medical approaches. The answer lies in a search for the truth. Unfortunately, the policeman at the crossroads wears the uniform of conventional medicine, even though the driver down the conventional path may be equally at fault as the driver down the alternative route! Some times accidents happen despite both drivers paying due care and attention to their tasks of compliance. The importance of the approach by Fredericks and Bailey (1971) is that they recognized the importance of a diet balanced in protein, fat and carbohydrate intake to keep the body function as near optimal as possible. These dietary proposals have been self-proclaimed as safe, sane and without 193 discomfort. Fredericks and Bailey were right, in the author’s opinion, even accepting the limitations of prevailing knowledge about health and weight reduction at the time of their recommendations. The Missing Links Are Discovered? The author has proposed that a measure of health or efficacy may exist in all of the popularized dietary approaches, including but not limited to the approaches of Atkins, Stillman, Ornish, Pritikin, Burkitt and others. A general consensus has emerged from more objective studies, such as those of Ornish, that movements of the diet towards vegetarian habits are both safe and efficacious in promoting health. Whilst the author has been free with his criticism of several dietary approaches to promote cardiovascular health and weight reduction, he wants to have some friends left. It is fair to state that comparisons among diets may be unfair to a certain degree because they are apples and oranges. For example, Atkins conceived his plans primarily with weight loss in mind and Pritikin had cardiovascular health at the root of this thoughts. However, during the process of analysis of dietary approaches, two key nutritional principles came to light which support the recommendations of the author to include soy and essential oils in a diet that is optimal for both weight loss and cardiovascular health. Just as it is unwise to just lower cholesterol, it is equally as unwise to plan a diet only with one disease state in mind. Pritikin (1979) endorsed the nutritional benefit of vegetable protein and dismissed the notion that animal protein is nutritionally “superior” to vegetable protein. If calorie intake is even only moderate with a balanced 194 diet, there is no risk of amino acid or protein deficiency. The myth of protein deficiency during average dieting regimens should be dispelled. Pritikin did not review the health benefits of switching from an animal protein source to a vegetable protein source even though evidence of such benefit was apparent at the time of Pritikin’s dietary recommendations. Ornish (1982) made much of the importance of switching towards a vegetarian source of protein. Early work had indicated that there was as much of a correlation between animal protein in the diet and mortality from coronary heart disease as there was between dietary fat and heart disease. Of course, animal protein brings with it a high saturated fat content and a cholesterol burden but animal protein diets may, per se, exert negative health effects. The negative effects operate in a manner independent of the saturated fat or cholesterol content of animal protein-rich foods. It is very notable that Ornish (1982) recognized the pivotal studies of Dr. K.K. Carroll in Canada and those of Dr. C. Sirtori in Italy, that showed that vegetable protein from soy protein lowers cholesterol; but Ornish indicated that these studies were controversial! Despite the apparent controversy, Ornish incorporated soy foods into his cardiovascular health program. This “closet approach” to the use of soy by Ornish may have been a function of his desire to float down the “mainstream” of medicine. Of course, many well-controlled clinical studies show an unequivocal benefit of soy protein containing isoflavones in reducing cholesterol and normalizing blood lipids. “The penny did start to drop” as other proponents of “cholesterol lowering” moved towards the recommendation of fiber supplementation of the diet and a recognition of the health benefits of plant 195 protein and essential fatty acids, such as fish oil (Kowalski, 1989). Soy, Essential Fatty Acids and Fiber Prevail The emerging keys to healthy cardiovascular health and weight control approaches by diet are found in a move towards plant protein ingestion, essential fatty acid supplementation and enhanced dietary incorporation of fiber. Although obvious to many, putting this together is a relatively new concept in dietary approaches to weight control, general health and, in particular, cardiovascular health. However, shoveling in fiber, chewing cardboard-like material, choking on tofu or retching on cod liver oil may not be acceptable to many, even though it could be perceived as necessary by some. The mechanism of incorporation of these nutrients into the diet is very important. This is part of the basis of the author’s recommendation to the appropriate use of palatable, inexpensive dietary supplements in nutritional programs to promote health. 196 CHAPTER 6 NUTRITIONAL INFLUENCES ON CARDIOVASCULAR DISEASE 197 Nutritional Therapy to Lower Lipids: The Dietary Supplement Dietary supplements are a relatively new class of products that are sold over-the-counter mainly in health food stores and, increasingly, in pharmacies. In the USA, the Dietary Supplement Health Education Act (DSHEA) of 1994 permits a somewhat restricted health claim to be applied to dietary supplements but this claim must be limited to a relatively nonspecific claim about wellness or a potential improvement in body structure or function (see Appendix I for a review of DSHEA). The most important feature of DSHEA is that it precludes the sale of dietary supplements for the prevention, diagnosis, or cure of disease, despite the fact that some dietary supplements have safe, reliable and effective biopharmaceutical actions. Some dietary supplements have been produced with a specific purpose of lowering blood lipids and promoting cardiovascular wellness but any health claims for these products are necessarily couched in conservative terms about a health benefit. The reality is that with diet and the “judicious use of dietary supplements”, drug-based, cholesterol-lowering programs could become obsolete for many individuals. There are several natural approaches to lowering blood cholesterol and improving blood lipid profiles which can be used as an adjunct to a well-balanced, low-cholesterol diet for the promotion of cardiovascular wellness. Some nutrients that have a variable role in lowering blood cholesterol are summarized in Table 37. 198 Some Important Dietary Details The selection of the ideal fat composition of a diet is an extraordinarily complex subject. In general, saturated fatty acids will tend to promote atheroma, whereas monounsaturated fats and polyunsaturated fats are not atherogenic. There is an important observation that when a polyunsaturated fat is hydrogenated, as occurs during common food processing (e.g. margarine), it becomes atherogenic, just like a saturated fat. The notion that most types of margarine are protective against heart disease is probably fallacious and whether or not margarine is “healthier” than butter has created enormous debate. Whilst butter contains cholesterol and many margarines do not, neither butter nor margarine are good choices for the serious dieter. The best way to deal with this dilemma is to use fresh vegetable or olive oil as a Nutrient Comment Soy Protein Containing Isoflavones Highly effective, safe, inexpensive. Lowers blood lipids with many ancillary health benefits. Omega 3 Series Fatty Acids Safe, effective, palatable in a delayed (Fish Oils) release format with cofactors to be effective. Fish oil that is not delayedrelease is often not practical or effective. Others: Fiber Garlic Orotic Acid several 199 Iodine Zinc Lecithin Fiber is highly effective and health giving, but unpalatable. Overall, the cholesterol lowering actions of Carnitine Niacin(B3) Vitamin C Chromium of these nutrients are not as well Selenium defined as they are for soy protein Magnesium containing isoflavones or fish oil. Table 37: Nutrients that are used in dietary supplement which lower blood cholesterol. Some nutrients can be used to lower cholesterol with variable success. The author proposes that these nutrients can be taken in food or dietary supplement format as an adjunct to a low-cholesterol diet to lower blood cholesterol. The most effective dietary supplements to lower cholesterol are soya protein containing isoflavones and fish oil containing omega 3 series fatty acids. Dietary supplementation with fish oil and soy protein are highly effective adjunctors to a low-cholesterol diet in lowering blood lipids. Fiber is strongly recommended by the author. substitute for butter or margarine. This inconvenient substitution can be beneficial for those individuals at special risk of cardiovascular disease. The dietary incorporation of polyunsaturated or monounsaturated fats in preference to saturated fat is highly advantageous in decreasing blood lipids and cardiovascular risk. This choice of fats in the diet is particularly important because polyunsaturated fatty acids are much less effective in lowering serum cholesterol than saturated fats are at raising blood cholesterol. Fussing About Fat What is the fuss about fat? Why not just do away with it? The 200 answers rest in a recognition of the beneficial effects of certain dietary fats and essential fatty acids. A grossly deficient fat diet does result in a low serum cholesterol and LDL, but HDL (good cholesterol) may also decrease. The implications of lowering HDL cholesterol are not entirely known and to add to the confusion, polyunsaturated fats (good fats) in the diet may also lower HDL. This has led many thought leaders to espouse the benefits of using monounsaturated fat as the ideal source of fat. Studies of Mediterranean people who eat monounsaturated fat in the form of olive oil show that their rates of cardiovascular disease are as low as people who consume low-fat diets. The main issue here is that monounsaturated fats do not lower HDL and this may be a key factor in promoting cardiovascular wellness. Olive oil in the diet is commended and recommended for the “heart smart’ person. Not all saturated fatty acids are necessarily atherogenic. The main offenders include palmitic, myristic and lauric acid which are ubiquitous in animal fat. Some foods have been rejected inappropriately as unhealthy because they contain saturated fat. Coconut oil, cocoa butter and eggs fall into this category. Eggs are rich in cholesterol but as much as 50% of the fat in eggs is monounsaturated and they are a rich source of lecithin, which can be considered an antiatherogic principle. Bad Eggs, Good Eggs? Eggs are an inexpensive source of enjoyable, dietary protein that are dumped by many diet plans. The most important reason for this is the highcholesterol content of the yolk. Egg whites are preferable but data on the 201 negative effect of eggs on blood lipids are far less than convincing. Whilst some controlled studies in lacto-vegetarians have shown that eggs raise plasma LDL and apoprotein B levels, others fail to demonstrate a significant effect of egg consumption in a free-living population on a standard kind of Western diet. The odd egg in the diet will probably do no harm, especially in view of the observations that blood cholesterol levels appear to be more responsive to saturated fat intake than they may be to dietary cholesterol intake. Rotten Fat Ratios It has been assumed that dietary cholesterol intake may determine serum cholesterol levels. This is a simplistic and naïve notion because the effect of increased dietary cholesterol intake on blood cholesterol depends to some degree on the polyunsaturated to saturated fat intake ratio. As this ratio increases (more polyunsaturated fat, less saturated fat), the effect of cholesterol intake on blood cholesterol is diminished. Fish oil is particularly beneficial in this manner in decreasing the impact of dietary cholesterol intake. Other factors operate to negate a direct relationship between dietary cholesterol intake and blood cholesterol levels. This situation leads to great inter-individual and intra-individual variations in the blood cholesterol response to dietary cholesterol intake. It has been indicated in some studies that over a range of cholesterol intake of 0 - 400 mg/1,000 kcal there appears to be a reasonable relationship between dietary cholesterol and blood cholesterol. Each increase of 1 mg/100 kcal of cholesterol in the diet will result in an increase in blood cholesterol of about 0.1 mg/dL. 202 Selecting Foods The importance of food selection and preparation in maintaining normal blood lipids requires emphasis. Some studies have shown a link between hydrogenated fats and atherosclerosis, implying that vegetable shortenings, margarine and other hardened fats are to be avoided. Indeed, several studies have shown that hydrogenated polyunsaturated fats may actually elevate blood cholesterol. This has been a big question that has been posed to the margarine industry when it rejects butter as “unhealthy”. The cholesterol-elevating effects of some hydrogenated vegetable oils is not completely understood but it may be related to their content of transfatty acids. The most plausible explanation of this phenomenon is that the trans-fatty acids that are found in processed vegetable oils have an antagonistic effect on the action of essential fatty acids. Several scientists have studied the concentration of trans-fatty acids in the fat tissue of individuals who died from coronary artery disease and they have found that the accumulation of trans-fatty acids appeared to be correlated with a risk of death. Thus, the hydrogenated vegetable oil product may not be entirely safe. If put to the test, the author would select modest amounts of butter over margarine, but would prefer to use a fresh untreated oil. Having recognized that some fats are healthy, it should be appreciated that frying and overheating of unsaturated fats makes these “good fats” into “bad fats”. Oxidation of fats tends to promote their atherogenic potential and deep fried foods are notoriously high in cholesterol. The heating of cholesterol during frying results in the oxidation of cholesterol. Oxidized 203 cholesterol is known to be toxic to arterial smooth muscle and it may promote atherosclerosis. At all times the use of a microwave oven is preferred over frying by the author because this cooking method reduces the formation of oxidized cholesterol in the diet. Dietary Fiber Soluble fibers, such as those found in apples (pectin) or beans (guar), are generally more effective at reducing blood cholesterol levels than insoluble fibers. The role of soluble fiber in decreasing cardiovascular risk has been grossly underestimated. In a review of the lipid-lowering ability of fibers, Anderson and Tietyen-Clark (1986) reviewed several controlled scientific studies that indicated that oat bran or beans in the diet can reduce cholesterol by 19%, whereas, guar, pectin and psyllium supplements in the diet can lower cholesterol by 8%, 15% and 16%, respectively. These findings imply that a diet that is high in fiber content is a very useful adjunct to promote cardiovascular wellness. The fiber content of beans, some fruit, carrots and a variety of cereals have been shown to lower cholesterol when incorporated into the diet. Much attention has focused on oat bran as being particularly valuable in the control of blood cholesterol, but it may not be more effective than other types of fiber, especially many of the soluble fibers. Dr. VanHorn (1988) undertook a study in 236 healthy volunteers who were following the American Heart Association guidelines on diet and noted a reduction of blood cholesterol over a period of one month. After this initial period, the volunteers were split into two groups, one of whom received oatmeal supplements and one that did not. It was determined that aatmeal caused 204 reductions in blood cholesterol. This and other studies show the beneficial effect of dietary supplementation with oatmeal on lowering blood cholesterol. Oatmeal is advised because it is inexpensive and quite effective. The efficacy of oat bran is impressive and like soy protein it has been proposed as a real option to avoid drug therapy in the control of blood cholesterol. Kinosian and Eisenberg (1988) performed an important study that examined oat bran as an alternative to drugs for treating high blood cholesterol. This study looked at the cost-effectiveness of oat bran versus two prescription cholesterol lowering drugs (colestipol and cholestyramine). In this study, oat bran was perceived as more cost-effective than these drugs with a conclusion that this natural option may be preferable to drug therapy. Whilst more potent lipid-lowering drugs have emerged since this study was performed in 1988, there is no reason to reject effective natural options to lower cholesterol, such as soluble fiber or soy protein. Focus on Fiber Dietary fiber is widely acclaimed as possessing general health benefits. Fiber in the diet is residue present in plant foods that is not readily digested by human digestive enzymes. Fiber has been called “unavailable carbohydrate”, since it contains complex polysaccharides that are not a significant energy source because of their lack of assimilation by the body. A minor amount of energy is derived from certain fibers in the form of absorbed fatty acids. Plant fiber is delivered into the colon (large bowel), where it is metabolized and fermented by bacteria to produce volatile fatty acids, gas and energy. 205 The delivery of the fiber to the colon is very important in understanding the effect of fiber on human physiology. First, most types of fiber are hydrophilic (adsorb, absorb, and retain water), and they produce bulk for the colon to exert its actions. This bulk assists in normalizing motor function and bulks up the stool. People who consume a high-fiber diet have softer, bulkier stool than those who consume a low-fiber diet. Fiber can alter the normal bacterial populations present in the large bowel, and it can promote the growth of more friendly type of bacteria. Generation of fatty acids and gas from the colonic fermentation of fiber explains why there may be a temporary and often unpleasant period of time when the colon adapts to an extra fiber load. Fatty acids derived from the metabolism of fiber by bacteria may promote frequency of bowel action and excessive gaseousness. Frequency of bowel actions and excessive flatus are common during the early stages of introduction of a high-fiber diet. Thus, many people may fail to assume a high-fiber diet if they are not prepared to withstand its early phase of gastrointestinal adaptation. Consuming a high fiber diet is often a physiological shock to most Westerners, who tend to have contracted, constipated colons that produce small, hard stools. The Fiber Hypothesis Painter et al. (1971, 1972) and Burkitt (1973) are regarded as the champions of the fiber hypothesis. These scientists proposed that a deficiency of plant fiber in the diet may predispose individuals to many of the chronic degenerative diseases that afflict Western society. The fiber 206 hypothesis, as first proposed, was dependent for its support on a great deal of epidemiological data derived by population studies and clinical experience. Drawing conclusions from the occurrence of certain disease profiles in Western culture, compared with those in more primitive cultures, assisted in clarifying the fiber hypothesis (Burkitt, 1973). On average, a vegetarian consumes more than twice the amount of fiber as an individual who consumes a recommended healthy Western diet (greater than 40 g/day versus less than 20 g/day). In more primitive cultures, such as those of African natives, the daily dietary fiber intake ranges from 50 to 150 g/day, especially when maize is the dietary staple. It is interesting to note that the stool weight of many Westerners may be 100 g/day or less, whereas the African native eating maize diets may pass up to 1 kg or more of stool per day. Comparisons of the diets of white and black South Africans have shown that as urbanization of the black person occurs, the diet changes to increase the proportion of fat and protein. In addition, the diet becomes enhanced in refined carbohydrate intake, and the total dietary fiber intake falls dramatically. Coincidental with these dietary changes, the urban black develops a disease profile similar to that of the urban white. Disorders, such as colon cancer, bowel problems, and heart disease, tend to increase in incidence as dietary fiber intake is reduced. Dietary fiber in a variety of forms has been shown to reduce cholesterol, and it may play a major role in the prevention of colon cancer, gallstones, inflammatory bowel disease, diverticular disease, diabetes mellitus, varicose veins, and functional gastrointestinal disease (spastic colon, irritable bowel syndrome). Fiber has an established therapeutic role 207 in the treatment of diverticular disease, colitis, constipation, and functional bowel disease. The fiber hypothesis has an interesting historical twist because it proves Hippocrates to be perhaps a little misguided at least on one occasion. In the fifth century BC, Hippocrates apparently recognized the laxative effect of fiber in bread, but he erroneously concluded that more refined bread was more desirable because it produced smaller quantities of stool. Little did Hippocrates realize that the objective of a good diet is to afford facilitated defecation rather than the early morning strain on the pot. Irritable Bowel Syndrome Irritable bowel syndrome, which has many variants and many names, is one of the commonest reasons for a patient to consult a primary care practitioner. Irritable bowel syndrome is mentioned because it is a classic psychosomatic disorder that is caused, in part, by stress. The Type A personality is familiar with the irritable bowel and the stressed individual with his or her own Cholesterol Time Bomb frequently has this problem. Fiber supplementation of the diet is the pivotal therapy for this disorder. Irritable bowel syndrome causes a spectrum of symptoms and signs, including diarrhea or constipation, abdominal pain, excessive mucus or slime in the stool, gaseous distention, and general dyspepsia. It is estimated that up to three-quarters of the patients attending a gastroenterology clinic may have manifestations of irritable bowel syndrome. The irritable bowel syndrome (also called mucous colitis, spastic colon, spastic colitis, functional colitis, functional bowel disease) appears to result from an inappropriate reaction of the gastrointestinal musculature to stress combined 208 with other physical factors in the gastrointestinal tract. The principal nutritional factor in the causation of this disorder appears to be a deficiency of fiber in the diet. Increasing Dietary Fiber Intake There are several ways to increase fiber in the diet. First, an individual may elect to seek dietary components that are rich in insoluble and soluble fibers. This is a difficult goal for the average person and it often involves moving toward a vegetarian diet. Because of the impracticalities of deriving fiber from natural food sources, many individuals have moved toward the habit of predictable fiber intake in the form of dietary supplements. Unprocessed wheat bran is desirable but unpalatable, and hydrophilic preparations that contain only gel fibers are lacking in the overall benefits of soluble and insoluble fiber. The types of fiber supplements and their properties are shown in Table 38. The advantages of soya-based fibers with insoluble and soluble components are readily apparent in comparison with other types of fiber. Fiber in Soya The fiber content of crudely processed soyabeans is of major interest in the potential promotion of cardiovascular health. Soya fiber shares many of the physical properties of the plant-derived fibers, which are characterized by their water-holding ability and their resistance to digestion. Resistance to digestion causes bulking of the stool. Individuals who consume waterholding (hydrophilic) indigestible fiber have more bulky stool, and the weight of stool passed in a 24-hour period is substantially increased by the addition 209 of fiber to the diet. Preparation Description Bran fiber Fibrous outer layer of cereal grains, usually wheat Contact with water Poorly soluble with water holding dependent on particle size. Plantago Species (Ispaghula) Small dried ripe seeds; Colorless transparent mucilage ovata cellulose-containing forms around insoluble seed P. pysllium walls of endosperm and indica mucilage-containing epidermis Ispaghula Husk Epidermis and collapsed adjacent layer of Plantago species Swells rapidly to form a stiff mucilage Sterculia Gum adhesive Gum obtained from Forms a homogeneous, Sterculia species gelatinous mass Methylcellulose Methyl ether of cellulose Slowly soluble, giving a viscous, colloid solution Soya fibers Insoluble and soluble cotyledon and pulp Universal beneficial properties Table 38: Fiber Supplement Ingredients 210 Dietary fiber is generally derived from the supporting structures of vegetation. These supporting structures are often found in the coverings of vegetables and are abundant in the stems and leaves of plants. Overall, fiber is composed of plant polysaccharides (complex sugars) and lignins that are not amenable to easy degradation by digestive enzymes that are secreted by the human gastrointestinal tract. However, fiber can be degraded by bacteria, which are abundant in the large intestine of humans. The bacterial decomposition of fiber in the colon may produce gas and untoward bloating of the abdomen. Fiber is sometimes considered to be a laxative, but this notice is misleading. For example, bran, when consumed with an adequate fluid intake, can cause a laxative effect. However, certain gel-forming fibers, such as pectin, can be used for their constipating effect to control diarrhea. Therefore, it is more appropriate to consider fiber as a modulator of bowel and other gastrointestinal functions. The effects of dietary fiber on the body are far reaching and differ depending on the type of fiber under consideration (Table 39). Dietary fibers have been generally classified into two broad categories; soluble fiber, such as that found in soyabeans, apples, and legumes, and insoluble fiber, such as wheat bran, which is rich in cellulose, lignin, and pentosan polysaccharides. 211 Insoluble fibers are generally more resistant to digestion or fermentation, but all types of dietary fiber can exert complex effects on the gastrointestinal tract. These effects include interference with the absorption of metals, fats, minerals, and other nutrients. Soluble fibers, such as those found in soyabeans, can be fermented in the colon to produce short chain fatty acids, which can stimulate colonic activity, but these types of fiber do not contribute to fecal bulk in the same manner as insoluble fibers, such as bran of other plant husks. Relatively little research has been performed on the health benefits of soya fiber in comparison with the enormous amount of research literature on the use of insoluble fibers in disease states. There are several reasons to explain this disproportionate interest in bran fiber. On the one hand, the benefits of cereal fiber have received considerable support from the cereal Physiochemical Property Clinical Implications Type of Fiber Physiological Effects Particle formation and water holding capacity Insoluble complexes, e.g., wheat bran, high pentosan polysaccharide plus lignin mixtures ↑Gastric emptying ↓Constipation ↓Mouth to cecum ↓Diverticular transit disease ↓Total gastrointestinal transit time ↓Colonic intraluminal pressure ↑Viscosity ↑Fecal bulk Dilute potential carcinogen Cation exchange Acid poly- ↑Small intestinal 212 Negative sacchardies losses of minerals (e.g., pectins) (±), trace elements (±), heavy metals probably compensated for by colonic salvage, after fermentation of fiber; antitoxic effect mineral balance, Antioxidant Lignin (reducing ↑Free radicals in phenolic groups) digestive tract Anticarcinogenesis (?) Degradability Polysacchardies ↑Gas and SCFAa (especially pectin, production gums, and ↓Cecal pH mucilages) Flatus, energy production Table 39: Physiochemical, Physiological, and Clinical Aspects of Fiber = SCFA, short chain fatty acids. industry, and on the other, this interest has led to the marketing and generation of the scientific support to promote several commercially available insoluble fiber products that are marketed as pharmaceuticals and over-the-counter medications. Fiber and Longevity The role of fiber in the diet and longevity requires discussion. The Zutphen study (Kromhout et al., 1982) not only supported the fiber hypothesis but showed a relationship between dietary fiber intake and a reduction in death from all causes that were examined in the study. The 213 importance of Zutphen’s study has been grossly underestimated in contemporary medical literature. Its strength was that it was a 10-year prospective analysis of diet and death in 871 middle-aged men in Holland between 40 and 59 years of age. In summary, this study showed that men with a low intake of dietary fiber had about a three times greater risk of death from all causes than men who had a high intake of dietary fiber. It was of major importance that the study showed clearly that the risk of death from a variety of causes seemed to decline with an increasing intake of dietary fiber. The Zutphen study indicates that a diet rich in fiber (of the order of about 35 g/day) is protective against death from several chronic disease in Western societies. There is always a problem in projecting a cause and effect relationship from studies of populations and diet (epidemiological studies). In the Zutphen study (Kromhout et al., 1982), other factors may have operated in addition to diet, including such factors as exercise, cigarette smoking, pollution, and psychological issues. However, urbanization and a rise in socioeconomic level have signaled the onslaught of several preventable chronic diseases. Diet seems to be pivotal in retarding this onslaught. Benefits of Eating Fiber Although the benefits of eating fiber are clear, it is difficult to convince an individual to take enough fiber to have a positive impact on health. It is generally agreed that between 20 and 30 g of dietary fiber in the diet is optimal, but there may be great differences in interindividual requirements. There is no magical dose of fiber, and certain people have a limited tolerance to dietary fiber as a consequence of altered frequency of 214 bowel habit or flatus production. In general, science supports the use of combinations of soluble and insoluble fiber because soluble fiber appears to be particularly effective at lowering blood cholesterol, whereas insoluble fiber may help protect against colon cancer. The lack of consumer acceptance of many fiber products has led to their availability in several modified forms. For example, bran is available in a gel-soft preparation, pea fiber can be added to flour, and psyllium has been incorporated into cereals. However, problems exist with these modified fiber products, including a lack of confidence that they have the same health-promoting benefits of the crude product and questionable enhancement of palatability. One of the major reasons that these health benefits of soya fiber and other dietary fiber products may not be generally known by consumers is related to the strict regulation the FDA placed on labeling of dietry supplements in the past. However, the Dietary Supplement Health Education Act of 1994 permits labeling claims on dietary supplements where scientific agreement exists to support the claim of health benefits (Appendix I). How Much Fiber? The Federation of American Societies for Experimental Biology (FASEB) recommended that a healthy dietary fiber intake should be in the range of 20 to 35 g/day, which matches recommendations made by the American Diabetes Association and the National Cancer Institute. The Reference Daily Intake (RDI) of dietary fiber proposed by the FDA for labeling purposes on nutritional products in the United States is 25 g/day, which matches recommendations in several European countries and those 215 made by the Department of Health in Australia. In contrast, the World Health Organization (WHO) has been more specific in defining dietary fiber requirements by expressing recommendations in terms of non-starch polysaccharides. The WHO recommendation for non-starch polysaccharides is 16 to 24 g of dietary fiber per day, which is consistent with estimates of 27 to 40 g of total dietary fiber per day. The WHO have tended to recommend higher fiber intake than other agencies, but the Department of Health in Australia is recommending 30 g/day of dietary fiber as a goal for the Australian public by the year 2000. Different Fibers Cause Much Confusion The notion of differences between products in terms of soluble fiber and insoluble fiber content can be misleading or confusing because analytical methods used to determine this fraction differ widely. The best measure of a fiber is demonstration of effects in clinical studies in humans. Soya fiber that contains insoluble and soluble fiber derived from whole soyabeans has been shown in many studies to exert physiological effects that are consistent with a health benefit. Soya fiber has been shown to play a significant role in normalizing bowel function, and it assists in the control of both constipation and diarrhea. Clinical research has shown that the consumption of 25 to 60 g/day of soya fiber increases the moisture content and weight of stool. In addition, the transit time (time taken for foodstuff to pass through the gut) through the gastrointestinal tract is reduced. Other studies have shown that the addition of 20, 30, or 40 g of soya fiber to the diet in a liquid formula resulted in an increase in the water content, weight, and frequency of bowel actions in young men. More significant were the findings in this study that even modest amounts of soya fiber may cause 216 desirable changes in stool weight. Soya Fiber Lowers Cholesterol Much interest has focused on the ability of several constituents of soyabeans to potentially lower blood cholesterol. Soya protein isolates containing isoflavones are effective a lowering cholesterol, and fiber derived from soya has also been shown to lower blood cholesterol levels when added to a low-cholesterol, low-fat diet. People with elevated blood cholesterol were shown in two clinical trials to have reduced cholesterol from the addition of soya fiber to a lipid-reduced diet. This effect is demonstrable with as little as 25 g of soya fiber per day, which is about the same quantity of soya protein isolate that is required to lower cholesterol. The most complete and relevant study on the lipid-lowering effects of soya fiber was performed by Lo and Cole in 1990. In this 15-week-long double-blind crossover study in 20 subjects, blood cholesterol levels were lowered by an average of 7.7 percent, and LDL cholesterol was lowered by 7.4 percent. The importance of the study is its relevance to day-to-day activity, since the subjects in this clinical trial were free-living individuals with mild elevations of total blood cholesterol levels. How does soya fiber lower blood cholesterol? Unfortunately, the answer to this question is not fully understood, as is the reason for the effect of soya protein isolates and soya isoflavones on blood cholesterol. Some clues to the cholesterol-lowering mechanism emanate from studies in rabbits, where comparisons of lipids were made on soya fiber diets and cellulose-containing diets. Soya fiber diets protected the rabbits from early 217 atherosclerosis of the aorta perhaps due to reduced cholesterol absorption, increases in bile acid secretion by the liver, or as an indirect effect of stool bulking. Increasing stool bulk may cause the elimination of cholesterol and bile acid from the intestine, thereby preventing their reabsorption into the body. Perhaps even more complex factors operate in reducing cholesterol, including effects on the metabolism within the colon or changes in body hormonal responses. Diabetes Mellitus a Cardiovascular Killer Diabetes mellitus is often associated with multiple risk factors for cardiovascular death, such as obesity, hypertension and high blood cholesterol. Soya fiber has an ever increasing role to play in control of diabetes mellitus, which affects many millions of Americans. Tsai et al. (1983) suggested the use of soya fiber as an adjunct to the management of diabetes mellitus. In early experiments, these workers showed that the addition of 15 g of soya fiber to a drink containing 100 g of glucose reduced post-prandial (after meal) hypoglycemia (low blood sugar). Thus, soya fiber was able to smooth the absorption and incorporation of glucose into the body. This work was followed by more definitive studies in which the addition of soya fiber to test meals significantly lowered the blood glucose levels at periods after eating (Tsai et al., 1987). In addition, certain blood lipid levels (triglycerides) were reduced at certain intervals after the meal (Tsai et al., 1987). Soy protein has advantages for the diabetic with renal disease because it is handled much more efficiently than animal protein by the kidney. In conclusion, considerable evidence supports the facts that soya fiber 218 normalizes bowel function, lowers blood lipids, and assists in control of blood glucose levels by avoiding high or low blood sugar in specific circumstances. Get the Right Type of Carbohydrate A diet that has a relatively high content of complex carbohydrates is somewhat protective against cardiovascular disease. Complex carbohydrates are often accompanied in the diet by fiber. One key study that dictates the important of selecting complex carbohydrates and fiber is the Ireland-Boston Diet-heart Study (Kushi, et al., 1985). In this prospective study, over a twenty year period, the diets of three groups of individuals was analyzed and subsequent mortality was surveyed about 23 years later. The analysis showed that cholesterol intake and the ratio of saturated to unsaturated fats were higher in those with coronary artery disease but the individuals who did of coronary disease tended to have much less total carbohydrate and fiber intake in their diet. In this study, Kushi et al. (1985) concluded that the dietary difference that accounted for the increase in coronary heart disease was most likely more related to a decrease in the intake of complex carbohydrates rather than a change in the intake of dietary fat. It is generally agreed that a restriction of refined sugar in the diet is advantageous in the prevention of atheroma. Yudkin (1987) reviewed evidence relating to metabolic changes that are induced by sugar in relationship to coronary artery disease and diabetes. The results of several studies indicate that high sugar (refined carbohydrates) diets tended to correlate with raised blood levels of trigylcerides and cholesterol. Other 219 observations support the evidence of a negative role for sugar (Reiser, 1985). It is known that long-term consumption of simple sugars, such as sucrose or fructose, enhances cardiovascular risk factors. Starches and glucose do not seem to share this negative effect. Alcohol and Coffee Consumption The effect of alcohol consumption on cardiovascular risk factors, particularly blood cholesterol levels, has provoked much debate. Overall, the evidence suggests that drinking in moderation is not overtly harmful. The best evidence for a beneficial effect of moderate drinking on cardiovascular risk comes from a study by Rimm and his colleagues that was published in the Lancet in 1991. In this study, the relationship between alcohol intake and coronary disease was examined in a prospective manner in 51,529 male health professionals. Increasing alcohol intake was found to be inversely related to the incidence of coronary disease after adjustment for other coronary risk factors were made. There are other beneficial effects of moderate drinking which include a reduction in platelet aggregation and an increase in diameter of the coronary arteries. However, alcohol directly suppresses myocardial function at high doses and heavy alcohol consumption is associated invariably with heavy cigarette smoking. The issues are complex but moderate drinking is presumed to be safe. Moderate drinking can be defined approximately at no more than two drinks daily, where one drink is equivalent to 1.5 oz. of liquor, 4 oz. of wine or 12 oz. of beer, approximately. The emphasis on moderation is important. This apparent beneficial effect of moderation of alcohol intake may be due to the fact that moderate drinkers may have 220 moderate lifestyles. These issues are addressed in detail in Chapter 4 of this book. There are no merits to coffee or cola drinking for the person at risk of cardiovascular disease. One alarming study undertaken in Norway indicated that coffee consumption is a predictor of coronary death and it operates at a level more than can be explained by its known effects on raising blood cholesterol. Unfortunately, decaffeinated coffee does not clearly afford protection. The jury remains out on the caffeine content of coffee and risk. However, caffeine, in coffee or cola, is to be avoided in the individual with established heart disease because it can alter heart rate and rhythm, as well as increasing platelet reactivity. There is no reason to avoid decaffeinated, diet cola for the person who seeks cardiovascular wellness. Vitamins A great deal of work exists on the role of vitamins in the prevention or treatment of cardiovascular disease but much of the data are conflicting. Few healthcare givers would argue with the concept that antioxidant vitamins (vitamins A, C and E) could exert a beneficial role in allaying atherosclerosis and heart disease but much emphasis has been placed on niacin because of its cholesterol lowering ability. Niacin has been shown to lower cholesterol and it may reduce the risk of myocardial infarction and death. However, niacin has unpleasant and significant side effects, such as “flushing”, which have limited its use and treatment. Niacin should always be undertaken with medical supervision. One serious limitation of niacin therapy is its relative contraindication in 221 patients with Type II diabetes mellitius. In this situation, niacin may cause poor blood sugar control and increases in serum uric acid. Several other vitamins, with the exception of vitamin D, have been shown to exert a beneficial effect in the treatment or prevention of atherosclerosis. In this regard, vitamin C and E may have a special role but the author believes much of their benefit is ascribable to their antioxidant effects (Table 30). Vitamin therapy in the cardiovascular patient should be undertaken with medical advice only. Minerals The role of mineral supplementation in the prevention or treatment of cardiovascular disease is still very unclear. Some minerals that promote free radical reactions and lipid peroxidation, such as copper, may be contraindicated. In contrast, calcium and magnesium are essential for normal contractile function of the heart. Table 41 summarizes information on minerals and atherosclerosis but it is necessary incomplete. Again, the reader Vitamin Niacin Effect on Atherosclerosis Lowers LDL, total cholesterol and raises HDL but has side effects. Folic Acid Supplementation may reduce plasma levels of homocysteine, an atherogenic amino acid. Vitamin B6 B6 deficiency in animals results in atherosclerosis. Blood B6 levels fall in myocardial infarction and supplementation of B6 may inhibit platelet aggregation and prolong 222 clotting time. Vitamin C Blood and leucocyte C levels are decreased in atherosclerosis. Cholesterol-7-alpha-hydroxylase is vitamin C dependent. Vitamin C stimulates lipoprotein lipose and is required to hydroxylate proline. Vitamin B12 Deficiency of B12 raises homocysteine levels which fall with B12 supplements. Vitamin E Supplement Plasma levels of E are lower in heart disease. may increase HDL, prevent oxidation of LDL, reduce the size of a myocardial infarct, inhibit platelet adhesiveness and stimulate endothelial repair. High doses of E are not recommended except under close medical supervision. Vitamin D Animal studies show deleterious effects of D on blood vessels. Not recommended as a supplement for cardiovascular health. Table 40: A summary of the putative role of some vitamins in the prevention or treatment of atherosclerosis. Readers are referred to a medical practitioner because of the potential danger of adverse effects from some vitamins in the presence of established cardiac disease. Minerals Effect on Atherosclerosis Calcium Ca can decrease total cholesterol and triglycerides and (Ca) deficiencies or excesses of Ca can promote atherosclerosis. It is believed that Ca within cells is involved in atheroma formation. Copper (Cu) Cu deficiency is associated with high blood cholesterol and decreased HDL. Cu is toxic. 223 Iron (Fe) Fe may contribute to atheroma formation. Chromium and (Cr) arteriosclerosis. Cr supplements may raise HDL and lower cholesterol Magnesium (Mg) Mg deficiency is more common than recognized. It can result in an increased risk of coronary disease, sudden cardiac heath, heart attack and abnormal heart rhythm. Selenium (Se) Low blood levels of Se predispose to atheroma. Zinc (Zn) may Zn blood levels may be reduced in atherosclerosis. It LDL. Deficiency of Cr is a risk factor for exert both beneficial and untoward effects on blood lipids. Table 41: A summary of some of the effects of minerals on atherosclerosis. Self-medication with minerals is not advised in the cardiac patient. is referred to a medical practitioner before taking mineral supplements. This subject is highly complex and some metals may compromise cardiac function. Miscellaneous Nutritional Factors There are a large number of nutrients that have interesting but relatively ill defined effects on atherosclerosis. Among the most import are 224 soy isoflavones, bioflavnoids and lecithin. The effects of some of the many nutrients on atherosclerosis are summarized in Table 42. Nutrients L-Arginine Effect on Atherosclerosis Supplementation may assist endothelial function in blood vessels. N-Acetylcysteine Administration has been reported to reduce lipoprotein(a) Aspartic Acid A nebulous role Mg+ and K+ in cardiac disease. Beta-carotene May reduce heart attacks in established coronary heart disease. Bioflavanoids Reduce platelet adhesiveness, antithrombotic. Carritine May improve lipid metabolism and has an effect on myocardial energy expenditure. 225 Coenzyme A Uncertain, beneficial effect on blood lipids. Coenzyme Q10 (Ubiquinane) Lipid soluble antioxidant with protective effect against atheroma, reduces blood viscosity, cardioprotective. Glycosaminoglycans Anticoagulant and lipid lowering effects. Lecithin May normalize blood lipids and reduce platelet aggregation. Effect on lipids is limited and probably related to linoleic acid content. Table 42: Miscellaneous nutrients that exert a potential benefit on atherosclerosis. In many cases the evidence to support their use is incomplete. 226 CHAPTER 7 SOY AND CARDIOVASCULAR HEALTH 227 Overlooking Diet as the Key to Cardiovascular Health Several options exist for the reduction of blood cholesterol, including diet, exercise, alteration of the type of protein consumed in the diet, and drug therapy. There has been an exponential increase in the use of cholesterollowering drugs in clinical practice, but such drugs are expensive, associated with unpleasant side effects, and, on occasion, they can be frankly dangerous (Table 43). The main type of synthetic pharmaceuticals that are used for their cholesterol-lowering effects and their adverse effects are shown in Table 43. These drugs are expensive, and in the author’s opinion, they are overused in conventional medical practice at the expense of considering dietary adjustments as first line options. Premature Prescription Practice? Several multinational pharmaceutical companies have developed cholesterol-lowering drugs as a consequence of the widespread nature of the problem of hypercholesterolemia and the lucrative prospects in this health care area. Physicians may be apt to prescribe synthetic cholesterol-lowering drugs without exhausting the possibility of more natural means of lowering Class/Drug Bile acid sequestrants Cholestyramine Colestipol Action Side Effectsb Remove bile acids from Gastrointestinal distress enterohepatic circulation Constipation lowers LDL by 15-30% Interference with drug and nutrient absorption Nicotinic acid Inhibits secretion of lipoproteinss by liver, modest changes in LDH, VLDL, and 228 Only tolerated by 50% of patients because of gastrointestinal distress, flushing, itching, skin HDL HMG Co Ac reductase inhibitors Lovastatin Provastatin Simvastatin Inhibits cholesterol synthesis in liver, lower LDL by 25%35%, raise HDL by rash, liver toxicity and gout Expensive Abnormal liver function, sometimes serious Needs monitoring of liver 10% Fibric acids Clofibrate Gemfibrozil distress Probucol Myopathy and weakness Increase activity of lipoprotein lipase Cause of gallstones Gastrointestinal and lower triglycerides Modest effect only on LDL and HDL Lowers LDL and protects LDL against oxidation but lowers HDL Myopathy Gastrointestinal distress Lowering HDL is dangerous Prevention of heart disease not well documented Table 43: Cholesterol-Lowering Drugsa. a) All are expensive, sometimes costing in excess of $120 for a month’s treatment, and they have troublesome side effects. b) Adverse effects may be dose dependent. c) HMG CoA, hydroxymethylglutaryl coenzyme A. blood cholesterol. It may be that many patients are being placed at risk from these drugs. For example, Ornish et al (1990) demonstrated that diet was highly effective not only in reducing blood cholesterol but also in causing a variable regression in atherosclerotic disease. Ornish (1990) has proposed a holistic program involving lifestyle change to improve cardiovascular health, but this program may be impractical for many individuals. 229 Soya Protein Isolates are Effective at Lowering Cholesterol The preoccupation with cholesterol-lowering strategies has led to a situation where the important effects of dietary protein sources on cholesterol have been overlooked. It has been recognized for approximately 100 years that animal protein may promote atherosclerosis and that vegetable protein lowers cholesterol and, by inference, the risk of atheroma. The main types of abnormalities of blood lipids are summarized in Table 44. Unlike the need to match one cholesterol-lowering drug with one type of blood lipid disorder, soya protein in the diet is effective for most types of hypercholesterolemia. Dr. James Anderson of Kentucky has demonstrated in his article in the New England Journal of medicine in 1995 that many studies indicate that soya protein lowers cholesterol. Soya protein supplementation of the diet is the Abnormal Blood Lipid Laboratory Findings Lipoprotein Patterns Hypercholesterolemia Mild Moderate Severe High Cholesterol 200-239 mg/dl 240-300 mg/dl ≥ 300 mg/dl High LDL Cholesterol 130-159 mg/dl 160-210 mg/dl ≥ 210 mg/dl Hypertriglyceridemia Moderate Severs High Triclycerides 250-500 mg/dl High VLDL >500 mg/dl High VLDL and high chylomicrons Mixed Hyperlipidemia High Cholesterol (>240 mg/dl) High Triglycerides 230 Lipoprotein Phenotype Classification Type II Type IV Type V (>250 mg/dl) Combined hyperlipidemia Dysbeltalipoproteinemia Chylomicroemia Low HDL None High LDL and high VLDL Type IIB High -VLDL High VLDL and high chylomicrons Low HDL (<35 mg/dl) Type III Type V Table 44: Type of Abnormalities of Blood Lipids obvious choice for lowering blood Cholesterol by natural means in clinical practice. Why has this been such a well-kept secret? The answer may lie in vested interests of conventional health care. Aggregation of the evidence for a cholesterol-lowering effect of soya protein provides a circumstance of excellent scientific agreement that supplementation of the diet with an appropriate soya protein isolate will lower blood cholesterol efficiently and safely. Dr. Carroll has published an excellent , well-referenced review of the beneficial effects of soya protein on blood cholesterol levels in 1991. In this review of 40 scientific studies of the effects of soya protein intake on blood cholesterol, Dr. Carroll concluded that 34 of the studies showed a positive effect of soya protein on lowering blood cholesterol by more than 15 percent of pretreatment levels in many 231 cases. In these studies, it was notable that soya protein significantly reduced low-density lipoproteins (LDL, so-called bad cholesterol), an effect that often occurred independently of dietary fat or cholesterol intake. Recently, Dr. Anderson (1995) presented an excellent statistical analysis of 36 reports of clinical studies. Table 45 is modified from Dr. Study No. of Subjects Soya Preparationb Amount of Soya (g/day) Bakhit et al. Bakhit et al. Carroll et al. Carroll et al. Descovich et al. Fumagalli et al. Fumagalli et al. Gaddi et al. Gaddi et al. Giovannetti et al. Goldberg et al. Goldberg et al. Holmes et al. Holmes et al. Huff et al. Jenkins et al. Laurin et al. Lovati et al. Meinertz et al. Meinertz et al. Mercer et al. Potter et al. Sacks et al. Shorey et al. Sirtori et al. Sirtori et al. Steele Steele van Raaij et al. van Raaij et al. van Raaij et al. Verrillo et al. Verrillo et al. 21 11 6 10 127 4 3 16 20 12 12 4 12 10 5 11 9 12 10 11 5 25 13 24 20 65 14 18 24 20 20 19 38 ISP ISP ISP, TSP ISP, TSP TSP TSP TSP TSP TSP ISP ISP TSP TSP TSP TSP, ISP ISP ISP TSP ISP ISP ISP ISP ISP ISP TSP TSP ISP ISP ISP ISP TSP TSP TSP 25 25 47 44 47 39 39 56 75 71 90 90 27 62 41 28 31 64 113 124 17 50 27 55 47 47 21 26 54 53 55 31 31 232 Vessby et al. Widhalm Widhalm et al. Wolfe et al. 6 11 23 7 TSP ISP ISP ISP 37 20 18 47 Table 45: Characterists of 38 Studies Used in the Analysis Reported by Anderson et al.a a ) Modified from Anderson et al. N Engl J Med 333:276-282, 1995. b) ISP, isolated soya protein; TSP, textured soya protein. Anderson’s review of these studies, which show substantial reductions of blood cholesterol by soya protein supplementation or switching to soy protein in the diet. It should be noted that the reductions in blood cholesterol and lipids are similar to those achieved with maintenance doses of synthetic pharmaceuticals. Synthetic, lipid-lowering pharmaceuticals produce significant reductions of blood lipids at relatively high doses. Since adverse effects of lipid-lowering drugs are often dose dependent, it is bewildering why the healthcare professional or the hypercholesterolemic patient would opt for pharmacotherapy instead of considering dietary supplementation with soya protein. This soy study by Dr. Anderson in 1995 has had a major impact on conventional and alternative medical practice. Anderson and his colleagues have traced work that demonstrates that vegetable protein in the diet, as a replacement for animal protein, appears to be associated with a lower risk of coronary artery disease. The major reason for this finding relates to the ability of vegetable-based diets, particularly soya-based diets, to lower blood cholesterol. This ability of soya protein to lower blood cholesterol and protect against vascular disease (atherosclerosis) has been recognized for nearly a century! 233 Is Soy Rabbit Food? The importance of the work of Anderson et al. (1995) is that it flies in the face of statements by the Nutrition Committee of the American Heart Association, which erroneously concluded that soy protein decreases serum cholesterol concentrations in rabbits but not in humans. This learned body must now reconsider its findings given the convincing data provided by meta-analysis of studies of soya proteins cholesterol-lowering effects. Anderson et al. (1995) have shown conclusively that the consumption of soya protein-containing isoflavones ins the diet, in contrast to animal protein in the diet, significantly decreases serum concentrations of total cholesterol, LDL cholesterol, and triglycerides without significant effects on HDL cholesterol. The analysis by Anderson et al. (1995) of 38 data sets derived from controlled clinical studies showed that replacement of animal protein in the diet with soya protein caused beneficial changes in blood lipids, although the mechanism of the effect is not entirely understood. The most important finding was that decreases in serum cholesterol were noted in a manner that appeared to be independent of any changes in body weight and dietary intake of total fat or saturated fat or cholesterol. The authors imply the folly of the conclusions of the Nutrition Committee of the American Heart Association, where no conclusion was reached on the cholesterol-lowering effects of soya protein in humans. It would appear that the conclusion of the American Heart Association was based on the findings of one study (Huff et al., 1977), whereas the conclusions of Anderson and his colleagues (1995) were based on an analysis of 38 studies (Table 45). The author has compared the use of soya protein isolates with synthetic, lipid-lowering 234 pharmaceuticals (Holt, 1996). Soya protein isolates have clear advantage over drug therapy as an initial adjunctive to a low-cholesterol diet in the reduction of blood cholesterol. How Does Soy Lower Cholesterol? Several authors have speculated on the mechanisms that may be responsible for the effects of soya protein on blood lipids. Reference has been made to a possible action of soya protein in altering the ratio of serum glucagon to serum insulin levels, which, in turn, may affect the synthesis or excretion of cholesterol by the liver. An alternate mechanism of an effect of soya protein may be related to increases in serum-free thyroxine levels in the blood (thyroid hormone). This thyroid hormone level appears to be variably elevated in individuals who consume soya protein in their diet. It is of particular note that some studies have shown that a dietary intake of 25 g of soyabean protein, with or without soya fiber, reduces blood lipids in men with elevated cholesterol concentrations. The amino acid composition of the diet seems to exert major effects on serum cholesterol levels, at least in animals. It would appear that increases in arginine are associated with decreases in blood cholesterol concentrations. The amino acid content of soya protein may exert effects on elevated blood cholesterol. Finally, there is a possibility that alterations in cholesterol absorption and the constituents of bile occur as a consequence of soya intake, but this cholesterol-lowering mechanism is not clearly defined. Some scientists believe that substitution of soya protein in the diet for meat or dairy protein may affect the metabolism of lipoproteins and 235 cholesterol in complex ways. These mechanisms of action of soya protein are believed to be due to increasing the turnover of very LDL (VDLD) or apoprotein B (a molecule involved in regulation of VLDL) or perhaps to effects on LDL receptor activity. Of all suggested mechanisms for the cholesterol-lowering effect of soya protein, Dr. Kenneth Setchell from Cincinnati, Ohio, believes that soya estrogens (isoflavones) may contribute greatly to the lipid-lowering effects of soya. This provides further insight into the incredible versatility of the soya isoflavones (genistein and daidzein). The rationale for implication of soya estrogens as cholesterol-lowering agents comes from experiments in which the administration of oral estrogens or the synthetic weak estrogen tamoxifen can be shown to decrease both serum LDL and cholesterol levels. It has been proposed that isoflavones in soya are capable of similar actions to those that occur with oral estrogens and tamoxifen. Very interesting studies in monkeys show that soya isoflavones account for up to three quarters of the measurable effect of lowering blood cholesterol. If soya protein that is lacking in isoflavones is fed to primates, blood cholesterol is not reduced, but when soya protein-containing isoflavone is given, blood cholesterol is lowered. Monkeys are the closest animal model to humans, and, therefore, the results of these experiments appear to have definite relevance to the observed human effects of a diet supplemented with soya protein-containing isoflavones. Further evidence of the effects of isoflavones on lowering blood cholesterol comes from several sources that are reviewed in a book titled 236 “Soya for Health” by the author of this book, Dr. Stephen Holt. It has been shown that adding isoflavones to the diet can cause blood cholesterol to fall by as much as 35 percent. These findings provide more support for the isoflavone content of soya protein isolates as a promoter of general wellbeing and health. The hypothesis that plasma amino acids and their effect on the insulin/glucagon ratio offer an explanation for the cholesterol-lowering effects of certain dietary protein combinations, is of special note. Soya protein contains large amounts of glycine and arginine, which tend to reduce blood insulin levels. Low insulin levels decrease the hepatic (liver) synthesis of cholesterol. In contrast, animal proteins are low in glycine and arginine but tend to contain more lysine than vegetable proteins. Lysine tends to raise insulin levels, and it promotes cholesterol synthesis. This occurrence is confirmed by the recognition that the greater the lysine content of certain foods, the greater of likelihood that blood cholesterol will increase. There is no question that vegetable protein, such as soya protein, is more effective at controlling blood cholesterol than diets that are based on a recommendation of meat protein, even when lean meat is incorporated in the diet. Several components of soyabeans other than protein may have a cholesterol-lowering effect, including isoflavones, fiber, phytosterols, saponins, and lecithin. Lecithin has been touted repeatedly as a cholesterollowering agent, and it has enjoyed considerable use in a relatively purified format for the reduction of blood cholesterol as a consequence of some early beneficial observations with its use. However, the relatively large amount of 237 lecithin required to lower blood cholesterol and the real concerns about its efficacy in reducing cholesterol limit the use of this dietary factor. The presence of lecithin in soya products is advantageous but apparently not critical to the health benefit of soyabeans, at least as far as lowering blood cholesterol is concerned. Fiber contained within soyabeans can lower blood cholesterol, and this lipid lowering effect is shared by many different types of dietary fiber. Total dietary fiber intake is important in maintaining good health, and other efficient sources of fiber include bran, oats, and other grains that are not over-refined. Soyabeans contain both soluble and insoluble types of fiber with potential health benefits. Unfortunately, whole soybeans are required for complete fiber content and few individuals in Western countries would accept the flatogenicity or unpalatability of intact soybeans. Saponins and phytosterols contained within soya products may also act to lower blood cholesterol. Saponins, which bear a chemical similarity to cholesterol, may cause blocking of absorption or enhancement of excretion of cholesterol by the body. A coincidental increase in the prevalence of cardiac disease in some countries has bee noted in association with a reduction in the levels of consumption of vegetables that contain saponins. The beneficial effects of saponins on cholesterol status that have been described by have not been universally confirmed in all studies. Phytosterols can lower cholesterol by competing with the intestinal absorption of cholesterol, but food processing of vegetable or soya oil by hydrogenation is known to diminish the action of phytosterols. 238 How Does Soy Promote Cardiovascular Wellness? One major aspect of the explosive interest in soy foods is the recognition of their potential to treat or prevent cardiovascular disease. Soy foods and recipes with bulk fractions or derivatives of soybeans have become increasingly popular. When soy is taken in these formats some uncertainty exists about the types or amounts of the various health giving fractions of soy that are incorporated into the diet. This drawback, together with the lack of palatability and inconvenience of some soy foods, has led to major activity in the Dietary Supplement Industry to produce products that can deliver certain specific fractions of soy in dosages that may assure the health giving benefits that can be ascribed to soy. Concern is being expressed by some scientists that the Dietary Supplement Industry may be producing soy products with irresponsible or inappropriate health claims. There may be a measure of truth in this point of view, but many manufacturers of soy products are pursuing the development of soy products with standardized contents so that the known health benefits of certain fractions of soy can be presented in a convenient format. In many cases, the amount of a certain soy fractions required to produce health benefits cannot be readily taken in a diet that relies on existing soy foods. This results from a lack of standardization of the content of some soy food and a lack of consumer acceptability of their taste, cost or palatability. What is in a Soyabean? The soybean is a complex legume with quite an amazing diversity of bioactive nutrients. The components of soybeans that have relevance to the 239 promotion of cardiovascular wellness are summarized in Table 46. There has been a considerable amount of interest in the cholesterol-lowering ability of soy protein. Soy protein is a principle ingredient in some cholesterollowering dietary supplements. It is true to say that the actual mechanism of the cholesterol-lowering effect of soy remains unknown to some degree. However, recent evidence suggests that the composition of soy protein per se has complex effects on lipid metabolism and the isoflavones profiles. Table 47 indicates the most recent research on the cholesterollowering effects of soy at the time of writing of this book. It describes the mechanisms of such effects. These data were presented at the Second International Symposium on the Role of Soy in Preventing and Treating Chronic Disease which was held at the Brussels Conference Center in Belgium between September 15-18, 1996. What Other Cardiovascular Benefits are Present in Soy? There are several beneficial cardiovascular effects of soy foods that can be explained in a manner independent of their effect on blood cholesterol Fraction of Soybean Cardiovascular Effect/Benefit Soybean Oil Fresh oil contains 7% omega 3, 50% omega 6 and 26% omega 9 fatty acids, lecithin, phytosterols. Commercial soybean oil is refined or partially hydrogenated. This destroys some essential fatty acids that are associated with cardiovascular wellness. Lecithin Made often from soybean oil and contains omega 3 240 fatty acids. It is a phospholipid with diverse functions on blood lipids and cell membranes. Isoflavones (genistein, daidzein) Soy Protein Isoflavones have a well defined role in cholesterol lowering and possess anti-atherogenic and antithrombotic effects. Protein of soy origin has a very convincing role for soy protein in lowering cholesterol and improving blood lipid profiles. Peptides Peptides in soy may chelate oxidizing elements in the diet and may lower blood pressure in a similar manner to angiotensin enzyme converting inhibitors. Table 46: Fractions of Soybeans with Cardiovascular Benefit Author Title Sirtori, C.R.; Manzoni, C. et al Soy and Cholesterol Soy protein lowers cholesterol Reduction: Clinical somewhat independent of Experience and isoflavone content. Soy Molecular Mechanisms globulins may cause liver LDL receptor stimulation Potter, S.M.; Baum J.; et al Effects of Soy Protein & Isoflavones on Plasma Lipid Profiles in Post-menopausal Women 241 Summary Soy protein (40 gm/day) with variable isoflavone contents lowers risk of cardiovascular disease in post-menopausal females by lowering cholestrol and improving lipid profiles. Kurowshal, E.M.; Role of the Main Jordon, J.; et al Components of Whole Soybean Products, Soy Protein and Soy Oil, in Reducing Hypercholesterolemia Whole soybean products can improve lipid profile by virtue of their protein content and the effect is greater in subjects with higher LDL and lower HDL. Nilausen, K; Variation in the Plasma There may be different types of Meinertz, H; Lipoprotein Response to responses to soy protein involvet al Dietary Soy Protein in ing anti-atherogenic and Normolipidemic Men atherogenic lipids. Auboiron, S; Effects of Soy Proteins In health men on low Catala, I; et al on Plasma Lipoproteins cholesterol diet not a direct in Healthy Men action via LDL as shown in hypercholesterolemic states. Table 47: Page 1 of 3 Author Title Summary Widhalm, K. Treatment of HyperCholesterol lowering drugs cholesterolemia in should be avoided in children Children by Diet Using and soy protein should be used Soy Protein preferentially to lower cholestrol in children and adolescents. Wong, W.W.; Hachey, D.L.; et al Mechanisms for the Hypocholesterolemic Effect of Soy Protein Normocholesterolemic and Hypercholesterolemic Men Yamamoto, S; Yamamoto, T; Anticholesterolemic Animal and human studies Effect of the Undigested suggest that the cholesterol 242 Soy protein was shown to enhance the cholesterol lowering effect of the National in Cholesterol Education Program Step 1 diet by up-regulation of cholesterol excretion. et al Fraction of Soybean reducing effect of soy protein Protein could be due to binding of soy peptides with steroids in the gut or peptides that are absorbed with a direct effect on lipid metabolism. Anthony, M.S.; Clarkson, T.B.; et al Mechanisms Effects of Soy Isoflavones on Atherosclerosis: Potential Isoflavones reduce atheroma and improve coronary artery reactivity in monkeys. Tumbelaka, S.; The Lack of Effect of Studies on monkeys indicate Sutanto, J.; et al Isoflavones on Plasma that the beneficial cardioLipid Concentrations vascular effects of isoflavones in Ovariectomized may not be due to altered lipids Cynomolgus Monkeys or prevention of LDL oxidation. And LDL Susceptibility to Oxidation Table 47: Page 2 of 3 Author Title Summary Moundras, C.; Interactions Between Rat studies show effects of soy Remesy, M.A.; Soy Protein and Soy fiber and isoflavones have et al Fiber on Lipid Metacomplex interacting effects on bolism in the Rat normalizing blood lipids. Chanussott, F.; Polichetti, E.; Stimulation by Soybean Soybean lecithin is effective in Lecithin of Cholesterol mild hyperlipidemia by stimulaet al Transfer from Plasma to tion of cholesterol transport at Biliary Compartment: the hepatocellular level. Mechanisms of Cholesterol- and Triglyceride Lowering Effects in the Liver Manzoni, C.; HEP G2 Catabolism of 243 In vitro experiments show the Lovati, M.E.; a and a’ Subunits From potential importance of the 7S 7S Soy Globulin, is soy globulin in the up-regulation Correlated With Their of LDL receptors. Up-Regulation of LDLReceptors Table 47: Page 3 of 3: Hypocholesterolemis Effects of Soy or lipid reduction. Soy isoflavones appear to be anti-atherogenic, antithrombotic and they have powerful anti-oxidant effects. Some of the most recent information on the beneficial cardiovascular effects of soy that occur independent of lipid reduction are summarized in Table 48. These data were presented at the Second International Symposium on the Role of Soy in Preventing and Treating Chronic Disease which was held at the Brussels Conference Center in Belgium between September 15-18, 1996. Summing Up On Soy Many popular magazines, newspapers and consumer books highlight the health giving properties of the soybean. However, it is apparent that the amount and range of the health giving fractions of soybeans that are required 244 to achieve the health benefit, cannot be obtained from ordinary soyfood supplement of the diet. In the author’s opinion, this creates a real need for responsible dietary supplements that are made with a high degree of quality control. Such dietary supplements will probably emerge in the near future. There is a switch away from animal protein to vegetable protein incorporation Author Title Summary Kanazawa, T. prevent- Anti-Atherogenic Soybeans are useful for Effects of Soybean ing cardiovascular disease by Protein. Viewpoints several mechanisms, including: from Peroxidizability antioxidant effect and suppresand Molecular Size of sion of enlargement of the LDL and from Antimolecular size of LDL, antiPlatelet Aggregation platelet aggregation, and lipid lowering. Astuti, M. The Role of Tempe Tempe contains soy protein, on Lipid Profile and Vitamin B12, iron, isoflavoids Lipid Peroxidation and super-oxide dismutase. Animal experiments show that fermented and unfermented soybeans lower lipids and exert effects through modulation of the effects of iron on lipid per- oxidation, probably by the formation of chelate com-plexes. Wang, W.; Antioxidant Properties Using an ex-vivo system to Franke, A.; et al of Dietary Phenolic measure changes in LDL Agents in a Human oxidation, isoflavones have LDL-Oxidation Ex antioxidant effects. Vivo Model Chait, A. Effects of Isoflavones Studies of in vitro and in vivo on LDL-Cholesterol in LDL oxidation confirm the 245 Vitro But Not in Vivo antioxidant properties of both genistein and daidzein, which may work in a similar manner to Vitamin C. Genistein and daidzein may be of value in the prevention of atherosclerosis. Table 48: Page 1 of 2 Author Title Summary Schoene, N.W.; Genistein Inhibits Genistein produces a decrease & Guidry C.A. Reactive Oxygen in platelet aggregatory Species (ROS) Forma- responses and has potential antition During Activation thrombotic action. Of Rat Platelets in Whole Blood Martinez, R.M.; Soy Isoflavonoids Soy isoflavones (genistein, Gimenez, I.; et al Possess Biological daidzein and equol) inhibit Activities of Loopcertain ion transport systems, Diuretics similar to the loop diuretic furosemide. Table 48: Page 2 of 2: Beneficial Cardiovascular Effect of Soy Independent of Lipid Reduction 246 in the human diet for a variety of reasons. Soy protein is a much more ecologically sound source of protein than animal protein and it appears to have many recognizable health benefits. Can Soy Milk Replace Cow’s Milk? It is clear from many large international studies that high blood cholesterol levels in children may have contributed to coronary artery disease in adults. Dr. Charles R. Attwood has drawn attention to studies from North and South America, Asia, Europe and Africa which confirms this situation. It is apparent that the increased intake the dairy products, particularly cow’s milk, has occurred in relatively recent times in several third world countries. A revealing study was reported in the International Journal of Cardiology in 1990 in which autopsy studies were reported in 100 children who died between the age of 1 and 20 years in Veneto, Italy. These children had died from causes unrelated to cardiovascular disease but a study was made of the changes in the major arteries in the body. Of particular note was the presence of thickening in the coronary arteries which was present even in children between the ages of 1 and 5 years. The researchers involved in this study related some of these changes of premature 247 arteriosclerosis to some of the reports of sudden death in young adults. Other studies in Italy have confirmed the alarming incidence of high blood cholesterol levels in children from the Northern parts of Italy. There has been a similar increase in the intake of dietary fat and cholesterol in African countries where high blood cholesterol has emerged among the more affluent black population among urban areas. Much of the increased intake of dietary fat and cholesterol in children is due to higher intakes of meat and particularly dairy products. Dr. Charles Attwood considers this situation of increased intake of milk products to be so pernicious that he has quoted statements from the Physicians Committee for Responsible Medicine (PCRM) who held a press conference in Boston in 1992 and made certain statements about the unhealthy nature of dairy products. This “Committee” was particularly critical about the consumption of cow’s milk during infancy in childhood and some evidence was quoted, indicating that this intake of cow’s milk may be responsible for causing several major diseases, including coronary artery disease, cancer, allergies and perhaps diabetes mellitus. On the one hand, some physicians such as Dr. Frank Oski (Chief of Pediatrics at the Johns Hopkins University), have indicated that there are no advantages to cow’s milk, whereas on the other hand, physicians such as Dr. Ronald E. Kleinman (Chairman of the American Academy of Pediatrics Committee on Nutrition) think that such opinions are well founded. Soy milk is now widely available in Western communities and in some Southeast Asian countries it has by far superseded the use of cow’s 248 milk. There are several advantages of soy milk versus cow’s milk which are summarized in Table 49. Dr. Charles R. Attwood in his book “Low Fat Prescription of Kids” stands firm on the position that cow’s milk intake may cause damaging effects in as many of three-quarters of children, based on his own clinical experience in his practice. Dr. Attwood points out that cow’s milk delivered during infancy and early childhood contributes to anemia, asthma, sinus disease, eczema and high blood cholesterol. In contrast to cow’s milk, soy milk is an insignificant source of saturated fat. The protein content of soy milk is equivalent to that of cow’s milk and although allergy to soy has been described, it appears to be far less prevalent than allergy to cow’s milk protein. There has been a recent debate about the importance of isoflavones in soy food as a potential problem for infants, but this matter seems to have been adequately resolved in recent studies where there is no evidence that untoward effects have occurred as a consequence of the administration of soy milk to infants. Missing TABLE 49 referenced above Is Soy Milk Dangerous in Infancy? This matter has been extensively reviewed in a recent meeting of world experts in Brussels at the Second International Symposium for the Use of Soy in the Prevention and Treatment of Chronic Disease. NOTE: Asked on tap to leave a space for this subject. 249 End of Tape 250 CHAPTER 8 THE OMEGA FACTORS 251 Do Not Skip This Chapter! Understanding the importance of omega 3 and omega 6 essential fatty acids in the diet is hard work, even for the healthcare professional. Before readers skip this stuffy chapter of this book they should pause a moment and consider that essential fatty acid deficiency is probably one of the most important, overlooked influences of cardiovascular and general health. It is estimated that four one fifths (80%) of the population of Western communities take insufficient quantities of essential fatty acids in their diet. This situation may be more important than vitamin deficiency. So important is this issue that the author would like to point to several contemporary sources of information that can supplement a reader’s knowledge of the subject. In addition, no apology is necessary that the author has been somewhat repetitive in his description of the concepts that underlie the health importance of essential fatty acids in the diet. Perseverance is rarely popular or enjoyable but it is often effective. The world of medicine has net yet taken “its cap off” to the pioneers of the field of essential fatty acid research, but will they soon? The pioneers in popularizing these important concepts include Dr. Udo Erasmus, Dr. Edward N. Signel, Dr. Caroline Shreeve, Dr. David Horrobin, and Dr. Michael T. Murray. Their works are highlighted in the bibliography of this book, where their readable accounts of the health implications of selected fats and oils are summarized. Not All Fats Are Bad 252 Fat is regarded as a dirty word by many health conscious individuals. This unfortunate assumption overlooks the importance of essential fats as health giving nutrients and it has led to a modern dietary deficiency state of essential fatty acids that has passed unrecognized by many. The role of a diet that is high in saturated fat in the causation of a variety of common killer diseases is quite clear, but the role of fats in the promotion of health is still clouded. Indeed, there are many fats that cause ill health but equally there are dietary fats that are obligatory to promote good health. The negative health connotation of excessive dietary fat has overshadowed the importance of the more “healthy types” of fat in disease prevention or cure. For example, the individual patient with cardiovascular disease or the person who wants to avoid colon cancer is told frequently to avoid fat in the diet. While saturated fat of animal origin is associated with cardiovascular disease and colon cancer, certain types of unsaturated fats are associated with the prevention or treatment of cardiovascular disease and cancer. This is the relatively poorly understood enigma. There is much confusion about the health giving benefits of certain types of dietary fats and ignorance about fat in the diet prevails among the health care giver, let alone among patients or health conscious individuals who are seeking an ideal diet for health. This situation has made dietary fat the most misunderstood of all dietary constituents in terms of its health implications. On the one hand, the readers of this book already know that many fats are unhealthy but on the other they probably know relatively little about the health giving benefits of essential fatty acids that are found in unsaturated fats. 253 There are two important categories of essential fatty acids including omega 6 series and omega 3 series fatty acids. Omega 6 series fatty acids are ubiquitous in the diet and are found to a major degree in vegetables, whereas, omega 3 fatty acids are relatively confined to marine sources. Omega 3 fatty acids are found largely in fish and marine mammals. There are interesting exceptions, certain legumes, such as soyabeans, contain significant fractions of omega 3 fatty acids. The two most important omega 3 fatty acids with health giving benefits are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Understanding the Chemistry of Essential Fatty Acids Fats may be solids or liquids and the key structure of a fat includes the presence of one molecule of glycerol to which is attached three fatty acid molecules. Fatty acids come in various sizes and their chemical nature determines their overall structure. Fats are incorporated into a variety of areas in the body. Neutral fat or triglycerides circulate in the blood stream. These substances contain fatty acids and fatty acids and they are found in fat stores throughout the body. In addition, fatty acids are part of the principle structural components of cells. They assist in the formation of membranes that compose cells walls or walls within cells. These intracellular walls surround organelles (cellular components), such as mitchondria or lysosomes. These organelles within cells of the body are key sites that are responsible for body metabolism. The biochemistry of fats is a complex subject but the main focus of interest is to understand the different types of fatty acids, since this 254 knowledge is a key to the understanding of the health giving benefit of fat in general. A saturated fatty acid is one in which the bonds between the carbon atoms in the molecule contain a shared pair of electrons to form a single bond. In contrast, unsaturated fatty acids contain double bonds. In broad general terms, saturated fatty acids are found within the “less healthy” type of fats, whereas unsaturated fatty acids are found within the “more healthy” type of fats. This oversimplification requires further explanation. Saturated fatty acids occur mainly in food of animal origin, whereas unsaturated fats tend to be found in food of vegetable origin. One key area in the understanding of fatty acids is that the presence of a double bond in the unsaturated type of fat. The unsaturated bond tends to make the fatty acid component less stable than that found in the saturated fat, where the fatty acid has a single bond. This means that unsaturated fatty acids tend to be more active chemically and capable of reacting with a variety of chemical substances that “crop up” in metabolic processes in the body. These metabolic processes which involve reactive, unsaturated fatty acids, include reactions with oxygen, sulfur (to form sulfydryl groups), or water (to form hydroxyl groups). The term polyunsaturated fatty acid merely refers to unsaturated fatty acids that have two or more double bonds within the molecule. The general use of the term “polyunsaturated” fat applies to omega 6 fatty acids which are found in vegetable oils that are used often in food and cooking. In contrast, omega 3 fatty acids are often referred to as “super-unsaturated” fatty acids to distinguish them from the garden variety omega 6 type fatty acids. There is a general belief that increasing the dietary intake of polyunsaturated fatty acids in the diet is an ideal goal. This belief has not worked to general benefit because it has led to the modern 255 dietary habit of consuming polyunsaturated fats at expense of forgetting the omega 3 factors or EPA and DHA which are cardiovascular protectors. Oils Produced by Bad Processes The manufacturers of essential oil products are confusing consumers on a daily basis when they engage in endless discussions of the advantages and disadvantages of various manufacturing techniques that are used to prepare oils containing essential fatty acids. Anyone who wants to make sense of how good oils are produced will be confused by manufacturing terms such as bleaching, hulling, tempering, degumming, deodorizing, expeller pressing, gravity settling and hydrogenation. The best mechanisms of oil production from vegetables or seeds utilize a manufacturing process that preserves the integrity of the oil and does not chemically alter the essential fatty acid content. This means that health giving oils are generally not highly processed. Oils that are excessively processed have been described as dangerous because of their trans-fatty acid content. Trans-fatty acids (in contrast to cisfatty acids) are believed to play a significant role in the propagation of heart disease and they may contribute to cancer and diabetes. Consumers may assume that health food stores carry only healthy types of oil, but this is not the case. The labeling of oil products is quite confusing. The application of terms like “organic” to oil labels may be accurate in terms of the growth of the original substance used to produce the oil, but the oil may be refined. Methods of processing oils at low temperatures without exposure to light and oxygen generally result in the retention of the essential fatty acid contents of the oil which are the main health giving fractions. Desirable oils 256 tend to be unrefined and free of trans-fatty acids and free radicals. Unfortunately, most oils available on a supermarket shelf are refined oils and they are not generally suitable for nutriceutical purposes (dietary supplements with predictable health benefits). If an individual is interested in obtaining oils that are unrefined, they must carefully shop in health food stores or pharmacies. In these locations, labeling may accurately reflect the health benefit of the oil or the shop staff are able to educate the purchaser on the health benefit of any oil preparation in question. What Do Fatty Acids Do? Fatty acids are a very efficient source of energy for the body. One gram of fat contains more energy than one gram of carbohydrates or protein. About nine calories of energy are derived from the body “burning” one gram of fat, whereas only five calories come from the “burning” of one gram of carbohydrate. Fats are the most efficient source of net energy intake. This means that they are higher in calories than protein or carbohydrate and are to be avoided if calorie control is an issue. Overall, it is recognized that fatty acids of longer chain length require more complex mechanisms of digestion and metabolism than do shorter length fatty acid chains. Saturated fatty acids containing less than 16 carbon atoms are used preferentially as an energy source by the body than fatty acids of a length between 16 and 18 carbon atoms. These “longer length”, fatty acids are used most often to construct cell membranes or to provide a substrate for the body’s manufacture of unsaturated fatty acids. One of the most important uses of omega 3 and omega 6 essential fatty acids by the body is that they are the precursors for hormonal compounds, especially 257 prostaglandins. Prostaglandins play a major role in the maintenance of body structure, function and homeostasis. The protean roles of essential fatty acids and prostaglandins in body metabolism are summarized in Table 50. The Essential Nature of the Essential Fatty Acids The term essential fatty acid implies that the fatty acid cannot be manufactured by the human body and it must be ingested in the diet. If an essential fatty acid is not consumed in the diet a deficiency will ensue in exactly the same way when vitamin or other obligatory nutrient deficiency occurs as a consequence of an unbalanced diet. The most common health giving types of polyunsaturated fats in the Western diet are of vegetable origin and these fats contain omega 6 type fatty acids. In contrast, only a relatively small quantity of the Western diet contains omega 3 type fatty acids. Omega 3 fatty acids are found predominately in fish and marine mammals. These type 3 fatty acids are found in salt water fish and shell fish of cold water origin. In simple terms, the importance of omega 3 and omega 6 types of fatty acids as precursor molecules in summarized in Table 51. The normal function of the immune system Formation of substrates for hormone production and effector properties Regulation of blood pressure by involvement in vascular tone and collateral circulations Regulation of responses to pain, inflammation, infection and cancer Controlling glandular secretions and their composition Regulation of smooth muscle and neural function Effecting cell membrane structure and mitosis of cells 258 Regulation of cell oxygenation and nutrient intake Providing energy substrates for key organs Table 50: The protean effects of essential fatty acids and prostaglandins on body function. Family Omega 3 Fatty Acids Omega 6 Fatty Acids Principal Precursors Found mainly in Vegetables Linolenic Acid (Omega 3) Linoleic Acid (Omega 6) Fatty Acid Derivatives Found mainly in Animals(6) or Fish(3) e.g., DHA EPA GLA, DGLA and e.g., Arachidonic Acid Prostaglindins Type 3 and less inflammatory Type 2 and leukotrienes leukotrienes Table 51: A simple schematic to understand the role of omega 3 and omega 6 fatty acids as precursors of compounds that are germane to health body 259 functions. The schematic is an oversimplification of the pathways in question and is presented for an easier understanding of the complex issues. Sources of Essential Fatty Acids The omega 3 family of fatty acids include alpha-linolenic acid (LNA), stearidonic acid (SDA), eicosopentanoic acid (EPA) and docosahexanoic acid (DHA). Confusion may arise in the reader’s mind because there are some omega 3 fatty acids in plant, especially seeds. LNA is found in oils derived from flax, hemp seed, soybean, canola, walnut, pumpkin seed, candlenut and other plants with dark-green leaves. In common with LNA, SDA is of vegetable origin and is found in several seeds of wild plants. Stearidonic acid is a significant constituent of black currant oil. In contrast, EPA and DHA are found only in oils of marine origin, such as those obtained from cold water fish and marine mammals. There are mammalian sources of EPA and DHA which include food that is normally termed “offal”. Offal is composed of key animal organs, such as the pancreas, adrenal glands, brain tissue and gonoal tissue. Offal is eaten sometimes as a special delicacy. Unfortunately, offal is loaded with cholesterol and should be avoided as a regular inclusion in the diet. The sources of different types of essential fatty acids and their derivatives in the diet is shown in Table 52. Essential Fat & Derivatives 260 Type of EPA Food Source Linoleic Omega 6 Vegetable Oils, and seeds or nuts Sunflower Walnut Soybean Linolenic Omega 3 Vegetable Oils, and seeds or nuts Linseed Walnut Soybean Arachidonic Omega 6 Mainly meat Liver Muscle (Steak) GLA Omega 6 Dietary Supplements Evening Primrose, Borage Oil, Blackcurrant Oil, and Pumpkin Seed Oil EPA, DHA Omega 3 Fish Oil Cold Water Fish Table 52: Dietary sources of essential fatty acids and their derivatives. Tracing the Origin of the Health Benefit of Fish Oils The health benefit of fish oils has been recognized for a long time. Many children in the past two centuries have choked on the end of a teaspoonful of cod liver oil. Why did grandmother think that cod liver oil was healthy for a child? 261 The answer rests in part in studies of the disease profile of races that ingest large quantities of omega 3 fatty acids in fish oil. For example, Eskimo populations living under traditional conditions have a very high consumption of fat and protein in the diet, but a remarkably low incidence of cardiovascular disease. The Inuit language of the Eskimo contains more than 40 words to refer to snow, but there is no word in this native tongue to describe heart disease. It is of interest that the term Inuit means “eaters of raw meat”. Inuits or Eskimos (natives of Greenland) in their natural habitat live largely upon both raw and cooked flesh and fat derived from fish or marine mammals, such as seals. Marine mammals and fish of cold water origin are the most abundant source of omega 3 fatty acids in the form of EPA and DHA. A great deal of the current research interest in the health benefits of omega 3 fatty acids has been precipitated by several epidemiological investigations of disease prevalence. The Eskimo rarely dies of cardiovascular disease, despite the high fat, high cholesterol, low carbohydrate diet that typifies their existence in their native habitat. There are a number of other differences in disease profile between the Eskimo and members of Western society. These differences include a relatively low prevalence of inflammatory bowel disease, arthritis and other degenerative disorders. Unfortunately, contemporary data on the epidemiology of disease in Inuit population shows a shift away from the lower incidence of such disease states. This has occurred coincidental with a move toward a Western type diet and the general introduction of popular types of adverse lifestyle. 262 The Health Benefits of Fish Oil Several authors have pointed out the benefit of fish oil consumption, especially in relationship to the promotion of cardiovascular health. These contemporary accounts of the benefit of fish oil have received far less attention than they deserve. Many studies published in leading medical journals have demonstrated the effectiveness of fish oil in the prevention of arteriosclerosis and the reduction of blood pressure. Unfortunately, the optimal amount of fish oil required to achieve a health benefit remains poorly defined. The estimates of the amount of omega 3 fatty acids that are required for health are surprisingly high. For example, the Council for Responsible Nutrition in the USA indicates that an individual may need to consume approximately 1.5 pounds daily of certain types of cold water fish. It is alleged that this is the quantity of fish that contains enough of omega 3 fatty acids to achieve a “health benefit”. Fresh fish is quite expensive and difficult to prepare. Not every individual finds “fatty”, cold water fish palatable in this quantity. The fish most likely to contain significant quantities of omega 3 fatty acids, include yellow fin tuna, cod, rainbow trout, sea bass, herrings, mackerel, salmon, shark, swordfish, grouper and sardines. Several of these fish are rather uncommon in food shops in Western locations and they tend to be quite expensive. This and other factors has led to the recognition that dietary supplementation with fish oil may be the more realistic option for those individuals who wish to supplement their diet with omega 3 fatty acids. 263 Dr. Richard Passwater PhD has drawn attention to be the ability of fish oil to lower blood pressure in his book entitled “The New Super Nutrition”. Dr. Passwater related the experience of researchers at the Brompton Hospital in London where sixteen patients with mild hypertension were shown to have a lowered blood pressure over a six week period in a placebo-controlled crossover study. This research indicated that fish oil supplementation of the diet could provide a safe, acceptable therapy for patients with mild essential hypertension, where systolic hypertension was preponderant. Studies in the United States at Vanderbilt University in Tennessee have confirmed these earlier findings in London, England, where relatively large doses (50 ml) per day of fish oil were found to produce modest reductions in systolic blood pressure. Among the most complete description of the health benefits of essential fatty acids is to be found in the book entitled “Fats That Heal, Fats That Kill” by Dr. Udo Erasmus PhD. Dr. Erasmus indicates the importance of essential fatty acids especially in relationship to their benefit on cardiovascular wellness and neurological functions. The omega 3 fatty acids (EPA and DHA) can be synthesized in humans relatively slowly from linolenic acid (LNA). Linolenic acid is an omega 6 polyunsaturated fatty acid which is found predominantly in safflower, sunflower, corn, sesame, soya beans, walnuts, flax seeds and pumpkin seeds. There are abundant food sources of omega 3 and omega 6 acids that are found especially in seeds. These sources are summarized in Table 53. The Importance of EPA and DHA 264 The omega 3 fatty acids (EPA and DHA) are superunsaturated fatty acids and exert physical chemical properties that are important in permitting the dispersion of aggregations of saturated fatty acids which form plaques in arterial blood vessels. This property of EPA and DHA accounts for its ability to prevent saturated fatty acid deposits with cholesterol that form the arteriosclorotic plaque. In addition, these omega 3 fatty acids inhibit platelet function and prevent the aggregation of platelets which occurs around the formation of a cholesterol plaque in an artery. One of the most important functions of EPA is that it is the precursor of the type 3 family of prostaglandins which have very potent anti-clotting effects. The omega 3 fatty acids found in fish oil are very important in terms of their function as a substrate for the production of prostaglandins. Prostaglandins play a variety of important roles in the modulation of acute and chronic disease. Name hemp flax pumpkin soybean walnut wheat germ evening primose safflower sunflower grape corn sesame rice bran Fat Content (%) Fatty Acid 18:3w3 35 35 46.7 17.7 60 10.9 20 58 0-15 7 5 5 60 14 42-57 50 51 50 12 19 34 26 28 25 2 4 0 6 5 18 6 5 9 9 11 11 13 23 17 24 42 48 2 12 12 12 17 13 17 6 1 81 75 65 71 59 45 35 17 59.5 47.3 20 4 49.1 10 265 Composition (% ofTotal Oil) 18:2w6 18:1w9 18:0 16:0 rape (canola) peanut almond olive avocado coconut palm kernel beech brazil pecan pistachio hictory 30 47.5 54.2 30 12 35.3 35.3 50 66.9 71.2 53.7 68.7 7 30 29 17 8 10 3 2 32 24 20 19 17 54 47 78 76 70 6 13 54 48 63 65 68 7 18 5 16 20 91 85 8 24 7 9 9 Table 53: This information is modified from the book by Dr. Udo Erasmus titled “Fats That Kill”. Whilst a formal cost-effect analysis has not been performed by Dr. S. Holt on the health benefits of seed oils, Dr. Holt believes that soybean oil may be very cost-effective as a source of essential oils because it is cheap and ubiquitous. There is a variety of other beneficial health effects attributed to omega 3 fatty acids. Several authors have drawn attention to the benefit of fish oils in the treatment of rheumatoid arthritis, psoriasis, migraine headaches, visual disturbance and even yeast infections. The potential health benefits of omega 3 fatty acids are legion. These benefits can be further understood by a basic knowledge of the biochemical functions of essential fatty acids in general. A Brief Overview of Essential Fatty Acids The most important essential fatty acids to consider are linoleic acid (LA), alpha-linolenic acid (LNA), and the two classic fish oil fatty acids EPA and DHA. Linoleic acid is an omega 6 polyunsaturated fatty acid which is found in many vegetable seeds. It should be noted that the health 266 benefits of linoleic acid are still the focus of intense research and their effects on the human body remain underexplored. The manifestations of linoleic acid deficiency are protean. Omega 6 fatty acids, like omega 3 fatty acids, promote cardiovascular and general health. A variety of symptoms have been ascribed to deficiency of linoleic acid which include: skin disorders, such as eczema or hair loss, liver dysfunction, kidney disorders, central nervous system disorders including behavioral problems, failure of certain immune function with susceptibility to infections, potent adverse effects on reproductive capacity including sterility in males and miscarriage in females, bone and joint disorders, cardiovascular disease, growth retardation and failure of general glandular function in the body. Many of these disorders that can be ascribed to LA deficiency have been encountered in patients who have been placed on longterm parenteral feeding (feeding via the intravenous route) where LA was deficient in the intravenously administered solutions. The contribution of LA deficiency to human disease still remains somewhat poorly defined and it is likely that a spectrum of disorders of varying severity may occur as a consequence of varying degrees of deficiency of LA. There are many signs, symptoms, and disorders that can be attributed to essential fatty acid deficiency as these are summarized in Table 54. Alpha-linolenic acid (LNA) is an example of a super-unsaturated fatty acid of the omega 3 type. The term super-unsaturated is used to distinguish LNA from LA. It is important to understand that LNA is an omega 3 fatty acid, whereas LA is an omega 6 fatty acid. This distinction is quite important because when one looks at the health implications of omega 6 and 267 omega 3 Chronic fatigue - all symptoms encountered in chronic fatigue syndrome Mental changes - depression, poor motivation, poor higher central nervous system function and perhaps dementia Reduced function of the immune system Cancer system and neurological disease Cardiovascular disease, angina, high blood pressure and poor exercise tolerance Frequent infections, e.g., colds and flu Bone and joint problems, e.g., arthritis Gastrointestinal upset - flatulence, constipation and bloating Dry skin, dry hair, cracked nails, and dry mucous membranes, e.g., eyes, mouth and vagina Table 54: Signs, symptoms and disorders that have been attributed to essential fatty acid deficiency. The reader is cautioned that these problems are not specific to fatty acid deficiency and occur due to other reasons. fatty acids their effects on occasion may be quite different. For an ease of understanding, the health implications of omega 3 versus omega 6 are best considered to be somewhat contrarian. The results of deficiency of LNA are as complex as those of LA. LNA has been associated with cardiovascular disease, central nervous system changes, including behavioral problems, paraesthesia (pins and needles in the arms and legs), motor incoordination, 268 muscle weakness, impairment in learning ability, visual loss, and growth retardation. Alpha-linolenic acid (LNA) deficiency has results similar to the deficiency of EPA and DHA. Therefore, it is reasonable to assume that the deficiency of LNA may resemble to some degree the deficiency of EPA and DHA. It should be noted that these deficiencies generally tend to occur together. Deficiencies of omega 3 fatty acids in general result in: hypertriglyceridemia, high blood pressure, a tendency to form blood clots due to platelet stickiness, inflammation in a variety of body tissues, cutaneous disorders, (especially dry skin), tissue swelling (edema), deterioration in mental function and general disorders of immune or metabolic functions in the body. There are no specific classic symptoms of omega 3 fatty acid deficiency, but it is now recognized that essential fatty acid deficiency, especially as a result of the deficiency of omega 3 fatty acids, is much more common than was hitherto suspected. Evidence has emerged that many of the negative effects of essential fatty acid deficiency (omega 3 fatty acid deficiency) can be reversed merely by supplying the diet with the deficient essential fatty acids from fish oil. Several studies have pointed out deficiencies of essential fatty acids in a variety of chronic diseases and a degree of amelioration of the chronic disease by EPA (omega 3 fatty acid, fish oil) supplementation of the diet. Putting Essential Fatty Acids in Pathways An understanding of the key role of omega 3 and omega 6 fatty acids 269 in health is dependent upon a knowledge of their metabolic fate in the human body. It is clear that essential fatty acids are needed for many metabolic functions. The metabolic pathways of omega 3 and omega 6 fatty acids are summarized in Table 55. Fatty Acids Omega 6 Omega 3 Linoleic Acid Alpha-Linolenic Acid Delta 6 Desaturase Enzyme ↓ ↓ Gamma-Linolenic Acid Intermediate Elongase Enzyme ↓ ↓ Di-Homon-Gamma -Linolenic Acid _ _ “Health “Unhealthy Pathway” Pathway” Prostaglandins Arachidonic Acid Type 1 _ _ _ Prostaglandins Leukotrienes Leukotrienes Type 2 Intermediate ↓ “Healthy Pathway” Eicosapentanoic Acid _ Prostaglandins Type 3 ↓ Intermediate ↓ Delta 4 Desaturase DHA 270 Table 55: The metabolic pathways of omega 3 and omega 6 fatty acids and their role in the production of prostaglandins and leukotrienes. It is apparent that the end result of the pathways of metabolism result in prostaglandin production. The types or families of prostaglandins and related compounds that are produced has important bearing on body homeostasis, health and disease states. Imagine the pathways as a complex series of roads where automobiles are filtering into lines of traffic. One car can compete with another, one route may be blocked and the other may be open. Each road must be driven down on the “right” side. This process of merging traffic assists in an understanding that many factors determine the end product of the pathways. The main feature of essential fatty acid metabolism is that they become active in body functions after their transformation into intermediates and prostaglandins or leukotrienes. The dichotomy of the process is of extreme importance to recognize. This can be referred to as a family rule. Only omega 6 fatty acids will produce the omega 6 progeny of type 1 or 2 prostaglandins and leukotrienes of an inflammatory nature. The best route for omega 6 precursors to take for health is the pathway towards the more health giving Type 1 prostaglandins. In the same way, only omega 3 precursors produce the omega 3 “daughters and cousin” compounds most of which are favorable in their health benefits. Table 56 summarizes a simple sequence to remember in terms of the fate of the major omega 6 and 3 precursors. There is no interchangeability between the pathway of omega 6 271 fatty acids and omega 3 fatty acids. This lack of “crossover” results in a circumstances where the balance of omega 6 and omega 3 fatty acids in the diet is of major importance. The terms healthy and unhealthy as applied to Type 1 and 3, or Type 2 prostaglandins, respectively, are relative terms to describe the physiological or pathophysiological properties of each type of prostaglandins. Type 3 prostaglandins tend to reduce blood clotting tendencies compared with Type 2 prostaglandines. Furthermore, the Type 2 prostaglandins are abundant in cardiovascular disease, hypertension and cerebrovascular disease (strokes), whereas Type 3 prostaglandins work to block some of these “unhealthy” consequences. The affects of different types of prostaglandins is very complex in view of the number of different types and subtypes of these “hormone like” substances. The terminal portions of the prostaglandin production pathways from omega 3 and omega 6 fatty acids are shown in Table 57. Cis-Linoleic Acid Omega 6 - - - Type 1 Prostaglandins Arachidonic Acid From Omega 6 - - - Type 2 Prostaglandins and Leukotrienes Alpha-Linolenic Acid Omega 3 - - - Type 3 Prostaglandins and Less Inflammatory 272 Types of Leukotrienes Table 56: The major precursor pathway of Type 1 (healthy), type 2 (unhealthy) and type 3 (healthy) prostaglandins. The terms health and unhealthy are relative terms. There is no interchangeability between the omega 6 and omega 3 pathways. This is the “family rule”. Omega 6 Omega 3 Arachidonic Acid 20:4 Omega (w)6 ↓ ↓ 22:4 w-6 ↓ Prostaglandin 22:5 w-6 H2 _ _ *Prostacyclin t Thromboxane PG12 TXA2 Eicosopentanoic Acid 20:5 Omega (w)3 ↓ ↓ 22:5 w-3 ↓ 22:6 w-3→ Prostaglandin H3 _ *Prostacyclin PG13 _ t Thromboxane TXA3 NOTES: (*) Prostacyclin PG12 is antiaggregatory for platelets and PG13 is more potent in this effect. (t) Thromboxane TXA2 is proaggregatory and TXA3 is less potent in this effect. 273 Table 57: This table shows the terminal portions of the pathways of metabolism of the omega 3 and omega 6 fatty acids as precursors of prostaglandins. The converstion of the omega 3 fatty acid, linolenic acid to eicosopentanoic acid is less efficient in the presence of large amounts of the omega 6 fatty acid linoleic acid. Good and Bad Oils From Fish The omega 3 fatty acids contained within fish oil have unequivocal health benefit but some oils within fish may be unhealthy. Cetoleic acid is a fatty acid containing 22 carbon atoms that is found in herrings, cod and capelin in varying amounts. Cetoleic acid resembles erucic acid, both chemically and functionally. Erucic acid, which is found in mustard and rape seed, has been shown to cause degenerative damage to the kidneys and hearts of rats, as a consequence of fatty deposition. However, the rat seems to metabolize erucic acid in a different manner than humans and the evidence for renal and myocardial toxicity of erucic acid in humans seems less clear. In addition to the presence of some type of fish oil that may not be particularly beneficial to health, it is important to note that fish oils may be easily damaged by heat, light, or oxygen. Eating raw fish is common in certain countries such as Japan but much of the fish oil is contained within the skin or subcutaneous area of the fish and this fraction of fish is often excluded during the preparation of sushi or sashimi. It has been suggested 274 that in some instances, the inspection of fish by food regulatory agencies is often less stringent than the inspection of meat. Much fish sold in stores in Western communities is not fit for consumption in raw form. The notion that freezing fish at very low temperature is capable of removing toxins or parasites is quite misleading. One of the author’s major concerns is the contamination of Northern Oceans with radioactivity following the irresponsible abandonment of the nuclear weapons and armory of the “cold war”. We still have very little idea about the degree of radioactive contamination of cold water fish in northern seas, especially water adjacent to the northwest shores of the former USSR where covert dumping of radio active waste may have occurred with alarming frequency. Many experts have indicated that fish caught away from coast lines may be more safe in terms of less parasitosis and contamination with environmental waste. However, large metal containers of radio active waste have been dumped on the bottom of the ocean bed far out at sea. It may be a few years before we experience the negative effects of this environmental crime or ever become aware of this modern day disaster. The author is not trying to make a case to avoid cold water fish, but an educated consumer might be wise to examine the origin of their diet. How Much Fish Oil Per Day? There is a Noble Prize waiting for the person who can characterize the precise required daily amounts and interactions of essential fatty acids in the human diet. Several authors have attempted to recommend certain dietary intakes of various essential fatty acids but many are hazarding a guess, at best. The concept of recommended daily allowance is quite misleading 275 because the human body has a variable requirement for a variety of nutrients and this requirement may be further varied by circumstances such as environmental conditions, stress, physical activity, general health and the great inter-individual variations in metabolic functions between different individuals. Practically nothing of real clinical significance is known about differences in requirements of essential fatty acids between male and female, except that hormonal activity dominates in either sex at varying times. This probably determines a requirement for varying amounts of essential fatty acids between genders. It has been estimated that up to 18 grams per day of linoleic acid in the diet may be optimal but individuals who are obese, have blood lipid disorders or ingest large quantities of saturated fatty acids may require more than this amount. To prevent deficiencies of LA, about 5 grams per day is required but the optimal intake may be about twice this amount. Some animal studies have attempted to define the optimal amount of essential fatty acid intake but these studies may not be relevant to humans. Significant differences exist in fatty acid metabolism between animal species. The rat is often the chosen model for experiment and this animal demonstrates uncanny, metabolic versatility. Many animal experiments have been undertaken to assess the toxic level of essential fatty acid intake rather than trying to assess any health giving benefit that may accrue from essential fatty acid supplementation. However, animal studies have underscored the need to provide co-factors with essential fatty acids to obtain an optimal metabolic effect during feeding. Essential Fatty Acids Need Co-Factors 276 Essential fatty acids require certain minerals and vitamins in order exert their important health functions. These co-factors include vitamins B3, B6, C, E, A and the minerals zinc and magnesium. To take essential fatty acids in the diet without the necessary co-factors in unadvisable. The absence of adequate co-factors is a problem with many dietary supplements of fish oil that exist on the market. Consumers who seek the health benefits of essential fatty acids must recognize the importance of taking adequate amounts of the important co-factors that permit the utilization of these essential fatty acids by the human body. Ideal Intakes? The ideal amount of alpha-linolenic acid (LNA) in the diet is even more of a guess than the optimal amount of linolenic acid (LA). Extrapolations of required amounts of essential fatty acids from body composition have been undertaken but it is likely that inaccuracies exist using this assumption alone. However, it is generally accepted that about one quarter to one half the amount of LNA is required in comparison to LA, which translates into approximately 5 to 9 grams of LA per day for a 70 kilogram human. These figures are only best guesses. Any understanding of the optimal amounts of EPA and DHA that are required must take into account the importance of the variability of the daily requirement depending upon the many aforementioned factors. If an average human can transform LNA into EPA at a rate of about 2 to 3% per day of the LNA administered, then the body can make approximately 4 to 6 grams of EPA daily from LNA. This is a projected, and by some an assumed, daily requirement of EPA and DHA that appears quite 277 astonishingly large to many individuals. If this is a required daily amount, it represents a need for several servings a fresh fish weekly, or a combination of supplementation of diet with precursors of EPA and DHA, such as oils containing LNA, assuming the conversion occurs optimally. Several dietary supplements have been made with fish oil and an average fish oil capsule that contains 1,000 milligrams of fish oil with varying concentrates of omega 3 fatty acid may have to be taken in a dose of approximately 20 capsules a day to meet the body need in the face of omega 3 fatty acid deficiency. The whole situation is very confused by the variability in the requirements for omega 3 fatty acids in states of disease, stress, lack of other dietary co-factors and many other variables. In disease, a therapeutic amount of omega 3 fatty acids may be required which is anticipated to be much greater than the requirements to maintain states of homeostasis. It is believed that once the body is saturated with essential fatty acids in the presence of deficiency then the subsequent amount of fish oils required to maintain adequate bioavailability of EPA and DHA is much lower. This reasoning assumes tolerance of fish oil supplements and their absorption and assimilation by the body. Delayed Release Fish Oil Supplements Are Desirable The whole situation is further complicated to some degree by the fact that not every individual can readily absorb large doses of fish oil and, of course, few individuals can tolerate very high doses of fish oil that are not given in a special formulation, such as a delayed release format. Individuals who have attempted to take several tablespoonfuls of any oils containing essential fatty acids will be aware of the problems of digestion and lack of 278 palatability of crude preparations. This has lead to the development of special encapsulation techniques for fish oils which deliver fish oils to the lower intestines where they are handled more efficiently and, it should be recognized that there may be a significant proportion of the population, perhaps as many as one in twenty, who have a varying degree of ability to make EPA and DHA from LNA and these individuals would have an absolute requirement for fish oil supplementation of their diet. For the individual who has the determination to use fresh oils, Dr. Edward N. Siguel has suggested a regimen for supplementing the individual with omega 3 fatty acid deficiency. This regimen is summarized in Table 58. Weeks Fish Oil Flax Oil Soybean Oil w3 Derivative w3 EFA w3 + w6 EFA 1-4 One teaspoon ½ Tablespoon 1-2 Tablespoons 4 - 10 Reduce Same Increase 10 - 20 Over 20 Reduce Same/Less Same Less: More if w3 Different Same/Less Same/Less 279 Table 58: A regimen of supplementation of the diet with fresh oils that is useful. This regimen was suggested by Dr. Edward N. Siguel. A Word of Caution The reader may be slightly frustrated with the lack of clarity concerning an optimal amount of fish oil supplementation of the diet. However, it should be noted that at tolerated levels (toleration being defined as comfortable intake of fish oil in crude format) no adverse effects of fish oils are to be expected by the average individual. There is one important word of caution and that is that at very high levels, fish oils can cause abnormal clotting function with a bleeding tendency. It is apparent from an understanding of the pathways of production of prostaglandins from omega 3 fatty acid that linolenic acid can be converted to EPA (eicosopentanoic acid) (Table 55). Although alpha-linolenic acid is found in fresh, green, leafy vegetables and a variety of vegetable oils, such as flax, soy and linseed oil, supplementation of the diet with these foods or nutrients will not result in an efficient production of EPA. This is due to the lack of efficiency of the conversion of alpha-linolenic acid to EPA due to weak activity of the converting enzyme systems. Furthermore, the presence of relatively large amounts of the omega 6 fatty acid, linoleic acid, as commonly occurs in standard Western diets, tends to inhibit the activity of the conversion of alpha-linolenic acid to EPA. 280 Much of the fish that passes our lips is prepared in a format that is not only deficient in essential fatty acids but probably contains toxic byproducts of fats by virtue of frying. The British tradition of fish and chips has evolved into the procurement of low-fat fish (low in EFA and DHA) with potatoes deep fried in damaged, saturated fat that contains carcinogens. The predilection of individuals from the north of Britain for their fish and chip diet may explain the reason why areas in the north of England and lowlands of Scotland have among the highest incidences of heart disease and cancer in Europe. Frying or Heating Dietary Fat Essential fatty acids and other unsaturated fats are heat labile. This means that they are damaged by cooling at high temperatures, especially as encountered in frying foods. High temperatures decompose fats to produce oxidized or denatured products and change healthful “cis” fatty acid structures into unhealthy “trans” structures. Table 59 illustrates the average temperatures at which commonly used fats and oils can be decomposed by Approximate Temperature Fat of Decomposition oC Corn Oil 227 Butter 208 Lard 218 Margarine 225 Olive Oil 175 Soy Oil 210 281 Table 59: Fats are readily decomposed by frying or heating. Average temperatures at which fats become decomposed are listed for common fats or oils. Note that the healthy fats in olive oil are the easiest to decompose with heat. heating. Thus, cooling habits may turn a healthy fat into an unhealthy fat containing food more unhealthy. Fish Oil is Essential The author believes strongly that fish oil supplementation of the diet is necessary because of the widespread deficiency of omega 3 fatty acids, the general lack of precursors of omega 3 fatty acids such as LNA and the overriding health benefits that can accrue from omega 3 fatty acids. It should be recognized that fish oils do not exert an immediate effect when taken in the diet because they may take several weeks to reach their sight of optimal biological effect and require considerable processing and conversion in the body with the assistance of co-factors. The Omega 6 and Omega 3 Balance The ratio between omega 6 and omega 3 fatty acid intake in the diet 282 has been the subject of much interest. The traditional Inuit diet has a ratio of omega 6 to omega 3 of approximately 1 to 3, whereas average Western diets have a ratio of omega 6 to omega 3 of anything ranging from 5 through to 30 to 1. Several dietary changes have been mapped over the past century and it is apparent that over the 150 years the consumption of omega 3 fatty acids has dramatically fallen with a corresponding rise in the consumption of omega 6 fatty acids in the average Western diet. This striking information has been almost forgotten by contemporary medicine and it must be realized that such a fundamental change in fat content in diet, with a shift from omega 3 to omega 6 fatty acids, will result in a completely different body composition of fat with important, but not very obvious, health implications. There have been many other dietary adjustments over the past 100 years but in addition to a switch in the ratio of omega 6 to omega 3 fatty acid in the diet, there has been an increasing preponderance of the inclusion of high cholesterol, high saturated fat foods. Studies of disease profiles in Eskimos has indicated a lower prevalence of common killer disease, such as cardiovascular disease, inflammatory disease, and idiopathic inflammatory disease (EG inflammatory bowel disease), and this has been ascribed to the presence of omega 3 fatty acids in the diet. However, other factors clearly operate in determining disease profiles. These other factors include other dietary inclusions and lifestyle. The life expectancy of the Eskimo or Inuit is not admirable and the prevalence of stroke is quite high among Inuits, presumably, as a result of a high salt intake that may promote hypertension. The native Inuit living in traditional circumstances has a deficiency of water soluble vitamins such as vitamins B and C. In addition, a Inuit diet is 283 relatively deficient in vitamin E. The relative amounts of omega 6 and omega 3 fatty acids in the body varies dramatically depending on the tissue in question. The omega 6 to omega 3 fatty acid ratio in nervous tissue is approximately 1:1, whereas the ratio in adipose tissue deposits is approximately in a range of 3 to 7 to 1. On average the ratio of omega 6 to omega 3 throughout most body tissue is about 4 or 5:1. I believe that an optimal ratio of omega 6 fatty acids to omega 3 fatty acids in the diet should be somewhere between 2 to 5:1. Remember, this ratio becomes unimportant if the co-factors required for the function of essential fatty acids are not present in the diet and if the diet is not generally well balanced. Visiting the Omega 3 Factor The idea of supplementing the diet with fish oil is neither novel nor new. A number of dietary supplements containing fish oil are sold in health food stores or pharmacies and over the past decade has been increasing attention in the media about the health benefits of fish oil. Much of this interest in the health benefits of fish oil stems from observations in epidemiological studies where a low prevalence and incidence of cardiovascular disease has been noted in populations, such as Eskimos, that consume large amounts of seafood. In addition to the well described cardiovascular benefits of fish oil (which include inhibition of platelet aggregation, lowering of cholesterol, lowering of blood pressure, and reductions of blood viscosity, together with an increase in high-density lipoproteins), it is not as commonly appreciated 284 that people who eat large amounts of fish oil have a lower incidence of chronic inflammatory disease such as inflammatory bowel disease, cutaneous disorders, rheumatoid arthritis, and auto-immune disorders. A number of important review articles have focused on the health benefits of fish oils but highlight the incomplete nature of available information on the health benefits of omega 3 fatty acids. An important editorial in the medical journal, the Lancet in 1983, drew attention to the lack of certain disease states in Eskimos who consumed a diet high in fish oils. This editorial pointed out that the high fat, high cholesterol and low carbohydrate nature of the Eskimo’s diet could be predicted to cause cardiovascular disease, rather than prevent cardiovascular disease. In fact, an autopsy study of 339 Alaskan natives found that only 35 of the 339 (10.3%) died of a cardiovascular cause, whereas approximately one half of all deaths in the United States (and other Western Societies) are related to cardiovascular disease. An inverse relationship between fish consumption and mortality from heart disease was reported by Dr. Kromhout over a 20 year period in the New England Journal of Medicine in 1985. These data from European studies supported the epidemiological findings among Eskimos where the prevalence of cardiovascular disease was perceived to be far less than that among members of Western society. In this study by Dr. Kromhout and his colleagues, a 20 year follow-up of coronary artery disease mortality was studied among men who had reported daily consumption of at least 30 grams of fish per day. In this study, the mortality due to coronary artery disease, after two decades, was half that in men who had reported no significant fish intake in their diet. This study concluded that the inclusion of a relatively small amount of fish in the diet, 285 approximately 2 servings of fish per week, make confer significant protection against coronary atheroma and its consequences. Several subsequent or contemporary epidemiological studies have shown a reduction in death rate from coronary heart disease as a consequence of fish consumption, but some other studies have partially contradicted these findings. Dr. Udo Erasmus in his book entitled “Fats That Heal, Fats That Kill” has ascribed negative observations of the health benefits of fish oil to some degree to poor quality of fish oil in the diet as a consequence of untimely or poor food processing and preparation. Other factors that contribute to the widespread occurrence of fatty acid deficiency in Western communities have been proposed by Dr. Michael T. Murray in his book “Understanding Fats and Oils” (Table 60). Essential Fatty Acids and Prostaglandins; The Important Health Link Essential fatty acids are important precursors of prostaglandins and leukotrienes. Arachidonic acid is an omega 6 fatty acid which is the prime precursor of prostaglandins and leukotrienes. Arachidonic acid is synthesized in humans from the omega 6 fatty acid linoleic acid which is also found in abundance in vegetable oils. The balanced Western diet is generally rich in omega 6 fatty acids and arachidonic acid which is converted by the enzyme cyclooxygenase to a series of primary prostaglandin molecules including prostacyclin and thromboxane A2. There is a situation of competition of metabolism between hydrogenated and trans fatty acids with essential fatty acids. 286 The health giving omega 3 and omega 6 fatty acids are transformed themselves in food processing or preparation into toxic, hydrogenated products or trans isomers. There is a relative unavailability of fresh oils that contain high concentrations of essential fatty acids due to commercial refinement and processing of fats and oils. Table 60: The primary reasons proposed as contributing to widespread essential fatty acid deficiency by Dr. Michael T. Murray. Dr. Murray is a naturopath who has contributed greatly to our knowledge about the use of oils in dietary supplements. Thromboxane A2 is a potent constrictor of blood vessels and it promotes platelet aggregation and in turn blood clotting. In contrast, prostacyclin has opposing physiological effects. It is generally believed that the ratio of thromboxane A2 to prostacyclin regulates vascular tone and controls the general tendency of the body to undergo the initiation of blood clotting by platelet aggregation. A variety of events may lead to a preponderance of thromboxane A2 or a deficiency of prostacyclin. These circumstances of increased thromboxane A2 and decreased prostacyclin would favor blood vessel constriction and platelet aggregation, both of which may increase the risk of cardiovascular disorders such as heart attack 287 or thrombotic stroke, leading to cerebrovascular disease with motor deficit or dementia. In contrast, the omega 3 fatty acids, EPA and DHA, may replace the omega 6 fatty acid derivative, arachidonic acid, as a substrate for the cyclooxygenase enzyme system with a resulting decrease in the synthesis of thromboxane A2. If these omega 3 fatty acids in fish oils replace the omega 6 fatty acids as substrates for prostaglandin synthesis, the type 3 series prostaglandins will be preferentially produced and the expense of the type 2 prostaglandin series. A decrease in the production of thromboxane A2 will shift the balance away from vasoconstriction and platelet aggregation towards a set circumstance of vasodilatation and a state of anti-aggregation of platelets. Incorporation of fish oils into the diet results in the production of a different form of thromboxane A2 which is a much weaker vasoconstrictor and platelet aggregator than classic thromboxane A2. As well as providing substrates for the production of prostaglandins, essential fatty acids provide material for the synthesis of leukotrienes. Leukotrienes are generally synthesized from arachidonic acid by an enzyme lipooxygenase. The role of leukotrienes in immune and inflammatory disease are well defined and leukotrienes play a significant part in the promotion of coronary artery disease and a variety of other common killer diseases. Dr. Samuelsson in a classic paper in the journal, Science in 1983, reviewed the importance of leukotrienes as mediators of hypersensitivity reactions in inflammation in the human body. Leukotrienes are a complex molecules and have been classified into a variety of different types which produce a number of inflammatory effects in the body. Leukotrienes C4, D4 288 and E4 have potent effects on constricting air passages in the lung and they act to increase the permeability of blood vessels. In addition, these leukotrienes increase mucus secretion. All of these factors may provoke or make lung disease worse. In addition, leukotrienes B4 causes the attraction of white cells to areas of inflammation and it precipitates the degranulation of acute phase white blood cells (neutrophil leukocytes). Fish Oil Shifts Away From Leukotrienes The importance of the inclusion of omega 3 fatty acids, such as EPA and DHA, in the diet is that they will tend to interfere with the conversion of arachidonic acid to leukotrienes and results in an overall decrease in the production of leukotrienes B4. The effects of fish oil ingestion on leukotriene production of quite complex and in some circumstances a different form of leukotriene may be produced. It is believed by many scientists that the ingestion of omega 3 fatty acids in the form of fish oil may exert beneficial effects on inflammatory processes in the body by alterations of leukotriene synthesis and metabolism. These effects on leukotriene synthesis by omega 3 fatty acids have far reaching implications in terms of the management of a variety of disorders, including cardiovascular disease, inflammatory bowel disease and chronic recurrent asthma. Fish Oil and the Generation of Prostaglandins The major importance of the health giving benefits of essential fatty acids can be explained by their effects on the generation of prostaglandins (see Table _____). Prostaglandins are very potent and versatile hormonal type substances that have been identified in most human tissues. Approximately 35 different prostaglandin molecules have been 289 characterized, but the exact function and structure of many of these molecules remains unknown. Prostaglandins are involved in a variety of important body processes and function by modulating a variety of metabolic and physiological processes, as well as modulating to some degree the effect of each other. There are three different types of prostaglandins described which can be most easily defined based upon the fatty acid molecule from which they were generated. The series or family type 1 and type 2 prostaglandins are derived from the omega 6 series of fatty acids. Linoleic acid is the prime precursor of series or type 1 prostaglandins and type 2 prostaglandins. Linoleic acid is converted into gamma-linolenic acid which is ultimately converted into arachidonic acid via an intermediary compound dihomogamma-linolenic acid. In contrast, series 3 or the type 3 family of prostaglandins are synthesized from omega 3 family of fatty acids which alpha-linolenic acid (LNA) is the prime substrate. In the human body, linolenic acid (LNA) is converted to stearidonic acid which is then converted to EPA via an intermediary known as eicosatetranaenoic acid. The series 3 prostaglandins are then produced from EPA. Overall, it is regarded that the type 2 series of prostaglandins tend to be the disease promoters, whereas the type 1 and type 3 family of prostaglandins appear to be the health giving types of prostaglandins. Of course, this classification is somewhat oversimplified but it is useful in understanding of the overall health implications of the three different families of prostaglandins. 290 Series 1 Prostaglandins Series 1 prostaglandins include the prostaglandin E1 which prevents platelet stickiness and promotes cardiovascular well being. In addition, prostaglandin E1 has important actions in the urinary tract where it facilitates sodium and water excretion. In addition, prostaglandin E1 tends to suppress inflammatory responses, promotes the action of insulin, improves neurological function, regulates calcium metabolism, improves immune (T cell) function and has important cardiovascular effects. These cardiovascular effects include vasodilatation, reduction of blood pressure and an addition of the release of arachidonic acid from cell membrane. Type 3 Prostaglandins Preferred Over Type 2 The type 3 prostaglandins which are made from EPA (found in fish oil) include prostaglandin E3 and prostaglandin 13. These prostaglandins prevent arachidonic acid release from cell membranes and interrupt the production of prostaglandin series 2 production. In fact, it is recognized that EPA is a very important factors that limits the production of the disease promoting type 2 prostaglandins. An understanding of the actions of type 2 prostaglandins will underscore the importance of the inhibitory effects of type 3 prostaglandins on type 2 prostaglandin production. The series 2 prostaglandins which are the compounds that exert overall negative health benefits are produced from arachidonic acid. Prostaglandin E2 promotes platelet aggregation, causes salt and water retention, promotes inflammation, and has a vasoconstrictor effect which results overall in a rise in blood pressure. Retiring Type 2 and Emerging Type 1 and 3 291 In summary, series 1 and series 3 prostaglandins both seem to regulate the production of series 2 type prostaglandins and they work together in retaining the balance of the body (homeostatic mechanism). The preponderance of series 1 and series 3 prostaglandins is regarding overall as more beneficial to health. However, series 2 prostaglandins are very important in the body’s attempts to fight disease, but overabundance of the type 2 series of prostaglandins is best avoided. This situation is most easily understood by appreciating the role of series 2 prostaglandins in the promotion of inflammatory processes in arthritis. Interference with the production of series 2 prostaglandins in inflammatory arthritis results in quiescence of joint inflammation. Type 1, 2, and 3 Prostaglandins Understood by Remembering 3 The reader will have recognized that providing certain substrates for prostaglandin synthesis in the form of essential fatty acids is very complex situation. Overall, the supply of EPA and DHA in fish oils tends to result in the synthesis of type 3 prostaglandins which have a number of health giving benefits. It should be emphasized that prostaglandin production from essential fatty acids requires a number of co-factors and that fish oils are not to be taken in isolation of these co-factors which include vitamin C, B3, B6 and the minerals magnesium and zinc. Overall, the balance of prostaglandins in health and disease is an extremely complex subject but it should be recognized that the missing essential fatty acids to make important health promoting prostaglandins should be taken in the diet. Since most diets in Western societies with reasonable affluence contain substantial amounts of omega 6 fatty acids, in general, fish oils are the missing link! It is easy to remember that omega 3 fatty acids produce predominantly type 3 292 prostaglandins and it is these type 3 prostaglandins that are more desirable. This is the basis of the omega 3 factor in the diet. Dangerous Animal Protein Diets and Prostaglandins The rate of conversion of different essential fatty acids to prostaglandins of varying types occurs at a variable rate to maintain balance in the body (homeostasis). A variety of stimuli can produce acceleration of the production of different types of prostaglandins. For example, the presence of inflammation in the body causes a cascade of production of type 2 prostaglandins. This cascade of production of type 2 prostaglandins is variably balanced by the production of type 1 and type 3 prostaglandins. In order to control the potentially deleterious effects of excessive releases of type 2 prostaglandins, the production of arachidonic acid (AA) from dihomo-gamma-linolenic acid (DGLA) occurs at a slow rate. This slow conversion rate of DGLA to AA can be overcome to some degree by supplying AA to the body in the diet. The principal dietary source of AA is animal protein. Thus a diet high in meat contains excess arachidonic acid which would favor the production of damaging type 2 prostaglandins. The overall result of tipping the balance towards type 2 prostaglandin production explains the negative health consequences of high animal protein diets which are associated with a higher prevalence of cardiac or renal problems and osteoporosis or inflammatory conditions. Dairy products contain abundant arachidenic acid and like meat, they are cholesterol rich. The role of excessive animal protein in the promotion of the production of prostaglandin type 2 series is a very important, often overlooked factor, in understanding the danger of high protein diets in Western society. There are 293 two overwhelming reasons to be cautious about animal protein (meat) and dairy products. First, they have a high saturated fat and cholesterol content. Second, they contain arachidonic acid with its predilection to form unhealthy Type 3 prostaglandins and leukotrienes. Animal protein based diets can be seen to work against the omega 3 factor. Fish Oil Lowers Cholesterol The ability of omega 3 fatty acids to reduce blood cholesterol and induce beneficial changes in other blood lipids such as lowering triglycerides, reducing levels of LDL and VDL, together with increases in HDL have been well documented. Several studies have shown that longterm dietary supplementation with fish oils may exert beneficial effects on blood lipids and cardiovascular disease. Beneficial effects on blood lipids have been observed in cases of familial high blood cholesterol, in patients with high blood triglycerides, in the suppression of VLDL concentrations in the blood, and fish oils have been shown to attenuate the cholesterol induced rise in lipoprotein cholesterol in humans. This latter observation implies that fish oils may be beneficial in protecting against rises in blood cholesterol from normal dietary intake of cholesterol. Overall, a large body of evidence exists to show a beneficial effect of fish oils on blood cholesterol, but there are a minority of studies have shown no conclusive benefits of fish oils on blood lipids. Dr. Phillipson’s Pivotal Study on Fish Oil Dr. Phillipson and his colleagues (1985) reported a very important study of the reduction of plasma lipids, lipoproteins and apoproteins by dietary fish oils in patients with raised blood triglycerides. In this study diet 294 high in fish and fish oil was examined in terms of its effect on blood lipids in 20 patients with raised blood triglycerides. Of these 20 patients, 10 had type 2B hyperlipidemia and the remainder had type 5 hyperlipidemia. In this study, the fish and fish oil containing diet was compared with a controlled diet which was composed of low fat and low cholesterol foods. In addition, it was compared with a third diet that contained a presumed health giving vegetable oil preparation that contained approximately 30% fat with 325 milligrams of cholesterol as a basic content. After the administration of these diets for four weeks lipid levels were measured in the blood. Blood lipids fell dramatically in the group taking fish oil and there was a consistent decrease in both total cholesterol and triglyceride levels. The importance of this study was that in the patients with type 5 hyperlipidemia cholesterol levels decreased by almost one half, and triglyceride levels decreased by a factor of almost three quarters. The 50% and 70% approximate reductions in cholesterol and triglyceride levels respectively, were noted despite the higher content of fat and cholesterol in the fish diet compared with the two other diets. It was of special interest in this study that the group taking the vegetable oil diet which was considered to be a “therapeutic” product had a significant and alarming rise in blood triglyceride levels. The Eskimo Research Project There have been reasons other than the fish oil consumption by Eskimos that have been proposed to explain the relatively low prevalence of coronary heart disease in this race. One proposal has been that there was a genetic factor that is protective. However, there are several races with 295 similar genetic compositions to the Inuit who have many more times the risk of heart disease. Genetic factors cannot be dismissed as irrelevant but do not appear to operate substantially in explaining the different incidences of cardiovascular disease. Dr. Dyerberg and Dr. Bang are two Danish scientists who joined with Dr. Sinclair, a nutritional researcher from Britain to study Eskimos in their native habitat. They collected blood samples from Eskimos in northern areas of Greenland and submitted them to an analysis of clotting function and lipid analysis. The findings of these analyses were very intriguing. The bleeding time of Eskimos was found to be prolonged and clotting tendencies were diminished. In addition, LDL levels in the blood were low coincidental with the finding of the presence of EPA and DHA (omega 3 fatty acids) in the blood. Following these field ventures which occurred in 1976, Dr. Sinclair undertook some extremely courageous nutritional studies on himself in Oxfordshire, England. Dr. Sinclair obtained a frozen seal and used it has an exclusive food source for himself over a period of about three months. The outcome of these self-experiments were reported by Dr. Sinclair in a classic scientific paper entitled “The Advantages and Disadvantages of an Eskimo Diet”. The outcome of this experiment was predictable to some degree. Dr. Sinclair’s tendency to blood clotting was reduced and his body weight fell by a factor of 12 kilograms. His blood cholesterol rose modestly by 10 mg% but LDL levels in his blood were reduced. Coincidental with these alterations in blood chemistry, Dr. Sinclair 296 developed bruising and nose bleeds with a fall in vitamin C levels to zero. The explanation of the adverse effects experienced by Dr. Sinclair is consistent with our knowledge of the intricacies of the effects of omega 3 fatty acids when supplemented in the absence of a balanced diet. These adverse events reinforce the need for Westerners to maintain balanced nutrition. The beneficial effects of omega 3 fatty acid content of the diet is apparent in races other than the Eskimo. Several elegant studies of individuals in Japan and some mediterranean locations, who live on diets preponderant in fish, show a lower incidence of cardiovascular disease, compared with people who live in urban areas. Epidemiological studies in Japan have shown conclusively that the fish eating inhabitants of Okinawa Island have particularly low death rates from coronary heart disease, in comparison with people who live on the mainland of Japan. Both Levels of Blood Cholesterol and Amounts of Fish Oil are Important Although the lack of benefit of omega 3 fatty acids in reducing blood lipids in some studies may be related to the quality of fish oil or omega 3 fatty acids given in the study. It seems likely that it is the amount of omega 3 fatty acids that determines the outcome. The study performed by Phillipson and his colleagues (1985) used very large quantities of fish oil of the order of 20 grams per day, which may be equivalent to eating approximately 1.5 kilograms of salmon or herrings per day. This important concept emerges in terms of the potential health giving benefits of fish oil. 297 On the one hand, fish oils at certain doses may exert more subtle physiological effects, but at high doses they may exert astounding therapeutic effects. Overall, the literature indicates that the lipid or cholesterol lowering benefits of fish oil is related to the dose of fish oil taken and it may be related also to the degree of hyperlipidemia experienced by the individuals. This situation is somewhat similar to the beneficial effects observed with soy protein on blood cholesterol levels where subjects with very high blood cholesterol seemed to achieve the best cholesterol reducing benefit. Preventing Atheroma and Thrombosis Dr. Dyerberg and his colleagues published an important study in the Lancet in 1978 which drew attention to the role of EPA in the prevention of thrombosis and atherosclerosis. These scientists proposed that omega 3 fatty acids resulted in a state of decreased platelet stickiness which was responsible for the observed low rate of coronary artery disease among Eskimos. A number of studies have confirmed these earlier observations and show that omega 3 fatty acid supplements may prolong bleeding time, decrease thromboxane A2 production, and inhibit the aggregation of platelets. The anti-thrombotic effects of omega 3 fatty acids that occurs a consequence of decreasing platelet stickiness are overall related to the amount of omega 3 fatty acids consumed. Some studies have noted a decrease in platelet count in individuals consuming fish oil but this reduction in blood platelets is often transient and usually of no clinical significance. Studies that have failed to show much in the way of significant antithrombotic effects of fish oil used only modest quantities of EPA as a dietary supplement. 298 A number of researchers have found that fish oil supplementation of the diet tends to result in a decrease of blood viscosity and a corresponding increase in the ability of red blood cells to undertake their usual acrobatics of deformation small blood vessels. Those individuals with the highest blood viscosity appear to have the greatest reduction in blood viscosity as a result fo fish oil ingestion and these effects may be dose dependent. It is notable that reductions of blood viscosity have been noted with relatively small quantities of EPA. Lowering Blood Pressure Omega 3 fatty acids have been investigated in detail in many clinical research studies to determine their effects on blood pressure. The most profound effect of fish oil on lowering blood pressure has been demonstrated in patients with renal failure undergoing hemodialysis therapy. In addition, modest reductions of blood pressure, including reductions of systolic and diastolic blood pressure can be observed on individuals fed a diet of mackerels. These effects can be achieved with a daily amount of 5 to 6 grams of essential fatty acids of omega 3 series. The mechanism of the hypotensive effect of fish oil is not entirely understood. Animal experiments suggest that omega 3 fatty acids may modify the responsiveness of arterial blood vessels to neurohormonal stimuli. Also, hypertension induced by mineralocorticoids (steroids) can be reduced by fish oil and the ability of catecholamines to cause contractions in isolated blood vessels is attenuated by the feeding of omega 3 series fatty acids to rats. 299 Fish Oils for Bypass Patients Several observations of the effects of omega 3 series fatty acids on blood vessels indicate that there may be special relevance of fish oil diets to prevent occlusion of vascular grafts. Vascular grafts are used in cardiac bypass surgery and surgery to bypass peripheral vascular disease. Dr. Landymore and his colleagues have undertaken extensive experiments with the use of cod liver oil in the prevention of the intimal hyperplasia (growth of the lining) of bypass grafts. In fact, these experiments have suggested that omega 3 series fatty acids may be more effective than aspirin and or dipyradamole (drugs to stop platelet aggregation) in reducing the intimal hyperplasia that occurs in arterial bypass grafts (Landymore et al., 1986). Fish Oil and Angina The effect of fish oil on the treatment of patients with angina (chest pain) due to coronary artery disease has been, at first sight, conflicting. Short-term (3 month) placebo controlled trial of fish oil supplementation have failed to show much measurable benefit in patients with angina but in longer term trials a decrease in the number of episodes of angina and a decrease in the consumption of nitroglycerin medication to relieve angina have been noted. Further studies imply a conflicting effect of fish oil in the control of anginal chest pain, but overall the data for the general benefit of omega 3 series fatty acids in coronary artery disease are compelling. Eicosopentanoic Acid in Focus A wealth of scientific research points to eicosopentanoic acid (EPA) as a key protector from cardiovascular disease by virtue of its potent and 300 versatile effects on cardiovascular physiology. The importance of maintaining a balance between the intake of omega 6 and omega 3 fatty acids cannot be under-emphasized because omega 6 fatty acids (cis-linoleic acid) will tend to inhibit the synthesis of EPA from alpha-linolenic acid, as will several other factors (Table 61). The factors that interfere with the endogenous production of EPA from alpha-linolenic acid operate at a level of interference with the converting enzyme delta-6-desaturase. This enzyme is a rate-limited step in the conversion of alpha-linolenic acid to EPA (Table 62). An absence or reduction in the availability of EPA has major negative effects on cardiovascular health. Eicosopentanoic acid can be summarized as a key heart protector in comparison with its relative decosohexanoic acid that seems to exert its health benefits in the brain and nervous system. The principle mechanisms of the protective effects of EPA on cardiovascular health are shown in Table 62. Diabetes mellitus or high blood glucose Advanced age Alcohol Starvation or malnutrition Low protein intake Certain fats in the diet: high saturated fat intake, high intake of trans-fatty acids Stress which leads to catecholamine release Viral disease, especially oncogenic viruses 301 Radiation exposure Miscellaneous disease states Table 61: Factors that inhibit the conversion of alpha-linolenic acid to eicosopentanoic acid. These factors operate by inhibiting the key enzyme delta-6-desaturase. Lowers blood pressure Reduces LDL in the blood Alters macrophage and monocyte function to act against atheromatous plaque formation Promotes the formation of Type 3 prostaglandins Favors the production of prostacyclines and thromboxanes that are less aggregatory to platelets Table 62: The mechanisms by which EPA exerts beneficial effects on the cardiovascular system. 302 Fish Oil Supplements There are several options available to supplement the dietary intake of omega 3 fatty acids from fish oil. First, is the eating of fatty (oily) fish of cold water origin in sufficient quantities to give health giving amounts of omega 3 fatty acids. This option is not practical for many individuals because of factors, such as cost, lack of palatability of fish diets and general inconvenience. To overcome these difficulties, several commercial organizations have produced marine lipid (fish oil) concentrates that have several advantages. Fish oil concentrates can be standardized for their content of EPA and DHA and are available in formats that are stable and reduced in their vitamin A contents. Hypervitaminosis A is a very serious problem that can cause bleeding, liver damage and brain disorders. Several fish oil concentrates have been marketed and they have been considered to be safe and somewhat convenient to take in recommended dosages. There are practical problems with the taking of many commercial fish oil concentrates. First, many are not palatable and may not have concentrations of EPA and DHA that are relatively low. This requires tht large quantities of some oil products need to be taken. Many cod liver oil preparations are not standardized and may have to be taken in large volumes to guarantee the health benefits that can be anticipated only from specific amounts of DHA and EPA. God liver oil in 303 unpalatable, given the breath a feculent odor and, when taken in excess, it invariably causes abdominal upset with cramp and diarrhea. These disadvantages have been overcome to some degree by encapsulation of fish oil but the most satisfactory mode of administration is in a delayed release format. The administration of fish oil in a delayed release format results in the advantages of overcoming common gastrointestinal side effects and enhancing the efficiency of absorption of omega 3 fatty acids. Reduction of side effects results in enhanced compliance and makes the long-term consumption of fish oil a very feasible option. It has been shows that the rate of absorption of the omega 3 fatty acid contents of fish oil is high from enteric coated (delayed release) capsules of fish oil. This means that the dose of fish oil required to achieve the desired beneficial health effects of fish oil is less when the oil is present in a delayed release formation. There have been estimates that delayed release preparation of fish oil may reduce the required amounts of certain fish oil by a factor of two-thirds. The value and advantages of enteric coated fish oil products have become apparent in recent clinical trials where excellent therapeutic outcome has been achieved with newer, delayed release formulations of fish oil. Delayed release capsules of fish oil, that contain good concentrations of EPA and DHA, can be made to resist gastric acid and enzymatic digestion so that the oil is preferentially delivered to its site of maximal absorption in the small bowel. An example of such a product is Fisol™, which is a proprietary delayed release soft-gel capsule that provides a convenient and efficient presentation of EPA and DHA for use by the body. 304 Finally, the importance of the addition of co-factors that are necessary for omega 3 fatty acids to exert their beneficial biological functions has been grossly underestimated. In this regard, an individual is advised to seek oil product that contains the important co-factor (vitamin B6, E, selenium and zinc), or take appropriate mineral or vitamin supplements with fish oil to supply these necessary co-factors. Conclusion The health benefits of fish oil inclusion in the Western diet is unequivocal. This underscores the value of dietary supplements in healthcare, since eating large amounts of food that contain the essential health giving nutrients, in this EPA and DHA, is not practical or often feasible. 305 CHAPTER 9 BOTANICAL INFLUENCES ON CARDIOVASCULAR DISEASES 306 Botanicals Influences on Cardiovascular Diseases Botanical extracts have been used for centuries for the prevention and cure of disease. Despite the length of use of such agents, relatively few scientific studies are available to support their use in the prevention or treatment of disease. Medicinal herbs have had major applications in the treatment of cardiovascular disease resulting in the assignment of nebulous terms to describe their cardiovascular benefits. For example, digitalis, derived from the foxglove, was once popularly described as a heart tonic or cardiac stimulant. Of course, digitalis is the basis of one of the commonest prescriptions for cardiac disease. In fact, the derivation of pharmaceuticals from plants is the basis of pharmacognosy through which modern day synthetic drug therapy was largely developed. More than one-quarter of all current prescription drugs are derived from plants. There are problems with self-medication with herbal remedies or botanicals. Botanical products which are sometimes freely available as dietary supplements may have quite powerful biopharmaceutical effects. The notion that herbs are natural and, therefore safe, is quite erroneous. Some of the most potent toxins known to man are of plant origin. In addition, there is a problem with many herbal remedies because the active ingredients with a presumed, alleged or demonstrated affect may not be standardized. This means that unless a standardized extract is obtained, the type and amount of the active ingredients may vary considerably from one brand of dietary supplement to the next or even within the same brand. 307 This situation has become overcome to some degree in countries such as Germany, where botanical formularies exist for standardized herbal cures. However, many countries lag behind Germany’s lead in this area of the regulation of botanical health products. The conventional medical literature is full of reports of serious and sometimes fatal adverse effects of medicinal herbs. This has led to a suspicion by the conventional medical practitioner that many herbs are dangerous and possess only dubious benefit. Chinese traditional medicine relies heavily on botanical compounds in treatment programs but much knowledge and experience is required for their safe and effective use. The author has traveled extensively in China and has had first hand experience of the application of traditional Chinese medicine and some of its benefits. A Warning About Botanicals The author would like to send a strong warning to the reader not to experiment with herbal remedies, especially where standardization of the content of the preparation is not clear. The safest option is to seek the advice and counsel of a healthcare giver who is qualified and experienced in herbal treatment before herbs or botanicals are even considered. Many physicians know very little about botanical remedies and some alternative healthcare givers who espouse knowledge about plant medicinals are inexperienced. The reader is advised to shop wisely for botanical medicines. There are more than twenty different botanical extracts or formulations that have been used with some frequency in Western countries 308 to combat atherosclerosis (Table 63). Not all of these botanical products can receive a detailed discussion in this book. Readers are referred to two important sources of information on botanical influences on cardiovascular disease in works by Drs. Melvyn R. Werbach, M.D., and Michael T. Murray, N.D. entitled, “Botanical Influences on Illness” and further work by Dr. Michael T. Murray entitled, “The Healing Power of Herbs”. Botanical Active Ingredient Effect Alfalfa Saponins Lowers cholesterol in animals. Artichoke Cynarin Alters blood lipids. Goldenseal Berberine Protects against cardiac ischemia. Bilberry Anthocyanoside Reduces platelet aggregation. Pineapple Bromelain (protease) Inhibits platelet, aggregation, vasodilator, antianginal. Turmeric Curcumin Antithrombotic in aminals. Eggplant ? Pigment Inhibits atheroma formation. Fenugreek Debitterized Power Lowers blood lipids. Rice Bran Ferulic Acid Lowers cholesterol. Garlic Allicin and other Lowers cholesterol. Sulfur compounds Onions Onion oil Ginger ? ground powder Inhibits platelet aggregation and aqueous or may lower cholesterol. 309 Lowers cholesterol. ethanolic extract Mukul Myrrh Tree Guggulsterones Improve lipid profile. Table 63: Page 1 of 2 Active Ingredient Effect Hawthorn Procyanidin Flavanoids Cardiotonic, improves myocardial function, antiarrhythmic. Khella Khellin Dilates coronary arteries and ameliorates anginal pain Malabar Tamarind Hydroxycitric Acid Lower cholesterol, inhibit atheroma formation, antithrombotic. Grape Seed Extract and Maritime Pine Bark Pycnogenols and Mixed Flavanoids Lower cholesterol, inhibit atheroma formation, antithrombotic. Milk Thistle Silymarin Reduces cholesterol. Botanical Table 63: A list of botanical products with their putative active ingredients that have been used with variable success to combat cardiovascular 310 problems and atheroma. The author stresses that not all of these botanicals are fit for human consumption. Some may not be safe and the evidence to support their use of often weak. Self-medication is not advised. Seek the advice of a qualified medical practitioner before using any herbal remedy for cardiovascular disease. Garlic Dr. Erich Block of the State University of New York has referred to garlic as the “spice of life” (Koch and Lawson, 1996). Koch and Lawson (1996) have reviewed extensively the basic science and clinical applications of garlic (Allium sativum and related species of plants) in their excellent and comprehensive book. So convincing is the scientific information to support the health giving benefits of garlic that the author strongly recommends its inclusion in the diet. Garlic and onions do not appeal to all palates and there are a variety of ways of taking odorless dietary supplements containing the health giving fractions of garlic, especially in relationship to cardiovascular health. Versatile Effects of Garlic Research on garlic and its constituents over the past two decades has firmly defined its role in the promotion of cardiovascular health. It is now well recognized that garlic is relatively safe and efficaceous in the management of arteriosclerosis by virtue of its versatile therapeutic effects. Garlic and some of its fractions have been shown unequivocally to reduce blood cholesterol, reduce serum triglyceride levels, exert an antihypertensive effect and it possesses antithrombotic actions. The versatility of garlic as a treatment or preventive agent for a variety of disease states is illustrated by a 311 consideration of its potential therapeutic effects and applications (Tables 64 and 65). Focus on Garlic and Cardiovascular Health Garlic and related extracts or products have been shown in scientific studies in both animals and man to exert several striking beneficial effects on cardiovascular function. Garlic has been shown to lower blood cholesterol and normalize blood lipids. More than forty clinical studies have been performed on the effects of garlic preparations on total blood cholesterol (Koch and Lawson, 1996). Only eight out of these forty cited studies showed no significant effect of garlic on serum total cholesterol. Whereas the remainder showed statistically significant percentage reductions of blood cholesterol ranging from -6 to -29% (Koch and Lawson, 1996). The effect of garlic on the reduction of serum triglyceride levels is equally impressive, where of more than 32 clinical studies only 11 showed no significant effect, in contrast to the remainder that reported significant percentage reductions of serum triglycerides ranging from -7 to -34%. Cardiovascular Effects Anticancer Effects - Protects blood vessels from attack by free radicals - Normalizes blood lipids - Lowers elevated blood pressure - Overall anti-atherogenic actions - Reduces platelet aggregation - By stimulation and protection of gastrointestinal function? - Epidemiological support that it may by cancer preventive - Good evidence for decreases in gastrointestinal cancer 312 - Activates fibrinolysis - Enhances blood flow - Decreases carcinogen induced cancer in many animal models Immunomodulating Activity Antimicrobial Actions - Enhances phagocytosis by - Antibacterial white blood cells - Antifungal - Increases suset lynphocyte counts - Antiprotozoal - Natural killer cell activity increase - Antiviral - Increased activity of B and T cells - Antiparasitic - Machado’s “Garlicin” (Antibiotic) Antidiabetic Effects Antioxidant Effects - Lowers blood glucose in the liver - Alters carbohydrate metabolism catalase - Effects on insulin production and inactivates - Prevents lipid peroxidation - Influences enzymes, such as Anti-inflammatory Effects Insecticidal & Repellent Properties - Antiarthritic - Modulates Prostaglandin synthesis - Kills mosquito larvae - Kills certain apahids - Repels blood feeding insects and glutathiane peroxidase Table 64: Potential therapeutic applications of garlic and its fractions are summarized. For a detailed review, the reader is referred to the book “Garlic: The Science and Therapeutic Applications of Allium Sativum and Related Species” by Koch and Lawson, 1996. Gastrointestinal Effects Homeopathic Effects - Carminative - Used for irritation of gastrointestinal - Stimulation of exocrine secretions tract, chronic bronchitis, coxo- Alters gastrointestinal motility femoral problems, and reduction 313 - Smooth muscle relavant process Antitoxic Effects in chronic inflammatory Respiratory Actions - Partial relife for lead poisoning - Beneficial effects in bronchita and - Protects against experimental asthma intoxication with cadmium - Amelioration of high altitude and mercury sickness - Activiates dotoxifying pathways - Antiallergic effects e.g., glutathione-S-transferase - Expectorant effect - Partial antidote to cyanide - Partial relief of hypoxia due to - Reduction in adverse effects of diffuse intrapulmonary shunting some chemotherapeutic drugs e.g., doxorubicin, cyclophosphamite Miscellaneous Effects - Enhances thiamine absorption - Modulates activity of many enzymes in body - Antihepatotoxic - Veterinary uses Hormone Like Actions - - Stimulates male and female sex hormones Aphrodisiac? Antifertility- spermicidal Modulates thyroid gland activity Effects on pituitary Table 65: Potential therapeutic applications of garlic and its fractions are summarized in continuation from Table 64. The differences in the outcome of these many studies on the lipid lowering effects of garlic can be accounted for by the different types and 314 amounts of garlic preparations that were used in the studies. The actual mechanism whereby garlic exerts these beneficial effects on blood lipids remains to be fully characterized. Most evidence seems to suggest that allicin is the active constituent that exerts the cholesterol lowering effects. Based on clinical studies, the optimal dose of allicin is the order of 0.05 - 0.1 mg/kg of body weight to achieve the lipid lowering effect. This represents an amount of fresh garlic of 2-3 grams per day and the duration of therapy required to achieve the effect is 4 to 8 weeks. Immediate or short-term effects of garlic on blood lipids are not to be expected. Garlic has complex, but well documented, effects on blood pressure, resistance in the vascular tree and it has direct actions on heart function. The blood pressure lowering effects of garlic are believed to be related to its ability to vasodilate (relax and make blood vessels bigger in diameter) (Rashid and Khan, 1985; Loeper and Debray, 1921). Koch and Lawson (1996) reviewed sixteen clinical studies of the effects of garlic preparations on blood pressure and show overall a significant reduction in both systolic and diastolic blood pressure with daily doses of different garlic preparations ranging from 18 mg to 1.2 grams. The actual constituents of garlic that lower blood pressure are not known. The hypotensive ingredients of garlic may be related to the adenosine content or the ability of garlic to raise blood adenosine levels (Melzig, 1995; Koch and Lawson, 1996). Other putative antihypertensive mechanisms of action of garlic include: membrane hyperpolarization with vasodilation (Siegel et al., 1991), calcium channel blocking effects (Mirhadi and Singh, 1987), inhibition of antiotensinconverting enzyme (Sendl et al., 1992), or increased production of nitric oxide by increasing nitric oxide synthetase activity (Das et al., 1995). 315 Garlic and some related compounds enhance fibrinolysis, impair blood coagulation and enhance blood flow. Arterioslerosis is associated with measurable decreases in fibrinolytic activity (blood clot dissolving activity), which can be reversed to some degree by garlic. Koch and Lawson have summarized eleven clinical studies of the effect of garlic on fibrinolytic activity which show conclusively that different garlic preparations in doses ranging from 4 mg to 1.5 mg per day result overall in significant and rapid enhancement of fibrinolytic activity. This potential effect of garlic on blood clots has been applied to thrombotic disorders and thromboembolic states as adjunctive therapy with variable success. The active constituents that account for fibrinolytic effects of garlic remains speculative. The possible active fibrinolytic elements in garlic preparations include: sulfur compounds (Bordia et al., 1975), cycloallii (Augusti et al., 1975) or phytic acid (Song et al., 1963). Platelets (thrombocytes) play a major role in the formation of atheroma in blood vessels. When circulating platelets clump together, they release substances that promote adverse changes in the lining of blood vessels that favor cholesterol deposition and vessel blockage. Many studies demonstrate that garlic preparations inhibit the adhesion and aggregation of platelets. Stopping the platelet clump with garlic is a fundamental basis for its use as standard therapy for the prevention of arteriosclerosis. The active constituents in garlic that inhibit platelet function include: allicin, allyl sulfides and adenosine (Koch and Lawson, 1996). Overall, allicin seems to be the most important antiplatelet element in garlic. 316 Garlic: How Much? What Type? The reader has some insight into the problems of selecting the right type and amount of garlic as a food source or dietary supplement. First, it is more than one constituent of garlic that accounts for its cardiovascular benefits. Second, garlic is a complex matrix of health giving substances (rather like the soybean) and many of these constituents could act synergistically to provide the desired therapeutic effect. Koch and Lawson (1996) have provided a discussion of the dosing and different preparations of garlic that are available. Clearly, a key health giving constituent of any of these preparations is allicin. If there is no reasonable assurance that allicin (or higher amounts, at least two times, of alliin) is present in the garlic preparation, it should be rejected as not possessing many of the desired health benefits. It should be understood that the amount of a certain constituent of garlic that is required for a health giving effect may vary considerably depending on the desired health effect. The logical solution is to use garlic in its natural form. At first sight, this seems to be the answer but several hundred species of garlic plants exist and each have differences in their contents of active constituents. Furthermore, the conditions of growth of these plants can alter the content of active substances within the same species of garlic plant. Add to this complex situation, the desire to seek odorless garlic preparations for use and one may give up the battle! The situation can be resolved to some degree by utilizing the scientific information to-date to try and select the most ideal available preparation. 317 Bearing in mind that the term “ideal” cannot be defined because our knowledge of the biopharmaceutical effects of all garlic fractions is quite incomplete. A lipid lowering effect of garlic can be achieved by using a daily dose of garlic powder which is standardized to contain approximately 1.3% alliin or 0.6% allicin which is approximately equivalent to 3.6 to 5.4 mg of allicin (Koch and Lawson, 1996). There have been several proposals made in the scientific literature to attempt to standardize the contents of garlic preparations. This process of standardization has been hampered by a relative lack of availability of pure standard compound for reference. There are two main types of garlic preparations which occur in the form of powder extracts or garlic oil preparations. The most important issue is not an intricate study of the chemistry of garlic preparations but a knowledge of their efficacy in human experiments or clinical studies. Garlic powders which have a reasonable standardized content of allicin are to be preferred over other products largely because most evidence, to-date, of an effect in humans has been noted with powder preparations. The quality of garlic preparations is related to measurements of certain marker compounds and the identification of alliin as the principal active substance in garlic preparations is well documented (Koch and Lawson, 1996). Aged garlic extract (kyolic, Kyoleopin, Leopin-Five) and odorless garlic extract (Tolstat) have little to offer over standardized garlic powder preparations which contain adequate allicin (alliin) together with variable amount of other active constituents, such as alliin homologs, scordinins, plant steroids, triferpenoids, flavanoids, fructans and gamma318 glutamyl peptides. In summary, about 3.5 and 5.5 mg of allicin on a daily basis will result in a general health benefit. This corresponds to 0.6 to 1.8 grams of fresh garlic (containing 0.3% allicin releasing potential. This translates into 0.3 - 0.9 gm of garlic powder per day that will yield 0.6% allicin (Koch and Lawson, 1996). In Europe, it has been frequently indicated that 4 grams per day of fresh garlic is required for a health benefit. The author believes that about 2.5 - 3 grams per day is adequate, based on prevailing literature. Procyanidolic Oligomers Anyone, except the most committed organic chemist, may want to skip this section because of the “off-putting” title. This would be a mistake because these flavonoids that are ubiquitous in plants are among the most exciting biochemical finds in modern nutritional practice. To narrow down the focus of this discussion, procyanidolic oligomers can be considered to include or be synonomous in some cases with pycnogenol, leukocyanidins and complexes of polyphenols or flavonoids. Plant Constituents: Polyphenols and Bioflavonoids Flavonoids are one type of naturally occurring polyphenols that are found in a wide variety of plants. In some circumstances, these flavonoids account for some of the colors that are found in a variety of herbs, vegetables or fruits. The overall effect of these polyphenols (bioflavonoids) in humans is to exert a potent antioxidant effect. By this mechanism bioflavonoids are believed to be capable of preventing a variety of diseases, including cardiovascular disease, viral infections and cancer. In addition, 319 these compounds may play a role in the regulation of blood glucose. Dr. Szent-Gyorgyi named bioflavonoids as vitamin P. It is apparent that many of these polyphenolic compounds work synergistically (together with) or in a mutually protective manner with vitamin C. There have been many studies that show the health benefits of bioflavonoids, especially in relationship to the promotion of cardiovascular wellness. Some of the most widely researched examples of bioflavonoids include compounds such as hesperidin, rutin and quercetin. These bioflavonoids occur as mixed constituents in citrus fruit, such as limes, lemons and oranges. Hesperidin, rutin and quercetin are known to protect capillary structure and they exert an important role in stabilizing cell membranes. In addition, these compounds are known to effectively lower cholesterol and they exert an antithrombotic effect by inhibiting platelet aggregation. Bioflavonoids are available in health food stores and are frequently mixed with vitamin C, which facilitates the effect of bioflavonoids or prevents them from degradation. Complexes of bioflavonoids are available in combinations in some dietary supplement preparations with recommended daily intakes of up to 1 gram per day. In these mixed formulations, the source of the active bioflavonoid constituents is often algae (from which quercetin is derived) and buckwheat (from which rutin is obtained). There are many different natural sources of bioflavonoids and it is difficult to make a specific recommendation as to the best type of bioflavonoid complex to take as a dietary supplement. There is no question that a mixture of bioflavonoids is preferable and an individual interested in taking polyphenols or bioflavonoids should look for specific information 320 about the amount of these agents that are standardized in the dietary supplement formulation. Several classes of herbal products that are recommended for health promotion have polyphenols and bioflavonoids as their active constituents. These commonly used herbs include bilberry, hawthorn, milk thistle, ginkgo and the increasingly popular agent pycnogenol. Pycnogenol is derived from the bark of European coastal pine. Other types of bioflavonoid complexes similar to pycnogenol have been produced, notably from grape pips, and there seems to be an increasing indication that grape pip extracts containing bioflavonoids may be equally as effective as extracts of European coastal pine. It makes more ecological sense to use grape pip extracts, since European coastal pine is a rather rare tree that could be depleted. Pycnogenol is rather expensive. Many health conscious individuals have sought bioflavonoids and polyphenols in the form of beverages and the most important sources of these agents include green tea, red wine (especially young wine) and red grape juice. Ginkgo has been used largely for its psychoactive effects which are alleged to cause an elevation of mood and a relief of depression. It appears that ginkgo can enhance cerebral circulation (blood flow to the brain), thereby increasing the nutrient and oxygen presentation to brain cells. In addition, ginkgo has an overall beneficial effect on blood circulation and its content of quercetin and other bioflavonoid compounds, such as flavone glycosides, may add to its beneficial health effects. It is recommended that ginkgo be taken in supplements that have a standardized flavoglycoside content of approximately 20% or more. In both animal and human studies, ginkgo has been shown to inhibit 321 platelet aggregation by a direct effect on platelet-activating factor. The effects of ginkgo are not immediate and in the experience of many healthcare givers, it may take up to three or four months before any beneficial effect is noted; especially if the desired effect is an enhancement of blood circulation. Anecdotal clinical observations indicate that improvement in blood circulation can occur up to as long as nine months or one year following initiation of therapy with ginkgo. The optimal dose of ginkgo is not known but is recommended to be approximately 40 or 50 mg of an average supplement that contains a standardized extract of ginkgo containing at least 20% of flavoglycosides. The berry of Vaccinium myrtillus, known as bilberry, is grown throughout Europe. It can be used to make a delicious fruit pie, that is often overbaked and, unfortunately, it does not contain heat labile nutrients that may promote health. This fruit is dark blue or purple in color and it contains active flavonoids known as anthocyanidins. It has been proposed that these anthocyanidins are capable of lowering blood cholesterol and blood triglyceride levels. Bilberry has been used for its beneficial effect on vision and several dietary supplements are available containing standardized amounts of anthocyanidins to a level of between 20 and 25%. The effects of bilberry on eye sight are of particular interest. The finding that bilberry could enhance the ability of the eye to adapt to dark was noted in a serendipitous manner by pilots of the Royal Air Force in the World War II who were engaged in the bombing of Germany. It is difficult to obtain enough anthocyanidins from fresh bilberry and concentrated extracts are required to provide optimal amounts to improve visual function. 322 The author has noted that some individuals with coronary artery disease who have taken bilberry extracts may notice spontaneous improvement in their vision, especially during twilight hours. Much interest has focused on extracts of the European coastal pine which is a tree that is native to the island of Corsica. It has been noted that extracts of the bark of the tree Pinus maritima (European, maritime, coastal pine) exert potent antioxidant effects and this extract has been marketed under the trade name Pycnogenol. It has been suggested that pycnogenol may strengthen capillary blood vessels and its antioxidant effects are believed to be preventive against heart disease, perhaps by diminishing the deposition of cholesterol within blood vessels. Like bilberry, pycnogenol and grape seed extract have been proposed as vision enhancers. Special mention is worthy of flavonoid compounds that occur in grapes, especially black or red grapes. The flavonoids within grapes are found mainly in the skin and pips and a variety of polyphenolic compounds have been isolated from grapes, including catechins, anthocyanidins (as found in bilberry) and proanthocyanidins. There are several bioflavonoid complexes derived from grape pips that have recently become available and they appear to offer similar advantages to pycnogenol. The story of the health benefit of red wine and grapes involved the observations that the death rate from cardiovascular disease in France, particularly coronary artery disease, is much lower than it is in Britain or North America. The reason for this lower death rate from coronary artery disease may be due, in part, to the high consumption of red wine and grapes 323 in France. Studies of the nutritional profile of French people versus British and American citizens indicate that the intake of saturated fat in the diet is quite similar. A famous study that was published in the Lancet in 1979 implied that the lower heath disease rate in France was most notable in regions of the country where red wine was consumed preferentially. The results of this study have caused some argument, since it is known that moderate alcohol intake may tend normalize blood lipids and increase HDL levels. Thus, some scientists have attributed the lower death rates from cononary artery disease in the French to a higher rate of moderate alcohol consumption. Alcohol itself may have a protective effect because it relieves stress and anxiety. However, it is believed by many individuals that it is the powerful bioflavonoid effect that may account for this improvement in cardiovascular wellness in several regions of France where wine consumption is prevalent. This observation is supported by studies that were performed in the United States at the University of Wisconsin, where drinkers of red wine were shown to have antithrombotic effects that were not noted in individuals who consumed white wine. With many advantages there are often disadvantages. It should be recognized that the incidence of liver cirrhosis in France in much higher than it is in the rest of the world and excessive consumption of any alcoholic beverage cannot be considered healthy. Many individuals find the situation concerning the effects of alcohol on health quite incongruous. On the one hand, alcohol is a promoter of free radicals which cause disease, whereas on the other, it seems to exert some beneficial effects when taken in 324 moderation. It should be stressed that alcohol can only be measured as beneficial on health when consumed in moderate quantities. Detail laboratory research has confirmed the proposed rationale for the use of red wine containing bioflavonoids. It appears that the bioflavonoid quercetin, which is found in abundance in red grapes, may exert effects similar to aspirin. Unfortunately, the news for white wine drinkers is not good. The amount of bioflavonoids in white wine is much less than that in red wine and it is important to note that red wine may tend to provoke heartburn more often that white wine. Unfortunately, the provocation of the symptoms of heartburn may in some individuals with coronary artery disease, may stimulate anginal episodes. For this reason, the author would recommend that individuals who want to achieve the health benefits from the bioflavonoids contained within red grapes, take the bioflavonoid complex that is produced from red grapes, rather than use red wine as the source of the bioflavonoids. It is interesting to note that following the publication of the epidemiologic studies a lower incidence of cardiovascular disease in French drinkers of red wine, the sales of red wine through the Western world escalated significantly. It is unfortunate that some individuals have used this health benefit of red wine to rationalize their excessive consumption of this beverage. The secret of health usually resides in moderation. Hawthorne is a plant that is quite rich in quercetin, catechin and vitexin. These polyphenols have been shown in research studies to lower serum cholesterol, on occasion lower blood pressure and certain beneficial effects have been noted on some cardiac arrhythmias (abnormal heart beats). 325 It is believed by some authorities that extracts of hawthorne are capable of dilating blood vessels and other constituents may have an effect on improving cardiac muscle function. Although not confirmed in controlled experiments, it has been suggested that hawthorne extracts can assist in the reversal of atherosclerosis and they may promote water excretion by the kidneys, thereby acting like a diuretic. Much further work needs to be done with the isolation of specific extracts of hawthorne because it is unlikely that all of its alleged health benefits are due merely to the mixed bioflavonoid content of extracts. Hawthorne should not be used in any self-medicating regime, especially if concurrent therapy is being undertaken with heart medications, such as digitalis, digoxin or lanoxin. The most valued component of hawthorne has been suggested to be vitexin. Vitexin and this agent should be standardized to approximately 2% or thereabouts in dietary supplements of hawthorne. Green tea has been increasingly popular because of its alleged ability to inhibit platelet function and prevent thrombosis, together with a cholesterol lowering effect. It is important to note that it is only green tea that has the most beneficial effects on cardiovascular health. Most tea that is consumed throughout the world is in the form of black tea. Black tea is produced by taking the leaves of Camellia sinensis (tea bush) and removing the leaves which are then dried, fermented and roasted. Green tea is processed in a different manner than black tea. Green tea is produced by taking fresh leaves from the tea plant and treating them with heat to prevent fermentation. It is the lack of fermentation of green tea leaves that results in the residual content of health giving polyphenol compounds. Green tea, 326 when appropriately processed, contain significant quantities of vitamin C and E, together with a reasonable range of minerals. The active constituents of green tea appears to be related to catechin which has similar effects to aspirin in terms of inhibition of platelets aggregation. It would appear that catechin can directly interfere with the production of platelet aggregating factor and other compounds exist in tea that may directly effect platelet function, thereby inhibiting thrombosis. Green tea is believed to have multiple beneficial effects, including the lowering of cholesterol, the normalization of blood pressure and in one Japanese study, drinking of green tea was associated with a lower risk of cerebalvascular accident (stroke). So convincing are the benefits of green tea, that some dietary supplement manufacturers have produced capsules and powders of green tea extracts which contain standardized polyphenol contents that may be equivalent to up to 5 cups of tea per day. In capsules where there is a content of approximately 50% polyphenols, than an average daily dose may be up to 200 milligrams. It may be more convenient for many people to take extracts of green tea rather than drink the beverage. Some green teas contain significant amounts of caffeine and excessive caffeine is to be avoided in individuals with coronary artery disease, especially is there is any increased susceptibility to irregular heart beat. Selecting the right kind of green tea is quite an exercise. The teas vary greatly in terms of their processing and source. The variability of the origin and processing methods of green teas make them somewhat of an 327 unreliable source of polyphenols in terms of consistent dosing. Furthermore, if tea is not prepared correctly then the polyphenols can become damaged or oxidized. If an individual desires to drink tea then the best varieties of green tea include gyokuro, sencha and gumpowder teas. It is not advisable to exceed more than 4 or 5 cups of green tea per day, especially if a variety of green tea is chosen that contains a significant amount of caffeine. Passwater and Kandaswami (1994) have described pycnogenol as a super protector nutrient which has versatile health giving effects. According to these authors, pycnogenol is capable of exerting protection for scores of different diseases which may have their foundation in cellular damage caused by free radicals. Pycnogenol and other related flavonoids are highly effective antioxidants that have ability to scavenge free radicals. The putative health benefits of pycnogenol are summarized in Table 66. The versatility of pycnogenol is shared by other antioxidants if the importance of the power of free radical scavengers is accepted. Pycnogenol is composed of flavonoids which are based on a single series of carbon ring structures composed of 15 carbon atoms that is referred to as a chromane ring. Although flavonoids possess chemical similarities, they may have very variable biochemical activities. When a flavonoid is Anti-inflammatory action Anti-arthritic effects Reduces oxidative stress Potential longevity benefit? Maintains normal capillary function 328 Improves red cell membrane flexibility Improves skin elasticity and smoothness Anti-allergic actions e.g., hay fever Reduces diabetic retinopathy Enhances immune function Beneficial in stomach ulcers Reduces risk of phlebitis, varicose veins May reduce tissue edema Table 66: The potential health benefits of pycnogenol, modified from Passwater and Kandaswami (1994). identified as having an effect in vitro, it is termed a bioflavonoid. Flavonoids have many metabolic effects which are summarized in Table 67. Pycnogenol is a mixed bag of natural chemicals with health giving benefits. Pycnogenol is extracted from maritime pine bark and 80% of its content is proanthocyanidins (PAC) with a variable amount of dimers or oligomers of PAC and organic acids making up the remaining 20%. A collection of proganidolic compounds similar to pycnogenol is extracted from from grape seed but unresolved arguments prevail about the relative merit of grapeseed extracts versus maritime pine bark extracts. 329 Whilst tremendous interest exists in the health applications of procyanidoli oligomers, the evidence for their benefit in cardiovascular disease is still somewhat scant. Interest in the cardio protective potential of bioflavonoids was fueled by studies that suggest that their presence in red wine was associated with a lower prevalence of heart disease in drinkers of red wine (St. Leger et all, 1979; Gaziano et al., 1993). In addition, the Zutphen Elderly Study (Hertog et al., 1993) drew attention to the inverse Facilitate phospholipid metabolism Vitamin C helper effects Antioxidant effects Vitamin E like activities Free radical scavengers Protein phosphorylation Effects on arachidonic acid metabolism Potent effects on redox reactions Influence gene expression Affect calcium ion transport Table 67: Metabolic effects of flavonoids and certain procyanidolic oligomers. 330 correlation between the dietary intake of flavonoids and the incidence of heart disease (the lower the flavonoid intake, the higher the incidence of heart disease). This relationship between flavonoid intake and heart disease was found to be present in the Zutphen Study even after correcting for other lifestyle or dietary influences on the incidence of heart disease (Hertog et al., 1993). Passwater and Kandaswami (1994) liken the potential beneficial effect of pycnogenol to the observed beneficial effects of vitamin E supplement. It is believed that one of the main protective effects of pycnogenol (or other procyanidolic oligomers) on atheroma formation is the inhibition of lowdensity lipoprotein (LDL) oxidation. Other ascribed cardiovascular benefits of procyanidolic oligomers include an antiplatelet adhesive effect and effects on collagen within blood vessels. Wegrowski et al., (1984) have shown in rabbits that procyanidolic oligomers will prevent partially experimentally induced atherosclerosis and lower blood cholesterol. In vitro studies by Chang and Hsu (1989) have shown inhibition of platelet aggregation and arachidonate prostaglandin metabolism. Overall, procyanidolic oligomers have promise for the prevention and perhaps therapy of coronary heart disease but the evidence for their use seems to be far less than the evidence to support the dietary incorporation of other botanical products, such as soy protein, soy isoflavones, omega 3 (predominately fish oil) and omega 6 fatty acids and garlic preparations. 331 Free Radical Damage to the Cardiovascular System In common with many other organs in the body, the heart is quite susceptible to damage by free radicals. This type of damage is sometimes referred to as oxidative stress. Tissue injury caused by free radicals is known to be a feature of a number of adverse cardiovascular events, such as ischemia of the heart muscle and damage to endothelial cells in the lining of blood vessels. Lipid peroxidation as a consequence of free radical activity is a form of chronic oxidative damage that plays a major role in the development of atheroma and arteriosclerosis. Of the many available antioxidant preparations, coenzyme Q10 has emerged as a potent blocker of free radical damage. It exerts potent inhibitory effects on lipid peroxidation in the body. Coenzyme Q10 is a benzoquinone compound that may be reduced to a compound called ubiquinol which acts as a potent and versatile free radical scavenger. Basic science research has shown that coenzyme Q10 exerts its effects in organelles such as mitochondria. In cells, mitochondria act as a distributor of charges that occur as a consequence of multiple enzyme activities. Many laboratory and clinical experiments have shown that coenzyme Q10 is able to reduce oxidative stress on the heart by a variety of mechanisms. Coenzyme Q10 can reduce oxidative stress induced by alcohol (ethanol) and it can prevent DNA damage that is induced by free radical application to cultures of myocardial cells (heart muscle cells grown in a laboratory). Dr. Debasis Bagchi, Ph.D., of the Department of Pharmacy at Creighton University, has performed extensive laboratory and human 332 experiments to show the cardio-protective benefit of oral supplementation with coenzyme Q10. Working in models of ischemia and reparfusion of heart muscle in pigs, Dr. D. Bagchi shown multiple benefits of coenzyme Q10. Coenzyme Q10 can protect pig hearts from injury that is induced by interruption and reconnection of blood supply (ischemia reparfusion) as a consequence of reducing overall oxidative stress. The mechanism of action of coenzyme Q10 remains incompletely understood but oral supplementation with this agent can result in up regulation of ubiquitin gene expression in cardiac tissues. The results of this research, together with many other observations, confirms that coenzyme Q10 supplementation of diet may have a particularly beneficial effect in cardio-protection from ischemic events. Antioxidant Effects of Coenzyme Q10 The term “free radical” is applied to a chemical compound which is essentially incomplete in its structure and highly reactive because of its arrangements of electrical charges which is called an electron arrangement. The role of free radicals in the causation of a variety of diseases is well recognized. Free radical reactions result in damage to cell membranes that may cause cardiovascular disease, cancer, and premature aging. The scientific discovery of the importance of free radical pathways in the causation of disease occurred as a consequence of improvements in understanding of the effects of ionizing radiation (x-rays or radio isotopes) on a variety of organisms. The theories of free radical damage to cells are somewhat complex but it known that the body can produce free radicals such as super-oxide and 333 nitric-oxide which are highly reactive compounds that will react with other molecules to produce damaging compounds. One example of these compounds is peroxynitrous acid which is known to be a potent oxidant of a variety of molecules that are contained within a cell. The idea that there are free radicals generated in the body as a consequence of processes such as food assimilation and energy production, or as a consequence of a variety of external influences, forms the basis of free radical theory. To prevent free radical damage to cells, it is possible to provide drugs or agents in the diet that are sometimes referred to as free radical scavengers. Good examples of free radical scavengers are a class of compounds which are referred to as antioxidants. The body has many “built-in” defenses to deal with free radicals that are generated by metabolic processes or other mechanisms. Whilst free radical generation is believed to play a major role in the causation of cancer and cardiovascular disease, it is used by cells to assist in body defenses. For example, white cells and other cells involved in immune function may manufacture free radicals in order to kill bacteria or viruses. Although the human body does have a number of natural defenses against free radicals, these defenses can be overcome by excessive free radical loads placed on the body. In this circumstance, antioxidant compounds such as vitamins C, E, beta-carotene, selenium and coenzyme-Q10 can exert a major beneficial effect by “mopping” up free radicals. These antioxidant compounds are a common component of dietary supplements. Ginger 334 Ginger in a non-toxic herb that is safe to take in large doses. Ginger is known to have versatile health benefits, including wellness promoting effects on the gastrointestinal tract and the cardiovascular system. One important study that was published in the New England Journal of Medicine in 1980, indicated that ginger may reduce blood cholesterol levels by unknown mechanisms. In addition, extracts of ginger may reduce platelet stickiness and have antithrombotic effects that are similar to garlic and aspirin. Whilst there is some argument about the effect of ginger on blood pressure, some studies have indicated that ginger may cause modest reductions in elevated blood pressure. Ginseng Ginseng is one of the most popular herbal tonics that is used on a worldwide basis for many health benefits. The potential health benefits that have been ascribed to the use of ginseng are summarized in Table 68 Ginseng is commonly available in health food stores in three distinct types. The first type is Panax ginseng, which is often termed Chinese or Korean ginseng. This type can be distinguished from Panax quinquefolium, which is known as American ginseng. The third type of ginseng is termed Siberian ginseng, but this type of ginseng does not belong to the same genus of plants (Panax) like Chinese or Korean and American ginseng. However, Siberian ginseng, Chinese or Korean ginseng and American ginseng all belong to the same family of plants which are termed Araliaceae. This Araliaceae family of plants produces different types of ginsengs which, overall, appear to have similar effects. The health-giving compounds within ginseng have been isolated to some degree and many have chemical 335 compositions that resemble the structure of human steroids and hormones. Ginseng has been characterized as containing a good range of vitamins, amino acids and trace minerals. Enhances physical performance and endurance. Improves sexual function. Lowers blood cholesterol. Enhances energy. Increases alertness. Exerts a protective effect on cellular damage from radiation or toxins. Improves memory and other psychomotor functions. Has anti-stress effects. •Promotes general homeostasis. Table 68: Beneficial health effects ascribed to the use of ginseng. The name ginseng means the essence (“sing”) of man (“gin”). It is the root of the plant that is used as the source of herbal concoctions and the shape of the root of the plant resembles the shape of the human body to some degree. In ancient Chinese medical writings, it was the morphological 336 resemblance of the ginseng root to the human body that led to the belief by ancient Chinese scholars that the root of the ginseng plant represented “the essence of the earth in the shape of the human”. This belief was extended to ascribe several health benefits to ginseng, including powers of healing, recuperation, rejuvenation and general revitalization. There appears to be major variation in the health-giving potential of different types of ginseng that are commercially available. The active components of ginseng are generally regarded to be ginsenosides and related compounds. Some analytic pharmaceutical studies have shown that the constituents of commercially available ginseng preparations vary to a major degree. For example, it is known that the ginsenoside content of commercially available ginseng supplements can vary from zero up to approximately 10%. Therefore, if an individual is considering taking a ginseng product then it is important to look for a supplement that has a standardized ginsenoside content. Several studies have shown that constituents of ginseng can reduce blood cholesterol levels and exert antithrombotic effects, in a manner similar to garlic and guggul. The mechanism of action of ginseng is not completely understood but it appears that ginseng directly effects the transport and metabolism of cholesterol with an overall effect of reducing LDL and increasing HDL cholesterol levels. Unfortunately, ginseng has an unpredictable effect on blood pressure and for this reason anyone with established heart disease is advised to take ginseng only under the supervision of a qualified healthcare giver. Some studies have shown that the administration of ginseng extracts may cause elevations in blood 337 pressure. It is believed that ginseng is quite safe but some researchers have described a syndrome (collection of signs and symptoms) that may occur as a consequence of ginseng abuse. The occurrence of this “ginseng abuse syndrome” is disputed by some experts but the author believes that it may occur when individuals take extremely large amounts of ginseng supplements. This syndrome is manifest by general excitability, including feelings of anxiety, nervousness and inability to sleep. Although not well characterized, this syndrome does have a potential pharmacological basis when one understands the effects of ginsenosides on the central nervous system. Ginsenosides are known to effect the release of neurotransmitters (chemical messengers) in the brain and they may alter blood flow to the brain. Despite some denials of the occurrence of the “ginseng abuse syndrome”, it seems prudent to avoid taking ginseng in the presence of irritability or anxiety and especially in the presence of uncontrolled hypertension. Siberian ginseng is popularly called “eleuthero” because of its origin from the shrub, Eleutherococcus senticosus. The active constituents of Siberian ginseng are termed “eleutherosides” which differ chemically from the ginsenosides that are found in American or Chinese ginseng. Many beneficial effects have been ascribed to Siberian ginseng and most of these effects are similar to those reported to occur with the use of Korean or American ginseng. The term “adaptogen” has been applied to Siberian ginseng based 338 largely on studies performed in Russia. The term adaptogen implies that an agent can enhance or modulate or normalize functions within the body. Thus, adapotgens result in the production of homeostasis within the body. The beneficial effects of Siberian ginseng on cardiovascular function are not as well described as they are for Panax ginseng. Siberian ginseng is often cheaper than Panax ginseng but there is even more variation in its quality than occurs with dietary supplements composed of Panax ginseng. Therefore, it is important to attempt to find a Siberian ginseng that has some standardization of its eleutheroside content. Ginseng is sold is variety of formats, including encapsulated extracts, ground whole root, tablets, capsules, tea bags, liquid preparations and even chewing gum. Despite the widespread use of ginseng, there is still relatively little known about the pharmacologic or pharmacodynamic responses to varying concentrations of ginsenosides or eleutherosides in dietary supplements. Some healthcare practitioners use varying doses of ginseng extract for different disorders. However, on average, when used as an agent to assist in cardiovascular wellness, a dose of approximately 150 to 500 milligrams of tablets or capsules are recommended, providing that they are standardized to contain between 4 and 9% of ginsenoside are used. Products that contain higher concentrations of ginsenosides or eleutherosides can be taken in smaller doses. One recommendation is to attempt to titrate (increase or lower) the dose of ginseng for an optimal effect. The author believes that it is unwise to exceed a dose of 700 milligrams of capsules or tablets that contain up to 10% ginsenoside on a daily basis without close medical supervision. 339 Guggul Guggul has been extensively researched in India as a “heart medicine”. Several studies have indicated that guggul is able to reduce blood cholesterol and triglyceride levels by a factor of up to 30% when taken over a period of approximately twelve weeks. Extracts of guggul have been shown to both reduce LDL cholesterol and increase HDL cholesterol. Guggul has not been popularized in Western medicine for cardiovascular wellness to the same degree as other botanicals. However, some authorities have argued that guggul may have as much therapeutic “treatment” potential as garlic and other lipid lowering agents, such as soy protein containing isoflavones. A number of laboratory experiments have indicated that extracts of guggul may exert an antithrombotic effect by reducing platelet stickiness. This potential dual effect of guggul compounds on lowering blood lipids and reducing platelet aggregation makes this botanical a very interesting natural approach to cardiovascular well-being. There are many different types of compounds contained within guggul. Guggul is extracted from the resin of the mukul tree (Commiphora mukul). It is the gum within the resin that is used to produce purified extracts of guggul that are terms “guggulipids”. Within this fraction of guggulipids there are several steroid compounds that are called “guggulsterones”. These steriods are believed to be the active agents. It is only recently that guggul has become popularized in North America and favorable reports of its use in Western medicine remain quite few. However, guggul appears to be quite safe and without significant toxicity, even when given in doses of up to 5 grams daily. Much further research is required with this interesting plant resin which seems to afford considerable 340 potential benefit for the prevention and perhaps treatment of coronary artery disease. Fo-ti Fo-ti is a traditional Chinese medicine that is used for a variety of medical purposes. It is most famous for the promotion of longevity and wellness. Research performed in China has shown that fo-ti in relatively large doses will reduce blood cholesterol levels and assist in the prevention of the formation of atherosclerosis. The active components of fo-ti include lecithin which has been associated in some studies with reduction in blood cholesterol levels. Fo-ti seems to be safe when taken in relatively large doses but the beneficial effects of this Chinese medicine on cardiovascular health is not as clear as the benefit that can be ascribed to agents such as soy, garlic or essential fatty acids. Some Natural Blood Pressure Lowering Agents Up to one-half of all individuals may be able to raise their blood pressure significantly by exceeding normal daily intakes of salt. The role of excessive salt intake in blood pressure control is well known and anyone with high blood pressure is advised to avoid excessive salt intake. Several natural agents have been proposed in playing a role in blood pressure lowering and these are listed in Table 69. “Salt” by Other Names and Types The adition of salt (sodium chloride) to food is a learned habit which can be broken with effort. It has been described as a habit “most people can’t shake”. Recently, some evidence has emerged that taking salt in the 341 diet from more natural sources may have some benefits. However, the body recognizes salt as salt and the author finds it difficult to believe that natural Decreased sodium intake Optimal potassium intake Optimal zinc intake Niacin Vitamin C Essential fatty acids Bioflavonoids Mushrooms (shiitake) Taurine Co-emzyme Q10 Mistletoe (Viscum album) Black Cohosh (Cimicifuga racemosa) Hawthorne Calcium Magnesium Celery Table 69: Nutrients and natural agents that have been described as capable of lowering elevated blood pressure. Individuals with high blood pressure are recommended to seek medical advice and attention. Do not selfmedicate to lower your own blood pressure. sources of salt have a great deal to offer in protecting the body from pressor (blood pressure elevating effects) of salt per se. 342 The best way to break the salt habit may not be just to quit using salt but to replace it in culinary activities with well selected, tasty herbs and spices. A number of true “salt substitute” products are available that contain no salt. However, one should be aware that a number of “salt substitutes” contain salt (sodium chloride). The most creative combinations of spices and herbs that can be used as salt substitutes include: onions, garlic, peppers, citrus peal, carrots, oregano, celery seed, marjoram, thyme, cumin, coriander, mustard and rosemary. The adventurous salt substituter has the option of mixing their own spice concoction to assist in kicking the salt habit. A “Salty” Education Ordinary table salt may have started from a natural salt source but the processing methods strip it of its natural mineral companions. Normal salt is usually prepared from a saline solution that is kiln dried at very high temperatures. In this process, many trace minerals with health-giving potential are lost. After drying, table sale has many chemical additives, including: potassium iodide, silico aluminate, tri-calcium phosphate, magnesium carbonate, sodium bicarbonate and yellow prussinate of soda. With the exception of iodide addition, these other agents are added to provide an ideal physical appearance to salt, prevent caking and ensure free flow of the material through a salt shaker. It is interesting that additions have nothing todo with health but more to do with aesthetics that make it easier for a consumer to “get hooked” on the salt habit. The individual who is able to stick with a low-salt diet that focuses only on the exclusion of salt addition at the table does not stand to benefit to 343 a major degree from salt exclusion in the diet. The importance of restricting sodium intake has over-shadowed the importance of optimal potassium intake for patients with elevated blood pressure. If potassium intake is not sufficient, then the body is not able to secrete of sodium load and sodium and water retention occurs with a resulting elevation in blood pressure by a mechanism involving renal hormones. However, self-medication with potassium supplements is quite dangerous, especially if an individual has poor kidney function. If potassium builds up in the blood, then it may cause abnormal heart beat and even cardiac arrest. Adequate supplementation of potassium is often forgotten in conventional medicine and it is quite easy to obtain potassium in the normal diet by drinking fruit juices or eating fruit that has a high potassium content. Several fruits are notably high in potassium and relatively low in their sodium content. An outstanding source of dietary potassium is the banana. An average size banana contains approximately 500 mg of potassium but only approximately 2 mg of sodium. There have been some scientific studies that have looked at populations of individuals who eat bananas and there is some evidence that, on average, their blood pressure tends to be lower than populations that do not consume this fruit. Other good sources of potassium, with relatively low sodium, include oranges, lemons, peaches, melons, potatoes and lima beans. In addition to potassium, adequate calcium and magnesium intake is required to have normal blood pressure. A deficiency of magnesium, which 344 is frequently found in people who drink excessive alcohol can result in high blood pressure and individuals with low calcium intake are prone to hypertension. Calcium supplements are a good addition to the diet of all adults and they may play a special role in promoting health by reducing osteoporosis in later life. Celery May Lower Blood Pressure Special mention is required of celery in terms of its ability to control blood pressure. Celery, when taken as the whole vegetable or as the seed, has been used for many years in traditional Chinese medicine and Ayurvedic medicine. It appears that celery seeds have a diuretic effect but caution is required with their use, because in high doses they appear to be toxic and they are contraindicated in excess during pregnancy. Essential oils derived from celery have been used to lower blood pressure and they are believed to exert a direct relaxant effect on the smooth muscle found in the wall of blood vessels. The active constituent of this essential oil is believed to be butyl phthalide which is known to cause modest reductions in systolic blood pressure and exert some effects on lowering cholesterol. It should be emphasized that if therapy is planned with celery, then one should seek the advice of a healthcare giver. Celery extracts are available in health food stores in a variety of formats but, unfortunately, their contents are not always standardized. The author believes that if celery is to be used then it is probably safely taken as three or four whole stalks of celery per day, because in this amount no adverse effects can be anticipated. Combination Remedies in Dietary Supplements: Mixed Blessings? 345 A variety of dietary supplements have emerged that contain mixtures of compounds that may claim to exert beneficial effects directly on cardiovascular function or more indirect benefits in the prevention of cardiovascular disease by lowering cholesterol. Several of these combination dietary supplements are sold with supporting literature that is anecdotal and sometimes based on questionable scientific evidence of safety and efficacy. A consumer should be aware of marketing literature on dietary supplements that promises that avoidance of sudden death or heart attack. Anything that is described as a quick method to prevent or reverse cardiovascular disease should be treated with skepticism. A variety of botanical extracts are available in combination with some simple products such as sugar or dietary fiber, but claims for using such combinations in the treatment or prevention of heart disease cannot be substantiated by credible observations of their effects in clinical use. The author is not attempting to reject the importance of some evidence that individual constituents in certain herbal concoctions may have some benefit. Botanical compounds derived from hawthorn berry and flower extracts have been claimed to exert diverse benefits, including reduction of blood pressure, improvements in contractility of heart muscle, favorable decreases in heart rate and some decrease in oxygen consumption by the heart muscle. Flavonoids of botanical origin, such as quercetin have been subjected to research to assess its ability for the promotion of cardiovascular wellbeing. Quercetin is known to inhibit the oxidation of LDL which may play an indirect role in the causation of atherosclerosis. There is emerging 346 evidence that some botanicals, such as extracts of hawthorn, have beneficial cardiovascular effects but, overall, the author advises against the use of these combinations of botanical remedies because many are not standardized and few have been subjected to any well controlled, clinical research. It is worth noting that some of the claims associated with botanical combinations are quite outrageous. Statements that indicate that natural cures can rapidly reverse atherosclerosis and result in the avoidance of cardiac surgery, when such surgery is necessary, are claims that should not be encouraged. The “hype” of this kind of hope contributes greatly to an appropriate rejection of that segment of the dietary supplement industry that behaves unscrupulously in marketing supplement products. 347 CHAPTER 10 GENERAL DIETARY FACTORS 348 Optimal Nutrition Everyone talks about optimal nutrition, but few individuals can comply with the ideal diet. This dilemma is amenable to some solution by the use of well chosen dietary supplements. Whilst one could be criticized for this approach of supplementing an existing diet rather than primary, but radical, modification of the diet, it is obvious that even the most dedicated homemaker would have difficulty in finding, preparing and affording an “optimal” diet for a family. The start of the solution to obtaining a nutritional program for cardiovascular health rests in a consideration of basic dietary principles. Looking at a diet that is just cholesterol focused is problematic. The human body can manufacture at least one and one-half grams of cholesterol per day. If diets low in cholesterol are selected, then the body will compensate in many subjects (about 50% of all individuals) by increasing the endogenous synthesis of cholesterol. This factor makes a low cholesterol diet alone a less effective means of reducing total blood cholesterol than many people may have presupposed. A Reasonable Composite Diet Most individuals can think in food groups which are composed traditionally of four categories, including: the meat or protein group, the dairy group, the fruit and vegetable group, and the grain group. It is generally accepted that most adults need a couple of serving from the meatprotein and dairy groups together with four servings from the vegetable-fruit and grain groups. 349 The meat-protein group intake on a daily basis is worthy of analysis. Red meat is especially high in cholesterol and is best avoided until blood lipids are controlled, when infrequent inclusions of red meat in the diet may be harmless. Poultry and fish are preferred to red meat for dietary inclusion in the healthy cardiovascular diet. It is often stated that fat should be trimmed always from this group but it should be noted that whilst this is true for poultry and meat, the fat on fish is abundant in health giving omega 3 series, essential fatty acids. The “meat protein” group is becoming increasingly redefined for health with much more emphasis being placed on the incorporation of vegetable protein into the diet from legumes, especially soybeans. Vegetable protein is often equally as nutritious as animal protein and it makes more ecological sense. Moving towards vegetable protein inclusion in the diet, especially of soy origin, at the expense of animal protein has been associated with a plethora of health benefits. Many of these benefits are discussed in Chapter 4 of this book. Dairy products are to be very limited in the diet planned to promote cardiovascular wellness because they present a cholesterol burden. Milk is an excellent source of protein, fat soluble vitamins (A and D) and calcium. These important, nutritious components of milk are available in low fat dairy products which are to be preferred at all times by the individual who seeks cardiovascular health. The fruit-vegetable and grain groups are highly desirable components 350 of a diet for cardiovascular health. The only limitation to this aspect of the diet is to watch total calorie intake. An individual with a high satiety level is advised to fill up with vegetables that have a low calorie density. The concept of caloric density of food is important. Certain foods are more “dilute” in calories than others because of their makeup of protein, fat, carbohydrate and fiber. Fiber-rich foods are generally “dilute” in calories and will help promote satiety. Excessive calories of carbohydrate origin, especially from simple sugars or refined carbohydrates, are readily converted into saturated fat in the body. One hallmark of the unhealthy American diet is the over-inclusion of refined carbohydrates which is tantamount, in metabolic terms, to eating excess saturated fat. This tendency to exclude dietary fat and promote carbohydrate intake is a popular, but ineffective, method proposed as a good pathway to weight loss by the uninformed. If carbohydrates are included to a major degree in any diet, they should be preferentially derived from complex carbohydrates which are found in foods that contain more dietary fiber, vitamins, minerals and essential fats. Complex carbohydrates are most obiquitous in fibrous vegetables and fruits. A special and repetitive mention of grains and cereals is necessary. Overall, these foods are an excellent source of dietary fiber with all of its known health giving benefits and fiber is non-calorigenic with an ability to promote satiety. A Primer of Digestion and Nutrition Many books on natural therapy have endless discussions about nutrients without giving the reader some basic understanding about the 351 physiology of digestion and the general importance of various food categories. Without this basic understanding it is impossible for a lay person to understand the significance of certain statements or recommendations concerning good versus bad nutrition. The acquisition of a basic knowledge about digestive processes and nutrition can permit an individual to select an appropriate type of food in the diet and make an informed judgment about the desirability of using certain dietary supplements. The author believes that some manufacturers of health food products may mislead consumers about the importance of certain formulations of dietary supplements or nutrients in order to promote the sale of specific products. Many examples of misleading advertising exist. For example, the presentation of minerals in a colloidal format are of little importance in overall nutrition and the manufacturers are selling the format rather than the minerals. In addition, the presentation of vitamins in delayed or slowrelease format is a gimmick. Advances in pharmaceutical research have produced novel delivery systems which can enhance the activity of natural or synthetic remedies. One such example of technology is the use of slowrelease tablets or capsules. Slow-release capsules can be particularly useful in delivering substances that may be destroyed in the upper digestive tract or to target the release of substances into the lower bowel. An example of the responsible use of slow-release formulations in natural health care is the encapsulation of certain oils that are difficult to take unless delivered in a slow-release format. Furthermore, certain oils, such as fish oil, may have more favorable absorption profiles when delivered in a slow-release format. 352 The amount of a substance that is absorbed is termed “the bioavailability” of the substance. Bioavailability is a very important issue in nutrition. If something is not given in a bioavailable format, then it is merely excreted in the stool. If the objective is merely to get something into the system, such as a readily absorbed water soluble vitamin, e.g., vitamin C or vitamin B, then there is no need whatsoever to use a delayed-release preparation. Despite this, delayed-release vitamin C preparations have emerged in the health supplement market with promises of greater health benefit. This type of misleading advertising should not be encouraged and is patent nonsense. It is not possible to give a comprehensive account of the importance of pharmaceutical formulations except to say that if a product is presented in a specific format, then adequate reason should be given for the specific formulation. Formulations of natural remedies leaves the door open for the unscrupulous manufacturer to engage the consumer in fads whilst they “dish up” fallacious arguments. From Mouth to Anus The gastrointestinal tract starts at the lips and finishes at the anal margin. Food is ingested and chewed where it is mixed with saliva in the mouth. Saliva initiates the digestive process of some carbohydrates but it functions primarily to facilitate the passage of a bolus of food through the upper gastrointestinal tract from the mouth to the stomach. The two greatest pleasures in life have been identified as eating and defecating, at least by more basic thinkers. Poor dentition is an important potential cause of malnutrition, especially in the elderly. Food should be chewed, preferably quite slowly, in 353 order to facilitate its transit through the upper gastrointestinal tract. A simple observation is that some obese people tend to eat quite quickly and deliver solid masses of food to their stomach. The process of chewing is quite a satisfying act and it can, in part, result in the promotion of satiety. The person who “bolts” their food tends to rush the rest of their life and this activity is common in the type A personality. The “bolting” (rapid ingestion) of food should not be encouraged in childhood where this learned behavior has its origin. Food passes from the esophagus through a muscular ring at the junction of the esophagus and the stomach that is called the lower esophageal sphincter. The function of this lower esophageal sphincter (muscular ring) is to prevent the retrograde (backward) flow of stomach contents back up into the esophagus. The stomach contains gastric acid which can irritate the lower esophagus if gastric (stomach) contents are regurgitated into the lower esophagus. The occurrence of retrograde flow of gastric contents into the esophagus precipitates heartburn. Heartburn is a very common phenomenon that effects almost one-half the population on a recurrent basis at sometime in their life. Persistent heartburn is a serious medical problem that required appropriate medical intervention. However, most cases of heartburn are related to simple reflux of gastric contents into the chest and these events are most often precipitated by adverse lifestyle, such as excessive eating, smoking or excessive alcohol intake. The widespread promotion of over-the-counter antacids and drugs, such as H2 receptor antagonists, for heartburn ignores the importance of lifestyle change to ameliorate heartburn. 354 The stomach receives food and stores it temporarily prior to mixing and grinding. The food is mixed and ground with gastric contents to form a slurry that is then discharged in a regulated manner to the upper small intestine where most nutrients are absorbed. Contrary to popular belief, the stomach is not a key sight of absorption of nutrients, most food is digested in the small intestine. Food in the stomach is mixed with acid and the digestive enzyme pepsin. The effluent from the stomach in termed “acid chyme”. This semi-fluid slurry of acid chyme enters the upper small intestine where it is neutralized by a number of alkaline digestive juices that are secreted by the pancreas (pancreatic juice), the liver (bile containing bile salts) and intestinal juice (succus entericus). Pancreatic juice facilitates the absorption of fats, carbohydrates and protein by virtue of its content of enzymes called lipase, amylase and trypsin. In addition to secreting digestive enzymes, the pancreas is important as the body’s source of insulin which is secreted into the blood stream rather into the small intestine. Bile does not contain digestive enzymes but it assists in the emulsification of fats prior to their digestion. Intestinal juice is very complex and a lot of digestive activity occurs at the surface of the cells that line the small intestines. At this interface between the digestive lumen (hollow of the small intestine) and the wall of the small intestine, proteins are broken down to small elements and sugars are further digested into small units. At this intestinal stage of digestion, most of the products of the digestive process are absorbed through the bowel wall into circulation. Much of the blood the drains from the gastrointestinal tract passed through 355 the liver which acts as a filter and storage organ during the process of digestion. The contents of the small intestine are delivered to the start of the large bowel which is called the cecum. In the small intestine much of the nutrients are absorbed by the simple process of diffusion. Carbohydrates tend to be absorbed as simple sugars called monosaccarides and protein is absorbed as amino acids and small peptides. The digestion of fats is an extremely complex process but fats are broken down to their basic units of glycerol and fatty acids which are then absorbed, preferentially through lymphatic channels called lacteals. In contrast, sugars and proteins tend to preferentially be absorbed into the blood stream. There are certain nutrients that are absorbed in quite complex ways. For example, vitamin B12 requires the presence of a certain factor that is secreted by the stomach and pancreas (called intrinsic factor) and it is absorbed preferentially in the lower reaches of the small intestine. The colon, or large bowel, is not a digestive organ. However, when the liquid material from the small bowel enters the large bowel, water and some minerals are absorbed by the large intestines. The process of passage of this material through the large intestine results in increasing degrees of water absorption to produce solid material that is present in the left side of the colon. This material is the fecal matter, or stool, that is passed with a frequency of between once and three times per day in a normal person. Main Dietary Constituents in Simple Forms Carbohydrates in the form of glucose is an immediately available source of energy for cells. Although glucose can be stored as glycogen in 356 the liver and muscle tissue, this store is quite small and provides only approximately 2,500 calories of immediate energy that is rapidly utilized during strenuous exercise. In contrast, fats have a higher energy potential and produce more than two times as many calories on a weight per weight basis as does carbohydrates or proteins. Fats stores within the body are the greatest source of energy and the body of a male of optimal weight is about 16% fat with a potential energy yield of more than 100,000 calories. Proteins are a source of nitrogen and they are composed of amino acids. For many years to was believed that eggs and meat were the most ideal source of protein. In the 1950s the United Nations Committee on Food and Agriculture indicated that eggs provided the best balance of essential amino acids. These concepts have been superseded as the importance of the amino acid profile of proteins in their health promoting effects has become increasingly understood. Understanding Vitamins Must information has accrued about the importance of vitamin intake for health. Overall, vitamins function in body metabolism and they facilitate many chemical reactions in the body. Vitamins are generally classified into two groups which include the fat soluble vitamins A, D, E and K and the water soluble vitamins which compose the vitamin B complex and vitamin C. This short overview of the main components of food is provided to permit those individuals without a basic knowledge of physiology to understand some of the concepts that are proposed, especially in relationship 357 to nutritional interventions and the promotion of cardiovascular wellness. Vitamin A in present in an intact form in fish and meat, or it can be taken indirectly as carotene in vegetables and fruit which is then converted in the body to vitamin A. Vitamin A is generally important for epithelial cells which are located in the skin, the respiratory system, the endocrine system and many parts of the central nervous system. Vitamin A deficiency is practically unknown in Western society and in some respects vitamin A is one of the least important vitamins to supplement in individuals given standard Western diets. However, vitamin A is quite toxic in large doses of should be used with caution in individuals with liver disease. Vitamin D is characterized by the occurrence of several subtypes, including vitamin D2 (ergosterol), calciferol and vitamin D3. Vitamin D is ubiquitous in fish and meat. Deficiency in vitamin D results in bone disease and again vitamin D should be avoid in excess. Vitamin E (tocopherol) exists in several chemical forms and is the classic antioxidant vitamin. Vitamin E is found naturally in many seed oils. Vitamin K is present in a variety of food and it exerts an important effect upon the maintenance of normal blood clotting and the integrity of blood vessels. Of the fat soluble vitamins, vitamin E has received particular attention in terms of its potential health giving benefits in coronary heart disease where it exerts its principle function as an antioxidant. In general, supplementation with the fat soluble vitamins A, D and K, is of questionable importance in individuals who take a balanced diet. Some authorities are concerned about excess intake of fat soluble vitamins. 358 In contract to the fat soluble vitamins which may be stored in the body, vitamins of the B complex are not stored in the body and require daily intake. For this reason, daily vitamin supplements with B complex vitamins is often advised by nutritionally-orientated physicians. Thiamin (vitamin B1) is present in a variety of grains, including wheat and it plays an essential role in the metabolism of carbohydrates by acting as a co-enzyme for the well known pyruvic acid cycle which is involved in energy production. Riboflavine (vitamin B2) is also found in grains and its has effects similar to those of vitamin B1 but it also seems to be important in the promotion of normal function of epithelial tissue. Niacin (vitamin B3) is known to be important in carbohydrate metabolism and it facilitates the functioning of thiamin and riboflavine. Niacin can cause unpleasant reactions when taken in large doses and this vitamin has been shown to be useful in some studies as a cholesterol-lowering agent. However, the adverse effects from this vitamin, when used in substantial doses, limits it use as a cholesterollowering agent. Vitamin C is well recognized as an important vitamin to supplement in the diet. Vitamin C is ubiquitous in fresh fruit and green vegetables and its effects include facilitation of the absorption of iron, actions in the transport of oxygen within the body and the promotion of health of connected tissues. Vitamin C is a classic antioxidant and its use has been associated with the prevention and treatment of a variety of chronic diseases, including cardiovascular disease. Vitamin C is destroyed by excessive cooking and its level is diminished in stored or preserved vegetables and fruits. An enormous amount of literature exists on the health-giving benefits 359 of vitamin C which has been identified by some authorities as a nutrient with a panacea benefit for many chronic diseases. Some Alarming Facts About Children Despite the importance of lifestyle in the maintenance of health in childhood and adulthood, there are few accounts of methods of correction of adverse lifestyle in children. One excellent attempt to analyze some of the health problems that present themselves in childhood is the book written by Dr. Charles Kuntzleman, entitled “Healthy Kids for Life” (1988). In the first chapter of his book Dr. Kuntzleman presents some alarming statistics on the health and well-being of children in North America. Table 70 summarizes some of these worrying observations of diet, lifestyle and physical fitness among American youth. A perusal of some of the statements on Table 70 are alarming and probably very revealing for the readings. The illustration on the front of this book was specifically created in a cartoon format with a child at the center of the cartoon. An unhealthy child will inevitably become an unhealthy adult and changing lifestyle in childhood will materially improve health, well-being in later life and longevity. The cartoon on the cover of this book is worth closer study. It draws out the importance of the interrelationship of several types of adverse lifestyle in the promotion of cardiovascular disease but it attempts to reinforce the issue that the roots of cardiovascular disease often rest in childhood. Average duration of vigorous exercise, less than 15 minutes per day. 360 Greater than 20% of calories from simple sugars. More than one-quarter may have high blood pressure. One-third have elevated blood triglycerides. One-half of all children may have high blood cholesterol. Two-thirds eat too much salt. Three-quarters eat excessive fat in their diet. Sixty-seven percent of all children have three or more risk factors for cardiovascular disease. All most 100% of all children have at least one major risk factor. Sixty-four percent of all children may fail to meet minimum physical fitness criteria. Table 70: Some facts on levels of fitness, lifestyle and general health issues among children in the United States based upon data presented by Dr. Charles Kuntzleman in his book entitled “Healthy Kids for Life” (1988). The support for these statements comes from the National Health and Nutrition Examination Survey (HANES). The HANES has that implied that there is a direct relationship between the weight of a child and the amount of time that a child may spend watching television. It has been estimated that data from the HANES implies that the occurrence of childhood obesity increases by approximately by 2% for each additional one hour that a child watches television. The factors that determine this association are made obvious in the cartoon on the front cover of the book. These factors appear to operate in adults to the same degree that they operate in children. Sitting on a couch and sharing cigarette smoke, eating simple sugars and excessive 361 salt and fat are obvious example of behavior that this to be avoided. The sad situation is that children tend to take their lead from adults. This is well portrayed in the cartoon that signifies the occurrence of the Cholesterol Time Bomb. Dr. Attwood’s Twelve Common Myths Dr. Charles R. Attwood M.D. is a pediatrician from Louisiana who has written a celebrated book entitled “Dr. Attwood’s Low-Fat Prescription for Kids”. In this book, Dr. Attwood draws upon his more than 30 years of experience in pediatrics to provide parents with very sound dietary advice for children. He subscribes to the theory that cardiovascular disease has its roots in childhood and the use of correct diet can result in the lowering of death rates from cardiovascular disease and the prolongation of life. The message is simple but quite profound. This book by Dr. Attwood is to be highly commended because it is written from a sound scientific basis in a manner that is readily understood by the lay person. The central theme of Dr. Attwood’s work is the description of twelve common myths that have percolated over the past few decades. Dr. Attwood’s twelve common myths are shown in Table 71. These twelve proposed myths have led to practical recommendations on changing diets in children to produce health and well-being, not only in childhood, but also in later life. Dr. Attwood recommends that an ideal diet has only approximately 10-15% of its calories derived from fat. This results in a situation where diets for children need to be quite selective, especially in relationship to meat or 362 dairy intake and the use of snacks that may contain large amounts of saturated fat. Dr. Attwood and others cited by him in her book have been somewhat critical of the U.S. Department of Agriculture’s “pyramid” of food intake. He Page 1 of 2 Myth Comment Controlling cholesterol Emphasis is placed upon cholesterol screencan wait. ing in childhood and intervention with diets to correct blood cholesterol levels of over 150 mg%. Controlling obesity can wait. “The Fat Taste” is natural behavior that is and in-born. Obesity must be controlled in childhood because even if weight is lost in later life, residual health risks exist. A taste for fat food is learned associated with rewards and social events in childhood. Fat taste is learned by conditioning and is not innate. Small reductions in dietary Scientific evidence exists that major reducfat will do. tion in dietary intake of saturated fatty acids and cholesterol are required for optimum health. Children’s diet are getting better. The food industry has presented more highfat food based upon consumer demand. Meat is need for protein and iron. Vegetables can provide complete ranges of essential amino acids and meat is not necessary to insure a dietary supply of complete protein. Milk is need for calcium and protein. Dairy products are rich in saturated fats and cholesterol. Vegetable based diets contain adequate calcium and protein and milk is not necessarily the best source of calcium. In 363 Southeast Asia, soy milk has overtaken dairy milk and it is “ideal”. Page 2 of 2 Myth Comment Low fat diets lack vitamins and minerals. provide Calories from fat that are replaced by vegetables, fruits, grains and legumes can adequate sources of vitamins and minerals. A low fat diet means limited choices. Dr. Attwood indicates that children’s diets that exclude meat and dairy foods have a greater variety of foods. Low fat diets retard growth. There may some flaws in studies that have reported growth retardation in children on low fat diets. Excluding the need for essential fatty acids in early life, there is little evidence to suggest that elimination of saturated fat and cholesterol poses any negative health effects, unless this elimination is not replaced by an adequate range of healthy food. Its obvious which foods are high in fat. Fat is available in food stuffs in a disguised manner. Close attention should be paid to food labels. No one knows what is really best for my child. Children eat too much fat and not enough complex carbohydrates. Modern diets are low in fiber. Unequivocal evidence now exists that low fat diets in childhood may be preventative against coronary artery disease in later life. Table 71: Twelve myths that have been proposed by Dr. Charles R. 364 Attwood in his book entitled “Dr. Attwood’s Low-Fat Prescription for Kids”. The comments are taken in part from the author’s interpretation of Dr. Attwood’s writings. refers to the “pyramid” of dietary recommendations as politically satisfying guidelines. Other authors have been quite critical of this “pyramid” series of recommendations, especially in relationship to its lack of recommendations of adequate intake of balance amounts of essential fatty acids. Dr. Attwood’s recommendations differ from those of the American Heart Association (AHA) in that they are much more stringent in recommendations concerning the control of fat intake. There appear to be four stages to an ideal diet. In stage 1 of Dr. Attwood’s dietary recommendations for children, he proposes that the AHA guidelines are followed by consuming up to 30% of calories from fat. Dr. Attwood believes that the allowance of fat proposed by the AHA is too liberal. In stage 2 he recommends reduction of fat intake to 20 - 25% of total calories. Stage 3 and stage 4 recommendations lead to a transition from 15 20% of calories from fat down to less than 15% of calories from total fat in the diet. Stage 4 is an ideal diet, according to Dr. Attwood and it contains only about 3 - 5% of calories from saturated fat. After reaching a stage 4 diet in childhood, it is proposed that children may lose their “taste” for fatty foods. However, he does recommend that children be provided with sources of vitamins, especially vitamin B12 or vitamin “supplements”, in general. Overall, Dr. Attwood’s recommendations can be best described as moving from a meat based diet to a more vegetarian type of diet. Dr. 365 Attwood is convinced that there is a phenomenon which he has termed the “fat taste” that appears to be at the basis of poor nutrition in childhood. The book, “Dr. Attwood’s Low-Fat Prescription For Kids” draws experiences from Southeast Asia to explain the importance of moving towards a vegetarian diet. He quotes the China Health Study which was conducted over a six year period beginning in 1983. This collaborative research effort between the Chinese government, Oxford University in England and Cornell University in New York studied measurements of lifestyle and dietary intake in 6,500 Chinese individuals. This study showed that much less coronary artery disease and cancer were present in individuals who had the lowest fat intakes. Dr. Attwood quotes the following statistics, “The rate of heart disease - not death rate from heart disease, just the disease itself - in these rural villages of China was 26 per 100,000. The rate in the United States is 4,036 per 100,000, or 150 times higher”. Dr. Attwood ascribed these beneficial outcomes as being related to greater physical activity and the consumption of low fat, low animal protein diets in Chinese subjects. However, other factors may have played a role, such as the amount of dietary fiber intake, soy incorporation in the diet and other lifestyle variables. The author believes that Dr. Attwood’s recommendations are quite sound and close to ideal. Unfortunately, it is difficult for a child in Western Society to avoid excessive fat in the diet and parents need to be extremely vigilant in supervising the diet of their children if they are to follow stringent guidelines, such as those proposed by Dr. Attwood. Whilst Dr. Attwood’s recommendations could be perceived as ideal, they are somewhat impractical. The author believes that any approach towards the ideal in 366 modifying nutrition in childhood is beneficial and a failure to comply with the strict recommendations proposed by Dr. Attwood should not provide a disincentive for parents to attempt to move their children’s diets towards a more vegetarian mode. Special Consideration: The Young and The Elderly Adolescents and teenagers with hypertension are a difficult group to manage. Young people are less likely to take arguments about the serious nature of high blood pressure as important consideration in their day-to-day activity. The profile of children with high blood pressure is often recognizable but not often spotted. Young people with high blood pressure often have a family history of hypertension, they may be obese and they may have a tendency to avoid physical activity. These are not normal kids but many kids match the profile. This is a sad reflection of our “advanced” society. Substance abuse in teenagers may be an important underlying factor in the causation of elevated blood pressure. The healthcare giver or parent should be vigilant to spot drug abuse and help the young person correct this type of adverse lifestyle. Mature and elderly individuals are the commonest group in which blood pressure lowering strategies are undertaken. It is recognized that the health risks associated with hypertension increase as an individual gets older. The mature individual must accept the concept that intervention in the presence of advanced age is still very beneficial. Recent clinical trials have shown benefit of reduction of diastolic blood pressures in people over the age of 65 to levels below 90 mmHg. In addition, it worthwhile to reduce systolic blood pressures in excess of 180 mmHg in elderly people to levels 367 that are less than 160 mmHg. Recent evidence exists that the elderly are in fact the group for which natural options may be the most ideal treatment approach. Elderly people with mild hypertension should always be considered a prime target by a healthcare giver for natural options or lifestyle intervention rather than drug therapy. The reasons for this are obvious. Elderly people may not tolerate the side effects of anti-hypertensive medication and the benefits of “strict” blood pressure control in the elderly are not as well defined as they are in younger people, even though they are reasonably well defined. Clinical evidence exists to show that reduction of isolated systolic hypertension or reductions in combined elevations of systolic and diastolic blood pressure can result in reductions in morbidity and mortality in mature individuals. The JNC program has shown that in fairly long follow-up periods of five years or more, mature individuals can substantially reduce their risk of heart attack, stroke and renal failure by appropriate management of high blood pressure. Several special factors are important in the treatment of an elderly individual with blood pressure, such that treatment interventions are only to be deemed appropriate when these factors are carefully considered. The aging process results in a situation where reflexes in the body are diminished in elderly individuals. Even in the absence of high blood pressure or the taking of anti-hypertensive medications, an elderly subject may become faint when they move quickly from a lying or sitting posture to the upright posture. This phenomenon of orthostatic hypotension is quite common in 368 the elderly and, of course, is made worse by the prescription of drugs that lower blood pressure. Elderly people may be less attentive to their diet and may engage in frequent variations in salt or alcohol intake in their diet. Substance abuse in the elderly is much more common than has hitherto been supposed by many healthcare givers. Self reliance (or plain stubborn behavior) may increase with age and elderly people may be very resistant to discussion about their lifestyle habits. Advanced age may bring to some individuals a tendency for relaxed behavior and errors of judgment. Measures that improve compliance with medication in the elderly are particularly important issue and it is recognized that errors in the taking of medication are quite common in the elderly. Periodically, every healthcare giver should ask an elderly patient who is taking medications to empty their cupboard and bring the contents to the office for examination. It is quite surprising what elderly people may take in terms of over-the-counter remedies. It is even more surprising these days that people will mix dietary supplements and prescription medications without any concern or consideration for their potential interactions. These problems are not confined to the elderly even though they may be more common in individuals of advanced years. Finally, and very important, the human body has a decreasing capacity to handle both synthetic and natural medications with age and, therefore, adjustments of dosages of some medications or dietary supplements are frequently required in the elderly. Diminished kidney function occurs with age and this means that compounds cannot be excreted or metabolized by the body in a normal manner. Specific concerns for health maintenance in 369 the elderly are of increasing significance as the elderly population increases. Examining Aspects of Popular Childhood Diets Dr. C. Kuntzleman writes about children “eating to lose”. In his book, Dr. Kuntzleman draws attention to the fact that 99% of American children will eat sweet deserts on at least six occasions in a week and that they may on an average drink about 24 ounces of soda per day. It is commonplace for meals to be taken outside the home and the occurrence of diets with inadequate levels of fiber and essential nutrients is often the norm. The author was surprised to find some recommendations for how a child may eat at a fast food restaurant in the appendix of Dr. Kuntzleman’s book. Obvious advice is to avoid the temptations of fast food. The most striking portion of Dr. Kuntzleman’s book discusses exercise as a key ingredient of promoting health in childhood. The author agrees with this approach and is astounded at reports that only about onethird of all American school children receive daily physical education classes. In Dr. Kuntzleman’s experience, these educational classes provide only about one to three minutes of rigorous exercise. It appears to be about time that more attention was paid to promoting lifestyle change among children in Western communities. Childhood Nutrition and Cardiovascular Risk Contrary to popular belief, children and adolescents are not immune to heart disease. The ‘old notion’ that children are resilient and any food “that passes their lips is good for building their body” is one of the biggest 370 mistakes ever made by the modern mother or father. Atheroma has its roots in childhood and evidence suggests that the children of modern times are accumulating an unprecedented burden of cardiovascular risk factors. Preventive medicine has focused on preventive medicine strategies in childhood. This “early” intervention for enhanced wellness is more important than previously recognized. Much of the preventive medicine activity in young people has focused recently on sex education and counseling about substance abuse. Although substance misuse or abuse and sexual risks are readily identifiable as immediate problems for youngsters, poor diet is not addressed effectively in many educational programs for children. In terms of overall public health significance, education about healthy eating should be given priority. Coronary heart disease is the number one killer in Western Society and it starts in childhood. Hypercholesterolemia is much more common in children than had been presupposed by many, including the medical profession. It is not, in any way, controversial to state that the dietary habits of the average “kid” is often focused on fast-food items. Burgers and fries, or “fried anything”, are loaded with cholesterol, saturated fats and damaged unsaturated fats. They are guaranteed, when taken in excess, to break any heart! How does one tackle this problem? The interventional principles to control high blood lipids in children are simple. Ideally, children should not be allowed to develop bad habits. It is like cigarette smoking; if one never did it, then it would not be something to miss. For a parent to let a child become permissively fat is a social crime. Childhood obesity is tragically common, often impossible to reverse completely, sets a stage for adult 371 obesity and it is a major social and physical handicap. Whilst the causes of childhood obesity remain poorly understood, several factors are known to contribute. Beyond some known genetic predispositions to obesity in children are the recognized contribution of emotional factors, family eating habits or behavior and misguided attitudes to food. Children are receptive to positive attitudes about healthy food choices and their implications for weight control, athletic performance and feeling good. Parents can do much to reinforce these attitudes and help “counter” the fast-food culture that has overtaken every highway worldwide. To deny a kid a visit to the eating parlor of their choice, once in a while, is probably wrong. It is the saturated fat content of fast food that leads to the need to limit its intake. The author is respectful of the fast food industry’s constant desire to examine and change the nutritional value of their meals to more beneficial compositions. In this regard, the beneficial content of fast food deserves mention (Table 72). The author does not wish to deny anyone fast food but its intake should be limited. Fast food parlours tempt even the most self-disciplined individual. Moderation is desirable and like the alcohol abuser who may seek controlled drinking behavior, the time to instill controlled eating behavior is in childhood. The author’s indulgence in continuing to remind parents about the obvious may not be perceived as constructive but the unfortunate issue is that many kids have “established” nutritional problems. These nutritional problems are true examples of malnutrition that occurs often as a consequence of dietary excesses. Hypercholesterolemia and abnormal blood lipid profiles should be taken seriously in childhood, at least when children 372 reach school age. Dietary interventions in children often fail and drug therapy with lipid lowering drugs is to be avoided in childhood. Indeed, many lipid lowering drugs are contraindicated in most circumstances in children. % RDA of Adult Female Vitamin A 5 Vitamin B6 13 Vitamin B12 63 Niacin 55 Riboflavin 33 Thiamin 52 Calcium 23 Phosphorus 44 Iron 23 Table 72: A large hamburger (7.5 ounces) from the most popular fast food restaurants worldwide may contain a reasonable array of vitamins and minerals which are expressed in percentages of recommended daily allowances (RDA) for an adult woman. Source: Consumer Report article cited by Zimmerman DR, in Zimmerman's Complete Guide to Nonprescription Drugs. Visibible Inc. Press, Detroit, MI, 1993. Such data vary by time. The problem with much fast food is its content of saturated fats, trans-fatty acids, cholesterol and salt. 373 Dietary Supplements Present Options One solution to the problem of established hypercholesterolemia in children is the use of dietary supplements with lipid lowering properties. Dr. C. Sirtori has emphasized the potential role of soy protein supplementation of the diet as an effective means of lowering blood lipids in children. If fact, Dr. Sirtori has gone as far as indicating soy protein inclusion in the diet may be a first line option for lowering blood lipids in childhood. The good news is that many soy beverages have a taste and consistency that is not too dissimilar from ‘unhealthy’, ice cream-loaded, dairy milk shakes. This is an excellent option to consider. There are dietary supplements containing soy protein isolates that are currently available in beverage formats. Some individuals have proposed soy milk as exerting potentially beneficial effects on blood lipids but less evidence exists to support this intervention in comparison to supplementation of the diet with soy protein isolates. Few children would swallow fish oil in preference to a cholesterolladen treat. However, omega 3 fatty acids of fish oil origin have become available recently in delayed release format. This format enhances the palatability of and tolerance to fish oil administration. Omega 3 fatty acids, from fish, form the basis of the health benefit of “granny’s spoonful” of cod liver oil. These essential fatty acids, found in fish oil, exert beneficial cardiovascular effects and lower blood cholesterol. Essential fatty acid deficiency is allegedly quite common but caution is required with dosing. Any intervention of significance to promote wellness in childhood should be undertaken with the advice of a qualified healthcare practitioner. 374 “Optimal” blood cholesterol levels in children are debatable but they should be generally lower than those in adult. A good range for blood cholesterol in childhood is 140 - 150 mg%, which is equivalent to an adult range below 200 mg%. Kids with high blood cholesterol will often grow up to become adults with high blood cholesterol. Intervention in early life should improve cardiovascular health and it could reduce the prevalence and incidence of coronary heart disease. Diet in the Mature Female A woman seeking relief from menopausal symptoms is one of the commonest problems that faces a health care giver in Western Society. Many women, however, suffer in silence or they take the plunge towards synthetic hormone replacement therapy (HRT). Whilst the untoward symptoms of the climacteric (change of life) are troublesome, the postmenopausal onslaught of degenerative diseases, such as cardiovascular disease, is the real health problem that faces the mature female. New information has surfaced about the dangers of conventional HRT that is provided in a synthetic format or in preparations derived from mare’s urine. The Committee on Safety of Medicines in the United Kingdom has issued recently (Sept., 1996) a warning of a three-fold risk of thrombotic episodes in women on conventional HRT. Simple Facts About Menopause There are more than 40 million menopausal or post-menopausal women in the USA, and at least a further 25 million women will become menopausal within the next ten years. The change of life is not a disease, but it can be a very distressing interval in a woman’s life. On the one hand, 375 conservative opinion advises against any interference with the course of nature during the climacteric. On the other hand, those females who suffer its consequences may see good reason to control the hot flushes, osteoporosis, irritability, lack of psychological well-being, fatigue, urinary tract infections, vaginal dryness, atrophy of female organs and the occurrence of coronary artery disease. While these menopausal problems are not universal among females, they are very common and they are the most important lifestyle issues affecting a mature woman. Difficult Decisions for the Mature Female Lack of estrogen and associated hormone imbalance are responsible for many of the adverse effects of the climacteric. The menopause poses the difficult decision for the female concerning the adoption of hormone replacement therapy (HRT) with potent, synthetic estrogens. Not only is the decision to embark upon estrogen replacement quite difficult, compliance due to second guessing about the safety of this intervention is very common. Estrogen may be, on occasion, a woman’s best friend, but its fluctuation throughout life causes a host of problems for some women. It has been documented that in the preceding calendar year in the USA, synthetic estrogen supplements (or animal estrogens) were the most commonly prescribed and dispensed drugs in community practice. The proponents of synthetic (or horse urine derived) hormone replacement therapy espouse the advantages of the control of unpleasant symptoms of menopause (hot flashes, profuse sweating, etc.) at the expense of considering the possible long-term side effects of these potent estrogens that are used as 376 replacement therapy. Increasing concern is being expressed about the dangers of conventional HRT, especially its role in promoting various thrombosis. Estrogenic hormone replacement therapy may assist in the reduction of the risk of osteoporosis and coronary artery disease, but it carries an uncertain risk of breast cancer, endometrial cancer, endometriosis and a wide range of frequent adverse effects such as: abdominal bloating, migraine or headache, weight gain, anxiety or depression and breast tenderness. Conventional hormone replacement is contra-indicated in many common circumstances, such as suspected genital or breast cancer, vaginal bleeding of unknown cause, significant liver disease and a history of thrombosis or embolism. A female may start to consider the option of hormone replacement over a period of up to ten years prior to the menopause, particularly when menstruation becomes irregular prior to its cessation. The decision to undertake synthetic hormone replacement is one of the most important decisions that faces an adult female in her life. Simple Observations in the Climacteric Certain simple observations often afford simple solutions but they are frequently overlooked! Many Asian and Oriental females do not seem to be as bothered by the menopause as are females in Western society. Why? The answer seems to rest in their diet. Soya based diets contain isoflavones which are natural “weak” estrogens of plant (phyto) origin. Considerable evidence appears to be accumulating that soya isoflavones in the diet exert “weak” estrogenic effects that may confer anti-aging benefits, beneficial effects in cancer prevention, the promotion of cardiovascular wellness, 377 assistance in the prevention of bone and joint disease and the maintenance of a health urinary tract, especially if soya protein is simultaneously incorporated in the diet. Plant estrogens are “weak” estrogens that can block the more powerful effects of endogenous estrogen. This “blocking effect” explains, in part, why phytoestrogens may be a “better option” than potent synthetic or animal derived estrogens that are used in conventional HRT. Soya isoflavones have very versatile health giving benefits. The principle soya isoflavones include the compounds genistein, daidzein and glycitein. These isoflavones have become available in predictable amounts in certain dietary supplements. Much research has occurred with these isoflavones to characterize their biopharmaceutical effects. The benefit of phytoestrogens may relate both to their much weaker effects than human, animal or synthetic estrogens and their different target organs of action in the human body. Soya isoflavones are active in inhibiting the growth of many different types of cancer and they have complex metabolic effects including a role in lowering blood cholesterol. It has been clearly documented by many leading world experts that soya isoflavones are hormonal in action, and this action accounts for their ability to have a beneficial effect in breast cancer prevention, and perhaps treatment. It is believed by many scientists that it is the soya isoflavones which exert the important anti-cancer effects in neoplasia affecting the prostate, breast and perhaps colon. Biopharmacological Complexity of Isoflavones 378 Soybeans contain two principal isoflavones, genistein and daidzein, with one minor isoflavone, glycitein. These are phenolic compounds which bear a chemical structure that resembles natural estrogens (17, betaestradiol) and they have "estrogen modulating" activity. Soy isoflavones have versatile and complex biochemical and physiological effects. The biochemical actions of these compounds is complicated and remains incompletely understood. Some dietary supplements and foods made from soyabeans contain variable concentrations of isoflavones. These dietary supplements, or soy containing foods, can be anticipated to have variable biological effects. It is the isoflavones in soy that possess many of the health implications of soy diets. Their wide range of biological activity dictates that many of the ascribed benefits, or lack thereof, of soy products are often speculative, unless the exact constituents of the products are clear. In the soybean, isoflavone concentrations and composition vary by site, and can be substantially altered by many agricultural factors, such as species of soybean, growing conditions and soil conditions. Many other circumstances further confound the clear definition of the biological effects of isoflavones. There are differences in the biodisposition of isoflavones in humans due to the potential differences in absorption, metabolism and excretion of these compounds. Disease states and a host of other underexplored factors alter the biological effects of dietary isoflavones. Despite this confusing situation, much contemporary research has unraveled many of the complexities of the biochemistry and biological actions of isoflavones of soy origin. 379 The isoflavones genistein, daidzein and glycitein exist in soybeans as a variety of chemical forms called glycosidic conjugates. Their chemical nature will vary depending on the method of food processing or the degree of fermentation of the soy product. It is not often appreciated that major compositional changes in isoflavones occur with soybean processing. Information that has been abstracted from studies of the isoflavone content of commercial soybean foods indicate that a variable content of isoflavones exist in different varieties of soybean. Soy flour has an isoflavone content similar to crude soybeans. Soy granules and textured protein are heat treated and they contain more b -glucosides which are 6"-0-acetyl derivatives of genistin and daidzin. Heat treatment results in the decarboxylation of the 6"0-malonyl glucosides, because they are heat sensitive. The chemistry of isoflavones is complex but worth noting because the right soy food or dietary supplement has to be chosen to contain the right isoflavones to exert the desired health benefit. Certain protein isolates of soybeans contained reduced amounts of isoflavones in comparison with crude beans and flours because of the use of extensive water processing. If alcohol is used in processing, isoflavones are substantially reduced because of their lipophilic nature and solubility in aqueous alcohol. However, common types of soyprotein that are used in the food industry have an isoflavone content ranging from 0.1 - 3.0 mg/g, and the industry standard soy protein isolates have a range of isoflavones from 0.7 to 2.8 mg/gm. Soy milk and other “oriental” beverages derived from soybeans are efficient sources of isoflavones but they tend to have a relatively reduced 380 concentration of the malonyl derivatives of the principal isoflavone types. In Western soy foods, tofu has emerged as a favorite, but tofu is generally low in isoflavones compared with other soy foods because it is subjected to aqueous processing. Tempeh is produced by enzymatic hydrolysis of soybeans with a result that aglycone forms of isoflavones predominate. The overall isoflavone content of tempeh and other fermented soy (e.g. miso or natto) may often be lower than that of tofu. Overall, tofu and fermented soy foods cannot be considered a practical means of incorporating enough isoflavones into a Western diet because of their lower relative isoflavone content, compared with soy milk, soy flour and non-alcohol extracted soy protein isolates. The average Westerner may “gag” on the end of the spoon that delivers enough tofu to provide enough health giving isoflavones. It has been estimated that more than one-half a pound of common tofu needs to be eaten to provide enough health giving isoflavones. Thus, great variation exists in the types and amounts of soy isoflavones that can be presented as foods or dietary supplements. Other factors operate in the optimum choice of a soy food that can be used as an efficient source of isoflavones for a Westerner. Crude soy products are flatogenic (produce intestinal gas) and they are often unpalatable. As noted, the volume of tofu or miso required to deliver enough isoflavones for a putative health benefit (>50 mg/day of isoflavones) is large and miso, tempeh and tofu share a general lack of palatability in Western society. Tempeh and miso may often contain additives by the time they reach Western stores and although miso can be a delicious culinary additive, it is often loaded with salt. Overall, soy protein isolates produced by methods that do not involve aqueous alcoholic extraction processes, 381 emerge as the most cost-effective, efficient and practical source of soy isoflavones for a Westerner. These isolates are versatile bulk food for the manufacturers of shelf stable soy meals, soy beverages and soy desserts. Dr. Kenneth D. Setchell (1996) (Second International Symposium of the Role of Soy in Preventing and Treating Chronic Disease, SISRS, September 15-19, Brussels, Belgium) has stated eloquently: “From a dietary perspective, what may be of greatest relevance is the total intake of isoflavones, rather than the chemical composition.” Dr. Setchell and his colleagues5 have spent many years researching the structure, metabolism, biodisposition and action of soy isoflavones. He and others have presented data that suggests that it is the aglycone forms of the principal isoflavones that posses the major biopharmaceutical actions of the isoflavones. However, it is recognized that the widespread occurrence of isoflavones in a conjugated format plays a role in determining intra- and inter-individual variation in the pharmacokinetics and ultimate metabolic fate of the isoflavones found in soybeans. Ingested isoflavones are acted upon by b-glucosidase enzymes that result in cleavage of the glycosidic variety of isoflavones to form the aglycone moieties. These moieties may be absorbed to a variable degree from the small and large intestine. Intestinal b-glucosidase enzyme activity is abundant in the intestine and the bacterial flora of the large intestine. Intestinal bacteria play a significant role in the metabolism of dietary isoflavones. These compounds undergo considerable first pass transformation (metabolism by the gastrointestinal tract) and transport to the liver where they are further metabolized into glucuronide or sulfate 382 conjugates. The biological activity of the glucuronide or sulfate conjugates of the isoflavones remains poorly defined but some evidence suggests that the sulfate conjugate may possess potent biological activity. Where Do isoflavones Act in the Body? Isoflavones and their metabolites can be detected in many body tissues and some metabolites have been shown to cross the blood brain barrier. The recent identification of a 4-ethylphenol metabolite of isoflavones in the brain tissue of rats is of great interest. This wide biodistribution of isoflavones and their metabolites may explain why only a small amount of administered isoflavones are accounted for by renal or fecal excretion and why complex neurohormonal effects of isoflavones are manifest. It has been noted that only about 10-30% of total administered doses of isoflavones are excreted in the urine or stool in human pharmacokinetic experiments. Equol is a mammalian isoflavone that is produced from daidzein but not genistein. Intestinal residence time (time spent in the gut), dietary cofactors and fermentation of daidzein by bacterial flora in the intestine exert major influences on the formation of equol in adults. However, between 30 and 40% of the population may be non-producers of equol, even following the ingestion of soya protein containing isoflavones. Estrogenic Activities of Isoflavones Soy isoflavones and their metabolites are “estrogen mimics” that are often freely bioavailable from soy protein diets. Unfortunately, the individual activities of each isoflavone and its many intermediary 383 metabolites remain to be adequately defined. A disproportionate amount of knowledge exists about the biological activity of genistein in comparison to the other isoflavones or their metabolites. This is primarily because genistein is often used in a pure format to study basic mechanisms of the actions of isoflavones in biological systems. The complex biopharmacology of isoflavones indicates that some of the results of experiments that use pure genistein may not be portable to an understanding of the effects of the natural inclusion of soy isoflavones or soy foods in the diet. Other issues cloud an understanding of the bioactivity of isoflavones. Observations in animal experiments may be made with pharmacological doses of isoflavones, as opposed to physiological doses of isoflavones, and the metabolic fate of isoflavones may vary considerably by species of animal or perhaps administered dose. For example, parrots and captive cheetahs in zoos may die when fed isoflavone rich food but humans do not. Thus, the ability of an organism to handle isoflavones varies greatly by species. Proposed mechanisms of the effect of isoflavones on estrogen receptors in humans is now complicated by the recent characterization of different forms of estrogen receptors in humans. Finally, isoflavones have clear non-linear dose response effects in many animal models, including humans. This non-linear effect is common in biosystems that are tested with biopharmaceuticals. This situation is often the hallmark of hormonal effects. Many studies that have been performed in several in vitro and in vivo models demonstrate that isoflavones are capable of binding to estrogen 384 receptors and they often exhibit varying degrees of “weak” estrogenic activity. In addition, some animal studies demonstrate an anti-estrogenic effect of isoflavones. Furthermore, it is documented that isoflavones can counteract the effects of relatively high doses of synthetic estrogens by “competitive” receptor binding or other mechanisms. Isoflavones and their metabolites show variable dissociation rates for estrogen receptor binding and this binding may often produce a series of cytosolic events that are very similar to the effects of estradiol. However, isoflavones do not show effective nuclear binding. The cell nucleus is a principal site of the estrogen receptors. It is recognized that the amino acid sequences of several receptors that bind hormonal steroids, or perhaps nonsteroidal phytoestrogens, have homologies with the result that isoflavones may regulate cellular activity by an interaction with homologous receptors. The affinity of estradiol receptors for phytoestrogens seems to be overall less than that of estradiol by a factor of about 100 times. For example, the relative binding affinity of estradiol receptors in the uterus of rabbits has been shown to be 175 times lower for genistein than for 17 betaestradiol. Studies performed three decades ago showed that genistein, when given at the same time as estradiol, resulted in a variable displacement of estradiol from receptors in the uterus of mice that had undergone oophorectomy. The Potential Significance of the Estrogenic Effects of Soy Isoflavones The phytoestrogens in soy have similar properties to other naturally occurring non-steroidal estrogens, such as coumestan. Coumestan is present 385 in forages and legumes. Another group of phytoestrogens called resorcyclic acid lactones (mycotoxins) are produced by the mold Fusarium roseum. This mold can grow on several types of grains during storage and it often produces zearalenone which can be metabolized to the compound zearalenol. Zearalenol has contraceptive properties and it can be used to ameliorate menopausal symptoms. In common with zearalenol, soy isoflavones have been proposed as having potential use as post-menopausal hormone replacement therapy. A Miracle of Menopause? Earl Mindell in his popular, consumer book titled, Earl Mindell’s Soy Miracle (a Fireside Book by Simon and Schuster, New York, 1995) points to the value of soya in suppressing menopausal symptoms. Earl Mindell clearly reports the results of studies by Canadian researchers of Japanese women where menopausal complaints such as “hot flushes or flashes” are much less in Japanese than in Western women. The use of a dietary supplement which contains enough isoflavones to achieve daily intakes of isoflavones similar to those taken by Japanese women in their diet may be beneficial in suppressing moderately severe symptoms of the menopause. Oriental females tend not to have troublesome menopausal symptoms. This lack of menopausal symptoms in Orientals is most likely a function of soya isoflavones. Dietary supplementation with phytoestrogens may offer a possible alternative to the commencement of synthetic, or animal derived, hormone replacement therapy, with all its known drawbacks. The climacteric marks the emergence of cardiovascular disease, osteoporosis and certain age-related cancers in females. Old age 386 complements the development of these degenerative diseases and heralds the occurrence of cerebrovascular disease and diminished renal function. The exciting prospect of using a natural means with soy isoflavone supplementation to reverse these adverse associations of the menopause is very exciting. Soy isoflavones, contained within soy protein, appear to have the potential to ameliorate many post-menopausal maladies. The Downside of Female Maternity The premenopausal period is heralded often by many unpleasant symptoms that relate to vasomotor instability, loss of psychological wellbeing and compromise of sexual activity and sexual organ function. Of greater concern is the menopausal milestone for the development of cardiovascular disease, hypercholesterolemia, osteoporosis and age related cancer of the uterus, breast and colon. The hallmark of the menopause is decreased endogenous estrogen and a large body of clinical research reinforces the role of estrogen supplementation (Hormone Replacement Therapy, HRT) as a useful therapeutic intervention for the post-menopausal female. Unfortunately, the use of potent synthetic, or animal derived, HRT is not without risk and arguments prevail about the safety of this intervention. Foremost in many peoples’ minds are the renewed concerns about cardiovascular risks of HRT and recent reports of incapacitating endometriosis. The relative merits and disadvantages of a natural approach to tackle the negative aspects of the menopause deserves careful consideration. Soy Isoflavones and Menopausal Symptoms 387 Convincing epidemiological data imply that the lower incidence of menopausal symptoms in the Asian female, compared with Western women, may be related to an enhanced dietary intake of isoflavones of soy origin. This epidemiological observation supports the potential role of soy isoflavones in controlling menopausal symptoms. Many recommendations have been made in contemporary medical literature and the lay press to incorporate soy into the diet during the climacteric. Formerly, considerable anecdotal evidence existed that soy products, containing isoflavones, are effective in relieving menopausal symptoms. These observations have remained unconfirmed, until recently. New controlled clinical studies in several countries demonstrate unequivocal benefits of soy isoflavones in the variable control of menopausal symptoms and its negative consequences. Double-Blind controlled Trials Show the Benefit of Soy Isoflavones in Menopausal Women Dr. John Eden and his colleagues at the Royal Hospital for Women in New South Wales, Australia are focusing their research on the potential hormonal effects of isoflavones in the menopausal female (SISRS, 1996). In pilot studies of nine women given 160 mg of isoflavones daily for three months, a statistically significant reduction occurred in several menopausal symptoms, especially hot flushes. The studies of Dr. Eden and his colleagues resulted in a conclusion that isoflavones appear to be usefultherapy for females with mild to moderate symptoms of the climacteric. These results have been confirmed to some degree in studies performed by Dr. Woods and his colleagues at Tufts University School of Medicine in Boston, Massachusetts where the use of a soy bar (containing 388 isoflavones) resulted in a small decrease in menopausal symptoms over a twelve week period, compared to placebo. It should be noted that the daily isoflavone intake in the latter study was much lower (at 40 mg per day) than that in the studies by Dr. Eden and his colleagues (at 160 mg per day). Studies in the United Kingdom by Dr. Sue Harding and her colleagues (SISRS, 1996) corroborate the findings of the benefit of soy isoflavones in the treatment of menopausal symptoms that have been observed in both Australia by Dr. Eden and his colleagues and the USA by Dr. Woods and his colleagues. This UK study is notable in that it included females with severe vasomotor symptoms and it was performed in a rigorous double-blind crossover format with a placebo control. Results in 20 of the 27 menopausal females in the study were reported at the Second International Symposium on the Role of Soy in Preventing and Treating Chronic Disease (Sept. 15-18, 1996, Brussels, Belgium, SISRS, 1996). In this carefully constructed study by Dr. Harding and her colleagues, several hormonal parameters were measured as a consequence of soy supplementation (80 mg per day of total isoflavones) and compared with placebo. Interim analyses of the data showed that serum isoflavones were, as anticipated, high in the soy supplemented group and increases in growth hormone and prolactin were noted with soy supplementation but not with placebo. In contrast, levels of luteinizing hormone and blood cholesterol fell during the period of soy supplementation. Of overriding significance in this UK study by Dr. Harding and her colleagues was the clear demonstration that a statistically significant 389 reduction in hot flashes was noted on the soy diet. It seems probable that these trends will be borne out upon completion of the study and these results justify the assertions of Dr. Harding and her colleagues. The study concluded that these findings suggest that soy isoflavones have estrogenic properties in menopausal women. Furthermore, the data indicate that isoflavones may act on the pituitary to increase prolactin and growth hormone levels, whilst conferring the benefit of reduced hot flushes and reductions in serum cholesterol. It should be noted that not all females can expect amelioration of menopausal symptoms with soy isoflavones in the same way that synthetic HRT is not universally successful. The main issue is that soy isoflavones are natural and very safe at controlled and “therapeutic” dosages, whereas estrogen supplements may not be safe at therapeutic dosages. Can Soy Isoflavones be Used as Natural HRT? Dr. Gregory Burke of Wake Forest University in North Carolina, USA, has performed clinical research that supports a possible role of soy isoflavones as a natural, dietary alternative to HRT with synthetic, or animal derived estrogens. In a scientific paper presented recently in Brussels, Belgium, Dr. Burke drew attention to the demonstrable reduction in the risk of osteoporosis and cardiovascular disease with synthetic HRT but questioned the risk/benefit ratio of this therapy. Soy isoflavones present an appealing alternative to current HRT strategies. The fact that 85% of post-menopausal females in the USA do not use HRT, makes a dietary consideration for menopausal relief, such as soy, a 390 major public health potential, according to Dr. Burke. This situation, together with the knowledge that dietary intake of soy protein containing isoflavones may account for the reduced risk of several chronic diseases, dictates the need for further studies to clarify the role of phytoestrogens as a natural alternative to synthetic HRT. The evidence that soy isoflavones may control perimenopausal symptoms is impressive. Dr. Burke has reported short-term studies of soy protein supplementation of the diet. In these studies, 50 perimenopausal women were enrolled in double-blind crossover studies over a period of six weeks and were shown to have improvements in both menopausal symptoms and health-related quality of life compared to those who received a placebo. Furthermore, the females who received soy showed improvements in both blood pressure and serum lipids, even despite their normal initial blood lipid and blood pressure status. Dr. Burke has pointed to something extremely important to support the option of natural phytoestrogen therapy. It is recognized from many animal and human studies that soy isoflavone supplementation of the diet does not seem to produce the unwanted effects of synthetic HRT, which include: a rise in blood triglycerides, proliferation of cellular growth in the breast and endometrium and risks of blood clotting. This points to the likelihood that isoflavones could serve as a natural and safe alternative to HRT with potent synthetic estrogens or estrogens derived from horse urine. Words of Caution About Isoflavone Dosages It should be noted that isoflavones in high doses have a number of 391 putative adverse effects. This has led to a stern warning that nutriceutical products or dietary supplements containing isoflavones must be used with caution. Dr. Setchell (and many others) have postured against what have been termed “nutrichemical supplements and pills” containing isoflavones because of negative effects that can be anticipated from the potent biological activity of certain isoflavones. The author agrees, generally, with this point of view and cautions against the misuse of dietary supplements containing high concentrations of isoflavones. Words of caution about high doses of isoflavones have been expressed by several scientists involved in isoflavone research. However, the negative posture against dietary supplements adopted by some scientists assumes, to some extent, a degree of irresponsibility in the Dietary Supplement Industry that is generally not present. The same rules of caution apply to synthetic drug therapy (HRT) and its potential for dose-related toxicity. The Dietary Supplement Industry recommends the use of potent biopharmaceuticals (nutriceuticals) under the supervision of a health care giver. This advice is given equally, if not more often, by the Dietary Supplement Industry for food supplements than it is given by ethical pharmaceutical companies concerning the use of their over-the-counter synthetic drugs. Dosages must be presented clearly on Dietary Supplements, as they are on synthetic drugs. Setting dosages cannot take account of an individual’s self-reliance to abuse any recommendations for dosages. It is hoped that Dietary Supplement Manufacturers and Multinational Pharmaceutical Companies will continue to exert their duty of care to consumers in defining optimal doses of dietary supplements and adverse effect labeling where appropriate. 392 Doses of Isoflavones for Health Benefits? The circumstances surrounding our understanding of the health benefits of isoflavones are clouded, to some degree, by the lack of definition of the optimal dose of isoflavones that could be used as natural HRT. The most reasonable approach would be to choose a recommended level of daily isoflavone intake that does not exceed the amount of isoflavones that are consumed in existing diets that contain plentiful amounts of soy. In the author’s opinion, this dose lies somewhere between 50 and 100 mg of isoflavones per day for the adult, and at this dose range toxicity is unlikely. Considerable precedent exists for the safety of isoflavones from Asian diets that may contain up to 100 mg of isoflavones per day without adverse effects. A safe compromise may be to not exceed 80 mg of total isoflavone intake daily and this level of intake certainly matches the level at which beneficial therapeutic effects have been noted in clinical research that has shown beneficial health effects of isoflavones in menopausal females. Isoflavone supplements are not recommended in childhood or during pregnancy and, in the author’s opinion, their use should be monitored by an experienced healthcare giver. Focus on Soy and Cardiovascular Disease in the Mature Female Overwhelming evidence exists that soy protein containing modest amounts of isoflavones lowers total cholesterol with a corresponding beneficial change in overall lipid profile. The evidence for the promotion of cardiovascular wellness by soy protein supplementation of the diet has been well documented in animal and human studies that show lowering of blood lipids and beneficial effects on other cardiovascular parameters, such as 393 blood pressure and platelet function. The most relevant studies of soy in the promotion of cardiovascular health in the post-menopausal female are those that directly examine the effect of soy diets on plasma lipid profiles in the post-menopausal state. Ground-breaking research in this area has been performed by Dr. Susan Potter and her colleagues at the University of Illinois. In addition, several clinical studies demonstrate beneficial cardiovascular effects of soy protein and isoflavones that work in a manner that is independent of serum cholesterol reductions. Dr. Susan Potter and her colleagues (1996) have performed many studies on the effects of soy protein and the mechanism of such effects in lowering blood cholesterol. In a recent study of 66 hypercholesterolemic post-menopausal females who received soy protein containing variable amounts of isoflavones, it was noted that soy protein with isoflavone exerted positive influences on blood lipids, thereby decreasing the risk of cardiovascular disease in the post-menopausal state. This conclusion is supported by the finding of several anti-atherogenic factors in soybeans, including antioxidant properties to protect against low density lipoprotein oxidation and the inhibition of platelet aggregation with an anti-thrombotic effect. The anti-thrombotic effects of isoflavones contrast with the thrombotic potential of conventional HRT. Other Benefits of Soy in the Post-Menopausal State Soy food consumption fits with interventions that don’t just lower cholesterol. Soy protein containing isoflavones has chemoprotective effects 394 against breast and colon cancer and its amino acid content promotes renal health and calcium retention. The prevention and potential treatment of prostatic cancer by soy isoflavones, should catch the eye of those interested in the andropause of the mature male. Dr. Mark Messina and his colleagues have extensively reviewed the in vitro and in vivo evidence for the cancer protective effects of soy. Much evidence seems to link this cancer protective action of soy with the isoflavone content of soybeans. A host of other studies suggest even more diverse health benefits of soy incorporation in the diet including observations that soy protein isolates are good protein sources in weight reduction diets. There are studies that indicate gallstone prevention is possible by soy intake. There are beneficial effects of soy on muscle tissue and even a possible role for daidzein in the suppression of alcohol intoxication and “appetites” for alcohol, at least in animals. Finally, genistein is antiangiogenic and it may play a role in the prevention or therapy of angiogenesis dependent diseases such as cancer, psoriasis, arthritis, and ocular disease. Are Phytoestrogens Safe? The worldwide consumption of soy in healthy population without evidence of reproductive problems provides good support for the safety of soy isoflavones. There is much reassurance about the safety of the use of isoflavones in amounts similar to those that are consumed in Asian diets that are plentiful in soybean foods. Several investigations have failed to show any significant untoward effects of commercial or natural soy based diets on embryonic development or male gonadal function and soy diets have never been associated with a risk of carcinogenesis. 395 Dr. Whitten and his colleagues (First International Symposium on the Role of Soy in Preventing and Treating Chronic Disease, Mesa, Arizona, 1995) have shown the toxicity of coumesterol in rate. Coumesterol is the most potent estrogen of the isoflavanoid category. However, coumesterol is not detectable in the urine of humans receiving soy diets and it is present in only small amounts in soy in comparison to other isoflavones. The putative adverse effects of phytoestrogens that include developmental disorders and male gonadal dysfunction have not surfaced in humans. There is no evidence that these adverse effects occur in humans at doses of isoflavone intake that are encountered in even the most “soy rich” diets. Arguments that soy protein is inferior to animal protein are fatuous and may have reemerged as a partial consequence of the challenge that soy food presents to the animal protein purveying, fast food industry. The isoflavones genistein and daidzein and their metabolites are potent and versatile in their biological effects. Their broad actions and variability of biological effects dictates that more work is required to define each isoflavone and its derivatives in terms of site of action, hormonal activities, and short- to long-term effects. Summing Up Soy Isoflavones There is a major potential for soy isoflavones contained within soy protein as potential alleviators of the negative consequences of “the change of life” in females. Soy diets have been used worldwide for thousands of years without major safety concerns. The incorporation of soy protein containing isoflavones at levels that do not exceed those obtained from an 396 Asian diet seems to offer a simple, natural solution to many problems associated with the menopause. The risks of soy incorporation into the diet of a menopausal female or the use of appropriately formulated dietary supplements by the perimenopausal female may be, on balance, safer than the risk of hormone replacement therapy with potent, synthetic or animal derived estrogens. Therapeutic equivalence between soy isoflavones and HRT cannot be assured. Many women are considering soy protein containing isoflavones as a first line option for menopausal relief and this is being continuously reinforced by the media, with apparent good cause. The mechanism by which a menopausal female seeks the health benefits of soy will be determined by convenience which in turn determines compliance to a major degree. Whilst some Western females may struggle with soy food recipes, it is likely that more will opt for a dietary supplement of soy containing a substantial quantity of isoflavones. Consumers are advised to use soy isoflavone supplements with caution, especially in relationship to dosing. The advice of a qualified health care giver with knowledge of the risk/benefit of isoflavones is recommended. It is not the intention of the author to offer medical advice. The author is not recommending soy products or dietary supplements of soy origin for the prevention, cure, diagnosis or treatment of any disease and he is not recommending specific levels of intake of isoflavones in any specific format. Interested parties are referred to the extensive emerging literature on the use of phytoestrogens in menopausal states and they are advised that differences of opinion may prevail. For more detailed accounts of the opinions, the readers are referred to books on soy food and health written by 397 the author and by Dr. Mark Messina and his wife Virginia Messina. Carnitine: Not Just for the Body-Builder Carnitine is a compound that is stored in muscle tissue throughout the body. The precise function of carnitine remains to be fully explored but this compound plays a specific role in the presentation of fuel in the form of fatty acids to mitochondra within cells. Mitrochondra are the organelles inside a cell that are involved in energy production which is very important in the supply of energy for normal muscle function, especially contractile function of the heart. It is known that carnitine deficiency may occur to a relative degree with advancing age and the overall levels of carnitine in the body fall in response to illness, poor diet and excessive exercise that is not accompanied by adequate dietary intake of carnitine. Carnitine is a favorite dietary supplement for body-builders who wish to create muscle mass. However, in these circumstances, it is often used in excess. In the presence of carnitine deficiency, normal production of energy is not facilitated and fatty acid transfer into mitochondra may be impaired. Several recent studies have implied that carnitine may be particularly useful in assisting patients with angina pectoris, severe arteriosclerosis and in some individual who have cardiac arrhythmia as a consequence of coronary artery disease. In addition to a direct effect on energy production, carnitine appears to exert beneficial effects in normalizing blood lipids and it has been shown in some anecdotal studies to increase HDL cholesterol. In fact, some researchers have proposed that carnitine may actually enhance the ability of the heart to withstand an increased demand as a consequence of exercise. 398 Carnitine is available in capsules or tablets as a dietary supplement and it is most often present in meat products in the diet. There is some argument as to which chemical type of carnitine is most effective and many experts believe that it is the L-carnitine that has to be taken preferentially because D-carnitine may not be quite as effective. Dietary supplements containing carnitine have this agent present in the L form. An average recommended daily dose of carnitine is approximately 400 mg per day. Chromium Much interest has focused on the ability of the trace element chromium to regulate blood glucose by facilitating the function of insulin. There is no question that chromium has an important role to play in the metabolism of fats and glucose, but exaggerated claims about chromium supplementation as a weight loss measure are somewhat questionable. Excessive dosing with chromium for weight loss may not be safe. Some evidence from epidemiological studies shows that populations of people who have high levels of chromium in their body may have a lower prevalence of heart disease. The importance of chromium has been doubted by some people but it has been suggested that chromium may be an important factor in explaining the difference in the rates of diabetes mellitus and atheroma in different geographic locations. The role of chromium in the regulation of glucose and insulin metabolism has some significance in the regulation of blood cholesterol levels. In fact, several recent studies has indicated that chromium supplementation may result in lowering of blood cholesterol. It would appear that chromium may have a synergistic (combined) effect when administered with niacin for lowering blood 399 cholesterol. Some caution is required with the use of chromium, since it is not entirely safe when taken in high doses. It is not recommended to exceed a dose of approximately 400 mcg per day and studies of the beneficial effect of chromium on blood cholesterol and other disorders have used much higher doses, of the order of 2,000 mcg per day. If high doses of chromium are used, then this use should occur only under medical supervision. Chromium supplements have become increasingly available and are often added to multivitamin supplements. It is believed that chromium exerts its most potent effects when in the form of chromium picolinate and when in the form of chromium polynicotinate. Chromium picolinate has been increasingly touted as important in the treatment of obesity but the data to support this beneficial health effect of chromium are quite conflicting. Cardiovascular Function Fights Father Time It is apparent that the average person in Western communities can anticipated that they may live into their seventh decade. If coronary artery disease were able to be eradicated, about six years could be added to an individual’s overall life expectancy. Approximately eleven years extra life could be achieved with the elimination of other disease of the cardiovascular system, including stroke. This means that effective prevention of cardiovascular disease could result in an approximate average life expectancy for most people of approximately 90 years, versus its current 70 years. 400 There are certain physiological events that effect the cardiovascular system with aging. Such events include a reduction in the efficiency of heart muscle function which results in a reduced cardiac output. This reduction in cardiac output becomes a very significant issue for an elderly person when they are in a situation of stress. Overall, it can be summarized in understanding that the elderly heart has less ability to respond to the demands of work because its performance is less efficient. The mature heart requires greater energy expenditure than the heart of a young person. There is a common misconception, even among physicians, that the heart generally becomes bigger with age. This apparent enlargement of the heart is more related to changes in the dimensions of the thoracic cage, resulting in an overall narrowing and an appearance of enlargement of the heart. It has been estimated that by the time most individuals reach the age of 60 years that a significant reduction in work responses of the heart muscles are apparent. Cardiac output diminishes by a factor of approximately one-third by the age of 65 years and by a factor of about onehalf by the age of 80 years. Coincidental with these changes may be an enhanced sensitivity of the heart to the precipitation of abnormal rhythms (arrhythmias). Of particular interest is the idea that there is a status of “presbycardia”. This terms really means “old heart”, and with age several normal physiologic parameters related to cardiac function may change quite dramatically. With age, decreases in heart rate in response to various stimuli occur slowly and the circulation time of blood in the body is significantly diminished. The overall significance of these changes is that elderly people 401 are compromised somewhat in their ability to engage in active physical exercise. In general it is not necessarily a bad thing for elderly people to accept that they should engage in moderation in strenuous daily activity. One of the most important issues to consider in cardiovascular function is the fact that the regulation of blood supply to the brain come somewhat sluggish in elderly people. This means that they may be more susceptible to sudden changes in blood pressure or posture and this factor makes them particularly susceptible to adverse effects of medication that lower blood pressure. Elderly people are to be encouraged that although age brings with it declining cardiovascular function, there is evidence that good cardiovascular function can be maintained by the change of lifestyle and reduction of cardiovascular risk factors, even in some circumstances if such risk factors have been present for a considerable amount of time during early life. The idea that high blood pressure or elevated cholesterol should not be corrected in elderly people because it is “too late” is a very old and inappropriate medical concept. It is never too late in engage in lifestyle modification to promote cardiovascular wellness. Diet for the Elderly at Risk of Cardiovascular Disease Until recently, it was generally believed that certain cardiovascular risks, such as high blood lipids or moderate hypertension, could be safely ignored. This misconception came from observations that blood pressure or high blood cholesterol are a function of age and a relative lack of observations that currently such risk factors could result in any material health benefit. It is now known that blood pressure control and cholesterol 402 reduction in the elderly are associated with reduction in cardiovascular morbidity and mortality. Several leading scientific and medical bodies have recommended a more aggressive approach to eliminating cardiovascular risk factors in the elderly. This does not mean that elderly people should be “falling down or faint” from the injudicious use of blood pressure lowering medication. Achieving an ideal cholesterol level of 200 mg/dl or less and maximum blood pressures of 150-160 systolic and 90 diastolic are worthy goals in the mature adult. Interventions in the elderly should be paced to give a chance for adaptation of the body. Father time moves slowly! The elderly may have well developed dependence on smoking or excessive alcohol intake but they are receptive to advice to enhance longevity. Lifestyle adjustments to promote cardiovascular health in the older individual do not differ materially from approaches in younger age groups. However, interventions should occur slower and be supervised by a healthcare giver. Advancing age leads to a reduced tolerance to rapid “therapeutic” intervention. This means that exercise programs, major nutritional change and drug interventions, where deemed appropriate, should be enacted with patience. Looking at Food: How to Eat? Several important recommendations for the diet are summarized in Table 73. The list of options is not exhaustive but it is important to highlight that eliminating cholesterol from the diet is only one of several important consideration in a nutritional program to promote cardiovascular wellness. The average American diet contains too many calories, too much fat, especially in a saturated form and it is lacking generally in vegetables and 403 essential fatty acids. Earlier references to the lower prevalence of cardiovascular disease in Asian populations and less developed nations than the United States or Western Europe is generally explained by the following: lower fat intake, higher fiber intake, more dietary inclusion of complex carbohydrates, lower total calorie intake and perhaps a much higher ingestion of essential fatty acids and soy. Considerable evidence has emerged that movement towards a more vegetarian diet results in several health benefits. However, many individuals Initiative Some Reasons Caloric Consciousness Prevents Obesity; Lowers Cholesterol Avoid High Cholesterol Foods Often High Calorie; Lowers Cholesterol Eat Only When Hungry Control Behavior Modification; Key to Weight Avoid High Sodium Content Foods Raises Blood Pressure; Fluid Retention Decrease Animal Protein Associated with Cholesterol in Diet, Promotes Osteoporosis Avoid Refined Sugar Functions Raises Triglycerides; Stops Antioxidant Increase Fiber Intake Normalizes Digestive Function; Lowers Cholesterol; Cancer Protective Increase Fresh Fruit and Vegetable Intake Good Micronutrient Sources; Health Giving Phytonutrients Switch to Vegetable Protein (e.g. Soy) Lowers Cholesterol (Soy); Associated with Lower Incidence of Chronic Disease Look for 100% RDA of Essential Body Functions 404 Vitamin and Minerals (Vitamin Supplements Convenient) Supplement Essential Fatty Acid Intake, Especially Omega 3 Series Essential Body Functions Lowers Cholesterol, Suppresses Inflammation Read Food Labels Avoid Undesirable Food Additives Table 73: Dietary Recommendations for Promotion of Cardiovascular Wellness. NOTE: Overall, a low saturated fat, low cholesterol, high fiber diet with adequate vitamins, minerals and important micronutrients is recommended. will not exclude meat or dairy foods and some good arguments exist for their limited inclusion in a healthy balanced diet. The move towards a vegetarian type of diet is perhaps becoming increasingly acceptable in the West and it confers several advantages for health promotion. Diets containing large fractions of vegetables and fruit involve the selection of more natural foods which are not concentrated sources of calories. Vegetables and fruits are bulky and induce a sensation of fullness after meals (satiety). Furthermore, vegetables often provide adequate protein, a rich source of essential fatty acids, abundant minerals and vitamins and they are devoid of saturated or hydrogenated, unsaturated fats. Aside from these nutrient qualities, some vegetables have special health giving fractions, including phytosterols, phytochemicals, unabsorbable carbohydrates and fiber. The king of the legumes with health giving fractions is the soybean with its multiple health giving benefits. Not only should an individual examine the foods that are eaten to 405 promote health, there is much importance in “better” dietary habits. These “habits” are important to consider because they involve behavior modification. Behavior modification in eating styles is a very necessary component of revising dietary intakes. However, there are “several traps” among the opinions about what many people may consider their normal eating habits. Meals that are processed and convenient should be avoided. Unfortunately, unhealthy food is often convenient and quite tasty. The cardiovascular health conscious individual should disqualify themselves from visits to fast-food restaurants and try, whenever possible, to prepare their own meals. Snacking during meal preparation is best avoided and the act of preparation of food can lead to greater appreciation of food and sometimes diminished appetite. If snacking is desired, vegetables and fruit are the best option, not potato chips, baked goods high in fat, trans-fatty acids and salt. The act of preparing and taking well-balanced foods to the workplace is advisable. There are some little tricks for better eating. Chewing food thoroughly may help suppress appetite and it improves the digestive process. Making more of a “ritual” of a meal is useful, with the setting of time aside and even the use of a stopwatch to lengthen eating time. The individual who eats to a sensation of fullness has usually overeaten. Some experts advise a departure from the dinner table with some residual hunger, but this is a difficult feat for many. It you starve yourself, have binges, vomit of your own volition, or have strange emotions about food, you may have an eating disorder. For this situation, an experienced professional’s advice is 406 required! Table 74 provides some simple guidelines to assist an individual in planning meals to prevent cardiovascular disease. It is generally accepted by most healthcare givers that less than 30% of the total calories in a diet should originate in fat. The importance of the type of fat included in this 30% allowance is clear. About one-third of the total fat derived calories should be derived ideally from each of the following three types of fat: saturated fatty acids, monounsaturated fats and polyunsaturated fats. It is necessary that the total daily intake of cholesterol does not exceed 300 mg and the incorporation of at least 30 grams of dietary fiber per day into the diet is ideal. More emphasis has been placed on limiting saturated fat intake but it should be emphasized that when carbohydrate is substituted for saturated fat, as is so often the case, there is a risk of the body producing saturated fat from Reduce saturated fat intake Reduce overall fat intake Eat essential fatty acids, omega-3 and -6 Control calorie intake for ideal weight Eat about 3 ounces of protein per day Shift towards vegetables and fruits Eat raw food where appropriate 407 Consider soy incorporation Table 74: Guideline for Meals for Cardiovascular Health carbohydrates. This occurs if calorie intake exceeds the body’s requirements and the carbohydrates are not from complex carbohydrate sources. The importance of essential fatty acid inclusion in the diet to promote cardiovascular health should not be underestimated. 408 CHAPTER 11 WEIGHT CONTROL 409 Cautions for the Dieter Being too fat (or too thin) is dangerous to an individual’s health. The obese individual places more mechanical stress on their heart and body than the person of normal body weight. The author has never met a grosslyobese, adult patient that did not have arthritis or pain in weight bearing joints. Stress on the heart is not immediately apparent. If any individual is very fat, has obesity dating back to childhood, or has adverse medical consequences of obesity they should seek supervision advice from the more informed healthcare giver. Few physicians or givers of natural health care have great experience or knowledge of the treatment of severe states of obesity, so the healthcare seeker is advised to choose their physician wisely. Bear in mind that treating obesity is a multi-billion dollar industry that is laden with quacks and quick-fix methods of weight loss. Eating Disorders May be Forgotten Before an individual decides to diet, they should assess their body habitus and decide if they fall into a category of being overweight. This sounds so obvious that a reader may question: “Why this is worthy of mention?” The reason is that eating disorders that involve weight status from the emaciated to the obese are, overall, as much as a problem as simple obesity and these disorders are sometimes much more life threatening the obesity per se. It has been suggested that eating disorders are more prevalent among females, especially in the 15 to 30 year age group. Estimations of the prevalence of eating disorders in this age group may shock the uninformed. With variable expression of severity, up to one-third of all females aged 15410 30 years may have an atypical eating disorder, up to 1 in 20 may have bulimia nervosa, 1 in 100 may have anorexia nervosa, whereas, about 1 in 20 are obese. Exact information on the prevalence or incidence of eating disorders is very difficult to estimate because the afflicted do not readily disclose their problem and will not respond to common survey methods. The major characteristics of common eating disorders are summarized in Table 33. Many purveyors of dietary advice forget the importance of spotting the “inappropriate dieter”. Catastrophes can ensue from assisting the bulimic or anorexic to lose weight! Current fad diets do not consider these important public health issues. Eating disorders (Table 75) can be a more immediate threat to life than cardiovascular disabilities. Disorder Main Characteristics Anorexia Nervosa - Morbid fear of becoming fat - Marked loss of weight - Amenorrhoea - Not due to organic or psychiatric disease, but but may be accompanied by such disease - BMI 15 or less, 75% of ABW - Unusual weight loss habits Bulimia Nervosa - Compulsive binge eating - Many features in common with anorexia nervosa - Binge more than twice per week for at least three months - Lack of control or severe dependence on eating - Regularly engages in strict weight loss regimens - Persistent concern with body shape and weight Atypical Eating Disorders - Eating disorders otherwise not specified - Chaotic eating patterns 411 - May have many but not all of the diagnostic criteria of anorexia or bulimia nervosa - May be recovering from or transitioning toward anorexia and bulimia Obesity - May or may not be an eating disorder per se - Very heterogeneous components - Has genetic, organic, psychological and nutritional potential of origin - Severe obesity usually has a well-developed psychological component Table 75: The Characteristics of the Main Four Types of Eating Disorders are summarized. Recognition of features in an individual should prompt the seeking of medical advice. Eating disorders are potentially life threatening. Dispelling the Fads: Looking at Diets All diets could be considered an attempt at self-imposed, distorted eating patterns. Unfortunately, good eating patterns are harder to achieve than bad eating patterns. The very fact that there are so many different diets is sure proof that none are entirely effective. It is not possible within the remit of this book to give an intricate account of the pros and cons of each diet, except to say that most weight reducing diets are designed for weight loss alone, sometimes at the expense of the promotion of cardiovascular wellness. Weight loss is often an important component of achieving cardiovascular wellness but some weight reduction strategies are to be avoided in the cardiac patient. Again, the reader is advised to check with a healthcare practitioner. A little knowledge or an “old wives” reassurance can be dangerous to your health and 412 longevity. Diets alone defuse only limited aspects of the Cholesterol Time Bomb and are not the complete answer to cardiovascular or more general health. Diets are usually planned for a reason, be it weight loss, cholesterol lowering, altering nutritional status or variable combinations of these objectives. The author believes that seeking a diet that achieves all three is ideal. The “balanced diet” is the optimal choice since this selection helps control hunger, is not monotonous and it improves overall health. Understanding why the diet in question or consideration was developed assists in matching dietary interventions for changing needs. For example, weight reducing diets should be time dependent and a maintenance diet that is more relaxed can be introduced subsequently to control weight or prevent weight gain. Some diets can improve overall health or correct existing disease. Some diets contain very specific meal recommendations. This degree of regimentation is preferred by some but complied with by few. The normal mode or pace of life it is very difficult to comply with a specifically regimented diet. If an individual does not choose a diet that matches their lifestyle to some degree, failure will be inevitable! Certain diets are recommended by institutions or organizations that have an aura of authority in their espoused opinions. Many scientists and authors agree that because a diet is promoted by a government or institution 413 of high standing then it does not mean that the dietary recommendations are ideal. Some organizations have axes to grind or receive support from industrial sources that may color their recommendations. However, the author has learned that people who fight “city hall” rarely win! Table 76 summarizes two of these diet proposals from conventional bodies of opinion. These diets have advantage but they also possess some disadvantages or limitations. Some of the more “popular” diets that have gained commercial acceptance are summarized in Table 77. In many cases, the medical profession, both of the “conventional” and “alternative ilk”, have rejected these diets for one reason or another in favor of more balanced and optimal nutrition. Like most things in life, it is generally the extremes that are dangerous. Optimization is often synonymous with moderation. Claims that you can eat what you like and lose weight are very misleading or they are, in the author’s opinion, frankly untrue. “Eat what you want”, “eat yourself thin”, “all you can eat” are statements without any common sense? Diet/Characteristics Comments The American Heart Association Diet (Less saturated fat, low salt, more complex carbohydrates) - Easy to follow - Widespread medical use - Evidence it may prevent heart disease - Omits the importance of essential fats in cardiovascular disease prevention or treatment - Some choices of polyunsaturated fat sources are suspect 414 - Forgot the role of soy and vegetable protein The U.S. Dept. of Agriculture Dietary Recommendations (Pyramid of Foods) of - Aimed at general health promotion but it fails in places - Does not consider importance essential fatty acids - Too accepting of processed foods - No real focus of the health benefit Table 76: Some Potential Drawbacks of Well Accepted Health Giving Diets Diet/Description Criticisms: Valid or Otherwise? Dr. Atkins Diet Revolution (high fat, high protein, low carbohydrates) - Not a revolution, used by Banting in the 1800’s - Accelerated early weight loss is water loss - May result in abnormal blood lipids - YoYo regain of weight can occur - Ketosis induced with potential negative metabolic consequences - Cannot be recommended for the person with cardiovascular disease 415 Dr. Stillman’s Quick Inches Off Diet (low protein, high carbohydrates) - The Zen Macrobiotic Diet and other macrobiotic diets (grain based vegetarian diet) - Nutritionally incomplete - Not recommended long-term because of dangers? - Beyond the average reach of compliance - Lack of certain essential fatty acids - Very variable dietary formulations that are complex with questionable basis The Living Foods Diet (Based on uncooked organic grains vegetables) - Ecological sense - Stresses inclusion of vegetables over (Continued) Diet/Description Weight Watchers (well established plan for weight reduction) Few merits Modification of 1950’s Rice Diet Accelerated early weight loss is water loss YoYo regain of weight can occur Nutritionally deficient in contrast to many macrobiotic diets - More to do with food preparation - Probably very healthy and is good for incorporation into a dietary regimen - Only for the very committed Criticisms: Valid or Otherwise? - Quite successful - Shortcomings in the control of blood cholesterol and hypertension - Expensive - Forgot essential fats and soy The New American Diet (A dietary transition program for a move away from a 416 - Much to commend this diet which is a variation of AHA and USDA diets - Well-balanced and flexible traditional American diet to a - Good accompanying manual more ‘vegetarian’ diet that is - Recognizes omega 3 benefits, underhigh in complex carbohydrates estimates omega 6 benefits and low in saturated fats) - Forgot to emphasize soy The Beverly Hills Diet or The Fit for Life Diet (Emphasizes fruit intake) - The notion that fruit melts fat is not valid - Causes diarrhea - May gain weight The Pritikin Program (Quite severe diet restrictions with cardiovascular wellness potential of low fat, low cholesterol) - Compliance problems - Nutritionally incomplete - Despite this, a major contribution The Dolly Parton Diet (‘Prescribed’ diet with on/off eating) - Little, if any, scientific basis - Food juggling regimen is too complex The Dean Ornish Program - Very sound program that has been (A complete lifestyle program subjected to objective research with low cholesterol objective - Compliance problems for cardiovascular wellness) (Continued) Diet/Description Criticisms: Valid or Otherwise? The Scarsdale Diet (Short-term ketosis induction plan) - The Last Chance Diet (Liquid protein diet) - Short-term - Risk of sudden death - Thrown out by many Fasting is a Way of Life (Essentially, just don’t eat) - Prolonged fasts are decidedly dangerous - Boring 417 Dangerous without medical supervision Use for only 2 weeks advised Loss of protein tissue (muscle) occurs Rejected by many as a fad - Stimulates overeating The Cambridge Diet or The Slim-Fast Plan (Beverage assisted weight loss) - Monotonous - No education on eating properly - Not nutritionally complete meal replacements - Compliance problems - Short-term success only The Set Point Diet (Based on the theory that everyone has a set point (weight point) which the body fights to maintain) - Balanced with natural foods Similar to AHA and USDA No emphasis on essential fatty acids Principal aim weight loss Table 77: This table contains subjective comments based on a study of the diets by the author and consultations with medical practitioners and patients who have experiences. Some of the commonly used diet programs are listed with putative or actual concerns about their application. With exception of the well accepted Ornish Program, the other dietary methodologies have been somewhat lacking in careful clinical study. Assessments of their safety and efficacy have been anecdotal. This situation may make criticisms of the diet plans appear anecodotal, so the author has focused on generally accepted medical interpretations of the basis, if any, for the dietary interventions. 418 CHAPTER 12 OBESITY 419 Overview of Obesity It is generally correct to state that: “individuals who eat too much will tend to be overweight and those who do not eat enough will tend to be underweight”. These general principles are forgotten by at least 25 percent of the United States population who are overweight and small percentage who are underweight by conventional definitions. Weight control and obesity management are among the largest industries in North America, and it is estimated that about one-quarter of the population expend about $30 billion on weight control aids in one year. Approximately 15 percent of the population are on some form of diet continuously, and three -quarters of all midteen girls try to lose weight. The causes of obesity are often complex but usually involve overeating combined with some type of emotional factors in individuals who are prone to obesity. Several identified causes of obesity are shown in Table 78. Being fat will break your heart at some stage. Obesity is not always a disease of failure of self-discipline with diet. Often, it is not clear what the fundamental problem is in the causation of obesity in many individuals except knowledge that excess calorie intake occurs in their diet. This excess calorie intake is often associated with Social gluttons Familial predisposition Genetic obesity Diet composition Eating patterns Lack of activity Emotional factors 420 Medical Causes Drugs Surgery Brain disease Endocrine causes Abnormal metabolism Table 78: Recognized Causes of Obesity. The most common forms of obesity is simple obesity that is not clearly determined by organic disease. inadequate energy expenditure by the body. Overeating and a sedentary lifestyle may go hand in hand to tip the balance toward being overweight. One popular theory of obesity is the so-called “body weight set point theory”. This theory implies that the body sets itself at a level in terms of weight and composition that is somewhat definded from change. The issue then becomes consideration of the degree of defense the body exerts to change. For example, this theory promotes the notion that obese individuals have a high set point and will tend to resist weight loss when placed on a low-calorie diet. Clearly, this notion is simplistic and probably only partially correct. The body weight set point theory affords an important argument against the “lack of self-discipline concepts” that can defeat an obese individual’s desire to want to change their body habitus. Measuring Weight Status There is an important and often overlooked issue in the management 421 of obesity, namely, the distinction between being “obese” and being “overweight”. The concept of ideal body weight is unfortunate, but it does provide a useful, crude reference point for determining a definition of overweight or obese. There is no ideal body weight per se but an ideal body weight range, which takes into account differences in age, body type, and other variables. There are many standard tables to define ideal or desirable body weight, but they do not make important allowances for the variables mentioned. The underlying importance of defining desirable body weight is really to identify a range of weight where morbidity and mortality that occur from being overweight are at their lowest. Table 79 shows the Metropolitan Height and Weight Tables, which are based on actuarial studies that look at health risk factors. The process of assessing desirable weight can be made very complex by the application of formulas. A useful and simple measure of assessment of obesity is the body mass index (BMI), which is essentially the relationship between height and weight. Overweight is approximately defined as a BMI of 25 to 30 kg/m2, and obesity is a BMI above 30 kg/m2. In general, obesity is crudely defined as more than 20 percent above ideal body weight, and by this definition, one-quarter of the United State population is obese. Of more concern is that at least one in three (33 percent) Americans has a degree of being overweight that puts them at a medical risk. Height (Without Shoes) Feet Inches Weight in Pounds (Without Clothing) Small Frame 422 Medium Frame Large Frame Men 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 5 11 6 0 6 1 6 2 6 3 Women 4 9 4 10 4 11 5 0 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 105-113 108-116 111-119 114-122 117-126 121-130 125-134 129-138 133-143 137-147 141-151 145-155 149-160 153-164 157-168 111-122 114-126 117-229 120-132 123-136 127-140 131-145 135-149 139-153 143-158 147-163 151-173 155-173 160-178 165-183 119-134 112-137 125-141 128-145 131-149 135-154 140-159 144-163 148-167 152-172 157-177 166-187 166-187 171-192 175-197 90-97 92-100 95-103 96-106 101-109 104-112 107-115 110-119 114-123 118-127 122-131 126-136 130-140 133-144 94-106 97-109 100-112 103-115 106-118 109-122 112-126 116-131 120-135 124-139 128-143 132-147 136-151 140-155 102-118 105-121 108-124 111-127 114-130 117-134 121-138 125-142 129-146 133-150 137-154 141-159 145-164 149-169 Table 79: 1959 Metropolitan Height and Weight Tables The confused Healthcare Giver There are so many methods for assessing the amount and distribution of body fat that even nutritionists become confused. The most reliable 423 simple techniques involve measurement of relative weight or recordings of skinfold thickness. A person’s weight can be expressed as a percentage or ratio of desirable, ideal, or acceptable weight using tables from the Metropolitan Life Insurance Company’s Build and Blood Pressure Study performed for the Society of Actuaries (Chicago, 1959). This information was updated in 1983 for inclusion in the Metropolitan Height and Weight Tables. More recent guidelines have appeared that define ideal weight, but in the author’s opinion, these re-definitions are of little overall significance in assessing obesity. The Importance of Body Fat Distribution Some nutritionists believe that it is important to assess the topographical distribution of body fat. This is easily estimated by measuring the waist to hip ratio (WHR). The WHR is measured as a ratio of the minimal circumference of the waist to the maximum circumference of the hips. There is some relationship between the WHR and general body fat distribution. The relationship of WHR is most predictable as a measure of central adiposity (fat tissue inside the body). The author believes that the WHR has major implications for the design of exercise programs aimed at selective weight loss from certain parts of the body. In addition, measures such as the WHR can assist in defining upper or lower types of body obesity, which may carry different health risks. Individuals with predominantly upper body obesity, affecting the back of the neck, shoulder areas, and inner abdomen, seem to have a greater risk of developing metabolic complications of obesity than those with lower body obesity. Such metabolic complications associated with upper body 424 obesity include diabetes mellitus, hyperlipidemia, and cardiovascular disease. It is believed that individuals with obesity of the lower body that affects the hips and buttocks may be more stable from the metabolic point of view, and they may not be at such a great risk of metabolic disease. The distribution of obesity appears to be relevant in dictating medical needs for weight reduction. Killer Types of Obesity One of the most problematic forms of obesity is termed morbid obesity, and there is a very dangerous form of obesity termed “malignant obesity”. Individuals with malignant obesity have advanced complications of obesity, with very limited survival prospects. Morbid obesity has been defined as body weight that is 50 to 100 percent 45.5 kg) above the desirable body weight. A more precise definition of morbid obesity is a BMI of greater than 39. By these criteria, a staggering number of individuals in the United States are morbidly obese. It has been estimated that approximately 2 million adults between the ages of 20 and 79 years are morbidly obese. Of these individuals, there are five times more women than men. Population Studies Define Risks The amount of epidemiological evidence that shows the pervasive nature of obesity in Western communities is overwhelming. A particular message of great importance comes from population studies of obesity in different countries worldwide. The seven country study of Keys (1970) is very important in understanding dietary patterns and obesity. This was a comparative study of obesity as estimates by relative weight and measurements of skinfold thickness. The results of this study are 425 summarized in Table 80. The striking finding in this study was that the Japanese, with their soya-based diets, are at the bottom of the table in being overweight. Obesity is a very uncommon state in Asia. Percent of Sample Overweight Obese Country Italy 33 28 United States 32 63 Yugoslavia 19 29 Finland 15 14 Netherlands 13 32 Greece 11 11 Japan 2 2 Table 80: Prevalence of Overweight and Obesity in Men from Seven Countries, from Keys (1970). 426 The risks and complications of obesity are shown in Table 81. Being overweight carries a risk of premature death, but obese individuals often have other risk factors for early death, including hyperlipoproteinemia, hypertension, coronary artery disease, renal failure, and other serious disorders. One cannot underestimate the social toll of obesity, and this is a key to understanding the defeat felt by many obese people. American and other Western societies exude constant messages about ideal body types, which, with other social issues, can lead to exceptional and often extreme discrimination against the obese person. Such discrimination is inappropriate and totally unacceptable. “Tailor-Made” Diets The importance of reviewing the complications of obesity is to indicate how “tailor-made” diets may serve the health needs of the obese person on a weight-reducing plan. Soya protein and other soya-based products are ideal candidates for incorporation into the “tailor-made” diets of the motivated patient with obesity who is trying to lose weight and promote health. A key issue is that the obese person may attempt to lose weight at all costs. This Glucose intolerance * 427 Diabetes mellitus * Hypertension * Hypercholesterolemia * Cardiac disease: atherosclerotic disease, congestive heart failure Pulmonary disease: sleep apnea, chronic lung disease Cerebrovascular disease, stroke * Cancer: breast, uterus, colon, prostate * Gallbladder: stones * Pregnancy risks Surgery risks Renal failure Gout Infertility Degenerative arthritis * Early death Psychological problems: poor self-image Social problems: discrimination in jobs, education, and marriage Table 81: Risks and Complications of Obesity. (*) Complications of obesity that are amenable to correction by soya-based diets. lack of regard for the promotion of healthy weight loss may sometimes be more of a risk than the obesity itself. Soya, particularly soya protein, can assist in counteracting some of the complications of obesity. In essence, soya will assist in reversing risks of glucose intolerance, arthritis, hypercholesterolemia, hypertension, renal disease, gallstones, cardiac disease, and obesity-associated cancer, all of which are susceptible to the beneficial effects of soya. These aspects of the health benefit of soya have been discussed in detail in earlier chapters. 428 Critical Elements of Diets The critical elements in the management of obesity are diet with reduced calorie and fat intake, nutrition education, and often, behavioral modification techniques. It is recognized that fat in the diet of Western society is a pivotal element in promoting obesity. Many nutritional surveys have shown that Western populations have changed their diets over the past century to increase calorie intake from fat while decreasing the dietary intake of calories derived from complex carbohydrates. It is significant that if calorie intake is kept the same, a diet rich in fat will produce enhanced gain of body fat. This finding is well documented in animal experiments. Routine medical treatment of obesity using diet alone has a failure rate of greater than 95 percent over a 3 year period. In addition, the practice of drastic calorie reduction is known to be associated with a YoYo pattern of weight loss and rebound weight gain. It has been documented that both men and women reducing their calorie intake below 1200 calories per day and then resuming prior dietary patterns may enter into a process of even increasing weight gain over time. this may be explained by the correction of body metabolism that occurs to accommodate to low-calorie intake, which does not rapidly reverse. This, reinstitution of normal eating could promote weight gain in the individual with an acquired low-calorie, diet-induced, down-regulation of body metabolism. Different Directions with Diets There are several different types of dietary approaches to weight loss (Table 82). Each approach has disadvantages or limitations, underscoring the need for the healthcare professional and the patient to consider a more 429 holistic approach to weight control. This approach should include at least a consideration of the following: a healthy calorie-controlled diet, nutrition, education, behavioral therapy, exercise therapy, and motivational interventions with training in dietary compliance. The importance of inducing a long-term change in behavior must be stressed, and the individual undergoing a weight control program should be aware of the risks of continued obesity and understand that the optimal approach is a long-term strategy. Drug therapy for obesity has been used as a useful adjunct to management in some patients, but amphetamines, although effective in the short-term, are, in my opinion, to be avoided at all costs. Treatment with drugs for obesity should be individualized, closely monitored, and stopped when efficacy is not achieved. Drug therapy for obesity, if used, should be short-term in selected patients. Obesity Defined and Re-Defined The definition of what constitutes obesity (the state of being fat) is elusive. In its simplest terms, obesity is having too much body fat. There are many ways of defining “fatness” or “thinness”, ranging from simple weight measurements to complex biochemical techniques that are only available in Diet Type Disadvantages 430 Balanced low-calorie diet* Hunger, preoccupation with food and frequent failure. Formula diets The discipline of the diet creates boredom and failure, and formulas are expensive. Specific nutrient addition Higher fiber is the frequent choice, but palatability is a problem; worthy of more study. Specific nutrient elimination Specific nutrient deficiency syndromes, special preparation, poor compliance. Fad diets Sometimes dangerous, often expensive, usually a variation of one or more of the above options. Table 82: Commonly used types of diet for weight loss or obesity management. (*) Balanced low-calorie diets with fiber and soya addition presented creatively with other lifestyle adjustments are the best option. centers of research excellence. For practical purposes, the simplest and least misleading definition of obesity is to measure an individual’s Body Mass Index (BMI). 431 The BMI is easily calculated by dividing weight by the height of an individual squared. An 80 kg person who is 2 meters (m) tall has a BMI of 80 ÷ 2m x 2m, which equals 20. The normal range of weight in terms of a BMI is 19 to 24.9. The simple calculation used above was chosen because an average weight is about 70 kg for a male and a weight of 80 kg may conjour up the idea that the person was chubby. However, the importance of height in the equation is revealed because 2 meters is taller than average – this is an example of height allaying fatness. The mathematical projections work in the opposite direction. An 80 kg person who is 1 meter tall has a BMI of 80 ÷ 1m x 1m, which equals 80. A BMI of 80 generally constitutes malignant obesity with impending death. Four groups of being normal or overweight can be defined by the BMI (Table 83). This classification of fatness is of medical significance, since a relationship exists between degrees of obesity and health risks. The Significance of Being Fat If an individual has a BMI greater than 30, they have a statistical, but real, risk of an increase in several diseases or adverse health consequences compared with people in the normal weight range. The widely used Metropolitan Life Insurance Company Tables of desirable or ideal weight for height were derived from statistical studies that showed that normal ranges in the Table were associated with less disease and a lower incidence of premature death. The BMI measure of being overweight is not foolproof. The mesomorph may fall into an overweight category but even being in this category means some increased risk of development musculoskeletal. 432 What Causes Obesity? Predictably, the answer to this question is very far from simple. However, the consumer of weight loss plans, books or products needs some insight into the pathophysiology of obesity in order to make an informed Body Mass Index Grade of Weight Description 40 or more 3 Severe or Morbid Obesity 30 - 39.9 2 Obese 25 - 29.9 1 Overweight 19 - 24.9 0 Normal Range Table 83: Four grades of being fat can be readily determined from Body Mass Index measures, calculated as weight divided by height squared. The formula for BMI can be used to define underweight. Some muscular individuals will be misclassified into grade 1 even though they may have no excessive body fat. 433 choice of weight loss program or diet. Understanding why one may be fat is a major step in the battle to getting thinner. Obesity occurs when the net amount of energy intake is greater than the net utilization of energy over a period of time. The overall occurrence of obesity is age dependent and the peak prevalence of obesity occurs in Western countries usually between the age of 55 and 65, when about onequarter of all women and one-fifth of all men are obese. The risk factors for obesity in females and males of these age groups have been defined to some degree. A female is more likely to be fat during her mature years if she has had more than three pregnancies, is not married and is of lower socioeconomic status. Both genetic and environmental factors play a variable role in the causation of obesity. Genetic or familial differences in how people handle energy intake and the utilization of energy by the body may be important considerations. Overall, the most common and important determinant of obesity if overeating. This overeating is controlled or not controlled by complex behavioral factors. This latter fact means that dieting cannot be successful in the intermediate to long-term without behavioral changes that influence eating habits. There are some special circumstances in which obesity occurs. The climacteric (menopausal period) often heralds the onset of weight gain for females. In addition, the less well defined or recognized male andropause often signals weight gain in the male. These circumstances 434 of weight gain can be approached in an effective manner but require sustained dietary intervention with special care to provide nutritional principles that help prevent chronic degenerative diseases in the mature adult. For the menopause, soy protein containing isoflavones has been seen as a key dietary adjunct. Isoflavones may suppress menopausal symptoms. Soy foods are often low in calories and soy protein lowers cholesterol, promotes cardiovascular wellness, prevents osteoporosis and it may prevent age-related cancer incidence for cancers of the breast and prostate in males. Obesity in childhood is notoriously difficult to treat. The author proposes soy food in this group because standard dietary interventions almost always fail. Obese children are disadvantaged and often emotionally upset. These children are at significant risk of organic disease. Most dietary interventions in children result only in prevention of further weight gain. Weight loss is very difficult to achieve in obese children. 435 CHAPTER 13 MAKING RECOMMENDATIONS 436 Pulling It All Together Unlike many books on natural health, this book has not been a series of pretty pictures, promises of exotic cures or recommendations for a “wayout” lifestyle. It is apparent that there are many natural ways to cardiovascular health and even more apparent, that many of these ways to health are based in simple common sense. During my extensive travels in Southeast Asia, I spent a great deal of time trying to understand the factors that would promote longevity. The Chinese revere the statue of “the longevity man” with his characteristic charismatic smile. Having spent some time with monks in several Buddhists temples, I began to learn that their secret of a long, healthy and happy life was not a great secret, it was more a function of lifestyle. Try as one may, it is not possible to live the cloistered existence of a Buddhist monk, but it is possible to learn from their experience. The feature of the Buddhist monk is his harmonious existence with nature. Anxiety, stress and depression are not permitted to enter the monk’s life even though these emotions present themselves to the Buddhist monk in the same way as they present themselves to everyone in society. The monks do not subscribe to a single or secret cure for illness, but they direct their attention to total body wellness by achieving a peaceful mind combined with the utmost personal care and nutrition. The answer to modern chronic disease that plague society, such as heart disease and cancer, rests in combining nutrition, natural healing processes and the power of the mind over the body. Therefore, a simple recommendation to promote cardiovascular health is quite erroneous. 437 The bouquet of barbed wire contains many damaging factors for cardiovascular health and these factors are not amenable to a single intervention. The natural substance purveyors and practitioners of natural health who promise a beneficial outcome from a simple herbal intervention are more guilty than the physician who prematurely prescribes a synthetic medication. For example, five cloves of garlic per day with two packs of cigarettes will not result in cardiovascular health. Table 84 summarizes what the author has termed the “CardioPlan” which is a holistic approach to cardiovascular health. The Author’s Recommendation on Diet Plans First and foremost, the author does not recommend that an individual think in dietary terms only, but rather consider an overall plan for lifestyle Maintain an optimal weight Control elevated blood pressure Engage in physical activity Do not smoke or inhale second hand smoke Reduce your dietary intake of saturated fat and cholesterol by moving towards more vegetarian sources of protein Pay special attention to your mind and psychological well-being Do not use dietary supplements as a way of supplementing a lousy diet Remember the mirror life: your imput is your return Moderation in most pleasures is advisable Use natural substances to promote cardiovascular well-being Conventional medicine when applied appropriate has immense 438 advantages for health Table 84: The “CardioPlan” which incorporates a holistic approach to cardiovascular health. adjustment. Diets are impositions or deviations of “normal” (in many people normal is abnormal) eating patterns and habits. The term habit is important because without motivation and considerable behavior modification all diets will fail. Huge books are written on behavioral change in relationship to eating. The issues can be summarized as getting to know yourself, recognize your tricks and catch yourself. The most important aspect of diet planning is to set objectives and goals. The individual must understand why they want to diet. What is the need? -- defined by a disease status or a global health requirement. No single diet can be given as a panacea recommendation, as indicated by the previous review of the many existing dietary recommendations. The important concept is that various meals work towards different health outcomes. In the absence of sufficient knowledge about the health potential of various foods, a rational dietary program cannot be constructed. Table 85 summarizes how certain selected dietary interventions may work in cardiovascular disease prevention or treatment. Note the multiple benefits, direct or indirect, that simple dietary changes may make on cardiovascular wellness. 439 Dietary Maneuver Health Outcome Prevents Heart Treats Heart Disease Disease Incorporate balanced omega 3 and omega 6 fatty acids in diet Yes (x, z, y) Yes (x, z, y) Add soy protein containing isoflavones Yes (x, z) Yes (x, z) Lower calorie intake Yes (y) Yes (y) Lower cholesterol intake Yes (x) Yes (x) Lower saturated fat intake Yes (x) Yes (x) Lower salt intake Yes (y) Yes (y) Switch from animal to vegetable protein, e.g. soy Yes (x, z) Yes (x) Move from simple to complex carbohydrate sources Yes (x) Yes (x) Lower alcohol intake Yes (x, z, y) Yes (x, z, y) Table 85: Dietary Changes That Both Prevent and Treat Heart Disease Directly and Indirectly. NOTE: (x) = Signifies lowers cholesterol; (z) = Signifies beneficial cardiovascular effects independent of lowering cholesterol; and (y) = signifies direct or indirect effect on lowering blood pressure. The author is not a great supporter of prescribed meals. The best 440 approach is to have an individual with dietary intent understand the value of food or dietary supplements and make their own informed choices. This is one major area that a healthcare giver, such as a dietitian, can be of major assistance. It would be wrong to expect a physician to give specific meal planning information. First, he or she will often consider themselves too busy. Second, he or she does not often know enough about the nutritional value of foods. Culinary arts do not form a part of the undergraduate medical curriculum. Incidentally, nor does training in nutrition. Finally, the “would-be” dieter may be a little suspicious of the physician who wrote a diet plan with an appended cookbook, since few such authors can even boil an egg. Meals are personal preferences. Living by another’s tastes is seldom successful in outcome. The characteristic of a meal plan that will result in reasonable efficacy, safety and compliance is shown in Table 86. Obviously, the reader must feel bereft of direction if some recommendations about various food groups were not made. Such recommendations are made in The right diet has the right objectives for the client. It should provide balanced nutrition, if possible. The benefits should be obvious to the dieter. For weight loss, the diet must supply less energy than the person’s energy requirements. When calorie intake is below 1,800 calories per day, mineral and vitamin 441 supplements are required. The diet must have a high degree of acceptability. Monotony spells failure. It should be part of a lifestyle adjustment regimen. Its success is equally dependent on food exclusion and healthy food substitution. Table 86: Some Advantageous Characteristics of a Meal Plan That Will Aid Compliance and Fulfill Health Objectives. Table 87. The plan that the author proposes is for weight reduction and cardiovascular health combined. The key to the plan is that it is not merely a diet but an adjustment of the calorie intake of the diet that will make the dietary plan effective at weight loss (Table 88). The author believes very strongly that serious dieting requires the help of a qualified healthcare giver. Concepts on the role of various nutrients or supplements in health promotion change overtime. One of the main features of the dietary recommendations by the author is that soy protein and essential fatty acids are the most underestimated nutritional interventions for cardiovascular health. It is hoped that the reader will try and challenge the uninitiated healthcare giver with this knowledge. The author believes that this adjunctive dietary intervention of adequate essential fatty acids and soy will make a real difference to cardiovascular health in Western Society. 442 Special Diets for Special People There are several highly effective short-term diets for weight loss that have been used quite successfully in conventional medical practice. It should A special health role exists for soy, essential fatty acids and fiber. Low saturated fat, normal protein intake of vegetable preference, low simple sugars, high complex carbohydrate, low salt and cholesterol conscious. Varying foods preferred. Calorie intake reduction is the key to weight loss. Calorie intakes of less than 2000 calories per day require supervision of a healthcare professional. Avoid dieting pills or dietary supplements with false claims. Educate yourself in calorie contents and nutritional values of foods. Read labels on food. Train yourself to eat properly, e.g. only when hungry, chew well, make a meal on occasion. Decrease intake of: animal foods, fried foods, and especially beef, cheese, butter and margarine. Watch for more ‘unhealthy’ fruits, e.g. avocado, coconut and nuts high in saturated fat. Avoid alcohol, food colorants, additives or sugar. Increase intake of: vegetables, fish, grains and low fat, non-salted, fresh nuts. The author believes that NutraSweet is safe. Supplement Western Diets with fiber (>25 gm/day), soy protein containing isoflavones (>25 gm/day), omega 3 and omega 6 oils in varying ways described in this book. 443 Table 87: Specific “Dietary Recommendations” by the Author Answer the following: Am I Fat? Am I a Cholesterol Time Bomb? How fat and How much at risk may I be? (Ask a healthcare giver) What are my dietary objectives, goals and what is my timetable? (Ask a healthcare giver) Have I eliminated other cardiovascular risk factors? (e.g. smoking, excessive stress) Can I decide on the lifestyle change and modify my behavior accordingly? (It’s make your mind up time) Do I know enough about food facts and fallacies? (Ask a healthcare giver) Create your plan. Go to work on the plan. What Foods? (See Table A) Are essential fatty acids and soy healthful? (Ask a healthcare giver who took the time to find out the answer) Table 88: Key Steps in the Diet Plan Proposed by the Author 444 be stressed that these diets require careful, obligatory close medical supervision. A widely applied diet for the treatment of more severe forms of obesity is the very low calorie diet (VLCD). This diet is used by some physicians as an option for rapid weight loss in the short-term, often to avoid surgery. It finds a special use in very obese people who have failed standard dieting regimens. The VLCD is fraught with problems. It supplies a 300 - 450 calorie per day (1,200 - 1,800 kilojoules) and it must be used only after a full medical assessment. Attempts to make the act of severe caloric restriction more appropriate include the incorporation of about 50 gm of protein to help stop loss of muscle tissue together with the addition of fiber, vitamins and minerals to the diet. The diet can result in weight losses up to 4 kg per week but less than 30% of individuals can comply with the diet for more than 6 to 8 weeks. Problems with the VLCD are inevitable loss of muscle mass, including heart muscle, and decreases in skin and blood protein. The VLCD induces a reduction in the individual’s metabolic rate which reduces the effectiveness of the diet. Gallstone formation is a common problem if the diet is continued for more than eight weeks. Attempts to enhance the diet by exercise usually fail because individuals on the diet are often fatigued and listless. Other diets that are used for rapid weight loss in the more obese person include the Milk Diet which is popular in the UK and the Egg White 445 Diet, or other single food low caloric approaches that have gained some popularity in the United States. They are, at best, short-term crutches and they may be counter-productive by stimulating weight upon their cessation (the YoYo effect). The YoYo effect of weight regain is regarded by many as very unhealthy and it has been associated with a risk of cardiovascular disease. Natural Substances for the CardioPlan The readers of this book may have reached a level of confusion in knowing which type of natural remedy to select in order to achieve optimal cardiovascular health. It is likely that as research advances are made, the relative importance of certain natural options versus others may become more obvious. It is apparent from the author’s review of available natural approaches to cardiovascular health that certain dietary supplements stand out in terms of their potential benefit for preventing and ameliorating coronary heart disease and other cardiovascular disorders. The natural substances that are recommended in the CardioPlan are summarized in Table 89. Of all the natural agents that are used to promote cardiovascular wellness, soy protein with isoflavones, garlic, essential fatty acids, an adequate intake of specific vitamins and minerals and polyphenols stand out as important. Whilst this list of recommendations of natural treatments for cardiovascular well-being is not complete, it is a list of recommendations for which there is most scientific evidence to support the use of these agents alone or in combination. 446 The recommendation of these natural agents is generally safe even in the presence of co-existing cardiac medication. However, an individual is advised to seek the advice of a healthcare giver when multiple medications are taken. Several dangers exist with natural therapies. For example, essential fatty acids of the omega-3 series may enhance the effect of anticoagulants and these circumstances require some monitoring. In addition, several botanical agents may act synergistically or counteract synthetic drugs. Soy Protein (at least 25 grams per day) contain isoflavones (at least 50 to 80 milligrams per day) is recommended to lower cholesterol and exert important antioxidant effects that can prevent atherosclerosis. Garlic which has versatile cardiovascular effects can be taken in doses of 600 milligrams to 1 gram of pure or concentrated garlic or garlic extract powder, or 1.8 to 3 grams of fresh garlic equivalent, or 1,800 to 3,600 mcg of allicin per day. A cardiac-specific vitamin supplement is recommended which contains adequate amounts of vitamin C, E and B complex, together with chromium, magnesium and the addition of Coenzyme Q10. Essential fatty acids, especially omega-3 fatty acids from fish oil in a delayed-release format. A polyphenol containing supplement with active bioflavonoids to deliver approximately 50 to 100 milligrams of mixed bioflavonoids daily. 447 Table 89: Natural substances that are recommended to be included in the CardioPlan. NOTE: This CardioPlan is not recommended to substitute for a healthy balanced diet and individuals with significant cardiovascular disease are advised to seek the attention of an experienced healthcare giver. The notion of homeostasis which has been otherwise termed, directly or indirectly, “spontaneous healing” or “self healing” is an important process to consider. Even if an individual has established coronary artery disease, they can improve their prognosis and well-being by change of lifestyle, together with conventional medical approaches and the use of safe natural substances. An individual should, by no means, reject conventional medical interventions, which can be life-saving. All medical practitioners are becoming increasingly aware of natural medical options and are beginning to believe much more in the importance of mind/body interactions. The author encourages the reader to share the information contained within this book with the healthcare giver of their choice. 448 APPENDIX A THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 Far-Reaching Consequences for Consumers and Manufacturers The Dietary Supplement Health and Education Act of 1994 (DSHEA) could revolutionize the regulation of the use of dietary supplements. Consumers, healthcare professionals, and manufacturers and distributors of such products are not sure about the content and implications of this legislation. While the Act provides new marketing opportunities for dietary supplements – and perhaps more informed use of such supplements by consumers – it is the first step in regulatory control of the rapidly expanding dietary supplement industry. The past several decades have seen a growing awareness of the key role nutrition plays in the quality of our health; it is now widely recognized, for example, that low fat diets can help prevent certain cancers and heart diseases. As manufacturers of health foods and nutritional supplements sought to bring this information to the attention of the public – including, in some cases, hyperbole about “brain food” and other questionable claims – Congress began to question whether health claims should be allowed for foods and supplements. Congress passed the Nutritional Labeling and Education Act (NLEA) in 1990 in an effort to provide the Food and Drug Administration (FDA) with the tools and direction it needed to determine which health claims could properly be made. The FDA took a position in response to the NLEA, which many, including some in Congress, took to 449 reflect an overeagerness to place undue restrictions upon claims made for dietary supplements. In response to this concern, and buoyed by an unusually strong public response, Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA). The DSHEA sought to moderate the approach to the regulation of dietary supplements embodied in the FDA’s proposed regulations under the NLEA. One of the key issues is the standard of proof a manufacturer needs to meet in order to make a health claim. The NLEA required a manufacturer to show “significant scientific agreement” supporting the proposed health claim. This standard was an effort to create an intermediate threshold for the approval of health foods, but it did not wish to place the expensive and technical requirements upon supplements that it had placed on drugs. The standard requiring “significant scientific agreement” was unsatisfactory to the health food industry and many consumers. One problem with the standard was that it was not one with a history developed at law, so that the meaning of the standard was unclear; it could be interpreted as a requirement as simple as a dozen published articles in agreement with the claim, or as difficult as agreement by a National Institutes of Health (NIH) consensus panel. The standard also raised concerns, given the hesitation and conservatism of the scientific community toward recognizing the positive health benefits of nutritional interventions, that this would create an unduly high threshold. The lobbying, which ultimately resulted in the passage of the DSHEA, arose in large measure because of dissatisfaction with this requirements. Unfortunately, the supporters of the DSHEA were not able to revise 450 this standard. The DSHEA thus took other approaches to moderate the severity of this standard. One approach taken was to allow a manufacturer of a supplement to make truthful structure and function claims – claims that do not describe an indication or make a specific “health” claim – without requiring that those claims be subjected to regulatory approval by the FDA. A manufacturer can claim, for example, that antioxidants help remove oxidized material in the body, but could not, without approval of a health claims, state that antioxidants have a beneficial effect in preventing cancer. The DSHEA also allows manufacturers and distributors of supplements greater latitude in information the public about the health benefits of their products. The law regulating claims made for food and drugs prescribes what can be placed on the label – the packaging affixed to the product – the separate materials that are distributed with the product, such as package insert or sales brochures. As discussed below, the DSHEA removed many types of literature from the definition of labeling, allowing consumers greater access to materials describing the health benefits of supplements, and allowing other members of the industry to make claims for products which the manufacturers of the products could not. The Findings Section The findings section of the act deserves special consideration because it reflects the underlying issues that Congress was addressing when the legislation was under consideration. Several important issues emerged in the findings section of the DSHEA. There was a general recognition that dietary supplements have 451 been shown to be of use in the prevention of chronic disease and an inference emerged that their use, in an appropriate manner, may reduce the prevalence of several common chronic disorders. The notion that this approach could lead to a reduction in long-term health care costs was entertained but nutrieconomic studies – investigations of the cost effectiveness of nutriceuticals – were not included in the Act. The rights of consumers to make informed decisions about preventive health care strategies was revisited in the Act, with an emphasis on the importance of the quest for scientific knowledge about the benefits of hazards of dietary supplements. It was noted that approximately one-half of all Americans may use dietary supplements to improve their nutrition and that much greater relevance to being placed on alternative healthcare providers because of the high cost of conventional medical interventions. This reinforced the need to product a consumer’s right to safe dietary supplements. These and other factors underscored the need for a framework to be established that supersedes what many perceived as “ad hoc” regulatory policies. Defining a Dietary Supplement The most important aspect of the characterization of a “dietary supplement” by the DSHEA is that the dietary supplement is not a new drug or a food additive. Section 3 of the Act refers to a dietary supplement as a substance intended to supplement the diet and that contains one or more of the following components or characteristics: vitamins, minerals, herbs, botanicals, amino acids. It also is a substance for use by humans that supplements the diet by increasing total dietary intake or it is a concentrate, 452 metabolite, constituent, extract, or combination of any of the above mentioned ingredients. Certain qualifications apply to this definition, including the necessity for labeling of a product as a dietary supplement and not representing the product as a conventional food or as a sole item of a meal or of the diet. Dietary supplements under this definition are to be applied in dosage forms, such as capsules, tablets, liquids, gels, or powders. Section 3(b) of the DSHEA clearly distinguishes between a dietary supplement and a food additive. Food additives are subject to strict regulation in a defined process of premarket approval by the FDA. This provision is very important to the health food industry and it prevents the FDA from claiming that certain dietary supplements are food additives that require a process of strict regulatory approval. Safety of Dietary Supplements The Secretary of Health and Human Services (HHS) may take action against a supplement which presents a significant or unreasonable risk of injury, or, in the case of a new dietary product, where there is inadequate documentation of safety. The Secretary may also suspend the sale of a dietary supplement if an imminent threat to public safety exists. If the FDA deems a product to be unsafe, then the burden of proof rests with the FDA to demonstrate any alleged lack of safety. The Act demands that the FDA both provide 10 days’ notice to the manufacturer or distributor of a product that a civil proceeding is imminent and grant an opportunity to discuss such action. 453 The Act provides useful guidelines as to what constitutes an unsafe product. If a substance is considered to present a significant or unreasonable risk of illness or injury under the conditions of the recommended use on the label or in accompanying labeling, then it is deemed unsafe. The FDA has to judge the safety of a product, in part, based on the labeling. This should encourage manufacturers to apply warning statements on products. This will lead to safer use of dietary supplements because warnings and cautions are quite permissible and specific dosage instructions should be disclosed by manufacturers or distributors wherever possible. The Act recognizes that public policy should be that a consumer could make an informed judgment about the use of a dietary supplement based on accurate information on the benefits of dietary supplements. This section is very important for those individuals in the industry who are involved in the creation of a platform for the advertising or promotion of dietary supplements and it presents many opportunities for creative marketing of dietary supplements. Such creativity should occur with conformity to the Act. Dietary Supplements and Literature Formerly, the use of literature by the distributors of dietary supplements that contained health claims was not allowed. Section 5 of the DSHEA has changed this situation radically. A publication that is reprinted in its entirety can be used in a retain environment, providing certain specific guidelines are followed. The Act indicates that the literature can be an 454 article, a publication, a book chapter, or an official abstract of a peerreviewed scientific publication that was prepared by the author or the editors of the publications. This area of the legislation will be open to interpretation and it will be a likely focus of further contention and definition. The literature that can be provided to a consumer in a retail outlet must not be false or misleading. Retailers of dietary supplements have some responsibility to be cognizant of what is being sold in their outlets. This means that if a government agency was to determine that dietary supplement literature was false, there is a potential liability for the retailer. The literature must not promote a particular manufacturer or brand of dietary supplement. The Act indicates that the literature should be displayed or presented with other items on the same subject so as to present a “balanced view” of the available scientific information on the dietary supplement. This is a very difficult problem with “unique” products which may be proprietary formulations or combinations. There may be only one type of a dietary supplement for an author to discuss. It the literature used to see dietary supplements is displayed in an establishment, such as a retail outlet, then the literature has to be physically separate from the dietary supplement. It seems likely that the responsible production of an accurate product monograph for consumers would be perceived as appropriate, but no test cases exist under the new legislation where “expanded” literature use as labeling has been used. This portion of the Act does not prevent the sale of books or publications by purveyors of dietary supplements. Section 5 of the Act in intimately related to dietary supplement claims 455 and labeling. This area of the legislation provides an exemption from the former basic rule that information used to sell a dietary supplement is considered to be “labeling,” when it is provided by a manufacturer, distributor, retailer, or even perhaps a healthcare professional. The Act does not enter into specific detail concerning situations where healthcare professionals may be selling their own brand of dietary supplements in their own clinic or treatment facilities. The general principles enunciated in the Act will apply in this setting, but this situation involving the healthcare professional is more complex and it is governed by other authorities such as State Licensing and Registration Departments and federal kickback and antireferral statutes. The Label on the Product Labeling – the manufacturer’s claims affixed directly to the product – is a critical aspect of information transfer from manufacturer to consumer and a primary area of a manufacturer’s legal responsibility. The DSHEA allows a labeling statement on a product to be made if the claim is a benefit related to a classical nutrient deficiency disease and the statement discloses the prevalence of the disease state in the United States. The label may also describe the role of a nutrient or dietary ingredient that is intended to affect the structure or function of the body or it may characterize a documented mechanism by which a nutrient or dietary ingredient acts to maintain a bodily structure or function. Finally, the label may describe general wellbeing from consuming a nutrient or dietary ingredient. It would seem reasonable to have a certain degree of uniformity in dietary supplement claims, but this is unlikely to occur and is not specifically mentioned in the Act. 456 Problems may emerge in the area of product labeling for many manufacturers. For example, a number of dietary supplements have wellrecognized effects in vitro but the conclusive demonstration of such effects in vivo may often be lacking. In addition, many alleged beneficial effects of certain dietary supplements are recorded from uncontrolled observations or are generated from epidemiologic information. These gray areas may never become distinct or even well demarcated in the near future. It is important to note that certain classes of claims for dietary supplements will likely receive intensive scrutiny by the FDA, especially those involving cancer, acquired immunodeficiency syndrome, or claims of immune modulation. It is of utmost importance to note that labeling statements made under the DSHEA, cannot make a claim to diagnose, mitigate, treat, cure, or prevent diseases. Only those specific claims linking a supplement to a disease state that have been preapproved by the FDA under the NLEA, such as soluble fiber and heart disease, may be made. The manufacturer or distributor must have substantiation that the statements used on a label are truthful and not misleading and retailers should be cautious in their presentations to consumers. Manufacturers must notify the Secretary of Health and Human Services within 30 days after first marketing a dietary supplement. This process of notification is a passive system for the FDA, but failure to notify will be regarded as misbranding. The outcome of such a situation is difficult to anticipate, but it could result in a request by the regulatory agencies to “purge the market” of the product. One important prerequisite of all 457 statements is that they be accompanied by a prominent display on the product or labeling document of the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This disclaimer is an attempt to distinguish dietary supplements from approved drugs that have been through the burdensome but necessary process of acceptance for marketing by the FDA. Section 6 of the Act and relevant supporting or complementary sections are often termed the “Structure Function” provisions of the DSHEA. Any purveyor of dietary supplements that ignores these “Structure Function” provisions will not be taking full advantage of the Act as these provisions allow the truthful claims about the dietary properties of the supplement without preapproval. Manufacturers or distributors of the dietary supplement must have adequate substantiation that the labeling statements are truthful. The problem is that the degree of adequacy of the required substantiation is not defined. Manufacturers of distributors of dietary supplements are advised to collect supporting documents and produce a comprehensive database to support any labeling statement. Such a database will be essential in the event that a dispute arises with a regulatory agency. This “Honest Label” Section of the DSHEA, Section 3, is very important. A persistent fear of the health food industry is the possibility of being issued with a misbranding charge. The ingredient labeling and nutritional information supplied to the consumer has to be accurate. Labels on dietary supplements must include: the name of each ingredient, the total 458 weight of the ingredients, the identity of any part of the plant from which a botanical ingredient is derived, and the term “dietary supplement.” Misbranding is present if the supplement claims to conform to an official standard (e.g., U.S.P.) and fails to meet the standard. If a dietary ingredient has no official standard but fails to have a composition or quality, including pharmaceutic formulation characteristics the manufacturer claims it to have, it is deemed misbranded. These regulations are designed to assist consumers in making informed decisions about the use of dietary supplements and protect them from the unscrupulous. The DSHEA provides an amendment to earlier nutrition labeling regulations. Earlier regulations mandated that dietary supplement labels should use a conventional food nutrition facts panel, but this process has been simplified under the DSHEA. Dietary supplement labels are required to declare an amount of a substance that is required for a Nutrition Fact Panel on conventional foods only if such substances are present in significant amounts. Doubt should be handled by disclosure. Overseeing Labeling and Literature of Dietary Supplements Section 12 of the DSHEA calls for the establishment of a commission on Dietary Supplement Labels. This commission is an independent agency within the Executive Branch that is charged with the responsibility to evaluate the regulation of dietary supplement label claims, labeling, and related literature. The defined need is to provide consumers with true and scientifically valid information so that they can make good judgments about self-management of their health. 459 The Commission of Dietary Supplement Labels will be comprised of seven members with appropriate experience and expertise. These individuals will make a final report of their activity to the President and the U.S. Congress. The commission will have a very broad charge in order to facilitate the collection of information and coordinate hearings on matter relevant to dietary supplements. Any required rulemaking that emanates from the recommendations of the Commission will have to be completed within 2 years of the submission of the report of the Commission or the final regulations on health claims for dietary supplements will be voided. New Dietary and Grandfathered Ingredients Section 8 of the DSHEA indicates that a dietary supplement that is first marketed after October 15, 1994 that contains an ingredient not sold prior to this date will be considered a new dietary ingredient. The DSHEA grandfathers all safe dietary supplements or ingredients that were sold prior to October 15, 1994. To be grandfathered, the product in the supplement must be unaltered from the form in which it existed, or there must be historic evidence that the product, when used as recommended, can be reasonably expected to be safe. In the event that a dietary supplement does not qualify as a “non-chemically altered food” but is not a new dietary substance because there is evidence of prior safe use or other relevant safety data, then the dietary supplement may move toward the market, providing that the Secretary of Health and Human Services is notified of these safety data 75 days prior to the sale of the product to a consumer. An individual or group must petition the FDA to obtain an order to permit the sale of a new dietary ingredient, but the process of the assessment of the ingredient by the FDA is likely to be stringent. 460 Other Issues Under the DSHEA, it may still not be possible to claim that a dietary supplement is a good, excellent, or rich source of a particular substance unless the Secretary of Health and Human Services has issued an authorizing regulation. This area of percentage level claims covered by the Act means that the Nutrient Contents Claim Regulations are now amended to permit statements on dietary supplement labels that characterize these percentage levels, so long as the FDA has not established a reference daily intake, a daily recommended value, or any other recommendation for daily consumption of a product or nutrient. In addition, under the Act, the Proxmire Amendment (21 U.S.C. 330) is amended to include not only vitamins or minerals but all dietary ingredients, as now defined. Section 9 of the Act covers matters related to good manufacturing practices. The FDA may issue regulations to establish good manufacturing practices for dietary supplements that are modeled after good manufacturing practices that are currently used for foods. However, the FDA may not impose standards if no analytic methods are available, and dietary supplements that are prepared or stored under conditions that do not meet current food good manufacturing practices will be considered adulterated under the Act. Section 11 of the Act declares that the advanced notice of proposed rulemaking concerning dietary supplements (58 FR 33690-33700) is declared null and void and of no effect, with a notice to be published in the Federal Register, so stating. The FDA stated its views concerning the 461 general lack of recognition that amino acids are safe and that many herbs are really drugs. In addition, the FDA has reinforced the notion in this report that upper daily intake limits exist for vitamins and minerals, primarily to avoid toxicities. Section 13 of the Act concerns the establishment of an Office of Dietary Supplements Research (ODSR) within the NIH. The purpose of the ODSR is to explore the role of dietary supplements to improve health and prevent disease. The Director of the ODSR is to conduct and coordinate research on dietary supplements and diseases and to act as an advisor to the Secretary of HHS, the Director of NIH, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the FDA with regard to dietary supplement regulations, safety, and claims. Conclusion The DSHEA has far-reaching consequences for the use of dietary supplements by consumers. FDA interpretation of the Act will be a critical element in assessing the success of the DSHEA in reaching its stated goals of providing consumers with safer, properly labeled dietary supplements that are, or may be, supported with information as to their use and benefit. To position a health food company for the future will require a team approach involving medical, scientific, and legal advice and the utilization of promotional services that are knowledgeable about the new provisions set forth in the DSHEA. On the horizon is increasing regulations, probable industry consolidation, and a rapid disappearance of those health food companies that do not have the foresight to position themselves for 462 important future regulatory issues. 463
