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Nutraceuticals vs. Pharmaceuticals: Safety Considerations Cope 23905-SD Stuart P Richer, OD, PhD, FAAO Chief, Optometry Section, DVA Medical Center Associate Professor, Family and Preventative Medicine, Rosalind Franklin University of Medicine & Science / Chicago Medical School North Chicago, Illinois 60064 [email protected] Therapeutic Eyecare The therapeutic care of chronic disease should be and will be a major element of both patient care and revenue for the eyecare practice in the next decade. J. James Thimons, OD, FAAO. May 2005. Vision Institute of Canada 24 October 2009 Principles of Integrative Medicine z A partnership between patient and practitioner in the healing process z Appropriate use of conventional and alternative methods to facilitate the body's innate healing response z A philosophy that neither rejects conventional medicine nor accepts alternative therapies uncritically z Use of natural, effective, less-invasive interventions whenever possible Naturopath (ND) z First, do no harm z Employ the healing power of nature z Identify and Tx the cause z Treat the whole person z The physician is a teacher z Prevention is the best cure z Establish health and wellness Expedient “Symptom” or Disease Care Highlights – Michael T Murray, ND z US is #1 in %GDP spent on health. z We use 40 % of all worldwide medications. z 700,000 US physicians @ estimated $60,000 per year in marketing per physician. z 1992 average senior used 19.6 Rx / year. z 2005 average senior used 34.4 Rx / year. z Simple measures: 2004 2009 What is Integrative Medicine? z Integrative medicine is a healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. z It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative. z AKA: CAM (complimentary and alternative medicine). z Integrative Optometry follows these same principles. Example - Vitamin C, D and Fish oil ignored. What is a Nutraceutical? zNutraceutical can be defined as, "a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease." zHowever, the term nutraceutical as commonly used in marketing has no regulatory definition. z* “Prescription drugs are approved through the rigorous new drug application process (NDA). In contrast, dietary supplements are regulated as foods and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" •About $7 billion spent on vitamins & $31 Billion spent annually on dietary supplements, herbal foods and products. RDA = Recommended Daily Allowance-”prevent 97% of deficiencies” RDI = Recommended Dietary Intake * J Pharmacol Exp Ther. 2005 Apr 15; [Epub ahead of print] Most Common Reasons For Visiting Doctors Office (Adults Over Age 45) Coutesy Bill Sardi, Knowledge of Health Condition Very effective and doesn’t cause drowsiness as drugs can Influenza Vitamin C to point of loose stool then Many senior Americans reduce dosage 25%; vitamin D3 to don’t develop sufficient 5000 IU 1–5 days for adults; zinc up antibodies after flu shots to 50 mg (adults); astragalus 1–5 because of poor nutrition. days for adults; Echinacea, goldenseal, oregano Don’t forget to gargle with salt water Heartburn HCL hydrochloric acid and Heartburn drugs may pancreatic enzyme are secreted less cause osteoporosis due to with advancing age; replace with loss of vitamin D and supplements; if symptoms persist try fatigue due to vitamin B12 mastic gum, aloe vera depletion. Alternatives Notes Cough (bronchitis) Chewable zinc Echinacea, propolis, Vitamin C (3000–15000 mg), licorice root, eucalyptus Colds Zinc, vitamin C, olive leaf, vitamin D, garlic Sore throat (laryngitis) Same as above for colds Allergy Vitamin C to point of loose stool then cut back 25%; quercetin, stinging nettle, Antronex, with Yakriton Wheezing (asthma) Vitamin C up to dose that Lower doses for causes loose stool then prevention cut back 25%; vitamin B6, magnesium, coleus forskohlii, ginkgo biloba Nasal sinus drainage Zinc, steam inhalation, (infection) arabinogalactin, olive leaf extract Chronic Our first remedy is to thin the blood headache as increased viscosity is a primary cause in our experience; garlic oil, magnesium, fish oil, bromelain, turmeric, ginkgo, ginger, ginseng, cayenne pepper, feverfew, nattokinase See a health professional if symptoms persist. Is Diet Enough ? Bruce Ames, PhD Percent Americans Consuming 100% of the RDA, Select Nutrients 120% % Population 100% 80% 64% 60% 70% 74% 72% 69% Vit. E Vit. B6 Zn Ca 46% 40% 20% 0% Vit. A Vit. C Vitamin / Mineral J Am J Am Coll Nutr 1994; 13:285-91 Coll Nutr, 1994 “It is a distortion of priorities for much of the world's population to have an inadequate intake of vitamins or minerals—at great cost to health—when a year's supply of a daily multivitamin/mineral pill costs less than a few packs of cigarettes. The poor, in general, have the worst diets and have the most to gain from improving their multivitamin and mineral supplementation and diet,” says Dr. Ames. [European Molecular Biology Organization) Journal (6, S20–S24, 2005] Drug Class Natural remedy RDAs needs to be updated to reflect new scientific studies Antidepressants Folic acid, SAMe Blood pressure drugs, immune suppressants, bone drugs Vitamin D Penicillin Garlic clove (crushed), oil of oregano z RDA for vitamin C was based on flawed data (half Hormone replacement, hair drugs Flaxseed meal, flax lignan pills Sleeping pills Vitamin B12, melatonin Cholesterol drugs, Vitamin C, vitamin D, resveratrol Blood thinners Fish oil DHA, magnesium, vitamin E, garlic, resveratrol Calcium blockers Magnesium, vitamin D, vitamin K, arginine Beta blockers – slows heart rate ~8 beats per minute Omega-3 fish oil – slows heart rate ~6 beats per minute life of vitamin C was never calculated). Virtually all humans on the planet are vitamin C deficient. z Vitamin D is not toxic at relatively high doses and major segments of the US population are suffering from diseases related to vitamin D deficiency (cancer, autoimmune disease, hypertension, bone loss). Fortification of foods with vitamin D would likely cause cancer rates to decline by as much as 30%. z 40% of adults over age 50 experience signs of vitamin B12 deficiency (short-term memory loss, fatigue, nerve tingling) because of a decline in the production of stomach acid. KEEP IT SIMPLE Examples of Basic economical $20 per month multivitamin –mineral (sufficiently potent) and fish oil combination Stomach acid blockers (histamine blockers) Magnesium, quercetin Anti-inflammatories, pain relievers, cortisone Tart cherry, resveratrol, quercetin, SAMe Anti-allergy anti-histamine Quercetin, vitamin C Antivirals, vaccines Resveratrol, quercetin, vitamin D Basic multivitamin / mineral formulations approx $15 per month NSI Basic Synergy v #3 LEF “Two per Day” 01215 Capsules BID MedOp Whole Body 50% DOSE 1 each with breakfast / dinner www.vitacost.com www.lef.or g www.medop.co m Increasing Rx Pharmaceutical & OTC Safety Concerns www.vitacost.com 24/7 Customer Service 1-800-381-0759 z NSI 3005017 240 Softgels 4 month supply z 2 per day • • • z 800 EPA z 400 DHA z $22 Also 120 softgels NSI #3001484 Drug Induced- Nutrient Interactions (examples) Chronic use of proton pump inhibitors for dyspepsia and gastroesophageal reflex disease (GERD) can induce vitamin B12 deficiency, which may cause secondary effects on optic nerve function. Chronic or high dose acetaminophen use may induce glutathione deficiency, which accelerates cataract formation and yields myriad effects on ocular tissues. Overuse of steroids, such as dexamethasone and prednisolone, can induce deficiencies of vitamins C and D, folic acid, zinc, potassium, magnesium and selenium. COQ10 Depleters--- statins, beta blockers, metformin • • • In 2007, Americans spent around $300 Billion on FDA approved prescription & OTC drugs 700,000 ER visits for overdoses & allergic rxns each year (2005) 15,000+ died from drug reactions compared to 5,519 people in 1998 • fatalities linked to generic pain pills (oxycodone, fentanyl, morphine & acetaminophen or Tylenol) (2005) 89,482 serious side effects to the FDA • 2.5 X the 34,966 reported in 1998 More than half of all approved drugs (like Vioxx) produce serious side effects not detected prior to approval. [Journal American Medical Assn. 279: 1571-73, 1998] only 3% of prescription medicines have been withdrawn from the American market for safety reasons over the last 20 years.' Even OTC Pharmaceuticals can induce nutritional deficiencies which are often treated with additional pharmaceuticals Nutritional and Fiscal cost of Pharmaceuticals z DRUGS z 2001: $120 Billion z 2006: $200 Billion estimate z 2008 $300 Billion AVERAGE age 65 y/o z 4 medications z Growing % of healthcare budget with political aspects Consumers Report 2008 “Prescription drugs have an intended effect on the body but they may be reducing vital nutrients in your cells causing all sorts of annoying and dangerous side effects. For example, cholesterol-lowering statin drugs mug you of Coenzyme Q10, which powers your heart beat and keeps you from becoming weak, or developing leg cramps. Estrogen-containing drugs mug you of certain nutrients, leaving you hypothyroid, depressed and tired. Diabetic medications mug a certain B vitamin that protects you from stroke & heart attack. There are hundreds of medications included as well as drug-food interactions (like grapefruit, oatmeal and cheese interactions that could harm you)... “ Brand name Generic name Class Aspirin Aspirin Pain reliever Nutrients depleted Vitamin C, folic acid, iron, potassium Tylenol Acetaminophen Pain reliever Glutathione Folic acid Advil, Motrin Ibuprofen Pain reliever Lipitor Atorvastatin Cholesterol drug Coenzyme Q10 Tenormin Atenolol Beta blocker Coenzyme Q10 Zithromax Aizithromycin Antibiotic B vitamins Furosemide Uroside, Uritol Diuretic, blood pressure Minerals, Vitamin B1, vitamin C, zinc Amoxycillin Amoxil, Biomox, Trimox Antibiotic B vitamins, acidophilus, inositol, vitamin K Hydrochlorothiazide Hydrodiuril, Esidrix Diuretic, blood pressure Minerals, Vitamin B1 Prilosec Omeprazole Heartburn drug Vitamin B12 Prevacid Heartburn drug Vitamin B12 Zocor Simvastatin Cholesterol drug Coenzyme Q10 Cephalexin Keflex Lansoprazole Antibiotic B vitamins, vitamin K Glucophage Metformin Diabetic drug Folic acid, vitamin B12 Vioxx Rofecoxib Pain reliever Folic acid Zestril Lisinopril Blood pressure Zinc Prempro Estrogen-progesterone Hormone replacement Folic acid, magnesium, zinc, Vitamins C, B2, B6 Prednisone Deltasone, Orasone, Prednicen Anti-inflammatory Minerals, folic acid, vitamins C&D Toprol XL, Lopressor Metoprolol Beta blcoker Coenzyme Q10 Pravachol Pravastatin Cholesterol Coenzyme Q10 Coumadin Warfarin Blood thinner Vitamin K Cipro Ciprofloxacin Antibiotic B vitamins, acidophilus Lanoxin Digoxin Heart drug Minerals, vitamin B1 Flonase, Flovent Flutacasone Asthma Minerals, folic acid, vitamins C & D, zinc Teach patients about food 14 SuperFoods ® z Spinach z Sardines z Turkey Breast z Broccoli z Walnuts z Tomato z Soy Blueberries Citrus Pumpkin Yogurt Oats Legumes Green Tea The FDA against the USDA & 29 Cherry Marketers (Oct 2006) “Eat 9 – 13 portions of Fruits & Vegetables per day” “20 cherries reduces inflammation in a similar manner as aspirin or Cox-2 inhibiting drugs without the lethal side effects of gastric bleeding or vitamin depletion associated with these drugs” The molecules in cherries, called anthocyanins, work to reduce inflammation at ten times less dosage than aspirin. [Journal Natural Products 1999 Feb; 62(2): 294–6] Daily sunlight and/or 1000 IU vitamin D daily also is very important for general health BRITAIN: Cherrios – 12 May 2009 z FDA questions General Mills' Cheerios marketing z Triangle Business Journal - by Joey Peters Minneapolis/St. Paul Business Journal z The FDA told General Mills to stop promoting Cheerios, the country’s best-selling cereal, as a product that can lower cholesterol levels, reduce heart disease and reduce the risk of cancer. The agency said that claiming the cereal can lower cholesterol levels by 4 percent in six weeks amounts to marketing it as a drug and violates the federal Food, Drug and Cosmetic Act. Warning letter threatening regulatory action if scientific “drug like” claims are not removed from the web. Tea Council under fire z Sept 26, 2007 - The UK Tea Council has been criticized for exaggerating the benefits of tea and banned from making further claims about the drinks antioxidant potential after running a series of adverts. The group came under fire after five people complained to the Advertising Standards Authority (ASA) about a media campaign which recommended drinking four cups a day as part of a healthy diet. z In a prepared statement, General Mills (NYSE: GIS) said the complaint doesn’t question whether the cereal actually lowers cholesterol levels and said the dispute is over language, not science. z “The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the heart health claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong,”. “We look forward to discussing this with FDA and to reaching a resolution.” z Cheerios boxes say that two, one-and-a-half-cup servings of the cereal every day have been clinically proven to lower cholesterol. The message has been on the box for more than two years. z ……despite the UK Tea Council (UKTC) submitting nearly 100 scientific studies backing up tea's health potential, the ASA said it had not seen evidence to "firmly substantiate" any health benefit in drinking four cups of tea per day and said the campaign "exaggerated" the health benefits. z …..under regulation (EC) No 1924/2006, which came into force in the UK from 1 July 2007, any food product claiming to have a health benefit must meet a list of European Commission approved wording and be supported by scientific evidence. Patients need better nutrition and higher doses of vitamins as they age * z z z z Mal-absorption including gastric hypo-chlorhydria occurs with age, disease and use of acid blockers. As we age, the ubiquitin system (Nobel Prize 2004) becomes less efficient due to free radical attack and glycosylation. We have accumulated more free radical DNA hits with less efficient repair. We become increasingly cross-linked and rigid due to carbonyl and glycosylation end products. CODEX 2005 z The international “harmonization” of foods including vitamin and mineral dosage in supplements. The FDA will abide unless it breaks US law. z United Nations Codex Alimentarius Commission z Several committees z Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNSFDU). z The meetings are open to delegations from all over the world and as well as non-governmental organizations such as the Council for Responsible Nutrition (CRN), the National Health Federation (NHF) and the American Holistic Health Association (AHHA). * Vitamins for chronic disease prevention in adults: scientific review. (JAMA. 2002 Jun 19;287(23):3116-26.) While the media creates “nutri-phobia” Multivitamins Oral Contraceptives Insulin Diuretics Cough & cold preps Review 145 (3) Issue 3/14/08 Aspirin Acetaminophen Antidepressants Adverse Reports 2811 9948 1686 7710 97710 5249 28991 92675 # of deaths 0 1 8 10 14 14 63 255 Comparative Safety of Multivitamins Am J Emergency Med 20: 391-452, 2002 Taking an aspirin every day is nearly as risky as working as a firefighter. z For 50-y/o men, taking a daily aspirin (which many do to help prevent heart disease and strokes) increases the risk of death by the equivalent of 10.4 deaths per 100,000 men per year. z Similar to the added risk that professional firefighters face. Firefighters have an added risk of 10.6 deaths per 100,000 people per year, compared to 3.9 for all occupations and 0.4 for office workers. z In comparison, drugs that have been withdrawn from the market, such as the painkiller Vioxx and the multiple sclerosis drug Tysabri, increased the risk of death by 76 deaths per 100,000 people per year and 65 deaths per 100,000 people per year, respectively. Tysabri may be reintroduced to the market if the FDA deems it worth using despite the risks. z Adverse drug events harm more than 1.5 million people and kill several thousand a year, costing at least $3.5 billion annually. (Institute of Medicine 2006) Anti-Dietary Supplement Propaganda Campaign Witch hunt (definition): An investigation carried out ostensibly to uncover subversive activities but actually used to harass and undermine. “often unsafe ?” Health Affairs, Vol. 26, No. 3, May/June 2007: 636-646 Government Sources on Herbs and Vitamins All 29,000 dietary supplement products American Association of Poison Control Centers data z 600 US manufacturers z 1000 more products each year z Use in older patients: 44% in 1980; 55% by 1994, and 63% by 2000. z In Europe, supplements like ginkgo biloba, kava kava, bilberry and even a citrus fruit extract for hemorrhoids, are all prescription drugs. z 23 yrs of poison control center adverse events: 1.6 million adverse rxns & 230 deaths (approx 12 per year). Most are ephedra diet products Guilt by association in aging Americans ? z Supplement Manufacturers are now required By Law to notify the FDA of adverse events (not drug manufacturers)Spanking the Wrong child ? z National Library of Medicine Medline Plus http://www.nim.nih.gov/medlineplus/druginformation.html z National Center Complementary / Alternative Medicine http://ncam.nih.gov z Office of Dietary Supplements http://dietray-supplements.info.nih.gov z The Center for Disease Control & Prevention http://www.cdc.gov/nutrition/everyone/basics/vitamins Certification Services zwww.usp.org zwww.nsf.org zwww.informed-choice.org zwww.ConsumerLab.com USA Dietary Patterns (1890-2009) z High simple carbohydrate consumption z z z z z Soda -3.5 cans/day (only 25 % diet) - started in 1890 White Flour Baked goods - started in 1890 Potatoes - French Fries as #1 “vegetable” Low Fruit & Vegetable (micronutrient/fiber) consumption 20:1 imbalance W6:W3 fatty acids 5-10 % calories from trans fats Grain-fed & fattened cows, pigs, chickens -and stable, (perhaps slightly lower %) saturated fat consumption Progressive increase in calories to 3700/capita in 1990s (fast food , meal super-sizing and nocturnal 24/7 eating) Herbs et al z Ginkgo biloba is associated with bleeding but researchers could not reproduce these same side effects in animals or humans even at blood concentrations 100 times greater than the recommended dosage for ginkgo. (Phytomedicine 12:10-6 2005; Blood Coagulation Fibrinolysis 15: 303-09, 2004). z Glucosamine triggers a rise in blood sugar among healthy adults in two separate studies Couldn’t reproduce this problem. (Osteoarthritis Cartilage 12: 506-11, 2004; Archives Internal Medicine163:1587-90, 2003). United States: The Revis family of North Carolina Food expenditure for one week: $341.98 “Modern Nutrition” and Ocular Disease Bhutan z Excess Macronutrients & Low Micronutrients Obesity and increased risk of CVD, HTN and +/- CANCER Obesity and increased risk of AMD & CATARACT Obesity, Diabetes and increased risk of RETINOPATHY Obesity and increased inflammation Insufficient Nutrition induced by average plant food consumption of only 3 servings/day induced by individual pharmaceuticals & poly pharmacy induced by an RDA for ascorbic acid that is too low induced by recommendations to avoid fish – omega III induced by recommendations to avoid sunlight – vitamin D Induced by mixed media messages and “nutri phobia” Mal-nutrition examples -- TRANS fats from corn & vegetable oils -- high fructose corn syrup (methylglyoxal) -- aspartame -- MSG z z z z z z Anatomy of www.MyPyramid.gov History of USDA’s Food Guidance Food for Young Children 2005 for Americans (over age 2) One Size Doesn’t Fit All 1992 z Activity 1916 1940s z Moderation 1970s z Personalization z Proportionality 2005 z Variety z Gradual Improvement Age ; Gender ; Activity; 12 tailored diet plans 1950s-1960s Supplements Common Misconceptions z Herbs/Vitamins are completely safe z Herbs/Vitamins are ineffective z More is better – potential high dose issues Vitamin E Beta Carotene Calcium Selenium Omega III Subconjunctival Hemmorhage 10 Questions z ValSalva ? Constipation Vomiting Coughing Straining z ASA or Coumadin ? z High Dose Vitamin E ? z High Dose Fish Oil ? z Ginkgo Biloba, Ginseng ? Reversible Minor Side effects z Diarrhea from vitamin C z Loose stools from magnesium z Finger tingling from megadose Vitamin B6 z Flushing from niacin z Reversible discoloration of skin from B carotene Caution Required z Vitamin K with Coumadin ? z Combining blood thinning agents Coumadin, Heparin ASA Vitamin E (above 1100IU) Fish oil above 2 grams Ginkgo biloba, ginseng z Riboflavin above 10mg (photosensitizer) z FE++ (iron) z Herbal Steroids / Body Building Supplements Discriminately READ Scientific Studies z Types of Studies – don’t discount multiple z z z z z z observations, but look at Power Calculation Bias – “follow the $” * Absolute Risk - pay close attention to this one Relative Risk – “ where’s the beef ” Odds Ratios - look for statistical significance Significance - is p = 0.06 worthy of our attention? Meta-analysis – was there selective inclusion ? Bias is still possible z Do conclusions understate or overstate the data ? z “Made in America” bias Is academic medicine for sale ? “No, the current owner is very happy with it” 1. Why are you prescribing this drug? 2. Are there older & safer less expensive drugs ? 3. Is a drug needed at all for this mild case? Marcia Angell, MD former Chief Editor , NEJM "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (Random House, 2004). How do we avoid “Disease Mongering” ? Relative risk or “Sleight of Hand” includes turning ordinary ailments into medical problems, seeing mild symptoms as serious, treating personal (i.e. Headline “Cholesterol-lowering statin drugs lower the risk for a heart attack by 30%”) problems as medical, seeing risks as diseases & framing prevalence estimates to maximize potential markets. A recent report in the Columbia Journalism Review of the news media’s complicity in drug marketing http://www.cjr.org/issues/2005/4/ lieberman.asp notes that noted medical journalists chose not to warn the American public of the potential dangers posed by Vioxx because pharmaceutical advertising is now a primary source of income for television and newspapers. Selling sickness: the pharmaceutical industry and disease mongering: British Medical Journal, Volume 324: 886-91, April 13, 2002 z A naïve reader would get the false impression that these drugs will result in 30 fewer heart attacks per 100 statin drug users z Let’s say heart attacks occur among 3% of 1000 patients over 5 years -- that would amount to 30 heart attacks. z A 30% relative risk reduction of 30 would be 9 less heart attacks (21 total over 5 years). z That’s 2 heart attacks that were prevented every year among 1000 statin drug users, or just 0.2% difference (2/10ths of one percent) between users and non-users of statin drugs. z Some 1,825,000 statin pills would be consumed to prevent 9 heart attacks – but not 9 lives saved. z 4 statin drug trials 67 of 7065 (0.948%- 9/10ths of one-percent) statin drug users died 102 of 7054 (1.446% - nearly 1½ of one percent) who did not take the drug *An absolute difference of 0.498% (1/2 of one percent, absolute difference). [British Medical Journal 323: 1-5, 2000] Figure 2a. Observational Studies HOPE (Heart Outcomes Prevention Evaluation) Vitamin E Meta analysis Odds Ratios, Vitamin C studies C and Nuclear on Vitamin Cataract OR or RR 1.31 1 1.00 0.48 0.56 0.62 0.70 1.00 NA NA 0.75 NA 0.90 0.70 0.54 0.80 0.54 0.40 0.32 0.31 0.30 INTAKE Lyle et al. (1999a), Beaver Dam Eye Study SUPP Leske et al. (1998), Longitudinal Study of Cataract INTAKE, SMOKERS Lyle et al. (1999a), Beaver Dam Eye Study Supplement duration, FEMALE; No association Jacques et al. (2005), NVP Intake form food and supplement, FEMALE; No association Jacques et al. (2005), NVP SUPP, FEMALE Jacques et al. (2001), NVP SUPP, NON-DIABETICS Mares-Perlman et al. (1994), Beaver Dam Eye Study 0.10 SUPP, FEMALE Jacques et al. (1997), NVP SUPP, FEMALE Jacques et al. (1997), NVP PLASMA, FEMALE; No association Jacques et al. (2005), NVP PLASMA Ferrigno et al. (2005), Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract (CTNS) PLASMA Vitale et al. (1993), Baltimore Longitudinal Study on Aging PLASMA Gale et al. (2001) PLASMA Italian-American Cataract Study (1991), Italian-American Cataract Study BLOOD Valero et al. (2002) PLASMA, FEMALE Jacques et al. (2001), NVP INTAKE, FEMALE Mares-Perlman et al. (1995a), Beaver Dam Eye Study INTAKE Cumming et al. (2000), Blue Mountains Eye Study INTAKE Valero et al. (2002) INTAKE, MALE Mares-Perlman et al. (1995a), Beaver Dam Eye Study INTAKE, FEMALE Jacques et al. (2001), NVP INTAKE Leske et al. (1991), Lens Opacities Case-Control Study 0.22 0.1 JAMA 293:1338-47, 2005 prospective retrospective 10 Chiu CJ & Taylor A, Nutritional antioxidants and age related cataract and maculopathy, Exp Eye Res July 2006. Safety: “Dose is the poison” z 19 studies, 135,000 people z “400 IU increased risk of dying by 4%” z What researchers claimed was that high-dose vitamin E increased the risk of heart failure by a whopping absolute 1% risk among people who took three drugs that induce heart failure (diuretics, statin drugs and beta blockers). The vitamin E got blamed for the problem & worse yet the researchers eliminated studies where there were no deaths and 2 studies with 2000 IU that showed a decrease! z 12% reduction in death in AREDS z 34% reduction in MIs & 49% reduction for high risk females over age 65 in the Womens Health Study, JAMA 294: 56-65, 2005 Antioxidants & All Cause Mortality Meta-analysis of 68 randomized trials, n=232,606 Goran Bjelakovic, MD, Copenhagen University Hospital in Denmark. JAMA. Feb 2007;297:842-857. z Safety of antioxidant vitamins and B carotene, Am J Clin Nutr 1995;62(suppl): 1510S-6S. z Safety of antioxidant vitamins. Arch Intern Med 156: 925-35, 1996. z Meta-analysis of 68 randomized trials, n=232,606 Goran Bjelakovic, MD, Copenhagen University Hospital in Denmark. JAMA. Feb 2007;297:842-857. Relative Risk for All-Cause Mortality With Antioxidant Vitamins Trials/Agent All trials- all agents Low Bias Trialsall agents Beta carotene Vitamin A **Vitamin E Relative Risk of Mortality 1.02 1.05 95 % CI 0.98 - 1.06 ns 1.02 – 1.08 1.07 1.16 1.04 1.02 – 1.11 1.10 – 1.24 1.01 – 1.07 High dose Vitamin A and Acutane® should be avoided by women who might become pregnant, patients with liver disease and those who drink heavily. B Carotene Contraindication for SMOKERS ATBC Trial z 18 % more lung cancers were diagnosed and 8 % more overall deaths occurred in participants taking 20 mg B carotene daily. N Eng J Med 330:1029-35, 1994. However vitamin A from B Carotene is produced on an “as needed” basis. Consider the issue of competition with D, another fat soluble vitamin, when talking about the bone mineralization issue. ß-Carotene - Intervention Studies increased risk increased risk 4 a) ß-Carotene 100 50 0.01 no effect preventive effect Linxian (20 mg/d) +Toc/Asc (15 mg/d) +Toc/Se 1 10 PHS CARET (50 mg/2d) (30 mg/d) +Retinol ATBC (20 mg/d) 150 100 50 0 0.01 0.1 1 10 Carotenoid (nmol/ mg cellular protein) 100 %= UV-induced TBARS-formation in controls without carotenoids: 1.4 ± 0.2 nmol MDA/mg protein (n=14) c) Lutein 95%ile U.S. HPS 0.1 Carotenoid (nmol/ mg cellular protein) no effect 2 b) Lycopene 150 0 TBARS (% control) Carotene Plasma Levels at the End of the Study (µmol/L) carotox1.jnb 6 Carotenoids and UV-induced TBARS formation in skin fibroblasts TBARS (% control) Slide: Helmut Sies,PhD University of Duesseldorf CARET z After 4 years, there were 28 % more lung cancer deaths and 17 % more deaths in participants taking 30 mg B carotene daily. N Eng J Med 334:1150-5, 1996. TBARS (% control) Beta Carotene 150 Eichler et al (2002) Photochem. Photobiol 75, 503-6. 100 50 0 0.01 0.1 1 10 Carotenoid (nmol/ mg cellular protein) Slide: Helmut Sies, University of Duesseldorf The predictive power of coronary artery CA++ scores Calcium z Heartbeat, nerve conduction, hormone secretion, z z z z z z z z blood clotting & skeleton (osteoporosis 4x more common in females) Are Americans over-calcified ? Arterial plaques are 50% calcium but only 3% cholesterol. Unwanted soft tissue deposition. Not balanced by Magnesium Aortic valve calcification and decreased elasticity and rising systolic BP Kidney stones Mitral valve defects Bruchs membrane calcifies with age S Seeley, International J Cardiology, 1991;33:191-8 z Among subjects whose coronary artery CA++ score was zero, the risk for any adverse coronary event was only about one-half of 1% (0.0044), or less than 1 in 200. z Those with a coronary CA++ score over 300, about 8.0% experienced an adverse event involving coronary arteries (0.0804), or about 8 in 100, an 18-fold difference (1800% !), over the 3.8 year period. University of Auckland Study, Sept 2007 CA++ link to heart attacks z N=1500 postmenopausal females z Placebo or 1000mg calcium to prevent ….For bone health, think about adding magnesium & boron (besides vitamin D) to simple calcium supplementation osteoporosis over 5 years z 36 heart attacks for calcium users’ z 22 heart attacks for placebos z * 3 smaller international studies had similar results 200 ug Selenium & increased risk of DM II z N=1202; self report of DM z National Prevention of CA trial z The claim is that, after 7.7 years of use, a 200 microgram selenium supplement increased the risk for diabetes by 50%. z A large long-term study reported in 1994 that the same dose of selenium resulted in a dramatic decline in cancer incidence z Mechanism: There is animal data showing that selenium, which helps to produce an antioxidant enzyme called glutathione peroxidase, may trigger over-expression of this enzyme which could possibly increase the inability of insulin to enter cells (called insulin resistance). 9.7% Flaws in this 10 yr post hoc study originally designed to look at cancer z The NP CA study was not designed to look at diabetes 6.5% ABSOLUTE STATS Self-reporting of DM z Limited data for analysis No diet or medication data z Ignored + CA findings (1 sentence in article) SE reduced deaths from prostate cancer by 63%. SE reduced deaths from colorectal cancer by 58%. SE reduced deaths from lung cancer by 46%. Effects of Long-Term Selenium Supplementation on the Incidence of Type 2 Diabetes: A Randomized Trial. Annals of Internal Medicine: 21 August 2007, 147(4). ORGANS with FAT Essential Fats for Thought and Health z Intelligence and breast feeding to 4 mo; 1st born and zBRAIN & RETINA zBREAST zPROSTATE z z z z z z z z z z z maternal DHA; visual acuity ADHD Depression: USA vs. Japanese elderly Mental disorders i.e. schizophrenia/ 3 studies Alcoholism- destroys DHA Postpartum depression Impulsive violent behavior Type A vs. Type H (Hostility) and MI Eczema and psoriasis Rheumatoid Arthritis AMD DRY EYES Omega 3 fatty acids 1. Diminish inflammatory tear components & meibomian gland dysfunction. 2. Augment the lipid component of the tear film (prevent evaporation). 3. Indirectly stimulate lacrimal tear secretion. IS THERE ANOTHER WAY TO TX DRY EYE ? ----or---IF THE WHOLE HOUSE IS ON FIRE, WHY SEND THE FIRE DEPARTMENT ONLY TO THE BARN ? Is dry eye an indicator of systemic essential fatty acid deficiency ? Fish oil & Coagulation Status Warfarin is an oral anticoagulant used to control and prevent thromboembolic disorders. The dose is adjusted to maintain the patient's prothrombin time (PT) international normalized ratio (INR) within a recommended therapeutic range. z CASE REPORT Ann Pharmacother. 2004 Jan;38(1):50-2. Omega-3 fatty acids may lower thromboxane A(2) supplies within the platelet as well as decrease factor VII levels. Although controversial, this case report illustrates that fish oil can provide additive anticoagulant effects when given with warfarin. CONCLUSIONS: This case reveals a significant rise in INR (2.8 to 4.3) after the dose of concomitant fish oil was doubled (1 g to 2g) . Patients undergoing anticoagulation therapy with warfarin should be educated about and monitored for possible drug-herb interactions. z STUDY: J Thromb Thrombolysis. 1998 Jul;5(3):257-261. Effects of Marine Fish Oils on the Anticoagulation Status of Patients Receiving Chronic Warfarin Therapy….. “Fish oil supplementation in doses of 3-6 grams per day does not seem to create a statistically significant effect on the anticoagulation status of patients receiving chronic warfarin therapy”. Current atrophic AMD intervention z z z z z z z z z z z z Decrease smoking Avoid obesity Exercise Avoid exposure to bright sunlight (blueblockers-yellow tint) Increase plant food (spinach) consumption Follow www. MyPyramid.Gov & SuperFoods Rx book by Steve Pratt, MD ……… 1 egg every day is a good source of lutein Avoid or control hypertension. Avoid high Fe(II) intake; give blood 3x/year (Lutein based multivitamin/multimineral) Omega 3 fatty acids A glass of red wine and blueberries. Soy (genistein), oranges, bananas & vitamin D against neovascularization (wet AMD) Intellectual Morons 1. Admit they read only 4 journals 1. (i.e NEJM, AMA, Annals Inter Med, Lancet) Don’t have time to research material that would improve a patient's care 3. Would be so obstinate and filled with so much self-importance they would allow a patient to die rather than try something that had strong clinical evidence of benefit without any complications 2. Benefits of offering Ocular Nutritional Counseling z Solving the patient’s main problem z Enhanced understanding of the patient’s overall health z Bringing patients back to the office frequently z Better from you than the health food store clerk z Enhanced reputation