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Complementary and Alternative Medicine, Dietary Supplements, and Medications 1 Learning Objectives • To define complementary and alternative medicine (CAM) in relationship to conventional medicine. • To discuss characteristics of CAM users and practitioners and their implications for primary care clinicians. 2 Learning Objectives • To review research in progress on CAM modalities for common problems. • To discuss issues CAM use raises for primary care clinicians related to communication and liability. 3 Complementary and Alternative Medicine (CAM) • a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine (1) • healing therapies that typically fall outside the Western biomedical model of disease, diagnosis, and treatment (2) (1) Eisenberg 1993; (2) Drivdahl 1998 4 Complementary and Alternative Medicine (CAM) The list of what is considered to be CAM changes continually as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. NCCAM 2003 5 Major Domains of CAM • • • • Alternative medical systems Mind-body interventions Biologically-based treatments Manipulative and body-based methods • Energy therapies NCAAM 2003 6 Who uses CAM? • Surveys show marked increase in past 50 years in US and other industrialized countries (1). • Between 1990 to 1997, increase from 34% to 42% of US households reporting CAM use (2). • In 1997 in US, more visits to CAM practitioners than to all primary care providers (2). (1) Kessler 2001; (2) Eisenberg 1998 7 Who uses CAM? • Surveys of primary care clinic populations show 28-47% utilization of CAM. • 21% of patients in primary care practices reported using CAM for the same health problem for which they sought conventional care on that visit. Palinkas 2000 8 Who uses CAM? • Herbal therapy is used by 12-14% of the US population, up from 2.5% in 1990. • 16-18% of patients taking prescription medications also take herbal remedies. Kaufman 2002 9 Why do people use CAM? • Desire for health and wellness (1) • Prevention • Pain – Musculoskeletal pain accounted for 1/3 of all CAM use among primary care patients (2). – Between 60 and 94% of rheumatic disease patients use CAM (3). (1) Wolsko 2002; (2) Palinkas 2000; (3) Ramos-Remus 1999 10 Why do people use CAM? • Very few individuals rely exclusively upon alternative modalities (1). • Most individuals who use CAM do so because of preference, related to the perception that the combination of CAM and conventional treatments are superior to either alone (2). (1) Astin 1998; (2) Eisenberg 2001 11 Who practices CAM? • Wide variation in background and approach • Diversity in training programs Barrett 2000 12 Who practices CAM? • No standardization of approach to accreditation and licensure • Controversies about regulation Chez 1999 13 Who practices CAM? • • • • Some common beliefs and values The body has self-healing potential. Body mind and spirit are all important. Therapy must be individualized. People are responsible for their own healing. Curtis 2003 14 Who practices CAM? • More nonphysicians than physicians practice CAM • Increasing numbers of dual-trained MDs – American Board of Medical Acupuncture – American Board of Holistic Medicine 15 Who practices CAM? How did I get to be a “dual-trained MD”? 16 What about communication? • Between 40 and 70% of CAM users do not disclose their use to their physician. WHY? • Patients usually say that they do not report because they are not asked. Eisenberg 2001 17 Why does this matter? • The substantial overlap between use of prescription medications and herbal supplements raises concerns about unintended interactions. • Patient use of CAM is often a clue to values and preferences that need to be acknowledged. Kaufman 2002 18 How can we communicate? 1. Always ask! “What else are you doing for your health?” 2. Be open and nonjudgmental. 3. Consider patient preferences and values. 4. Encourage self-monitoring of results. Eisenberg 1997 19 How can we communicate? 5. Coordinate care as appropriate. 6. Be honest about your lack of knowledge and open to education. 7. Monitor safety and efficacy, arrange follow-up. 8. Document all discussions and advice. Eisenberg 1997 20 EBM and CAM While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies— questions such as whether they are safe and whether they work for the diseases or medical conditions for which they are used. NCCAM 2003 21 Where are we now? There is an urgent need for more and better trials of CAM therapies! There may be hope: • OAM funding FY 1992: $2 M • NCCAM funding FY 2003: $113.2 M . 22 Research in Progress NCCAM funded Research Centers Program • 12 Centers for CAM Research, each with focus on a particular condition • 4 Centers for Dietary Supplements Research • Many clinical trials in progress, for example – 18 on acupuncture – 16 on cancer www.nccam.nih.gov/clinicaltrials 23 Research in Progress Biologically-based therapies • Safety of “natural” products • Efficacy of glucosamine and/or chondroitin for pain of osteoarthritis – NIH-GAIT www.nihgait.org www.nccam.nih.gov/clinicaltrials 24 Research in Progress Mind-body approaches • Some now mainstream – Clinical hypnosis – Cognitive therapy – Biofeedback • Meditation for fibromyalgia – Transcendental meditation – Mindfulness meditation – Relaxation response Hadhazy 2000 25 Research in Progress Manipulative therapies: chiropractic • Most accepted professional therapy • Good review of safety • Current trials of effectiveness for – Chronic neck pain – Low back pain Stevinson 2002 26 Research in Progress Manipulative therapies: massage Low back pain • • Comparison with acupuncture & self-care (1) Combined with education and exercise (2) (1) Cherkin 2001; (2) Furlan 2002 27 Research in Progress Alternative medical systems: Traditional Chinese Medicine (TCM) Current trials of acupuncture for • • • • Fibromyalgia Knee osteoarthritis Repetitive stress disorder TMJ pain www.nccam.nih.gov/clinicaltrials 28 Research in Progress “Frontier Medicine Program” NCCAM initiative to encourage research on widely used CAM practices for which there is “no plausible biomedical explanation” – Energy therapies – Homeopathy – Prayer – Spiritual healing www.nccam.nih.gov/clinicaltrials 29 Where does this leave us? Many conventional treatments • have been adopted without good quality research • are costly • are invasive • are likely to have adverse effects • AND often provide inadequate relief. 30 Where does this leave us? CAM interventions generally • are low cost • are low-risk • are free of serious side effects • AND are widely used. 31 Advising patients about CAM Use evidence for efficacy safety to place therapy on continuum recommend accept discourage Weiger 2002 32 Towards Integration Liability Risks Based on Evidence • Support for safety and efficacy • Support for safety, inconclusive for efficacy • Support for efficacy, inconclusive for safety • Indication of serious risk or inefficacy Cohen 2002 33 Framework for approaching CAM in clinical situations • • • • Protect against dangerous practices. Permit practices that are harmless and that may help. Promote and use practices that are safe and effective. Partner with patients and encourage communication about CAM. Jonas 2000 34 Framework for approaching CAM in clinical situations Question: Is “permit” the right word here? Do physicians have the power to “permit” practices that their patients choose? 35 Integrative Medicine a combination of mainstream medical therapies and CAM therapies for which there is high-quality scientific evidence of safety and effectiveness NCCAM 2003 36 Integrative Medicine requires a paradigm shift from • the disease-centered approach of conventional biomedicine to • an approach in which patient values and participation of patients are central. Maizes 1999 37 Towards Integration The satisfaction that patients report from relationship-centered and individualized CAM therapies serves to remind us: We can never know with certainty what therapy- alternative or otherwise- will work for an particular patient, no matter what randomized controlled clinical trials indicate. 38 Towards Integration Our patients’ use of CAM invites us • to ask and listen to our patients, • to contribute what evidence based medicine offers, • to advocate for better evidence-based research, and at the same time • to acknowledge the existence of other types of information that may be more relevant to a given individual or for a particular situation. 39 Framework for approaching CAM in clinical situations • Protect against dangerous practices. • Permit practices that are harmless and that may help. • Promote and use practices that are safe and effective. • Partner with patients and encourage communication about CAM. Jonas 2000 40 Partner with patients and communicate about CAM • ASK! • “Build” a history that includes CAM use. (Don’t “take” one.) • When patients tell, LISTEN! Haidet 2003 41 Integrative Medicine • an opportunity to bring together strengths and balance weaknesses of different systems of health care • “a coming together of heart, head, and hand” Owen 2001 42 Integrative Medicine “Could this be a healing process in itself”? Owen 2001 43 An Integrative Approach to Complementary and Alternative Medicine in Primary Care Settings Maureen A. Flannery MD, MPH Department of Family Practice University of Kentucky College of Medicine 44 Sports Supplements Andrew Gregory, MD Assistant Professor, Orthopedics/ Pediatrics Team Physician, Vanderbilt University Jan. 10, 2002 Definition: Ergogenic Aids • Ergo = work • Gennan = to produce • Any substance or method used to enhance performance through increased energy utilization: – production – control – efficiency Classification • Drugs: – – – – – Hormones Stimulants Narcotics Diuretics B-Blockers • Supplements: – – – – – Prohormones? Amino Acids Metals Antioxidants Herbs Prevalence: • Estimated 11% of HS athletes, college, and professional. • Majority of Olympic swimmers, cyclists, sprinters, & weight lifters • 2/3 of the 1998 Tour de France teams • Billion Dollar Industry Reasons: • • • • • Have to use them to be competitive Need the edge Not genetically gifted Dissatisfaction with size/ weight Peer/ Team Pressure Hormones • • • • HGH EPO BHCG Steroids Human Growth Hormone • Normally secreted by the pituitary • Normal function of GH is growth and development of every body system, including bone and muscle • Can be stimulated by propanolol, vasopressin, clonidine, and levodopa • Synthetic growth hormone Side Effects: • • • • • • Acromegaly (may be irreversible) Peripheral Neuropathy Coronary Artery Disease Cardiomyopathy Diabetes, Hypothyroidism, arthritis No available urine test available, but banned by NCAA and IOC Erythropoietin • Hormone released by the kidneys in response to low Hct • Stimulates RBC production from bone marrow • Has recently been manufactured by recombinant DNA technique • Can increase Hct in renal patients by up to 35%, lasting up to 7 months • Used most by cyclists Blood Doping • Induced Erythrocythemia: An increase in Hb following reinfusion of an athlete’s blood • Goal: to increase the oxygencarrying capacity of Hb • Has been used as far back as 1947 • 1984: seven US Olympic cyclists guilty • Banned by IOC in 1985 Pathophysiology • Muscles depend on ATP for energy • Aerobic metabolism = breakdown of glycogen in presence of O2 >>>ATP • Aerobic metabolism-higher yield of ATP • More O2 carrying capacity>>more ATP production, more energy to muscle • 1 U PRBC>>500 ml / min increase in Methods: • Autologous reinfusion method: 2 units blood removed 4-8 weeks prior to competition & frozen c glycerol • Hb / Hct returns to pre-transfusion levels • Reinfusion 1-7 days prior to event • Can produce up to 25% improvement in endurance, with poorer conditioned athletes showing greatest benefits Side Effects: • Heterologous blood: transfusion rxn (3-10%), Hepatitis (10%), HIV (?%) • Autologous blood: bacterial infections • Polycythemia: increased viscosity >>CHF, HTN, CVA • Most young healthy athletes show no side effects Detection: • Blood doping and Erythropoietin: banned by IOC • No known urine test to detect • Testing: Measured Hct >50 • Measurement of serum Fe and Bilirubin to detect hemolysis after frozen PRBC transfusion Anabolic Steroids • The ultimate ergogenic aid aka “Juice” • Creates the Superhuman Athlete • Testosterone derivatives (cholesterol) • Produced in the adrenal/ testes Anabolic/Androgenic Steroids • Anabolism - Constructive • Catabolism - Destructive • Anabolic effects : inc. skeletal mm mass • anticatabolism • Androgenic effects: secondary sexual characteristics - pubic hair, genital size • No Pure Anabolic Steroids History of Steroids • • • • • First Available - 50’s (Dianabol) Drug Banned - 60’s Testing Initiated- ‘76 Athletes Banned - ‘83 Pan Am Games Schedule III Controlled Substance ‘90 Anabolic Steroid Control Act • US Dietary Supplement Act - ‘94 no FDA approval if no “drug intent” Administration: • Athletes may take up to 40-100x therapeutic dose (200-2000 mg/ wk) • IM adm bypasses the liver/ PO does not • “Stacking”: using various aids in combination • “Cycling” : gradual inc. then taper over 6-10 weeks, 1-3 cycles /year, “bridging” between Desired Effects: • • • • Increase in strength Increase in weight Increase in aggressiveness Increased capability of sustaining repetitive, high intensity workouts • Enhanced performance Side Effects: • CV: MI - hypertension, inc. LDL, dec. HDL, cardiac hypertrophy, thrombosis • Endocrine: virilization, testis atrophy, azospermia, priapism, prostatic hypertrophy/ CA, gynecomastia, erectile dysfct, libido • Liver : peliosis hepatitis, hyperplasia, adenoma, no carcinoma, elevated LFTs Side Effects (cont’d): • Skin: acne, hirsuitism, striae, androgenic alopecia, inc. sebaceous glands • Metabolic: hypernatremia, kalemia, phosphatemia, calcemia, “prediabetic” • Psychiatric : aggressiveness, extreme mood swings - depression/ mania, dependence, other drug use, “Reverse Anorexia” Specific Side Effects • Women (Virilzation): – Clitoril enlargement, Deepening of voice, Male pattern baldness, dec. breast size, libido • Children: – premature closure of growth plate in long bones & thus “Prohormones” • • • • Androstenedione DHEA Androstenediol Norandrostenedion e • Norandrostendiol Androstenedione • 1/2 of the “ Mark McGuire Special” • A natural steroid hormone found in all animals and some plants • Metabolite of DHEA • Precursor of testosterone • Synthesized in Adrenals/ Gonads • Metabolized in the liver to testosterone Effects: • Benefits: Same as Testosterone – Increased energy – Enhanced recovery and growth from exercise – heightened sexual arousal and function – greater sense of well-being • Plasma levels of testosterone increased from 140% to 330% of normal levels after 50mg and 100mg doses DHEA (Dehydroepiandrosterone ) • What it is: A hormone produced by adrenal gland • Claims: Anabolic effect • What is does: Increases testosterone levels • Banned by the NCAA, NFL Stimulants • • • • Caffeine Amphetamines Cocaine Ephedrine Amphetamines • Have been used as far back as WWII when soldiers used them to delay fatigue • First study in 1959 showed significant improvement in performance • Available data suggest Amphetamines can improve performance in sports where speed, power and endurance are required Side Effects: • Related to drugs’ effect on CNS: insomnia, instability, agitation and restlessness • Confusion, paranoia, hallucinations • Dyskinesias, especially in facial muscles • Cardiac complications: HTN, arrhythmias • GI disturbances Caffeine • A Methylxanthine: same class as theophylline and theobromine • Exerts its’ effects by: – Translocation of Calcium for more muscular availability – Increase in cAMP by inhibition of phosphodiesterase – Blockage of adenosine receptors, blocking the sedative properties of adenosine Caffeine (cont’d) • Is banned by IOC and NCAA in large doses • Legal limit = 15 micrograms / ml • Equal to 6-8 cups of coffee at one sitting, with testing within 2-3 hours • Beneficial most in endurance events, such as cycling • Doses up to 5 mg / kg were required to see benefits. Doses of 17 mg/kg Side Effects: • Similar to s/e of other stimulants: – insomnia, irritability, nervousness – Tachcardia, arrthymias, and possibly death! Ephedrine • What it is: Is a drug found in herbal products containing Ma haung, antiasthmatic medications, and many cold and cough products. • Claims: Increases body fat loss • What really does: Acts as a CNS stimulant, delays fatigue by sparing body glycogen reserves. Increase in B/p respiratory, heart rate, insomnia, and nervousness Amino Acids • • • • • Creatine L-Carnitine Choline Inosine HMB (B-OH-BMethylbutyrate) Amino Acids • Essential amino acids: found in a balanced diet • Recommended protein intake: 0.8 g /kg/day • Athletes may benefit from up to 1.4 2.4 g/kg/day • Most beneficial for athletes on a poor diet, or vegetarians • In endurance athletes, up to 10% of Creatine • The Other 1/2 of the “Mark Mcguire Special” - The Creatine Craze - Sales expected to reach $200 million in 1998 • Use has spread: – 13% of HS athletes – 80% of University of Nebraska football team – 50% of NFL players – Vast majority of Olympic sprinters, Creatine • Methylguanidine-acetic acid - made from glycine, arginine & methionine • Estimated Daily requirement: 2gms • Available in meats and fish (1/2 EDR) • Sold as Creatine Monohydrate • Stored in Skeletal MM • 2000 NCAA banned distribution in training rooms Pathophysiology: • Energy Substrate for muscle contraction • Creatine binds Phosphorus as substrate for formation of ATP (main source of energy of contraction) • PCr also buffers Lactic Acid • After PCr is depleted must resort to glycolysis for ATP production Benefits: • Improved performance in repeated bouts of high intensity strength work and sprints • Single sprint activity results are equivocal • Does not enhance endurance exercise • More work with less lactic acid production • No studies on competetion benefits Dosing: • Loading Phase: 20-30 gm/d, x 5 -7 days • Maintenance phase: 2-5 gm/day • Loading increases PCr stores by 1040% • Normal resting levels of creatine: 100-150 mM/kg • Most striking benefits occur in subjects with lower resting Cr level Side Effects: • • • • • Muscle Cramping Diarrhea Dizziness Dehydration Biggest danger: getting “impure” creatine • Significant WEIGHT GAIN common 2nd to water retention The Perfect Supplement? • “The secret is to find something that is effective in improving performance, but not against the rules, and with no side effects” • “…no clear evidence of harmful side effects of creatine use has emerged…”--The Physician and Sportsmedicine, June 1998 • Long term effects of Creatine not yet studied: Concerns focus on Counseling your patients • Creatine may or may not improve performance • Weight gain will occur • Side effects (especially long-term) not well known • Need to have renal and liver fct. Monitored – should not be used in patients with chronic kidney/ liver disease L-Carnitine • Synthesized in Liver/ Kidney from Lysine & Methionine • found in meats & dairy products • Assists in Fat transportation into muscle mitochondria for oxidation, sparing Glycogen & may prevent lactic acid accumulation • Improved endurance performance not shown in studies HMB • Metabolite of KIC (ketoisocaproate) which is a metabolite of leucine • Leucine & KIC found to have anticatabolic effects • decreased mm proteolysis, inc. lean mm mass, inc. strength • no known side effects Choline • Precursor for the neurotransmittor Acetyl Choline & the lipoprotein Lecithin (Phosphattidylcholine) • choline depletion in marathoners • no studies supporting Inosine • Increases myocardial contractility • no performance enhancement in runners/ cyclists Metals/ Minerals • • • • Chromium Magnesium Boron Vanadium Chromium • • • • Insulin Cofactor inc. AA uptake into mm cells increase mm mass, dec. body fat found in meats, grains, raisins, apples, & mushrooms • SE’s: anemia, chromosomal damage, cognitive impairment & interstitial nephritis in excessive doses Magnesium • Involved in ptn synthesis & mm contraction • + effects on oxygen consumption & lactate production • no change in performance Boron • Originally thought to inc. testosterone levels • not born out in studies Vanadium • What it is: Non-essential trace mineral • Claims: Anabolic effect, enhances insulin action • What it does: No studies to show anabolic effect. Doses>10gms/day causes abd. Pain, cramps, green Antioxidants • Vitamins E & C • potential damage from free oxygen radicals produced by lipid peroxidation in exercise • exercise performance is not improved Herbs • Ginseng • Yohimbe • Tribulus Terresteris • Ma haung Ginseng • What it is: A root from an Asian plant (panax ginseng). • Claims: Enhanced performance. Improved recovery rate. • What it really does: Acts as an adaptogen- may boost immune system and protect cells. May cause insomnia, and should not be used if B/p is elevated. Yohimbe • What it is: Supplement derived from tree bark. • Claims: Anabolic effect, Increased virility • What it does: Stimulant effect, no anabolic effect. Can cause nervousness, HA, nausea, Vomiting, increased B/P Tribulus Terresteris • What is it: A plant hormone • Claims: Anabolic effect • What it does: Increases testosterone levels • Banned by NFL Miscellaneous: • Bicarbinate Loading • Coenzyme Q • Linoleic Acid Bicarbonate Loading • Used prior to competition to neutralize lactic acid produced by anaerobic activities • Lactic acid>>lower pH>>fatigue • May improve runners’times if taken 30 min prior to competition : best in intermediate distances 800-1500 meter events • 300mg/kg required Conjugated (coQ10,Ubloquinone) Linoleic Acid • Produced by the body in mitochondria • claims: Enhances performance, delays fatigue, prevents injury • What really does:Functions as an antioxidant • Safe levels:60200mg/day but also$$$$$ • Naturally occurring fatty acid found in beef ,lamb and dairy • claims: decreases body fat ,increases muscle gain,antioxidant • What really does: No effect on performance References • Blue J, Lombardo J, Nutritional Aspects of Excercise: Steroids & Steroid-like compounds, Clinics in Sports Medicine, Vol 18, Num 3, July 1999, pp 667-689 • Stricker P, Other Ergogenic Agents, Sports Pharmacology, Vol 17, Num 2, April 1998, pp283297 • Agee R, Ergogenic Aids, ASMI Lecture, Nov. 99 Useful Resources • Organizations: • A) Gatorade sports science Institute 800-616-4774 • B) Herb Research Foundation 303-449-2625 • C) USOC Drug Information Hotline 800-233-0393 • Web Sites: • • • • • • FDA:http//vm.cfsan.fda.gov/~dms/aems.html U.S. pharmacopeia:www.usp.org/did/mgraphs/botanica/index.htm Dietary Supplements Reference: http://dietarysupplements.info.nih.gov USOlympicCommittee: www.usoc.org IOC: www.olympics.org NCAA: www.ncaa.org