Objectives. Herbs Definition. Buyer Beware! Montgomery; CAM-Herbals 11/30/2009. Herbal Practice: Knowledge and Precautions

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1 Herbal Practice: Knowledge and Precautions November 6 th,2009 Christopher Kit Montgomery MD, MS Professor of Anesthesiology, Pediatrics and Pharmacology University of Kentucky College of Medicine Objectives Definitions Demographics, scope of use, regulation The ephedra scare and other herbals What are your medico legal obligations Resources for managing patients Herbs Definition Nutraceutical diet supplements delivering bioactive ingredient from food in nonfood matrix, to enhance health in ways that could not be obtained from normal food Herb any part of a plant, algae, lichen or fungus or preparation thereof used for therapeutic purposes CAM (Complementary and Alternative Medical Therapy) Acupuncture Chiropractic Diets Herbals Homeopathy Hypnosis Massage Mega vitamins Nutrition supplements Naturopathy Relaxation Self help groups Spiritual healing Yoga Buyer Beware! Lack of FDA regulatory oversight. Classified as dietary supplements by the Dietary Supplement Health & Education Act (DSHEA) in Someone must die before the FDA can do something Jessie Leak, M.D. Some evidence based medicine: Efficacy? Dose? Bioavailability? Toxicity? Under DSHEA, herbal manufacturers can label their products for support of structures/functions of the body but not for disease rx (e.g. promote vascular health or enhance mood rather than decrease blood pressure or treat depression). 1

Herbal/Complementary Alternative Medicine (CAM) is Growing State Medical Society subcommittees; CAM Centers at major Medical Universities/Hospitals.

2 Buying Herbals Up to 30% of herbal remedies may have contaminants (lead, arsenic, sawdust, NSAIDS, other herbs etc.) ConsumerLab.com independent testing of preparations for purity, advertised dose, other problems. Look for the seal. Herbal/Complementary Alternative Medicine (CAM) is Growing State Medical Society subcommittees; CAM Centers at major Medical Universities/Hospitals. Third party reimbursement for CAM therapies increasing (MD referral usually required) NIH Center for CAM (NCCAM): 125 million budget for 2009 UK Chandler Medical Center CAM Project Five year NIH funded grant Bill Elder, PhD Dept.of Family Medicine Principal Investigator Purpose: Integrate CAM knowledge and interdisciplinary care skills into existing curricula Courses involved to date: Healthy Human, Family Practice Clerkship, Advanced Clinical Pharmacology and Anesthesiology Herbals 20,000 available Consumed for centuries. Currently accounts for 75% of healthcare worldwide Remember: morphine from poppy, digitalis from foxglove, vincristine from periwinkle 30% use CAM; 70% don t tell MD in USA 5 6 billion/yr industry in USA; (CAM 50 billion/yr) Herbals users more likely to be years old Female C ll d t d College educated Earn > $50,000/yr 2

3 Natural Medicines Comprehensive Database Eds: JM Jellin, F Batz, K Hitchens Evaluated 964 nutraceuticals 46 effective; 72 likely effective 500 unclassifiable due to lack of data 15% safe 30% unsafe Ephedra Seneca (Ma Huang) Contains ephedrine. Claims: rx URI, flu, HA, arthritis, asthma, also OTC diet preparation. Side effects: HTN, tachycardia, cardiomyopathy, dysrhythmias, seizure, psychosis, death. Case reports of DEATH: hypertensive crisis with MI and/or CVA. FDA ban on sales since 4/13/04. Echinacea Echinacea URI S Daisy family Stimulates immune system; avoid with autoimmune disease, HIV, atopy Unpleasant taste; hepatotoxic URI: limited data suggests it may limit symptoms but not prevent common cold 5 controlled studies; 4 German literature, 1U.S. 1 suggested it helps with symptoms, but echinacea preparation had other herbs. NET: very limited data suggests it may limit severity and duration of URI but not prevent URI Garlic Allin Allicin via Allinase Efficacy Hypertension: no effect Hypercholesterolemia: 93 study 9% decrease; 00 randomized controlled trial no effect Flavor: sure Decreased platelet function; spinal/epidural hematoma case report Ginkgo Biloba 1997 sales = 240 million dollars Antioxidant, circulatory stimulant Side effects: GI upset, HA, antiplatelet effect case reports of hyphema, SAH, subdural hematomas Leaf and seed neurotoxic, epileptogenic 3

4 Ginkgo Biloba RCT: potential improvement of claudication symptoms Peters et al Vasa 27(2) 1998 RCT: stabilization and measurable improvement of cognitive performance and social functioning in dementia patients LeBars et al JAMA RCT: no help in reducing dementia or Alzheimer s onset DeKosky et al JAMA 300 (19) 2008 Ginger Treatment of nausea, vomiting, motion sickness, vertigo RCT: antivertigo effect Grontved et al J Otolaryngol Superior anti motion sickness versus dimenhydrinate Holtman et al Acta Otolaryngol Improved gastric emptying and motility in pregnancy Wu et al Eur J Gastroenterol and Hepatol Inhibits thromboxane synthetase therefore prolonged bleeding time Ginseng Ginseng Active compound: ginsenoside (may augment adrenal steroidogenesis) Many claims: boost energy, anti aging, aphrodisiac, treat cancer and DM Effects documented: hypoglycemia, HTN, hypotension, CNS stimulant or depressant, epistaxis, HA, vomiting Caution when used in diabetics Decrease INR in patients on warfarin Possible anti platelet effect St. John s Wort Used for depression, anxiety and sleep disorders MOA: inhibits GABA receptors; may inhibit serotonin reuptake One meta analysis suggests effective for mild/moderate depression. Recent Duke Study not efficacious. Side effects: xerostomia, fatigue, dizziness, photosensitivity, nausea, constipation, serotonergic syndrome with SSRI s Saw Palmetto From dry ripe berries of saw palmetto palm tree Benefits micturition in men with benign prostatic hypertrophy Wilt et al., JAMA 280:18 Nov 11,1998 Unproven folklore: increased breast size, sperm production and sexual vigor Few side effects or drug interactions reported 4

5 Glucosamine Endogenous aminomonosaccharide Important in biosynthesis of cartilage building blocks (proteoglycans & glycosaminoglycans) May promote formation and repair of cartilage and may have anti inflammatory effects RCT of 202 patients showed less knee joint space narrowing on 1500 mg/day Arch Intern Med 2002;162:2113 RCT of 1583 patients showed no benefit from glucosamine/chondroitin therapy NEJM 2006; 354: 795 Herbals Drug Interaction Examples St John swort: lower digoxin levels 25%; lower HIV retrovirals; cyclosporin interaction; potentiates tetracycline photosensitivity Echinacea: potential hepatotoxicity with anabolic steroids, methotrexate, amiodarone, acetaminophen Herbals Drug Interaction Examples Ephedra: glycosides or halothane arrythmias; monoamine oxidase inhibitors or antidepressants hypertension Garlic, Ginger, Ginkgo, Ginseng: increase bleeding in patients on warfarin and other anti coagulants. Potential Physician Malpractice Liability Associated with Complementary and Integrative Medical Therapies Cohen and Eisenberg Ann Intern Med. 2002;136: CAM Safety and Efficacy: Four Categories of Malpractice Liability 1. Safe and efficacious (chiropractic or acupuncture for low back pain) Liability: VERY LOW 2. Efficacious but safety inconclusive (chondroitinfor osteoarthritis) Liability: LOW 3. Safe but efficacy inconclusive (massage for low back pain) Liability: POSSIBLE 4. Inefficacy or safety risk (inattention to ginkgo / warfarin interaction) Liability: PROBABLE Ann Intern Med 2002:136 Chondroitin for osteoarthritis Liability Low Safety Inattention to Ginkgo/warfarin interaction Liability Likely Efficacy Acupuncture for LBP Liability Very Low Massage for LBP Liability Possible Annals Int Med 2002: 136 5

6 Liability Strategies for Offering CAM Treatment Determine clinical risk level. Document literature supporting CAM treatment. t t Provide adequate informed consent If possible, obtain written agreement Continue to monitor patient conventionally. Ann Intern Med 2002:136 Herbal Use at UK Hospital? No endorsement if no established evidence. Initial RN assessment about use. If warranted, independent practitioner (with pharmacist and dietician prn) must determine safety, efficacy and dosage. If OK, patient supplies own product as directed by M.D. Only rarely will UK pharmacy dispense an herb Herbals: Educational Resources taryandalternativemedicine.html Herbals: Educational Resources Herbals: Educational Resources Herbals: Take Home Messages Text: Natural Medicines Comprehensive Database, phone: Text: ExpandedCommission E Monographs. Blumenthal M, ed. American Botanical Council, Text: PDR for Herbal Medicines 4 th Edition. Greenwald J, ed. Thomson Healthcare Inc., 2007 Natural doesn t mean safe What are your patients taking? Very little evidence based medicine Very little evidence based medicine No FDA regulation Discontinue herbals 1 2 weeks before procedure 6

Chapter 11. Major Characteristics of CAM. Research. CAM Healing Methods. Complementary and Alternative Medicine (CAM) CAM Healing Methods (continued)

Chapter 11. Major Characteristics of CAM. Research. CAM Healing Methods. Complementary and Alternative Medicine (CAM) CAM Healing Methods (continued) Chapter 11 Herbal and Alternative Therapies Complementary and Alternative Medicine (CAM) Considered outside mainstream health care Upper Saddle River, New Jersey 07458 All rights reserved. Major Characteristics