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Herbs and Health: Real World Basics Leslie Shimp, PharmD Professor College of Pharmacy Asst Prof of Pharm, Dept of Family Medicine Suzanna M. Zick, ND MPH UM Integrative Medicine Research Invest, Dept of Family Medicine Historical Context Physical evidence dates back 60,000 years All cultures have traditions of herb use for healing 2000 BC - First known materia medica in Sumeria 1st Century AD - Chinese Materia Medica Cultural Context In China, 40-50% of meds used are traditional herbs In Africa, 80% of population uses herbal medicine for primary care In Germany, 90% of adults use herbs in lifetime Ethnic populations in US very likely to be using herbs 25% of prescription drugs from plants Context Herbalism Traditional Healers – Native American, Ayurvedic, Tibb, Unani, Tibetan, etc Traditional Chinese Western Folkloric Western Scientific Earth-centered Ethno-botanical Example categories from the American Herbalist Guild Expertise – Who has it? Consumer/patient Clerk in store Herbalist – what tradition? How certified? Chiropractor (DC) Nutritionist (RD) Pharmacist (PharmD, PhD) Naturopathic Doctor (ND) Board Certified Holistic Physician (MD, DO) Fellowship-trained Integrative Physician Evidence Traditional use Basic science Clinical science Traditional use Often based on hundreds to thousands of years of observation 60-70% of traditionally used herbs are pharmacologically active German Commission E Traditional preparations Infusion - flowers and leaves steeped in hot water, ie, teas Decoction - bark, roots or seeds boiled in water Tincture – extraction with alcohol or vinegar or glycerin and water More preparations Capsules – dried and ground herbs in a gelatin or vegetable capsule – dried extract of plant part Salve - an oil and beeswax/lanolin mixture used topically Basic Science Mechanism of action Pharmacokinetics, etc Toxicity Often done AFTER clinical studies Clinical Science Federally funded studies 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Echinacea Ginseng Gingko biloba Garlic SJW Peppermint Ginger Soy Chamomile Kava kava 19 22 8 48 28 0 9 >200 1 6 Herbal Products -- Herbal Market Regulated -- or -- Unregulated? Herbal regulations differ significantly from drug (pharmaceutical) regulations. Both FDA and FTC have a role in regulating herbal products. Major federal laws governing herb products: – FD&C Act (1938) – Kefauver-Harris Amendments (1962) – DSHEA (1994) Role of FDA Stop the marketing of toxic or unsanitary products Stop the marketing of products with false or unsubstantiated claims Take action against a product which poses “ a significant unreasonable risk of illness or injury” Prohibit claims that a product cures or treats a disease Stop the marketing of a new (post 1994) dietary ingredient if safety data is lacking Role of FTC FTC governs the advertising and promotion of herbs and dietary supplements. It can: – Outlaw unfair or deceptive practices – Stop unsubstantiated advertising – Investigate complaints and seek civil penalties for violations of trade regulations Concept of Effectiveness Two elements – Causation - Did the Treatment make a difference? – Quantification Is the degree of change clinically important? 80% Rule (K. B. Thomas) – “80% of those who seek medical care get better no matter what hand waving or pill popping is provided”. Concept of Risk - Adverse Reaction Risk is likely for any substance with pharmacologic effects GRAS list Reporting an adverse reaction to an herb – FDA Medwatch – 1-800-FDA-1088 – www.fda.gov/medwatch Detecting an Adverse Reaction Number of Persons who need to be exposed to a drug to have a 95% chance of detection Frequency of Adverse Drug Reactions (ADR) 1 out of 100 1 out of 200 1 out of 1000 1 out of 2000 1 out of 10,000 1 300 600 3000 6000 30,000 Number of ADR Cases 2 480 960 4800 9600 48,000 3 650 1300 6500 13,000 65,000 WB Jonas and JS Levin (eds), Essentials of Complementary and Alternative Medicine. Lippincott Williams & Wilkins, Philadelphia, PA. 1999 Product Quality Genetics, growing conditions, harvest time Misidentification, contamination, adulteration Lack of Standardization – product preparation Quality Solutions Standardization Independent testing – www.consumerlab.com – www.nsf.org – www.usp.org Health Care Providers Actions Avoid products with multiple herbs Consider following LFT’s, BUN, CrCl Consider herbs in differential Obtain samples when problems suspected Report to MedWatch 1-800-332-1088 Health Professional’s Actions Honor your patients reasons for usage Encourage open communication Read about herbal remedies Be honest about what you learn Avoid criticism List herbal remedies in the patient chart Weigand JM et al, FP Recertification, 22(9):45-62 The Importance of Knowledge “Only ignorance! Only ignorance! How can you talk about only ignorance? Don’t you know that ignorance is the worst thing in the world next to wickedness? -- and which does the most mischief Heaven only knows. If people can say, “Oh I did not know, I did not mean any harm,” they think it is all right.” From the Book - Black Beauty by Anna Sewell Lisa Vincler, JD When Ignorance isn’t Bliss: What Healthcare Practitioners and Facilities should know about CAM, 1998