1. Sara L. Warber, MD Co-Director, UM Integrative Medicine Assist Prof, Dept of Family Medicine Herbs and Health: Real World Basics

2. Context

3. Historical Context Physical evidence dates back 60,000 years Physical evidence dates back 60,000 years All cultures have traditions of herb use for healing All cultures have traditions of herb use for healing 2000 BC - First known materia medica in Sumeria 2000 BC - First known materia medica in Sumeria 1st Century AD - Chinese Materia Medica 1st Century AD - Chinese Materia Medica

4. Cultural Context In China, 40-50% of meds used are traditional herbs In China, 40-50% of meds used are traditional herbs In Africa, 80% of population uses herbal medicine for primary care In Africa, 80% of population uses herbal medicine for primary care In Germany, 90% of adults use herbs in lifetime In Germany, 90% of adults use herbs in lifetime Ethnic populations in US very likely to be using herbs Ethnic populations in US very likely to be using herbs 25% of prescription drugs from plants 25% of prescription drugs from plants

7. Pediatric Herbal Remedies Aloe vera43% Aloe vera43% Chamomile tea29% Chamomile tea29% Echinacea28% Echinacea28% Garlic11% Garlic11% Ginger11% Ginger11% Tea tree oil8% Tea tree oil8% Goldenseal7% Goldenseal7% Ginseng5% Ginseng5% Ginkgo biloba4% Ginkgo biloba4% St John’s wort4% St John’s wort4% Feverfew4% Feverfew4% Ottolini MC. Ambulatory Peds Mar-Apr 2001

8. Asking about herbs

9. Do we really need to ask? 458 VA patients (Pittsburgh, LA) 43% taking herbs/supplements plus medications 2% at risk for serious adverse event 42-48% at risk for minor adverse events 59-88% never asked by physicians about use Glassman P. quoted in Family Practice News. June 15, 2000.

10. Regulations Federal Trade Commission (FTC) Federal Trade Commission (FTC) Food & Drug Administration (FDA) Food & Drug Administration (FDA)

11. Role of FTC FTC governs the advertising and promotion of herbs and dietary supplements. It can: 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

12. Role of FDA Stop the marketing of toxic or unsanitary products Stop the marketing of toxic or unsanitary products Stop the marketing of products with false or unsubstantiated claims 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” 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 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 Stop the marketing of a new (post 1994) dietary ingredient if safety data is lacking

13. Case study: Ephedra Ephedra HWLDS - 0.95 kg lost/mo Ephedra HWLDS - 0.95 kg lost/mo Ephedrine alone - 0.5 kg lost/mo Ephedrine alone - 0.5 kg lost/mo Ephedrine/caffeine combo - 1.0 kg lost/mo Ephedrine/caffeine combo - 1.0 kg lost/mo Ephedrine/caffeine modest dose response effect over multiple trials Ephedrine/caffeine modest dose response effect over multiple trials Rand Meta-analysis

14. Ephedra/Ephedrine Safety RCTs - no serious adverse effects RCTs - no serious adverse effects Sentinel events: MI, CVA, seizures, & psychiatric cases. Sentinel events: MI, CVA, seizures, & psychiatric cases. Adverse events reports Adverse events reports –Ephedra - 21 sentinel serious adverse events (including 2 deaths) –Ephedrine - 11 sentinel events (including 3 deaths) Rand Meta-analysis

15. Expertise – Who has it? Consumer/patient Consumer/patient Clerk in store Clerk in store Herbalist – what tradition? How certified? Herbalist – what tradition? How certified? Chiropractor (DC) Chiropractor (DC) Nutritionist (RD) Nutritionist (RD) Pharmacist (PharmD, PhD) Pharmacist (PharmD, PhD) Naturopathic Doctor (ND) Naturopathic Doctor (ND) Board Certified Holistic Physician (MD, DO) Board Certified Holistic Physician (MD, DO) Fellowship-trained Integrative Physician Fellowship-trained Integrative Physician

16. Evidence Traditional use Traditional use Basic science Basic science Clinical science Clinical science

17. Traditional use Often based on hundreds to thousands of years of observation Often based on hundreds to thousands of years of observation 60-70% of traditionally used herbs are pharmacologically active 60-70% of traditionally used herbs are pharmacologically active German Commission E German Commission E

18. Traditional preparations Infusion - flowers and leaves steeped in hot water, ie, teas Infusion - flowers and leaves steeped in hot water, ie, teas Decoction - bark, roots or seeds boiled in water Decoction - bark, roots or seeds boiled in water Tincture – extraction with alcohol or vinegar or glycerin and water Tincture – extraction with alcohol or vinegar or glycerin and water

19. More preparations Capsules 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 Salve - an oil and beeswax/lanolin mixture used topically

20. Basic Science Mechanism of action Mechanism of action Pharmacokinetics, etc Pharmacokinetics, etc Toxicity Toxicity Often done AFTER clinical studies Often done AFTER clinical studies

21. Clinical Science

22. Federally funded studies 1. Echinacea 19 2. Ginseng 22 3. Gingko biloba 8 4. Garlic 48 5. SJW 28 6. Peppermint 0 7. Ginger 9 8. Soy >200 9. Chamomile 1 10. Kava kava 6

23. Problems Toxicity Interactions Adverse reactions

24. Toxicity Renal toxicity Renal toxicity –Stephania (Fang ji) –Aristolochia (Fang chi) Lobelia Lobelia Yohimbe Yohimbe Liver toxicity Liver toxicity –Chaparral –Comfrey –Germander –Jin Bu Huan

25. Physician Actions Avoid products with multiple herbs Consider following LFT’s, BUN, Cr Consider herbs in differential Obtain samples when problems suspected Report to MedWatch 1-800-332-1088

26. Interactions St John’s wort St John’s wort –Studies - digoxin, protease inhibitors, TCAs –Case reports - cyclosporine, warfarin, oral contraceptives, theophylline, SSRIs –Theoretical - iron

27. Adverse Reactions 52 y.o. male for R knee replacement 52 y.o. male for R knee replacement Surgery went well, some oozing of blood Surgery went well, some oozing of blood Continued bleeding post operatively Continued bleeding post operatively Smart medical student saves the day Smart medical student saves the day –Ginkgo biloba, garlic, green tea

28. Product Quality Genetics, growing conditions, harvest time, product preparation Genetics, growing conditions, harvest time, product preparation Misidentification, contamination, adulteration Misidentification, contamination, adulteration

29. Quality Solutions Standardization Standardization Independent testing Independent testing –www.consumerlab.com –www.nsf.org

30. Searching for answers: real world work

31. Health Actions Health Professional’s Actions Honor your patients reasons for usage Honor your patients reasons for usage Encourage open communication Encourage open communication Read about herbal remedies Read about herbal remedies Be honest about what you learn Be honest about what you learn Avoid criticism Avoid criticism List herbal remedies in the patient chart List herbal remedies in the patient chart Weigand JM et al, FP Recertification, 22(9):45-62