Leslie Shimp, PharmD Professor College of Pharmacy Asst Prof of Pharm, Dept of Family Medicine

1. 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

2. 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

3. 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

6. Context

7. 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

8. 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

9. Evidence • Traditional use • Basic science • Clinical science

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

11. 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

12. 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

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

14. Clinical Science

15. Federally funded studies • Echinacea 19 • Ginseng 22 • Gingko biloba 8 • Garlic 48 • SJW 28 • Peppermint 0 • Ginger 9 • Soy >200 • Chamomile 1 • Kava kava 6

16. Herbal Products -- Herbal MarketRegulated -- 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)

17. 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

18. 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

19. 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”.

20. 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

21. Detecting an Adverse ReactionNumber of Persons who need to be exposed to a drug to have a 95% chance of detection

22. Product Quality • Genetics, growing conditions, harvest time • Misidentification, contamination, adulteration • Lack of Standardization • product preparation

23. Quality Solutions • Standardization • Independent testing • www.consumerlab.com • www.nsf.org • www.usp.org

24. 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

25. 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

26. 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