1. Herbs and supplements What and Why we care Andrea Gordon, MD April 29, 2015

2. Historical perspective 2000 B.C. Here, eat this root. 1000 B.C. That root is heathen, say this prayer 1850 A.D. That prayer is superstition, drink this potion. 1940 A.D. That potion is snake oil, swallow this pill. 1985 A.D. That pill is ineffective, take this antibiotic. 2000 A.D. That antibiotic is artificial Here, eat this root.

3. Who uses herbs or supplements?

4. Multivitamin Tea or Coffee Fish oil Most of us. WHO estimates $60 billion spent annually More than $25 billion in US in 2007

5. Who uses herbs? Rates vary by gender, race, age, ethnicity, socioeconomic class BUT All of these groups use herbs and/or supplements in substantial numbers

6. Who uses herbs? 2002 study showed about 19% of US population using herbs or supplements Most use in sickest patients Only 1/3 tell their medical practitioner

7. Why do we care? Safety! Natural =/= safe But many people believe it does Different standards for manufacturing and marketing than drugs Potential interactions with drugs Dosing concerns

8. Isn’t there monitoring for safety? Dietary Supplement Health and Education Act (DSHEA) of 1994 Dietary supplements include herbs, vitamins, minerals, metabolites, or extracts Companies not required to prove efficacy or safety before marketing Burden of proving inefficacy or lack of safety fell to FDA

9. Can market with : Health Claim Food / ingredient & influence on reducing risk of disease or health condition Nutrient content claim Specifies nutrient concentration per serving Structure/Function Describes the relationship between organ function and the supplement (ex. Support cardiovascular function) Cannot mention specific diseases Must have disclaimer: not evaluated by FDA, not intended to diagnose, cure or prevent disease

10. But they can’t say it treats_____ No explicit claims about how a supplement may play a role in preventing or treating a particular disease condition Structure/function claims are often vague, or not sufficiently specific for some consumers

12. New Good Manufacturing Practices Effective 2008-2010 GOOD NEWS New regulatory framework Companies have to follow GMP guidelines BAD NEWS Lack of enforcement provision Difficult for consumer to distinguish good from bad companies

13. So why use herbs? Some have thousands of years of use Ginseng Chamomile Often more gentle/safer than drugs in their natural form Butterbur, Kava Herbs may have many active compounds vs. one that has been purified out. Often fewer side effects St. John’s Wort vs. Amitriptyline

14. Why do doctors need to know about herbs and supplements? Many patients are using them and may not tell you – need to ask Avoid interactions Know what is working or not Some may be more acceptable to patients Due to values, beliefs, experiences with conventional medications Have more options to offer Some may be as or more effective for some conditions

15. What do patients use?

16. Issues with studying herbs Often a group of compounds, not just one Can’t patent a plant so hard to get the $$ to do research RCT doesn’t reflect how it’s used in practice So may need to look at outcomes research or historical date

17. So what do I do?! Ask!!! Don’t assume you know what a person is or is not taking Don’t assume they know why or how to take it Find out their source Contamination with some herbs from India, China Some brands are better than others

18. Where do I find information? Free: USP : www.usp.orgwww.usp.org Medline plus: http://www.nlm.nih.gov/medlineplus/drugin formation.html http://www.nlm.nih.gov/medlineplus/drugin formation.html NIH office of dietary supplements http://ods.od.nih.gov/ http://ods.od.nih.gov/

19. Where do I find information? Paid sources: Consumer lab (www.consumerlab.com)www.consumerlab.com Think of it like Consumer Reports for herbs and supplements Looks at ingredients, contaminants The Natural Standard Info on herbs, conditions, interactions Institutions buy but can go through IntegrativePractioner.com

20. Where do I find information? Natural Medicine Comprehensive Database – now merged with Natural Standard Monographs including uses, efficacy, safety, interactions and dosing https://naturalmedicines.therapeuticresearch.co m/ Reputable books Integrative Medicine- Edited by David Rakel Organized by disorder

21. Let’s look at some specifics Do you know any of these?

22. Echinacea Mixed studies about preventing/treating colds Seems to work best if taken very early May reduce severity and duration BUT Need to have right species, plant parts Most evidence for Echinacea purpurea Use aerial parts, not roots Look for good brands

23. Black cohosh Used for menopause –historical and moderns use, has been studied Most consistent evidence for “Remifemen” Concerns over estrogen stimulation Seems to work more like an SSRI Can cause GI upset Few case reports of liver damage, mostly when in combination with other herbs

24. Fish oil What is it used for?

25. Fish oil: uses Heart – prevent or treat cardiovascular disease Dysmenorrhea, psoriasis, rheumatoid arthritis, Raynaud’s syndrome – maybe due to effects on inflammation Omega 3 fatty acids (to balance Omega 6) Very skewed in processed diet Mixed evidence for these

26. Fish oil: Good evidence High trigylcerides? – can reduce levels by 20-50% Cardiovascular disease? Eating fish twice weekly reduces risk Better evidence in those who already have CV disease

27. Fish oil: in patients with CV disease Studies with 1-10 grams daily -> reduced overall mortality by 20%,,MI by 20%, sudden death by 30% Two meta-analyses show consumption of fish oil from fish or supplements decrease risk of overall mortality by 16% to 23% (statins lower by 13%) - death due to cardiovascular causes such as myocardial infarction by 24% to 32% (statins lower by 22%)

28. Fish oil: safety/tolerability concerns Mercury exposure Depending on source More than 3 grams/day may increase risk of bleeding Fishy taste or “fish burps” Objectionable to vegetarians Plant sources of Omega 3’s include flaxseeds, nuts – but not studied

29. St. John’s Wort Historically used for depression, anxiety, menopausal sx, headaches Most research on depression Seems as effective as SSRI’s (Prozac, Paxil, Zoloft) Tricyclics (amitriptyline, nortriptyline) Best for mild to moderate depression

30. St. John’s Wort: concerns Interacts with a LOT of drugs Side effects: GI, vivid dreams, insomnia, photosensitivity, rash, headache Still better tolerated than TCA’s, about the same as SSRI’s Some question about which component should be used to standardize Hypericin vs hyperforen

31. Peppermint – oil or tea Chamomile Ginko biloba Garlic Ginseng Vitamin D What do you use/recommend/know about? Other commonly used herbs/supp’s:

32. How do you know what to say? Look at safety vs. efficacy If it’s safe and effective –yes! If safe and possibly effective – maybe – look at cost, interactions Not safe and effective- look at risk/benefit ratio (many drugs fall here) If not safe or effective – don’t use it!