1 Herbs Supplements Did you remember

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Herbs & Supplements Did you remember to take your Gingko today ? Robert Baldor, MD Professor Family Medicine & Community Health 2

Why patients use CAM • • 38% of US/$34 billion out-of-pocket in 2007 Arthritis/Back/Neck/Joint pain Anxiety Cholesterol management URIs Headache/Migraine Insomnia 3

A Clinician’s Perspective • What’s available • Efficacy • Safety 4

Herbal Therapies (Top Dozen) • • • Gingko biloba St John’s Wort Ginseng Garlic Echinacea Saw Palmetto • • • Kava Valerian Soy Evening Primrose Grape seed Milk Thistle 5

Gingko Extracts • • Ancient Chinese herbal treatment Maidenhair tree leaves Effects from flavonoids - antioxidant Reduces capillary fragility, vasodilator 6

Ginkgo Considerations • Recommended to stabilize cognition in Alzheimer's or multi-infarct dementia; improves walking with claudication • 120 -240 mg BID, TID • Appears safe • Avoid with anticoagulants (2002 Cochrane) 7

Marketed For. . . • Memory enhancement • Improved concentration • No evidence for improved memory/concentration in normal, healthy individuals (NEJM 2002) 8

St. John’s Wort • Flowering plant (H. perforatum) • Hypericin, a naphthodianthrone is the main active ingredient • Inhibits neurotransmitter uptake of serotonin, norepinephrine, & dopamine • Binds to GABA receptors 9

St. John’s Wort • Outsells Prozac in Germany 7: 1 • Meta-analysis - appears effective as low doses of standard antidepressants • Phototoxicity 10

Depression Consumers Report 2004 11

Ginseng • From genus panax (panacea!) • An adoptogen - no studies compared to stimulants such as caffeine • Considered safe • Siberian Ginseng – An abundant Russian herb thought to have the same properties as Ginseng – No published studies 12

The wonder herb. . . • Ginseng is expensive - study of 54 products 85% contained little or no ginseng, but …. varying amounts of caffeine! • Glacial Tropical Citrus Vitamin Water 21 mg of caffeine – Coke has 24 mg! 13

Red Bull… • Taurine (essential amino acid) 1000 mg • Glucuronolactone (conjugates with toxic metabolites for excretion) 600 mg • B complex vitamins • Caffeine 80 mg (24 gms in Coke) • Sugar 27 grams (39 gms in Coke) 14

• B Vitamins – Niacin: 30 milligrams, or 150% of the RDV – Vitamin B 6: 40 milligrams, or 2, 000% of RDV – Vitamin B 12: 0. 5 milligrams , or 8, 000% of RDV and…… – As much caffeine as a cup of premium coffee • A cup (8 oz) of Starbucks has 180 mg of caffeine

Garlic (allium sativum) • • Organosulfer compounds May block carcinogens in food Garlic extract - decreases cholesterol 7% Available in ‘odor free’ capsules • Active agent (allium) is odoriferous 16

Long regarded to deter vampires • Norwegian experiment with leeches (lack of vampires) • Garlic-smeared hand preferred in 66% of time • Leeches attached in 14. 9 secs vs 44. 9 secs when going to the non-garlic hand (p < 0. 05) • The traditional belief that garlic can deter vampires is probably wrong • The reverse may in fact be true Tidsskr Nor Laegeforen. 1994 Dec 10; 114(30): 3583 -6. 17

Echinacea • For Rx of colds ($100 million in sales) • Appears to alleviate some cold symptoms no evidence for cure • 1998 randomized trial showed no ability to prevent colds (JFP 1999) 18

Zinc & Colds • Inhibits rhinovirus in tissue culture • Meta-analysis showed no conclusive evidence for reducing colds (Arch IM 1997) • Controlled trial of lozengers - ineffective & side effects - taste, N&V (JAMA 1998) • Randomized blinded trial of nasal gel – decreased length of cold by 2 days (ENT J 2000) • Improved Rx vs. antibiotics ? 19

Saw Palmetto • Appears safe and effective for BPH, comparable to finasteride (Proscar) • Inhibits the 5 a reductase conversion of testosterone to dihydrotestosterone (a prostate growth stimulator) • 160 mg bid or 320 mg qd JAMA 1998; AFP 2003 20

Anxiolytics GABA Binding Activity • Valerian (insomnia) • Kava kava (anxiety) • Chamomile (insomnia) 21

Valerian • Some efficacy for insomnia • Unclear evidence for anxiety • Appears safe, maybe helpful to wean from benzodiazepines dependence • 300 - 600 mg before bedtime or as tea (2 -3 gm of dried root) AFP 2003 22

KAVA & Hepatotoxicity • 70 reports of kava induced liver failure, with 4 deaths and 7 liver transplants • FDA 2002 advisory – avoid kava if having or at risk for liver disease • Last year UK banned Kava sales 23

Phytoestrogens for Menopause • Plant compounds resembling estradiol • Isoflavones most potent • Supplements of unclear benefits v. foods - Soy, Tofu, Black Cohosh • Consider for mild menopausal Sx • Reports of Black Cohosh induced hepatitis 24

Relief of Hot Flashes Consumers Report 2004 25

Milk Thistle • Flavonoid complex called silymarin • Used for improving liver function in hepatitis, cirrhosis • Meta- analysis – appears safe but no clear benefit…. Am J Med 2002 26

“Not much - just flushing out my arteries. ” The New. Yorker 27

What about Red Wine? • ‘The French paradox’ – low incidence of CVD – but a relatively high fat diet. • Grapes contain flavonoids (resveratol), potent antioxidants - ? account for positive effects • Red wine has 160 ug/oz; peanuts 70 ug/oz • Grape juice is not fermented –negligible amounts • No enough evidence to conclude that red wine is more effective than other alcoholic bevearges in lowering CVD risk 28

“It’s a B-complex. Didn’t they used to put chocolate on the pillow? ” 29

Chocolate (flavonoids) • 1 oz has as much flavonoids as 6 apples, 5 cups of tea or 2 glasses of red wine • Flavonoids reduce platelet aggregation • Decreased platelet activation 6 hours after eating chocolate – Didn’t measure glucose or lipid levels (MARS funded) • Recent meta-analysis dark cocoa products reduce BP 5/2 mm. Hg (AJH, 2010) 30

Ginger (zigiber officinale) • • Used for centuries to treat nausea Post-op nausea, motion & sea sickness Chemotherapy results disappointing Commonly used but not recommended for pregnancy (bleeding, miscarriage) 31

“Michael has had an interesting side-effect from taking St. John’s Wort” 32

FDA Approval • Drugs must be safe and effective • Average $230 million & 12 years • No patent to recoup costs for herbs 33

Dietary Supplement Act Of 1994 • Applies to ‘dietary supplements’ – vitamins, minerals, herbs, natural substances • Health claims not specified on label • FDA must prove unsafe before removing 34

Health Foods? …. L-Trypthophan • An amino acid - assumed safe • Used for insomnia • Eosinophilia myalgia syndrome developed – 38 deaths!! • Banned by FDA in 1990 35

FDA Concerns …. • Over 2000 reports of adverse effects in 2009 • No manufacturing oversight: – 1/3 rd of supplements <50% of stated ingredients (Ginseng products only contain caffeine) – Niacin product contained 10 x safe level ( GI distress, hepatic damage, MI) • Proposed rule to prevent the sale of supplements that are sub- or super- potent, that contain drugs, or contaminants (i. e. bacteria, pesticides, glass, lead) 36

“Something from the supplement cart? ” The New. Yorker 37

Common Supplements • Glucosamine/ chondroitin • Co. Q-10 • Melatonin • Amino Acids • • • Fish Oils/omega FA DHEA Acidophilus Chromium Sports enhancement 38

Glucosamine & Chondroitin Glucosamine (crab shell chitin) Chondritin (cow cartilage) The ‘raw materials for new cartilage’ Evidence for pain & disability relief in osteoarthritis, comparable to ibuprofen & acetaminophen • Safe – few side effects • • Cochrane Review 2005 39

Consumers Report 2004 40

Coenzyme Q 10 • • Fat soluble vitamin Involved in mitochondrial oxidation producing ATP Some anti-oxidant properties In CHF, cardiac tissues under ↑’d oxidative stress w/decreased tissue levels of Q 10 Approved in Japan since 1974 to treat CHF Some evidence for benefit in Parkinson’s & mitochondrial diseases 200 mg qday lower BP 16/10 mm. HG Safe but expensive (50 -1200 mg/day) AFP 2005 41

Melatonin • Modified amino acid (tryptophan) • Released from pineal gland by diminishing light levels • Role in humans not fully elucidated • Small, conflicting sleep studies 42

Melatonin for Sleep • • Induces sleep if plasma levels are low Shift workers Jet Lag 0. 1 – 10 mg qhs 43

Insomnia Consumers Report 2004 44

Fish Oils & Omega 3 fatty acids • Fish oil supplements supported by RCTs – Lower triglycerides – Reduce CAD and stroke risk with known CVD disease – Lowers BP slightly (10/4 mm. Hg) • No evidence for primary prevention 45

DHEA (Dihydroepiandrosterone) • Produced by adrenals, unclear role outside of Rx for adrenal insufficiency • Converted to estrogens and testosterone • Plasma levels decline with age • Schedule II - an anabolic steroid • DHEA supplements are Yam extracts, not converted to DHEA 46

Marketed as. . . • • Anti-aging Hirsutism & deeping voice seen Concern for prostate or breast cancer Series of studies 1995 - 1998 in J. Clin Endocrinology - some perceived sense of well being, but no obvious benefits 47

Acidophilus - a probiotic (organism used medically) • Lactobacillus acidophilus - bacteria that live in the intestine and vagina • Good evidence to support L. acidophilus vaginal suppositories to Rx bacterial vaginosis • Some studies suggest eating yogurt enriched with L. acidophilus may be similarly beneficial • Benefit in colic treatment ? • Marketed to improve digestion, no clear evidence of benefit 48

Chromium for weight loss ? ? • • • Essential trace mineral - Insulin cofactor China & Israeli studies for DM treatment Diabetics not chromium deficient Mixed results from a variety of studies Safe up to 1000 mcg/day The Medical Letter 2006 49

Marketed To. . • Loose fat • Boost energy • . . . no published support for such effects 50

Weight loss …. Health Foods? ? • Metabolife contains Ma Hung • Bitter orange extract contains synephrine • Chomper is a natural laxative, contains digitalis - induces arrhythmias • Tryptophan & phenylalanine - amino acids ? efficacy 51

Health Foods? …. • Associated Press 5/22/00 …Herbalife Founder Mark Hughes dies at the age of 44 of. . . Natural causes! 52

Ma-Huang or Ephedra Metabo. Life, Herbal Ecstasy Contains Ephedrine Linked to 155 deaths & strokes Banned by NFL, NCAA after heat stroke deaths while using the supplement • FDA Ban in 2004 • Ban overturned, FDA overstepped authority • • 53

“I’m taking you off wine, women and song and putting you on broccoli” 54

A Clinician’s Perspective. . . varying approaches • Acceptance - ask about & tolerate use of herbal products by patients • Endorsement - accept patient use of natural products as initial therapy, monitor for effects • Integration - prescribe herbs with advice on use, dosing, etc. 55

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Resources • www. Natural. Standard. com • NIH CAM Center (nccam. nih. gov) • NIH Office of Dietary Supplements (odp. od. nih. gov/ods/) • Food & Drug Administration (fda. gov) • www. consumerlab. com • Medical Letter • Published studies 57

Current Consensus …the best nutritional strategy for promoting optimal health & reducing the risk of chronic disease is to choose wisely from a wide variety of foods, with emphasis on anti-oxidant rich fruits, vegetables & whole grains. AHA 2002 ADA 2002 58

Best Advice. . . • Buy from well-known national companies • Label includes: – Herbs common & scientific name – Manufacture’s name & address – Dosing guidelines – Potential side effects – Batch & Lot number and expiration date • US Pharmacopoeia verification seal 59

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A Final Thought…. . • The Japanese eat very little fat and suffer fewer heart attacks than the British or Americans • However, the French eat a lot of fat and also suffer fewer heart attacks than the British or Americans • The Germans drink very little red wine and suffer fewer heart attacks than the British or Americans • While the Italians drink excessive amounts of red wine & suffer fewer heart attacks than British or Americans • Conclusion: Eat and drink what you like. Speaking English is apparently what kills you! 61

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