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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

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Herbal Therapies

(Top Dozen) • • • • • • Gingko biloba St John’s Wort Ginseng Garlic Echinacea Saw Palmetto • • • • • • Kava 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)

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Marketed For ...

• •

Memory enhancement Improved concentration

•

No evidence for improved memory/concentration in normal, healthy individuals

(NEJM 2002)

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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

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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!

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Red Bull…

• • • • • Taurine (essential amino acid) 1000mg 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 B6: 40 milligrams, or 2,000% of RDV – Vitamin B12: 0.5 milligrams , or 8,000% of RDV and…… – As much caffeine as a cup of premium coffee • A cup (8oz) of Starbucks has 180mg 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.

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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 ?

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Saw Palmetto

• • • Appears safe and effective for BPH, comparable to finasteride (Proscar) Inhibits the 5a reductase conversion of testosterone to dihydrotestosterone (a prostate growth stimulator) 160 mg bid or 320 mg qd JAMA1998; AFP2003 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

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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 NewYorker 27

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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 160ug/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 mmHg (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 10x 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 NewYorker 37

Common Supplements

• • • • Glucosamine/ chondroitin CoQ-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

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Consumers Report 2004

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Coenzyme Q10

• • • • • • • • 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 Q10 Approved in Japan since 1974 to treat CHF Some evidence for benefit in Parkinson’s & mitochondrial diseases 200mg qday lower BP 16/10 mmHG Safe but expensive (50-1200 mg/day)

AFP 2005

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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

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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 mmHg) 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 1000mcg/day

The Medical Letter 2006

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Marketed To....

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Loose fat Boost energy

•

... no published support for such effects

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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!

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Ma-Huang or Ephedra

• • • • • • MetaboLife, 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”

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A Clinician’s Perspective .....

varying approaches

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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.NaturalStandard.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

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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!

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