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					Herbal Medicine— What’s the Evidence?
What you need to know about the herbs your patients are using

Victor S. Sierpina, M.D.
Associate Professor Family Medicine University of Texas Medical Branch at Galveston

Patients Use Herbs but Doctors are Reluctant to Prescribe Them. Why?



Knowledge deficit Tradition Real concerns about product safety, drugherb interactions Unnecessarily high concerns about liability

Trends in Alternative Medicine Use in the United States, 1990-1997*
 Biggest

increase in usage patterns of Alternative Therapies from 1990 was in the use of herbs, massage, megavitamins, self-help groups, folk remedies, energy healing, homeopathy

*Eisenberg, et al, JAMA, Nov 11, 1998;280(18);1569-1575

Herbal Quality

Proper identification and plant taxonomy
Different lots, genetic variation


Time of harvesting, proper part of plant
Environmental and soil conditions

Herbal Standardization
 Determining active constituents is a

biochemical challenge  Echinacea--caffeic acids, alkylamides, “marker compounds,” interspecies variation  Ginseng--ginsenosides, 30 different types  St. John’s Wort--hypericin or hyperforin as active ingredient. To which do you standardize?

The Promise of Standardization
 THE critical quality issue  Need refined efforts in:
 Chemical characterization  Bioactivity assessment

 Correlation with clinical endpoints
 Botanical identity  Analytical testing of marketed materials for

quality and strength

Points to Remember
 FDA neither establishes nor regularly

enforces any standards of quality for herbs
 Herbs are technically unapproved drugs, in

an OTC limbo
 Best advice: obtain a standardized extract

marketed by a reputable firm

Reasonable Certainty
 Absolute proof of safety  Reasonable certainty of efficacy

 

Best collective judgments from clinical trials, laboratory studies, practice experience, RCT’s German FDA (Bundesgesundheitsamt) and Commission E Most accurate body of scientific knowledge on herbal safety and efficacy to date

To End the Dilemma
1. Preparation of botanical codex to establish standard of identity, purity, and quality 2. Herbs must be identified by Latin binomial and a method of determining compliance with standards must be implemented

To End the Dilemma
3. Safety of all herbs sold to consumer must be established 4. Herbs should be allowed to be sold for tx of specific conditions if proven with reasonable certainty

Policy Issues

WHO (1993) Policy Statement--historic use of an herbal is valid form of information on safety and efficacy in the absence of scientific evidence to the contrary

Regulatory Reform
 Consider a excise tax on herbs and dietary

supplements for support of industry standards, compliance, research  Assemble a Commission E type panel in the FDA to address the problems in herbal medicinals  Use data from Germany and elsewhere--we drive their cars don’t we?

“I found the secret to happiness, but the FDA won’t let me release it.”

My Favorite Therapies—things you can use every day in primary care practice
 

 


Glucosamine sulfate 1500 mg/d Ginkgo 120-240 mg/d St. John’s Wort 300 mg tid Echinacea 300 mg tid Horse Chestnut 35-70 mg/d aescin Saw Palmetto 160 mg bid Kava 45-70 mg tid

Glucosamine Sulfate for Osteoarthritis 1500 mg/day
  

Patient use

Do you prescribe?
Safety, side effects, dosing, preparations


What about Chondroitin?

Recent studies on Glucosamine

McAlindon, TE, et al. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and metaanalysis. (JAMA 283(11): 1483-84. Feb 2000)
RPC study showed reduction in cartilage loss and symptoms of OA over a 3 yr period in 106 pts (Reginster, Jan 2001 Lancet)


Ginkgo Biloba: Dose is 120-240 mg daily
taken in 2-3 doses, 0.5ml tid of extract
INDICATIONS: Memory loss, Alzheimer’s, cerebrovascular insufficiency, peripheral vascular disease
- Gingkgold/Nature’s Way

- Ginkoba/Pharmaton
- Quanterra/Warner Lambert

- Ginkai/Lichtwer


Over 120 published studies
RCT, prospective study of beneficial effect of Ginkgo Biloba Extract in slowing progression of dementia in Alzheimer’s patients*

*Le Bars PL. et al. JAMA. 1997;278(16):1327-1332

And what about some more science? Studies on Ginkgo


Meta-analyses of 100 articles found significant improvement in age-related cognitive function in Alzheimer’s* Meta-analysis concluded GB is effective for intermittent claudication**

*Kleijnen J. Pharm Weekbl Sci. 1992; 14(6):316-320 and Oken BS. Arch Neurol. 1998;55(11):1409-1415 **Pittler & Ernst, Am J Med. 2000;108:276-281

Drug Interactions with Ginkgo
 

Anti-coagulants Stop before surgery

St. John’s Wort: Dose 300 mg tid std
extract (0.3%), 3-4 ml tid tincture
INDICATIONS: Mild to moderate depression, anxiety, insomnia

- Jarsin/Lichter Pharma

- Quanterra Emotional Balance/ Warner Lambert
- Perika/Nature’s Way

- Movana/Pharmaton

Studies on St. John’s Wort
 


Ongoing study at Duke comparing SJW with SSRI’s Cochrane Collaboration review concluded SJW superior to placebo. Could not conclude it was as effective as TCA therapy* SJW and fluoxetine equipotent in mild-moderate depression. Much lower side-effect profile with SJW**

*Linde K, Murrow CD. The Cochrane Library. 4/2000. Oxford: Update Software **Schrader E. Int Clin Psychopharmacol. 2000;15(23):61-8

Drug Interactions with SJW
     

SSRI’s General anesthetics Benzodiazepines OCP’s Retrovirals Digoxin

Echinacea: Dose 300 mg tid, tincture 15-30
gtts qid, or 3-4 cups of tea qd
INDICATIONS: Colds and flu, boosting immune function
- Echinagard/Nature’s Way

Studies on Echinacea

Review of 26 controlled clinical trials concluded that published clinical studies provide evidence that some preparations can be efficacious as immunomodulators*
9 treatment and 4 prevention RPC trials found Echinacea may be beneficial (dosage and preparation issues?), non-continuous use**


*Melchart D, Linde K. et al. Phytomed. 1994;1:245-254 **Barrett B, Vohmann C. et al. J Fam Pract. 1999;48(8):628-635

Some Cautions with Echinacea
    

Ragweed, daisy, sunflower allergy HIV/AIDS Connective tissue or other autoimmune dz MS TB

Saw Palmetto: Dosage is 160 mg capsule
bid, 15 gtts of extract bid

- Elusan Prostate / Plantes & Medicines - ProstActive/Nature’s Way

Studies on Saw Palmetto

Meta-analysis of 7 PC trials showed increase in peak urinary flow and decrease nocturia in BPH over a 3 month period*
Compared to finasteride, a 6 month DBPCRCT, 1098 pts showed equally improved BPH sx score and peak urinary flow**


*Lowe F, Robertson C. et al. J Urol. 1998;159:257 (Abstract 986) **Carraro JC, Raynaud JP. et al. Prostate. 1996;29(4):231-240

Horse Chestnut: 35-70 mg aescin/day
INDICATIONS: Varicose veins, hemorrhoids

- Venastat/Pharmaton

Studies on Horse Chestnut

Systematic review of 14 RDBC trials concluded HC superior to placebo in venous disease with mild and infrequent side effects*

*Pittler MH, Ernst E. Arch Dermatol. 1998;134(11):1356-1360

Kava: 45-70 mg tid, 180-210 mg hs
INDICATION: Anxiety, insomnia

- Kavatrol/Natrol - Laitan/Schwabe - Neuronika

Studies on Kava:

6 DBPCR on 335 participants conclude that kava significantly reduces anxiety in several different populations Meta-analysis of 7 RDBPC confirms the anxiolytic effects*


*Pittler M, Ernst E. J Clin Psychopharmacol. 2000;20(1):84-9

“Doctor, what else can I take for my menopause besides those hormones? I am afraid of breast cancer since it runs in my family.”

BLACK COHOSH-traditional use includes dysmenorrhea, PMS, and menopausal symptoms. Active ingredients (27deoxyacteine). Occasional stomach upset. No evidence on protection against CV dz, and osteoporosis

Studies on Black Cohosh


Several clinical trials (N=375) showed significant decrease in Kupperman-Menopause Index using black cohosh extract, Remifemin Liske and Wustenberg reported on 152 patient that after 6 months, positive KPI response in 90% of pts with no changes in LH, FSH, SHBG, prolactin, estradiol: a “non-hormone (estrogen)like effect”*

*Menopause. 1998;5(4): 250; *ESCOP. The European Phytojournal. 1998

Black cohosh:

Dose 250 mg tid, tincture 2-4 ml/d or 1-2 tabs Remifemin bid (provides 2-4 mg of active 27deoxyacteine or 40-80 mg crude black cohosh drug)


“I’ve heard garlic can lower my cholesterol and blood pressure. What’s the story, doc?”

GARLIC--has been shown in a number of studies to reduce blood pressure and improve lipid levels. Acts as anti-oxidant, inhibits platelets, decreases blood viscosity.

Studies on Garlic show evidence (mixed results)
      


Lipid-lowering Antithrombotic Antihypertensive Antimicrobial Anticancer Antiallergenic Antioxidant Immunomodulatory

Studies on Garlic:HTN, Lipids


Meta-analysis of 8 trials, 415 participants; 3 of trials with HTN pts. 7 PC trials showed reduction in either SBP or DBP(suggested more studies needed)* Meta-analyses of 800 participants,13 RDBPC found approx. 6% decrease in serum cholesterol(small effect,?meaningful)**

*Silagy CA, Neil HA. J Hypertens. 1994b: 12(4):463-468 **Stevinson, C, Pittler MH, Ernst E. Ann Intern Med. 2000;133;420-429.

Garlic: Dose 1-2 cloves a day, 5000mcg
allicin (250-500mg caps)

Integrative Healthcare: Complementary and Alternative Therapies for the Whole Person

By: Victor S. Sierpina, MD
FA Davis Philadelphia, 2001

Blumenthal, M, Goldberg A, Brinckman J. 2000. Herbal Medicine— Expanded Commission E Monographs. Boston, MA: Integrative Medicine Communications

Other Useful References
PDR for Herbal Medicines. 2000. Montvale, NJ: Medical Economics Co.

Murray M, Pizzorno J. 1998. Encyclopedia of Natural Medicine. Rocklin, CA: Prima. American Botanical Council’s website

UTMB’s Alternative and Integrative Health Care Program Website

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