Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation
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Herbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs.
Unfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products.
Herbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products.
KEY WORDSherbal medicine efficacy safety regulation
The author thanks Erin Hartman, MS, Department of Medicine, University of California, San Francisco, for her editorial assistance on this manuscript. Dr. Bent had full access to all of the data in this presentation and takes responsibility for the integrity of the data and the accuracy of the presentation. This work was supported by Grant Number 1 K08 ATO1338-01 (Dr. Bent) from the National Center for Complementary and Alternative Medicine (NCCAM). The funding organization had no role in the design and conduct of the review; the collection, management, analysis, and interpretation of the data, or the preparation, review, or approval of the manuscript.
Conflict of Interest Statement
Dr. Bent previously served as an expert witness for plaintiffs in cases of injury related to the use of ephedra (last case completed in July 2004).
- 2.Swerdlow JL. Modern Science Embraces Medicinal Plants. Nature’s Medicine: Plants that Heal. Washington, DC: National Geographic Society; 2000:110–57.Google Scholar
- 3.Swerdlow JL. Medicine Changes: late 19th to early 20th century. Nature’s Medicine: Plants that Heal. Washington, D.C.: National Geographic Society; 2000:158–91.Google Scholar
- 5.Rotblatt M , Ziment I. Evidence-based herbal medicine. Philadelphia, PA: Hanley & Belfus; 2002.Google Scholar
- 7.Institute of Medicine, National Academies Press. Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: National Academies Press; 2005.Google Scholar
- 9.Linde K, Barrett B, Wolkart K, Bauer R, Melchart D. Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2006(1):CD000530.Google Scholar
- 16.Birks J, Grimley EV, Van Dongen M. Ginkgo biloba for cognitive impairment and dementia. Cochrane Database Syst Rev. 2002(4):CD003120.Google Scholar
- 22.Linde K, Mulrow CD, Berner M, Egger M. St John’s wort for depression. Cochrane Database Syst Rev. 2005(2):CD000448.Google Scholar
- 29.Lethaby AE, Brown J, Marjoribanks J, Kronenberg F, Roberts H, Eden J. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007(4):CD001395.Google Scholar
- 31.Ulbricht C , Basch E. Natural standard herb and supplement reference: evidence-based clinical reviews. St. Louis, MO: Elsevier Mosby; 2005.Google Scholar
- 32.Pittler MH, Ernst E. Kava extract for treating anxiety. Cochrane Database Syst Rev. 2003(1):CD003383.Google Scholar
- 33.Centers for Disease Control and Prevention. Hepatic toxicity possibly associated with kava-containing products—United States, Germany, and Switzerland, 1999–2002. MMWR Morb Mortal Wkly Rep. 2002;51:1065–7.Google Scholar
- 44.DHHS, FDA. Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. Final rule. Fed Regist. 2004;69:6787–6854.Google Scholar
- 45.Hoffman BB , Taylor P. Neurotransmission. In: Hardman JG, Limbird LE, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10New York, NY: McGraw-Hill; 2001:115–53.Google Scholar
- 47.DHHS. Adverse event reporting for dietary supplements: An inadequate safety valve. US:: Office of the Inspector General, HHS.; 2001.Google Scholar
- 50.Miracleburn with Hoodia and Advantra-Z! http://miracleburn.com/productinfo.htm. Accessed March 26, 2008.
- 57.Fugh-Berman A. The 5-Minute Herb & Dietary Supplement Consult. Philadelphia, PA: Lippincott Williams & Wilkins; 2003.Google Scholar