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Ephedra-Containing Dietary Supplements Linked to Heart and Nervous System Problems
By Donald Brown, ND

Healthnotes Newswire (November 9, 2000)—The New England Journal of Medicine this week ordered the early release of a paper linking the herbal supplement ephedra to medical problems such as high blood pressure, heart palpitations, and stroke.1 Citing cases of permanent disability and even death, the journal chose to release the article prior to the planned December 21st date “because of its potential health implications.”

Two medical doctors from the University of San Francisco, Christine Haller and Neal Berkowitz, completed a review of 140 reports of health problems in persons taking dietary supplements containing the herbal stimulant ephedra—a popular ingredient in weight-loss, athletic-performance, and energy-boosting products. Presenting brief summaries of heart and nervous-system emergencies, the authors conclude that 43 of the adverse health reports were “definitely or probably related” to ephedra and 44 were “possibly related.” Citing estimates that approximately 12 million people used ephedra-containing supplements in 1999, they conclude, “dietary supplements that contain ephedra alkaloids pose a serious risk to some users.”

Ephedra-containing products are sold in the United States as dietary supplements under such names as Ripped Fuel, Metabolife 356, and Shape-Fast Plus. The Food and Drug Administration (FDA) funded this analysis of adverse health events possibly related to the supplement. The FDA’s concern about ephedra-containing products has spanned two decades and culminated in proposed regulations in 1997 that would have dramatically limited the total daily dose of the active compounds in the herb known as ephedra alkaloids.2 The proposal also sought to ban combining the herb with stimulants such as caffeine or caffeine-containing herbs like guaraná.

In August 1999, the U.S. General Accounting Office (GAO), an organization that monitors the accountability of federal agencies such as the FDA, issued a 68-page report that challenged the FDA’s arguments to support their proposed ban on ephedra.3 While acknowledging the FDA’s concerns for public safety, the GAO report criticized the FDA’s analysis of the adverse medical events that were supposedly tied to ephedra-containing supplements.

Ephedra (Ephedra sinica), also known as ma huang, was the original source of two popular over-the-counter drugs—the bronchodilating medication ephedrine and the nasal decongestant pseudoephedrine. Ephedrine also stimulates the central nervous system, increases heart rate, and is thought to help promote weight loss. The herb ephedra contains about 1–3% total alkaloids with ephedrine accounting for about 30–90% of this total.4

While ephedra has a long history of use in traditional Chinese medicine and is approved by the German government for treating bronchial spasms of the respiratory tract,5 the popular use of the herb for weight loss is new and largely unproven turf. Initial weight-loss studies focused primarily on products combining isolated ephedrine and caffeine.6 Daily doses of 60 to 150 mg of ephedrine have been used safely in most of these clinical trials with minimal reports of increased heart rate and blood pressure.

The authors of the New England Journal of Medicine article point out that all of the people presented in their paper were taking ephedra together with either caffeine and/or drugs with known cardiovascular side effects, such as theophylline and phenylpropanolamine. The latter is a substance found in weight-loss and cold remedies that may be banned by the FDA due to a possible link to strokes. While caffeine is thought to enhance the weight-loss promoting actions of ephedra, it may also significantly heighten the risk of increased blood pressure and heart palpitations in some people.

Although the herb industry has fought proposed FDA regulations of ephedra, there has been increased movement by many supplement companies toward more responsible labeling of ephedra-containing supplements. In addition to recommending accurate labeling of ephedra alkaloid content in products and limiting daily intake of these alkaloids to no more than 100 mg, the American Herbal Products Association in 1994 recommended that companies warn consumers to avoid ephedra-containing products if they have high blood pressure, heart or thyroid disease, diabetes, or urination problems due to prostate enlargement.7 Reduction of dose or discontinuation of use is encouraged for those who experience nervousness, tremor, sleeplessness, loss of appetite, or nausea. These warnings and guidelines have become the standard adopted by many states for labeling ephedra products.

While consumers are clamoring for products that help shed pounds and give them that extra boost of energy to make it through the work day, the New England Journal of Medicine article is a reminder that “natural” doesn’t always equate to completely safe. People wishing to take ephedra-containing products should choose those that provide accurate information about the amount of ephedrine and other alkaloids contained in the product. They should closely monitor blood pressure while taking ephedra-containing products—particularly those preparations that include caffeine or caffeine-containing herbs. Finally, ephedra should be strictly avoided by people with high blood pressure or heart disease.

References
1. Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. New Engl J Med 2000;pre-publication release.
2. Food and Drug Administration (FDA). Dietary supplements containing ephedrine alkaloids: Proposed rule. Federal Register 1997;62:30678–717.
3. General Accounting Office (GAO). Dietary supplements: Uncertainties in analyses underlying FDA’s proposed rule on ephedrine alkaloids. Washington, DC: United States General Accounting Office; July 1999.
4. Leung AY, Foster S. Encyclopedia of Common Natural Ingredients Used in Foods, Drugs, and Cosmetics. New York: John Wiley and Sons, 1996, 227–9.
5. Blumenthal M, Busse WR, Goldberg A, et al (eds.). The Complete Commission E Monographs: Therapeutic Guide to Herbal Medicines. Boston, MA: Integrative Medicine Communications, 1998, 125–6.
6. Werbach MR, Murray MT. Botanical Influences on Illness. Tarzana, CA: Third Line Press, 2000, 476–80.
7. McGuffin M, Hobbs C, Upton R, Goldberg A (eds.). American Herbal Product Association’s Botanical Safety Handbook. Boca Raton, FL: CRC Press, 1997, 45–6.

Donald Brown, ND, is a naturopathic physician and one of the leading authorities in the United States on evidence-based herbal medicine. He is the founder and director of Natural Product Research Consultants, Inc., and serves on the Advisory Board of the American Botanical Council and the President’s Advisory Board of Bastyr University.




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