Ephedra Linked With Heart, Psychiatric, and Gastrointestinal Problems
Please note: On Dec. 30, 2003, the U.S. Food and Drug Administration (FDA) issued a consumer alert regarding the safety of dietary supplements containing ephedra. The FDA has determined that consuming these supplements poses an unnecessary risk of illness or injury, and that consumers should stop buying and using ephedra products immediately. The FDA also notified manufacturers and marketers of these dietary supplements that effective 60 days (March 2004) after the publication of its final ruling, the sale of all products containing ephedra in the United States will be banned.
]]>Ephedra]]> is a naturally occurring substance derived from the Chinese herb Ma Huang. Its principle active ingredient, ephedrine, was once a primary treatment for asthma. Its other major ingredient, pseudoephedrine, has been used as a decongestant. More recently, ephedra has been used as a dietary supplement for its stimulant and appetite suppressant effects.
However, mounting evidence suggesting that ephedra may be associated with significant health risks, coupled with recent well-publicized reports of adverse events, such as the death of Baltimore Orioles pitcher, Steve Bechler, a 23-year-old ephedra user, has led several large groups to ask the Food and Drug Administration (FDA) to ban the sale and production of ephedra products.
Recently, the U. S. Department of Health and Human Services requested a comprehensive analysis of the available evidence regarding the efficacy and safety of ephedra. This information is to be used by the National Institutes of Health to guide expanded research on this topic.
The results of this analysis were published in the March 26, 2003 issue of the Journal of the American Medical Association . The researchers found that there is not only insufficient evidence to support the use of ephedra as a means of weight loss or to enhance athletic performance, but that it was linked with important health risks, such as heart palpitations and psychiatric, gastrointestinal, and nervous system problems.
About the study
The researchers searched nine electronic databases for research studies on ephedra or ephedrine. All the studies identified in the search were independently analyzed by two trained reviewers, who selected the clinically controlled trials in which one of the substances was used for either weight loss or enhancing athletic performance. They also selected case reports of adverse events following ephedra use.
For studies assessing ephedra’s efficacy in weight loss, the researchers included only those trials lasting for eight weeks or more. For studies assessing ephedra’s ability to enhance athletic performance, the researchers included only studies with no minimum follow-up period. For the adverse event case reports, the researchers included only reports in which ephedra or ephedrine had been taken 24 hours before the event or traces of ephedrine or its byproducts were found in the patient’s blood or urine, and where all other possible explanations for the event had been eliminated. Of the 530 articles screened, 52 were controlled trials, 65 were case reports.
Regarding weight loss, the researchers found that only high doses of ephedrine yielded statistically significant results. No controlled trials assessing the effect of ephedra on athletic performance were found, and none of the studies assessed ephedra’s effects with repeated use, which is how it is most commonly used among the general public.
What researchers did find was that ephedra and ephedrine were associated with a two to three fold increased risk of psychiatric, gastrointestinal, nervous system and heart symptoms. An evaluation of more than 16,000 adverse event reports revealed five deaths, five heart attacks, eleven strokes, four seizures, and eight psychiatric cases.
How does this affect you?
The results of this study call into question any claim that the use of ephedra or ephedra-containing supplements may help achieve long-term weight loss or improve athletic performance. They also strongly suggest that the use of ephedra and ephedra-containing compounds may be accompanied by an increased risk for serious adverse effects.
In an editorial accompanying the study, the editors of JAMA call for new legislation for defining and regulating dietary supplements. Currently, dietary supplements are not required to have FDA approval or to be registered with the FDA before they are produced and marketed. The editors of JAMA suggest that all dietary supplements should be evaluated and regulated under the same stringent guidelines as prescription drugs, a position that has already sparked a great deal of controversy.
National Institute of Health
U.S. Department of Health and Human Services
Shekelle PG, Hardy ML, Morton SC et al. Efficacy and Safety of Ephedra and Ephedrine For Weight Loss and Athletic Performance. JAMA . 2003;289(12):1537-1545.
Fontanaroas PB, Rennie D, DeAngelis C. The need for regulation of dietary supplements—lessons from ephedra. JAMA . 2003;289(12):1537-1545.
Last reviewed Mar 27, 2003 by ]]>Richard Glickman-Simon, MD]]>
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