11-11-2004, 08:36 AM
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#9 (permalink)
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Mjollnir Incarnate
Location: Lost in thought
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Source
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* The Chinese botanical ephedra, or ma-huang, is sold as a dietary supplement in the United States. It is a natural source of the alkaloids ephedrine and pseudoephedrine. Some dietary supplement products used for weight loss and to enhance athletic performance contain these alkaloids.
* Synthetic ephedrine and pseudoephedrine are found in over-the-counter decongestants and cold medicines and are used to treat asthma. Ephedrine is not approved in the United States as a drug for weight loss or to enhance athletic performance.
* The use of ephedrine, ephedrine plus caffeine, or dietary supplements containing ephedra and botanicals with caffeine is associated with a modest but statistically significant increase in weight loss over a relatively short time (less than or equal to 6 months). No studies have assessed their long-term effects (greater than 6 months).
* No studies have assessed the effect of dietary supplements containing ephedra and botanicals on athletic performance. The few studies that assessed the effect of ephedrine support a modest effect of ephedrine plus caffeine on very-short-term (1-2 hours after a single dose) athletic performance in a highly selected physically fit population.
* Results of controlled trials show that the use of synthetic ephedrine, ephedrine plus caffeine, or ephedra plus botanicals containing caffeine is associated with 2-3 times the risk of nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations compared with placebo.
* RAND analyzed adverse event reports filed with the U.S. Food and Drug Administration (FDA) and with a manufacturer of ephedra-containing dietary supplements as well as published case reports. Although this analysis raises concerns about the safety of botanical dietary supplements containing ephedra, most of these case reports are not documented sufficiently to support an informed judgment about the relationship between the use of ephedra-containing dietary supplements or ephedrine and the adverse event in question.
* According to the RAND report, the number of deaths, myocardial infarctions, cerebrovascular accidents, seizures, and serious psychiatric illnesses in young adults is sufficient to warrant further evaluation of the safety of these products in a controlled manner (such as a hypothesis-testing case-control study) to test the possibility that consumption of ephedra or ephedrine causes these serious adverse events.
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* Ephedrine vs. placebo: 5 studies. Ephedrine was associated with a statistically significant weight loss of 1.3 pounds/month more than was associated with placebo for up to 4 months of use.
* Ephedrine plus caffeine vs. placebo: 12 studies. Ephedrine plus caffeine was associated with a statistically significant weight loss of 2.2 pounds/month more than was associated with placebo for up to 4 months of use.
* Ephedrine plus caffeine vs. ephedrine: 3 studies. Ephedrine plus caffeine was associated with a statistically significant weight loss of 0.8 pounds/month more than was associated with ephedrine alone.
* Ephedrine vs. other active weight loss products: 2 studies. No conclusions could be drawn because of the small sample size in each of these studies.
* Ephedra plus herbs containing caffeine vs. placebo: 4 studies. Ephedra plus herbs containing caffeine was associated with a statistically significant weight loss of 2.1 pounds/month more than was associated with placebo for up to 4 months of use.
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Are 1.3 pounds per month worth the potential serious side effects?
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