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The literature review was conducted by our staff with the assistance of several clinical experts. Only controlled clinical trials and randomized controlled trials of effectiveness—that is, studies that satisfied a strict set of quality criteria—were included in our analysis.
Randomized controlled trials RCT are clinical trials in which participants are assigned randomly to one of two or more treatment groups. Controlled clinical trials are those in which participants are assigned to a treatment group using a semi-random procedure such as a participant's date of birth, a patient identification number, or the order of enrollment.
In all, we reviewed the results of 52 clinical trials that measured the effects of ephedra or ephedrine on weight loss and athletic performance. Most of these studies included one group of participants who were randomly chosen to receive only a placebo an inactive dummy pill. This type of study maximizes the likelihood that any differences found between the groups taking the test supplement and those taking the placebo are real, not due to chance or bias.
Studies of weight loss usually measure the weight lost over the course of the study, the weight lost per month, or the proportion of an individual's original weight that was lost. For each group of studies that made the same comparisons for example, all studies that compared the effects of ephedra and herbal caffeine on weight loss with the effects of a placebo , we combined the results of all studies in that group, using a statistical technique called meta-analysis, and calculated the average total weight lost as well as the average lost per month.
Over the short term four to six months , ephedrine, ephedrine plus caffeine, and supplements containing ephedra or ephedra plus caffeine promoted modest increases in weight loss, about two pounds per month more than the weight loss of persons taking the placebo. Products containing caffeine seemed to promote slightly more weight loss than those containing only ephedrine. However, none of the studies lasted longer than six months, far less than the twelve months researchers consider the minimum necessary to establish the value of a weight loss product studies that lasted less than two months were excluded from our analysis because two months is simply too short a time to assess a meaningful change in weight.
We found no studies that assessed the effects of ephedra-containing dietary supplements on athletic performance.
Thus we analyzed only studies of products containing ephedrine or ephedrine plus caffeine, seven studies in all. No two studies were judged similar enough in design to combine their results: Measures of athletic performance varied widely from one study to another.
As a result, our conclusions regarding the effects of ephedrine on athletic performance are based on a nonquantitative synthesis of the research rather than on meta-analysis. In addition, no study looked at long-term changes in performance. Our analysis found that one-time use of ephedrinecontaining products seems to enhance immediate physical performance, but only when taken in combination with caffeine.
These results, too, must be interpreted with caution. The studies assessed performance immediately after a single dose; none of the studies examined the type of chronic, long-term use typical of consumers of these products.
What's more, the study participants,all young, fit males,may not be typical of the average consumer. To assess the safety of ephedra- and ephedrine-containing products, we reviewed four sources for reports of adverse events. First, we reviewed the clinical trials included in our analyses of weight loss and athletic performance, most of which reported adverse events for both treatment and placebo groups.
The trials contained no reports of very serious adverse events such as death and cardiovascular events.
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