Weight loss supplements: Ephedrine

Ephedrine is a plant-derived alkaloid, the active principle of ephedra. It is a stimulant belonging to the class of sympathomimetic agents. Like other sympathometic stimulants, it produces a variety of physiologic effects. Those include increased heart rate, elevated blood pressure, stimulation of the central nervous system and others. Two of ephedrine's effects are particularly relevant to weight loss: thermogenesis through increased fat metabolism and appetite suppression.

Ephedrine is one of the very few natural agents reliably proven to cause weight loss - at least in the short-term (most studies were less than a year duration). It appears at least as effective as sympathomimetic prescription drugs FDA-approved for weight loss, such as phentermine.

The RAND study, commissioned by the US government's Office of Dietary Supplements, has reviewed the available research data on ephedrine and came to the following conclusions:

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.

In regard to effectiveness, the bottom line of the RAND study was that:

The short-term use of ephedrine, ephedrine plus caffeine, or the assessed dietary supplements containing Ephedra and herbs with caffeine is associated with a statistically significant increase in short-term weight loss (compared to placebo).

So, the effectiveness is apparently not in question. The main problem with ephedrine and Ephedra is side effects.

RAND conducted meta-analysis (a form of statistical analysis) on data from 50 trials for subgroups of adverse events, including psychiatric symptoms, autonomic hyperactivity, nausea/vomiting, palpitations, hypertension, and tachycardia. No serious adverse events (death, myocardial infarction, cerebrovascular/stroke events, seizure, or serious psychiatric events) were reported in the clinical trials. However, because participants in clinical trials must meet eligibility criteria, including the absence of specific underlying health risks, they may not represent the general population. In fact, the total number of patients in the clinical trials was not sufficient for adequately assessing the possibility of rare outcomes. Although such adverse event reports are not conclusive evidence of a cause-and-effect relationship, they can indicate the potential for such a relationship.

RAND also reviewed 71 cases reported in the published medical literature, 1820 case reports provided by FDA, and more than 18,000 consumer complaints reported to a manufacturer of Ephedra-containing dietary supplements. Most of the cases were not well documented so decisions could not be made about the potential relationship between the use of Ephedra-containing dietary supplements or ephedrine and the adverse event. A total of 65 cases from the published literature, 241 cases from FDA, and 43 cases from a manufacturer of Ephedra-containing dietary supplements were included in the adverse event analysis. Sentinel events with prior Ephedra consumption included 2 deaths, 3 myocardial infarctions, 9 cerebrovascular/stroke events, 3 seizures, and 5 psychiatric cases. Sentinel events with prior ephedrine consumption included 3 deaths, 2 myocardial infarctions, 2 cerebrovascular/stroke events, 1 seizure, and 3 psychiatric cases. About half of the sentinel events occurred in individuals 30 years of age or younger. An additional 43 cases were identified as possible sentinel events with prior Ephedra consumption and an additional 7 cases were identified as possible sentinel events with prior ephedrine consumption.

As a result of RAND's review and other investigations, FDA decided to err on the side of caution and banned Ephedra and ephedrine as an over-the-counter ingredient. However, the ban was subsequently challenged in court. As of the time of this writing, ephedrine and Ephedra remain in legal limbo in the US.

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