Health Professionals

A Summary of Recent Studies That Show That Dietary Supplements Containing Ephedrine Alkaloids Are Effective for Weight Loss

Issue: Whether dietary supplements containing ephedrine alkaloids are safe and effective for weight loss.

Findings ‚ Prominent Experts in Obesity Treatment Find Products Safe and Effective for Weight Loss:

Data from studies conducted in the U.S., as well as evidence from studies conducted in Denmark, show that dietary supplements containing ephedrine alkaloids are safe and effective products for weight loss. Prominent clinical researchers in bariatric medicine (obesity experts) called for the continued availability of these weight loss products given the available data and the urgent health crisis faced by the American public from obesity, and they also urged the federal government to fund additional research on these products.

Studies Conducted in Denmark by Dr. Arne Astrup, M.D., Ph.D.

Dr. Arne Astrup, Professor and Director of Research, Department of Human Nutrition, University of Copenhagen, is a leading researcher in the treatment of obesity and has spent the last twenty years doing research on all different aspects of obesity. Some of his research includes studies on ephedrine and caffeine to determine whether this combination is safe and effective for weight loss. One six-month study of 180 obese subjects found that ephedrine, when combined with caffeine, is effective as a weight loss product, even more so than ephedrine or caffeine alone. The study also found that side effects associated with consumption of the ephedrine/caffeine combination were mild and transient, only lasting the first two weeks of treatment.

Based in part on Dr. Astrup's research, since 1990, ephedrine/caffeine combination compounds have been licensed by the Danish Drug Administration (DDA) to treat obesity. The DDA has collected reports of side effects from the compound, but the side effects have been mild and expected (e.g., tremor, insomnia, palpitations). There have been no serious adverse effects from these products, even though they have been widely sold and marketed in Denmark for ten years. Reflecting the safety and usefulness of these products for weight loss, the ephedrine/caffeine combination holds the majority of the weight loss market share ‚ around 70-90% ‚ in Denmark.

Studies by Dr. Patricia Ann Daly, M.D., York Hospital, and Carol Boozer, D.Sc., Columbia University

Drs. Patricia Daly and Carol Boozer have completed two studies on dietary supplements containing ephedrine alkaloids combined with caffeine when used for weight loss. The first study, an eight-week study in 48 subjects published in abstract form in early 1999, showed that the commercial product, Metabolife 356, produced significant weight loss compared to placebo. The authors concluded that safety for long term use required further study.

The same researchers have now completed a much larger and more significant study on ephedrine/caffeine combination products and their effectiveness in weight loss. Once published, the study will be the most comprehensive clinical trial on the safety and efficacy of ephedra products when used for weight loss. The study involved 167 mildly to severely overweight subjects, and the test product used was a "generic" ephedra/caffeine combination product consisting of daily servings totaling 192 mg of caffeine and 90 mg of ephedrine for six months. None of the subjects experienced a life-threatening medical condition, such as seizure, stroke, or myocardial infarction. Currently, there are no data available on the efficacy of the product for weight loss. Drs.ÝDaly and Boozer are preparing a report of the study for publication.

Studies by Dr. Gary Huber, Texas Nutrition Institute

Dr. Gary Huber, of the Texas Nutrition Institute, conducted a randomized, placebo-controlled, double-blinded study on 60 subjects to evaluate the effects of dietary supplements containing ephedrine alkaloids on weight loss. The study involved four different brands of ephedra-containing dietary supplements, three with caffeine and one without, and each brand of product induced significant weight loss compared to placebo (i.e., one to two or slightly more pounds per week) over the six-week period of study that has been completed to date. This study is continuing and additional data through six months will be collected. Dr. Huber has reported that no serious adverse events occurred and that, for most subjects, weight loss was associated with diminution in the symptoms associated with undesired excess weight, including joint pain, high blood pressure, and blood triglycerides.

This study was preceded by a six-month prospective open-label study in over 100 subjects. The open-label study provided data that are consistent with the placebo-controlled study, again showing that ephedra products are useful for weight loss and are safe.

Dr. Huber was accompanied at the August 8-9 HHS meeting by three patients who reported on their life-changing successes with dietary supplements containing ephedrine alkaloids. Their stories were similar to the reports of many other consumers of ephedra-based weight loss products, as well as treating physicians, who also testified at the HHS meeting. Having tried and failed to lose weight through diet and exercise, these consumers and physicians reported on their successes with these dietary supplements, resulting in enormous gains in overall physical and mental health.

Testimony of Dr. George A. Bray, M.D.

I am here today to argue for the continued availability of over-the-counter products containing ephedra alkaloids as one tool to help combat [obesity]. Let us not throw out the baby with the bath water.

- Dr. George A. Bray, at the HHS Ephedra Meeting

Dr. George Bray, Boyd Professor and Professor of Medicine at the Louisiana State University and a leading expert and researcher in the area of obesity, testified at the August 8-9, 2000 HHS meeting on the safety of dietary supplements containing ephedrine alkaloids. He advocated for the continued over-the-counter availability of these products because of their safety and effectiveness in helping people lose weight.

Dr. Bray noted that both the World Health Organization and the National Heart, Lung, and Blood Institute have labeled obesity as an epidemic. In addition, he stated that more than 20% of adult Americans are now obese and that the prevalence of obesity in adults and children has increased almost 50% in the past decade. Dr. Bray also noted that obesity is a major risk to health and increases mortality.

Dr. Bray stated that dietary supplements containing ephedrine alkaloids, when used "judiciously and according to [label] recommendations," are effective, inexpensive, and safe to use to help individuals lose weight. He noted that the efficacy of these products is supported by their rapid and continuing growth in sales: over 3 billion doses of ephedra were sold in 1999. He also noted how the studies conducted in Denmark show that these products are both effective and safe. He urged the HHS panel to continue to allow these products on the market so that they may continue to improve the quality of life for so many individuals.

Conclusion ‚ Dietary supplements containing ephedrine alkaloids are safe and effective for weight loss.

Data from U.S. and Danish studies on the effects of ephedrine alkaloids, with or without caffeine, in weight loss shows that these products are both safe and effective. Continued consumer access to and use of these products is now advocated by leading bariatric researchers who have had first-hand experience in seeing the beneficial effects of these products. Given the epidemic of obesity in this country, dietary supplements provide a safe, effective, and economically sensible alternative to their prescription drug counterparts for weight loss as well as new hope for millions of Americans who have tried and failed to lose weight through diet and exercise alone.

Back to top