Ephedra-Caffeine Combo Deemed Safe for Weight, Fat Loss

Ephedra-Caffeine Combo Deemed Safe for Weight, Fat Loss

NEW YORK--The combination of ephedra and caffeine has again been found to be effective and safe for reducing body weight and body fat in obese individuals, according to a study published in the April 25 issue of the International Journal of Obesity (26:593-604, 2002) (www.nature.com/ijo). A collaboration of researchers, including those from the New York Obesity Research Center at St. Luke's Roosevelt Hospital and Columbia University, recruited 167 patients who were healthy but overweight (with a body mass index of 25 to 40). Patients were screened prior to inclusion in the study, and those with high blood pressure, high daily caffeine intakes or abnormal laboratory test results were excluded.

"There are exclusion criteria and selection criteria for the study population," said John Hathcock, Ph.D., vice president of nutritional and regulatory science at the Council for Responsible Nutrition (CRN). "The exclusion and restriction criteria are suggested in the labeling, which consumers should read and pay attention to, and are exactly commensurate with the clinical trial exclusion criteria. If you've got heart disease, high blood pressure, are taking medication, etc., you should not be using ephedra, and the label says so."

For six months, patients were randomly assigned to either the placebo group (n=84) or the treatment group (n=83), which included taking in three doses a total of 90 mg/d of ephedrine alkaloids from ma huang and 192 mg/d of caffeine from kola nut. In addition, subjects were counseled to limit intake of dietary fat to 30 percent of calories and exercise moderately. A total of 87 patients completed the study: 46 in the treatment group and 41 in the placebo group.

Patients in the herbal treatment group exhibited greater reductions in body weight and body mass at the end of the study than those in the placebo group. And while patients in both groups experienced a decrease in waist-to-hip ratios, the losses in the herbal group were significantly greater. Researchers also noted the supplement regimen reduced low-density lipoprotein (LDL, or "bad") cholesterol, as well as increased high-density lipoprotein (HDL, or "good") cholesterol.

The adverse symptoms that were most commonly reported in the herbal treatment group were dry mouth, heartburn and insomnia. Researchers stated there were no significant differences between groups in self-reported chest pain, palpitations, blurred vision, headache, nausea or irritability at any time. However, patients in the treatment group experienced a small, persistent increase in heart rate. Despite this, there were no significant increases subsequent to herbal treatment in any of the cardiac arrhythmias assessed. The study's authors concluded that the caffeine-ephedra mixture used in this study was safe and effective for enhancing body weight and fat loss in healthy, overweight individuals.

Richard L. Atkinson, M.D., editor of the International Journal of Obesity, wrote an editorial comment for this issue (26:589, 2002), saying the use of herbal supplements containing ephedra and caffeine for weight loss has grown controversial. Atkinson stated, "Herbal supplement manufacturers should act responsibly in advertising their supplements, and the lay public should be aware that these papers do not assure the safety, or even the efficacy, of herbal supplements containing ephedra-caffeine in individuals who differ from the carefully selected study subjects. The lay public should use ephedra-caffeine supplements with great caution and, in the opinion of this editor, only under the supervision of a physician."

A guest editorial by A.G. Dulloo of the University of Fribourg in Switzerland was also included to "revisit" the topic (26:590-2, 2002). In his review of the science behind ephedra, Dulloo stated that while "the herbal industry contends that their botanical products are safe and effective for weight loss when used within the labeled dosage range," adverse events have been reported in correlation with their use.

In addition, Dulloo postulated that while both synthetic and natural ephedrine alkaloids have proven effective for weight loss, synthetic alkaloids appear to be safer--perhaps because "largely unregulated supplements" contain ingredients in addition to ephedra and caffeine, or because patients in clinical trials including synthetic mixtures are carefully supervised by physicians. "Several of these supplements include non-negligible amounts of ephedrine isomers, some of which have been implicated in adverse cardiovascular effects..." he wrote. "Whatever the explanations for such discrepancy, however, individual susceptibility to potentially serious adverse effects associated with the consumption of these herbal supplements cannot be ignored."

Hathcock disagreed with the premise that synthetic ephedrine is safer than natural ephedra, saying, "I take exception to the implication in the guest editorial that synthetic ephedrine is safer. I think it's the other way around, and there is biological evidence to support that."

The active preparation used in this study was supplied by Science, Toxicology and Technology, based in San Francisco, and consisted of ma huang from Gardena, Calif.-based Nutratech Inc. and kola nut from Santa Ana, Calif.-based Ashland Distribution Corp.