Clinical Briefs: Ephedra for Weight Loss

With Comments by John La Puma, MD, FACP

Source: Boozer CN, et al. Herbal ephedra/ caffeine for weight loss: A 6-month randomized safety and efficacy trial. Int J Obes Relat Metab Disord 2002;26:593-604.

To examine long-term safety and efficacy for weight loss of an herbal ma huang and Kola nut supplement (90/192 mg/d ephedrine alkaloids/caffeine), a six-month randomized, double-blind placebo controlled trial was undertaken. A total of 167 subjects (body mass index 31.8 ± 4.1 kg/m2) were randomized to placebo (n = 84) or herbal treatment (n = 83) at two outpatient weight control research units. Primary outcome measures were changes in blood pressure, heart function, and body weight. Secondary variables included body composition and metabolic changes. By last observation carried forward analysis, herbal vs. placebo treatment decreased body weight (-5.3 ± 5.0 kg vs. -2.6 ± 3.2 kg, P < 0.001), body fat (-4.3 ± 3.3 kg vs. -2.7 ± 2.8 kg, P = 0.020) and LDL-cholesterol (-8 ± 20 mg/dL vs. 0 ± 17 mg/dL, P = 0.013), and increased HDL-cholesterol (+2.7 ± 5.7 mg/dL vs. -0.3 ± 6.7 mg/dL, P = 0.004). Herbal treatment produced small changes in blood pressure variables (+3 to -5 mm Hg, P < 0.05) and increased heart rate (4 ± 9 beats/min vs. -3 ± 9 beats/min, P < 0.001), but cardiac arrhythmias were not increased (P > 0.05). By self-report, dry mouth, heartburn, and insomnia increased and diarrhea decreased. Irritability, nausea, chest pain, palpitations, and numbers of subjects who withdrew did not differ. Herbal ephedra/caffeine (90/192 mg/d) promoted body weight and body fat reduction and improved blood lipids without significant adverse events.

Comment

This study was well-conducted, with substantial exclusion criteria—anyone with a chronic disease, recent weight loss, use of weight loss agents, or the slightest hint of illness.

These data show that an ephedra- caffeine combination in moderately high dosage helps promote weight loss. With lost weight and body fat comes a reduction in LDL; with extra sympathomimetics comes a boost in energy, blood pressure, and pulse.

Research support was provided in part by an ephedra trade group, which notes that "¼ researchers were granted the right to publish study results regardless of outcome. Funding was provided by the Ephedra Research Foundation" (available at: www.ephedrafacts.com/overviewharvard.html; accessed Nov. 11, 2002).

The investigators offer "coincidence, pre-existing pathology, non-recommended usage, and increased individual sensitivity" as possible explanations for the difference between their positive results, the negative Mayo Clinic data (see page 147), and a Harvard analysis of FDA data, published in 2001. They believe that adverse events are inevitable, and that "The real question is not whether adverse events occur in a population undergoing treatment, but whether these occur at a rate that is higher than that of a matched, untreated group."

Unfortunately, for clinicians, the real question is whether real patients with complicated medical histories deserve a chemical stress test. It’s obvious that anyone with any vascular illness or at risk for same should not use this combination. These same patients don’t want to be told "No" by their doctor, so they may not show up not for a routine office visit, but for an urgent EKG. That’s why ephedra and its combinations should be banned.

Recommendation

There are better ways to lose weight, although they are harder than taking pills.