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| Paper |
| Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial |
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| C N Boozer1, P A Daly2, P Homel3, J L Solomon1, D Blanchard2, J A Nasser1, R Strauss4 and T Meredith5,a |
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1New York Obesity Research Center, St Luke's-Roosevelt Hospital and Columbia University, New York, USA
2Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
3Beth Israel Medical Center, New York, USA
4Cigna Health Care, Los Angeles, California, USA
5Vanderbilt University Medical Center, Nashville, Tennessee, USA
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Correspondence to: C N Boozer, New York Obesity Research Center, WH 1029, St Luke's-Roosevelt Hospital Center, 1111 Amsterdam Avenue, New York, NY 10025, USA. E-mail: cnb7@columbia.edu | |
a†Current address: World Health Organization, Geneva, Switzerland. |
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| Abstract |
| Objective: To examine long-term safety and efficacy for weight loss of an herbal Ma Huang and Kola nut supplement (90/192 mg/day ephedrine alkaloids/caffeine). Design: Six-month randomized, double-blind placebo controlled trial. Subjects: A total of 167 subjects (body mass index (BMI) 31.8±4.1 kg/m2) randomized to placebo (n=84) or herbal treatment (n=83) at two outpatient weight control research units. Measurements: Primary outcome measurements were changes in blood pressure, heart function and body weight. Secondary variables included body composition and metabolic changes. Results: By last observation carried forward analysis, herbal vs placebo treatment decreased body weight (-5.3±5.0 vs -2.6±3.2 kg, P<0.001), body fat (-4.3±3.3 vs -2.7±2.8 kg, P=0.020) and LDL-cholesterol (-8±20 vs 0±17 mg/dl, P=0.013), and increased HDL-cholesterol (+2.7±5.7 vs -0.3±6.7 mg/dl, P=0.004). Herbal treatment produced small changes in blood pressure variables (+3 to -5 mmHg, P£0.05), and increased heart rate (4±9 vs -3±9 bpm, P<0.001), but cardiac arrhythmias were not increased (P>0.05). By self-report, dry mouth (P<0.01), heartburn (P<0.05), and insomnia (P<0.01) were increased and diarrhea decreased (P<0.05). Irritability, nausea, chest pain and palpitations did not differ, nor did numbers of subjects who withdrew. Conclusions: In this 6-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg/day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events. International Journal of Obesity (2002) 26, 593-604. DOI:10.1038/sj/ijo/0802023 |
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| Keywords |
| Ma Huang; Kola nut; ephedrine; ephedra alkaloids; obesity; weight loss; clinical trial; herbal medicine; alternative medicine |
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| Received 26 October 2001; revised 6 February 2002; accepted 11 February 2002 |
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| May 2002, Volume 26, Number 5, Pages 593-604 |
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