Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial

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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, Pvs −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, P0.05). By self-report, dry mouth (PPPP<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.