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

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±6.7mg/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. CONCLUSION: 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.