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 AE 4.1 kg=m 2 ) randomized to placebo (n ¼ 84) or herbal treatment (n ¼ 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 ( 7 5.3 AE 5.0 vs 7 2.6 AE 3.2 kg, P < 0.001), body fat ( 7 4.3 AE 3.3 vs 7 2.7 AE 2.8 kg, P ¼ 0.020) and LDL-cholesterol ( 7 8 AE 20 vs 0 AE 17 mg=dl, P ¼ 0.013), and increased HDL-cholesterol ( þ 2.7 AE 5.7 vs 7 0.3 AE 6.7 mg=dl, P ¼ 0.004). Herbal treatment produced small changes in blood pressure variables ( þ 3 to 7 5 mmHg, P 0.05), and increased heart rate (4 AE 9 vs 7 3 AE 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.

GREENWAY, FRANK L., LILIAN DE JONGE, DAMIAN BLANCHARD, MADLYN FRISARD, AND STEVEN R. SMITH. Effect of a dietary herbal supplement containing caffeine and ephedra on weight, metabolic rate, and body composition. Obes Res. 2004;12:1152-1157. Objective: To evaluate the effect of a dietary supplement containing herbal caffeine (70 mg/dose) and ephedra (24 mg/dose; C&E) on metabolic rate, weight loss, body composition, and safety parameters. Research Methods and Procedures:In phase I, 12 healthy subjects with a BMI of 25 to 35 kg/m 2 had resting metabolic rate (RMR) measured for 2 hours after ingesting C&E or a placebo on two occasions 1 week apart, followed by a 1-week washout before phase II. In phase II, these 12 and 28 additional subjects were randomized to a 12-week, doubleblind trial comparing C&E (3 times/day) to placebo. In phase III, the C&E group was given open-label C&E for 3 months, and the placebo group was given C&E for 6 months. Results: In phase I, C&E gave an average 8 Ϯ 0.1% (SE) rise in RMR over 2 hours compared with placebo (p Ͻ 0.01). In phase II, weight loss at 12 weeks was 3.5 Ϯ 0.6 kg with C&E compared with 0.8 Ϯ 0.5 kg with placebo (p Ͻ 0.02). The percentage fat lost, shown by DXA, was 7.9 Ϯ 2.9% with C&E and 1.9 Ϯ 1.1% with placebo (p Ͻ 0.05). Pulse decreased more in the placebo group that in the C&E group (p Ͻ 0.03). There were no differences in lipid levels or blood pressure. In phase III, there was a 6-month loss of 7.3% and 7.8% of initial body weight for the groups on placebo and C&E during phase II, respectively. There were no serious adverse events. Discussion: C&E increased RMR significantly by 8% compared with placebo, promoted more weight and fat loss than placebo, and was well tolerated.