Safety and efficacy of treatment with an ephedrine/caffeine mixture.: The first double-blind placebo-controlled pilot study in adolescents

OBJECTIVE: The present study was performed to investigate the efficacy and safety of a caffeine/ephedrine (CE) mixture in obese adolescents. SUBJECTS: Thirty-two (m/f=16/16) obese children were included into the study. They were treated by diet (calculated daily energy requirement minus 500 kcal) and either CE or placebo (PL) for 20 weeks in a randomized double-blind placebo-controlled trial. Those weighing less than 80 kg took one tablet three times (100 mg/10 mg), whereas those weighing more than 80 kg took two tablets three times per day. There were three dropouts (girls) from the PL group. The age, weight body mass index (BMI) values (mean (range)) of the PL and CE groups were 16.0 (14.3-17.6) and 16.0 (14.2-17.7) y, 103.0 (77.2-126.4) and 104.8 (69.8-150.2) kg, 35.2 (28.3-42.3) and 36.5 (31.3-51.8) kg/m(2), respectively. RESULTS: The decrease in relative body weight, BMI and body fat (measured by bioelectric impedance) was significantly (P < 0.05) greater in the CE group (mean+/-s.d.; 14.4+/-10.5%, 2.9+/-1.9 kg/m(2), 6.6+/- 6.0 kg) than in the PL group (2.2+/-5.8%, 0.5+/-1.6 kg/m(2), 0.5+/-2.7 kg). Relative body weight decreased by more than 5% in 81% of the CE group, out only in 31% of the PL group. Adverse events were negligible and did not differ between the CE and PL groups. Withdrawal symptoms were mild, transient and their frequency and severity were not different between the placebo and active groups. CONCLUSION: According to the present pilot study, CE can be a safe and effective compound for the treatment of obesity in adolescents.