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 stud y. 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-bl ind placebo-controlled trial. Those weighing less than 80 kg took one table t three times (100 mg/10 mg), whereas those weighing more than 80 kg took t wo 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 th e 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) k g/m(2), respectively. RESULTS: The decrease in relative body weight, BMI and body fat (measured b y bioelectric impedance) was significantly (P < 0.05) greater in the CE gro up (mean+/-s.d.; 14.4+/-10.5%, 2.9+/-1.9 kg/m(2), 6.6+/- 6.0 kg) than in th e PL group (2.2+/-5.8%, 0.5+/-1.6 kg/m(2), 0.5+/-2.7 kg). Relative body wei ght decreased by more than 5% in 81% of the CE group, out only in 31% of th e PL group. Adverse events were negligible and did not differ between the C E and PL groups. Withdrawal symptoms were mild, transient and their frequen cy and severity were not different between the placebo and active groups. CONCLUSION: According to the present pilot study, CE can be a safe and effe ctive compound for the treatment of obesity in adolescents.