[A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects]

Author: Zhao Y, Wang X, Yan Z

Author affiliation: Department of Endocrinology, Rui-jin Hospital, Shanghai 2nd Medical University, Shanghai 200025, China.

Publication date & source: 2001.09, Zhonghua Yu Fang Yi Xue Za Zhi., 35(5):329-32.

Publication type: Clinical Trial; English Abstract; Multicenter Study; Randomized Controlled Trial

OBJECTIVES: To assess weight loss efficacy, safety and tolerability of sibutramine in simple obese subjects. METHODS: Randomized, double-blind, placebo-controlled clinical trial. Four hospital outpatient clinics in Shanghai, Chongqing, Shandong and Tianjin, respectively. Participants: 233 men and women, 18-65 years old, with body mass index (BMI) ranging from 27 to 40 kg/m2 were randomly divided into an intervened group and a placebo control group. Sibutramine 10 mg or placebo once a day. Main outcome measures: Body weight, routine laboratory and clinical safety monitoring. RESULTS: Of 233 eligible patients, 120 received sibutramine and 113 placebo. Weight reduction was significantly greater in the intervented group (6.8 +/- 3.1) kg than the placebo control group (0.48 +/- 2.6) kg from week 4 onwards to week 24 (P < 0.001). Some minor side effects were noticed in the subjects who took sibutramine. But the symptoms were light and short term. Sibutramine was well tolerated. CONCLUSIONS: Sibutramine 10 mg once a day is an effective and safe therapy for weight reduction in simple over-weighted and obese subjects.