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


METHODS
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.


METHODS
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.
Zhao
Y
Y
Department of Endocrinology, Rui-jin Hospital, Shanghai 2nd Medical University, Shanghai 200025, China.
Wang
X
X
Yan
Z
Z
D000293:Adolescent; D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine