Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine] · 2001
[A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects].
Клиническое исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Zhao Y, Wang X, Yan Z
Аннотация
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.
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.