Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss

医学 减肥 随机对照试验 气球 体质指数 不利影响 肥胖 外科 内科学
作者
Shelby Sullivan,James Swain,George Woodman,Steven A. Edmundowicz,Tarek Hassanein,Vafa Shayani,John C. Fang,Mark D. Noar,George M. Eid,Wayne J. English,Nabil Tariq,Michael Larsen,Sreenivasa S. Jonnalagadda,Dennis Riff,Jaime Ponce,Dayna S. Early,Eric Volckmann,Anna Ibele,Matthew D. Spann,Kumar Krishnan,Juan Carlos Bucobo,Aurora D. Pryor
出处
期刊:Surgery for Obesity and Related Diseases [Elsevier]
卷期号:14 (12): 1876-1889 被引量:107
标识
DOI:10.1016/j.soard.2018.09.486
摘要

Background Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. Objective Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. Setting Fifteen academic and private practice centers in the United States. Methods This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. Results Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. Conclusions Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.
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