TY - JOUR
T1 - Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss
AU - Sullivan, Shelby
AU - Swain, James
AU - Woodman, George
AU - Edmundowicz, Steven
AU - Hassanein, Tarek
AU - Shayani, Vafa
AU - Fang, John C.
AU - Noar, Mark
AU - Eid, George
AU - English, Wayne J.
AU - Tariq, Nabil
AU - Larsen, Michael
AU - Jonnalagadda, Sreenivasa S.
AU - Riff, Dennis S.
AU - Ponce, Jaime
AU - Early, Dayna
AU - Volckmann, Eric
AU - Ibele, Anna R.
AU - Spann, Matthew D.
AU - Krishnan, Kumar
AU - Bucobo, Juan Carlos
AU - Pryor, Aurora
N1 - Publisher Copyright:
© 2018 American Society for Bariatric Surgery
PY - 2018/12
Y1 - 2018/12
N2 - 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.
AB - 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.
KW - Endoscopic bariatric therapy
KW - Intragastric balloon
KW - Swallowable gas-filled intragastric balloon system
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U2 - 10.1016/j.soard.2018.09.486
DO - 10.1016/j.soard.2018.09.486
M3 - Article
C2 - 30545596
AN - SCOPUS:85058050258
SN - 1550-7289
VL - 14
SP - 1876
EP - 1889
JO - Surgery for Obesity and Related Diseases
JF - Surgery for Obesity and Related Diseases
IS - 12
ER -