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

Shelby Sullivan, James Swain, George Woodman, Steven Edmundowicz, Tarek Hassanein, Vafa Shayani, John C. Fang, Mark Noar, George Eid, Wayne J. English, Nabil Tariq, Michael Larsen, Sreenivasa S. Jonnalagadda, Dennis S. Riff, Jaime Ponce, Dayna Early, Eric Volckmann, Anna R. Ibele, Matthew D. Spann, Kumar KrishnanJuan Carlos Bucobo, Aurora Pryor

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)1876-1889
Number of pages14
JournalSurgery for Obesity and Related Diseases
Volume14
Issue number12
DOIs
StatePublished - Dec 2018
Externally publishedYes

Keywords

  • Endoscopic bariatric therapy
  • Intragastric balloon
  • Swallowable gas-filled intragastric balloon system

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    Sullivan, S., Swain, J., Woodman, G., Edmundowicz, S., Hassanein, T., Shayani, V., Fang, J. C., Noar, M., Eid, G., English, W. J., Tariq, N., Larsen, M., Jonnalagadda, S. S., Riff, D. S., Ponce, J., Early, D., Volckmann, E., Ibele, A. R., Spann, M. D., ... Pryor, A. (2018). Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surgery for Obesity and Related Diseases, 14(12), 1876-1889. https://doi.org/10.1016/j.soard.2018.09.486