Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial

A. Courcoulas, B. K. Abu Dayyeh, L. Eaton, J. Robinson, G. Woodman, M. Fusco, V. Shayani, H. Billy, D. Pambianco, C. Gostout

Research output: Contribution to journalArticle

38 Scopus citations

Abstract

Background/objectives:This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.Subjects/methods:In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m - 2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.Results:At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P≤0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P≤0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.Conclusions and relevance:Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Original languageEnglish (US)
Pages (from-to)427-433
Number of pages7
JournalInternational Journal of Obesity
Volume41
Issue number3
DOIs
StatePublished - Mar 1 2017

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

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    Courcoulas, A., Abu Dayyeh, B. K., Eaton, L., Robinson, J., Woodman, G., Fusco, M., Shayani, V., Billy, H., Pambianco, D., & Gostout, C. (2017). Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial. International Journal of Obesity, 41(3), 427-433. https://doi.org/10.1038/ijo.2016.229