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

Int J Obes (Lond). 2017 Mar;41(3):427-433. doi: 10.1038/ijo.2016.229. Epub 2016 Dec 23.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain
  • Adult
  • Body Mass Index
  • Device Removal
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gastric Balloon* / adverse effects
  • Gastroscopy* / adverse effects
  • Gastroscopy* / methods
  • Humans
  • Male
  • Nausea
  • Obesity, Morbid / epidemiology
  • Obesity, Morbid / prevention & control*
  • Obesity, Morbid / therapy*
  • Postoperative Complications
  • Prospective Studies
  • Risk Reduction Behavior*
  • Time Factors
  • Treatment Outcome
  • United States / epidemiology
  • Vomiting
  • Weight Loss