title: Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial.
abstract: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.
  
  
  
  In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m-2were 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.
  
  
  
  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.
  
  
  
  Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.
authors.affiliation: Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Courcoulas
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: B K
authors.initials: BK
authors.lastname: Abu Dayyeh
authors.affiliation: UltaMed Corporation, Huntington Beach, CA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Eaton
authors.affiliation: Simulstat Incorporated, San Diego, CA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Robinson
authors.affiliation: George Woodman, MD, PC, Memphis, TN, USA.
authors.forename: G
authors.initials: G
authors.lastname: Woodman
authors.affiliation: Health First Medical Group, Melbourne, FL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Fusco
authors.affiliation: St James Hospital, Olympia Fields, IL, USA.
authors.forename: V
authors.initials: V
authors.lastname: Shayani
authors.affiliation: Ventura Advanced Surgical Associates, Ventura, CA, USA.
authors.forename: H
authors.initials: H
authors.lastname: Billy
authors.affiliation: Charlottesville Medical Research, Charlottesville, VA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Pambianco
authors.affiliation: Mayo Clinic, Rochester, MN, USA.|Apollo Endosurgery, Austin, TX, USA.
authors.forename: C
authors.initials: C
authors.lastname: Gostout
mesh_terms: D015746:Abdominal Pain; D000328:Adult; D015992:Body Mass Index; D020878:Device Removal; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015905:Gastric Balloon / Q000009:adverse effects; D005773:Gastroscopy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008297:Male; D009325:Nausea; D009767:Obesity, Morbid / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy*; D011183:Postoperative Complications; D011446:Prospective Studies; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014839:Vomiting; D015431:Weight Loss