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

• Published in: International Journal of Obesity Vol. 41; no. 3; pp. 427 - 433
• Main Authors: Courcoulas, A, Abu Dayyeh, B K, Eaton, L, Robinson, J, Woodman, G, Fusco, M, Shayani, V, Billy, H, Pambianco, D, Gostout, C
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.03.2017; Nature Publishing Group
• Subjects: 692/308; 692/308/2778; 692/308/2779/777; 692/699/2743/393; 692/700/2817; 692/700/459/284; Abdominal Pain; Adult; Adverse events; Balloon treatment; Body Mass Index; Body size; Body weight; Body weight loss; Cardiovascular disease; Care and treatment; Clinical trials; Device Removal; Digestive system surgery; Double-Blind Method; Endoscopy; Epidemiology; Female; Follow-Up Studies; Gastric Balloon - adverse effects; Gastrointestinal surgery; Gastroscopy - adverse effects; Gastroscopy - methods; Health aspects; Health Promotion and Disease Prevention; Humans; Internal Medicine; Intervention; Life style; Lifestyles; Male; Medicine; Medicine & Public Health; Metabolic Diseases; Methods; Nausea; Obesity; Obesity, Morbid - epidemiology; Obesity, Morbid - prevention & control; Obesity, Morbid - therapy; original-article; Pain; Patient outcomes; Postoperative Complications; Prospective Studies; Public Health; Risk Reduction Behavior; Time Factors; Treatment Outcome; Ulcers; United States - epidemiology; Vomiting; Weight control; Weight Loss; Weight loss measurement; United States; United States > US; Pittsburgh Pennsylvania
• ISSN: 0307-0565; 1476-5497; 1476-5497
• DOI: 10.1038/ijo.2016.229

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.