Journal Article

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

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

2017

Overview

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.

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: 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