Background Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. Objective: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. Setting: Academic and community practice, United States. Methods Participants (n = 326) with body mass index (BMI) 30-40 kg/m2 were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. Results Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P =.004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). Conclusion The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.
Bibliographical noteFunding Information:
The Clinical Events and Data Monitoring Committee members were: Sreeni Jonnalagadda, M.D., FASGE (Chair), University of Missouri at Kansas City, Garth Jacobsen, M.D., FACS, UCSD Medical Center, Peter Denk, M.D., F.A.C.S., GI Surgical Specialists, PLLC, and Richard Chiacchierini, Ph.D., R. P. Chiacchierini & Associates, LLC. The REDUCE Pivotal Trial was supported financially by ReShape Medical. Monitoring was provided by ReShape Medical, Inc. with support from NAMSA (North American Science Associates). Statistical analysis was provided by NAMSA.
- Endoscopic bariatric therapy
- Intragastric balloon
- Nonsurgical weight loss
- Randomized controlled trial
- Weight loss therapy