Jaime Ponce1, George Woodman2, James Swain3, Erik Wilson4, Wayne English5, Sayeed Ikramuddin6, Eric Bour7, Steven Edmundowicz8, Brad Snyder4, Flavia Soto5, Shelby Sullivan8, Richard Holcomb9, John Lehmann9. 1. Chattanooga Bariatrics, Chattanooga, TN, and Hamilton Weight Management Center, Hamilton Medical Center, Dalton, GA. Electronic address: JPonceMD@gmail.com. 2. MidSouth Bariatrics, Memphis, TN, and Baptist Memorial Hospital, Memphis, TN. 3. Scottsdale Healthcare Bariatric Center, Scottsdale Healthcare System, Scottsdale, AZ. 4. Department of Surgery, University of Texas Medical School at Houston, Houston, TX. 5. Department of Surgery, Marquette General Hospital, Marquette, MI. 6. Department of Surgery, University of Minnesota, Minneapolis, MN. 7. Department of Surgery, Greenville Health System, Greenville, SC. 8. Division of Gastroenterology, Washington University, St Louis, MO. 9. ReShape Medical, Inc., San Clemente, CA.
Abstract
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/m(2) 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.
RCT Entities:
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/m(2) 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.
Authors: Alia Hadefi; Marianna Arvanitakis; Vincent Huberty; Jacques Devière Journal: United European Gastroenterol J Date: 2020-07 Impact factor: 4.623