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.
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.
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%).
The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Surgery for Obesity and Related Diseases
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Evidence-based review of the BioEnterics intragastric balloon for weight loss.Obes Surg. 2008; 18: 1611-1617
- Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.Obes Surg. 2008; 18: 841-846
- Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity.Surg Obes Relat Dis. 2012; 9: 290-295
- BioEnterics Intragastric Balloon (BIB): a short term, double blind, randomized, controlled crossover study on weight reduction in morbidly obese patients.Int J Obes. 2006; 30: 129-133
- Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity.Obes Surg. 2007; 17: 649-657
- Fasting and meal-induced CCK and PP secretion following intragastric balloon treatment for obesity.Obes Surg. 2013; 23: 622-633
- Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up.Gastrointest Endosc. 2005; 61: 19-27
- 500 Intragastric Balloons: What Happens 5 Years Thereafter?.Obes Surg. 2012; 22: 896-903
- BioEnterics® intragastric balloon (BIB®). Single ambulatory center Spanish experience with 714 consecutive patients treated with one or two consecutive balloons.Obes Surg. 2010; 21: 5-9
- Impact on obesity-related illnesses and quality of life following intragastric balloon.Obes Surg. 2010; 20: 1128-1132
- Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience.Obes Surg. 2013; 23: 515-521
- Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study.Obes Surg. 2010; 20: 692-697
- Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients.Obes Surg. 2010; 20: 1496-1500
- Comparison of results of laparoscopic gastric banding and consecutive intragastric balloon application at 18 months: a clinical prospective study.J Laparoendosc Adv Surg Tech A. 2011; 21: 471-475
- Assessment of the application of the intragastric balloon together with sibutramine: a prospective clinical study.Obes Surg. 2010; 20: 1117-1120
- Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity.Obes Surg. 2012; 22: 565-571
- Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy.Obes Surg. 2005; 15: 101-105
- Small-bowel migration: a possible complication of adjustable intragastric balloons.Endoscopy. 2012; 44: E224
- Intragastric balloon in obese patients.Obes Surg. 2000; 10: 578-581
- BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients.Obes Surg. 2005; 15: 1161-1164
- Perforation of the esophagus caused by the insertion of an intragastric balloon for the treatment of obesity.Obes Surg. 2006; 16: 667-670
- Intragastric balloon for "non-morbid" obesity: a retrospective evaluation of tolerance and efficacy.Obes Surg. 2004; 14: 539-544
- Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.National Institute of Health, NIH Publication Number 00-4084. October 2000;
- An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation--a VA cooperative study.Stat Med. 1996; 15: 1421-1434
- Assessment of blinding in clinical trials.Control Clin Trials. 2004; 25: 143-156
- A review of unmet needs in obesity management.Obes Surg. 2012; 22: 956-966
- The rate of NSAID-induced endoscopic ulcers increases linearly but not exponentially with age: a pooled analysis of 12 randomised trials.Ann Rheum Dis. 2007; 66: 417-418
- Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial.Lancet. 2010; 376: 173-179
- Haemoglobin decreases in NSAID users over time: an analysis of two large outcome trials.Aliment Pharmacol Ther. 2011; 34: 70808-70816
- Fernandez-Corbelle J. A prospective evaluation of a new dual intragastric balloon.Obes Surg. 2014; 24: 1131
Published online: December 16, 2014
Accepted: December 8, 2014
Received: September 30, 2014
© 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.