The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity

Surg Obes Relat Dis. Jul-Aug 2015;11(4):874-81. doi: 10.1016/j.soard.2014.12.006. Epub 2014 Dec 16.

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.

Keywords: Endoscopic bariatric therapy; Intragastric balloon; Nonsurgical weight loss; Obesity; Randomized controlled trial; Weight loss therapy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Body Mass Index*
  • Double-Blind Method
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Gastric Balloon*
  • Gastroscopy / methods*
  • Humans
  • Male
  • Middle Aged
  • Obesity, Morbid / physiopathology
  • Obesity, Morbid / therapy*
  • Prospective Studies
  • Quality of Life
  • Treatment Outcome
  • Weight Loss / physiology*
  • Young Adult