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/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.
Keywords
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Article info
Publication history
Published online: December 16, 2014
Accepted:
December 8,
2014
Received:
September 30,
2014
Identification
Copyright
© 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
