Sixteen studies (n=3,608) were included in the review: two RCTs and 14 studies uncontrolled case series. Fifteen studies were included in the analysis. Both RCTs met all validity assessment criteria. Nine uncontrolled case series met all relevant validity assessment criteria.
Pooled analysis (two RCTs, n=75) reported that the intragastric balloon with conventional treatment demonstrated greater weight loss compared to placebo with conventional treatment at end of treatment. Mean differences were: weight loss of 6.7kg; 1.5% of initial weight loss; 3.2kg/m2 lowering of body mass index; and 17.6% of excess weight lost. There was evidence of statistical heterogeneity for this analysis (data not reported).
The estimates for weight lost at balloon removal for intragastric balloon with conventional treatment were (15 studies, n=3,608): 14.7kg lost; 12.2% of initial weight lost; 5.7 kg/m2 lowering of body mass index; and 32.1% of excess weight lost. There was evidence of statistical heterogeneity for these measures (data not reported).
The early balloon removal rate was 4.2% (13 studies, n=3,442). Almost 43% of early removals were voluntary. Most complications were mild; however, 26 patients experienced digestive tract obstructions and four patients experienced gastric perforation, which resulted in two deaths.