Background: The intragastric balloon (IGB) is an adjunctive treatment for obesity. This meta-analysis aimed to evaluate the efficacy and safety of IGB treatment by reviewing randomized controlled trials (RCTs).
Methods: A total of 20 RCTs involving 1195 patients were identified. Weight loss results before and after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were compared.
Results: Our meta-analysis calculated the following significant effect sizes: 1.59 and 1.34 kg/m2 for overall and 3-month BMI loss, respectively; 14.25 and 11.16 % for overall and >3-month percentage of excess weight loss, respectively; 4.6 and 4.77 kg for overall and 3-month weight loss, respectively; and 2.81, 1.62, and 4.09 % for overall, 3-month, and >3-month percent of weight loss, respectively. A significant effect size was calculated that favored fluid-filled IGBs over air-filled IGBs. Flatulence (8.75 vs. 3.89 %, p = 0.0006), abdominal fullness (6.32 vs. 0.55 %, p = 0.001), abdominal pain (13.86 vs. 7.2 %, p = 0.0001), abdominal discomfort (4.37 vs. 0.55 %, p = 0.006), and gastric ulcer (12.5 vs. 1.2 %, p < 0.0001) were significantly more prevalent among IGB patients than among non-IGB control patients. No mortality was reported from IGB treatment.
Conclusion: IGB treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not sufficient evidence confirming its safety or long-term efficacy.
Keywords: Bariatric surgery; Efficacy; Intra-gastric balloon; Meta-analysis; Systematic review; Weight loss.