Introduction
Intragastric balloon (IGB) is a minimally invasive intervention used for obese patients who do not achieve adequate weight loss with standard medical therapy (SMT), which includes lifestyle interventions with or without pharmacological treatment. It is also an option for individuals who do not meet the criteria for bariatric surgery or choose not to undergo it. Despite its growing use, there is little data on the short and long-term effectiveness of IGB compared to SMT in randomized controlled trials (RCTs).
Aims & Methods
This systematic review and meta-analysis aimed to compare the efficacy of IGB therapy for at least six months versus SMT in the treatment of obesity, assessing outcomes at 6, 9, and 12 months. A comprehensive literature search was conducted in the MEDLINE, EMBASE, and Cochrane Library databases. The primary outcome was the percentage of excess weight loss (%EWL), while secondary outcomes included absolute weight loss (AWL), percentage of total weight loss (%TWL), and body mass index reduction (BMIR). We calculated mean differences (MD) with 95% confidence intervals (CI) for continuous outcomes. Meta-regression was performed using baseline body mass index (BMI) as a covariate, and subgroup analyses were conducted based on IGB type, baseline BMI, and pharmacological therapy in the SMT group.
Results
A total of 15 RCTs, including 1,961 patients, were included. Compared to SMT, IGB therapy resulted in significantly greater %EWL at 6 months (MD 16.80%; 95% CI [9.22%; 24.38%]), 9 months (MD 14.36%; 95% CI [7.67%; 21.04%]), and 12 months (MD 13.10%; 95% CI [10.43%; 15.77%]). IGB was also superior in AWL, %TWL, and BMIR across all time points (Table 1). Subgroup analyses revealed that results remained consistent regardless of pharmacological therapy use in the SMT group (p=0.77). The Orbera balloon showed superior %TWL at 6 months (p<0.01) and AWL at 6 months (test for subgroup differences with p=0.01), while the Spatz3 balloon demonstrated better %TWL at 9 months (p<0.01). Studies with a baseline BMI >40 kg/m² had significantly greater %TWL at 6 months (p=0.04) and AWL at 6 months (p<0.01) than those with BMI ≤40 kg/m². Meta-regression analysis indicated that higher baseline BMI was associated with greater AWL and BMIR at 6 months.
Conclusion
IGB therapy was significantly more effective than SMT, even when pharmacological therapy was included, leading to superior weight loss outcomes at 6, 9, and 12 months.
Table 1. Summary of findings.
| Outcome | Single-arm analysis, mean (95% CI) | Two-arm analysis,
Mean difference (95%CI) |
| IGB group | SMT group |
| %EWL 6 months | 30.37 (23.25, 37.48) | 13.07 (8.17, 17.98) | 16.80 (9.22, 24.38) |
| %EWL 9 months | 28.31 (7.93, 48.68) | 12.09 (-0.82, 25.01) | 14.36 (7.67, 21.04) |
| %EWL 12 months | 34.51 (32.40, 36.62) | 20.62 (16.61, 24.62) | 13.10 (10.43, 15.77) |
| %TBWL 9 months | 13.11 (9.80, 16.41) | 3.78 (2.72, 4.83) | 7.66 (3.34, 11.98) |
| %TBWL 12 months | 9.70 (6.13, 13.27) | 4.63 (1.84, 7.42) | 5.33 (4.16, 6.50) |
| AWL 9 months, kg | 13.14 (8.82, 17.45) | 4.37 (2.91, 5.83) | 8.65 (4.93, 12.37) |
| AWL 12 months, kg | 10.175 (4.61, 15.73) | 5.38 (1.97, 8.78) | 4.87 (1.87, 7.88) |
| BMI loss 12 months, kg/m² | 4.85 (2.01, 7.69) | 2.61 (1.24, 3.98) | 2.27 (0.80, 3.74)
|
AWL, absolute weight loss; BMI, body mass index; CI, confidence interval; IGB, intragastric balloon; MD, mean difference; RCTs, randomized controlled trials; SMT, standard medical treatment; %EWL, percentage of excess weight loss; %TBWL, percentage of total body weight loss.
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