1. A significantly greater reduction in total body weight was seen in the adjustable intragastric balloon group compared to the control group.
2. The intragastric balloon was removed early in 17% of patients due to intolerance.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Since the turn of the century, over 300 million adults globally are obese, leading the World Health Organization (WHO) to announce an “obesity epidemic.” Weight loss strategies are a controversial topic with varying success rates and patient compliance. A new minimally invasive intervention which follows a similar mechanism of the gastric bypass is a space-occupying intragastric balloon (IGB). This randomized-control trial tested the effectiveness of an adjustable silicone IGB (aIGB) for weight loss in adults with obesity. All patients enrolled in the study received dietary and exercise counselling. The study found that the aIGB group had a significantly greater percentage of total body weight loss compared to the counselling-only (control) group. Weight loss was also maintained in the majority of patients for six months after the aIGB device was removed. The aIGB was also well tolerated, with only 4% of individuals having serious adverse events. This study may have limited generalizability as the majority of patients were female. However, as the first randomized control trial of an IGB device, this study provides promising results for a minimally invasive medical device for weight loss.
In-Depth [randomized controlled trial]: This randomized control trial enrolled patients aged 22-65 years of age with obesity (BMI ≥30) and a history of unsuccessful non-surgical weight loss attempts (n=288). Participants were randomized 2:1 to receive an adjustable intragastric balloon (aIGB) plus dietary and exercise counselling or counselling alone for a duration of 32 weeks. Age, sex, and initial weight distribution were similar between the two groups. Lifestyle modifications in both groups included a 1000-1200 kcal/day diet plus exercise plans. aIGB volumes varied from 400 mL to 550 mL initially based on height and could be increased or decreased based on patient needs. For patients in the intervention group, the aIGB was removed after 8 months and weight loss maintenance was assessed 6-months later. The primary outcome was weight loss as a percentage of total body weight.
In the intention-to-treat analysis, the aIGB group had a 15% total body weight loss compared with 3.3% in the control group (p<0.0001). The pre-defined superiority margin of 4.5% was exceeded (11.7%). In the 6-month post-removal follow-up, 74% of patients in the aIGB group maintained their pre-specified endpoint goal. There were 7 (4%) related adverse events in the aIGB group related to the device, but no deaths. No health issues, such as micronutrient deficiencies, were seen due to the device.
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