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Published on: August 22, 2025
Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial
A Courcoulas1, B K Abu Dayyeh2, L Eaton3
1Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
The Orbera Intragastric Balloon combined with lifestyle changes significantly improved short-term weight loss compared to lifestyle intervention alone. However, adverse gastrointestinal events were frequent.
Area of Science:
- Bariatric interventions
- Clinical trials
- Obesity management
Background:
- Obesity is a significant public health concern requiring effective management strategies.
- Lifestyle interventions are a cornerstone of obesity treatment.
- Adjunctive therapies are being explored to enhance weight loss outcomes.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.
- To compare weight loss outcomes between patients receiving the intragastric balloon plus lifestyle intervention versus lifestyle intervention alone.
Main Methods:
- A multicenter, randomized, open-label clinical trial involving 255 adults with a body mass index (BMI) of 30-40 kg/m².
- Participants were randomized to either endoscopic placement of an intragastric balloon plus lifestyle intervention or lifestyle intervention alone.
- Outcomes, including weight loss, were assessed up to 12 months, with balloon removal at 6 months.
Main Results:
- The intragastric balloon group achieved significantly greater weight loss at 6 months (-10.2%) compared to the lifestyle-only group (-3.3%) (P<0.001).
- This weight loss advantage persisted post-balloon removal, with the balloon group showing greater loss at 9 months (-9.1%) and 12 months (-7.6%) versus the control group (-3.4% and -3.1%, respectively).
- A higher percentage of subjects in the balloon group achieved substantial excess weight loss, though adverse gastrointestinal events like nausea and vomiting were common.
Conclusions:
- The Orbera Intragastric Balloon, when used with lifestyle intervention, leads to greater short-term weight loss compared to lifestyle intervention alone.
- Adverse gastrointestinal events are a common occurrence with intragastric balloon use.
- The findings suggest a potential benefit of intragastric balloons for short-term obesity management, but safety considerations are important.
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