Intragastric balloons With Lifestyle Modification lead to significant Weight Loss: Lancet
Several strategies are available to address the obesity epidemic and range from noninvasive lifestyle interventions to medications and bariatric surgical procedures.
In a recent study, researchers have found that adjustable intragastric balloons combined with lifestyle modification help to achieve weight loss and maintain it for 6 months following removal. The study findings were published in the journal The Lancet on November 15, 2021.
Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. Enhancing its tolerance and durability could help broaden clinical adoption. Therefore, Prof Barham K Abu Dayyeh, MD and his team investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity.
It was a prospective, multicentre, open-label, randomized clinical trial done at seven US sites. The researchers included a total of 288 patients with obesity and randomized them to aIGB (n=187 [65%]) with a lifestyle intervention group and with lifestyle intervention alone (n=101 [35%]) group (control group). They determined balloon volume could be increased to facilitate weight loss or decreased for tolerability. The primary endpoints of the study were mean percentage total body weight loss and responder rate (≥5% total body weight loss) at 32 weeks. The researchers used a multiple imputed intention-to-treat population analysis.
Key Findings of the Study were:
- By the end of 32 weeks, the researchers observed that the mean total body weight loss was 15·0% in the aIGB group and 3·3% in the control group.
- They also observed clinical response in 171 (92%) patients in the aIGB group.
- They made adjustments to the aIGB in 145 (80%) patients for weight loss plateau or intolerance.
- After adjustments, they noted that upward volume adjustment facilitated an additional mean of 5·2% total body weight loss.
- They further noted downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy.
- They reported that intolerance caused early removal of the device in 31 (17%) patients.
- They observed no micronutrient deficiencies in the aIGB cohort.
- They reported seven device-related serious adverse events without any deaths.
The authors concluded, "When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualized therapy, maximising weight loss and tolerance."
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