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Intragastric Balloons Improve Obesity-related Metabolic Risk Factors
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Intragastric balloons led to superior improvements in obesity-related metabolic risk factors compared with dietary interventions, and were associated with a low rate of adverse events, according to the results of a systematic review and meta-analysis.
However, investigators acknowledged the evidence is limited by small study sample sizes, lack of long-term follow-up data, and a limited number of randomized controlled trials reporting metabolic outcomes.
Violeta Popov
“Intragastric balloons are a minimally invasive endoscopic weight loss method that recently became available in the U.S. Their main indication is treatment of obesity in patients with BMI 30-40 kg/m2,” Violeta Popov, MD, PhD, assistant professor of medicine at NYU Langone Medical Center, and director of bariatric endoscopy at N.Y. VA Harbor Healthcare, told Healio Gastroenterology. “Our study is the first meta-analysis to evaluate the effect of the second generation of intragastric balloons, in use since 1996, on metabolic parameters.”
Popov and colleagues from NYU Langone Medical Center and Brigham and Women’s Hospital reviewed relevant medical literature published through July 2016, and included 10 randomized controlled trials and 30 observational studies involving a total of 5,668 patients in their analysis. Most patients were women, younger than 65, and had a mean BMI of 43.4 kg/m2. Most studies used the Orbera balloon, and one RCT used the ReShape balloon. Treatment duration ranged from 13 weeks to 6 months, and follow-up generally ranged from 13 weeks to 6 months, with some reporting follow-up data beyond 1 year.
“Therapy with the balloons led to significant improvements in most metabolic parameters (fasting glucose, HbA1C, triglycerides, ALT, waist circumference, diastolic blood pressure) compared to placebo in randomized trials or prior to treatment, with a low risk of serious adverse events,” Popov said.
Between patients treated with intragastric balloons and control groups in RCTs, the mean differences were –12.7 mg/dl (95% CI, –21.5 to –4) for fasting glucose change, –19 mg/dl (95% CI, –42 to 3.5) for triglycerides, –4.1 cm (95% CI, –6.9 to –1.4) for waist circumference, and –2.9 mm Hg (95% CI, –4.1 to –1.8) for diastolic blood pressure. Patients treated with intragastric balloons were also more likely to have resolution of their diabetes (OR = 1.4; 95% CI, 1.3-1.6).
“These changes were more pronounced in subjects who had metabolic disease at baseline; fasting glucose decreased by 15%, and HbA1C decreased by 17% from baseline in the subgroup with abnormal baseline values,” Popov said.
The most common adverse event was vomiting in 20% of cases after balloon placement, which resolved on its own within 1-2 weeks. Serious adverse events occurred in 1.3% of balloon patients, including five gastric perforations in one study which led to two deaths, for a mortality rate of 0.04%.
“Our conclusion is that intragastric balloons may be considered as a low-risk treatment option in patients with metabolic disease and obesity, as part of a multidisciplinary program,” Popov said. – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.
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