1. Approximately three-quarters (77%) of patients who underwent endoscopic sleeve gastroscopy with lifestyle modifications achieved 25% or more reduction in excess weight.
2. There were three serious adverse events associated with ESG (2%), but none requiring further surgery, intensive care or resulted in death.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Current available treatment options for obesity have many limitations, including the invasive nature of bariatric surgery and the subjective effectiveness of lifestyle modifications. Endoscopic sleeve gastroplasty (ESG) is a reversible endoscopic procedure with no prior large randomized trials evaluating its efficacy and safety in the management of obesity. The MERIT study enrolled and randomized eligible participants to either ESG and moderate-intensity lifestyle modifications or moderate-intensity lifestyle modifications alone. After 52 weeks, the percentage of excess weight loss in the ESG group was significantly higher than in the control group. Over three quarters of participants in the ESG group achieved 25% or more EWL compared to 12% in the control group. This weight loss was maintained in over a majority of the ESG group at the 104-week follow-up. The procedure was well tolerated with only three (2%) serious adverse events, none leading to further surgery, intensive care or death. Limitations of this study include the lack of “sham” control, inherent to the nature of the intervention. Nevertheless, this study provides promising results for a non-conservative management option for obesity.
In-Depth [randomized control trial]: MERIT took place in nine centres in the United States. The study enrolled individuals aged 21-65 years old with a BMI between 30-40 kg/m2. Participants had to have a history of previous failure with non-surgical weight loss methods. Participants were excluded if they had a history of gastrointestinal surgery. After enrollment, participants were randomized 1:1.5 to either endoscopic sleeve gastroplasty (ESG) plus moderate-intensity lifestyle modifications (n=85) or moderate-intensity lifestyle modifications alone (control, n=124) for 52 weeks. The primary outcome measured was percentage of excess weight loss at 52 weeks. EWL was calculated by the formula: (weight loss/baseline excess weight)x100. Baseline excess weight was defined as baseline index weight minus ideal weight (25 kg/m2).
At 52 weeks, the mean percentage of EWL was 49.2% for the ESG group compared to 3.2% for the control group (p<0.0001). 77% of participants in the ESG group reached 25% or more of EWL at 52 weeks compared to 12% of the control group (p<0.0001). Further follow-up at 104 weeks showed that 68% of the ESG group maintained 25% or more of EWL. There were three serious adverse events (2%) in those that underwent ESG requiring surgical, endoscopic or radiological intervention. The three events were an abdominal abscess, upper gastrointestinal bleed and a case of malnutrition requiring reversal of the ESG. There were no deaths related to ESG.
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