In a randomized, controlled trial, endoscopic sleeve gastroplasty (ESG) combined with lifestyle modifications was safe and effective for weight loss among individuals with class I and class II obesity, compared with lifestyle modifications alone.
“Lifestyle modifications and pharmacological therapy have several limitations, and the use of bariatric surgery is hampered by its invasive nature and patient perceptions,” the study authors wrote. ESG is a minimally invasive, reversible, organ-sparing bariatric procedure that might be able to fill those care gaps, they explained.
Previous retrospective studies have suggested that ESG is effective, and a meta-analysis of 1,772 patients found an average total body weight loss of 15.1% at 6 months (95% confidence interval, 14.3%-16.0%) and 16.5% at 12 months (95% CI, 15.2%-17.8%). However, according to the authors of the current study, known as MERIT and published in the Lancet, there have been no randomized clinical trials investigating ESG's efficacy to date.
“[This is] the kind of study that we have been looking forward to. The outcomes were very impressive,” said Danny Issa, MD, who was asked to comment on the study. He is a clinical assistant professor of medicine at the University of California, Los Angeles. meta-analysis of 1,772 patients found an average total body weight loss of 15.1% at 6 months (95% confidence interval, 14.3%-16.0%) and 16.5% at 12 months (95% CI, 15.2%-17.8%).
Understanding the study and its results
Between December 2017 and June 2019, the researchers randomized 209 participants to ESG plus lifestyle modification or lifestyle modification only, which served as the control. The mean age was 47.3 in the ESG group (88% female) and 45.7 in the control group (84% female). The mean body mass index (BMI) was 35.5 kg/m2 in the ESG group and 35.7 among controls.
After 1 year, the intervention group had a mean percentage of excess weight loss (EWL) of 49.2% , compared with 3.2% for the control group (P < .0001). The mean percentage of total body weight lost was 13.6% in the ESG group and 0.8% in the control group (P < .0001). After adjustment for age, sex, type 2 diabetes, hypertension, and baseline BMI, the ESG group had a mean difference of excess weight loss of 44.7% (95% CI, 37.5%-51.9%) and a mean difference of total weight loss of 12.6% (95% CI, 10.7%-14.5%), compared with the control group at 52 weeks. At 52 weeks, 77% of the ESG group had at least a 25% excess weight loss, which was the secondary endpoint, compared with 12% of the control group (P < .0001).
Overall, 80% of the ESG group had an improvement in at least one metabolic comorbidity, while 12% experienced a worsening. Among the control group, 45% had an improvement and 50% worsened. Among 27 patients in the treatment group with diabetes, 93% experienced an improvement in hemoglobin A1c levels, compared with 15% of patients with diabetes in the control group. Similarly among patients with hypertension, 60% in the intervention group had an improvement, compared with 40% of controls. Of those with metabolic syndrome, 83% improved after undergoing surgery, compared with 35% of controls.
At 2 years, 68% of the ESG group who achieved a 25% EWL continued to have at least 25% EWL; 2% in the treatment group had a serious ESG-related adverse event, but there was no mortality or need for intensive care or follow-up surgery.