1. Patients in the sleeve gastrectomy and Roux-en-Y bypass groups reported significantly greater resolution of NASH compared to those in the lifestyle plus medical intervention group.
2. 70% of patients in the surgical group achieved NASH resolution at the 1-year follow-up.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Non-alcoholic steatohepatitis (NASH) is a form of chronic liver disease with a high burden of morbidity and eventual mortality. Although weight loss is generally recommended in these patients, the role of specific surgical or pharmacologic interventions remains unclear. This randomized controlled trial aimed to compare the safety and efficacy of bariatric metabolic surgery versus medical therapy and lifestyle modifications on patients with biopsy-proven non-alcoholic steatohepatitis (NASH). The primary outcome was the resolution of NASH at 1-year follow-up while the key secondary outcome included improvement in liver fibrosis. According to study results, bariatric surgery, both sleeve gastrectomy and Roux-en-Y bypass groups, resulted in significantly improved NASH resolution compared to medical therapy and lifestyle interventions alone. This study was strengthened by a randomized design with comparative baseline demographics between surgical and non-surgical patients, adding to its validity.
In-depth [randomized-controlled trial]: Between Apr 15, 2019, and Jun 21, 2021, 431 patients were screened for eligibility across 3 hospitals in Rome, Italy. Included were patients ≥ 25 years with a BMI of 30-55 kg/m2 and histologically confirmed NASH. Altogether, 288 patients (96 in the lifestyle modification plus medical care group, 96 in the Roux-en-Y bypass group, and 96 in the sleeve gastrectomy group) were included in the final analysis. The primary outcome of NASH resolution was greatest in the sleeve gastrectomy group (3.67 times greater, 95% confidence interval [CI] 2.23-6.02, p<0.0001), followed by Roux-en-Y gastric bypass (3.60 times greater, 95% CI 2.19-5.92, p<0.0001), compared with the lifestyle modification group. Moreover, significantly more patients in the Roux-en-Y gastric bypass group and sleeve gastrectomy group (70% for both groups) achieved resolution versus the lifestyle modification group (19%). There were no deaths reported. Findings from this study suggest that bariatric surgery is more effective than lifestyle interventions for the treatment of NASH.
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