A randomized trial from Italy showed that two types of bariatric-metabolic surgery are more effective than lifestyle modification plus best medical care in treating non-alcoholic steatohepatitis (NASH). In the study, over 200 patients with obesity and biopsy-confirmed NASH who completed the trial were assigned to Roux-en-Y and sleeve gastrectomy. The primary endpoint of histological resolution of NASH without worsening of fibrosis was met by 56% of patients assigned to Roux-en-Y and 57% of those randomized to sleeve gastrectomy. This is in comparison to only 16% of participants who underwent lifestyle modification.
Improved Fibrosis and NASH Resolution
The secondary endpoint of the trial was improvement of fibrosis of at least one stage without worsening of NASH. This was observed in 37% of patients in the Roux-en-Y gastric bypass group, in 39% of those in the sleeve gastrectomy group, and in 23% of participants in the lifestyle modification group. The probability of NASH resolution was 3.60 times greater (95% CI 2.19-5.92, P<0.0001) in the Roux-en-Y group and 3.67 times greater (95% CI 2.23-6.02, P<0.0001) in the sleeve gastrectomy group when compared with the lifestyle modification group.
Impact on Public Health
NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is the most common cause of chronic liver disease. NAFLD affects 75% of people with obesity and 55% of people with type 2 diabetes. NAFLD is a growing public health issue and is expected to be a major cause of liver transplantation and liver cancer. The level of weight loss needed to improve liver fibrosis “is seldom reached with lifestyle change, let alone maintained in the longer term.”
The study, called BRAVES, was conducted at three hospitals in Italy and was a 52-week open-label multicenter trial comparing lifestyle modification plus best medical care to the two types of bariatric-metabolic surgery. It included 288 patients with obesity and NASH proven by biopsy who were randomly assigned to either Roux-en-Y gastric bypass, sleeve gastrectomy, or lifestyle modification plus best medical care; 236 participants completed the trial.
The authors of the study conclude that the ability of surgery to control and improve fibrosis associated with NASH is of particular clinical relevance given that fibrosis is the main predictor of liver complications and cardiovascular mortality and morbidity in NASH. The findings further support the use of bariatric-metabolic surgery in people with metabolic diseases.
Leave a Reply