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Two types of bariatric-metabolic surgery were more effective than lifestyle modification plus best medical care in the treatment of non-alcoholic steatohepatitis (NASH), a randomized trial from Italy showed.

In over 200 patients with obesity and biopsy-confirmed NASH who completed the study, 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, as compared with only 16% of participants who underwent lifestyle modification, reported Geltrude Mingrone, MD, PhD, of King's College London, and colleagues.

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, noted the authors in .

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.

Previous studies have found that a is needed to achieve a clinically significant rate of NASH resolution.

"The ability of surgery to control and even improve fibrosis associated with NASH is of particular clinical relevance given the fact that fibrosis is the main predictor of liver complications and cardiovascular mortality and morbidity in NASH," the authors stated. "These findings further support the use of bariatric-metabolic surgery in people with metabolic diseases."

Lifestyle modification with physical activity and weight-loss strategies is "the mainstay" for treating NASH, said Sara Mahgoub and Philip N. Newsome, MD, PhD, of the Institute of Immunology and Immunotherapy at the University of Birmingham in England. In a , they added that aerobic and resistance training have "been shown to reduce hepatic steatosis and NAFLD-associated cardiovascular risks."

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, Mahgoub and Newsome noted. 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. No similar study appears to have been conducted previously, according to the authors. 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.

To be included in the study, participants had to have a body mass index (BMI) of 30 to 55, with or without type 2 diabetes, and histologically confirmed NASH, a NAFLD activity score of at least 1, and no signs of other forms of liver disease.

Levels of fibrosis were measured by NAFLD fibrosis score. All participants with an NAFLD fibrosis score greater than -1.455 were considered appropriate candidates for liver biopsy for histological confirmation.

There were no deaths or life-threatening complications in the study. Ten of the patients who had surgery had severe adverse events, but none required reoperations. These severe adverse events were resolved medically or endoscopically.

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