Bariatric-metabolic surgery is more effective than lifestyle modifications in treating nonalcoholic steatohepatitis (NASH) with obesity, according to study findings in the Lancet.
Recent studies suggest that bariatric-metabolic surgical interventions could be the ideal treatment for NASH in patients with obesity. However, limited data have compared surgical procedures with lifestyle interventions and current standard treatments.
Researchers conducted the Bariatric Surgery Vs Nonalcoholic Steatohepatitis study (BRAVES; ClinicalTrials.gov Identifier: NCT03524365) to assess the efficacy and safety of bariatric-metabolic surgery compared with lifestyle interventions and standard of care for patients with confirmed NASH.
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BRAVES was a 52-week, multicenter, open-label, randomized trial conducted in 3 major hospitals. NASH was diagnosed using NAFLD fibrosis scores, and operation was considered for patients with type 2 diabetes who had a BMI of at least 30 kg/m2.
The primary endpoint was the resolution of NASH without fibrosis progression, defined by an increase in at least 1 stage on the NASH fibrosis score. The main secondary endpoint of the study was liver fibrosis improvement by 1 stage on the NASH fibrosis score.
Of 431 patients screened for eligibility, 288 were enrolled in the study. The patients, who were all White, were randomly assigned to 3 different treatment groups: lifestyle modification (n=96), Roux-en-Y gastric bypass (n=96), and sleeve gastrectomy treatment (n=96).
Among the intention-to-treat (ITT) population, the diabetes prevalence was 35 (37%) people in the lifestyle modification group (average HbA1c, 7.87), 32 (33%) in the Roux-en-Y gastric bypass group (average HbA1c, 9.05%), and 25 (26%) in the sleeve gastrectomy group (average HbA1c, 7.06%).
There were 139 participants with stage F1 fibrosis, 114 with stage F2, 32 with stage F3, and 3 with stage F0 fibrosis.
In the ITT analysis, a greater proportion of patients met the primary endpoint in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; P <.0001).
Additionally, the probability of NASH resolution was 3.6 times greater in the Roux-en-Y gastric bypass group (95% CI, 2.19-5.92; P <.0001) and 3.67 times greater in the sleeve gastrectomy group (95% CI, 2.23-6.02; P <.0001), compared with the lifestyle modification group.
There were 236 (82%) patients included in the per-protocol analysis, with 80 patients undergoing lifestyle modification, 77 who underwent gastric bypass, and 79 patients who underwent gastrectomy. A total of 70% of participants in the Roux-en-Y gastric bypass group and 70% of participants in the sleeve gastrectomy group met the primary endpoint, compared with 19% in the lifestyle modification group (P <.0001).
Diabetes remission (HbA1c < 6.5%) was observed in 2 (6%) of 34 participants in the lifestyle modification group, 17 (68%) of 25 in the Roux-en-Y gastric bypass group, and 11 (65%) of 17 in the sleeve gastrectomy group (P <.0001).
“Roux-en-Y gastric bypass and sleeve gastrectomy had similar efficacy on NASH, even though Roux-en-Y gastric bypass was generally more effective at improving glycemic control, lipid profile, insulin resistance, and weight loss,” the study authors wrote. “This finding might be explained by the existence of a threshold in the weight loss or degree of metabolic improvement that is necessary to resolve NASH.”
Study limitations include establishing a protocol design before FDA NAFLD activity score guidance was published, lack of baseline BMI and glycemic controls, and inability to generalize to some populations.
Reference
Verrastro O, Panunzi S, Castagneto-Gissey L, et al. Bariatric–metabolic surgery vs lifestyle intervention plus best medical care in nonalcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial. Lancet. Published online April 20, 2023. doi:10.1016/ S0140-6736(23)00773-0
This article originally appeared on Gastroenterology Advisor
