Role of Farnesoid X Receptor Ligand Obeticholic Acid Versus Vitamin E for Patients with Nonalcoholic Steatohepatitis

Background: Non-alcoholic fatty liver disease (NAFLD) is a leading metabolic disorder that commonly progresses to non-alcoholic steatohepatitis (NASH), potentially complicated with cirrhosis, liver failure, and hepatocellular carcinoma.Aim: To compare obeticholic acid (OCA) vs. vitamin E on serum aminotransferases and fibrosis in non-diabetic adults with NASH.Methods: In the current open-label, randomized, active-controlled study, 150 non-diabetic adults with NASH were randomized into three groups: Group A received OCA (10 mg daily, N=50) plus lifestyle modification, Group B received vitamin E (800 mg daily, N=50) with lifestyle modification, and Group C underwent only lifestyle modification (N=50). The intervention period was 18 months.Results: The pharmacotherapy groups showed significantly greater reductions in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in comparison to the control group (P<0.001). The greatest ALT reduction was observed in the vitamin E group. AST reductions were comparable between the OCA and vitamin E groups and significantly greater than in the control group (P<0.001). Longitudinal changes in the controlled attenuation parameter (CAP) differed significantly among the groups (P<0.001), with the greatest reduction in the vitamin E group, followed by the OCA group. The OCA group improved liver stiffness significantly compared to vitamin E and control groups (P<0.001).Conclusions: In non-diabetic adults with NASH, vitamin E improved biochemical markers and inflammatory parameters but did not significantly improve fibrosis. OCA 10 mg daily dose improved liver stiffness after 18 months of treatment, but with negative effects on lipid profile compared to other study arms.