A randomized controlled trial comparing the effects of Vitamin E, Ursodeoxycholic acid and Pentoxifylline on Egyptian non-alcoholic steatohepatitis patients

Abstract

OBJECTIVE: Currently, no NASH-specific therapies are approved by the US Food and Drug Administration. This study aimed to compare the clinical effect of vitamin E (Vit. E), Ursodeoxycholic Acid (UDCA) and pentoxifylline (PTX) on Egyptian patients with NASH with exploration of their possible roles on inflammatory cytokines and chemokines mainly Interleukin 6 (IL6) and Monocyte Chemoattractant Protein-1 (CCL2/MCP-1).\n\nPATIENTS AND METHODS: We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 received Vit. E 400 mg twice a day, group 2 received UDCA 250 mg twice a day and group 3 received PTX 400 mg twice daily. Liver aminotransferases (AST, ALT), IL6, CCL2/MCP-1, albumin, bilirubin, and lipid panel were measured both before and after intervention intake.\n\nRESULTS: A significant decrease was found in liver aminotransferases, serum cytokine and chemokine in participants after Vit. E, UDCA or PTX intake. Compared to the UDCA and PTX groups, liver aminotransferases, serum cytokine and chemokine showed a more statistically significant reduction after Vit. E administration (50%, 43%, 57% and 55% for ALT, AST, IL6 and CCL2/MCP-1, respectively). In contrast, other biochemical tests showed non-significant change after any drug intake. None of the tested drugs showed significant safety issues in this population.\n\nCONCLUSIONS: Treatment with Vit. E, UDCA and PTX was both safe and effective in improving hepatic aminotransferases and inflammatory markers in Egyptian NASH patients. The superior effect of Vit. E compared to UDCA and PTX may suggest that oxidative stress plays a key role in disease progression of NASH patients. Moreover, IL6 and CCL2/MCP-1 may be used with or without ALT for treatment evaluation of NASH people.