Vitamin E + Ursodeoxycholic Acid (UDCA) Versus Vitamin E for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Emerging prevalence of obesity and subsequently metabolic syndrome induced increment in non-alcoholic fatty liver disease (NAFLD). Incidence no definite treatment is still available for NAFLD and different groups of drugs were used to treat this condition and it’s related hypertranaminasemia. This study aimed to compare efficacy of vitamin E with or without ursodexycholic acid (UDCA) as two routine treatment modalities in NAFLD.

The study was done in a parallel-arms clinical trial; one using 400 IU vitamin E alone and another associated with 250 mg UDCA TDS. The patients enrolled in the study if they had ultrasound report of NAFD and abnormal ALT level, and were randomized in two groups, than followed for 6 months. ALT decrease to less than 1.5 times upper limit normal was assumed as the target therapeutic response.

Age of two groups (58.5 ± 4.2) did not differ, neither the gender portion varied (54% were male). Body mass index was not different in two groups before the intervention and did not change significantly during the study (28.8 ± 1.2 kg/m2). In the combination treatment group, 13 cases and in the single therapy, 4 persons reached to therapeutic target (P = 0.46). Mean of ALT and AST variations following intervention did not differ in two groups, but transaminase levels significantly decreased at least for 30 IU/L after treatment (P = 0.02).

Single therapy with vitamin E or combined therapy with UDCA caused recovery of NAFLD in 60% of patients; although adding UDCA had no significant effect on treatment outcome. Small sample size could cause a pitfall in this study that limits ability to establishing equivalence of two modalities.