Ursodeoxycholic acid with vitamin E in patients with nonalcoholic steatohepatitis: Long-term results

Summary Background The combination of ursodeoxycholic acid (UDCA) and vitamin E is a therapeutic option for nonalcoholic steatohepatitis (NASH) but randomized controlled studies have produced inconsistent results. The objective of this study was to report the long-term tolerability and efficacy of this combination in our ten-year single center experience. Methods The study group included 101 adult patients with persistent elevation of serum aminotransferases (AST and ALT) and/or γ glutamyl-transferase (GGT), in whom a histological diagnosis of NASH was made from January 1998 to January 2009, and who were treated with a combination of UDCA with vitamin E. Results Median body mass index (30 kg/m2 ) remained unchanged during the study. UDCA and vitamin E were well tolerated (5% withdrawal for side effects). Mean serum AST, ALT and GGT levels (expressed as times of Upper Normal Limit) diminished significantly (1.39 ± 0.74 to 0.78 ± 0.34 for AST, 1.72 ± 0.92 to 0.91 ± 0.69 for AST and 3.25 ± 2.85 to 1.30 ± 1.30 for GGT). AST, ALT and GGT reached normal range in 80%, 70% and 65% of the patients, respectively. From the ten patients who had a second liver biopsy during follow-up, NAS score improved in seven, and worsened in one. Conclusions The combination of UDCA with vitamin E significantly improves liver function tests in long-term and is very well tolerated.