Ursodeoxycholic acid therapy for chronic type C hepatitis: A multicenter, dose-finding trial

Abstract

Ursodeoxycholic acid (UDCA) was administered orally for 12 weeks to 40 patients with chronic type C hepatitis. Patients were randomly assigned to receive UDCA 150 mg/day (n = 20) or 450 mg/day (n = 20). In the 450-mg group, alanine aminotransferase (ALT) decreased significantly ( P < 0.05) during treatment but increased ( P < 0.05) 4 weeks after the drug was withdrawn. In contrast, in the 150-mg group, ALT showed no significant decrease during treatment. In the 450-mg group, aspartate aminotransferase (AST) at weeks 8 and 12 and ALT at week 12 were significantly decreased compared with the 150-mg dose group ( P < 0.01). No significant difference between groups was observed in gamma-glutamyltransferase (GGT) levels, although in both groups GGT significantly decreased ( P < 0.05). The UDCA fraction to serum bile acid ratio increased to 29 mol% in the 150-mg group and to 47 mol% in the 450-mg group. There was a good correlation between the increase in the serum UDCA fraction and the decrease in ALT and GGT levels. These results suggest that in chronic type C hepatitis, UDCA at a dose of 450 mg/day significantly improves AST, ALT, and GGT levels and that these improvements are associated with an increase in the serum UDCA fraction.