Effect of ursodeoxycholic acid treatment on alanine aminotransferase and gamma-glutamyltranspeptidase serum levels in patients with hypertransaminasemia. Results from a double-blind controlled trial.

The ability of ursodeoxycholic acid (UDCA, 600 mg/day) to lower alanine aminotransferase (ALT) blood levels in blood donors rejected for donation because of fluctuating hypertransaminasemia was evaluated in a randomized, controlled, double-blind clinical trial vs. placebo. All subjects with ALT values at least twice the normal upper limit in at least two out of three previous checks (the last one not more than 1 month previously) were admitted to the study. Checks were carried out 1, 2 and 3 months after the admission. 59 out of 65 patients completed the study. Although all patients were asked to abstain from alcohol, more than 50% of them in both groups had basal gamma-glutamyltransferase (gamma-GT) values higher than normal. After 1 month of treatment and throughout its duration, UDCA was effective in lowering ALT in all patients (30% decrease with respect to the basal value) and, especially, in lowering gamma-GT in those patients with elevated levels (50% decrease with respect to the basal value). This decrease was significantly different from the spontaneous 10% decrease of the ALT and gamma-GT levels observed in the placebo group. 3 months after suspension of therapy a rebound of both ALT and gamma-GT to values comparable to the basal ones or even higher was found only in UDCA-treated patients. We conclude that the short-term administration of UDCA is free of hepatotoxic effects and could be useful in lowering ALT and gamma-GT serum levels. The real significance of UDCA treatment in the natural history of chronic liver diseases deserves further investigation.

RCT Entities:   Population Interventions Outcomes