EFFECT OF TAUROURSODEOXYCHOLIC ACID ON SERUM LIVER-ENZYMES AND DYSPEPTIC SYMPTOMS IN PATIENTS WITH CHRONIC ACTIVE HEPATITIS

The short-term ability of tauroursodeoxycholic acid (TUDCA) to lower t he blood levels of alanine aminotransferase (ALT), aspartate aminotran sferase (AST), and gamma-glutamyl transpeptidase (GGT) in patients wit h hypertransaminasemia and chronic active hepatitis was assessed in a 3-month, randomized, controlled clinical trial. A total of 53 patients with histologic evidence of chronic active hepatitis in a liver biops y sample and an increase in the serum values of ALT of at least twice the upper limit of normal in two separate checkups in the previous 6 m onths were enrolled in the study. TUDCA 500 mg/day divided into two do ses with meals was given to 27 patients; the remaining 26 patients ser ved as controls. Follow-ups were performed in both the treated and con trol patients at 1 month, 2 months, and the end of the study period. A ll patients completed the study. The effect of TUDCA on liver serum en zymes was evident after 1 month and reached a maximum effect after 3 m onths, when TUDCA had significantly lowered AST (-44%), ALT (-49%), an d GGT (-38%) (P < 0.001, compared with baseline values). Throughout th e study, serum levels of alkaline phosphatase and bilirubin remained w ithin a normal range in all patients. A spontaneous slight decrease in AST (11% to 14%), ALT (13% to 15%), and GGT (5% to 7%) was observed i n the control group during the study. None of the patients receiving T UDCA reported side effects. Dyspeptic symptoms were evident in 70% of the TUDCA patients and 62% of the controls and were individually score d at the beginning of the trial. After 3 months, the score decreased s ignificantly in the TUDCA group but not in the control group (P < 0.00 1). Short-term therapy with TUDCA is effective in lowering serum level s of transaminases and GGT, is free of hepatotoxic effects, and improv es dyspeptic symptoms in patients with chronic active hepatitis. Furth er studies are needed to investigate the influence of TUDCA therapy on the natural history of chronic active hepatitis.