The short-term ability of tauroursodeoxycholic acid (TUDCA) to lower the blood levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT) in patients with 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 biopsy 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 months were enrolled in the study. TUDCA 500 mg/day divided into two doses with meals was given to 27 patients; the remaining 26 patients served as controls. Follow-ups were performed in both the treated and control patients at 1 month, 2 months, and the end of the study period. All patients completed the study. The effect of TUDCA on liver serum enzymes was evident after 1 month and reached a maximum effect after 3 months, when TUDCA had significantly lowered AST (-44%), ALT (-49%), and GGT (-38%) (P <0.001, compared with baseline values). Throughout the study, serum levels of alkaline phosphatase and bilirubin remained within 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 in the control group during the study. None of the patients receiving TUDCA reported side effects. Dyspeptic symptoms were evident in 70% of the TUDCA patients and 62% of the controls and were individually scored at the beginning of the trial. After 3 months, the score decreased significantly in the TUDCA group but not in the control group (P <0.001). Short-term therapy with TUDCA is effective in lowering serum levels of transaminases and GGT, is free of hepatotoxic effects, and improves dyspeptic symptoms in patients with chronic active hepatitis. Further studies are needed to investigate the influence of TUDCA therapy on the natural history of chronic active hepatitis.
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