Ursodeoxycholic acid improves liver tests in chronic hepatitis - Results of a randomised controlled trial

Objective: The present study was designed to investigate the effect of urso deoxycholic acid (UDCA), a drug widely utilised in the management of choles tatic conditions, on liver function tests and symptom relief in a group of patients with chronic hepatitis of different aetiologies. Patients and Design: 219 patients (128 males, 91 females) with a histologic al diagnosis of chronic hepatitis were enrolled in a multicentre randomised trial with UDCA (300mg twice daily orally) and folic acid as a placebo. Tr eatment was carried out for 6 months. Biochemical markers of liver disease activity and scores for dyspeptic and systemic symptoms were determined. 21 3 patients completed the study (112 in the UDCA group, 101 in the placebo g roup). Results: UDCA induced a significant decrease (p < 0.001) in serum ALT, AST and gamma-GT; folic acid induced a significant reduction (p < 0.05) of ALT at 4 and 6 months of treatment, and of AST at 6 months. As assessed by ANCO VA, the changes in enzyme levels were significantly (p < 0.001) more pronou nced in the UDCA group compared with placebo. This was accompanied by a sig nificantly higher (p < 0.05) percentage of patients showing normalisation o f liver enzymes. Analysis of the interference of pre-existing factors on th e biochemical outcome showed a more marked effect of UDCA in reducing ALT i n patients with elevated gamma-GT. Finally, the frequency and score of most symptoms were significantly reduced (p < 0.05) with ursodeoxycholic acid. Conclusions: The effectiveness and tolerability of ursodeoxycholic acid mak e it worth consideration as a useful therapeutic tool in the treatment of c hronic hepatitis.