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



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



Clinical Drug Investigation 17(6): 425-434



Objective: The present study was designed to investigate the effect of ursodeoxycholic acid (UDCA), a drug widely utilised in the management of cholestatic 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 histological diagnosis of chronic hepatitis were enrolled in a multicentre randomised trial with UDCA (300mg twice daily orally) and folic acid as a placebo. Treatment was carried out for 6 months. Biochemical markers of liver disease activity and scores for dyspeptic and systemic symptoms were determined. 213 patients completed the study (112 in the UDCA group, 101 in the placebo group). 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 ANCOVA, the changes in enzyme levels were significantly (p < 0.001) more pronounced in the UDCA group compared with placebo. This was accompanied by a significantly higher (p < 0.05) percentage of patients showing normalisation of liver enzymes. Analysis of the interference of pre-existing factors on the biochemical outcome showed a more marked effect of UDCA in reducing ALT in 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 make it worth consideration as a useful therapeutic tool in the treatment of chronic hepatitis.

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Accession: 011618904

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