EFFECTS OF URSODEOXYCHOLIC ACID ON HEPATIC INFLAMMATION AND HISTOLOGICAL STAGE IN PATIENTS WITH PRIMARY BILIARY-CIRRHOSIS

Objectives: Ursodeoxycholic acid (UDCA) has been reported to be of ben efit in the treatment of primary biliary cirrhosis; however, the effec ts of UDCA on the histological features of primary biliary cirrhosis a re uncertain. The goal of this study was to determine the histological effects of 2 yr of treatment with UDCA compared to placebo in a prosp ective randomized trial of primary biliary cirrhosis. We also sought t o correlate the changes in inflammation and histological stage with ch anges in serum bilirubin, Mayo Risk Score, and the percentage of UDCA in bile in these patients. Methods: Sixty-one patients (32 receiving U DCA, 29 receiving placebo) who had initial and 2-yr biopsies were stud ied, Biopsy specimens were evaluated by a single pathologist under cod ed identification, The degree of inflammation and histological stage w ere graded on a scale of 0 to 4. Results: There was no significant dif ference in the degree of inflammation with UDCA treatment when compare d to the placebo group at 2 yr, There was a significant but weak indir ect association between degree of enrichment of UDCA and changes in in flammation (r = -0.34, p = .02). There was no detectable change in sta ge in either the UDCA-treated or placebo group when comparing pre- and posttreatment specimens. There were no associations with changes in s erum bilirubin or Mayo Risk Score and degree of inflammation. Conclusi ons: No significant changes in the degree of inflammation or histologi cal stage were apparent after 2 yr of treatment with UDCA or in the pl acebo group. A tendency toward improvement in inflammation was noted w ith greater degrees of biliary UDCA enrichment, Longer term studies wi ll be necessary to determine whether UDCA has a beneficial effect on h istological stage.