Combined analysis of the effect of treatment with ursodeoxycholic acid on histologic progression in primary biliary cirrhosis

Background/Aims: This study aimed at evaluating the effect of ursodeoxycholic acid (UDCA) treatment on histologic progression in primary biliary cirrhosis (PBC). Methods: Using combined individual histologic findings from four clinical trials, we selected the patients in whom paired liver-biopsy specimens were available with a time interval of about 36 months between biopsies. A total of 367 patients were selected (UDCA: 200 vs. placebo: 167). Results: Overall, there was no significant difference in the progression of the histologic stage between the two groups. By contrast, in the subgroup of patients with initial stages I-II (n = 177) there was a significant decrease in the histologic stage progression in the UDCA group relative to the placebo group (P < 0.03). Overall, there was a significant delay in the progression of periportal necroinflammatory lesions (P = 0.03), and an improvement in the degree of ductular proliferation (P = 0.02) in the UDCA group compared with the placebo group. There was no significant difference in the progression of other specific lesions. Conclusions: A 2-year UDCA treatment reduces periportal necroinflammation and improves ductular proliferation, and when initiated at the earlier stages I-II of the disease also delays the progression of histologic stage. These data support the early initiation of the drug to prevent these histologic features of PBC.