The use of ursodeoxycholic acid in patients with primary biliary cirrhosis: sense or nonsense.

Ursodeoxycholic acid is the most widely evaluated drug for the treatment of primary biliary cirrhosis. The results of the first randomized controlled trials are very discordant in terms of survival benefit. This, however, can be explained by differences in methodology and insufficiently long period of treatment and follow-up. It has clearly been demonstrated that serum bilirubin levels and histological parameters such as piecemeal necrosis and fibrosis are validated predictors of prognosis in PBC. We re-analyzed the already published data using these parameters as surrogate endpoints. This analysis reveals that there is a significant positive effect of treatment of PBC with UDCA on serum bilirubin levels as well as on the progression of piecemeal necrosis and fibrosis. We therefore conclude that UDCA has a positive effect on the prognosis of PBC and can slow down the progression to end stage liver disease.