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 ran- domized controlled trials are very discordant in terms of survival benefit. This, however, can be explained by differences in metho- dology 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 alre- ady published data using these parameters as surrogate end- points. 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 progno- sis of PBC and can slow down the progression to end stage liver disease. (Acta gastroenterol. belg., 2003, 66, 283-287).