Combined treatment with ursodeoxycholic acid and prednisone in primary biliary cirrhosis

Abstract

Objective: To assess the effect of combined therapy (CT) of ursodeoxycholic acid (UDCA) with prednisone on symptoms and biochemistry in patients with non-advanced primary biliary cirrhosis (PBC), who had responded insufficiently to either drug alone.

Methods: Retrospective evaluation of the effect of 1 year of CT on symptoms (pruritus, fatigue, arthralgia) and biochemical parameters [bilirubin, alkaline phosphatase (APh), aspartate aminotransferase (AST) and IgM] in 7 symptomatic patients.

Results: Five of the 7 patients became asymptomatic. Pruritus disappeared in 2 of 3 patients, fatigue in 4 of 6 and arthralgia in both symptomatic patients. APh and AST decreased in all patients (median 41% and 59%, respectively). IgM decreased, although to a lesser degree (median 16%), in all but 1 patient. Normal levels for AST were achieved in 4 patients. In 2 of these APh normalized too. In 2 patients IgM became normal. Bilirubin, only slightly elevated in 1 patient, remained stable in all. The beneficial effects were maintained during follow-up (median 1.5 years). The treatment was well tolerated by all patients.

Conclusions: In PBC, combined treatment with UDCA and prednisone appears to improve symptoms and biochemical parameters to a larger extent than either treatment alone; randomized controlled trials should be performed to establish the benefit/risk ratio of this combination therapy.