Combined treatment with ursodeoxycholic acid and prednisone in primary biliary cirrhosis.

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.