THE COMBINATION OF URSODEOXYCHOLIC ACID AND METHOTREXATE FOR PRIMARY BILIARY-CIRRHOSIS IS NOT BETTER THAN URSODEOXYCHOLIC ACID ALONE

Backgrourd/Aims: Many therapies have been tried in primary biliary cir rhosis, It has been suggested that a combination of ursodeoxycholic ac id and methotrexate may offer advantages, Because the benefit and safe ty of this combination is uncertain, we conducted this prospective, ra ndomized, double-blind, controlled trial, Methods: Twenty-five patient s with well-defined primary biliary cirrhosis mere randomly assigned t o receive either ursodeoxycholic acid (500 mg/day) plus methotrexate ( 10 mg/week) or ursodeoxycholic acid plus placebo for a period of 48 we eks, Clinical, biochemical and histologic evolution were assessed, Res ults: In both groups the clinical response was similar and heterogeneo us, In patients of ursodeoxycholic acid alone group, biochemical and h istologic changes mere comparable to those of patients of ursodeoxycho lic acid plus methotrexate at 48 weeks, The addition of methotrexate w as not associated with substantial adverse affects, Conclusions: The u se of methotrexate in combination with ursodeoxycholic acid was not fo llowed by an additive benefit over ursodeoxycholic acid alone, nor was substantial toxicity added, Unless larger and longer controlled trial s with clinical, biochemical and histologic controls show it to be a s afe and effective therapy for primary biliary cirrhosis, ursodeoxychol ic acid+methotrexate should not be used as a proven and accepted treat ment.