A Cochrane review [Abstract] 1 included 5 studies; 4 studies (n=370) compared methotrexate with placebo or no intervention (3 studies added an equal dose of ursodeoxycholic acid to the intervention groups). There were not statistically significant effects of methotrexate on mortality (RR 1.32, 95% CI 0.66 to 2.64; 3 studies, n=351), mortality or liver transplantation combined, pruritus, fatigue, liver complications, liver biochemistry, liver histology, or adverse events. In one study (n=60), the pruritus score (MD - 0.17, 95% CI - 0.25 to - 0.09) was significantly lower in patients receiving methotrexate. The prothrombin time was significantly worsened in patients receiving methotrexate (MD 1.60 s, 95% CI 1.18 to 2.02; 1 study, n=60). One study (n=85) compared methotrexate with colchicine. The trial had low risk of bias. Methotrexate, when compared to colchicine, did not significantly affect mortality, fatigue, liver biopsy, or adverse events. Methotrexate significantly benefited pruritus score (MD - 0.68, 95% CI - 1.11 to - 0.25), serum alkaline phosphatases (MD - 0.41 U/l, 95% CI - 0.70 to - 0.12), and plasma immunoglobulin M (MD - 0.47 mg/dl, 95% CI - 0.74 to - 0.20) compared with colchicine. Other outcomes showed no statistical difference.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment and blinding) and by imprecise results (few patients and wide confidence intervals).
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