Silymarin in the treatment of patients with primary sclerosing cholangitis: an open-label pilot study.

No effective medical therapy is available for patients with primary sclerosing cholangitis (PSC). We evaluated the safety and estimated the efficacy of silymarin in patients with PSC in a pilot study. Thirty patients with PSC were enrolled. Silymarin, 140 mg orally three times daily, was given for 1 year. A statistically significant improvement in serum alkaline phosphatase activity (1131 +/- 216 vs. 861 +/- 139, P = 0.007), and aspartate aminotransferase (AST) levels (116 +/- 15 vs. 83 +/- 11, P = 0.01) occurred with treatment. Serum bilirubin levels were not significantly affected by the treatment, while serum albumin and the Mayo risk score remained essentially unchanged. Overall, 34% of patients had a positive response to silymarin as defined by > or =50% improvement or normal status in liver tests. The results of this pilot study warrant further evaluation of silymarin in patients with PSC in a large-scale, controlled trial.