Clinical Studies With Silymarin: Fibrosis Progression Is the End Point

We read with interest the report by Angulo et al. 1 on 27 patients with primary biliary cirrhosis (PBC) who did not respond biochemically to ursodeoxycholic acid (UDCA).In a noncontrolled one-armed study the authors investigated the effect of adding oral silymarin for 1 year to the standard regimen with UDCA.Since silymarin did not alter alkaline phosphatase, bilirubin, aspartate transaminase, albumin, or the Mayo risk score, they concluded that silymarin is not effective in patients with PBC who do not respond to UDCA and that further controlled trials of silymarin in PBC are not warranted.We would take issue with several aspects of the study.1.The patients were at an early clinical stage of the disease, in which the Mayo score has limited prognostic value.3][4][5][6][7] If one chooses to argue that 1 year is sufficient, then the finding of no progression of disease could be interpreted as evidence for a beneficial effect of silymarin.3][4][5][6][7] Since progression of fibrosis ultimately determines the prognosis of PBC, fibrosis-related parameters should be monitored, including sequential histology, aminoterminal procollagen type III peptide, collagen IV, hyaluronic acid, and others. 8.