Evaluation of the effects of additional therapy with Berberis vulgaris oxymel in patients with refractory primary sclerosing cholangitis and primary biliary cholangitis: A quasi-experimental study.

Abstract

There are several studies reporting the therapeutic effects of Berberis vulgaris on liver diseases. This study was done with the purpose of examining the effect of B. vulgaris oxymel (BO) in patients with refractory primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), who did not respond to current treatment. Patients with PSC or PBC who were receiving ursodeoxycholic acid (UDCA, 13-15 mg/kg/day) for at least six months, but their serum levels of alkaline phosphatase (ALP) were still 1.5 folds higher than the normal upper limit during the last six months, were asked to participate in this quasi-experimental study. Patients were asked to take 0.5 ml/kg/day of BO two times a day for three months along with UDCA. At the end of the study, serum levels of ALP, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), total bilirubin (TB), direct bilirubin (DB), and creatinine as well as prothrombin time (PT), international normalized ratio (INR) and quality of life (QOL) based on PBC-40 questionnaire were assessed as outcomes. Our results showed that BO notably attenuated the serum levels of ALP, AST, ALT, GGT, TB, and DB, as well as PT and INR and significantly improved QOL. For first time, we showed that additional therapy with BO has a promising effect in the treatment of refractory PSC and PBC.