Comparison between Ursodeoxycholic acid and Silymarin in Anticonvulsive drugs induced Hypertransaminasemia

Abstract

Liver is the central organ to metabolize almost all drugs and foreign substances so drug -induced liver injury is a potential complication of nearly every medication that is prescribed. In this randomized open-label clinical trial we have compared Ursodeoxycholic acid (UDCA) versus Silymarin effectiveness and tolerability in anticonvulsant induced hypertransaminasemia in children. Silymarin is an antioxidant and UDCA is a primary bile salt with hepatoprotective effects. 54 children aged between 4mo-14yr with anticonvulsant induced hypertransaminasemia were randomized based on block randomization in two groups; they were recruited over two year (2012 to 2014) from Valiasr hospital pediatric neurology clinic, a referral and public educational center. Other common causes of hepatitis and anatomic anomalies were excluded before randomization. Any patient with viral, autoimmune or metabolic evidences or transaminases levels under twice the upper normal limits or without parents' consent was excluded from study. None of patients were suffered from functional liver failure. We used UDCA (with commercial name of Ursobil) capsule 250 mg in dose of 10-15 mg/kg/day once a day and silymarin (with commercial name of Livergol) 70 mg tablet in dose of 5 mg/kg/day once a day for one month and followed our patients for another month. 46 patients (25 boys and 21 girls) completed two months trial and follow up. Pre intervention transaminases quantities were similar in both groups. After one month trial transaminases decreased in both groups significantly (P< 0.05) except for γGT in UDCA group. Normalization of transaminases (AST and ALT less than 40 IU/l) was occurred in 3 patients in silymarin group and 5 patients in UDCA group. Comparing between UDCA and silymarin, ALT changes were better in silymarin group (P= 0.017). Both of them were tolerated well and no known side effects of them seen. Keywords: Drug induced hepatitis-Silymarin-Ursodeoxycholic acid