Clinical trial comparing the efficacy of ursodeoxycholic acid and cholestyramine on idiopathic neonatal hepatitis.

ABSTRACT

common cause of neonatal cholestasis is idiopathic neonatal hepatitis. Several agents have been proposed to counteract the effects of accumulated toxic bile acid such as phenobarbital and cholestyramine. Ursodexycholic acid ( UDCA) is a choleretic agent used in chronic intrahepatic cholestasis. The aim of this study is to compare the efficacy of ursodeoxycholic acid and cholestyramine on hepatic function in idiopathic neonatal hepatitis. Twenty patients were enrolled in this study. The patients were randomized to receive UDCA or cholestyramine orally. There were ten patients in each group. The doses of UDCA and cholestyramine were 15 mg/ kg / day and 350 mg / kg/ day respectively. The duration of the study was 8 weeks. Conventional liver function tests were done initially and at 1,2,4, and 8 weeks. Any side effects of these medications were noted. The ursodeoxycholic acid group showed a significant improvement in levels of total bilirubin, direct bilirubin, and alkaline phosphatase ( P< 0.05). The cholestyramine group showed a significant improvement in levels of total bilirubin, and direct bilirubin ( P< 0.05). There was no significant difference on liver function tests between the groups at any time ( P> 0.05). No side effects were observed. The results showed that both drugs improved cholestasis resulting from idiopathic neonatal hepatitis. The results of this study suggest that UDCA would be an alternative choleretic agent in treatment of idiopathic neonatal hepatitis.