Randomized Placebo-Controlled Trial of Ursodeoxycholic Acid With Vitamin E in Nonalcoholic Steatohepatitis

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• 作者：Jean– ; Franç ; ois Dufour^?/sup> ; ^{jf.dufour@ikp.unibe.ch} ; Carl M. Oneta^&Dagger ; ; Jean– ; Jacques Gonvers^&Dagger ; ; Florian Bihl^§ ; ; Andreas Cerny^§ ; ; Jean– ; Michel Cereda^¶ ; ; Jean– ; Franco Zala^?/sup> ; Beat Helbling^# ; Michael Steuerwald^?? ; Arthur Zimmermann^&dagger ; &dagger ; ; Swiss Association for the Study of the Liver
• 关键词：ALT ; alanine aminotransferase ; AST ; aspartate aminotransferase ; BMI ; body mass index ; GGT ; ¦Ã-glutamyltransferase ; HBV ; hepatitis B virus ; HCV ; hepatitis C virus ; NASH ; nonalcoholic steatohepatitis ; P ; placebo ; UDCA ; ursodeoxycholic acid
• 刊名：Clinical Gastroenterology and Hepatology
• 出版年：2006
• 出版时间：December 2006
• 年：2006
• 卷：4
• 期：12
• 页码：1537-1543
• 全文大小：513 K

文摘

Background & Aims: Nonalcoholic steatohepatitis (NASH) is a frequent liver disease that can progress to cirrhosis and for which there is no recognized therapy. UDCA and vitamin E have been considered separately as therapeutic options and have not been shown to be effective. This study tested their combination. Methods: Patients with elevated aminotransferase levels and drinking less than 40 g alcohol/week with biopsy-proven NASH were randomly assigned to receive UDCA 12?5 mg ¡¤ kg^? ¡¤ day^? with vitamin E 400 IU twice a day (UDCA/Vit E), UDCA with placebo (UDCA/P), or placebo/placebo (P/P). After 2 years, they underwent a second liver biopsy. Biopsy specimens were collected, blinded, and scored by a single liver pathologist. Results: Forty eight patients were included, 15 in the UDCA/Vit E group, 18 in the UDCA/P group, and 15 in the P/P group; 8 patients dropped out, none because of side effects. Baseline parameters were not significantly different between the 3 groups. Body mass index remained unchanged during the study. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels diminished significantly in the UDCA/Vit E group. Neither the AST nor the ALT levels improved in the P/P group and only the ALT levels in the UDCA/P group. Histologically, the activity index was unchanged at the end of the study in the P/P and UDCA/P groups, but it was significantly better in the UDCA/Vit E group, mostly as a result of regression of steatosis. Conclusions: Two years of treatment with UDCA in combination with vitamin E improved laboratory values and hepatic steatosis of patients with NASH. Larger trials are warranted.