The role of Ursodeoxycholic acid in non-alcoholic steatohepatitis: a systematic review

BMC Gastroenterology

Research Article

Yue-fang Ye¹  Yi-peng Chen²  Xi Jin²  You-ming Li²  Zun Xiang²  Lin Zheng³  Yi-da Yang³  Kui-fen Ma⁴ 

[1] Department of Gastroenterology, The Affiliated Hospital, College of Medicine, Hangzhou Normal University, Hangzhou, China;Department of Gastroenterology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China;Department of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China;Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China;

关键词: Ursodeoxycholic acid;    UDCA;    Non-alcoholic steatohepatitis;    NASH;    Clinical trial;   

DOI  :  10.1186/1471-230X-13-140

 received in 2012-11-09, accepted in 2013-09-17,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundNon-alcoholic steatohepatitis (NASH) is a condition that occurs during the progression of non-alcoholic fatty liver disease. Effective therapy for NASH is still lacking. In this study, we investigated the effects of Ursodeoxycholic acid (UDCA) in the treatment of NASH.MethodsWestern and Chinese databases were searched by independent investigators using appropriate MESH headings to identify randomized, controlled Western and Chinese clinical trials, published between January 1990 and October 2012, testing the effects of UDCA in patients with NASH. Patient characteristics and trial endpoints were analyzed, with quality assessment according to widely acknowledged criteria. P < 0.05 was defined as statistically significant in all trials.ResultsTwelve qualified randomized clinical trials, including six from China and involving 1160 subjects, were selected. Seven of these trials assessed the effects of UDCA Monotherapy, with the other five testing combinations of UDCA with vitamin E, polyene phosphatidylcholine, silymarin, glycyrrhizin and tiopronin. The duration of therapy ranged from 3 to 24 months, with two studies using high doses of UDCA (23–35 mg/kg/d). The average quality point was 2.69, and was significantly lower in articles from China than in those from Western countries (2.2 ± 0.4 vs. 3.8 ± 1.1, respectively, p < 0.05). UDCA Monotherapy significantly improved liver function in five studies and improved steatosis and fibrosis in two studies. All five studies assessing UDCA combination therapy showed significant improvements liver function, while two studies also improved steatosis and inflammation. One study of high-dose UDCA showed significant improvements in ALT, γGT and liver fibrosis, whereas the other study showed no significant change in ALT and liver pathology.ConclusionsUDCA therapy is effective in NASH, especially when combined with other drugs. However, the low quality of these studies and the heterogeneity of their results precluded further meta-analysis. Additional carefully designed clinical trials are needed, especially in China.

【 授权许可】

Unknown   
© Xiang et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.