No evidence to support or refute the effect of bile acids in patients with non-alcoholic fatty liver disease and/or steatohepatitis

Orlando R, Azzalini L, Orando S, Lirussi F

Published Online:

January 21, 2009

Non-alcoholic fatty liver disease is a condition characterised by fatty deposition in the hepatocytes in patients with minimal or no alcohol intake. Hepatic injury might be improved by bile acids. This systematic review identified four randomised clinical trials. Bile acids did not cause any liver-related deaths and were associated with only minor, non-specific adverse events. However, these agents did not show any significant amelioration of common liver function tests as compared with placebo. Moreover, data on the radiological (ultrasonography and computer tomography scan) and/or histological response were too limited to draw any conclusions. Further randomised placebo-controlled trials are necessary.

Abstract (click to read)

Background:

Non-alcoholic fatty liver disease is a condition characterised by fatty deposition in the hepatocytes of patients with minimal or no alcohol intake. Some patients develop non-alcoholic steatohepatitis. Bile acids may potentially protect cellular structures and may be of benefit in patients with non-alcoholic fatty liver or steatohepatitis.

Objectives:

To systematically evaluate the beneficial and harmful effects of bile acids versus no intervention, placebo, or other interventions for patients with non-alcoholic fatty liver or steatohepatitis.

Search strategy:

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2005), the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 2, 2005), MEDLINE (1966 to July 2005), EMBASE (1980 to July 2005), and the Chinese Biomedical Database (1978 to July 2005). No language restrictions were applied.

Selection criteria:

Randomised clinical trials evaluating any bile acids versus no intervention, placebo, or other interventions in patients with NAFLD.

Data collection and analysis:

We extracted data from the identified trials as well as contacted authors. We evaluated the methodological quality of the randomised trials by assessing the generation of allocation sequence, allocation concealment, blinding, and follow-up. We made our analyses following the intention-to-treat method by imputing missing data.

Main results:

We identified four randomised clinical trials randomising 279 patients. Only one of the trials was considered a low-bias risk trial. One of the trials reported a non-liver-related death in the bile acid group. No significant differences were found regarding mortality or improvement in liver function tests observed after treatment with ursodeoxycholic acid. Data on the radiological and histological responses were too scant to draw any definite conclusions. Adverse events were non-specific and considered of no major clinical relevance.

Authors' conclusions:

Presently, there are insufficient data to support or refute the use of ursodeoxycholic acid for patients with non-alcoholic fatty liver or steatohepatitis. It may be advisable to carry out large randomised clinical trials on this topic.

This record should be cited as:

Orlando R, Azzalini L, Orando S, Lirussi F. Bile acids for non-alcoholic fatty liver disease and/or steatohepatitis. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005160. DOI: 10.1002/14651858.CD005160.pub2

Assessed as up to date:

September 21, 2006

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Primary Review Group:

Hepato-Biliary Group

Health topics:

Gastroenterology > Fatty liver > Obesity-related

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

No evidence to support or refute the effect of bile acids in patients with non-alcoholic fatty liver disease and/or steatohepatitis

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