Intervention Review

Bile acids for non-alcoholic fatty liver disease and/or steatohepatitis

  1. Rocco Orlando1,*,
  2. Lorenzo Azzalini2,
  3. Serena Orando3,
  4. Flavio Lirussi4

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 24 JAN 2007

Assessed as up-to-date: 20 SEP 2006

DOI: 10.1002/14651858.CD005160.pub2

How to Cite

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.

Author Information

  1. 1

    University of Padua Medical School, Department of Medical and Surgical Sciences, Padova, Italy

  2. 2

    Hospital de la Santa Creu i Sant Pau, Servei de Cardiologia, Barcelona, Spain

  3. 3

    Universitá Degli Studi di Firenze, Instituto di Anestesia e Rianimazione, Firenze, Italy

  4. 4

    WHO Regional Office for Europe, European Office for Investment for Health and Development, Scientist, Socioeconomic Determinants of NCDs, Venice, Italy

*Rocco Orlando, Department of Medical and Surgical Sciences, University of Padua Medical School, via Giustiani, 2, Padova, 35128, Italy. rocco.orlando@unipd.it.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JAN 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 methods

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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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

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.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

膽酸對於非酒精性脂肪肝疾病和/或非酒精性脂肪蓄積性肝炎的成效

非酒精性脂肪肝疾病是一種在很少或沒有飲酒患者的肝細胞中特有的脂肪沉積。有些患者會發展成為非酒精性脂肪蓄積性肝炎。膽酸可能潛在地保護細胞結構,可能是有益於非酒精性脂肪肝疾病或肝炎。

目標

系統性地評估膽酸與沒有治療,安慰劑,或其他治療對於非酒精性脂肪肝疾病或肝炎患者有益和有害的效應。

搜尋策略

作者檢索了Cochran e HepatoBiliary Group Controlled Trials Register(2005年7月),the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library(2005年第2期),MEDLINE(1966年至2005年7月),EMBASE(1980年至2005年7月)和Chinese Biomedical Database(1978年至2005年7月)。沒有應用語言限制進行搜尋。

選擇標準

評估任何種類膽酸與沒有治療,安慰劑,或其他治療對於非酒精性脂肪肝疾病患者的隨機臨床試驗

資料收集與分析

作者從找到的試驗以及聯繫作者提取數據。作者經由分析分配順序的產生,分配隱藏,雙盲,和追蹤來評估隨機試驗方法學的品質。作者利用意圖治療分析法做出數據。

主要結論

作者找到4個隨機化279病患的隨機臨床試驗。只有一個試驗被認為是低偏差風險的試驗。其中一個試驗中報告在膽酸組別有一位非肝臟疾病相關的死亡。ursodeoxycholic acid治療後有關死亡率或肝功能檢查結果的改善沒有顯著性差異。放射性檢查和病理組織學反應的數據太過於稀少以至於無法做出任何肯定的結論。不良的反應沒有特異性,並且被認為沒有重大的臨床意義。

作者結論

目前,沒有充分的數據來支持或反對對於非酒精性脂肪肝疾病或肝炎的病人使用ursodeoxycholic acid。 這也許應該建議對這一議題進行大規模的隨機臨床試驗。

翻譯人

本摘要由臺中榮民總醫院王建得翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有數據支持或反對膽酸對於非酒精性脂肪肝疾病和/或肝炎病人的效應。非酒精性脂肪肝疾病是一種在很少或沒有飲酒患者的肝細胞中特有的脂肪沉積。肝臟的損傷可能藉由膽酸改善。膽酸不會引起任何肝臟相關的死亡並且只有非常少數和非特異性的不良反應。然而,這些藥物和安慰劑比較對於一般肝功能檢查結果並沒有顯著的改善。而且,放射性檢查(超音波和電腦斷層掃描)和病理組織學反應的數據太過於稀少以至於無法做出任何肯定的結論。需要進一步隨機安慰劑對照的試驗。