Intervention Review

Nonabsorbable disaccharides for hepatic encephalopathy

  1. Bodil Als-Nielsen1,*,
  2. Lise Lotte Gluud2,
  3. Christian Gluud2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 19 APR 2004

Assessed as up-to-date: 10 FEB 2004

DOI: 10.1002/14651858.CD003044.pub2

How to Cite

Als-Nielsen B, Gluud LL, Gluud C. Nonabsorbable disaccharides for hepatic encephalopathy. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD003044. DOI: 10.1002/14651858.CD003044.pub2.

Author Information

  1. 1

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

  2. 2

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

*Bodil Als-Nielsen, Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Dept. 3344, Blegdamsvej 9, Copenhagen, DK-2100, Denmark. bodil.als@dadlnet.dk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 APR 2004

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Abstract

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

Background

Nonabsorbable disaccharides (lactulose or lactitol) are considered the treatment of choice for hepatic encephalopathy.

Objectives

To assess the beneficial and harmful effects of nonabsorbable disaccharides for patients with hepatic encephalopathy.

Search methods

Trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register (March 2003), The Cochrane Central Register of Controlled Trials (Issue 1, 2003), MEDLINE (1966 to 2003/03), EMBASE (1980 to 2003/03), manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies.

Selection criteria

Randomised trials comparing lactulose or lactitol versus no intervention, placebo, or antibiotics and trials comparing lactulose versus lactitol for hepatic encephalopathy.

Data collection and analysis

The primary outcome measures included no improvement of hepatic encephalopathy and all-cause mortality. Binary outcomes are reported as relative risks (RR) based on a random effects model. Subgroup analyses were performed with regard to methodological quality and form of hepatic encephalopathy.

Main results

Thirty trials assessed nonabsorbable disaccharides versus placebo, no intervention, or antibiotics or assessed lactulose versus lactitol. We could not extract data from all trials. Compared with placebo or no intervention, nonabsorbable disaccharides had no statistically significant effect on mortality (RR 0.41, 95% CI 0.02 to 8.68, four trials), but appeared to reduce the risk of no improvement of hepatic encephalopathy (RR 0.62, 95% CI 0.46 to 0.84, six trials). However, this result may reflect bias due to low methodological quality of the majority of included trials. Trials of high methodological quality found no significant effect of nonabsorbable disaccharides on the risk of no improvement (RR 0.92, 95% CI 0.42 to 2.04, two trials). We found no statistically significant difference between lactulose and lactitol on mortality (two trials) or risk of no improvement (four trials). However, our meta-analyses were underpowered to establish whether these treatments have comparable effect. Nonabsorbable disaccharides appeared to be inferior to antibiotics on reducing the risk of no improvement (RR 1.24, 95% CI 1.02 to 1.50, 10 trials).

Authors' conclusions

This systematic review questions the beneficial effects of nonabsorbable disaccharides and highlights that there is insufficient high-quality evidence to support this treatment. We found that antibiotics appeared to be superior to nonabsorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference in treatment effect is clinically important to patients. Nonabsorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.

 

Plain language summary

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

There is insufficient evidence to confirm or exclude whether nonabsorbable disaccharides have an effect on patients with hepatic encephalopathy

Nonabsorbable disaccharides (lactulose or lactitol) are considered the treatment of choice for hepatic encephalopathy. When all the identified trials were combined, nonabsorbable disaccharides appeared to have a modest effect on improving encephalopathy. However, this effect was not seen when only trials of high quality were analysed. Antibiotics appeared to be superior to nonabsorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference in treatment effect is important to patients. Too few patients have been randomised to establish whether lactulose and lactitol have comparable effect.

 

摘要

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

背景

不可吸收的雙醣類治療肝腦病變

不可吸收的雙醣類 (乳果糖或乳糖醇)被認為是肝腦病變的首選治療。

目標

評估不可吸收的雙醣類治療肝腦病變的利弊 。

搜尋策略

透過搜尋The Cochrane HepatoBiliary Group Controlled Trials Register (2003年3月)The Cochrane Central Register of Controlled Trials (2003年第1期),、MEDLINE (1966年−2003年03), EMBASE (1980年 2003年3月), 手動搜索目錄和期刊,聯繫試驗作者和製藥公司。

選擇標準

乳果糖或乳糖醇,相對於無干預法,安慰劑或抗生素的隨機試驗以及比較乳果糖和乳糖醇治療肝腦病變的試驗。

資料收集與分析

主要結果端視肝腦病變無改善和全因死亡率。根據隨機效果模式,二分法結果記錄成相對風險度 (relative risks ,RR)。從研究方法學品質和肝腦病變的形式等方面,實施亞組分析。

主要結論

共評估了不可吸收的雙醣類對照安慰劑,無干預法或抗生素,或乳果糖對照乳糖醇的30個試驗。我們無法提取所有試驗的資料。 比較安慰劑或無干預法,不可吸收的雙醣類在死亡率上沒有統計上顯著 (RR 0.41, 95% CI 0.02 8.68, four次試驗), 但是可以降低肝腦病變無改善的風險 (RR 0.62, 95% CI 0.46 0.84, 6次試驗)。但是,由於包含的試驗多數方法學品質較差,所以結果可能反應出了偏誤。研究方法品質較高的試驗發現不可吸收的雙醣類對於肝腦病變無改善的風險沒有顯著作用(RR 0.92, 95% CI 0.42  2.04,2次試驗)。我們發現乳果糖和乳糖醇在死亡率 (2個試驗) 或無改善風險(4個試驗)等方面,沒有統計學上顯著差異。但是,我們的統合分析因效度(power)不足而無法顯示這些藥物是否具有療效。不可吸收的雙醣類似乎在「肝腦病變無改善」的風險方面不如抗生素(RR 1.24, 95% CI 1.02 1.50, 10次試驗).

作者結論

本次系統性文獻回顧提出了是否不可吸收的雙醣類能夠有效治療肝腦病變,強調由於高品質的證據不足,無法支持該藥物。 我們發現在改善肝腦病變方面,抗生素似乎優於不可吸收的雙醣類,但是我們還無法肯定是否兩種藥物的療效差異,對病人具有臨床的重要性。不可吸收的雙醣類不能作為肝腦病變的隨機試驗之比較因素。

翻譯人

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

總結

沒有足夠的證據確定或排除是否不可吸收的雙醣類能夠有效治療肝腦病變。不可吸收的雙醣類(乳果糖或乳糖醇) 被認為是治療肝腦病變的首選。當結合所有已判定的試驗後,不可吸收的雙醣類似乎可收到改善肝腦病變的效果。但是從我們分析的唯一一個高品質試驗中,我們無法看到這種結果。我們發現在改善肝腦病變方面,抗生素似乎優於不可吸收的雙醣類,但是我們還無法肯定是否兩種藥物的療效差異,對病人具有臨床的重要性。由於隨機挑選的病人太少,所以是否乳果糖和乳糖醇具有療效尚無法定論。