Intervention Review

Probiotics for maintenance of remission in Crohn's disease

  1. Vivien E Rolfe1,*,
  2. Paul J Fortun2,
  3. Christopher J Hawkey2,
  4. Fiona J Bath-Hextall3

Editorial Group: Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group

Published Online: 18 OCT 2006

Assessed as up-to-date: 24 JUL 2006

DOI: 10.1002/14651858.CD004826.pub2

How to Cite

Rolfe VE, Fortun PJ, Hawkey CJ, Bath-Hextall FJ. Probiotics for maintenance of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD004826. DOI: 10.1002/14651858.CD004826.pub2.

Author Information

  1. 1

    The University of De Montford, School of Allied Health Sciences, Leicester, UK

  2. 2

    The University of Nottingham, Wolfson Digestive Diseases Centre, Nottingham, UK

  3. 3

    The University of Nottingham, School of Nursing, Faculty of Medicine and Health Science, Nottingham, UK

*Vivien E Rolfe, School of Allied Health Sciences, The University of De Montford, Hawthorn Building, Leicester, LE1 9BH, UK. vrolfe@dmu.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 OCT 2006

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Abstract

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

Background

Crohn's disease (CD) is characterised by episodes of disease activity and symptom-free remission. Probiotics are microorganisms that can potentially benefit health, and have been evaluated as an alternate means of preventing relapse in patients with CD.

Objectives

To assess the effectiveness of probiotics for the maintenance of remission in CD.

Search methods

The following databases were searched: the Cochrane Database of Systematic Reviews (2005, Issue 3); the Cochrane Central Register of Controlled Trials (2005, Issue 3); the Cochrane IBD/FBD Group Trials Register (2005), MEDLINE (1966 - 2005); EMBASE (1980 - 2005); ISI Web of Knowledge (BIDS) 1981 - 2005; On-line clinical trials databases (2005); and review articles. Experts in the field were contacted for unpublished data.

Selection criteria

Randomised controlled trials of probiotic therapy.

Data collection and analysis

Two independent reviewers performed data extraction and assessment of methodological quality. The primary outcome was the relative risk (RR) of relapse after maintenance treatment (and 95% confidence intervals [CI]).

Main results

Seven small studies were identified and varied according to probiotics tested, methodological quality and medication regimen. No studies were pooled for statistical analysis.

There was no statistically significant benefit of E. coli Nissle for reducing the risk of relapse compared to placebo (RR 0.43, 95% CI 0.15 to 1.20), or Lactobacillus GG after surgically-induced remission (RR 1.58, 95% CI 0.30 to 8.40) or medically-induced remission (RR 0.83, 95% CI 0.25 to 2.80).

There was no statistically significant benefit of probiotics for reducing the risk of relapse compared to maintenance therapy employing aminosalicylates or azathioprine (RR 0.67, 95% CI 0.13 to 3.30), and in this study the probiotic Lactobacillus GG was associated with adverse events.

In children, there was there was no statistically significant difference between Lactobacillus GG and placebo for reducing the risk of relapse (RR 1.85, 95% CI 0.77 to 4.40).

A small study using the yeast Saccharomyces boulardii demonstrated a difference that was not statistically significant in favour of probiotic combined with a reduced level of maintenance therapy over standard maintenance treatment alone (RR 0.17, 95% CI 0.02 to 1.23).

Authors' conclusions

There is no evidence to suggest that probiotics are beneficial for the maintenance of remission in CD. All of the included studies enrolled small numbers of patients and may have lacked statistical power to show differences should they exist. Larger trials are required to determine if probiotics are of benefit in Crohn's disease.

 

Plain language summary

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

Probiotics for maintenance of remission in Crohn's disease

Crohn's disease causes chronic inflammation of the intestines. Common symptoms include abdominal pain and diarrhoea. Probiotics are living microorganisms that are thought to benefit health by altering the growth and activity of bacteria in the intestines thereby reducing inflammation. Seven small studies of variable quality were reviewed. The studies tested the effect of maintenance treatment with probiotics (e.g. Lactobacilli GG, Escherichia coli strain Nissle 1917, VSL#3, Saccharomyces boulardii) among patients with Crohn's disease in remission. Remission was induced by medical or surgical treatment. The studies lasted for 6 months to a year. The studies did not demonstrate any benefit for probiotic treatment. Probiotics were generally well tolerated and few side effects were reported. Reported side effects include bloating, diarrhoea, constipation, nausea and epigastric pain. Currently, there is no evidence to support the use of probiotics for the maintenance treatment of Crohn's disease. It is possible that larger studies might show that this approach to treatment is effective.

 

摘要

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

背景

益生菌對於克隆氏症緩解維持的效應

克隆氏症(CD)的特點是疾病活動有症狀和無症狀緩解交替。益生菌是對健康有益的微生物,並且已經被評估為防止CD病患復發的替代治療。

目標

評估益生菌對於CD緩解維持的效力。

搜尋策略

作者搜尋以下資料庫︰Cochrane Database of Systematic Reviews (2005,第3期) ; Cochrane Central Register of Controlled Trials (2005,第3期) ; Cochrane IBD/FBD Group Trials Register (2005), MEDLINE (1966 – 2005) ; EMBASE (1980 – 2005) ; ISI Web of Knowledge (BIDS) (1981 �2005); 線上臨床試驗數據庫(2005);和評論的文章。作者聯繫在該領域方面的專家取得沒有發表的數據。

選擇標準

益生菌治療的隨機對照試驗。

資料收集與分析

兩位獨立的作者進行數據抽取和評估方法學的品質。主要結果是在維持治療後復發的relative risk (RR)(和95% confidence intervals [CI])。

主要結論

找到7個小研究,根據測試的益生菌,方法學的品質和藥物處方,各研究有所不同。沒有對這些研究做匯整統計分析。整體而言,E. coli Nissle對於降低復發的風險與安慰劑或Lactobacillus GG比較沒有顯著的好處(RR 0.43, 95% CI 0.15 to1.20),分別對於外科導致的緩解(RR 1.58, 95% CI 0.30 to 8.40)或內科療法導致的緩解(RR 0.83, 95% CI 0.25 to 2.80)也是沒有顯著的好處。使用益生菌對於降低復發的危險與aminosalicylates或者azathioprine當做維持治療做比較並沒有顯著的好處(RR 0.67, 95% CI 0.13 to 3.30),並且在這項研究中發現益生菌Lactobacillus GG與不良事件有關。在孩童,Lactobacillus GG和安慰劑對於降低復發的風險統計上沒有明顯的不同(RR 1.85, 95% CI 0.77 to 4.40)。一個使用酵母菌Saccharomyces boulardii的小型研究顯示對於益生菌合併減量的維持療法與單純標準的維持療法比較並沒有統計學上有意義的差異(RR 0.17, 95% CI 0.02 to 1.23)。.

作者結論

沒有證據建議益生菌對CD緩解的維持是有益的。所有被包括的研究都只招收少量病患,並且可能缺乏統計的效力而顯示它們的差別。需要更大的試驗來確定是否益生菌在CD具有好處。

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

益生菌對於克隆氏症的研究回顧七個小型品質不一的研究。這些研究測試使用益生菌(例如Lactobacilli GG, Escherichia coli strain Nissle 1917, VSL#3, Saccharomyces boulardii)對於CD緩解的患者當做維持治療的效應。緩解藉由內科或外科治療達成。這些研究持續6個月到一年。何謂CD?益生菌對CD有療效嗎? CD引起腸子的慢性發炎。常見的症狀包括腹痛和腹瀉。益生菌是活的微生物,被因為藉由改變腸道細菌生長與活性而降低發炎被認為有益健康。這些研究顯示什麼? 這些研究沒有顯示益生菌治療有任何益處。益生菌的安全性如何? 益生菌大致性被接受的情況不錯並且很少的副作用被報導。報告的副作用包括腹脹, 腹瀉, 便秘,嘔心和上腹疼痛. 底線 至今,沒有證據支持使用益生菌對於克隆氏症做維持治療。大型研究或許可能顯示這個治療方法是有效的。

 

Plain language summary

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

Probiotici za održavanje remisije Crohnove bolesti

Probiotici za održavanje remisije Crohnove bolesti

Crohnova bolest uzrokuje kroničnu upalu crijeva. Česti simptomi uključuju bol u trbuhu i proljev. Probiotici su živi organizmi za koje se smatra da mogu pospješiti zdravlje tako što mijenjaju rast i aktivnost bakterija u crijevima i na taj način smanjuju upalu. U Cochrane sustavnom pregledu analizirano je sedam malenih studija različite kvalitete. Studije su testirale učinak terapije održavanja pomoću probiotika (mikroorganizmima kao što su Lactobacilli GG, Escherichia coli soj Nissle 1917, VSL#3, Saccharomyces boulardii) među oboljelima od Crohnove bolesti koji su bili u remisiji. Remisija je bila postignuta lijekovima ili kirurškim zahvatima. Studije su trajale od 6 mjeseci do 1 godine. Studije nisu pokazale ikakvu korist od liječenja probioticima. Ispitanici su općenito dobro podnosili liječenje probioticima i prijavljeno je svega nekoliko nuspojava, uključujući nadutost, proljev, zatvor, mučninu i bol u gornjem dijelu trbuha. Trenutno nema dokaza koji bi poduprli uporabu probiotika kao terapije održavanja Crohnove bolesti. Moguće je da bi veće studije pokazale da je ovakav pristup liječenju učinkovit.

Translation notes

Translated by: Croatian Branch of the Italian Cochrane Centre
Translation Sponsored by: Ministry of Education, Science and Sports