Intervention Review

Anti-tuberculous therapy for maintenance of remission in Crohn's disease

  1. Mark Borgaonkar2,
  2. Don MacIntosh3,
  3. John Fardy1,*,
  4. Lorinda Simms4

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

Published Online: 26 APR 1999

Assessed as up-to-date: 22 FEB 1999

DOI: 10.1002/14651858.CD000299


How to Cite

Borgaonkar M, MacIntosh D, Fardy J, Simms L. Anti-tuberculous therapy for maintenance of remission in Crohn's disease. Cochrane Database of Systematic Reviews 1999, Issue 2. Art. No.: CD000299. DOI: 10.1002/14651858.CD000299.

Author Information

  1. 1

    Memorial University of Newfoundland, Dept. of Medicine Health Sciences Centre StJohn`s, CA-Newfoundland, Canada

  2. 2

    Memorial University of Newfoundland, Department of Medicine, St. John's, Newfoundland, Canada

  3. 3

    Dalhousie University, Halifax, Nova Scotia, Canada

  4. 4

    Eli Lilly and Company (Canada), Statistics and Information Sciences, Toronto, Ontario, Canada

*John Fardy, Dept. of Medicine Health Sciences Centre StJohn`s, Memorial University of Newfoundland, St John`s Centre, CA-Newfoundland, AIB 3V6, Canada. jfardy@mun.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 26 APR 1999

SEARCH

 

Abstract

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

Background

There have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed to evaluate the use of anti-tuberculous therapy for the maintenance of remission in Crohn's disease.

Objectives

To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease.

Search methods

We searched the Inflammatory Bowel Disease Trials Register, the Cochrane Controlled Trials Register and MEDLINE from 1966 to 1998 (supplemented by a manual search of Index Medicus from 1966 to 1994). We also searched for abstracts in Gut, Gastroenterology, and The American Journal of Gastroenterology from 1990 to 1996. Date of most recent search: August 1998.

Selection criteria

Randomized trials of anti-tuberculous therapy in patients with Crohn's disease.

Data collection and analysis

Data on the number of patients maintaining remission for each treatment group were abstracted. These data were pooled to yield Mantel-Haenszel odds ratios and numbers needed to treat for maintenance of remission in treated versus control groups.

Main results

A total of seven randomized trials which included 355 patients were identified. Two trials used anti-tuberculous therapy (clofazimine or clofazimine, rafmpin, ethambutol, and dapsone) in combination with corticosteroids to induce remission. Maintenance therapy consisted of the anti-tuberculous agents without corticosteroids. Control patients received corticosteroids to induce remission but no anti-tuberculous therapy.

The analysis of all seven trials yielded an odds ratio for maintenance of remission of 1.36 (95% CI 0.87-2.13). Removing the two studies that were published as abstracts did not significantly affect this result: the pooled odds ratio was 1.14 (95% CI 0.71-1.83).

The two trials reported as abstracts were excluded from subgroup analyses because they did not include any information on adjunct therapy.

Subgroup analysis of the two trials which used steroids to induce remission yielded an odds ratio for maintenance of remission of 3.37 (95% CI 1.38-8.24). The number needed to treat was three. However, these two trials included only 89 patients, and the results should be interpreted with caution.

The remaining three trials compared the combination of anti-tuberculous therapy and 'standard therapy' with 'standard therapy alone'. The pooled odds ratio was 0.70 (95% CI 0.39-1.25).

Authors' conclusions

Anti-tuberculous therapy may be effective in maintaining remission in patients with Crohn's disease when remission has been induced with corticosteroids combined with anti-tuberculous therapy. However, the results which support this conclusion come from a subgroup of only two trials with small numbers of patients and should be interpreted with caution. Use of this therapy cannot be recommended on the basis of this evidence.

 

Plain language summary

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

Anti-tuberculous therapy for maintaining remission in Crohn's disease

Tuberculous bacteria have been suggested as a possible cause of Crohn's disease due to a similarity between Crohn's and tuberculous lesions when viewed under a microscope. The use of anti-tuberculous therapy among patients with non-active Crohn's disease does not appear to be effective in reducing the risk of disease recurrence over a 6 to 24 month period.

 

摘要

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

背景

抗結核治療在維持克隆氏症(Crohn's disease)的緩解效果

有多個探討抗結核治療克隆氏症的研究在結果上有互相衝突的現象。擬以統合分析來評估抗結核治療對維持克隆氏症緩解效果的效果。

目標

評估抗結核治療對維持克隆氏症患者的緩解效果。

搜尋策略

搜尋1966年至1998年 Inflammatory Bowel Disease Trials Register、 Cochrane Controlled Trials Register 及MEDLINE, (並輔以人工搜尋1966年至1994年Index Medicus)。同時搜尋1990年至1996年Gut、Gastroenterology及The American Journal of Gastroenterology的摘要。最近一次搜尋在1998年8月。

選擇標準

抗結核療法治療克隆氏症患者的隨機性試驗。

資料收集與分析

擷取每一治療組中維持緩解效果的病患人數。這些數據會被彙整計算出 MantelHaenszel勝算比(odds ratios)和在治療組相對對照組治療以維持緩解效果需要的病患數目。

主要結論

納入共355名患者7個隨機性試驗。有2個試驗使用抗結核藥物治療 (clofazimine 或 clofazimine, rafmpin, ethambutol, 和dapsone)搭配類固醇治療來產生緩解效果。維持性治療包括使用抗結核藥物不加類固醇。對照組的患者使用類固醇產生緩解效果,但沒接受抗結核藥物治療。針對這7個試驗分析得到維持緩解效果的勝算比為1.36 (95%信賴區間 0.87至2.13)。去除兩個僅以摘要發表的試驗後分析沒有顯著影響結果:彙集的勝算比為1.14(95%信賴區間 0.71至1.83)。因這兩個僅以摘要發表的試驗沒有收納任何輔助治療的資訊,所以這兩個試驗未包含到次群組分析。兩個使用類固醇造成來緩解試驗進行次群體分析得到維持緩解效果的勝率比為3.37(95%信賴區間1.38至8.24),兩組有差別需要進行治療的患者數為3。但這兩個試驗只納入89名病患,所以應該謹慎解釋試驗結果。其餘的3個試驗則是比較抗結核治療加上“標準療法”與標準療法比較,彙集的勝算比值為0.70(95%信賴區間0.39至1.25)。

作者結論

當使用皮質類固醇併用抗結核療法來緩解克隆氏症時,抗結核治療可能可以對維持緩解功效。但做這樣的結論必須小心,因為他是來自兩個小型試驗的次群組分析所得果。在目前的證據基礎不能建議使用這種治療策略。

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

抗結核治療無法有效維持緩解克隆氏症。因在顯微鏡下克隆氏症和結核病的病灶相似,所以一度推測結核菌可能是克隆氏症的病原因。對於非活性克隆氏症的患者施以抗結核療法,為呈現在6至24個月內降低疾病復發的風險。