Intervention Review

Corticosteroids for maintenance of remission in Crohn's disease

  1. A Hillary Steinhart1,*,
  2. Klaus Ewe2,
  3. Anne Marie Griffiths3,
  4. Robert Modigliani4,
  5. Ole Ostergaard Thomsen5

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

Published Online: 20 OCT 2003

Assessed as up-to-date: 3 JUL 2008

DOI: 10.1002/14651858.CD000301


How to Cite

Steinhart AH, Ewe K, Griffiths AM, Modigliani R, Thomsen OO. Corticosteroids for maintenance of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD000301. DOI: 10.1002/14651858.CD000301.

Author Information

  1. 1

    University of Toronto, Department of Medicine, Toronto, Ontario, Canada

  2. 2

    55128 Mainz, Germany

  3. 3

    The Hospital for Sick Children, Division of Gastroenterology, Hepatology & Nutrition, Toronto, Ontario, Canada

  4. 4

    Hopital Saint Louis, Service d'hepato gastroenterologie, 75475 Paris Cedex 10, France

  5. 5

    Herlev Hospital, Department of Medicine C, Herlev, Denmark

*A Hillary Steinhart, Department of Medicine, University of Toronto, Room 445, 600 University Avenue, Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada. hsteinhart@mtsinai.on.ca.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 OCT 2003

SEARCH

 

Abstract

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

Background

The efficacy of corticosteroids in the setting of maintenance therapy for Crohn's disease has never been clearly demonstrated. It would be important to determine, based upon the currently available data from controlled trials, if the use of chronic corticosteroid therapy is of benefit in patients with quiescent Crohn's disease or if there is an identifiable subgroup of Crohn's disease patients, such as those in whom therapy cannot be successfully tapered, who might benefit from such treatment.

Objectives

To evaluate the effectiveness and safety of conventional systemic corticosteroid therapy in maintaining clinical remission in Crohn's disease.

Search methods

A computer-assisted search of the on-line bibliographic database MEDLINE of studies published in English, French, Spanish, Italian and German between 1966 and July, 2008. Manual searches of the reference lists from the potentially relevant studies were performed in order to identify additional studies that may have been missed using the computer-assisted search strategy. Proceedings from major gastrointestinal meetings were also manually searched from 1985 to 2003 in order to identify unpublished studies. The Cochrane Central Register of Controlled Trials and the Inflammatory Bowel Disease Review Group Specialized Trials Register were also searched.

Selection criteria

Randomized double-blind placebo-controlled trials involving patients of any age with Crohn's disease in clinical remission as defined by a CDAI < 150 or by the presence of no symptoms or only mild symptoms at the time of entry into the trial. The experimental treatment consisted of oral conventional corticosteroid therapy (excluding budesonide, fluticasone, etc). Clinical disease relapse was used as the outcome measure of interest.

Data collection and analysis

Eligible studies were selected by 4 reviewers and data were extracted onto standardized data extraction forms. Disagreements in eligibility or data extraction were resolved by consensus. Data were converted into individual 2x2 tables for each study. The presence of significant heterogeneity among studies was tested using the chi-square test. The 2x2 tables were synthesized into a summary test statistic using the pooled odds ratio and 95% confidence intervals as described by Cochran and Mantel and Haenszel (the 'odds ratio' in MetaView). A fixed effects model was used for the pooling of data.

Main results

Four studies were initially judged as being eligible for inclusion. After obtaining additional information on one of the studies it was excluded because it was not double-blind. The total number of subjects included in the analysis at the time points of 6, 12 and 24 months were 142, 131 and 95 for the corticosteroid group and 161, 138 and 87 for the control group. The odds ratios for relapse on active treatment and the corresponding 95% confidence intervals were 0.71 (0.39, 1.31), 0.82 (0.47, 1.43) and 0.72 (0.38, 1.35) at 6, 12 and 24 months respectively.

Authors' conclusions

The use of conventional systemic corticosteroids in patients with clinically quiescent Crohn's disease does not appear to reduce the risk of relapse over a 24 month period of follow-up. An updated literature search performed in July 2008 did not identify any new trials.

 

Plain language summary

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

Corticosteroids for maintenance of remission in Crohn's disease

The use of corticosteroids among patients with non-active Crohn's disease does not appear to be effective in reducing the risk of disease recurrence over a 24 month period. Side effects associated with the long term use of corticosteroids include osteoporosis and cataracts. There may be subgroups of patients who would benefit from low dose corticosteroids but the long-term effectiveness of this type of treatment has not been studied.

 

摘要

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

背景

皮質類固醇維持克隆氏症的緩解效果

使用皮質類固醇來維持克隆氏症的緩解效果未曾被確定過。根據當下對照性試驗中的既有數據來決定長期使用皮質類固醇對於無症狀的克隆氏症或是被被判定為克隆氏症某次族群(如治療無法逐漸減少)的病患是否有效是非常重要的。

目標

評估使用傳統全身性皮質類固醇治療來維持克隆氏症臨床上緩解的有效性和安全性。

搜尋策略

電腦輔助搜尋線上書目資料庫MEDLINE,1966年至2003年七月以英文、法文、西班牙文、義大利文及德文發表的試驗。以人工的方式 搜尋可能相關試驗的參考文獻清單,以防以電腦搜尋時有所遺漏掉。並人工方式搜尋1985年至2003年重要的腸胃道研討會手冊,找出未發表的研究。此外也搜尋The Cochrane Central Register of Controlled Trials and the Inflammatory Bowel Disease Review Group Specialized Trials Register 。

選擇標準

對任何年齡克隆氏症患者,其臨床上克隆氏症活性指數小於150或在進入試驗時並沒有或只有輕微症狀,所進行隨機性雙盲與以安慰劑為對照組的試驗。實驗治療包括有傳統口服皮質類固醇治療(排除budesonide、 fluticasone等)。臨床症狀的復發為重要的評估結果。

資料收集與分析

由4個審閱者挑選符合納入的試驗,並將擷取數據填入標準數據擷取格式。當對於納入的試驗或是擷取的數據有不一致的意見時,則進行協商以達成共識。數據被轉換為個別的2�表格。以卡方檢定檢測試驗間是否有顯著異質性。2�的表格會以 Cochran、Mantel和Haenszel所提出的彙整的勝算比及95%信賴區間的總結方法統計(MetaView軟體中的勝算比)。彙整數據以固定效應模式進行計算。

主要結論

起初判定有4個試驗符合納入標準。但取得詳細資料後,有一個試驗因不是雙盲試驗所以將該試驗剔除。在第6、12和24個月時間點納入分析受試者總數在使用皮質類固醇組分別為142、131和95人,而對照組分別為161、138和87人。在第6、12和24個月時,在治療組復發的勝算比及其相對95%信賴區間分別為0.71(0.39至1.31)、0.82(0.47至1.43)和0.72(0.38至1.35)。

作者結論

傳統全身性使用皮質類固醇於臨床上無症狀的克隆氏症患者無法降低追蹤24個月以上疾病復發的風險。本回顧更新在Cochrane Library 2003年第2期發表針對使用皮質類固醇維持克隆氏症緩解效果的回顧。

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

皮質類固醇無法有效維持緩解克隆氏症。對無症狀的克隆氏症患者使用皮質類固醇未減少疾病在24個月之後復發的風險。而長期使用皮質類固醇的副作用包括骨質疏鬆症和白內障。可能有某些次族群病患會因使用低劑量皮質類固醇而受惠,但這種長期治療的效果則尚無研究予以評估。