Intervention Review

Budesonide for induction of remission in Crohn's disease

  1. Cynthia H Seow1,*,
  2. Eric I Benchimol2,
  3. Anne Marie Griffiths2,
  4. Anthony R Otley3,
  5. A Hillary Steinhart4

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

Published Online: 16 JUL 2008

Assessed as up-to-date: 2 MAR 2008

DOI: 10.1002/14651858.CD000296.pub3


How to Cite

Seow CH, Benchimol EI, Griffiths AM, Otley AR, Steinhart AH. Budesonide for induction of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD000296. DOI: 10.1002/14651858.CD000296.pub3.

Author Information

  1. 1

    University of Calgary, Departments of Medicine & Community Health Sciences, Calgary, Alberta, Canada

  2. 2

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

  3. 3

    IWK Health Centre, Head, Division of Gastroenterology, Halifax, Nova Scotia, Canada

  4. 4

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

*Cynthia H Seow, Departments of Medicine & Community Health Sciences, University of Calgary, TRW Building Rm 6D18, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6, Canada. cynthia.seow@albertahealthservices.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 16 JUL 2008

SEARCH

 

Abstract

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

Background

Corticosteroids play a key role in the induction of remission in Crohn's disease. However, corticosteroids can cause significant adverse events. Budesonide is an alternate enteral glucocorticoid with limited systemic bioavailability.

Objectives

The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in Crohn's disease.

Search methods

The following electronic databases were searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched. Pharmaceutical companies were also contacted.

Selection criteria

Randomized controlled trials comparing budesonide to a control treatment were included. The study population included patients of any age with active Crohn's disease (CDAI > 150). The primary outcome was induction of remission (CDAI < 150) by week 8 to 16 of treatment. Secondary outcomes included: time to remission, mean change in CDAI, clinical, histological or endoscopic improvement, improvement in quality of life, adverse events and early withdrawal.

Data collection and analysis

Two independent investigators reviewed studies for eligibility, extracted the data and assessed study quality. A random effects model was used and studies were weighted using the DerSimonian & Laird method. Meta-analysis was performed using RevMan 4.2.10 software.

Main results

Twelve studies were included: 9 compared budesonide with conventional corticosteroids, 2 were placebo-controlled, and 1 compared budesonide with mesalamine. After 8 weeks of treatment, budesonide was significantly more effective than placebo (RR 1.96, 95% CI 1.19 to 3.23) or mesalamine (RR 1.63; 95% CI 1.23 to 2.16) for induction of remission. Budesonide was significantly less effective than conventional steroids for induction of remission (RR 0.86, 95% CI 0.76 to 0.98), particularly among patients with severe disease (CDAI > 300) (RR 0.52, 95% CI 0.28 to 0.95). Fewer adverse events occurred in those treated with budesonide compared to conventional steroids (RR 0.64, 95% CI 0.54 to 0.76) and budesonide was better able to preserve adrenal function (RR for abnormal ACTH test 0.65, 95% CI 0.55 to 0.78).

Authors' conclusions

Budesonide is more effective than placebo or mesalamine for induction of remission in Crohn's disease. Although short-term efficacy with budesonide is less than with conventional steroids, particularly in those with severe disease or more extensive colonic involvement, the likelihood of adverse events and adrenal suppression is lower.

 

Plain language summary

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

Budesonide for treatment of active Crohn's disease

Traditional corticosteroids are often used as treatment for active Crohn's disease. Unfortunately, corticosteroids can cause side effects. Budesonide is a newer corticosteroid drug which is quickly metabolized by the liver thereby reducing corticosteroid related side effects. Budesonide is more effective than placebo (fake medicine) or mesalamine for the treatment of active Crohn's disease. Traditional corticosteroids are more effective than budesonide for the treatment of active Crohn's disease, particularly in patients with severe disease. However, budesonide is less likely than traditional corticosteroids to cause side effects.

 

摘要

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

背景

Budesonide 用於克隆氏症(Crohn's disease)的緩解誘導治療

皮質類固醇對於克隆氏症的緩解誘導治療具有關鍵作用。然而,皮質類固醇亦會造成嚴重的副作用。Budesonide屬於一種替代性的腸道類固醇,並具有局限的全身性生體可用率(bioavailability)。

目標

本研究的主要目標(primary objective)在評估口服Budesonide對於克隆氏症的緩解誘導治療的有效性及安全性。

搜尋策略

作者搜尋下列的電子資料庫:MEDLINE、EMBASE、the Cochrane Central Register of Controlled Trials、the Cochrane IBD/FBD Group Specialised Trial Register、ClinicalTrials.gov。並且以人工的方式搜尋文章裡面列舉的參考文獻,以及研討會論文,此外並與藥廠聯絡。

選擇標準

作者納入隨機控制試驗,比較Budesonide與對照組。研究族群為任何年齡,有活動性克隆氏症(CDAI>150)患者。主要研究結果(primary outcome)是看治療後第8至16週的疾病緩解誘導情形。次要研究結果(secondary outomce)包括:疾病緩解時間,CDAI指數的平均改變數值,臨床組織學或內視鏡發現的進步情形,生活品質,副作用以及提早退出試驗的情形。

資料收集與分析

兩位獨立的作者,負責研究的資格審查、擷取數據,及評估研究品質。我們使用隨機效應模式,並藉由Der Simonian & Laird method來衡量研究。並採用Rev Man 4.2.10軟體進行統合分析(Metaanalysis)。

主要結論

共納入12個研究.其中9個研究比較budesonide與傳統皮質類固醇的差異,2個研究是安慰劑對照(placebocontrolled),1個研究比較budesonide與mesalamine的差異。經過8週治療以後,budesonide在誘導緩解治療的效果比安慰劑組顯著(RR 1.96; 95%信賴區間1.19 – 3.23),也比mesalamine有效(RR 1.63; 95%信賴區間1.23 – 2.16)。 Budesonide在誘導緩解方面的療效明顯不及常規使用的類固醇(RR 0.86, 95% CI 0.76 – 0.98),此情形在病況嚴重的患者當中特別明顯(CDAI > 300) (RR 0.52, 95% CI0.28 – 0.95)。而與使用常規類固醇者相比,使用budesonide的不良事件較少(RR 0.64, 95% CI 0.54 – 0.76), 而且budesonide較能維持腎上腺功能(異常ACTH檢驗結果RR 0.65, 95% CI 0.55 – 0.78)。

作者結論

Budesonide對於克隆氏症的緩解誘導治療,效果比安慰劑以及mesalamine好,雖然budesonide短期療效比傳統類固醇差(特別是在那些患有嚴重克隆氏症或影響大腸範圍更廣的病患),其副作用和腎上腺抑制效果均較傳統類固醇低。

翻譯人

本摘要由臺中榮民總醫院張崇信翻譯。

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

總結

傳統類固醇時常被用來治療活動性的克隆氏症。但是不幸的皮質類固醇可能會引起副作用。Budesonide是新一代皮質類固醇藥物,其很快在肝臟代謝,從而減少皮質類固醇的副作用。Budesonide是比安慰劑(假藥)或mesalamine對活動性克隆氏症更有效的藥物。傳統的皮質類固醇對於活動性克隆氏症的療效比budesonide好,特別是在嚴重克隆氏症患者。但是budesonide引起的副作用比較少。