Budesonide for induction of remission in Crohn's disease
Published Online: 16 JUL 2008
Assessed as up-to-date: 2 MAR 2008
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: Edited (no change to conclusions)
- Published Online: 16 JUL 2008
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.
The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in Crohn's disease.
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.
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.
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).
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
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.
Budesonide 用於克隆氏症(Crohn's disease)的緩解誘導治療
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。
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。
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(Metaanalysis)。
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(placebocontrolled)，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)。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。