Interventions for treating collagenous colitis

  • Review
  • Intervention

Authors


Abstract

Background

Collagenous colitis is a cause of chronic diarrhea. Treatment has been based mainly on anecdotal evidence. This review was performed to identify therapies for collagenous colitis that have been proven in randomized trials.

Objectives

To determine effective treatments for patients with collagenous colitis.

Search methods

Relevant papers published between 1970 and December 2007 were identified via the MEDLINE and PUBMED databases. Manual searches from the references of identified papers, as well as review papers on collagenous or microscopic colitis were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Finally, the Cochrane Controlled Trials Register and the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group Specialized Trials Register were searched for other studies.

Selection criteria

Ten randomized trials were identified. Seven of these compared active treatment to placebo for treating active disease. Of these, 1 trial studied bismuth subsalicylate, 1 trial studied Boswellia serrata extract, 3 trials studies budesonide, 1 trial studied prednisolone, and 1 trial studied probiotics. One trial compared mesalamine to mesalamine + cholestyramine for treating active disease. Two trials compared budesonide to placebo in maintaining response induced by budesonide.

Data collection and analysis

Data were extracted independently by each author onto 2x2 tables (treatment versus comparator and response versus no response). For therapies assessed in one trial only, P-values were derived using the chi-square test. For therapies assessed in more than one trial, summary test statistics were derived using the Peto odds ratio and 95% confidence intervals. Data were combined for analysis only if the outcomes were sufficiently similar in definition.

Main results

In treating active disease, there were 9 patients with collagenous colitis in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks). Clinical response occurred in 100% of patients who received bismuth subsalicylate compared to 0% of patients who received placebo (P = 0.03). Thirty-one patients were enrolled in the trial studying Boswellia serrata extract (three 400 mg capsules daily for 8 weeks). Clinical response occurred in 44% of patients who received Boswellia serrata extract compared to 27% of patients who received placebo (P = 0.32). A total of 94 patients were enrolled in 3 trials studying budesonide (9 mg daily or in a tapering schedule for 6 to 8 weeks). Clinical response occurred in 81% of patients who received budesonide compared to 17% of patients who received placebo (P < 0.00001). The pooled Peto OR for clinical response to treatment with budesonide was 12.32 (95% CI 5.53 to 27.46), with a number needed to treat of 2 patients. Statistically significant histological response occurred with treatment in all 3 trials studying budesonide therapy. Eleven patients were enrolled in the trial studying prednisolone (50 mg daily for 2 weeks). Clinical response occurred in 63% of patients who received prednisolone compared to 0% who received placebo (P = 0.15). Twenty-nine patients were enrolled in the trial studying probiotics (2 capsules containing 0.5 x 1010 CFU each of L. acidophilus LA-5 and B. animalis subsp. lactis strain BB-12 twice daily for 12 weeks). Clinical response occurred in 29% of patients who received probiotics compared to 13% of patients who received placebo (P = 0.38). Twenty-three patients were enrolled in the trial studying mesalamine (800 mg three times daily) with or without cholestyramine (4 g daily) for 6 months. Clinical response occurred in 73% of patients who received mesalamine alone compared to 100% of patients who received mesalamine + cholestyramine (P = 0.14). In maintaining response, 80 patients who had responded to open-label budesonide were enrolled in 2 trials studying budesonide (6 mg daily for 6 months). Clinical response was maintained in 83% of patients who received budesonide compared to 28% of patients who received placebo (P = 0.0002). The pooled Peto OR for maintenance of clinical response to treatment with budesonide was 7.17 (95% CI 3.00 to 17.12), with a number needed to treat of 2 patients. Histological response was maintained in 48% of patients who received budesonide compared to 15% of patients who received placebo (P = 0.002).

Authors' conclusions

Budesonide is effective for inducing and maintaining clinical and histological response in patients with collagenous colitis. The evidence for benefit with bismuth subsalicylate and for mesalamine with or without cholestyramine is weak. There is no evidence for the effectiveness of Boswellia serrata extract, prednisolone, or probiotics. These agents and other therapies require further study.

摘要

背景

對於膠原性腸炎的介入治療.

膠原性腸炎為慢性腹瀉的原因之一.其治療方面都以“觀察性證據”為根基.本篇回顧之目的在於探討針對膠原性腸炎的治療,哪些經由隨機試驗證實有效.

目標

對於臨床活動性的膠原性腸炎的病患,決定哪些為有效的治療.

搜尋策略

我們從1970年至2006年間,在MEDLINE以及PUBMED搜尋相關文獻.我們並利用人工搜尋那些選出的文章之參考文獻,以及回顧關於膠原性腸炎或微觀性腸炎的文獻,來找出更多的研究.我們也搜尋從大型消化系會議的摘要,納入可能只有附摘要的那些研究.最後,我們搜尋Cochrane控制臨床研究, Cochrane發炎性腸炎及功能性腸疾病群的專業的試驗,以納入其他的研究.

選擇標準

有七個隨機試驗被選入.其中一個試驗針對鉍鹽(僅有摘要),一個針對齒葉乳香樹萃取物(僅有摘要),一個針對益生菌,一個針對prednisolone,三個針對budesonide之於膠原性腸炎的治療.

資料收集與分析

數據由每位評審員獨立自主的擷取,化為二乘二的表格(治療組相對於對照組,有反應相對於無反應).若針對某治療只有一個試驗在進行,那麼我們用卡方測試及其p值來判讀.若有大於一個試驗在進行,那麼就用summary test statistics及其Peto odds ratio和95%信賴區間來判讀.若結果的定義是極為相似的,那麼數據才可以合併分析.

主要結論

有9個罹患膠原性腸炎的病人,接受鉍鹽治療(每日每錠262毫克,共八週療程).鉍鹽治療組在臨床上及組織學上,與對照組相較起來比較好. 有11個病人接受prednisolone治療(每日50毫克,共兩週療程).服用prednisolone組,臨床療效有比較好的趨勢,但對於組織學上的改善就沒有被研究. 有31個病人接受齒葉乳香樹萃取物治療.在治療組的臨床療效達44%,而對照組達27%(p值 0.32). 有29個病人接受益生菌治療.在治療組的臨床療效達29%,而對照組達13%(p值 0.635). 另有3個試驗,共94個病人接受budesonide治療(每日9毫克或依照劑量遞減的方式治療,療程6至8週).加總的odds ratio在治療組為12.32(95%信賴區間為5.53至27.46),其number need to treat(NNT)僅兩人.在這3個試驗中, budesonide組在組織學上的進步亦有顯著的差異,且對於病人的生活品質似乎也有改善.

作者結論

Budesonide對於膠原性腸炎的治療是有效的.鉍鹽的證據等級較弱.另外對於prednisolone,齒葉乳香樹萃取物,益生菌用於引導消失或維持膠原性腸炎的效果就不確定了,且需要將來的研究評估.

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

Budesonide對於膠原性腸炎的治療是有效的.其為一種類固醇,可迅速被肝臟代謝,因此降低類固醇相關的副作用.本篇回顧顯示, budesonide對於因膠原性腸炎導致慢性腹瀉的治療是有效的,療程約6至8週.其對於病人的生活品質提升亦有幫助.鉍鹽(Pepto Bismol)是一種非類固醇藥物,療程八週對於膠原性腸炎的證據等級較薄弱.其他prednisolone,齒葉乳香樹萃取物,益生菌就需要將來研究來評估了.它們對於膠原性腸炎的長期效果,以及避免復發的效果,目前並未被研究.

Plain language summary

Treatments for collagenous colitis

Budesonide is a corticosteroid drug that is rapidly metabolized by the liver thereby reducing corticosteroid-related side effects. This review demonstrates that budesonide is effective for treating chronic diarrhea associated with collagenous colitis over a 6 to 8 week period, and maintaining that response over 6 months. Budesonide also appears to improve patients' quality of life. There is also weaker evidence that bismuth subsalicylate (Pepto Bismol), a non-steroid therapy, may be effective for treating collagenous colitis over an 8 week period. Mesalamine with or without cholestyramine may also be effective for treating chronic diarrhea associated with collagenous colitis over a 6 month treatment period. There is no evidence of the effectiveness of other treatments such as Boswellia serrata extract, prednisolone and probiotics. These agents require further study before they can be recommended as treatment options for collagenous colitis.