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Intervention Review

Oral versus Intravenous Steroids for Treatment of Relapses in Multiple Sclerosis

  1. Jodie M Burton1,*,
  2. Paul W O'Connor1,
  3. Marika Hohol1,
  4. Joseph Beyene2

Editorial Group: Cochrane Multiple Sclerosis Group

Published Online: 8 JUL 2009

Assessed as up-to-date: 31 JUL 2008

DOI: 10.1002/14651858.CD006921.pub2


How to Cite

Burton JM, O'Connor PW, Hohol M, Beyene J. Oral versus Intravenous Steroids for Treatment of Relapses in Multiple Sclerosis. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006921. DOI: 10.1002/14651858.CD006921.pub2.

Author Information

  1. 1

    St. Michael's Hospital, Division of Neurology, Toronto, Ontario, Canada

  2. 2

    The Hospital for Sick Children, Population Health Sciences, Toronto, Ontario, Canada

*Jodie M Burton, Division of Neurology, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada. burtonj@smh.toronto.on.ca.

Publication History

  1. Publication Status: New
  2. Published Online: 8 JUL 2009

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Abstract

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

Background

Multiple Sclerosis (MS), a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS), is characterized by recurrent relapses of CNS inflammation ranging from mild to severely disabling.  Relapses have long been treated with steroids to reduce inflammation and hasten recovery.  However, the commonly used intravenous methylprednisolone requires repeated infusions with the added costs of homecare or hospitalization, and may interfere with daily responsibilities. Oral steroids have been used in place of intravenous steroids, with lower direct and indirect costs.

Objectives

The primary objective was to compare efficacy of oral versus intravenous steroids for MS relapses <= 6 weeks. Secondary comparisons included subsequent relapse rate, disability, ambulation, hospitalization, immunological markers, radiological markers, and quality of life.

Search methods

A literature search was performed using Cochrane MS Group Trials Register (July 2008), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2008, issue 3, MEDLINE (PubMed) (1966-July 2008), EMBASE (1980-July 2008), abstracts from meetings of the American Academy of Neurology (2002-2008), the European Federation of Neurological Sciences (2002-2008), the European Committee for Treatment and Research in Multiple Sclerosis and American Committee for Treatment and Research in Multiple Sclerosis (2002-2008)  handsearching.  No language restrictions were applied.

Selection criteria

Randomized or quasi-randomized trials comparing oral and intravenous steroids for acute relapses (<=30 days) in clinically definite MS patients over age 16 were eligible.

Data collection and analysis

Methodological was assessed using trial publications and personal communication.  Elevant data was extracted, and effect size was reported as mean difference (MD),weighted mean difference (WMD), odds ratio (OR) and absolute risk difference (ARD).

Main results

Eligible studies (167 patients) were identified. Only one outcome, the proportion of patients with EDSS improvement at 4 weeks, was common to three trials. Otherwise outcomes were too heterogeneous to pool. Only one trial employed an equivalence design, but all reported no statistically significant difference in outcomes between groups. Namely, there was no significant difference in the degree of recovery 4 weeks following treatment. No difference was found in subsequent relapse rate, disability, hospitalization, ambulation, bioavailability, or in magnetic resonance imaging (MRI). Due to methodological limitations, heterogeneous treatment regimens and limited data, formal conclusions about equivalence of oral and intravenous steroidscannot be made.  Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) trial, designed to address such limitations, is currently underway.

Authors' conclusions

The trials reviewed support the hypothesis that no significant differences in clinical, radiological or pharmacological outcomes oral and intravenous steroids for MS relapses exist. However, with the small number of patients and methodological limitations, conclusions of equivalence are premature.

 

Plain language summary

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

A comparison of oral and intravenous corticosteroid treatments in persons with MS (multiple sclerosis) shows that there are no major differences in clinical outcomes and both treatments appear to be equally effective and safe

Relapsing-remitting MS is characterised by periods of disability due to inflammation in the central nervous system. These episodes are called relapses. All research has shown that a speed up recovery is obtained by corticosteroids, given most often in intravenous form. If oral steroids worked as well as intravenous ones for relapse events, they would be easier to take and are more affordable.
The objective of this review was to assess if oral and intravenous steroids are equally effective and safe. Among the pertinent literature, only four studies met the inclusion criteria, comprising a total of 167 participants. All the studies found that there were no differences in clinical, pharmacological or radiological outcomes in the patients taking oral or intravenous steroids for relapses.
Nevertheless, some limitations in the studies analysed suggest that a definitive conclusion is premature and more rigorous study designs will better address the question of equivalence.

 

摘要

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

背景

口服和針劑類固醇用於多發性硬化症復發的治療

多發性硬化症是一種會導致中樞神經退化的慢性發炎疾病。中樞神經反覆發炎會造成輕度到重度的殘障。發作的時候會使用類固醇減少發炎造成的傷害以及促進恢復的時間。但是現行使用的針劑注射甲基固醇治療常常使得病人必須住院,或是造成居家照顧的困擾。口服類固醇若能取代針劑類固醇,會減少很多醫療上的支出。

目標

初級目標是口服和針劑類固醇使用於多發性硬化症復發後六個星期內治療的效果。次級目標則比較二者在復發率,身體殘障程度,活動力,住院時間,免疫標記,放射標記及生活品質。

搜尋策略

搜尋的範圍包括:Cochrane MS Group Trials Register(July 2008), Cochrane Central Register of Controlled Trials (CENTRAL) The Cochrane Library 2008, issue 3, MEDLINE (PubMed) (1966July 2008), EMBASE(1980July 2008)), abstracts from meetings of the American Academy of Neurology(2002 – 2008), the European Federation of Neurological Sciences (2002 – 2008), the European Committee for Treatment and Research in Multiple Sclerosis and American Committee for Treatment and Research in Multiple Sclerosis (2002 – 2008)

選擇標準

患者是大於16歲臨床上診斷多發性硬化症的確定病例,比較在急性發作(定義為三十天內)時使用口服和針劑類固醇治療的隨機或半隨機試驗。

資料收集與分析

我們用文章本身公布的試驗方法再經過私下聯繫討論決定被收錄試驗的方法學。擷取相關的資料。效果的大小用平均差,加權平均差,勝算比以及絕對風險差異來表示。

主要結論

總共找到了四個試驗,合計167個病人。其中三篇試驗有得到相同的結果的只有病人在四周之後擴展殘疾狀態的評分有進步。其他的結果差異性大無法彙整。其中一個試驗選用了等價設計,但所有的結果都告訴我們不同組別間沒有統計上有意義的差異。也就是說,不同的治療方式四周之後恢復的程度差不多。包括之後的復發率,殘障程度,住院天數,行動能力,生物利用率,核磁共振的發現都沒有差別。由於方法學上的差異,不同試驗各異的治療內涵和有限的樣本數,還無法得到最後的結論,口服和針劑的類固醇治療是否相等。目前正在進行的研究,Acute Exacerbations of Multiple Sclerosis(OMEGA) trial,未來希望能夠打破這個困境,得到最後的結論。

作者結論

目前搜尋到的試驗,是支持我們不論是口服或針劑類固醇在治療多發性硬化症,不管是臨床,影像學或藥理學上能得到相同治療結果的假設。然而,因為方法學和樣本數上的限制,現在下結論還太早。

翻譯人

本摘要由新光醫院王瑄翻譯。

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

總結

復發型多發性硬化症是中樞神經發炎造成的陣發性身體殘障,一陣陣的殘疾就是一次次的復發。過去的研究告訴我們類固醇治療是加速恢復的方法,而且多是使用注射的劑型。假若是口服和針劑的類固醇治療效果一樣,那麼這種疾病的控制就是更容易也方便取得。這篇回顧性文章的目的就是要看口服和針劑的類固醇是否一樣安全有效。目前的研究只有四篇文獻符合搜尋的條件,一共是167個病人。所有收錄的研究都顯示二種給藥方式對於復發的臨床症狀,影像檢查,藥理方面的結果都沒有統計上有意義的顯著差異。然而,目前的研究在統計時遇到的困難限制了我們下最後的結論,更進一步的研究是必須的。