Intervention Review

Corticosteroids for the long-term treatment in multiple sclerosis

  1. Alfonso Ciccone1,*,
  2. Sandro Beretta2,
  3. Fabio Brusaferri3,
  4. Ian Galea4,
  5. Alessandra Protti1,
  6. Chiara Spreafico1

Editorial Group: Cochrane Multiple Sclerosis Group

Published Online: 23 JAN 2008

Assessed as up-to-date: 2 AUG 2007

DOI: 10.1002/14651858.CD006264.pub2


How to Cite

Ciccone A, Beretta S, Brusaferri F, Galea I, Protti A, Spreafico C. Corticosteroids for the long-term treatment in multiple sclerosis. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD006264. DOI: 10.1002/14651858.CD006264.pub2.

Author Information

  1. 1

    Azienda Ospedale Niguarda Ca' Granda, Department of Neurology, Milano, Italy

  2. 2

    A.O. Ospedale Civile di Vimercate e Desio, Neurology, Vimercate, Italy

  3. 3

    Ospedale Maggiore di Crema, U.O. Neurology, Crema, Cremona, Italy

  4. 4

    Wessex Neurosciences Centre, Department of Neurology, Southampton, Hampshire, UK

*Alfonso Ciccone, Department of Neurology, Azienda Ospedale Niguarda Ca' Granda, Piazza Ospedale Maggiore 3, Milano, 20162, Italy. alfonso.ciccone@ospedaleniguarda.it.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 23 JAN 2008

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Abstract

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

Background

Short term high dose corticosteroid treatment improves symptoms and short term disability after an acute exacerbation of multiple sclerosis (MS) but it is unknown whether its long-term use can reduce the accumulation of disability.

Objectives

To determine the efficacy and safety of long-term corticosteroid use in MS.

Search methods

We searched The Cochrane MS Group Trials Register (February 2007),the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 1), MEDLINE (1966 to February 2007) and EMBASE (1980 to February 2007). In an effort to identify further published, unpublished and ongoing trials we searched reference lists and contacted trial authors and one pharmaceutical company.

Selection criteria

We considered controlled, randomised trials (RCTs), with or without blinding, of long term treatment (i.e. longer than 6 months) of any type of corticosteroid in MS, irrespective of disease course.

Data collection and analysis

Reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information.

Main results

Three trials, all classified at high risk of bias, contributed to this review (Miller 1961; BPSM 1995; Zivadinov 2001) resulting in a total of 183 participants (91 treated). Corticosteroid therapy did not reduce the risk of being worse at the end of follow-up (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.26 to 1.02) but there was a substantial heterogeneity between studies (I2: 78.4%). I. v. periodic high dose methylprednisolone (MP) was associated with a significant reduction in the risk of disability progression at 5 years in relapsing-remitting (RR) MS (OR 0.26, 95% CI 0.10 to 0.66), while oral continuous low dose prednisolone was not associated with any risk reduction in disability progression at 18 months (OR 1.23, 95% CI 0.43 to 3.56). Risk of experiencing at least one exacerbation at end of follow-up was not significantly reduced with corticosteroid treatment (OR 0.36; 95% CI 0.10 to 1.25).
Only one study recorded adverse events: in one patient i. v. MP was discontinued after the fourth pulse when he developed acute glomerulonephritis; a second patient was removed from the study after the fifth i. v. MP pulse because of severe osteoporosis.

Authors' conclusions

There is no enough evidence that long-term corticosteroid treatment delays progression of long term disability in patients with MS. Since one study at high risk of bias showed that the administration of pulsed high dose i. v. MP is associated with a significant reduction in the risk of long term disability progression in patients with RR MS, an adequately powered, high quality RCT is needed to investigate this finding.

 

Plain language summary

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

The long-term use of anti-inflammatory corticosteroids for treating multiple sclerosis

Multiple sclerosis is an inflammatory disease affecting the brain and spinal cord. It results in episodes of neurological deficit which recover (relapses) as well as accumulation of sustained disability with the passage of time. Corticosteroids are potent anti-inflammatory drugs. It is postulated that long-term use of steroids may reduce the accumulation of disability. The reviewers found three studies addressing this issue. A meta-analysis showed a trend towards a beneficial effect of long-term corticosteroids on accumulation of disability; however only two small studies contributed to this result. It was not possible to reliably comment on the effect of long-term corticosteroids on the frequency of relapses. Side effects were poorly documented. Therefore rigorous randomised controlled trials of this treatment are warranted.

 

摘要

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

背景

多發性硬化症的長期類固醇療法

短期高劑量的類固醇治療可以改善多發性硬化症(MS)急性惡化後的症狀和失能,但是類固醇的長期使用是否可以減少失能的累積仍是未知數.

目標

為了了解類固醇長期使用在MS上的效果和安全性

搜尋策略

我們收尋了下列的資料庫:CENTRAL (Issue 1, 2007), MEDLINE(1966 到2月2007) and EMBASE (1980 到2月2007).為了努力收尋已經出版,尚未出版,和正在進行的試驗,我們尋找了參考資料清單和聯絡了研究的作者和一家藥品公司.

選擇標準

我們選擇了不論是有或沒有隨機化的對照組隨機試驗,而且必須是長期的治療,(例如大於6個月),但不限定使用的類固醇種類和疾病的病程。

資料收集與分析

文獻審查者獨立的評估試驗品質和擷取資料,並與研究的作者連絡,以取得更多的資訊。

主要結論

共找到三個試驗(Miller 1961; BPSM 1995; Zivadinov 2001),但此三個試驗全部都有高度研究偏差的風險,其中共有183個受試者(包括91例治療個案)。在研究追蹤期結束時,使用類固醇治療無法降低病情惡化的風險(odds ratio [OR] 0.51, 95% 信賴區間[CI] 0.26 to 1.02),但是此類研究結果間卻有很大的基本差異性(I2: 78.4%)。以週期性靜脈注射高劑量類固醇methylprednisolone (MP)可以減少復發緩解型relapsingremitting (RR) MS 5年後的失能惡化(OR 0.26, 95% CI 0.10 to 0.66),但是持續的口服低劑量的類固醇prednisolone並不能減少18個月後的失能惡化(OR 1.23, 95% CI 0.43 to 3.56)。在研究追蹤期結束時,類固醇治療並不能減少至少一次惡化的風險(OR 0.36; 95% CI 0.10 to 1.25)。只有一篇研究紀錄到副作用:一個病人在接受第四次靜脈類固醇MP治療後,發生急性腎絲球腎炎,所以停止治療;第二個病人在接受第五次靜脈類固醇MP治療後,發生嚴重的骨質疏鬆症,所以被排除在研究外。

作者結論

沒有足夠的證據顯示長期的類固醇治療可以延緩多發性硬化症長期的失能進展.雖然一篇可能有高度偏差的研究顯示注射高劑量的類固醇MP可以減少反覆發作型MS的長期失能進展,但需要有一個足夠效度和高品質的隨機對照組試驗來調查這項發現.

翻譯人

本摘要由新光醫院李建欣翻譯。

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

總結

多發性硬化症的長期類固醇療法。 多發性硬化症是一種會影響大腦和脊髓的發炎性疾病。它會造成多次的神經損傷,它會復原也會隨著時間累積造成持續性的失能。類固醇是強效的抗發炎藥物,理論上長期使用類固醇有可能減少這些失能的累積。回顧者找到三篇研究討論了這項論點。統合分析後顯示長期類固醇治療對於失能的累積是有正向幫助的趨勢,然而只有2個小型的研究促成這項結論。因此,目前長期類固醇對於降低復發頻率的療效,是不可能作出可靠結論的。另外,長期類固醇使用的副作用在文獻中還沒有很清楚被報導出來。因此,嚴格的隨機對照組試驗對於多發性硬化症的長期類固醇療法是需要的。