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Anti-spasticity agents for multiple sclerosis

  • Review
  • Intervention

Authors


Abstract

Background

Spasticity is a common problem in multiple sclerosis (MS) patients causing pain, spasms, loss of function and difficulties in nursing care. A variety of oral and parenteral medications are available.

Objectives

To assess the absolute and comparative efficacy and tolerability of anti-spasticity agents in MS patients.

Search methods

We searched the Cochrane MS Group trials register (June 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE (January 1966 to June 2003), EMBASE (January 1988 to June 2003), bibliographies of relevant articles, personal communication, manual searches of relevant journals and information from drug companies.

Selection criteria

Double-blind, randomised controlled trials (either placebo-controlled or comparative studies) of at least seven days duration.

Data collection and analysis

Two independent reviewers extracted data and the findings of the trials were summarised. Missing data were collected by correspondence with principal investigators. A meta-analysis was not performed due to the inadequacy of outcome measures and methodological problems with the studies reviewed.

Main results

Twenty-six placebo-controlled studies (using baclofen, dantrolene, tizanidine, botulinum toxin, vigabatrin, prazepam, threonine and cannabinoids) and thirteen comparative studies met the selection criteria and were included in this review. Only fifteen of these studies used the Ashworth scale, of which only three of the eight placebo-controlled trials and none of the seven comparative studies showed a statistically significant difference between test drugs. Spasms, other symptoms and overall impressions were only assessed using unvalidated scores and results of functional assessments were inconclusive.

Authors' conclusions

The absolute and comparative efficacy and tolerability of anti-spasticity agents in multiple sclerosis is poorly documented and no recommendations can be made to guide prescribing. The rationale for treating features of the upper motor neurone syndrome must be better understood and sensitive, validated spasticity measures need to be developed.

摘要

背景

治療多發性硬化症的抗痙攣藥物

痙攣是多發性硬化症﹝MS﹞常見的症狀,會導致疼痛、抽蓄、功能喪失,且會增加照護的困難。有許多口服及非腸道給藥得藥物能治療。

目標

評估抗痙攣藥物在MS病人身上產生的絕對及相對療效及耐受性。

搜尋策略

我們搜尋了Cochrane MS Group trials register﹝2003年6月﹞、the Cochrane Central Register of Controlled Trials﹝CENTRAL﹞﹝2003年第2期﹞、EMBASE﹝1966年1月到2003年6月﹞、相關文章的參考資料、個人通訊、手動搜尋相關期刊及向藥廠取得相關資訊。

選擇標準

雙盲、為期七天以上的隨機對照試驗﹝安慰劑對照或比較研究﹞。

資料收集與分析

兩位評論者分別擷取數據並統整試驗中的資料。遺失的資料則向主要研究者取得。由於我們所評論的研究,在結果的量測及方法上有問題,因此並沒有做整合分析。

主要結論

26個安慰劑對照試驗﹝使用baclofen、dantrolene、tizanidine、botulinum toxin、vigabatrin、prazepam、threonin和cannabinoids﹞以及13個比較研究符合我們的收錄標準,被我們納入這次的評論中。這其中只有15個研究是使用Ashworth scale,其中的8個安慰劑對照試驗,只有3個試驗的實驗結果顯示這些試驗藥物有統計上的明顯差異,其它的7組比較研究也沒有。抽蓄、其它症狀及整體表現,都只有用未校驗的評分去評估,而功能評估的結果則沒有定論。

作者結論

關於抗痙攣藥物用於治療多發性硬化症的絕對或相對療效及耐受性評估的紀錄不多,而且也沒有任何建議能做為處方準則。必須去了解上運動神經徵狀的治療原理,並且發展出一套靈敏度高、經過確效的痙孿測定標準。

翻譯人

本摘要由朱奕蓁翻譯。

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

總結

我們需要更多關於抗痙攣藥物治療多發性硬化症產生的影響的研究。多發性硬化症﹝MS﹞是一個會影響年輕到中年成人神經系統的慢性疾病。抽蓄是多發性硬化症常見的症狀,是由於中樞神經系統損壞導致動作失調的現象。四肢失去反應被動動作的能力是其主要的徵象,但其他相關的特徵疼痛、抽蓄、功能喪失更直接影響了病患的生活品質。現在有許多抗痙攣藥物能取得,但審視試驗後發現沒有足夠的證據能比較出它們的療效。需要更多相關的研究。

Plain language summary

The effect of anti-spasticity agents in people with multiple sclerosis

Multiple sclerosis (MS) is a chronic disease of the nervous system which affects young and middle-aged adults. Spasticity, a common problem in people with MS, is a disorder of voluntary movement caused by damage to the central nervous system. The main sign is the resistance to passive movement of a limb but other associated features - pain, spasms, loss of function - affect people's quality of life more directly.
Many anti-spasticity drugs are available but the review of trials found that there is not enough evidence to compare their effectiveness.
More research is needed.

Laienverständliche Zusammenfassung

Die Wirkung von Wirkstoffen gegen Spastizität bei Personen mit Multipler Sklerose

Multiple Sklerose (MS) ist eine chronische Erkrankung des Nervensystems, welche Menschen im jungen und mittleren Alter betrifft. Spastizität ist ein häufiges Problem bei MS-Betroffenen. Dabei kommt es durch eine Schädigung des Zentralnervensystems zu einer Beeinträchtigung der willentlich ausgeführten Bewegungen. Das Hauptmerkmal ist der Widerstand gegen passive Bewegungen. Jedoch wirken sich andere Merkmale, wie Schmerzen, Krämpfe und Funktionsverlust direkter auf die Lebensqualität der Betroffenen aus. Es gibt viele Medikamente gegen Spastizität, aber diese Übersichtsarbeit zeigt, dass es nicht genügend Evidenz zu ihrer Wirkung gibt. Mehr Forschung auf diesem Gebiet ist notwendig.

Anmerkungen zur Übersetzung

Koordination durch Cochrane Schweiz

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