Intervention Review

Pharmacological interventions for spasticity following spinal cord injury

  1. Mariangela Taricco1,*,
  2. Roberto Adone2,
  3. Christina Pagliacci3,
  4. Elena Telaro4

Editorial Group: Cochrane Injuries Group

Published Online: 24 APR 2000

Assessed as up-to-date: 15 JUL 2008

DOI: 10.1002/14651858.CD001131


How to Cite

Taricco M, Adone R, Pagliacci C, Telaro E. Pharmacological interventions for spasticity following spinal cord injury. Cochrane Database of Systematic Reviews 2000, Issue 2. Art. No.: CD001131. DOI: 10.1002/14651858.CD001131.

Author Information

  1. 1

    Policlinico Sant'Orsola Malpighi, Unità operativa di Medicina Fisica e Riabilitazione, Bologna, Italy

  2. 2

    Ospedale Casati, Servizio di Riabilitazione Funzio (Unita spinale), Passirana Di Rho (MI), Italy

  3. 3

    Ospedale Silvestrini, Unit Spinale, Perugia, Italy

  4. 4

    Mario Negri Institute, Italian Cochrane Centre, Milan, Italy

*Mariangela Taricco, Unità operativa di Medicina Fisica e Riabilitazione, Policlinico Sant'Orsola Malpighi, Via Albertoni 15, Bologna, 40138, Italy. mariangela.taricco@aosp.bo.it.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 24 APR 2000

SEARCH

 

Abstract

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

Background

Spasticity is a major health problem for patients with a spinal cord injury (SCI). It limits their mobility and affects their independence in activities of daily living (ADL) and work. Spasticity may also cause pain, loss of range of motion, contractures, sleep disorders and impair ambulation in patients with an incomplete lesion. The effectiveness of available drugs is still uncertain and they may cause adverse effects. Assessing what works in this area is complicated by the lack of valid and reliable measurement tools. The aim of this systematic review is to critically appraise and summarise existing information on the effectiveness of available treatments, and to identify areas where further research is needed.

Objectives

To assess the effectiveness and safety of baclofen, dantrolene, tizanidine and any other drugs for the treatment of long-term spasticity in SCI patients, as well as the effectiveness and safety of different routes of administration of baclofen.

Search methods

We searched the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE/PubMed, EMBASE, Zetoc, Web of Knowledge, CINAHL and Current Controlled Trials. We also checked the reference lists of relevant papers to identify any further studies. The searches were last conducted in July 2008.

Selection criteria

All parallel and cross-over randomised controlled trials (RCTs) including spinal cord injury patients complaining of 'severe spasticity'. Studies where less than 50% of patients had a spinal cord injury were excluded.

Data collection and analysis

Methodological quality of studies (allocation concealment, blinding, patient's characteristics, inclusion and exclusion criteria, interventions, outcomes, losses to follow up) was independently assessed by two investigators. The heterogeneity among studies did not allow quantitative combination of results.

Main results

Nine studies met the inclusion criteria. Study designs were: 8 cross-over and 1 parallel-group trial. Two studies (14 SCI patients), showed a significant effect of intrathecal baclofen in reducing spasticity (Ashworth Score and ADL performances), compared to placebo, without any adverse effects. The study comparing tizanidine to placebo (118 SCI patients) showed a significant effect of tizanidine in improving Ashworth Score but not in ADL performances. The tizanidine group reported significant rates of adverse effects (drowsiness, xerostomia). For the other drugs (gabapentin, clonidine, diazepam, amytal and oral baclofen) the results did not provide evidence for clinically significant effectiveness.

Authors' conclusions

There is insufficient evidence to assist clinicians in a rational approach to antispastic treatment for SCI. Further research is urgently needed to improve the scientific basis of patient care.

 

Plain language summary

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

Not enough evidence about the effects of drugs used to try and reduce spasticity in the limbs after spinal cord injury

A major problem after spinal cord injury is muscle resistance to having the arms or legs moved (spasticity). There can also be spasms. This can severely limit a person's mobility and independence, and can cause pain, muscle problems, and sleep difficulties. Treatments to try and reduce spasticity include exercise, and drugs to try and decrease the muscle tone. The review found there was not enough evidence from trials to assess the effects of the range of drugs used to try and relieve spasticity after spinal cord injury. The authors of the review call for more research and make recommendations as to how this research should be conducted.

 

摘要

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

背景

藥物治療對於脊髓損傷後的痙攣(spasticity)

痙攣是脊髓損傷病患的主要健康問題。它限制了病患們的活動以及影響日常生活和工作的獨立性。痙攣也許還會造成病患的疼痛、活動度喪失、攣縮、睡眠失調及損害機能未完全喪失患者的行走。而有效的藥物的作用仍處於未確定並且還有其副作用。因為缺乏有效且可信的評估工具,在評估上仍屬複雜。因此這篇系統性回顧目的就是要精密地評論及概括那些可用治療方法的有效性之現有資料,和確認那些領域未來仍繼續研究。

目標

評估baclofen、dantrolene、tizanidine(一些肌肉鬆弛劑)和其他治療脊髓損傷長期痙攣之藥物的效用及安全性以及baclofen之不同的投藥途徑的效果和安全性。

搜尋策略

我們搜尋了Cochrane Injuries Group Specialised Register、the Cochrane Controlled Trials Register、MEDLINE、EMBASE 與CINHAL 等到2004/07的資料。並且與藥廠和相關專家聯繫。

選擇標準

所有平行和交叉性隨機對照試驗,且脊髓損傷病患都主訴“嚴重之痙攣”。個案當中脊髓損傷患者不到50%的研究被排除在外。

資料收集與分析

研究方法的品質(包括分組隱匿、盲法、病人的特點、納入和排除標準、介入因子、結果、無法繼續追蹤之原因)都各自獨立交由兩位審查者評估。研究間彼此的異質性導致無法做結果的統合。

主要結論

55個研究有9個符合標準。分別是8個交叉試驗,1個平行試驗。其中2個研究(14個脊髓損傷病患)顯示經由脊髓腔注射方法投與baclofen在降低痙攣相較於使用安慰劑有明顯的差異(以Ashworth Score及日常生活表現評估)且無任何副作用。而tizanidine相對於安慰劑的研究中(118個脊髓損傷病患)顯示了只在Ashworth Score有進步而在日常生活表現評估並無差異。此外在tizanidine的實驗組中有出現困倦(drowsiness)和口乾燥症(xerostomia)等副作用。對於其他藥(gabapentine、clonidine、diazepam、amytal與oral baclofen)其臨床明顯效用上並無提供證據其有效。

作者結論

仍沒有足夠的證據,以協助醫師在合理地治療脊髓損傷的痙攣。須更緊急地進行更多的研究去改進病人照顧上的科學性基礎。

翻譯人

本摘要由高雄榮民總醫院洪碧蓮翻譯。

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

總結

沒有足夠的證據有關在脊髓損傷的肢體痙攣的藥物治療的效果是否有效。脊髓損傷病患的主要問題是因為肌肉對於上肢或下肢的活動產生的阻抗。這些也可以是痙攣(spasms)。這可以嚴重地影響病人的活動度和獨立性,並會造成疼痛、肌肉問題和睡眠困難。去治療並減少痙攣的方法包括運動和藥物來降低肌肉張力。這回顧發現,這些研究無足夠的證據去評估藥物對脊髓損傷後痙攣的緩解效果。而這篇回顧的作者要求更多的研究並建議該研究如何被進行。