Pharmacological interventions for spasticity following spinal cord injury
Editorial Group: Cochrane Injuries Group
Published Online: 24 APR 2000
Assessed as up-to-date: 15 JUL 2008
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
- Publication Status: New search for studies and content updated (no change to conclusions)
- Published Online: 24 APR 2000
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.
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.
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.
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.
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.
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
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.
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。
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。
此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。