van Tulder Maurits W, Touray Tony, Furlan Andrea D, Solway Sherra, Bouter Lex M
Institute for Research in Extramural Medicine, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
Spine (Phila Pa 1976). 2003 Sep 1;28(17):1978-92. doi: 10.1097/01.BRS.0000090503.38830.AD.
A systematic review of randomized and/or double-blinded controlled trials.
The use of muscle relaxants in the management of nonspecific low back pain is controversial. It is not clear if they are effective, and concerns have been raised about the potential adverse effects involved.
The aim of this review was to determine if muscle relaxants are effective in the treatment of nonspecific low back pain.
A computer-assisted search of the Cochrane Library (Issue 2, 2002), MEDLINE (1966 up to October 2001), and EMBASE (1988 up to October 2001) was carried out. These databases were searched using the algorithm recommended by the Cochrane Back Review Group. References cited in the identified articles and other relevant literature were screened. Randomized and/or double-blinded controlled trials, involving patients diagnosed with nonspecific low back pain, treated with muscle relaxants as monotherapy or in combination with other therapeutic methods, were included for review. Two reviewers independently carried out the methodologic quality assessment and data extraction of the trials. The analysis comprised not only a quantitative analysis (statistical pooling) but also a qualitative analysis ("best evidence synthesis"). This involved the appraisal of the strength of evidence for various conclusions using a rating system based on the quality and outcomes of the studies included. Evidence was classified as "strong," "moderate," "limited," "conflicting," or "no" evidence.
Thirty trials met the inclusion criteria. Twenty-three trials (77%) were of high quality; 24 trials (80%) were on acute low back pain. Four trials studied benzodiazepines, 11 nonbenzodiazepines, and 2 antispasticity muscle relaxants in comparison with placebo. Results showed that there is strong evidence that any of these muscle relaxants are more effective than placebo for patients with acute low back pain on short-term pain relief. The pooled relative risk for nonbenzodiazepines versus placebo after 2 to 4 days was 0.80 (95% confidence interval: 0.71 to 0.89) for pain relief and 0.49 (95% confidence interval: 0.25 to 0.95) for global efficacy. Adverse events, however, with a relative risk of 1.50 (95% confidence interval: 1.14 to 1.98) were significantly more prevalent in patients receiving muscle relaxants and especially the central nervous system adverse effects (relative risk 2.04; 95% confidence interval: 1.23 to 3.37). The various muscle relaxants were found to be similar in performance.
Muscle relaxants are effective in the management of nonspecific low back pain, but the adverse effects require that they be used with caution. Trials are needed that evaluate if muscle relaxants are more effective than analgesics or nonsteroidal anti-inflammatory drugs.
对随机和/或双盲对照试验的系统评价。
在非特异性腰痛的治疗中使用肌肉松弛剂存在争议。目前尚不清楚它们是否有效，并且人们对其潜在的不良反应表示担忧。
本综述的目的是确定肌肉松弛剂在治疗非特异性腰痛方面是否有效。
利用计算机检索Cochrane图书馆（2002年第2期）、MEDLINE（1966年至2001年10月）和EMBASE（1988年至2001年10月）。使用Cochrane背部综述小组推荐的算法对这些数据库进行检索。对已识别文章及其他相关文献中引用的参考文献进行筛选。纳入随机和/或双盲对照试验进行综述，这些试验涉及被诊断为非特异性腰痛的患者，采用肌肉松弛剂作为单一疗法或与其他治疗方法联合治疗。两名评价者独立进行试验的方法学质量评估和数据提取。分析不仅包括定量分析（统计合并），还包括定性分析（“最佳证据综合”）。这涉及使用基于所纳入研究的质量和结果的评分系统来评估各种结论的证据强度。证据被分类为“强”、“中等”、“有限”、“矛盾”或“无”证据。
30项试验符合纳入标准。23项试验（77%）质量较高；24项试验（80%）针对急性腰痛。4项试验研究了苯二氮䓬类药物，11项研究了非苯二氮䓬类药物，2项研究了抗痉挛肌肉松弛剂，并与安慰剂进行了比较。结果表明，有强有力的证据表明，对于急性腰痛患者，这些肌肉松弛剂中的任何一种在短期缓解疼痛方面都比安慰剂更有效。非苯二氮䓬类药物与安慰剂相比，在2至4天后缓解疼痛的合并相对危险度为0.80（95%置信区间：0.71至0.89），整体疗效的合并相对危险度为0.49（95%置信区间：0.25至0.95）。然而，接受肌肉松弛剂治疗的患者不良事件的相对危险度为1.50（95%置信区间：1.14至1.98），明显更为普遍，尤其是中枢神经系统不良反应（相对危险度2.04；95%置信区间：1.23至3.37）。发现各种肌肉松弛剂在性能上相似。
肌肉松弛剂在治疗非特异性腰痛方面有效，但因其不良反应需要谨慎使用。需要进行试验来评估肌肉松弛剂是否比镇痛药或非甾体抗炎药更有效。
