Waseem Zeeshan, Boulias Chris, Gordon Allan, Ismail Farooq, Sheean Geoffrey, Furlan Andrea D
Division of Physiatry, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Cochrane Database Syst Rev. 2011 Jan 19(1):CD008257. doi: 10.1002/14651858.CD008257.pub2.
Adequate relief from low-back pain (LBP) is not always possible. Emerging evidence suggests a role for botulinum neurotoxin (BoNT) injections in treating pain disorders. Proponents of BoNT suggest its properties can decrease muscle spasms, ischemia and inflammatory markers, thereby reducing pain.
To determine the effects of botulinum toxin injections in adults with LBP.
We searched CENTRAL (The Cochrane Library 2009, issue 3) and MEDLINE, EMBASE, and CINAHL to August 2009; screened references from included studies; consulted with content experts and Allergan. We included published and unpublished randomised controlled trials without language restrictions
We included randomised trials that evaluated BoNT serotypes versus other treatments in patients with non-specific LBP of any duration.
Two review authors selected the studies, assessed the risk of bias using the Cochrane Back Review Group criteria, and extracted the data using standardized forms. We performed a qualitative analysis due to lack of data.
We excluded evidence from nineteen studies due to non-randomisation, incomplete or unpublished data. We included three randomised trials (N =123 patients). Only one study included patients with chronic non-specific LBP; the other two examined unique subpopulations. Only one of the three trials had a low risk of bias and demonstrated that BoNT injections reduced pain at three and eight weeks and improved function at eight weeks better than saline injections. The second trial showed that BoNT injections were better than injections of corticosteroid plus lidocaine or placebo in patients with sciatica attributed to piriformis syndrome. The third trial concluded that BoNT injections were better than traditional acupuncture in patients with third lumbar transverse process syndrome. Both studies with high risk of bias had several key limitations. Heterogeneity of the studies prevented meta-analysis. There is low quality evidence that BoNT injections improved pain, function, or both better than saline injections and very low quality evidence that they were better than acupuncture or steroid injections.
AUTHORS' CONCLUSIONS: We identified three studies that investigated the merits of BoNT for LBP, but only one had a low risk of bias and evaluated patients with non-specific LBP (N = 31). Further research is very likely to have an important impact on the estimate of effect and our confidence in it. Future trials should standardize patient populations, treatment protocols and comparison groups, enlist more participants and include long-term outcomes, cost-benefit analysis and clinical relevance of findings.
下背痛（LBP）并不总是能得到充分缓解。新出现的证据表明肉毒杆菌神经毒素（BoNT）注射在治疗疼痛性疾病中发挥作用。BoNT的支持者认为其特性可减少肌肉痉挛、局部缺血和炎症标志物，从而减轻疼痛。
确定肉毒杆菌毒素注射对成年LBP患者的影响。
我们检索了截至2009年8月的Cochrane中心对照临床试验注册库（CENTRAL，2009年第3期）、MEDLINE、EMBASE和护理学与健康领域数据库（CINAHL）；筛选纳入研究中的参考文献；咨询内容专家和艾尔建公司。我们纳入了无语言限制的已发表和未发表的随机对照试验。
我们纳入了评估BoNT血清型与其他治疗方法对任何病程的非特异性LBP患者疗效的随机试验。
两名综述作者选择研究，使用Cochrane背痛综述小组的标准评估偏倚风险，并使用标准化表格提取数据。由于数据不足，我们进行了定性分析。
由于非随机化、数据不完整或未发表，我们排除了19项研究的证据。我们纳入了3项随机试验（N = 123例患者）。只有1项研究纳入了慢性非特异性LBP患者；另外2项研究考察的是独特的亚组人群。3项试验中只有1项偏倚风险较低，该试验表明，与注射生理盐水相比，BoNT注射在3周和8周时减轻了疼痛，在8周时改善了功能。第二项试验表明，对于梨状肌综合征引起的坐骨神经痛患者，BoNT注射比注射皮质类固醇加利多卡因或安慰剂效果更好。第三项试验得出结论，对于第三腰椎横突综合征患者，BoNT注射比传统针灸效果更好。两项偏倚风险较高的研究都有几个关键局限性。研究的异质性妨碍了进行Meta分析。有低质量证据表明，与注射生理盐水相比，BoNT注射在改善疼痛、功能或两者方面效果更好，而有极低质量证据表明其比针灸或类固醇注射效果更好。
我们确定了3项研究BoNT治疗LBP疗效的研究，但只有1项偏倚风险较低，且评估的是非特异性LBP患者（N = 31）。进一步的研究很可能对效应估计及其可信度产生重要影响。未来的试验应规范患者人群、治疗方案和对照组，招募更多参与者，并纳入长期结局、成本效益分析以及研究结果的临床相关性。
