Chou Dean, Lau Darryl, Hermsmeyer Jeffrey, Norvell Daniel
University of California, San Francisco, CA, USA.
Evid Based Spine Care J. 2011 Feb;2(1):45-56. doi: 10.1055/s-0030-1267086.
Systematic review using a modified network analysis.
To compare the effectiveness and morbidity of interspinous-device placement versus surgical decompression for the treatment of lumbar spinal stenosis.
Traditionally, the most effective treatment for degenerative lumbar spinal stenosis is through surgical decompression. Recently, interspinous devices have been used in lieu of standard laminectomy.
A review of the English-language literature was undertaken for articles published between 1970 and March 2010. Electronic databases and reference lists of key articles were searched to identify studies comparing surgical decompression with interspinous-device placement for the treatment of lumbar spinal stenosis. First, studies making the direct comparison (cohort or randomized trials) were searched. Second, randomized controlled trials (RCTs) comparing each treatment to conservative management were searched to allow for an indirect comparison through a modified network analysis approach. Comparison studies involving simultaneous decompression with placement of an interspinous device were not included. Studies that did not have a comparison group were not included since a treatment effect could not be calculated. Two independent reviewers assessed the strength of evidence using the GRADE criteria assessing quality, quantity, and consistency of results. The strengths of evidence for indirect comparisons were downgraded. Disagreements were resolved by consensus.
We identified five studies meeting our inclusion criteria. No RCTs or cohort studies were identified that made the direct comparison of interspinous-device placement with surgical decompression. For the indirect comparison, three RCTs compared surgical decompression to conservative management and two RCTs compared interspinous-device placement to conservative management. There was low evidence supporting greater treatment effects for interspinous-device placement compared to decompression for disability and pain outcomes at 12 months. There was low evidence demonstrating little to no difference in treatment effects between the groups for walking distance and complication rates.
The indirect treatment effect for disability and pain favors the interspinous device compared to decompression. The low evidence suggests that any further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate. No significant treatment effect differences were observed for postoperative walking distance improvement or complication rates; however, findings should be considered with caution because of indirect comparisons and short follow-up periods.
采用改良网络分析的系统评价。
比较棘突间装置置入术与手术减压治疗腰椎管狭窄症的有效性和发病率。
传统上,退行性腰椎管狭窄症最有效的治疗方法是手术减压。近来,棘突间装置已被用于替代标准椎板切除术。
对1970年至2010年3月发表的英文文献进行综述。检索电子数据库和关键文章的参考文献列表,以确定比较手术减压与棘突间装置置入术治疗腰椎管狭窄症的研究。首先,检索进行直接比较的研究(队列研究或随机试验)。其次,检索将每种治疗方法与保守治疗进行比较的随机对照试验(RCT),以便通过改良网络分析方法进行间接比较。不包括涉及同时进行减压并置入棘突间装置的比较研究。没有对照组的研究不纳入,因为无法计算治疗效果。两名独立评审员使用评估结果质量、数量和一致性的GRADE标准评估证据强度。间接比较的证据强度被下调。分歧通过协商解决。
我们确定了五项符合纳入标准的研究。未发现将棘突间装置置入术与手术减压进行直接比较的RCT或队列研究。对于间接比较,三项RCT将手术减压与保守治疗进行了比较,两项RCT将棘突间装置置入术与保守治疗进行了比较。证据不足,支持在12个月时,与减压相比,棘突间装置置入术在残疾和疼痛结局方面有更大的治疗效果。证据不足表明,两组在步行距离和并发症发生率方面的治疗效果几乎没有差异。
与减压相比,棘突间装置在残疾和疼痛方面的间接治疗效果更好。证据不足表明,任何进一步的研究都很可能对疗效估计的可信度产生重要影响,并可能改变估计值。术后步行距离改善或并发症发生率方面未观察到显著的治疗效果差异;然而,由于是间接比较且随访期较短,研究结果应谨慎看待。