Zaina Fabio, Tomkins-Lane Christy, Carragee Eugene, Negrini Stefano
ISICO (Italian Scientific Spine Institute), Via Roberto Bellarmino 13/1, Milan, Italy, 20141.
Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD010264. doi: 10.1002/14651858.CD010264.pub2.
Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging.
To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer).
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases and two trials registries up to February 2015. We also screened reference lists and conference proceedings related to treatment of the spine.
Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings.
For data collection and analysis, we followed methods guidelines of the Cochrane Back and Neck Review Group (Furlan 2009) and those provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants).Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58).Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis.Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function.All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema.
AUTHORS' CONCLUSIONS: We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis.
腰椎管狭窄症（LSS）是一种与脊柱随年龄退化相关的使人衰弱的疾病。
评估不同类型的手术与不同类型的非手术干预措施相比，对有症状的成年腰椎管狭窄症患者的有效性。主要结局包括生活质量、残疾程度、功能和疼痛。此外，还要考虑并发症发生率和副作用，并评估短期、中期和长期结局（六个月、六个月至两年、五年或更长时间）。
我们检索了截至2015年2月的Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE、其他五个数据库和两个试验注册库。我们还筛选了与脊柱治疗相关的参考文献列表和会议论文集。
通过临床和影像学检查确诊为腰椎管狭窄症的参与者中，比较手术治疗与非手术治疗的随机对照试验（RCT）。
对于数据收集和分析，我们遵循Cochrane背部和颈部综述小组的方法指南（Furlan，2009年）以及Cochrane干预措施系统评价手册中提供的指南（Higgins，2011年）。
从筛选的12966篇文献中，我们评估了26篇全文文章，纳入了5项RCT（643名参与者）。对两项试验进行荟萃分析得出的低质量证据，使用Oswestry残疾指数（与疼痛相关的残疾）比较单纯减压术（无论是否融合）与多模式非手术治疗，在六个月时（平均差（MD）-3.66，95%置信区间（CI）-10.12至2.80）和一年时（MD -6.18，95%CI -15.03至2.66）无显著差异。在24个月时，显著差异有利于减压术（MD -4.43，95%CI -7.91至-0.96）。一项小型研究的低质量证据显示，在三个月时（风险比（RR）1.38，95%CI 0.22至8.59）、四年时（RR 7.50，95%CI 1.00至56.48）和十年时（RR 4.09，95%CI 0.95至17.58），减压术与常规保守治疗（支具和运动）在疼痛结局方面无差异。一项小型研究的低质量证据表明，在六周时，接受微创轻度减压术的患者与接受硬膜外类固醇注射的患者在Oswestry残疾指数方面无差异（MD 5.70，95%CI 0.57至10.83；38名参与者）。在六周时，苏黎世跛行问卷（ZCQ）结果显示硬膜外注射更好（MD -0.60，95%CI -0.92至-0.28），而视觉模拟量表（VAS）改善在轻度减压组更好（MD 2.40，95%CI 1.92至2.88）。在12周时，许多交叉情况妨碍了进一步分析。一项纳入191名参与者的单一研究的低质量证据表明，在六周、六个月和一年时，对于症状严重程度和身体功能，棘突间间隔器优于常规保守治疗。所有其余研究均报告了与手术相关的并发症以及治疗的保守性副作用：两项研究报告手术组无重大并发症，另一项研究报告参与者中有10%和24%出现并发症，包括棘突骨折、冠状动脉缺血、呼吸窘迫、血肿、中风、再次手术风险和因肺水肿导致的死亡。
我们对得出手术治疗还是保守治疗对腰椎管狭窄症更好的结论信心不足，也无法提供新的建议来指导临床实践。然而，应注意手术病例的副作用发生率为10%至24%，而任何保守治疗均未报告有副作用。手术治疗与非手术治疗相比未观察到明显益处。这些发现表明，临床医生在告知患者可能的治疗选择时应非常谨慎，特别是考虑到保守治疗选择未报告有副作用。需要高质量的研究来比较腰椎管狭窄症患者的手术治疗与保守治疗。
