Department of Physiotherapy, São Paulo State University, Presidente Prudente, Brazil.
Sydney School of Public Health, University of Sydney, Sydney, Australia.
Spine (Phila Pa 1976). 2020 Nov 1;45(21):E1405-E1415. doi: 10.1097/BRS.0000000000003651.
Systematic with meta-analysis OBJECTIVES.: The aim of this study was to investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection in reducing leg pain and disability in patients with sciatica.
Conservative treatments, including pharmacological and nonpharmacological treatments, are typically the first treatment options for sciatica but the evidence to support their use is limited. The overall quality of evidence found by previous systematic reviews varies between moderate and high, which suggests that future trials may change the conclusions. New placebo-controlled randomized trials have been published recently which highlights the importance of an updated systematic review.
The searches were performed without language restrictions in the following databases from 2012 to 25 September 2019: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, PubMed, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and trial registers. We included placebo-controlled randomized trials investigating epidural corticosteroid injections in patients with sciatica. The primary outcomes were leg pain intensity and disability. The secondary outcomes were adverse events, overall pain, and back pain intensity. We grouped similar trials according to outcome measures and their respective follow-up time points. Short-term follow-up (>2 weeks but ≤3 months) was considered the primary follow-up time point due to the expected mechanism of action of epidural corticosteroid injection. Weighted mean differences (MDs) and risk ratios (RRs) with their respective 95% confidence intervals (CIs) were estimated. We assessed the overall quality of evidence using the GRADE approach and conducted the analyses using random effects.
We included 25 clinical trials (from 29 publications) providing data for a total of 2470 participants with sciatica, an increase of six trials when compared to the previous review. Epidural corticosteroid injections were probably more effective than placebo in reducing short-term leg pain (MD -4.93, 95% CI -8.77 to -1.09 on a 0-100 scale), short-term disability (MD -4.18, 95% CI: -6.04 to -2.17 on a 0-100 scale) and may be slightly more effective in reducing short-term overall pain (MD -9.35, 95% CI -14.05 to -4.65 on a 0-100 scale). There were mostly minor adverse events (i.e., without hospitalization) after epidural corticosteroid injections and placebo injections without difference between groups (RR 1.14, 95% CI: 0.91-1.42). The quality of evidence was at best moderate mostly due to problems with trial design and inconsistency.
A review of 25 placebo-controlled trials provides moderate-quality evidence that epidural corticosteroid injections are effective, although the effects are small and short-term. There is uncertainty on safety due to very low-quality evidence.
系统评价与荟萃分析
本研究旨在探讨硬膜外皮质类固醇注射与安慰剂注射相比，在减轻坐骨神经痛患者的腿部疼痛和残疾方面的疗效和安全性。
包括药物和非药物治疗在内的保守治疗通常是坐骨神经痛的首选治疗方案，但支持其使用的证据有限。之前的系统评价发现的总体证据质量在中等和高之间变化，这表明未来的试验可能会改变结论。最近发表了新的安慰剂对照随机试验，这凸显了更新系统评价的重要性。
从 2012 年至 2019 年 9 月 25 日，我们在以下数据库中进行了无语言限制的检索：Cochrane 对照试验中心注册库（CENTRAL）、MEDLINE、MEDLINE 正在处理和其他非索引引文、PubMed、Embase、CINAHL、PsycINFO、国际药学文摘和试验注册处。我们纳入了在坐骨神经痛患者中进行硬膜外皮质类固醇注射的安慰剂对照随机试验。主要结局是腿部疼痛强度和残疾。次要结局是不良事件、总体疼痛和背部疼痛强度。我们根据结局测量和各自的随访时间点将类似的试验分组。短期随访（>2 周但≤3 个月）被认为是主要随访时间点，因为硬膜外皮质类固醇注射的预期作用机制。使用加权均数差值（MD）和风险比（RR）及其各自的 95%置信区间（CI）进行估计。我们使用 GRADE 方法评估总体证据质量，并使用随机效应进行分析。
我们纳入了 25 项临床试验（来自 29 篇出版物），共纳入 2470 名坐骨神经痛患者，与之前的综述相比，增加了 6 项试验。与安慰剂相比，硬膜外皮质类固醇注射可能更有效地减轻短期腿部疼痛（MD-4.93，0-100 量表上的 95%CI-8.77 至-1.09）、短期残疾（MD-4.18，0-100 量表上的 95%CI-6.04 至-2.17），并且可能在减轻短期总体疼痛方面略为有效（MD-9.35，0-100 量表上的 95%CI-14.05 至-4.65）。硬膜外皮质类固醇注射和安慰剂注射后主要是轻微的不良事件（即无需住院治疗），但组间无差异（RR 1.14，95%CI：0.91-1.42）。证据质量最好为中等，主要是由于试验设计和一致性问题。
25 项安慰剂对照试验的综述提供了中等质量的证据，表明硬膜外皮质类固醇注射是有效的，尽管效果较小且为短期。由于低质量证据，对安全性存在不确定性。
