Staal J Bart, de Bie Rob, de Vet Henrica Cw, Hildebrandt Jan, Nelemans Patty
Department of Epidemiology and Caphri Research Institute, Maastricht University , P Debyeplein 1, Maastricht, Netherlands, 6200 MD.
Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD001824. doi: 10.1002/14651858.CD001824.pub3.
The effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis.
To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low-back pain.
We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases from January 1999 to March 2007 for relevant trials reported in English, French, German, Dutch and Nordic languages. We also screened references from trials identified.
RCTs on the effects of injection therapy involving epidural, facet or local sites for subacute or chronic low-back pain were included. Studies which compared the effects of intradiscal injections, prolotherapy or Ozone therapy with other treatments, were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded.
Two review authors independently assessed the quality of the trials. If study data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a best evidence synthesis to summarize the results. The evidence was classified into five levels (strong, moderate, limited, conflicting or no evidence), taking into account the methodological quality of the studies.
18 trials (1179 participants) were included in this updated review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender- and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics and a variety of other drugs. The methodological quality of the trials was limited with 10 out of 18 trials rated as having a high methodological quality. Statistical pooling was not possible due to clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy.
AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.
注射疗法治疗腰痛的有效性仍存在争议。随机对照试验(RCT)中普遍存在的靶组织、药物制剂和剂量的异质性表明,在文献综述中需要进行具有临床有效性的比较。
确定注射疗法对亚急性或慢性腰痛患者是否比安慰剂或其他治疗方法更有效。
我们更新了对早期系统评价的检索,并检索了Cochrane对照试验中心注册库、MEDLINE和EMBASE数据库,检索时间为1999年1月至2007年3月,检索用英文、法文、德文、荷兰文和北欧语言报道的相关试验。我们还筛选了已识别试验的参考文献。
纳入关于注射疗法对亚急性或慢性腰痛的硬膜外、小关节或局部部位疗效的随机对照试验。除非将使用另一种药物制剂(无安慰剂治疗)的注射疗法作为其中一个治疗组的一部分,否则排除比较椎间盘内注射、增殖疗法或臭氧疗法与其他治疗效果的研究。关于骶髂关节注射的研究以及评估硬膜外类固醇治疗根性疼痛效果的研究也被排除。
两位综述作者独立评估试验质量。如果研究数据在临床和统计学上过于异质而无法进行荟萃分析,我们使用最佳证据综合法来总结结果。考虑到研究的方法学质量,证据被分为五个级别(强、中、有限、矛盾或无证据)。
本次更新综述纳入了18项试验(1179名参与者)。注射部位从硬膜外部位和小关节(即关节内注射、关节周围注射和神经阻滞)到局部部位(即压痛点和触发点)不等。所研究的药物包括皮质类固醇、局部麻醉剂和多种其他药物。试验的方法学质量有限,18项试验中有10项被评为具有较高的方法学质量。由于试验中的临床异质性,无法进行统计合并。总体而言,结果表明没有强有力的证据支持或反对使用任何类型的注射疗法。
没有足够的证据支持在亚急性和慢性腰痛中使用注射疗法。然而,不能排除特定亚组患者可能对特定类型的注射疗法有反应。