Nielsen Sabrina Mai, Tarp Simon, Christensen Robin, Bliddal Henning, Klokker Louise, Henriksen Marius
The Parker Institute, Copenhagen University Hospital, Frederiksberg & Bispebjerg, Frederiksberg, 2000, Denmark.
Clinical Research Unit, The Parker Institute, Copenhagen University Hospital, Frederiksberg & Bispebjerg, Frederiksberg, 2000, Denmark.
Syst Rev. 2017 Mar 24;6(1):64. doi: 10.1186/s13643-017-0458-y.
Spinal manipulative therapy (SMT) is a widely used manual treatment, but many reviews exist with conflicting conclusions about the safety of SMT. We performed an overview of reviews to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.
We searched five electronic databases from inception to December 8, 2015. We included reviews on any type of studies, patients, and SMT technique. Our primary outcome was SAEs. Quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, we used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.
We identified 283 eligible reviews, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.
It is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
PROSPERO CRD42015030068 .
脊柱推拿疗法(SMT)是一种广泛应用的手法治疗,但许多综述对SMT的安全性得出了相互矛盾的结论。我们进行了一项综述的概述,以阐明和量化与SMT相关的严重不良事件(SAE)的风险。
我们检索了从数据库建立至2015年12月8日的五个电子数据库。我们纳入了关于任何类型的研究、患者和SMT技术的综述。我们的主要结局是SAE。使用一种评估系统综述的测量工具(AMSTAR)评估纳入综述的质量。由于计算SAE发生率的数据不足,我们采用了另一种方法;提取每项综述中关于SMT安全性的结论,并由两名评审员独立将传达的意见判断为安全、有害或中性/不明确。计算传达SMT安全且符合每个AMSTAR项目要求的综述的风险比(RR)。
我们识别出283篇符合条件的综述,但只有118篇提供了用于综合分析的数据。最常描述的不良事件(AE)是中风、头痛和椎动脉夹层。54篇综述(46%)表示SMT是安全的,15篇(13%)表示SMT是有害的,49篇综述(42%)为中性或不明确。13篇综述报告了SAE的发生率估计值,大致范围为每20000至250000000次推拿中有1例。方法学质量较低,11项AMSTAR项目中符合的中位数为4项(四分位间距,3至6)。符合每个AMSTAR项目要求(即内部效度良好)的综述更有可能表示SMT是安全的。
目前无法对SMT的安全性给出总体结论;然而,报告的SAE类型确实可能很严重,表明存在一定风险。需要高质量的研究以及对AE和SAE进行一致的报告。
PROSPERO CRD42015030068 。