Povlsen Bo, Hansson Thomas, Povlsen Sebastian D
London Hand Clinic, London Bridge Hospital, 27 Tooley Street, London, UK, SE1 2PR.
Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD007218. doi: 10.1002/14651858.CD007218.pub3.
Thoracic outlet syndrome (TOS) is one of the most controversial diagnoses in clinical medicine. Despite many reports of operative and non-operative interventions, rigorous scientific investigation of this syndrome leading to evidence-based management is lacking. This is the first update of a review first published in 2010.
To evaluate the beneficial and adverse effects of the available operative and non-operative interventions for the treatment of TOS a minimum of six months after the intervention.
On 23 June 2014 we searched the Cochrane Neuromuscular Disease Group Trials Specialized Register, CENTRAL, The Database of Abstracts of Reviews of Effects (DARE), MEDLINE, EMBASE, CINAHL Plus and AMED. We also searched reference lists of the identified trials.
We selected randomized or quasi-randomized studies involving participants with the diagnosis of TOS of any type (neurogenic, vascular, and 'disputed'), without limitations as to language of publication.We accepted studies that examined any intervention aimed at treating TOS.The primary outcome measure was change in pain rating, measured on a validated visual analog or similar scale at least six months after the intervention.The secondary outcomes were change in muscle strength, disability, experiences of paresthesias (numbness and tingling sensations), and adverse effects of the interventions.
Three authors independently selected the trials to be included and extracted data. Authors rated included studies for risk of bias, according to the methods recommended in the Cochrane Handbook for Systematic Reviews of Interventions.
This review was complicated by a lack of generally accepted criteria for the diagnosis of TOS and had to rely exclusively on the diagnosis of TOS by the investigators in the reviewed studies. We identified one study comparing natural progression with an active intervention. We found three randomized controlled trials (RCTs), but only two of them had a follow-up of six months or more, which was the minimum required follow-up for inclusion in the review. The first trial that met our requirements involved 55 participants with the 'disputed type' of TOS and compared transaxillary first rib resection (TFRR) with supraclavicular neuroplasty of the brachial plexus (SNBP). The trial had a high risk of bias. TFRR decreased pain more than SNBP. There were no adverse effects in either group. The second trial that met these requirements analyzed 37 people with TOS of any type, comparing treatment with a botulinum toxin (BTX) injection into the scalene muscles with a saline placebo injection. This trial had a low risk of bias. There was no significant effect of treatment with the BTX injection over placebo in terms of pain relief or improvements in disability, but it did significantly improve paresthesias at six months' follow-up. There were no adverse events of the BTX treatment above saline injection.
AUTHORS' CONCLUSIONS: This review was complicated by a lack of generally accepted diagnostic criteria for the diagnosis of TOS. There was very low quality evidence that transaxillary first rib resection decreased pain more than supraclavicular neuroplasty, but no randomized evidence that either is better than no treatment. There is moderate evidence to suggest that treatment with BTX injections yielded no great improvements over placebo injections of saline. There is no evidence from RCTs for the use of other currently used treatments. There is a need for an agreed definition for the diagnosis of TOS, especially the disputed form, agreed outcome measures, and high quality randomized trials that compare the outcome of interventions with no treatment and with each other.
胸廓出口综合征(TOS)是临床医学中最具争议的诊断之一。尽管有许多关于手术和非手术干预的报道,但缺乏对该综合征进行严格科学调查以实现循证管理。这是对2010年首次发表的一篇综述的首次更新。
评估现有手术和非手术干预措施在干预后至少六个月治疗TOS的有益和不良影响。
2014年6月23日,我们检索了Cochrane神经肌肉疾病组试验专门注册库、CENTRAL、效果综述文摘数据库(DARE)、MEDLINE、EMBASE、CINAHL Plus和AMED。我们还检索了已识别试验的参考文献列表。
我们选择了涉及任何类型(神经源性、血管性和“争议性”)TOS诊断参与者的随机或半随机研究,对发表语言没有限制。我们纳入了检查任何旨在治疗TOS的干预措施的研究。主要结局指标是疼痛评分的变化,在干预后至少六个月使用经过验证的视觉模拟或类似量表进行测量。次要结局包括肌肉力量、残疾、感觉异常(麻木和刺痛感)的变化以及干预措施的不良反应。
三位作者独立选择纳入的试验并提取数据。作者根据Cochrane系统评价干预措施手册中推荐的方法对纳入研究的偏倚风险进行评分。
由于缺乏普遍接受的TOS诊断标准,本综述变得复杂,不得不完全依赖综述研究中研究者对TOS的诊断。我们确定了一项比较自然进展与积极干预的研究。我们找到了三项随机对照试验(RCT),但其中只有两项随访时间为六个月或更长,这是纳入本综述所需的最短随访时间。第一项符合我们要求的试验涉及55名“争议性”TOS患者,比较了经腋第一肋切除术(TFRR)与臂丛神经锁骨上神经成形术(SNBP)。该试验存在较高的偏倚风险。TFRR比SNBP更能减轻疼痛。两组均无不良反应。第二项符合这些要求的试验分析了37名任何类型TOS患者,比较了向斜角肌注射肉毒杆菌毒素(BTX)与注射生理盐水安慰剂的治疗效果。该试验存在较低的偏倚风险。就疼痛缓解或残疾改善而言,BTX注射治疗与安慰剂相比没有显著效果,但在六个月随访时确实显著改善了感觉异常。BTX治疗组的不良事件并不多于注射生理盐水组。
由于缺乏普遍接受的TOS诊断标准,本综述变得复杂。有非常低质量的证据表明经腋第一肋切除术比锁骨上神经成形术更能减轻疼痛,但没有随机证据表明两者优于不治疗。有中等证据表明,与注射生理盐水安慰剂相比,BTX注射治疗没有显著改善。随机对照试验中没有证据支持使用其他目前使用的治疗方法。需要对TOS的诊断,特别是争议形式的诊断,达成一致的定义,商定结局指标,并开展高质量的随机试验,比较干预措施与不治疗以及相互之间的结局。