Stanak Michal, Wolf Sarah, Jagoš Harald, Zebenholzer Karin
Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; Department of Philosophy, University of Vienna, Vienna, Austria.
Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
J Neurol Sci. 2020 May 15;412:116725. doi: 10.1016/j.jns.2020.116725. Epub 2020 Feb 6.
The aim of this systematic review was to analyze the effectiveness and safety of the external trigeminal nerve stimulator (eTNS) for the prevention and acute treatment of migraine attacks in episodic and chronic migraine patients.
We have conducted a systematic literature search in four databases that yielded 433 citations and additional seven citations were found via hand-search. Two randomised placebo-controlled trials and five prospective case series were included in the analysis.
Concerning prevention, statistically significant differences were found with respect to reduction of migraine attacks (0.67 less migraine attacks per month), migraine days (1.74 less migraine days per month), headache days (2.28 less headache days per month), and acute antimigraine drug intake (4.24 less instances of acute drug intake per month). Concerning acute treatment, statistically significant differences were found with respect to pain reduction on a visual analogue scale at 1/2/24 h post-acute treatment (1.68/1.02/1.08 improvement, respectively). No serious adverse events occurred in any of the studies.
While e-TNS has the potential to improve migraine symptoms, for its establishment in the standard practice, high quality comparative data, studies with larger sample sizes, and studies with standard and relevant primary outcome parameters are needed.
本系统评价旨在分析外用三叉神经刺激器(eTNS)预防和急性治疗发作性和慢性偏头痛患者偏头痛发作的有效性和安全性。
我们在四个数据库中进行了系统的文献检索,共获得433条引文,通过手工检索又发现了另外7条引文。分析纳入了两项随机安慰剂对照试验和五项前瞻性病例系列研究。
在预防方面,在减少偏头痛发作(每月减少0.67次偏头痛发作)、偏头痛天数(每月减少1.74天偏头痛天数)、头痛天数(每月减少2.28天头痛天数)和急性抗偏头痛药物摄入量(每月减少4.24次急性药物摄入实例)方面发现了统计学上的显著差异。在急性治疗方面,在急性治疗后1/2/24小时的视觉模拟量表疼痛减轻方面发现了统计学上的显著差异(分别改善1.68/1.02/1.08)。在任何一项研究中均未发生严重不良事件。
虽然e-TNS有改善偏头痛症状的潜力,但要将其确立为标准治疗方法,还需要高质量的比较数据、更大样本量的研究以及具有标准和相关主要结局参数的研究。