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Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine: an open-label study

机译:非侵入性迷走神经刺激(nVNS)作为月经/经期偏头痛的微型预防措施:一项开放标签研究

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Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine. Fifty-six enrolled subjects (menstrual migraine, 9?%; menstrually related migraine, 91?%), 33 (59?%) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61?%) or as monotherapy (20/51; 39?%) on day ?3 before estimated onset of menses through day +3 after the end of menses. The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean?±?standard error, 7.2?±?0.7?days) to the end of treatment (mean?±?standard error, 4.7?±?0.5?days; P?
机译:与非经期发作相比,月经偏头痛和与经期有关的偏头痛发作通常更长,更致残,并且对药物的反应性更差。这项研究的目的是评估预防性治疗经期偏头痛/经期相关偏头痛的无创迷走神经刺激的功效,安全性和耐受性。共有56名受试者(月经偏头痛,占9%;经期相关偏头痛,占91%),其中33人(占59%)正在接受其他预防性治疗,他们进入了12周的基线期。 51名受试者随后进入为期12周的治疗期,在第3天接受开放标签的预防性非侵入性迷走神经刺激(31/51; 61%)或作为单一疗法(20/51; 39%)在月经结束后+3天之前估计月经来潮之前。从基线(平均标准误为7.2±0.7天)到治疗结束(平均标准误为4.7±4.7天),每月与经期偏头痛/经期相关的偏头痛天数明显减少。 0.5天; P 0.001)(主要终点)。在所有受试者中,有39%(95 %%的置信区间:26%,54%)(20/51)降低了≥50%%(第二终点)。对于其他次要终点,止痛药的临床意义上的减少(平均变化±标准误差,每月3.3次±0.6次; P <0.001),6项头痛影响试验评分(平均变化?观察到±标准偏差为±3.1±0.7,P <0.001,偏头痛残疾评估得分(平均变化±标准偏差为11.9±3.4,P <0.001)。疼痛强度适度降低(平均值变化±±标准误差,±0.5±0.2); P = 0.002)。无需担心安全/公差。这些发现表明,非侵入性迷走神经刺激是一种有效的治疗方法,可减少经期偏头痛/经期相关偏头痛的天数,减少使用止痛药而无安全/耐受性问题。随机对照研究是必要的。

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