From the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.
Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.
To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.
A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes.
nVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%; = 0.012) and 60 minutes (21.0% vs 10.0%; = 0.023) but not at 120 minutes (30.4% vs 19.7%; = 0.067; primary endpoint; logistic regression) after the first treated attack. A post hoc repeated-measures test provided further insight into the therapeutic benefit of nVNS through 30, 60, and 120 minutes (odds ratio 2.3; 95% confidence interval 1.2, 4.4; = 0.012). nVNS demonstrated benefits across other endpoints including pain relief at 120 minutes and was safe and well-tolerated.
This randomized sham-controlled trial supports the abortive efficacy of nVNS as early as 30 minutes and up to 60 minutes after an attack. Findings also suggest effective pain relief, tolerability, and practicality of nVNS for the acute treatment of episodic migraine.
NCT02686034.
This study provides Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 hours poststimulation (absolute difference 13.2%).
评估非侵入性迷走神经刺激（nVNS；gammaCore；electroCore，LLC，Basking Ridge，NJ）在一项多中心、双盲、随机、假对照试验中对偏头痛急性发作的疗效、安全性和耐受性。
共有 248 例有先兆或无先兆的发作性偏头痛患者随机在疼痛发作后 20 分钟内接受 nVNS 或假刺激治疗。如果 15 分钟后疼痛未缓解，患者应重复治疗。
nVNS（n = 120）在 30 分钟（12.7%比 4.2%；= 0.012）和 60 分钟（21.0%比 10.0%；= 0.023）时比假刺激（n = 123）更能缓解疼痛，而在 120 分钟时（30.4%比 19.7%；= 0.067；主要终点；logistic 回归）则无差异。事后重复测量检验通过 30、60 和 120 分钟进一步深入了解 nVNS 的治疗益处（比值比 2.3；95%置信区间 1.2，4.4；= 0.012）。nVNS 在其他终点也表现出获益，包括 120 分钟时的疼痛缓解，且安全性和耐受性良好。
这项随机假对照试验支持 nVNS 在偏头痛发作后 30 分钟内甚至 60 分钟内具有 abortive 疗效。研究结果还表明 nVNS 在缓解发作性偏头痛急性发作时具有有效、耐受和实用的疼痛缓解作用。
临床试验.gov 标识符：NCT02686034。
这项研究提供了 I 级证据，表明对于有发作性偏头痛的患者，nVNS 可显著增加刺激后 2 小时时轻度疼痛或无痛的可能性（绝对差异 13.2%）。
