BackgroundThere is a significant unmet need for new, effective and well tolerated acute migraine treatments. A recent study has demonstrated that a novel remote electrical neuromodulation (REN) treatment provides superior clinically meaningful pain relief with a low rate of device-related adverse events. The results reported herein compare the efficacy of REN with current standard of care in the acute treatments of migraine.MethodsWe performed a post-hoc analysis on a subgroup of participants with migraine from a randomized, double-blind, parallel-group, sham-controlled, multicenter study on acute care. The original study included a 2–4 weeks run-in phase, in which migraine attacks were treated according to patient preference (i.e., usual care) and reported in an electronic diary; next, participants entered a double-blind treatment phase in which they treated the attacks with an active or sham device. The efficacy of REN was compared to the efficacy of usual care or pharmacological treatments in the run-in phase in a within-subject design that included participants who treated at least one attack with the active REN device and reported pain intensity at 2 h post-treatment.ResultsOf the 252 patients randomized, there were 99 participants available for analysis. At 2 h post-treatment, pain relief was achieved in 66.7% of the participants using REN versus 52.5% participants with usual care (p < 0.05). Pain relief at 2 h in at least one of two attacks was achieved by 84.4% of participants versus 68.9% in usual care (p < 0.05). REN and usual care were similarly effective for pain-free status at 2 h. The results also demonstrate the non-inferiority of REN compared with acute pharmacological treatments and its non-dependency on preventive medication use.ConclusionREN is an effective acute treatment for migraine with non-inferior efficacy compared to current acute migraine therapies. Together with a very favorable safety profile, these findings suggest that REN may offer a promising alternative for the acute treatment of migraine and could be considered first line treatment in some patients.Trial registrationClinicalTrials.gov NCT03361423. Registered 18 November 2017.

中文翻译：

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偏头痛急性治疗中的远程电神经调节 (REN)：与常规护理和急性偏头痛药物的比较

背景对于新的、有效且耐受良好的急性偏头痛治疗存在显着未满足的需求。最近的一项研究表明，一种新型远程电神经调节 (REN) 治疗可提供具有临床意义的卓越疼痛缓解，并且与设备相关的不良事件发生率较低。本文报告的结果比较了 REN 与当前偏头痛急性治疗标准的疗效。 方法我们对来自随机、双盲、平行组、假手术控制的偏头痛患者亚组进行了事后分析，关于急性护理的多中心研究。最初的研究包括一个 2-4 周的磨合阶段，其中根据患者的偏好（即常规护理）治疗偏头痛发作并在电子日记中报告；下一个，参与者进入双盲治疗阶段，他们用主动或假设备治疗攻击。在受试者内设计中，将 REN 的功效与磨合阶段的常规护理或药物治疗的功效进行比较，该设计包括使用主动 REN 装置治疗至少一次发作并在治疗后 2 小时报告疼痛强度的参与者。治疗。结果 在随机分配的 252 名患者中，有 99 名参与者可供分析。在治疗后 2 小时，使用 REN 的参与者中有 66.7% 的参与者实现了疼痛缓解，而使用常规护理的参与者则为 52.5%（p < 0.05）。84.4% 的参与者在两次发作中至少有一次在 2 小时内实现了疼痛缓解，而常规护理中的这一比例为 68.9%（p < 0.05）。REN 和常规护理对 2 小时的无痛状态同样有效。结果还证明了REN与急性药物治疗相比具有非劣效性，并且不依赖于预防性药物的使用。结论REN是一种有效的急性偏头痛治疗方法，与目前的急性偏头痛疗法相比疗效非劣。连同非常有利的安全性特征，这些发现表明 REN 可能为偏头痛的急性治疗提供一种有希望的替代方案，并且可以被视为某些患者的一线治疗。试验注册 ClinicalTrials.gov NCT03361423。2017 年 11 月 18 日注册。连同非常有利的安全性特征，这些发现表明 REN 可能为偏头痛的急性治疗提供一种有希望的替代方案，并且可以被视为某些患者的一线治疗。试验注册 ClinicalTrials.gov NCT03361423。2017 年 11 月 18 日注册。连同非常有利的安全性特征，这些发现表明 REN 可能为偏头痛的急性治疗提供一种有希望的替代方案，并且可以被视为某些患者的一线治疗。试验注册 ClinicalTrials.gov NCT03361423。2017 年 11 月 18 日注册。