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Cardiovascular risk considerations in triptan therapy for migraine: Reflections on the study by Peles et al. 曲坦类药物治疗偏头痛的心血管风险考虑:对Peles等人研究的反思
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-01 Epub Date: 2025-09-22 DOI: 10.1111/head.15063
Nav La, Schawanya K Rattanapitoon, Nathkapach K Rattanapitoon
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引用次数: 0
2025 guideline update to acute treatment of migraine for adults in the emergency department: The American Headache Society evidence assessment of parenteral pharmacotherapies. 2025年急诊科成人偏头痛急性治疗指南更新:美国头痛学会对肠外药物治疗的证据评估
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-01 DOI: 10.1111/head.70016
Jennifer Robblee, Mia T Minen, Benjamin W Friedman, Miguel A Cortel-LeBlanc, Achelle Cortel-LeBlanc, Serena L Orr
<p><strong>Objective: </strong>To update the 2016 American Headache Society (AHS) guideline on parenteral pharmacologic therapies for the management of migraine attacks in the emergency department (ED).</p><p><strong>Methods: </strong>We conducted a systematic review and meta-analysis using the same methodology as the 2016 guideline. The original search strategy was repeated and expanded to include studies of nerve blocks and sphenopalatine ganglion (SPG) blocks. We searched Medline, Embase, Cochrane, clinicaltrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform through February 10, 2025. Eligible studies were randomized controlled trials (RCTs) involving adults diagnosed with migraine, treated in the ED with intravenous (IV), intramuscular (IM), subcutaneous (SC), or nerve block (including SPG block) interventions. Two reviewers independently screened titles/abstracts and full texts; a third reviewer resolved disagreements. Data were extracted using a standardized form and verified by a second reviewer. Risk of bias was assessed using the American Academy of Neurology (AAN) criteria. Where applicable, meta-analyses were performed. Efficacy was categorized as highly likely, likely, or possibly effective or ineffective. Clinical recommendations were developed using the AAN guideline development process.</p><p><strong>Results: </strong>The search identified 26 new RCTs evaluating 20 injectable treatments. Of these, 12 were rated class I (low risk of bias), 9 class II, and 4 class III. Prochlorperazine IV, dexketoprofen IV, sumatriptan SC, and greater occipital nerve blocks (GONB) were considered highly likely to be effective based on multiple class I studies. Chlorpromazine IV, metoclopramide IV, eptinezumab IV, ketorolac IV, and supraorbital nerve blocks (SONB) were considered likely effective based on one class I or multiple class II studies. Hydromorphone IV, propofol IV, and paracetamol IV were considered likely ineffective based on class I or multiple class II studies. After review of the evidence and a consensus process, recommendations were made for each intervention.</p><p><strong>Conclusions: </strong>Prochlorperazine IV and GONB must be offered to eligible adults presenting to the ED with a migraine attack for treatment of headache requiring parenteral therapy (level A - must offer) in those without contraindications, while hydromorphone IV must not be offered (level A - must not offer). Treatments that should be offered when appropriate (level B - should offer) include dexketoprofen IV, ketorolac IV, metoclopramide IV, sumatriptan SC, and SONB. Chlorpromazine IV, dexamethasone IV, and valproate IV may be offered (level C - may offer). Paracetamol IV may not be offered (level C - should not offer). Eptinezumab should be offered (level B) only for patients matching the clinical trial population but is rated level U - no recommendation for an ED-specific population. Additional evidence is needed
目的:更新2016年美国头痛学会(AHS)关于急诊科(ED)偏头痛发作管理的肠外药物治疗指南。方法:我们采用与2016年指南相同的方法进行了系统回顾和荟萃分析。最初的搜索策略被重复并扩展到包括神经阻滞和蝶腭神经节(SPG)阻滞的研究。我们检索了截至2025年2月10日的Medline、Embase、Cochrane、clinicaltrials.gov和世界卫生组织(WHO)国际临床试验注册平台。符合条件的研究是随机对照试验(RCTs),涉及诊断为偏头痛的成年人,在ED中接受静脉注射(IV)、肌肉注射(IM)、皮下注射(SC)或神经阻滞(包括SPG阻滞)干预。两位审稿人独立筛选标题/摘要和全文;第三位审稿人解决了分歧。使用标准化表格提取数据,并由第二审稿人进行验证。偏倚风险采用美国神经病学学会(AAN)标准进行评估。在适用的情况下,进行了荟萃分析。功效分为极可能、可能、可能有效或无效。临床建议是根据AAN指南制定过程制定的。结果:搜索确定了26个新的随机对照试验,评估了20种注射治疗方法。其中,12个被评为I类(低偏倚风险),9个被评为II类,4个被评为III类。基于多项I类研究,丙氯哌嗪IV、右酮洛芬IV、舒马匹坦SC和更大枕骨神经阻滞(GONB)被认为很可能有效。氯丙嗪IV、甲氧氯普胺IV、依替单抗IV、酮罗拉酸IV和眶上神经阻滞(SONB)在一项I类或多项II类研究中被认为可能有效。基于I类或多个II类研究,氢吗啡酮IV、异丙酚IV和扑热息痛IV被认为可能无效。在对证据进行审查并达成共识后,对每项干预措施提出建议。结论:在没有禁忌症的情况下,有偏头痛发作的成年人必须给予丙氯拉嗪IV和GONB治疗,以治疗需要肠外治疗的头痛(a级必须提供),而不能给予氢吗啡酮IV (a级必须提供)。适当时应给予的治疗(B级-应给予)包括dexketoprofen IV, ketorolac IV, metoclopramide IV,舒马匹坦SC和SONB。氯丙嗪IV,地塞米松IV,丙戊酸IV可提供(C级-可提供)。对乙酰氨基酚IV不能提供(C级-不应该提供)。Eptinezumab仅适用于符合临床试验人群的患者(B级),但额定值为U级-不推荐用于ed特异性人群。咖啡因、格拉司琼、布洛芬、氯胺酮、利多卡因、生理盐水、异丙酚和SPG阻滞剂目前都被评为U级——不推荐。
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引用次数: 0
The effect of vestibular rehabilitation in the management of vestibular migraine in adults: A systematic review and meta-analysis. 前庭康复在成人前庭偏头痛治疗中的作用:一项系统回顾和荟萃分析。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-25 DOI: 10.1111/head.70002
Jad El Ahdab, Marina Vilardo, Bradley Ong, Nicolas R Thompson, Neil Nero, Ahmet Günkan, Neil Cherian, Julia Bucklan

Background: Vestibular migraine (VM) is a common migraine subtype characterized by recurrent vestibular symptoms. Despite its prevalence, evidence-based treatment guidelines are lacking. Vestibular rehabilitation (VR) has been proven effective in many vestibular disorders, but its role in managing VM has not been well established. This systematic review aimed to summarize and pool the evidence on the effectiveness of VR for VM using standardized outcome measures, primarily focusing on patient-reported dizziness-related quality-of-life assessments.

Methods: We systematically searched MEDLINE, Embase, Cochrane Library, and Scopus from inception to March 2025 for studies evaluating self-reported and physical outcome measures of VR in patients with VM. Meta-analysis of mean change in Dizziness Handicap Inventory (DHI) scores was performed. Risk of bias was assessed using the Cochrane RoB 2 tool for the randomized controlled trials and the ROBINS-I tool for observational studies.

Results: Seven studies comprising 413 patients (mean age, 45.4; 76% female) with VM treated with VR were included. The effect of vestibular rehabilitation on DHI scores showed a pooled mean difference of -29.3 (95% confidence interval [CI], -40.2 to -18.3), more than the clinically important difference of 18 points. Although, our meta-analysis had high heterogeneity (Cochran's Q p value <0.001, I2 = 94.7%).

Conclusion: VR demonstrated a reduction in DHI scores, meeting the clinically significant difference of 18 indicating clinical improvement. However, the considerable heterogeneity limits the generalizability of these results and highlights the need for further standardized randomized controlled trials with subgroup analyses to better determine the specific benefits and optimal protocols of VR in managing VM.

背景:前庭偏头痛(VM)是一种常见的偏头痛亚型,其特征是反复出现前庭症状。尽管它很普遍,但缺乏循证治疗指南。前庭康复(VR)已被证明对许多前庭疾病有效,但其在治疗VM中的作用尚未得到很好的确定。本系统综述旨在总结和汇总使用标准化结果测量的VR治疗VM有效性的证据,主要关注患者报告的与眩晕相关的生活质量评估。方法:我们系统地检索了MEDLINE、Embase、Cochrane Library和Scopus从成立到2025年3月的研究,以评估VM患者的VR自我报告和物理结果测量。对头晕障碍量表(DHI)评分的平均变化进行meta分析。随机对照试验使用Cochrane RoB 2工具评估偏倚风险,观察性研究使用robins - 1工具评估偏倚风险。结果:纳入了7项研究,包括413例接受VR治疗的VM患者(平均年龄45.4岁,76%为女性)。前庭康复对DHI评分的影响,合并平均差异为-29.3分(95%可信区间[CI], -40.2 ~ -18.3分),大于临床重要差异18分。然而,我们的meta分析具有很高的异质性(Cochran’s Q p值2 = 94.7%)。结论:VR可降低DHI评分,达到18分的临床显著差异,表明临床改善。然而,相当大的异质性限制了这些结果的普遍性,并强调需要进一步标准化的随机对照试验和亚组分析,以更好地确定VR治疗VM的具体益处和最佳方案。
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引用次数: 0
Chinook winds and migraine attack onset in children and adolescents: A prospective longitudinal clinical cohort study. 奇努克风与儿童和青少年偏头痛发作:一项前瞻性纵向临床队列研究。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-05 DOI: 10.1111/head.15093
Rylan Heart Villaruz, Jonathan Kuziek, Kirsten Sjonnesen, Lindsay Craddock, Werner J Becker, Ashley D Harris, Serena L Orr
<p><strong>Objective: </strong>To explore the relationship between migraine attack onset in children and adolescents and Chinooks, which are dry and warm westerly winds that generally occur in the winter and bring about abrupt weather changes to the east of the Rocky Mountains in Southern Alberta, Canada.</p><p><strong>Methods: </strong>This was a prospective longitudinal clinical cohort study with recruitment from November 2020 to May 2024. Participants were: 8-18 years old, had migraine as per International Classification of Headache Disorders 3rd edition criteria, had 1-15 headache days/month, lived in the geographical location where Chinook winds occur, and had exposure to at least one pre-Chinook or Chinook day during the study period. Chinook days were defined using Nkemdirim's criteria and Environment Canada data were used to categorize day type as either Chinook, pre-Chinook, or non-Chinook. Weather data were merged with data from daily headache diaries, completed for periods of 8-30 days. The primary outcome was attack onset, defined as a day with a new migraine attack of moderate or severe severity, as per the 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). Both univariate and adjusted models were used to determine if there was an association between migraine attack onset and day type (i.e., pre-Chinook, Chinook, or non-Chinook) at the aggregate study sample level. The adjusted models controlled for age and sex, and both models included a random intercept. Subsequently, individual n = 1 models were fitted to explore each individual participant's personal odds of migraine attack onset on both pre-Chinook and Chinook days versus non-Chinook days. Pre-Chinook/Chinook sensitivity values were calculated for each individual by dividing the model's regression coefficient by its standard error. Sensitivity values >1.96 suggest a significant association between pre-Chinook/Chinook days and attack onset.</p><p><strong>Results: </strong>Sixty youth with 1253 days of complete data, of which 144 (12%) were attack onset days, participated in the study. There were 158 Chinook (13%), 124 pre-Chinook (10%), and 971 non-Chinook days (77%). There were 39 female participants (39 of 60; 65%), with a median age of 14 years (quartile [Q] 1 = 12, Q3 = 16), and a median headache frequency of 6.2 days/month (Q1 = 4, Q3 = 11). Neither the univariate nor the adjusted models found any significant association between day type and attack onset at an aggregate level (pre-Chinook adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.54-1.78, p = 0.947; Chinook adjusted OR, 1.15; 95% CI, 0.69-1.91, p = 0.596). No individual participants met the threshold for statistically significant pre-Chinook or Chinook sensitivity.</p><p><strong>Conclusion: </strong>We did not find a relationship between pre-Chinook and Chinook conditions and migraine attack onset. This may be due to the lack of an association between Chinooks and attack onset in youth wi
目的:探讨儿童和青少年偏头痛发作与奇努克风的关系。奇努克风是一种干燥温暖的西风,通常发生在冬季,导致加拿大阿尔伯塔南部落基山脉以东的天气突变。方法:这是一项前瞻性纵向临床队列研究,招募时间为2020年11月至2024年5月。参与者年龄为8-18岁,根据国际头痛疾病分类第三版标准患有偏头痛,每月头痛天数为1-15天,居住在奇努克风发生的地理位置,并且在研究期间至少接触过一次奇努克风前或奇努克风日。使用Nkemdirim的标准和加拿大环境部的数据来定义奇努克日,将日类型分为奇努克日、前奇努克日和非奇努克日。天气数据与每日头痛日记的数据合并,完成时间为8-30天。主要结局是偏头痛发作,定义为一天中出现中度或重度偏头痛的新发作,按照4分制(0 =无,1 =轻度,2 =中度,3 =重度)。在总体研究样本水平上,单变量模型和调整模型都被用来确定偏头痛发作与日类型(即,前切努克、切努克或非切努克)之间是否存在关联。调整后的模型控制了年龄和性别,两个模型都包含一个随机截距。随后,对个体n = 1模型进行拟合,以探索每个个体参与者在奇努干前和奇努干日与非奇努干日偏头痛发作的个人几率。通过将模型的回归系数除以其标准误差,计算出每个个体的Chinook/Chinook敏感性值。敏感度值>1.96表明在支奴干前/支奴干日与攻击发作之间存在显著关联。结果:60名青少年参与研究,数据完整1253天,其中144天(12%)为发病天数。共有158天(13%)、124天(10%)和971天(77%)非奇努克天。共有39名女性参与者(60人中有39人,占65%),中位年龄为14岁(四分位数[Q] 1 = 12, Q3 = 16),中位头痛频率为6.2天/月(Q1 = 4, Q3 = 11)。单变量和调整后的模型均未发现日类型和发作发作在总体水平上有任何显著关联(Chinook调整前的优势比[OR]为0.98;95%可信区间[CI]为0.54-1.78,p = 0.947; Chinook调整后的OR为1.15;95% CI为0.69-1.91,p = 0.596)。没有个体参与者达到统计上显著的前切努克或切努克敏感性的阈值。结论:我们没有发现支奴干前和支奴干条件与偏头痛发作之间的关系。这可能是由于Chinooks与青年偏头痛发作之间缺乏关联,或者由于我们的研究缺乏统计能力。未来具有更大统计能力的研究应该旨在评估支努干和发作之间的潜在关系,因为它可能具有重要的治疗意义。
{"title":"Chinook winds and migraine attack onset in children and adolescents: A prospective longitudinal clinical cohort study.","authors":"Rylan Heart Villaruz, Jonathan Kuziek, Kirsten Sjonnesen, Lindsay Craddock, Werner J Becker, Ashley D Harris, Serena L Orr","doi":"10.1111/head.15093","DOIUrl":"10.1111/head.15093","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To explore the relationship between migraine attack onset in children and adolescents and Chinooks, which are dry and warm westerly winds that generally occur in the winter and bring about abrupt weather changes to the east of the Rocky Mountains in Southern Alberta, Canada.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This was a prospective longitudinal clinical cohort study with recruitment from November 2020 to May 2024. Participants were: 8-18 years old, had migraine as per International Classification of Headache Disorders 3rd edition criteria, had 1-15 headache days/month, lived in the geographical location where Chinook winds occur, and had exposure to at least one pre-Chinook or Chinook day during the study period. Chinook days were defined using Nkemdirim's criteria and Environment Canada data were used to categorize day type as either Chinook, pre-Chinook, or non-Chinook. Weather data were merged with data from daily headache diaries, completed for periods of 8-30 days. The primary outcome was attack onset, defined as a day with a new migraine attack of moderate or severe severity, as per the 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). Both univariate and adjusted models were used to determine if there was an association between migraine attack onset and day type (i.e., pre-Chinook, Chinook, or non-Chinook) at the aggregate study sample level. The adjusted models controlled for age and sex, and both models included a random intercept. Subsequently, individual n = 1 models were fitted to explore each individual participant's personal odds of migraine attack onset on both pre-Chinook and Chinook days versus non-Chinook days. Pre-Chinook/Chinook sensitivity values were calculated for each individual by dividing the model's regression coefficient by its standard error. Sensitivity values &gt;1.96 suggest a significant association between pre-Chinook/Chinook days and attack onset.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Sixty youth with 1253 days of complete data, of which 144 (12%) were attack onset days, participated in the study. There were 158 Chinook (13%), 124 pre-Chinook (10%), and 971 non-Chinook days (77%). There were 39 female participants (39 of 60; 65%), with a median age of 14 years (quartile [Q] 1 = 12, Q3 = 16), and a median headache frequency of 6.2 days/month (Q1 = 4, Q3 = 11). Neither the univariate nor the adjusted models found any significant association between day type and attack onset at an aggregate level (pre-Chinook adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.54-1.78, p = 0.947; Chinook adjusted OR, 1.15; 95% CI, 0.69-1.91, p = 0.596). No individual participants met the threshold for statistically significant pre-Chinook or Chinook sensitivity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;We did not find a relationship between pre-Chinook and Chinook conditions and migraine attack onset. This may be due to the lack of an association between Chinooks and attack onset in youth wi","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"96-107"},"PeriodicalIF":4.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12849522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145444582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rising together: Building the next generation of reviewers in headache medicine. 共同崛起:打造头痛医学的下一代审稿人。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-15 DOI: 10.1111/head.70022
Nan Cheng, Risako Shirane, Patricia A Olson
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引用次数: 0
A unifying disease model of idiopathic intracranial hypertension: A narrative review. 特发性颅内高压的统一疾病模型:叙述性回顾。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-31 DOI: 10.1111/head.70030
Derrek Schartz, Alan Finkelstein, Matthew T Bender

Objective: The aim of this study was to synthesize a unifying disease model for idiopathic intracranial hypertension (IIH) based on the current literature.

Background: IIH is a complex neurological condition defined by abnormally elevated intracranial pressure in the absence of an identifiable etiology. Although various causal mechanisms are thought to contribute to the development of IIH pathophysiology, how they interrelate remains poorly understood.

Methods: Here, we synthesize emerging evidence indicating that cerebrospinal fluid (CSF) and interstitial fluid (ISF) dyshomeostasis drive IIH pathology and how alterations in neurofluid regulation are associated with transverse sinus stenosis, brain volume, and the cerebral glymphatic system.

Results: We propose a unified disease model where obesity-mediated metabolic dysfunction results in impaired glymphatic clearance with consequential accumulation of brain ISF with resultant increased brain volume. This subsequently results in extramural compression of the dural venous sinuses. Dural venous stenosis causes venous hypertension with further veno-glymphatic congestion and a positive feedback loop on impaired glymphatic drainage, which further perpetuates interstitial fluid stasis and increased brain volume with increased intracranial pressure.

Conclusions: The presented unifying disease model integrates various observations and suspected drivers of the condition into a cohesive framework of IIH pathogenesis that may be used for future investigations and clinical conceptualization.

目的:本研究的目的是在现有文献的基础上,综合一个统一的特发性颅内高压(IIH)疾病模型。背景:IIH是一种复杂的神经系统疾病,在没有明确病因的情况下,由颅内压异常升高定义。尽管各种因果机制被认为有助于IIH病理生理学的发展,但它们之间的相互关系仍然知之甚少。方法:在这里,我们综合了新出现的证据,表明脑脊液(CSF)和间质液(ISF)失衡驱动IIH病理,以及神经液调节的改变如何与横窦狭窄、脑容量和脑淋巴系统相关。结果:我们提出了一个统一的疾病模型,肥胖介导的代谢功能障碍导致淋巴清除受损,随之而来的脑ISF积累导致脑容量增加。这随后导致硬脑膜外静脉窦受压。硬脑膜静脉狭窄引起静脉高压,并伴有进一步的静脉-淋巴充血和淋巴引流受损的正反馈循环,这进一步使间质液停滞和脑容量随着颅内压的增加而增加。结论:提出的统一疾病模型将各种观察结果和可能的病症驱动因素整合到IIH发病机制的内聚框架中,可用于未来的研究和临床概念化。
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引用次数: 0
Comparing single- and repeat-dose psilocybin with active placebo for migraine prevention in an exploratory randomized controlled clinical trial. 在一项探索性随机对照临床试验中比较单剂量和重复剂量裸盖菇素与有效安慰剂对偏头痛的预防作用。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-29 DOI: 10.1111/head.70024
Emmanuelle A D Schindler, Christopher H Gottschalk, Brian P Pittman, Deepak C D'Souza
<p><strong>Objective: </strong>The goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent.</p><p><strong>Background: </strong>The administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot trial in migraine, although the ability of a pulse dose regimen, as practiced by patients with cluster headache, to potentially improve magnitude and/or duration of transitional preventive effects has not been studied. Furthermore, comparison to an active placebo agent that adequately mimics the acute subjective effects of psilocybin is required to improve blinding integrity and measure placebo effects.</p><p><strong>Methods: </strong>In an exploratory randomized, double-blind, placebo-controlled, parallel group study, adults with migraine having at least two weekly migraine days at baseline (n = 18) participated in two drug administration sessions separated by 7 days during which they received zero, one, or two doses of psilocybin (10 mg; psi). Whenever participants did not receive psilocybin, they received diphenhydramine (25 mg; diph). Participant recruitment took place between September 2021 and August 2023. The primary outcome measure was a change in migraine frequency using headache diary data collected starting 2 weeks before and continuing through 8 weeks after the second drug session.</p><p><strong>Results: </strong>In the 2 weeks after completion of the two drug administration sessions, the change from baseline in migraine days/week was not significantly different among groups [diph-diph: -0.7 (95% confidence interval, -1.5 to 0.2); diph-psi: -2.0 (-3.0 to -1.0); psi-psi: -1.7 (-4.1 to 0.7); Χ<sup>2</sup> <sub>(2)</sub> = 4.56, p = 0.102], despite large effect sizes against the placebo group in the those receiving one (diph-psi; d = 1.66) or two (psi-psi; d = 0.69) doses of psilocybin. Similar reductions in migraine frequency approximating 50% were seen in all groups over the 8 weeks measured. The difference in 50% response rate among groups over 2 weeks, however, approached significance (diph-diph: 17%; diph-psi: 80%; psi-psi: 80%; p = 0.087). Drug confidence ratings (i.e., blinding integrity) suggested that diphenhydramine partially substituted for the acute effects of psilocybin. No correlations were observed between changes in migraine frequency after psilocybin and drug confidence, acute general drug effects, or acute psychedelic effects. No serious or unexpected adverse events occurred.</p><p><strong>Conclusion: </strong>This exploratory study found similar reductions in migraine frequency with single-dose psilocybin, a two-dose pulse of psilocybin, or diphenhydramine placebo. Whereas blinding was incomplete in this study, this important topic is highlighted in the study design and findings. The potential for psilocybin to serve as a tra
目的:本研究的目的是检查裸盖菇素作为一种脉冲治疗方案用于预防偏头痛的治疗效果和安全性,并考虑一种活性对照剂的致盲完整性。背景:在一项针对偏头痛的小型试点试验中,单次低剂量裸盖菇素被观察到具有持久的治疗效果,尽管尚未研究集束性头痛患者采用脉冲剂量方案的能力,以潜在地改善过渡性预防效果的程度和/或持续时间。此外,需要与一种充分模仿裸盖菇素急性主观效应的活性安慰剂剂进行比较,以提高盲法的完整性并测量安慰剂效应。方法:在一项探索性随机、双盲、安慰剂对照、平行组研究中,在基线时每周至少有两天偏头痛的成年人(n = 18)参加了两个间隔7天的给药疗程,在此期间,他们接受0、1或2剂量的裸盖菇素(10mg; psi)。当参与者没有接受裸盖菇素时,他们接受苯海拉明(25mg; diph)。参与者招募在2021年9月至2023年8月期间进行。主要结果测量是偏头痛频率的变化,使用从第二次服药前2周开始到第二次服药后8周持续收集的头痛日记数据。结果:在两次给药疗程结束后的2周内,组间偏头痛天数/周的基线变化无显著差异[diph-diph: -0.7(95%可信区间,-1.5至0.2);Diph-psi: -2.0(-3.0至-1.0);Psi-psi: -1.7(-4.1至0.7);Χ2 (2) = 4.56, p = 0.102],尽管与安慰剂组相比,接受一剂(dip -psi; d = 1.66)或两剂(psi-psi; d = 0.69)裸盖菇素的组有很大的效应。在8周的测量中,所有组的偏头痛频率都减少了大约50%。2周后,两组间50%有效率的差异接近显著性(diph-diph: 17%; diph-psi: 80%; psi-psi: 80%; p = 0.087)。药物置信度评级(即盲性完整性)表明苯海拉明部分取代了裸盖菇素的急性作用。未观察到裸盖菇素后偏头痛频率的变化与药物信心、急性一般药物效应或急性迷幻效应之间的相关性。未发生严重或意外的不良事件。结论:这项探索性研究发现,单剂量裸盖菇素、双剂量裸盖菇素或苯海拉明安慰剂对偏头痛频率的降低相似。虽然本研究的盲法是不完整的,但这一重要主题在研究设计和研究结果中得到了强调。裸盖菇素作为偏头痛过渡性治疗的潜力仍然存在,但需要在未来的研究中仔细规划,以区分药物和非药物作用。此外,在这些未来研究的设计和执行中纳入头痛专家是必要的,以保持裸盖菇素在头痛药物治疗中的可行性。
{"title":"Comparing single- and repeat-dose psilocybin with active placebo for migraine prevention in an exploratory randomized controlled clinical trial.","authors":"Emmanuelle A D Schindler, Christopher H Gottschalk, Brian P Pittman, Deepak C D'Souza","doi":"10.1111/head.70024","DOIUrl":"https://doi.org/10.1111/head.70024","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot trial in migraine, although the ability of a pulse dose regimen, as practiced by patients with cluster headache, to potentially improve magnitude and/or duration of transitional preventive effects has not been studied. Furthermore, comparison to an active placebo agent that adequately mimics the acute subjective effects of psilocybin is required to improve blinding integrity and measure placebo effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In an exploratory randomized, double-blind, placebo-controlled, parallel group study, adults with migraine having at least two weekly migraine days at baseline (n = 18) participated in two drug administration sessions separated by 7 days during which they received zero, one, or two doses of psilocybin (10 mg; psi). Whenever participants did not receive psilocybin, they received diphenhydramine (25 mg; diph). Participant recruitment took place between September 2021 and August 2023. The primary outcome measure was a change in migraine frequency using headache diary data collected starting 2 weeks before and continuing through 8 weeks after the second drug session.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In the 2 weeks after completion of the two drug administration sessions, the change from baseline in migraine days/week was not significantly different among groups [diph-diph: -0.7 (95% confidence interval, -1.5 to 0.2); diph-psi: -2.0 (-3.0 to -1.0); psi-psi: -1.7 (-4.1 to 0.7); Χ&lt;sup&gt;2&lt;/sup&gt; &lt;sub&gt;(2)&lt;/sub&gt; = 4.56, p = 0.102], despite large effect sizes against the placebo group in the those receiving one (diph-psi; d = 1.66) or two (psi-psi; d = 0.69) doses of psilocybin. Similar reductions in migraine frequency approximating 50% were seen in all groups over the 8 weeks measured. The difference in 50% response rate among groups over 2 weeks, however, approached significance (diph-diph: 17%; diph-psi: 80%; psi-psi: 80%; p = 0.087). Drug confidence ratings (i.e., blinding integrity) suggested that diphenhydramine partially substituted for the acute effects of psilocybin. No correlations were observed between changes in migraine frequency after psilocybin and drug confidence, acute general drug effects, or acute psychedelic effects. No serious or unexpected adverse events occurred.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;This exploratory study found similar reductions in migraine frequency with single-dose psilocybin, a two-dose pulse of psilocybin, or diphenhydramine placebo. Whereas blinding was incomplete in this study, this important topic is highlighted in the study design and findings. The potential for psilocybin to serve as a tra","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145849855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Migraine prevalence and phenotype in autism: A retrospective cohort study using a US National Health Survey and large academic health system electronic health record. 自闭症患者偏头痛患病率和表型:一项使用美国国家健康调查和大型学术卫生系统电子健康记录的回顾性队列研究。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-29 DOI: 10.1111/head.70035
Maria Pia Grant Tejada, Alexandra M Klomhaus, Rebecca Ortiz, Tristan D Tibbe, Sinifunanya E Nwaobi

Objective: We analyzed data from both a national survey and a single hospital system to determine the prevalence of migraine in individuals with autism as well as identify sociodemographic and clinical characteristics associated with migraine in individuals with autism.

Background: Few studies have examined the prevalence of migraine in autism and there are no studies examining the migraine phenotype and clinical features associated with migraine in autism.

Methods: This retrospective cohort study used two databases-the National Survey of Children's Health (NSCH) and the University of California Los Angeles hospital system electronic health record (UCLA EHR). NSCH survey data from 2018, 2019, 2020, and 2021 (data collection period for each year is June to January; e.g., NSCH 2021 period is June 2021 to January 2022; N = 50,892) were queried to identify cohorts based on responses to two survey questions identifying the presence of frequent/severe headache and autism. For UCLA cohorts, patients (12/01/1979-4/16/2023, N = 4,334,162) were queried for migraine and autism based on the International Classification of Diseases diagnosis codes. We tested the hypothesis: Headache/migraine occurs more frequently in individuals with autism versus without autism. Variables including social determinants of health (SDoH) and co-occurring illnesses were compared between autism with versus without headache/migraine.

Results: Headache and migraine prevalence was higher in individuals with autism versus those without (2021 NSCH-headache % [95% confidence interval {CI}], 7.1% [4.62-9.56] vs. 3.0% [2.62-3.19], p < 0.001 and UCLA-migraine: 3.1% [2.86-3.43] vs. 2.0% [1.97-1.99], p < 0.001). Among those with autism, the presence of headache/migraine was associated with increased odds of adverse childhood experiences such as bullying (NSCH-'Weekly/Almost daily' bullying aOR = 5.93 [2.01-17.50], p = 0.001, 'Never' reference) and being a victim of violence (NSCH-'Yes' aOR = 2.82, [1.19-6.66], p = 0.018), poor general health (NSCH-'Fair/Poor' health aOR = 9.68, [3.01-31.19], p < 0.001, 'Excellent' reference), mood disturbances, including anxiety (NSCH-'Yes' aOR = 4.50, [1.63-12.41], p = 0.004; UCLA aOR = 3.40, [2.78-4.17], p < 0.001), and depression (NSCH-'Yes' aOR = 5.70, [2.50-12.97], p < 0.001; UCLA aOR = 3.76, [3.08-4.60], p < 0.001), as well as increased rates of concussion (NSCH-'Yes' aOR = 9.05, [3.19-25.66], p < 0.001; UCLA aOR = 10.28, [6.91-15.30], p < 0.001).

Conclusions: Headache/migraine occurs at higher rates in individuals with autism and is associated with increased odds of negative SDoH and clinically relevant co-occurring illnesses. This study highlights the importance of migraine screening in individuals with autism. Future work is needed to understand the burden and impact of migraine in autism.

目的:我们分析了来自全国调查和单一医院系统的数据,以确定自闭症患者偏头痛的患病率,并确定与自闭症患者偏头痛相关的社会人口学和临床特征。背景:很少有研究调查自闭症患者偏头痛的患病率,也没有研究调查自闭症患者偏头痛的表型和临床特征。方法:本回顾性队列研究使用了两个数据库——全国儿童健康调查(NSCH)和加州大学洛杉矶分校医院系统电子健康记录(UCLA EHR)。查询2018年、2019年、2020年和2021年的NSCH调查数据(每年的数据收集期为6月至1月;例如,NSCH 2021年的数据收集期为2021年6月至2022年1月;N = 50,892),根据对两个调查问题的回答确定频繁/严重头痛和自闭症的存在,以确定队列。在UCLA队列中,根据国际疾病分类诊断代码查询偏头痛和自闭症患者(1979年1月12日- 2023年4月16日,N = 4,334,162)。我们测试了这个假设:自闭症患者比非自闭症患者更容易出现头痛/偏头痛。包括健康的社会决定因素(SDoH)和并发疾病在内的变量在患有和不患有头痛/偏头痛的自闭症之间进行了比较。结果:自闭症患者的头痛和偏头痛患病率高于非自闭症患者(2021 nsch -头痛%[95%可信区间{CI}], 7.1%[4.62-9.56]对3.0% [2.62-3.19],p结论:自闭症患者的头痛/偏头痛发生率更高,且与SDoH阴性和临床相关共发疾病的几率增加有关。这项研究强调了自闭症患者偏头痛筛查的重要性。未来的工作需要了解偏头痛对自闭症的负担和影响。
{"title":"Migraine prevalence and phenotype in autism: A retrospective cohort study using a US National Health Survey and large academic health system electronic health record.","authors":"Maria Pia Grant Tejada, Alexandra M Klomhaus, Rebecca Ortiz, Tristan D Tibbe, Sinifunanya E Nwaobi","doi":"10.1111/head.70035","DOIUrl":"https://doi.org/10.1111/head.70035","url":null,"abstract":"<p><strong>Objective: </strong>We analyzed data from both a national survey and a single hospital system to determine the prevalence of migraine in individuals with autism as well as identify sociodemographic and clinical characteristics associated with migraine in individuals with autism.</p><p><strong>Background: </strong>Few studies have examined the prevalence of migraine in autism and there are no studies examining the migraine phenotype and clinical features associated with migraine in autism.</p><p><strong>Methods: </strong>This retrospective cohort study used two databases-the National Survey of Children's Health (NSCH) and the University of California Los Angeles hospital system electronic health record (UCLA EHR). NSCH survey data from 2018, 2019, 2020, and 2021 (data collection period for each year is June to January; e.g., NSCH 2021 period is June 2021 to January 2022; N = 50,892) were queried to identify cohorts based on responses to two survey questions identifying the presence of frequent/severe headache and autism. For UCLA cohorts, patients (12/01/1979-4/16/2023, N = 4,334,162) were queried for migraine and autism based on the International Classification of Diseases diagnosis codes. We tested the hypothesis: Headache/migraine occurs more frequently in individuals with autism versus without autism. Variables including social determinants of health (SDoH) and co-occurring illnesses were compared between autism with versus without headache/migraine.</p><p><strong>Results: </strong>Headache and migraine prevalence was higher in individuals with autism versus those without (2021 NSCH-headache % [95% confidence interval {CI}], 7.1% [4.62-9.56] vs. 3.0% [2.62-3.19], p < 0.001 and UCLA-migraine: 3.1% [2.86-3.43] vs. 2.0% [1.97-1.99], p < 0.001). Among those with autism, the presence of headache/migraine was associated with increased odds of adverse childhood experiences such as bullying (NSCH-'Weekly/Almost daily' bullying aOR = 5.93 [2.01-17.50], p = 0.001, 'Never' reference) and being a victim of violence (NSCH-'Yes' aOR = 2.82, [1.19-6.66], p = 0.018), poor general health (NSCH-'Fair/Poor' health aOR = 9.68, [3.01-31.19], p < 0.001, 'Excellent' reference), mood disturbances, including anxiety (NSCH-'Yes' aOR = 4.50, [1.63-12.41], p = 0.004; UCLA aOR = 3.40, [2.78-4.17], p < 0.001), and depression (NSCH-'Yes' aOR = 5.70, [2.50-12.97], p < 0.001; UCLA aOR = 3.76, [3.08-4.60], p < 0.001), as well as increased rates of concussion (NSCH-'Yes' aOR = 9.05, [3.19-25.66], p < 0.001; UCLA aOR = 10.28, [6.91-15.30], p < 0.001).</p><p><strong>Conclusions: </strong>Headache/migraine occurs at higher rates in individuals with autism and is associated with increased odds of negative SDoH and clinically relevant co-occurring illnesses. This study highlights the importance of migraine screening in individuals with autism. Future work is needed to understand the burden and impact of migraine in autism.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145849890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
OnabotulinumtoxinA treatment among diverse racial groups: Post hoc analysis of the phase 4 Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trial. 单肉毒杆菌毒素在不同种族人群中的治疗:慢性偏头痛4期单肉毒杆菌毒素延长疗效开放标签(强迫)试验的事后分析
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-15 DOI: 10.1111/head.70007
Andrew M Blumenfeld, Larry Charleston, Deena Kuruvilla, Belinda Savage-Edwards, Richard B Lipton, Ritu Singh, Patricia Jacob, Nicole A Lawrence, Cuiwei Wang, Hope L O'Brien
<p><strong>Objective: </strong>Examine treatment responses to and safety of onabotulinumtoxinA for the preventive treatment of chronic migraine (CM) among diverse racial groups.</p><p><strong>Background: </strong>Evidence suggests there are differences in headache treatment patterns, symptom profiles, and burden based on race. However, limited data are available describing the response to preventive migraine treatments among these groups.</p><p><strong>Methods: </strong>The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) trial was a single-arm, open-label, multicenter, prospective study (January 23, 2012-November 16, 2015) that enrolled adults of various races with CM to receive onabotulinumtoxinA 155 U every 12 weeks over 108 weeks. These analyses assessed White, Asian (primarily Republic of Korea residents), and Black/African American subgroups based on self-report. Pacific Islander/American Indian/Alaska Native and Hispanic/Latinx subgroups were not analyzed separately because of the small sample sizes and potential overlap with predefined racial categories (e.g., Hispanic/Latinx White) for the latter. Analyses of baseline demographics and clinical characteristics, including headache features, across the subgroups were performed. Change from baseline in the number of monthly headache days (MHDs), including proportions with ≥50% reduction in MHDs, and change from baseline scores on the 6-item Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS) absenteeism, presenteeism, and total scores, and Migraine-Specific Quality of Life questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive (RFR), Emotional Function (EF), and Role Function-Preventive (RFP) domains were evaluated for each subgroup.</p><p><strong>Results: </strong>Of 716 enrolled participants, 582 (81.3%) were White, 89 (12.4%) were Asian, 41 (5.7%) were Black/African American, and 4 (0.6%) were Pacific Islander/American Indian/Alaska Native. Withdrawal from the study occurred for 50.5% of the White subgroup, 32.6% of the Asian subgroup, and 48.8% of the Black/African American subgroup. The most common reasons for study discontinuation were participant withdrawal of granted consent (12.8%) and lost to follow-up (11.5%). After treatment with onabotulinumtoxinA 155 U every 12 weeks, all subgroups demonstrated significant reductions from baseline in MHDs at all time points to week 108 (all p < 0.001) and 60.3%-73.3% experienced ≥50% reduction from baseline in MHDs at week 108. Each analyzed subgroup demonstrated significant reductions from baseline to week 108 in HIT-6 total (all p < 0.001), MIDAS total (White, p < 0.001; Asian, p < 0.001; Black/African American, p = 0.0062), MIDAS absenteeism (White, p < 0.001; Asian, p < 0.001; Black/African American, p = 0.002), MIDAS presenteeism (all p < 0.001), MSQ v2.1 RFR (all p < 0.001), MSQ v2.1 EF (White, p < 0.001; Asian, p < 0.001; Black/African American, p = 0.009), and MSQ v2.1 RFP (all p < 0.00
目的:探讨不同种族人群对肉毒杆菌毒素预防治疗慢性偏头痛(CM)的疗效和安全性。背景:有证据表明,头痛的治疗模式、症状特征和负担因种族而异。然而,这些群体对预防性偏头痛治疗的反应的可用数据有限。方法:慢性偏头痛OnabotulinuMtoxinA延长疗效开放标签(open Label,强迫性)试验是一项单组、开放标签、多中心、前瞻性研究(2012年1月23日- 2015年11月16日),招募了不同种族的CM成人患者,每12周接受OnabotulinuMtoxinA 155u治疗,持续108周。这些分析基于自我报告评估了白人、亚洲人(主要是韩国居民)和黑人/非裔美国人亚群。太平洋岛民/美洲印第安人/阿拉斯加原住民和西班牙裔/拉丁裔亚组没有单独分析,因为样本量小,并且后者可能与预定义的种族类别(例如西班牙裔/拉丁裔白人)重叠。对亚组的基线人口统计学和临床特征(包括头痛特征)进行分析。评估每个亚组每月头痛天数(mhd)的基线变化,包括mhd减少≥50%的比例,以及6项头痛影响测试(hit6)、偏头痛残疾评估(MIDAS)缺勤、出勤和总分、偏头痛特异性生活质量问卷2.1版(MSQ v2.1)角色功能-限制性(RFR)、情绪功能(EF)和角色功能-预防性(RFP)域的基线变化。结果:在716名入组参与者中,白人582人(81.3%),亚洲人89人(12.4%),黑人/非裔美国人41人(5.7%),太平洋岛民/美洲印第安人/阿拉斯加原住民4人(0.6%)。50.5%的白人亚组、32.6%的亚洲亚组和48.8%的黑人/非裔美国人亚组退出研究。终止研究最常见的原因是受试者撤回同意(12.8%)和失去随访(11.5%)。在每12周接受onabotulinumtoxinA 155u治疗后,所有亚组在截至第108周的所有时间点均显示MHD从基线显著降低(所有p)。结论:onabotulinumtoxinA在不同亚组中安全降低了MHD频率和患者报告的残疾,并改善了生活质量,作为CM的预防性治疗,各亚组的结果方向一致。试验注册:强迫,ClinicalTrials.gov标识符:NCT01516892。
{"title":"OnabotulinumtoxinA treatment among diverse racial groups: Post hoc analysis of the phase 4 Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trial.","authors":"Andrew M Blumenfeld, Larry Charleston, Deena Kuruvilla, Belinda Savage-Edwards, Richard B Lipton, Ritu Singh, Patricia Jacob, Nicole A Lawrence, Cuiwei Wang, Hope L O'Brien","doi":"10.1111/head.70007","DOIUrl":"https://doi.org/10.1111/head.70007","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;Examine treatment responses to and safety of onabotulinumtoxinA for the preventive treatment of chronic migraine (CM) among diverse racial groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Evidence suggests there are differences in headache treatment patterns, symptom profiles, and burden based on race. However, limited data are available describing the response to preventive migraine treatments among these groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) trial was a single-arm, open-label, multicenter, prospective study (January 23, 2012-November 16, 2015) that enrolled adults of various races with CM to receive onabotulinumtoxinA 155 U every 12 weeks over 108 weeks. These analyses assessed White, Asian (primarily Republic of Korea residents), and Black/African American subgroups based on self-report. Pacific Islander/American Indian/Alaska Native and Hispanic/Latinx subgroups were not analyzed separately because of the small sample sizes and potential overlap with predefined racial categories (e.g., Hispanic/Latinx White) for the latter. Analyses of baseline demographics and clinical characteristics, including headache features, across the subgroups were performed. Change from baseline in the number of monthly headache days (MHDs), including proportions with ≥50% reduction in MHDs, and change from baseline scores on the 6-item Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS) absenteeism, presenteeism, and total scores, and Migraine-Specific Quality of Life questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive (RFR), Emotional Function (EF), and Role Function-Preventive (RFP) domains were evaluated for each subgroup.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 716 enrolled participants, 582 (81.3%) were White, 89 (12.4%) were Asian, 41 (5.7%) were Black/African American, and 4 (0.6%) were Pacific Islander/American Indian/Alaska Native. Withdrawal from the study occurred for 50.5% of the White subgroup, 32.6% of the Asian subgroup, and 48.8% of the Black/African American subgroup. The most common reasons for study discontinuation were participant withdrawal of granted consent (12.8%) and lost to follow-up (11.5%). After treatment with onabotulinumtoxinA 155 U every 12 weeks, all subgroups demonstrated significant reductions from baseline in MHDs at all time points to week 108 (all p &lt; 0.001) and 60.3%-73.3% experienced ≥50% reduction from baseline in MHDs at week 108. Each analyzed subgroup demonstrated significant reductions from baseline to week 108 in HIT-6 total (all p &lt; 0.001), MIDAS total (White, p &lt; 0.001; Asian, p &lt; 0.001; Black/African American, p = 0.0062), MIDAS absenteeism (White, p &lt; 0.001; Asian, p &lt; 0.001; Black/African American, p = 0.002), MIDAS presenteeism (all p &lt; 0.001), MSQ v2.1 RFR (all p &lt; 0.001), MSQ v2.1 EF (White, p &lt; 0.001; Asian, p &lt; 0.001; Black/African American, p = 0.009), and MSQ v2.1 RFP (all p &lt; 0.00","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145756266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Plain Language Summary Publication: Efficacy and safety of rimegepant for the preventive treatment of migraine in Japan: A double-blind, randomized controlled trial. 发表:利美格坦在日本预防偏头痛的有效性和安全性:一项双盲、随机对照试验。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-11-17 DOI: 10.1111/head.15095
Shigekazu Kitamura, Yasuhiko Matsumori, Toshimasa Yamamoto, Tomofumi Ishikawa, Yuko Hoshino, Hiroki Yoshimatsu, Alexandra Thiry, Akio Arakawa, Robert Croop, Terence Fullerton, Fumihiko Sakai, Takao Takeshima
{"title":"Plain Language Summary Publication: Efficacy and safety of rimegepant for the preventive treatment of migraine in Japan: A double-blind, randomized controlled trial.","authors":"Shigekazu Kitamura, Yasuhiko Matsumori, Toshimasa Yamamoto, Tomofumi Ishikawa, Yuko Hoshino, Hiroki Yoshimatsu, Alexandra Thiry, Akio Arakawa, Robert Croop, Terence Fullerton, Fumihiko Sakai, Takao Takeshima","doi":"10.1111/head.15095","DOIUrl":"https://doi.org/10.1111/head.15095","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145540474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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