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A critical appraisal of the International Classification of Headache Disorders migraine diagnostic criteria based on a retrospective multicenter cross-sectional headache registry study in youth. 基于青少年头痛多中心横断面回顾性登记研究,对国际头痛疾病分类偏头痛诊断标准进行批判性评估。
IF 8.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-27 DOI: 10.1111/head.14858
Carlyn Patterson Gentile, Andrew D Hershey, Christina L Szperka

Objectives: We used Cluster Analysis of Migraine-associated Symptoms (CAMS) to critically evaluate current International Classification of Headache Disorders-Third Edition (ICHD-3) migraine-associated symptoms criteria.

Background: Diagnostic criteria play a central role in guiding clinical trial inclusion, and therefore available treatments. Migraine and tension-type headaches (TTH) are differentiated in ICHD-3 by many headache characteristics, including associated symptoms. A diagnosis of probable migraine indicates some but not all features of migraine are met. Photophobia and phonophobia, or nausea and/or vomiting, are required to meet a diagnosis of migraine; however, CAMS-a model that describes associated symptoms across youth with headache-indicates that a broader range of symptoms contain information about migraine burden.

Methods: In this multisite retrospective cross-sectional study, we evaluated ICHD-3 migraine criteria. Youth aged 6-17 years with migraine (including probable migraine) or TTH were included in the analysis. We used CAMS to evaluate the migraine-associated symptom criterion. With CAMS as a guide, we evaluated how changes to the migraine-associated symptom criterion altered who met the diagnosis of migraine.

Results: Of the 9017 participants included in this study, 66.7% were female and had a median (interquartile range) age of 13 (10-15) years. Most participants had migraine or probable migraine (99.0%), and the remainder had TTH (1.0%). A sizable percentage (10.1%) of youth under the umbrella diagnosis of migraine were diagnosed with probable migraine because they did not meet migraine-associated symptom criterion D; however, many in this group reported several non-ICHD migraine-associated symptoms. We explored alterations to criterion D based on CAMS. Allowing for photophobia or phonophobia re-categorized 55.6% of youth as having migraine, though some only had one symptom. Including lightheadedness or lightheadedness and spinning re-categorized 19.7% and 25.8% of youth with migraine, respectively, but all of those who were re-categorized had at least two migraine-associated symptoms.

Conclusion: The ICHD-3 captures the most prevalent migraine-associated symptoms; however, many youths with probable migraine who do not meet full criteria due to insufficient associated symptoms nonetheless experience multiple non-ICHD migraine-associated symptoms. Changes to criterion D should be considered for the ICHD-4.

目的:我们使用偏头痛相关症状聚类分析(CAMS)对现行的《国际头痛疾病分类-第三版》(ICHD-3)偏头痛相关症状标准进行了严格评估:背景:诊断标准在指导临床试验的纳入方面发挥着核心作用,因此也是可用治疗方法的基础。在ICHD-3中,偏头痛和紧张型头痛(TTH)通过许多头痛特征(包括相关症状)进行区分。可能偏头痛的诊断表明符合偏头痛的某些特征,但并非所有特征。畏光、畏声或恶心和/或呕吐是诊断偏头痛的必要条件;然而,CAMS--一种描述青少年头痛相关症状的模型--表明更广泛的症状包含有关偏头痛负担的信息:在这项多地点回顾性横断面研究中,我们对 ICHD-3 偏头痛标准进行了评估。分析对象包括患有偏头痛(包括可能的偏头痛)或TTH的6-17岁青少年。我们使用CAMS评估偏头痛相关症状标准。以偏头痛相关症状标准为指导,我们评估了偏头痛相关症状标准的变化对偏头痛诊断结果的影响:在这项研究的 9017 名参与者中,66.7% 为女性,年龄中位数(四分位数间距)为 13(10-15)岁。大多数人患有偏头痛或可能患有偏头痛(99.0%),其余人患有 TTH(1.0%)。在被诊断为偏头痛的青少年中,有相当大的比例(10.1%)被诊断为可能患有偏头痛,因为他们不符合偏头痛相关症状标准D;然而,该群体中的许多人报告了几种非ICHD偏头痛相关症状。我们探讨了根据CAMS对标准D进行修改的问题。如果考虑到畏光或畏声,55.6%的青少年会被重新归类为偏头痛患者,尽管有些人只有一种症状。包括头晕或头晕和旋转在内,分别有19.7%和25.8%的青少年被重新归类为偏头痛患者,但所有被重新归类的患者都至少有两种偏头痛相关症状:结论:ICHD-3捕捉到了最普遍的偏头痛相关症状;然而,许多可能患有偏头痛的青少年因相关症状不足而不符合完整标准,但他们仍有多种非ICHD偏头痛相关症状。应考虑在ICHD-4中修改标准D。
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引用次数: 0
Cluster Analysis of Migraine-associated Symptoms (CAMS) in youth: A retrospective cross-sectional multicenter study. 青少年偏头痛相关症状(CAMS)聚类分析:一项回顾性横断面多中心研究。
IF 8.3 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-27 DOI: 10.1111/head.14859
Carlyn Patterson Gentile, Christina L Szperka, Andrew D Hershey

Objective: To conduct a retrospective cross-sectional multicenter study to validate the relationships between migraine-associated symptoms.

Background: Symptoms associated with headache-photophobia and phonophobia, nausea, and/or vomiting-are required criteria for migraine diagnosis based on the International Classification of Headache Disorders-Third Edition (ICHD-3). However, individuals with migraine report high rates of other symptoms (e.g., lightheadedness, difficulty thinking). We recently completed a single-center study assessing the relationships between an expanded set of migraine-associated symptoms.

Methods: A pre-registered cross-sectional multicenter retrospective analysis was conducted on standardized questionnaire data of youth ages 6-17 years from two headache registries at pediatric tertiary care centers. Cluster Analysis of Migraine-associated Symptoms (CAMS) was implemented to assess associations between 11 migraine-associated symptoms. We explored differences between the two centers, and how CAMS was associated with demographics, including sex and age, and headache burden.

Results: There were 10,721 participants who were 66.5% female and had a median (interquartile range) age of 13 (10-15) years. The first three CAMS dimensions accounted for 46.5% of the variance and were consistent across sites. The first dimension indicated those reporting any migraine-associated symptoms were likely to report multiple. The second dimension separated symptoms into those included in ICHD-3 migraine diagnostic criteria and non-ICHD symptoms (e.g., lightheadedness, difficulty thinking). The third dimension separated sensory hypersensitivity and vestibular symptoms. An abundance of migraine-associated symptoms correlated with greater headache severity (Spearman's ρ = 0.18, 95% confidence interval [CI] 0.17-0.20; small effect size) and disability (ρ = 0.26, 95% CI 0.25-0.28; small effect size). We also observed differences in associated symptoms across age and sex.

Discussion: Associations between an expanded set of migraine-associated symptoms are informative for headache burden and reveal intriguing changes across child development and sex. We were able to replicate findings across two centers, indicating that these symptom clusters are inherent to migraine.

目的: 对偏头痛相关症状之间的关系进行回顾性横断面多中心研究:开展一项回顾性横断面多中心研究,以验证偏头痛相关症状之间的关系:背景:根据《国际头痛疾病分类-第三版》(ICHD-3),与头痛相关的症状--畏光、畏声、恶心和/或呕吐--是诊断偏头痛的必要标准。然而,偏头痛患者报告其他症状(如头晕、思考困难)的比例也很高。我们最近完成了一项单中心研究,评估了偏头痛相关症状扩展集之间的关系:方法:我们对儿科三级医疗中心两个头痛登记处的 6-17 岁青少年标准化问卷数据进行了预先登记的横断面多中心回顾性分析。偏头痛相关症状聚类分析(CAMS)用于评估11种偏头痛相关症状之间的关联。我们探讨了两个中心之间的差异,以及 CAMS 与人口统计学(包括性别和年龄)和头痛负担之间的关联:共有 10,721 名参与者,其中 66.5% 为女性,年龄中位数(四分位数间距)为 13(10-15)岁。头三个 CAMS 维度占变异的 46.5%,并且在不同地点保持一致。第一个维度表明,那些报告了任何偏头痛相关症状的人很可能报告了多种偏头痛相关症状。第二个维度将症状分为ICHD-3偏头痛诊断标准中的症状和非ICHD症状(如头晕、思考困难)。第三个维度将感觉过敏症状和前庭症状分开。大量偏头痛相关症状与头痛严重程度(Spearman's ρ = 0.18,95% 置信区间[CI] 0.17-0.20;影响较小)和残疾程度(ρ = 0.26,95% 置信区间 0.25-0.28;影响较小)相关。我们还观察到不同年龄和性别的相关症状存在差异:讨论:与偏头痛相关的一系列症状之间的关联可为头痛负担提供信息,并揭示出儿童发育和性别之间的有趣变化。我们能够在两个中心重复研究结果,这表明这些症状群是偏头痛的固有症状。
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引用次数: 0
The effectiveness of parenteral agents to mitigate relapses after severe acute migraine headache presentations: A systematic review and network analysis. 减轻严重急性偏头痛复发的肠外药剂的有效性:系统综述与网络分析。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-04 DOI: 10.1111/head.14841
Scott Kirkland, Jillian Meyer, Lloyd Visser, Sandra Campbell, Cristina Villa-Roel, Benjamin W Friedman, Nana Owusu Essel, Brian H Rowe

Objectives: To compare the effectiveness of parenteral agents to reduce relapse in patients with acute migraine and identify factors that predict relapse.

Background: Following discharge from emergency settings, many patients with acute migraine will experience a relapse in pain; severe relapses may result in re-visits to emergency settings.

Methods: A comprehensive literature search, updated to 2023, was conducted to identify randomized controlled trials assessing the effectiveness of parenteral agents on relapse outcomes in patients with acute migraine discharged from emergency settings. Two independent reviewers completed study selection, quality assessment, and data extraction. A traditional meta-analysis compared parenteral corticosteroids to placebo; a frequentist network analysis assessed direct and indirect comparisons. Results are reported as risk ratios (RRs) and 95% confidence intervals (CIs). The review protocol was registered with the International Prospective Register of Systematic Reviews (identifier: CRD42018099493).

Results: From 8949 citations, a total of 53 unique studies were included involving 6167 patients. Most studies had a high or unclear risk of bias. Corticosteroids significantly reduced relapses compared to placebo (RR 0.67, 95% CI 0.52-0.88; I2 = 0%). Patients receiving lidocaine (RR 0.10, 95% CI 0.01-0.82), sedatives/hypnotics (RR 0.33, 95% CI 0.14-0.75), ergot agents (RR 0.44, 95% CI 0.25-0.75), neuroleptics (RR 0.47, 95% CI 0.31-0.71), opioids (RR 0.58; 95% CI 0.35-0.94), or corticosteroids (RR 0.64, 95% CI 0.47-0.86) were significantly less likely to relapse. Lidocaine (RR 0.09, 95% CI 0.01-0.71), combination therapy (RR 0.12, 95% CI 0.02-0.74), or adding corticosteroids (RR 0.61, 95% CI 0.44-0.84) were more likely to reduce severe relapses. Longer duration of headache and residual pain at discharge were significantly associated with higher relapses.

Discussion: Corticosteroids remain the recommended first-line option to reduce relapse outcomes. Some parenteral agents typically provided for pain relief including ergot agents, neuroleptics, or combination therapy may effectively reduce relapse; however, opioids are not recommended due to safety concerns. Additional research is needed for some lesser studied, albeit promising, agents including lidocaine and propofol. Effective pain control in emergency settings prior to discharge and duration of headache may play a role in the success of such treatments and further investigations could provide further insight regarding how and why some parenteral agents are effective in mitigating relapse events.

目的:比较减少急性偏头痛患者复发的肠外药物的有效性,并确定预测复发的因素:比较减少急性偏头痛患者复发的肠外用药的有效性,并确定预测复发的因素:背景:许多急性偏头痛患者从急诊出院后,疼痛会复发;严重的复发可能导致患者再次到急诊就诊:方法:我们进行了一项更新至 2023 年的全面文献检索,以确定评估肠外用药对急诊出院急性偏头痛患者复发结果的有效性的随机对照试验。两名独立审稿人完成了研究筛选、质量评估和数据提取。传统的荟萃分析比较了肠外皮质类固醇和安慰剂;频数网络分析评估了直接和间接比较。结果以风险比 (RR) 和 95% 置信区间 (CI) 的形式报告。综述方案已在国际系统综述前瞻性注册中心注册(标识符:CRD42018099493):结果:从 8949 条引文中,共纳入了 53 项研究,涉及 6167 名患者。大多数研究的偏倚风险较高或不明确。与安慰剂相比,皮质类固醇能显著降低复发率(RR 0.67,95% CI 0.52-0.88;I2 = 0%)。接受利多卡因(RR 0.10,95% CI 0.01-0.82)、镇静剂/催眠药(RR 0.33,95% CI 0.14-0.75)、麦角制剂(RR 0.44,95% CI 0.25-0.75)、神经安定剂(RR 0.47,95% CI 0.31-0.71)、阿片类药物(RR 0.58;95% CI 0.35-0.94)或皮质类固醇(RR 0.64,95% CI 0.47-0.86)的复发率明显较低。利多卡因(RR 0.09,95% CI 0.01-0.71)、联合疗法(RR 0.12,95% CI 0.02-0.74)或添加皮质类固醇(RR 0.61,95% CI 0.44-0.84)更有可能减少严重复发。头痛持续时间较长和出院时的残余疼痛与复发率较高明显相关:讨论:皮质类固醇仍是减少复发的一线推荐方案。一些通常用于缓解疼痛的肠外用药,包括麦角制剂、神经安定剂或联合疗法,可有效减少复发;但出于安全考虑,不推荐使用阿片类药物。对于一些研究较少但前景看好的药物,包括利多卡因和异丙酚,还需要进行更多的研究。出院前急诊环境中有效的疼痛控制和头痛持续时间可能会对此类治疗的成功与否起到一定的作用,进一步的研究可以让人们进一步了解某些肠外用药如何以及为何能有效减少复发事件。
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引用次数: 0
The 2024 Scottsdale Headache Symposium: A banner year. 2024 斯科茨代尔头痛研讨会:辉煌的一年
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-10-17 DOI: 10.1111/head.14855
Deborah I Friedman, Carrie Dougherty, Scott W Powers
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引用次数: 0
The impact of updates in headache quality measures on adherence to best practices in a neurology resident clinic: A quality improvement study. 头痛质量衡量标准的更新对神经病学住院医师诊所坚持最佳实践的影响:质量改进研究。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-06-23 DOI: 10.1111/head.14754
Robert H Cascella, Christopher C Anderson, Enmanuel J Perez

Objective: To apply the 2019 joint American Academy of Neurology (AAN) and American Headache Society (AHS) quality measures for headache management to a cohort of neurology resident physicians and then assess outcomes related to guideline adherence.

Background: The optimization of headache management is essential to reduce both the individual and systemic impact of these disorders. In 2014, the AAN developed 10 quality measures for evidence-based management of patients with headache. A workgroup updated and condensed its headache quality measures in 2019, narrowing the set to six measurements, four of which would primarily focus on the management of migraine and two of which would address the management of cluster headache.

Methods: This quality improvement study was conducted using a pretest-posttest study design. A pre-intervention survey based on retrospective analysis of five clinic notes for adherence to the measures was designed and distributed to all neurology residents (n = 32) at a large, academic tertiary referral center. The intervention included the creation of an electronic medical record template to aid residents in following the measures during clinical encounters, as well as the provision of direct feedback based on pre-intervention results. Finally, a post-intervention survey was distributed for completion based on notes written during the intervention period. Analysis was limited to migraine, given the low percentage of cluster headache seen in clinic.

Results: An increase in adherence was seen in three of the four migraine-related quality measures, with the Use of Abortive Medications for Migraine and Documentation of Counseling on Modifiable Lifestyle and Chronification Factors demonstrating statistically significant improvements (75.8% to 88.0% [p = 0.013] and 83.9% to 94.0% [p = 0.029] adherence, respectively). For secondary outcomes, the increase in the utilization of appropriate diagnostic criteria (82.6% to 93.2%, p = 0.018) was significant, and the self-assessed confidence rating for adherence to guidelines was significant (p < 0.001).

Conclusions: This study provides evidence that the quality improvement intervention led to increased adherence to the AAN and AHS migraine-related measures. It is anticipated that increased adherence may lead to improved patient outcomes.

目的:将 2019 年美国神经病学学会 (AAN) 和美国头痛学会 (AHS) 联合制定的头痛管理质量标准应用于神经病学住院医师队列,然后评估与遵守指南相关的结果:背景:优化头痛管理对于减少这些疾病对个人和系统的影响至关重要。2014 年,AAN 针对头痛患者的循证管理制定了 10 项质量措施。2019年,一个工作组更新并精简了头痛质量测量方法,将测量方法缩减为六种,其中四种主要针对偏头痛的管理,两种针对丛集性头痛的管理:这项质量改进研究采用了前测-后测研究设计。在对五份门诊记录进行回顾性分析的基础上,设计了一项干预前调查,并分发给一家大型三级学术转诊中心的所有神经病学住院医师(n = 32)。干预措施包括创建电子病历模板,以帮助住院医师在临床诊治过程中遵守措施,并根据干预前的结果提供直接反馈。最后,根据干预期间撰写的笔记,分发干预后调查表供填写。鉴于集束性头痛在门诊中所占比例较低,因此分析仅限于偏头痛:结果:在四项偏头痛相关质量测量中,有三项的依从性有所提高,其中偏头痛终止药物的使用和可改变的生活方式及慢性化因素的咨询记录在统计学上有显著改善(依从性分别从75.8%提高到88.0% [p = 0.013] 和83.9%提高到94.0% [p = 0.029])。在次要结果方面,适当诊断标准使用率的提高(从 82.6% 提高到 93.2%,p = 0.018)具有显著性,对遵守指南的自评信心评级也具有显著性(p 结论:本研究为质量改进项目提供了证据:本研究提供的证据表明,质量改进干预措施提高了对 AAN 和 AHS 偏头痛相关措施的依从性。预计遵守率的提高可能会改善患者的治疗效果。
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引用次数: 0
Ubrogepant users' real-world experience: Patients on ubrogepant, characteristics and outcomes (UNIVERSE) study. 优搏定使用者的真实体验:使用优搏定的患者、特征和结果(UNIVERSE)研究。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-09-26 DOI: 10.1111/head.14839
Anand R Shewale, Weijie Poh, Michael L Reed, Jinjie Liu, Francois Cadiou, Ali Ezzati, Kate Burslem, Shivaji Manthena, Richard B Lipton

Objective: To assess the real-world effectiveness of ubrogepant by evaluating self-reported satisfaction with pain relief, ability to think clearly, and return to normal function in individuals who had used ubrogepant to treat a migraine episode within the preceding 14 days.

Background: Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Few studies have evaluated the real-world effectiveness of ubrogepant.

Methods: The UNIVERSE study was an observational, cross-sectional survey conducted between February 2021 and April 2021 in US adult Migraine Buddy application (app) users currently treated with ubrogepant. Individuals who were 18 years of age or older and reported at least one dose of ubrogepant in the previous 14 days completed a 30-question survey in the app. The survey assessed respondent demographics, migraine history, acute treatment patterns, and treatment satisfaction with ubrogepant. Respondents also reported prior acute medication use and reasons for switching to ubrogepant.

Results: Of the 1303 ubrogepant users contacted, 302 (23.2%; 50 mg, 120 participants; 100 mg, 182 participants) were included in this study. The mean (standard deviation) age was 41.9 (11.2) years, and 90.1% (272/302) were female. Satisfaction with migraine relief at 2, 4, and 24 h post-dose was reported by 75.8% (229/302), 83.4% (252/302), and 78.5% (237/302) of participants, respectively. Satisfaction with the ability to think clearly after taking ubrogepant was reported by 85.1% (257/302) of participants, and 83.8% (253/302) were satisfied with their ability to return to normal function. Furthermore, 90.7% (274/302) of participants reported that they were likely to continue using ubrogepant to treat their migraine. Most participants (n = 264 [87%]) reported switching to ubrogepant due to inadequate treatment response with their previous treatment. In this subgroup, comparable outcomes were observed with respect to satisfaction with migraine relief, ability to think clearly, and return to normal function.

Conclusions: Ubrogepant demonstrated real-world effectiveness in the acute treatment of migraine, as evidenced by high levels of treatment satisfaction and a strong indication of their intent to continue using the medication.

目的通过评估曾在14天内使用优搏定治疗偏头痛发作的患者对疼痛缓解的自述满意度、清晰思考的能力以及恢复正常功能的情况,评估优搏定的实际疗效:背景:乌溴盖坦是一种口服降钙素基因相关肽受体拮抗剂,已被批准用于成人偏头痛的急性治疗。很少有研究对乌布格潘的实际疗效进行评估:UNIVERSE 研究是一项观察性横断面调查,于 2021 年 2 月至 2021 年 4 月间在目前使用 ubrogepant 治疗偏头痛的美国成人偏头痛 Buddy 应用程序(app)用户中进行。年龄在 18 周岁或以上并报告在过去 14 天内至少服用过一次乌罗盖板的用户在应用程序中完成了一项包含 30 个问题的调查。该调查评估了受访者的人口统计学特征、偏头痛病史、急性治疗模式以及对乌罗盖板的治疗满意度。受访者还报告了之前的急性期用药情况以及改用乌罗盖板的原因:在所联系的 1303 名优氯吉潘使用者中,有 302 人(23.2%;50 毫克,120 人;100 毫克,182 人)被纳入本研究。平均(标准差)年龄为 41.9(11.2)岁,90.1%(272/302)为女性。75.8%(229/302)、83.4%(252/302)和78.5%(237/302)的参与者对服药后2、4和24小时偏头痛缓解情况表示满意。85.1%(257/302)的受试者对服用乌洛格班后能否清晰思考表示满意,83.8%(253/302)的受试者对能否恢复正常功能表示满意。此外,90.7%(274/302)的参与者表示他们可能会继续使用优搏定治疗偏头痛。大多数参试者(n = 264 [87%])表示,由于之前的治疗效果不佳而改用优搏定。在这一分组中,观察到的结果与偏头痛缓解满意度、清晰思考能力和恢复正常功能方面的结果相当:优搏定在偏头痛的急性期治疗中显示出了实际疗效,患者对治疗的满意度很高,并强烈表示愿意继续用药。
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引用次数: 0
A placebo controlled, randomized clinical trial of galcanezumab for vestibular migraine: The INVESTMENT study. 安慰剂对照随机临床试验:加坎珠单抗治疗前庭性偏头痛:INVESTMENT 研究。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1111/head.14835
Jeffrey D Sharon, Roseanne Krauter, Ricky Chae, Adam Gardi, Maxwell Hum, Isabel Allen, Morris Levin

Objective: To study if galcanezumab is effective for vestibular migraine (VM).

Background: There are currently no placebo-controlled trials showing that treatment is effective for VM. Therefore, we performed the first placebo controlled, randomized clinical trial of a calcitonin gene-related peptide-targeted monoclonal antibody for VM.

Methods: This was a single site, prospective, double-blind placebo controlled randomized clinical trial. Key inclusion criteria were as follows: participants aged 18-75 years with a diagnosis of VM or probable VM per Barany Society criteria. The primary outcome was change in VM-PATHI (Vestibular Migraine Patient Assessment Tool and Handicap Inventory) score, and secondary outcomes included change in DHI (Dizziness Handicap Inventory) score, and count of definite dizzy days (DDDs). Participants were randomized 1:1 to 3 months of treatment with galcanezumab or placebo via subcutaneous injection with a pre-filled syringe, 240 mg the first month, and 120 mg for the second and third months.

Results: Forty participants were randomized, and 38 participants were in the modified intent to treat analysis. VM-PATHI score was reduced 5.1 points (95% confidence interval [CI] -13.0 to 2.7) for placebo (N = 21), and 14.8 points (95% CI -23.0 to -6.5) for galcanezumab (N = 17), a difference of -9.6 (95% CI -20.7 to 1.5, p = 0.044). DHI dropped 8.3 points in the placebo arm (95% CI -15.0 to 1.6), and 22.0 points in the galcanezumab arm (95% CI -31.9 to -12.1), a difference of -13.7 (95% CI -20.4 to -8.5, p = 0.018). The count of DDDs per month dropped from 18 days (standard deviation [SD] 7.6) in the baseline month to 12.5 days (SD 11.2) in month 4 for those in the placebo arm, and from 17.9 days (SD 7.9) in the baseline month to 6.6 days (SD 7.3) in month 4 for those in the galcanezumab arm, a difference of -5.7 days (95% CI -10.7 to -0.7, p = 0.026). No serious adverse events were observed.

Conclusions: In this pilot study, galcanezumab was effective in treating VM.

目的:研究加康珠单抗对前庭性偏头痛(VM)是否有效:研究 galcanezumab 是否对前庭性偏头痛(VM)有效:背景:目前还没有安慰剂对照试验显示治疗前庭性偏头痛有效。因此,我们对降钙素基因相关肽靶向单克隆抗体治疗前庭性偏头痛进行了首次安慰剂对照随机临床试验:这是一项单点、前瞻性、双盲安慰剂对照随机临床试验。主要纳入标准如下:年龄在18-75岁之间,根据巴拉尼学会标准诊断为VM或可能患有VM的参与者。主要结果是 VM-PATHI(前庭性偏头痛患者评估工具和障碍量表)评分的变化,次要结果包括 DHI(头晕障碍量表)评分的变化和确诊头晕天数(DDDs)的计数。参与者按1:1的比例随机接受为期3个月的galcanezumab或安慰剂治疗,使用预充注射器皮下注射,第一个月240毫克,第二和第三个月120毫克:40名参与者接受了随机治疗,38名参与者接受了修改后的意向治疗分析。安慰剂(21 人)的 VM-PATHI 评分降低了 5.1 分(95% 置信区间 [CI] -13.0 至 2.7),加仑珠单抗(17 人)的 VM-PATHI 评分降低了 14.8 分(95% 置信区间 [CI] -23.0 至 -6.5),差异为 -9.6(95% 置信区间 [CI] -20.7 至 1.5,p = 0.044)。安慰剂治疗组的DHI下降了8.3点(95% CI -15.0至1.6),加卡尼珠单抗治疗组的DHI下降了22.0点(95% CI -31.9至-12.1),差异为-13.7(95% CI -20.4至-8.5,p = 0.018)。安慰剂组患者的每月DDD次数从基线月的18天(标准差[SD]7.6)降至第4个月的12.5天(标准差11.2),而加坎珠单抗组患者的每月DDD次数从基线月的17.9天(标准差7.9)降至第4个月的6.6天(标准差7.3),差异为-5.7天(95% CI -10.7至-0.7,p = 0.026)。未观察到严重不良事件:在这项试点研究中,加卡尼珠单抗对治疗血管瘤有效。
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引用次数: 0
Cost per treatment responder analysis of atogepant compared to rimegepant for the preventive treatment of episodic migraine. 阿托格潘与利美昔康预防性治疗发作性偏头痛的每次治疗应答成本分析。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-09-09 DOI: 10.1111/head.14824
Jessica Ailani, Pranav Gandhi, Anjana Lalla, Rashmi Halker Singh, Peter McAllister, Jonathan H Smith, Brett Dabruzzo, Natty Chalermpalanupap, Kari Kelton, Stephanie J Nahas
<p><strong>Objective: </strong>To estimate the number needed to treat and cost per additional responder for atogepant and rimegepant versus placebo for the preventive treatment of episodic migraine (EM) in the United States.</p><p><strong>Background: </strong>Migraine has an enormous impact on a person's daily activities and quality of life, and results in significant clinical and economic burden to both individuals and society. It is important to understand the comparative efficacy and economic value of oral calcitonin gene-related peptide receptor antagonists (gepants) for preventive treatment of EM. Currently, atogepant and rimegepant are US Food and Drug Administration approved for preventive treatment of migraine (rimegepant for EM and atogepant for EM and for chronic migraine). In the absence of head-to-head trials, we utilized an indirect treatment comparison on efficacy data from clinical trials conducted for the preventive treatment of EM. We estimated number needed to treat, a valuable metric used in clinical practice to compare treatment efficacy, and cost per additional responder, which can be used to establish the cost effectiveness of a treatment.</p><p><strong>Methods: </strong>An indirect treatment comparison was conducted to compare the efficacy of atogepant 60 mg once daily and rimegepant 75 mg once every other day as preventive treatments for EM using published data from the registrational trials of atogepant (ADVANCE) and rimegepant (BHV3000-305). The efficacy outcome of interest was ≥50% reduction from baseline in mean monthly migraine/headache days (≥50% responder rate), which was variably defined for a base case and two scenario analyses. Number needed to treat and cost per additional responder versus placebo were calculated and compared between both treatments (weeks 9-12 in the base case analysis; weeks 1-12 and 9-12 for atogepant and during weeks 9-12 for rimegepant in the scenario analyses).</p><p><strong>Results: </strong>In the base case analysis, ≥50% responder rates were 64.9% (95% confidence interval [CI], 53.9-74.5) for atogepant and 51.8% (95% CI, 42.9-60.6) for rimegepant, compared to 44.1% (95% CI, 39.4-49.0) for placebo. The median number needed to treat versus placebo in the base case scenario was 4.8 (95% CI, 3.1-9.0) for atogepant compared to 13.0 (95% CI, 5.9-75.1) for rimegepant. The cost per additional responder versus placebo in the base case scenario was estimated to be $15,823 (95% CI, $11,079-$29,516) for atogepant compared to $73,029 (95% CI, $32,901-$422,104) for rimegepant. Results of the two scenario analyses were consistent with the base case analysis.</p><p><strong>Conclusions: </strong>Atogepant had substantially lower numbers needed to treat and costs per additional responder versus placebo than rimegepant for the preventive treatment of EM across all evaluated scenarios. These analyses suggest that atogepant may be more cost effective than rimegepant for the preventive treatment of EM. Limit
目的估算在美国阿托格潘和利美昔康与安慰剂相比用于发作性偏头痛(EM)预防性治疗的治疗人数和每名额外应答者的成本:背景:偏头痛对患者的日常活动和生活质量产生巨大影响,并给个人和社会带来严重的临床和经济负担。了解口服降钙素基因相关肽受体拮抗剂(gepants)在预防治疗偏头痛方面的疗效比较和经济价值非常重要。目前,美国食品和药物管理局已批准阿托吉潘和利美昔班用于偏头痛的预防性治疗(利美昔班用于偏头痛,阿托吉潘用于偏头痛和慢性偏头痛)。由于缺乏头对头试验,我们采用了间接治疗比较的方法,对预防性治疗偏头痛的临床试验中的疗效数据进行比较。我们估算了需要治疗的人数(这是临床实践中用于比较治疗效果的重要指标)和每增加一名应答者的成本(这可用于确定治疗的成本效益):利用阿托吉潘(ADVANCE)和利美昔康(BHV3000-305)注册试验的公开数据,对阿托吉潘60毫克、每日一次和利美昔康75毫克、隔日一次作为EM预防性治疗的疗效进行了间接治疗比较。关注的疗效结果是每月偏头痛/头痛的平均天数比基线减少≥50%(应答率≥50%),基本情况分析和两种情况分析对这一结果的定义各不相同。计算并比较了两种治疗方法(在基础病例分析中为第9-12周;在情景分析中为阿托吉潘的第1-12周和第9-12周,以及利美君的第9-12周)的治疗所需人数和每额外应答者相对于安慰剂的成本:在基础病例分析中,阿托格班的≥50%应答率为64.9%(95%置信区间[CI],53.9-74.5),利美君的≥50%应答率为51.8%(95%置信区间,42.9-60.6),而安慰剂的≥50%应答率为44.1%(95%置信区间,39.4-49.0)。在基础方案中,阿托格潘与安慰剂相比所需的治疗人数中位数为 4.8(95% CI,3.1-9.0),而利美昔康为 13.0(95% CI,5.9-75.1)。在基础方案中,与安慰剂相比,阿托吉潘每增加一名应答者的成本估计为15,823美元(95% CI,11,079-29,516美元),而利美昔康为73,029美元(95% CI,32,901-422,104美元)。两种情况分析的结果与基础病例分析一致:在所有评估方案中,阿托格潘与安慰剂相比,在预防性治疗急性心肌梗死方面,阿托格潘的治疗人数和每名额外应答者的成本均大大低于利美君。这些分析表明,在预防性治疗EM方面,阿托格潘可能比利美昔班更具成本效益。局限性包括纳入/排除标准的差异以及不同试验之间≥50%应答率报告的差异。
{"title":"Cost per treatment responder analysis of atogepant compared to rimegepant for the preventive treatment of episodic migraine.","authors":"Jessica Ailani, Pranav Gandhi, Anjana Lalla, Rashmi Halker Singh, Peter McAllister, Jonathan H Smith, Brett Dabruzzo, Natty Chalermpalanupap, Kari Kelton, Stephanie J Nahas","doi":"10.1111/head.14824","DOIUrl":"10.1111/head.14824","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To estimate the number needed to treat and cost per additional responder for atogepant and rimegepant versus placebo for the preventive treatment of episodic migraine (EM) in the United States.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Migraine has an enormous impact on a person's daily activities and quality of life, and results in significant clinical and economic burden to both individuals and society. It is important to understand the comparative efficacy and economic value of oral calcitonin gene-related peptide receptor antagonists (gepants) for preventive treatment of EM. Currently, atogepant and rimegepant are US Food and Drug Administration approved for preventive treatment of migraine (rimegepant for EM and atogepant for EM and for chronic migraine). In the absence of head-to-head trials, we utilized an indirect treatment comparison on efficacy data from clinical trials conducted for the preventive treatment of EM. We estimated number needed to treat, a valuable metric used in clinical practice to compare treatment efficacy, and cost per additional responder, which can be used to establish the cost effectiveness of a treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An indirect treatment comparison was conducted to compare the efficacy of atogepant 60 mg once daily and rimegepant 75 mg once every other day as preventive treatments for EM using published data from the registrational trials of atogepant (ADVANCE) and rimegepant (BHV3000-305). The efficacy outcome of interest was ≥50% reduction from baseline in mean monthly migraine/headache days (≥50% responder rate), which was variably defined for a base case and two scenario analyses. Number needed to treat and cost per additional responder versus placebo were calculated and compared between both treatments (weeks 9-12 in the base case analysis; weeks 1-12 and 9-12 for atogepant and during weeks 9-12 for rimegepant in the scenario analyses).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In the base case analysis, ≥50% responder rates were 64.9% (95% confidence interval [CI], 53.9-74.5) for atogepant and 51.8% (95% CI, 42.9-60.6) for rimegepant, compared to 44.1% (95% CI, 39.4-49.0) for placebo. The median number needed to treat versus placebo in the base case scenario was 4.8 (95% CI, 3.1-9.0) for atogepant compared to 13.0 (95% CI, 5.9-75.1) for rimegepant. The cost per additional responder versus placebo in the base case scenario was estimated to be $15,823 (95% CI, $11,079-$29,516) for atogepant compared to $73,029 (95% CI, $32,901-$422,104) for rimegepant. Results of the two scenario analyses were consistent with the base case analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Atogepant had substantially lower numbers needed to treat and costs per additional responder versus placebo than rimegepant for the preventive treatment of EM across all evaluated scenarios. These analyses suggest that atogepant may be more cost effective than rimegepant for the preventive treatment of EM. Limit","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1253-1263"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153709","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
Low-dose psilocybin in short-lasting unilateral neuralgiform headache attacks: results from an open-label phase Ib ascending dose study. 低剂量迷幻药治疗短时单侧神经性头痛发作:一项开放标签 Ib 期剂量递增研究的结果。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-09-20 DOI: 10.1111/head.14837
James Rucker, Matt Butler, Sadie Hambleton, Catherine Bird, Mathieu Seynaeve, Sanjay Cheema, Kete Campbell-Coker, Carolina Maggio, Fiona Dunbar, Giorgio Lambru, Manjit Matharu

Background: Short-lasting unilateral neuralgiform headache attacks (SUNHA) are trigeminal autonomic cephalalgias that feature intense and recurrent paroxysms of pain and autonomic symptoms. Many patients are left with debilitating symptoms despite best-available treatment. Psychedelics, such as the serotonin 2A partial agonist psilocybin, have shown promise in related disorders such as migraine and cluster headache. In this open-label phase Ib ascending dose study, we aimed to assess the effects of low-dose oral psilocybin with psychological support in six to 12 patients with chronic SUNHA. Study objectives were to determine effects on cognition, as well as safety, tolerability, and effects on headache severity and frequency.

Methods: Oral psilocybin in ascending doses of 5, 7.5, and 10 mg (one dose per session; three dosing sessions in total) were administered. Cognition was assessed via the Cambridge Neuropsychological Tests Automated Battery. Headache attacks were assessed via headache diaries and the six-item Headache Impact Test (HIT-6). Subjective dose intensity was assessed via the five-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). The study was terminated early due to recruitment difficulties; four patients were enrolled, three of whom were study completers. Post hoc, we undertook a thematic analysis of the applicable free-text clinical trial notes from the dosing and subsequent visits (n = 22). An inductive method was employed to establish emergent themes.

Results: No significant adverse events were recorded. We were unable to collect data as planned on cognitive function during the acute experience due to high ratings of subjective dose intensity (mean 5D-ASC scores 37.8-45.7). The impact of the headaches remained severe throughout the duration of the trial (HIT-6 mean scores 64.3-65.7). There were limited effects on headache duration and severity based on the diaries; however, mean daily attack frequency decreased by >50% in two participants at final follow-up (22.9 to 11.0 and 56.4 to 28.0, respectively). Completing participants and their clinicians recorded "much" (two participants) or "minimal" improvements (one participant) at final follow-up via the Clinical Global Impression rating scale. Thematic analysis indicated that psychological insights were key features of participants' experience; these insights included re-configured relationships to their headache pain.

Conclusion: The study met with recruitment difficulties and cognition could not be assessed during the acute experience due to subjective dose intensity, likely mediated in part by expectancy effects. The clinical results provide no conclusive evidence for the use of psilocybin in SUNHA. We suggest that accounting for psychological factors in chronic SUNHA may be an important facet of treatment.

背景:短程单侧神经性头痛发作(SUNHA)是一种三叉神经自律性头痛,其特征是剧烈和反复发作的阵发性疼痛和自律性症状。许多患者尽管接受了现有的最佳治疗,但仍会出现使人衰弱的症状。迷幻剂,如 5-羟色胺 2A 部分激动剂迷幻素,已在偏头痛和丛集性头痛等相关疾病中显示出治疗前景。在这项开放标签的 Ib 期递增剂量研究中,我们旨在评估小剂量口服迷幻剂和心理支持对 6 至 12 名慢性 SUNHA 患者的影响。研究目标是确定对认知的影响、安全性、耐受性以及对头痛严重程度和频率的影响:口服迷幻剂的剂量依次为 5 毫克、7.5 毫克和 10 毫克(每次服药一次;共服药三次)。认知能力通过剑桥神经心理测试自动电池进行评估。头痛发作通过头痛日记和六项头痛影响测试(HIT-6)进行评估。主观剂量强度通过五维意识状态改变问卷(5D-ASC)进行评估。由于招募困难,研究提前结束;共招募了四名患者,其中三人完成了研究。事后,我们对用药和后续就诊的适用自由文本临床试验笔记(n = 22)进行了专题分析。我们采用归纳法确定了新出现的主题:无重大不良事件记录。由于主观剂量强度评分较高(平均 5D-ASC 评分 37.8-45.7),我们无法按计划收集急性期认知功能方面的数据。在整个试验期间,头痛的影响仍然很严重(HIT-6 平均分 64.3-65.7)。日记对头痛持续时间和严重程度的影响有限;不过,两名参与者的每日平均发作频率在最终随访时下降了 50% 以上(分别从 22.9 降至 11.0 和从 56.4 降至 28.0)。完成日记的参与者及其临床医生在最后随访时通过临床总体印象评分表记录了 "很大"(两名参与者)或 "很小"(一名参与者)的改善。主题分析表明,心理洞察力是参与者体验的主要特征;这些洞察力包括重新配置与头痛的关系:结论:这项研究在招募参与者时遇到了困难,由于主观剂量强度的原因,在急性体验期间无法对认知进行评估,这可能在一定程度上受到预期效应的影响。临床结果没有为在 SUNHA 中使用迷幻药提供确凿证据。我们建议,考虑慢性 SUNHA 的心理因素可能是治疗的一个重要方面。
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引用次数: 0
Spontaneous intracranial hypotension mimicking iatrogenic spinal cerebrospinal fluid leaks. 模仿先天性脊髓脑脊液漏的自发性颅内低血压。
IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2024-11-01 Epub Date: 2024-09-02 DOI: 10.1111/head.14826
Angelique Sao-Mai S Tay, Marcel M Maya, Wouter I Schievink

Objective: To raise awareness that patients with persistent post-dural puncture headache should be considered for evaluation of spontaneous cerebrospinal fluid (CSF) leak.

Background: Spontaneous intracranial hypotension (SIH) due to a spinal CSF leak may occur following more-or-less trivial traumatic events. We report our experience with spontaneous spinal CSF leaks that occur following percutaneous or open spine procedures, a potential source of diagnostic confusion.

Methods: In a retrospective cohort study, using a prospectively maintained database of patients with SIH, we identified all new patients evaluated between January 1, 2022, and June 30, 2023, who were referred for evaluation of an iatrogenic spinal CSF leak but were found to have a spontaneous spinal CSF leak.

Results: Nine (4%) of the 248 patients with SIH were originally referred for evaluation of an iatrogenic spinal CSF leak. The spinal procedures included epidural steroid injections, laminectomies, epidural anesthesia, and lumbar puncture. Brain magnetic resonance imaging (MRI) showed changes in intracranial hypotension in seven of the nine patients (78%). The spontaneous CSF leak was found to be at least five levels removed from the spinal procedure in all patients.

Conclusions: A spontaneous spinal CSF leak should be suspected in patients with recalcitrant orthostatic headaches following a spinal procedure, even if symptoms of the leak occur within hours of the spinal procedure and especially if brain MRI is abnormal.

目的:提高对硬膜穿刺后持续头痛患者应考虑进行自发性脑脊液(CSF)漏评估的认识:背景:硬膜穿刺后持续头痛的患者应考虑评估自发性脑脊液(CSF)漏:背景:脊髓 CSF 漏导致的自发性颅内低血压(SIH)可能发生在轻微或不轻微的创伤事件之后。我们报告了经皮或开放式脊柱手术后发生的自发性脊髓CSF漏的经验,这可能会造成诊断上的混乱:在一项回顾性队列研究中,我们利用前瞻性维护的 SIH 患者数据库,对 2022 年 1 月 1 日至 2023 年 6 月 30 日期间接受评估的所有新患者进行了鉴定,这些患者被转诊接受先天性脊髓 CSF 漏的评估,但被发现患有自发性脊髓 CSF 漏:248例SIH患者中,有9例(4%)最初是被转诊评估先天性脊髓CSF漏的。脊柱手术包括硬膜外类固醇注射、椎板切除、硬膜外麻醉和腰椎穿刺。脑磁共振成像(MRI)显示,9 名患者中有 7 人(78%)出现颅内低血压变化。所有患者的自发性脑脊液漏都与脊柱手术至少相隔五层:结论:脊柱手术后出现顽固性直立性头痛的患者,即使在脊柱手术后数小时内出现漏液症状,尤其是脑部磁共振成像出现异常时,也应怀疑脊柱CSF自发性漏液。
{"title":"Spontaneous intracranial hypotension mimicking iatrogenic spinal cerebrospinal fluid leaks.","authors":"Angelique Sao-Mai S Tay, Marcel M Maya, Wouter I Schievink","doi":"10.1111/head.14826","DOIUrl":"10.1111/head.14826","url":null,"abstract":"<p><strong>Objective: </strong>To raise awareness that patients with persistent post-dural puncture headache should be considered for evaluation of spontaneous cerebrospinal fluid (CSF) leak.</p><p><strong>Background: </strong>Spontaneous intracranial hypotension (SIH) due to a spinal CSF leak may occur following more-or-less trivial traumatic events. We report our experience with spontaneous spinal CSF leaks that occur following percutaneous or open spine procedures, a potential source of diagnostic confusion.</p><p><strong>Methods: </strong>In a retrospective cohort study, using a prospectively maintained database of patients with SIH, we identified all new patients evaluated between January 1, 2022, and June 30, 2023, who were referred for evaluation of an iatrogenic spinal CSF leak but were found to have a spontaneous spinal CSF leak.</p><p><strong>Results: </strong>Nine (4%) of the 248 patients with SIH were originally referred for evaluation of an iatrogenic spinal CSF leak. The spinal procedures included epidural steroid injections, laminectomies, epidural anesthesia, and lumbar puncture. Brain magnetic resonance imaging (MRI) showed changes in intracranial hypotension in seven of the nine patients (78%). The spontaneous CSF leak was found to be at least five levels removed from the spinal procedure in all patients.</p><p><strong>Conclusions: </strong>A spontaneous spinal CSF leak should be suspected in patients with recalcitrant orthostatic headaches following a spinal procedure, even if symptoms of the leak occur within hours of the spinal procedure and especially if brain MRI is abnormal.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1339-1342"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142106742","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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