Cephalalgia最新文献

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Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program. 偏头痛患者降钙素基因相关肽单克隆抗体与肉毒杆菌毒素A的脑血管风险:美国国立卫生研究院所有人研究项目的现实世界药物流行病学研究
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-07-01 Epub Date: 2026-07-02 DOI: 10.1177/03331024261464438
Sedat Gül, Bradley Ong, Stephen Trudeau, Nicolas Thompson, Hsiangkuo Yuan
{"title":"Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program.","authors":"Sedat Gül, Bradley Ong, Stephen Trudeau, Nicolas Thompson, Hsiangkuo Yuan","doi":"10.1177/03331024261464438","DOIUrl":"10.1177/03331024261464438","url":null,"abstract":"<p><p>AimTo evaluate whether initiation of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) was non-inferior to initiation of onabotulinumtoxinA with respect to the hazard of ischemic stroke or transient ischemic attack (IS + TIA) in a real-world cohort of adults with migraine.MethodsWe conducted a retrospective, active-comparator, new-user pharmacoepidemiology study using the NIH All of Us Research Program Registered Tier Dataset (v8). Adults with migraine initiating CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) were compared with initiators of onabotulinumtoxinA from January 2018 through September 2023. The primary outcome was IS + TIA occurring more than 90 days after treatment initiation. Inverse probability of treatment weighting (IPTW) with stabilized propensity scores was used to adjust for 23 baseline covariates. Non-inferiority was assessed on the hazard ratio (HR) scale using a prespecified margin of 1.5, with non-inferiority concluded if the upper bound of the 95% confidence interval (CI) was less than 1.5. Prespecified subgroup analyses included migraine with aura and without aura. Prespecified sensitivity analyses included a per-protocol analysis, a crossover-excluded analysis, and an IS-only analysis. Fracture was used as a negative control outcome.ResultsAmong 16,147 patients with migraine in the cohort, the primary comparison included 1,581 CGRP mAb initiators and 947 onabotulinumtoxinA initiators. IPTW achieved a good covariate balance for the primary comparison (maximum standardized mean difference 0.016). For the primary outcome, 14 IS + TIA events occurred among CGRP mAb initiators and 22 among onabotulinumtoxinA initiators. The hazard ratio for IS + TIA was 0.524 (95% CI 0.263-1.046), which met the prespecified statistical criterion for non-inferiority because the upper confidence bound was below 1.5; however, the estimate was imprecise because of the small number of events. In the migraine with aura subgroup, the estimate also met the non-inferiority criterion (HR 0.419, 95% CI 0.163-1.080), whereas the migraine without aura subgroup, per-protocol analysis, and major adverse cardiovascular events analysis were inconclusive for non-inferiority. For major adverse cardiovascular events the HR was 1.068 (95% CI 0.589-1.935). The fracture negative control was also not significantly different (HR, 1.175; 95% CI, 0.692-1.993; p = 0.551), arguing against systematic healthy-user confounding. A formal adjusted comparison with untreated patients was not feasible due to structural confounding inherent to the stepped-care treatment pathway.ConclusionsIn this real-world diverse cohort, initiation of CGRP mAbs met the prespecified statistical criterion for non-inferiority relative to onabotulinumtoxinA for the primary IS + TIA outcome. However, this finding was based on few events and wide CIs and should be interpreted cautiously as limited evidence against a large relative increase in incident IS + TIA r","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 7","pages":"3331024261464438"},"PeriodicalIF":5.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148367000","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
Association between insulin resistance surrogate indicators and six-month prognosis in patients with medication-overuse headache: A retrospective cohort study. 胰岛素抵抗替代指标与药物过度使用头痛患者6个月预后的关系:一项回顾性队列研究
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-07-01 Epub Date: 2026-07-09 DOI: 10.1177/03331024261464213
Changling Li, Peiqi He, Hui Lang, Shiqin Li, Qian Liu, Yanbo Li, Yang Zhang, Mengmeng Ma, Jinghuan Fang, Ning Chen, Li He
{"title":"Association between insulin resistance surrogate indicators and six-month prognosis in patients with medication-overuse headache: A retrospective cohort study.","authors":"Changling Li, Peiqi He, Hui Lang, Shiqin Li, Qian Liu, Yanbo Li, Yang Zhang, Mengmeng Ma, Jinghuan Fang, Ning Chen, Li He","doi":"10.1177/03331024261464213","DOIUrl":"10.1177/03331024261464213","url":null,"abstract":"<p><p>BackgroundInsulin resistance (IR) may influence the treatment responses of medication-overuse headache (MOH), but evidence is limited. This study explored the relationship of four surrogate IR indices-triglyceride-glucose (TyG) index, triglyceride to HDL-C (TG/HDL-C) ratio, TyG-body mass index (TyG-BMI), and metabolic score for IR (METS-IR)-with six-month treatment responses in MOH patients after withdrawal and preventive therapy.MethodsMOH patients from June 2020 to July 2024 were consecutively enrolled in this retrospective cohort study. Patients were categorized into four groups according to quartiles of each baseline IR index. Six months post-treatment, patients reducing monthly headache days by at least 50% from baseline and stopping acute medication overuse were deemed to achieve a '50% response status'; others were classified as a 'non-50% response status'. Logistic regression analyses were utilized to assess the relationship of the IR indices with 50% response status.ResultsIn the final analysis of 201 enrolled MOH patients (71.6% female) out of an initial 264, 109 (54.2%) achieved a 50% response status at the six-month follow-up. In unadjusted analysis, the TyG index (continuous: OR 1.72, 95% CI 0.97-3.06, P = 0.064; highest vs. lowest quartile: OR 2.16, 95% CI 0.97-4.81, P = 0.058) showed no significant association with 50% response status. After adjustment, both the continuous TyG index (OR 2.25, 95% CI 1.07-4.70, P = 0.032) and the highest quartile (OR 2.95, 95% CI 1.09-8.00, P = 0.033) became significantly associated with the outcome. In contrast, the TG/HDL-C ratio, METS-IR, and TyG-BMI index did not reach significance in the final adjusted model.ConclusionsThe TyG index was associated with 50% response status in MOH patients, warranting further validation.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 7","pages":"3331024261464213"},"PeriodicalIF":5.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148410840","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
Cervical strengthening and stabilization exercises in migraine management: A systematic review. 偏头痛管理中的颈椎强化和稳定练习:系统综述。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-07-01 Epub Date: 2026-07-25 DOI: 10.1177/03331024261471179
Jennifer Burus, Denise R O'Dell, Cayla Robinson, Annabelle Holt, Johanna M Hoch
{"title":"Cervical strengthening and stabilization exercises in migraine management: A systematic review.","authors":"Jennifer Burus, Denise R O'Dell, Cayla Robinson, Annabelle Holt, Johanna M Hoch","doi":"10.1177/03331024261471179","DOIUrl":"10.1177/03331024261471179","url":null,"abstract":"<p><p>BackgroundPatients with migraine are frequently referred to physical therapy, particularly when neck pain is present or symptoms remain inadequately controlled with medical management. Cervical strengthening and stabilization exercises are commonly prescribed; however, the quality and consistency of supporting evidence remain unclear. This review evaluated the effectiveness and safety of cervical-focused exercise interventions for migraine.MethodsA systematic search of nine medical and rehabilitation databases identified studies evaluating cervical or upper-body strengthening and stabilization interventions in individuals aged ≥14 years with migraine diagnosed according to International Classification of Headache Disorders criteria. Eligible studies reported headache or disability outcomes. Methodological quality and risk of bias were assessed using the Downs and Black Checklist, CARE guidelines, and Cochrane Risk of Bias 2 tool. Random-effects meta-analyses were performed for headache frequency, headache intensity, and migraine-related disability.ResultsTwelve studies met inclusion criteria, including five randomized controlled trials, three observational studies, one case report, and three conference abstracts. Interventions varied in duration, supervision, and comparators. Meta-analysis demonstrated a moderate, statistically significant improvement in migraine-related disability (SMD=0.69; 95% CI, 0.19-1.18; I<sup>2</sup>=70.7%). Effects for headache frequency (SMD=0.61; 95% CI, -0.25-1.47; I<sup>2</sup>=73.7%) and headache intensity (SMD=0.41; 95% CI, -0.35-1.18; I<sup>2</sup>=74.1%) were not statistically significant. Observational studies reported within-group improvements.ConclusionsCervical strengthening and stabilization exercises may have potential for improving migraine-related disability; however, current evidence remains insufficient to establish clear benefit for migraine prevention outcomes. Findings are based on very low to low certainty evidence, limited by risk of bias and substantial heterogeneity. Future research should prioritize adequately powered, multicenter randomized controlled trials with rigorous methodology and standardized reporting to determine whether these interventions provide clinically meaningful benefit for individuals with migraine.Registration: Prospero IDCRD420251051356.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 7","pages":"3331024261471179"},"PeriodicalIF":5.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148590659","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
Treatment patterns and Reasons for Discontinuing Preventive Treatment in Cluster Headache: A prospective cohort study. 丛集性头痛的治疗模式和停止预防性治疗的原因:一项前瞻性队列研究。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-07-01 Epub Date: 2026-07-27 DOI: 10.1177/03331024261456265
Anja Sofie Petersen, Sophie Bryde Laursen, Marie-Louise Kulas Søborg, Mads Barløse, Rigmor Højland Jensen, Nunu Lund
{"title":"Treatment patterns and Reasons for Discontinuing Preventive Treatment in Cluster Headache: A prospective cohort study.","authors":"Anja Sofie Petersen, Sophie Bryde Laursen, Marie-Louise Kulas Søborg, Mads Barløse, Rigmor Højland Jensen, Nunu Lund","doi":"10.1177/03331024261456265","DOIUrl":"10.1177/03331024261456265","url":null,"abstract":"<p><p>BackgroundPharmacological prevention of cluster headache aims to reduce the frequency and intensity of attacks, but the long-term effect and tolerance of treatments remain uncertain. The aim of the study was twofold. First, to quantify the discontinuation rates of preventive treatment due to side effects; and second, to assess the proportion of verapamil responders who maintained preventive effectiveness at follow-up<b>.</b>MethodsIn total, 596 participants with cluster headache fulfilling the ICHD-criteria (the baseline cohort) completed a semi-structured interview between 2017 and 2023. Of these, 430 were re-interviewed after a median time of 4.6 years constituting the follow-up cohort.ResultsIn the baseline cohort, 457 participants (76.7%) had taken a preventive medicine for cluster headache. Among these, 123 (26.9%) had discontinued a treatment due to intolerable side effects. The discontinuation rate for the first-line treatment verapamil was 18%, whereas the second-line treatments with lithium or topiramate had been discontinued in nearly half. The odds of discontinuing due to intolerable side effects of lithium or topiramate therapy were four times higher than for verapamil (p < 0.0001).In the follow-up cohort, only 143 participants (33.3%) still received a preventive treatment at the time of the second interview. Of the initial 182 verapamil users, 77 (42.3%) continued, 54 (29.7%) had discontinued due to remission, and 51 (28%) discontinued due to intolerable side effects, lack of effect, or for other reasons. At follow-up including new users, a total of 91 participants were treated with verapamil and 50 of them (54.9%) were 50% responders.ConclusionEffective therapeutic prevention of cluster headache is hindered by intolerance and insufficient efficacy of the available preventives. Though verapamil remains effective over time for initial responders, there is a high rate of discontinuation due to side effects or lack of efficacy. Taken together with the low proportion of 50% responders, the findings underscore the need for new tolerable and effective preventive treatment for cluster headache.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 7","pages":"3331024261456265"},"PeriodicalIF":5.8,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148590640","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
SafeTy and effectiveness of Atogepant accoRding to the IHS outcome categories: A multicentric, prospective observational study in real life (the 24-week STAR study). 根据IHS结果分类,Atogepant的安全性和有效性:一项现实生活中的多中心、前瞻性观察性研究(24周STAR研究)。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 Epub Date: 2026-06-26 DOI: 10.1177/03331024261435922
Claudia Altamura, Luigi Francesco Iannone, Flavia Lo Castro, Gabriele Sebastianelli, Marilena Marcosano, Federico De Santis, Michele Corrado, Raffaele Ornello, Licia Grazzi, Danilo Antonio Montisano, Francesco De Cesaris, Antonio Munafò, Gianluca Avino, Michele Trimboli, Maria Albanese, Antonio Russo, Marcello Silvestro, Giorgio Dalla Volta, Marina Romozzi, Paolo Calabresi, Alberto Boccalini, Paola Merlo, Maria Pia Prudenzano, Maria Rosaria Valente, Innocenzo Rainero, Giada Giuliani, Marta Altieri, Luisa Fofi, Alberto Doretti, Gloria Vaghi, Francesca Pistoia, Delfina Ferrandi, Stefania Battistini, Gianluca Coppola, Simona Guerzoni, Simona Sacco, Cristina Tassorelli, Fabrizio Vernieri
{"title":"SafeTy and effectiveness of Atogepant accoRding to the IHS outcome categories: A multicentric, prospective observational study in real life (the 24-week STAR study).","authors":"Claudia Altamura, Luigi Francesco Iannone, Flavia Lo Castro, Gabriele Sebastianelli, Marilena Marcosano, Federico De Santis, Michele Corrado, Raffaele Ornello, Licia Grazzi, Danilo Antonio Montisano, Francesco De Cesaris, Antonio Munafò, Gianluca Avino, Michele Trimboli, Maria Albanese, Antonio Russo, Marcello Silvestro, Giorgio Dalla Volta, Marina Romozzi, Paolo Calabresi, Alberto Boccalini, Paola Merlo, Maria Pia Prudenzano, Maria Rosaria Valente, Innocenzo Rainero, Giada Giuliani, Marta Altieri, Luisa Fofi, Alberto Doretti, Gloria Vaghi, Francesca Pistoia, Delfina Ferrandi, Stefania Battistini, Gianluca Coppola, Simona Guerzoni, Simona Sacco, Cristina Tassorelli, Fabrizio Vernieri","doi":"10.1177/03331024261435922","DOIUrl":"10.1177/03331024261435922","url":null,"abstract":"<p><p>BackgroundThe improved prevention of migraine, driven by the introduction of calcitonin gene-related peptide (CGRP)-targeted therapies, has prompted the International Headache Society (IHS) to propose new goals in migraine management. This study aimed to evaluate the safety and effectiveness of atogepant for migraine prevention over 24 weeks, in accordance with the IHS-defined goals.MethodsThis is a multicenter, prospective, observational, real-world study on patients starting atogepant 60 mg for migraine prevention. We describe efficacy and safety outcomes at weeks 9-12 (T3) and 21-24 (T6) relative to baseline (T0) from the initiation of atogepant treatment. We also report the proportion of patients achieving migraine freedom, optimal, modest or insufficient control according to the IHS position paper categories.ResultsOne hundred twenty-eight (<i>n</i> = 128) patients (63 (49.2%) with chronic migraine, 115 (89.9%) female, aged 48.3 ± 13.3 years) from 17 centers were analyzed. Monthly migraine days decreased from 16.5 ± 8.5 at T0 to 8.0 ± 8.4 at T3 (<i>p</i> < 0.001 vs. T0) and 8.6 ± 9.2 at T6 (<i>p</i> < 0001 vs. T0, <i>p</i> = 0.265 compared to T3). Overall, 64.8% of patients were responders (at least 50% reduction in monthly migraine days from T0) at T3 and 61.7% at T6; 81.9% of responders at T3 maintained the responder status at T6, while 24.4% of patients among non-responders at T3 became responders at T6. At T3 and T6, 39.1% of the entire cohort achieved at least optimal migraine control (20.6% in chronic migraine and 56.9% in episodic migraine).ConclusionsThe STAR study demonstrates, in a real-world setting, the safety and the sustained effectiveness of atogepant 60 mg over 24 weeks and indicates that more than one-third of treated patients can achieve at least optimal disease control, with markedly better outcomes in episodic than in chronic migraine.Trial RegistrationThe study was preregistered on clinicaltrial.gov, NCT06414044.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261435922"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148337952","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
Weekend headache in migraine - fact or fiction? An observational study from DMKG-app data. 偏头痛的周末头痛——事实还是虚构?来自DMKG-app数据的观察性研究。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 Epub Date: 2026-06-18 DOI: 10.1177/03331024261444664
Ruth Ruscheweyh, Thomas Dresler, Gudrun Gossrau, Torsten Kraya, Lars Neeb, Bianca Raffaelli, Victoria Ruschil, Jörg Scheidt
{"title":"Weekend headache in migraine - fact or fiction? An observational study from DMKG-app data.","authors":"Ruth Ruscheweyh, Thomas Dresler, Gudrun Gossrau, Torsten Kraya, Lars Neeb, Bianca Raffaelli, Victoria Ruschil, Jörg Scheidt","doi":"10.1177/03331024261444664","DOIUrl":"10.1177/03331024261444664","url":null,"abstract":"<p><p>BackgroundIt has long been proposed that some individuals with migraine are especially prone to experience headache on weekends, however, results have been contradictory. Electronic headache diaries offer the possibility to analyze this question more thoroughly in larger populations.MethodsTwo non-overlapping samples of individuals with migraine from the DMKG-App electronic headache diary were investigated. Cluster analysis and logistic regression were performed to study existence, prevalence and predictive factors of weekend headache.ResultsWe included 1793 and 5840 patients with ≥35 headache day entries in the two samples (\"registry sample\" and \"app-only sample\"), respectively. In both samples, cluster analysis identified a cluster of patients with headache occurring preferably on weekends, accounting for 14-15% of all patients, and 18% of individuals with episodic migraine. Compared to the three other clusters identified (an early week cluster, a midweek cluster and a flat cluster without preference for a specific day), the weekend cluster was more frequent in working patients (p < 0.001, OR = 3.57 to 3.97) and in patients with lower headache frequencies (p < 0.001, OR = 0.86). A small association with older age (p < 0.001, OR = 1.01) was limited to the app-only sample. Longitudinal analysis showed that headache patterns of single patients were variable over time.ConclusionsResults from two large samples corroborate that there is a subgroup of individuals with migraine prone to weekend headache. Association with working status supports the notion that release from stress could be a trigger factor in these patients, although change in sleep, caffeine and alcohol intake and other factors might also contribute.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261444664"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148270503","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
Placebo or active comparator in chronic migraine trials: Balancing evidence and practicality. 慢性偏头痛试验中的安慰剂或活性比较物:平衡证据和实用性。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 Epub Date: 2026-06-25 DOI: 10.1177/03331024261439282
Nancy van Veelen, Raffaele Ornello, Gisela M Terwindt, Simona Sacco
{"title":"Placebo or active comparator in chronic migraine trials: Balancing evidence and practicality.","authors":"Nancy van Veelen, Raffaele Ornello, Gisela M Terwindt, Simona Sacco","doi":"10.1177/03331024261439282","DOIUrl":"10.1177/03331024261439282","url":null,"abstract":"<p><p>This debate addresses the choice of placebo versus active comparator in randomized controlled trials (RCTs) for chronic migraine (CM), a disabling condition with high global burden. Placebo-controlled designs have traditionally been considered the gold standard for new treatments, allowing quantification of placebo and pharmacological effects, ensuring internal validity, smaller sample sizes, and regulatory acceptance. Yet, ethical concerns arise from the possibility that participants may be denied effective treatments. The emergence of migraine-specific therapies targeting the calcitonin gene-related peptide (CGRP) pathway has prompted calls for active comparator designs. Such trials may enhance clinical relevance, support recruitment, and better mirror clinical practice compared with placebo-controlled RCTs. However, defining a universal standard of care may be challenging given global disparities in access, cost, and treatment preferences, limiting the feasibility of RCTs with active comparators. Placebo-controlled trials remain valuable, but alternative strategies, including short placebo phases with open-label extensions, add-on designs, or three-arm trials (investigational treatment, placebo, active comparator) may reconcile scientific rigor with ethical considerations. Ultimately, the optimal trial design depends on the research question, regulatory requirements, and evolving definitions of standard care in CM prevention.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261439282"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148316006","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
Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis. 生物反馈辅助放松治疗偏头痛的预测因素:一项探索性分析。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 DOI: 10.1177/03331024261441579
Kristin L Szuhany, Julia Dorf, Ryan C Bostic, Kristina M Fanning, Mia T Minen
{"title":"Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis.","authors":"Kristin L Szuhany, Julia Dorf, Ryan C Bostic, Kristina M Fanning, Mia T Minen","doi":"10.1177/03331024261441579","DOIUrl":"10.1177/03331024261441579","url":null,"abstract":"&lt;p&gt;&lt;p&gt;BackgroundFew studies have examined which patients with migraine might be responders for mind-body interventions. Thus, we examined whether certain baseline mindfulness traits and interest in physical exercise might predict response to treatment.MethodsThis is a planned exploratory analysis of a phase 2 randomized controlled study (&lt;i&gt;N&lt;/i&gt;  =  50; 25 per arm) comparing a 6-week physical therapist (PT)-delivered biofeedback-assisted relaxation (BAR) program vs. an Enhanced Usual Care (EUC) migraine self-management program (diary tracking and emailed migraine-related educational materials). We conducted moderation analyses to determine whether the Multidimensional Assessment of Interoceptive Awareness (MAIA), Difficulties in Emotion Regulation Scale (DERS) and Physical Activity Enjoyment Scale (PACES) at baseline influenced the effect of BAR on migraine-related outcomes (Migraine-Specific Quality of Life Role Function Restrictive (MSQv2.1-RFR) and Migraine-Related Disability (MIDAS)) at 6 months.ResultsAmong the &lt;i&gt;n&lt;/i&gt; = 40 participants (BAR = 19; EUC = 21), the majority were female (95%), non-Hispanic (77.5%) and white (67.5%). Mean (SD) age was 45.6 (11.2) years. For the MAIA Not-Worrying subscale, BAR produced the greatest improvement in 6-month MSQv2.1-RFR scores among participants with low baseline Not-Worrying scores (those who tended to worry about bodily sensations/discomfort more) (BAR = 77.1 ± 6.6 vs. EUC = 48.9 ± 5.0; &lt;i&gt;p&lt;/i&gt; = 0.002, &lt;i&gt;g&lt;/i&gt; = 4.75). The benefit diminished at average levels (&lt;i&gt;p&lt;/i&gt; = 0.060, &lt;i&gt;g&lt;/i&gt; = 2.72) and was absent at high baseline Not-Worrying (&lt;i&gt;p&lt;/i&gt; = 0.528, &lt;i&gt;g&lt;/i&gt; =  -0.91). For the MAIA Self-Regulation subscale, BAR was most effective among those low in baseline self-regulation (BAR = 71.7 ± 5.3 vs. EUC = 44.3 ± 7.2; &lt;i&gt;p&lt;/i&gt; = 0.004, &lt;i&gt;g&lt;/i&gt; = 4.27). The DERS total score showed that BAR demonstrated little benefit among participants with better baseline emotion regulation (i.e. lower DERS score; &lt;i&gt;p&lt;/i&gt; = 0.907, &lt;i&gt;g&lt;/i&gt; = 0.17) but was more effective as baseline emotion regulation difficulties increased, showing a moderate benefit at average levels (BAR = 69.2 ± 4.2 vs. EUC = 55.8 ± 4.0, &lt;i&gt;p&lt;/i&gt; = 0.027, &lt;i&gt;g&lt;/i&gt; = 3.25) and a large, significant difference at high levels (BAR = 70.6 ± 6.3 vs. EUC = 44.7 ± 5.7; &lt;i&gt;p&lt;/i&gt; = 0.004, &lt;i&gt;g&lt;/i&gt; = 4.22). The PACES total score indicated that BAR benefits were strongest among those with low (BAR = 76.1 ± 7.0 vs. EUC = 47.1 ± 5.3, &lt;i&gt;p&lt;/i&gt; = 0.002, &lt;i&gt;g&lt;/i&gt; = 4.60) to average (BAR = 71.2 ± 4.2 vs. EUC = 58.6 ± 4.0, &lt;i&gt;p&lt;/i&gt; = 0.035, &lt;i&gt;g&lt;/i&gt; = 3.07) enjoyment of physical activity.ConclusionsWe found subgroups of individuals with migraine who may be better responders to PT-delivered BAR, specifically those who tend to worry more about bodily sensations (lower MAIA Not-Worrying score), those with low self-regulation (lower MAIA Self-Regulation score), those with worse emotion regulation (higher DERS score) and those with lower levels of physical acti","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261441579"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148136810","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
Is achieving higher standards in real-world migraine care feasible with anti-CGRP monoclonal antibodies preventive therapies?: Insights from the EUREkA cohort. 抗cgrp单克隆抗体预防治疗在实际偏头痛治疗中达到更高的标准是否可行?:来自EUREkA队列的见解。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 Epub Date: 2026-06-19 DOI: 10.1177/03331024261440370
Edoardo Caronna, Rut Mas-de-Les-Valls, Gabriella Egeo, Manuel Millán Vázquez, Candela Nieves Castellanos, Javier A Membrilla, Gloria Vaghi, Joana Rodríguez-Montolio, Neus Fabregat Fabra, Francisco Sánchez Caballero, Alex Jaimes, Albert Muñoz-Vendrell, Renato Oliveira, Gabriel Gárate, Yesica González Osorio, Daniel Guisado-Alonso, Raffaele Ornello, Cem Thunstedt, Iris Fernández-Lázaro, Antonio Sánchez-Soblechero, Andreas Kattem Husøy, Beatriz Nunes Vicente, Hauke Basedau, Nuria Pilar Riesco Pérez, Belen Flores Pina, Catarina Fernandes, Alberto Andrés-López, Elisa Martins-Silva, Sławomir Budrewicz, Pablo Ros Arlanzón, André Caetano, Victor José Gallardo, Laura Gómez-Dabó, Marta Torres-Ferrús, Alicia Alpuente, Paola Torelli, Cinzia Aurilia, Silvana Zapata, Raquel Lamas Pérez, Maria José Ruiz Castrillo, Roberto De Icco, Grazia Sances, Sarah Broadhurst, Hui Ching Ong, Jed Winstanley, Sonsoles Aranceta, Izaro Kortazar Zubizarreta, Amalia Echeverria Urabayen, Andrea Gómez García, Sergio Campoy, Inês Marques, Elsa Parreira, Vicente González-Quintanilla, Ángel Luis Guerrero-Peral, Isabel Miró, Julia Peris-Subiza, Valeria Caponnetto, Andreas Straube, Alicia Gonzalez-Martinez, Sonia Quintas, Margarita Sánchez-Del-Río, Erling Tronvik, Begoña Venegas Pérez, Agustin Oterino Durán, Miguel Rodrigues, Ana Fries Ramos, Yago Vaamonde Esteban, Sabina Cevoli, Bruno Colombo, Michele Trimboli, Fabio Frediani, Florindo d'Onofrio, Marco Aguggia, Antonio Salerno, Antonio Carnevale, Maurizio Zucco, Maria Albanese, Cinzia Finocchi, Angelo Ranieri, Francesco Zoroddu, Massimo Autunno, Jordi Sanahuja, Gonçalo Cabral, Isabel Beltrán Blasco, Marta Waliszewska-Prosół, Liliana Pereira, Almudena Layos-Romero, Isabel Luzeiro, Laura Dorado, Maria Rocio Álvarez Escudero, Arne May, Alba López-Bravo, Isabel Pavão Martins, Christina Sundal, Pablo Irimia, Alberto Lozano Ros, Ana Beatriz Gago-Veiga, Fernando Velasco Juanes, Ruth Ruscheweyh, Simona Sacco, Elisa Cuadrado-Godia, David García-Azorín, Julio Pascual, Raquel Gil-Gouveia, Mariano Huerta-Villanueva, Jaime Rodriguez-Vico, Javier Viguera Romero, Victor Obach, Sonia Santos-Lasaosa, Mona Ghadiri-Sani, Cristina Tassorelli, Javier Díaz-de-Terán, Samuel Díaz Insa, Carmen González Oria, Piero Barbanti, Patricia Pozo-Rosich
{"title":"Is achieving higher standards in real-world migraine care feasible with anti-CGRP monoclonal antibodies preventive therapies?: Insights from the EUREkA cohort.","authors":"Edoardo Caronna, Rut Mas-de-Les-Valls, Gabriella Egeo, Manuel Millán Vázquez, Candela Nieves Castellanos, Javier A Membrilla, Gloria Vaghi, Joana Rodríguez-Montolio, Neus Fabregat Fabra, Francisco Sánchez Caballero, Alex Jaimes, Albert Muñoz-Vendrell, Renato Oliveira, Gabriel Gárate, Yesica González Osorio, Daniel Guisado-Alonso, Raffaele Ornello, Cem Thunstedt, Iris Fernández-Lázaro, Antonio Sánchez-Soblechero, Andreas Kattem Husøy, Beatriz Nunes Vicente, Hauke Basedau, Nuria Pilar Riesco Pérez, Belen Flores Pina, Catarina Fernandes, Alberto Andrés-López, Elisa Martins-Silva, Sławomir Budrewicz, Pablo Ros Arlanzón, André Caetano, Victor José Gallardo, Laura Gómez-Dabó, Marta Torres-Ferrús, Alicia Alpuente, Paola Torelli, Cinzia Aurilia, Silvana Zapata, Raquel Lamas Pérez, Maria José Ruiz Castrillo, Roberto De Icco, Grazia Sances, Sarah Broadhurst, Hui Ching Ong, Jed Winstanley, Sonsoles Aranceta, Izaro Kortazar Zubizarreta, Amalia Echeverria Urabayen, Andrea Gómez García, Sergio Campoy, Inês Marques, Elsa Parreira, Vicente González-Quintanilla, Ángel Luis Guerrero-Peral, Isabel Miró, Julia Peris-Subiza, Valeria Caponnetto, Andreas Straube, Alicia Gonzalez-Martinez, Sonia Quintas, Margarita Sánchez-Del-Río, Erling Tronvik, Begoña Venegas Pérez, Agustin Oterino Durán, Miguel Rodrigues, Ana Fries Ramos, Yago Vaamonde Esteban, Sabina Cevoli, Bruno Colombo, Michele Trimboli, Fabio Frediani, Florindo d'Onofrio, Marco Aguggia, Antonio Salerno, Antonio Carnevale, Maurizio Zucco, Maria Albanese, Cinzia Finocchi, Angelo Ranieri, Francesco Zoroddu, Massimo Autunno, Jordi Sanahuja, Gonçalo Cabral, Isabel Beltrán Blasco, Marta Waliszewska-Prosół, Liliana Pereira, Almudena Layos-Romero, Isabel Luzeiro, Laura Dorado, Maria Rocio Álvarez Escudero, Arne May, Alba López-Bravo, Isabel Pavão Martins, Christina Sundal, Pablo Irimia, Alberto Lozano Ros, Ana Beatriz Gago-Veiga, Fernando Velasco Juanes, Ruth Ruscheweyh, Simona Sacco, Elisa Cuadrado-Godia, David García-Azorín, Julio Pascual, Raquel Gil-Gouveia, Mariano Huerta-Villanueva, Jaime Rodriguez-Vico, Javier Viguera Romero, Victor Obach, Sonia Santos-Lasaosa, Mona Ghadiri-Sani, Cristina Tassorelli, Javier Díaz-de-Terán, Samuel Díaz Insa, Carmen González Oria, Piero Barbanti, Patricia Pozo-Rosich","doi":"10.1177/03331024261440370","DOIUrl":"10.1177/03331024261440370","url":null,"abstract":"<p><p>BackgroundThe International Headache Society has proposed new treatment goals for migraine prevention in real world, as a way to set higher standards of care. This study provides the first assessment of the proportion of individuals achieving them after 6 months of migraine-specific treatment with anti-CGRP monoclonal antibodies (MAbs).MethodsThis was a prospective, real-world, European multicenter study, including adults with migraine treated with anti-CGRP MAbs (EUREkA cohort). We assessed the proportions of individuals in each treatment goal category-migraine freedom (no monthly migraine days [MMD]); optimal control (< 4 MMD), modest control (4-6 MMD); insufficient control (>6 MMD)-after 6 months of treatment. We also assessed the proportion of individuals with ≥50% reduction in MMD in the insufficient control group.ResultsOf the 5818 individuals in the EUREkA cohort, 4963 had 6 months data. Of these, 82.3% (4086/4963) were females and the median age was 48.0 [40.0-55.0] years. At baseline, the median monthly headache days [MHD] and MMD were 20.0 [13.3-28.0] and 15.0 [10.0-20.0], respectively. All participants were classified as having insufficient headache control (>6 MMD) at baseline. At month 6, 6.9% (342/4963) had migraine freedom, 22.9% (1137/4963) optimal control, 24.6% (1223/4963) modest control and 45.6% (2261/4963) insufficient control. In the insufficient control group, 27.1% (613/2261) had ≥50% reduction in MMD.ConclusionsHigh standards of care, defined as optimal disease control or even migraine freedom, are achieved in real-world settings with anti-CGRP MAbs in approximately 30% of individuals with a high migraine burden. These findings highlight the need to expand global access to these treatments. Future studies should explore whether initiating migraine-specific preventive treatments earlier could further reduce residual migraine days in responders, enabling a larger proportion of patients to achieve optimal disease control.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261440370"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148276303","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
Optimized and validated clinical diagnostic criteria for burning mouth syndrome. 优化并验证了灼口综合征的临床诊断标准。
IF 5.8 2区 医学
Cephalalgia Pub Date : 2026-06-01 Epub Date: 2026-06-04 DOI: 10.1177/03331024261455835
Mohamed El-Rubaiy, Thomas List, Anna Truedsson, Jean-Paul Goulet, Peter Svensson, Per Alstergren
{"title":"Optimized and validated clinical diagnostic criteria for burning mouth syndrome.","authors":"Mohamed El-Rubaiy, Thomas List, Anna Truedsson, Jean-Paul Goulet, Peter Svensson, Per Alstergren","doi":"10.1177/03331024261455835","DOIUrl":"10.1177/03331024261455835","url":null,"abstract":"<p><p>ObjectivesBurning mouth syndrome (BMS) is defined as a chronic intraoral burning sensation occurring in the absence of identifiable local or systemic causes. Several classification systems have proposed diagnostic criteria for BMS, including the International Classification of Headache Disorders (ICHD-3), the International Classification of Diseases (ICD-11), the International Classification of Orofacial Pain (ICOP-1), and the World Congress of Oral Medicine (WCOM). However, none of these have been validated. This study aims to evaluate the diagnostic performance of ICHD-3, ICD-11, ICOP-1, and WCOM criteria for BMS and to suggest optimized diagnostic criteria.MethodsWe assessed 76 consecutive patients referred for burning oral pain. Of these, 34 (28 women) were diagnosed with BMS according to the reference standard, and 42 (37 women) had other oral mucosal pain conditions. Two control groups were also recruited: 31 TMD patients (28 women) and 30 pain-free participants (26 women). Assessment involved self-report questionnaires and comprehensive clinical examinations. All patients with burning oral pain underwent additional laboratory tests. Consensus-based diagnosis constituted the reference standard, and a blinded examiner applied each set of different diagnostic criteria as the index tests. We calculated sensitivity, specificity, positive (PPV) and negative predictive values (NPV), and positive and negative likelihood ratios (LR + and LR-), and the area under the ROC curve for each index tests. Because some ICHD-3 criteria were ambiguously defined, we created operational definitions and tested three versions of the criteria.ResultsNo significant group differences were found in age, sex, or smoking status. None of the criteria exhibited both high sensitivity and specificity. WCOM showed the highest sensitivity (91.2%), NPV (99.2%), LR- (0.14), and AUC (0.717). In contrast, ICHD-3 definition 3 showed the highest specificity (93.2%), PPV (8.2%), and LR + (5.2), but the lowest sensitivity (35.3%). Based on these findings, we developed an optimized version of the ICOP criteria. The new criteria showed the highest sensitivity (94.1%), NPV (99.9), LR- (0.07), and AUC (0.874), while maintaining acceptable specificity (79.6%), PPV (7.4%), and LR + (4.4).ConclusionSubstantial variation exists in the diagnostic performance of current BMS criteria, with each set showing either high sensitivity or specificity. This study provides the first data-driven proposal for modified diagnostic criteria for BMS, offering a foundation for improving future versions of ICHD and ICOP.</p>","PeriodicalId":10075,"journal":{"name":"Cephalalgia","volume":"46 6","pages":"3331024261455835"},"PeriodicalIF":5.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148162077","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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