Headache最新文献

{"title":"A post hoc analysis of migraine-associated symptoms from the phase 3 randomized, double-blind, sham-controlled Trial of External trigeminal nerve stimulation for the Acute treatment of Migraine (TEAM) study.","authors":"Gregory A Panza, Michael A L Johnson, Deena E Kuruvilla","doi":"10.1111/head.14860","DOIUrl":"https://doi.org/10.1111/head.14860","url":null,"abstract":"<p><strong>Background: </strong>The Trial of External trigeminal nerve stimulation (eTNS) for the Acute treatment of Migraine (TEAM) study demonstrated that eTNS use during active migraine resulted in significantly higher rates of resolution of migraine-associated most bothersome symptom (MBS) compared to sham. However, no previous studies have examined the association between pretreatment MBS subtype and efficacy of eTNS treatment for active migraine.</p><p><strong>Objective: </strong>We conducted a post hoc analysis examining efficacy of eTNS for different pretreatment MBS subtypes using TEAM study data.</p><p><strong>Methods: </strong>Pretreatment MBS subtypes included photophobia (n = 345), nausea (n = 109), phonophobia (n = 73), and vomiting (n = 11). We examined MBS sub-group × treatment group (verum n = 259; sham n = 279) interaction for each post-treatment outcome to explore differential effects conditional on the total sample. We further explored direct, between treatment group comparisons for each MBS subtype, as well as compared treatment outcomes among all MBS subtypes within the sham, verum, and total sample. Finally, clinical heterogeneity of treatment effect (HTE) was assessed using a 1% absolute treatment effect difference as the clinically important threshold.</p><p><strong>Results: </strong>Significant sub-group × treatment interactions were found for resolution of MBS at 2 h (p = 0.008), pain relief at 2 h (p = 0.001), rescue medication between 2 and 24 h (p = 0.012), sustained pain freedom at 24 h (p = 0.033), and sustained pain relief at 24 h (p = 0.003). Significant sub-group × treatment interactions were not found for pain freedom at 2 h (p = 0.054) or absence of all symptoms at 2 h (p = 0.265). Between treatment group comparisons indicated that pain freedom after 2 h of eTNS was not significantly different between the verum and sham groups for any pretreatment MBS. The verum group had a significantly greater proportion of participants who had resolution of nausea MBS after 2 h of treatment compared to sham (37/55 [67.3%] vs. 25/54 [46.3%], respectively; p = 0.028) and resolution of photophobia MBS compared to sham (85/162 [52.5] vs. 71/183 [38.8%], respectively; p = 0.011). There were no significant differences between treatment groups for phonophobia or vomiting. Pain freedom after 2 h of eTNS was not significantly different among pretreatment MBS groups. Within the sham group and total sample, a greater proportion of participants who had vomiting MBS had resolution of their MBS compared to any other pretreatment MBS (p < 0.05 after Bonferroni adjustment). A greater proportion of participants with nausea MBS used rescue medications between 2 and 24 h after eTNS compared to participants with photophobia or phonophobia MBS within the verum and total sample (p < 0.05 after Bonferroni adjustment). No statistical differences were found among MBS groups for any other treatment outcomes. Clinically important HTE was present in v","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142728018","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}

{"title":"Group text messaging as a residency teaching tool in outpatient neurology and headache: A mixed-methods observational study.","authors":"Anjeli Song, Joseph E Safdieh, Matthew S Robbins","doi":"10.1111/head.14870","DOIUrl":"https://doi.org/10.1111/head.14870","url":null,"abstract":"<p><strong>Objective: </strong>To assess the feasibility and efficacy of group text messaging as a teaching tool to improve neurology resident knowledge and clinical pearl dissemination in an outpatient setting enriched with headache encounters, and to evaluate if learning points from this teaching method would influence resident care of subsequent patients.</p><p><strong>Background: </strong>Inpatient neurology teaching during training is most often accomplished in team settings during rounds or conferences such as morning report, but outpatient teaching where headache is more likely encountered may be less consistently performed in such a setting where learning points may be shared. Few studies have evaluated whether group text messaging can be an innovative tool for teaching in residency training.</p><p><strong>Methods: </strong>Neurology residents in a continuity clinic pod at New York Presbyterian-Weill Cornell were included in this cohort from December 2020 through March 2024. Group text messages deidentified of any patient information were sent to the resident pod by their preceptor after each clinic session featuring one text message regarding a takeaway learning point pertaining to each patient encounter. Residents were surveyed on their satisfaction with this teaching method and whether these text messages improved their outpatient neurology knowledge.</p><p><strong>Results: </strong>A total of 230 text messages were sent to a cohort of 21 residents across 4 academic years. Text message topics covered a variety of neurological subspecialties, most commonly headache and facial pain (44.8%), general neurology (15.7%), and neuromuscular (14.3%). In our survey, 93% of resident respondents reported that receiving clinical pearls improved their outpatient neurology knowledge and changed how they cared for subsequent patients.</p><p><strong>Conclusion: </strong>Reinforcement of traditionally one-on-one learning points in a teaching outpatient setting to engage a group of residents was feasible across visit types. There was an overall very positive response to this teaching method, and residents reported improved knowledge, which influenced their care of subsequent patients.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142728037","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}

{"title":"Validity, reliability, and sensitivity to change of the Arabic version of the Migraine-Specific Quality-of-Life Questionnaire after prophylactic treatment.","authors":"Mona Hussein, Amr Hassan, Mona A F Nada, Zeinab Mohammed, Wael Fathy, Nawal F Abdel Ghaffar, Hanaa Kedah, Rehab Magdy","doi":"10.1111/head.14874","DOIUrl":"https://doi.org/10.1111/head.14874","url":null,"abstract":"<p><strong>Background: </strong>The Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ 2.1) is one of the most frequently used tools in assessing the impact of migraine in clinical practice and in migraine research. This work aimed to examine the reliability and validity of the Arabic version of the MSQ 2.1 in Arabic-speaking patients with migraine and to assess its ability to detect subtle changes in quality of life after receiving prophylactic migraine medications.</p><p><strong>Methods: </strong>This multicenter prospective observational study was conducted with 140 patients experiencing migraine and indicated for prophylactic medications. Headache assessment was done at baseline and 3 months after receiving prophylactic medications using the Arabic version of MSQ 2.1, Headache Impact Test (HIT-6), and visual analog scale (VAS). The MSQ 2.1 was repeated 1 week after the first visit to a group of patients (n = 70) to assess test-retest reliability.</p><p><strong>Results: </strong>Cronbach's alpha for the MSQ 2.1 was 0.973, indicating excellent internal consistency. The intraclass correlation coefficient (average measure) was 0.99, indicating excellent test-retest reliability. There were statistically significant correlations between the MSQ 2.1 total score and monthly migraine days, VAS, and HIT-6 scores before and 3 months after prophylactic medications. The receiver operating characteristic curve revealed that an increase of 8.5 in the total score of the MSQ 2.1 represents the minimally important change that means significant improvement (area under the curve = 0.785, sensitivity = 0.861, specificity = 0.656, p < 0.001).</p><p><strong>Conclusion: </strong>The Arabic version of the MSQ 2.1 is a valid, reliable, and sensitive tool that can precisely assess the impact of migraine on quality of life.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142727989","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}

{"title":"Occipital neuralgia as an initial manifestation of atypical Lemierre syndrome: A case report.","authors":"Akira Hanazono, Keita Yasuda, Atsuyoshi Nagata, Toshiharu Kitamura, Masashiro Sugawara","doi":"10.1111/head.14876","DOIUrl":"https://doi.org/10.1111/head.14876","url":null,"abstract":"<p><p>Lemierre syndrome is a life-threatening but treatable septic thrombosis of the internal jugular vein (IJV) derived from a craniocervical bacterial infection. Metastatic septic embolization is common. However, diagnostic delay and poor prognosis remain a problem, largely due to the diverse clinical presentations and unclear symptomatology of Lemierre syndrome. In contrast, occipital neuralgia is a common disease typically treated with symptomatic therapy in emergency settings, as most cases are not life-threatening. The present case involved a 70-year-old female with Lemierre syndrome stemming from Streptococcus anginosus infection originating in sinusitis or periodontitis. The onset was characterized by headache with typical occipital neuralgia, a severe trigger point in the posterior neck ipsilateral to the infected IJV, and reduced sensation of the C2 nerve root area. Given the anatomical relationship of the cranial venous emissary system into the posterior cervical venous plexus, the case highlights the potential for the neighboring occipital nerve to be directly involved in Lemierre syndrome. Interestingly, despite Lemierre syndrome typically arising from pharyngeal bacterial infections and infected IJV located in the \"anterior\" neck, many prior case reports have described \"occipital\" or \"posterior\" pain at the head or neck. History taking and physical examination remain essential to identify the causes of these posterior/occipital symptoms, since imaging investigations, as in this case, often fail to identify them. Early recognition of occipital neuralgia as a potential initial symptom of Lemierre syndrome could lead to earlier diagnosis and treatment, potentially improving patient outcomes.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686899","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}

{"title":"Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study.","authors":"Jessica Ailani, Richard B Lipton, Andrew M Blumenfeld, Laszlo Mechtler, Brad C Klein, Molly Yizeng He, Jonathan H Smith, Joel M Trugman, Rosa de Abreu Ferreira, Elimor Brand-Schieber","doi":"10.1111/head.14871","DOIUrl":"https://doi.org/10.1111/head.14871","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine (EM).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the preventive treatment of migraine in adults and ubrogepant is an oral CGRP receptor antagonist approved for the acute treatment of migraine in adults, with or without aura. The safety and tolerability of the concomitant use of ubrogepant and atogepant have not been previously evaluated in a clinical setting.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The TANDEM study, a phase 4, two-period, multicenter, open-label study conducted in the United States, enrolled adults with migraine, with or without aura, and &lt;15 headache days/month. In Treatment Period 1, participants took atogepant 60 mg once daily (QD) for 12 weeks and their own non-gepant acute headache medication for breakthrough migraine attacks. In Treatment Period 2, participants continued taking atogepant 60 mg QD and ubrogepant 100 mg was taken as needed (PRN) for the treatment of breakthrough migraine attacks (up to eight per 4-week interval) for 12 weeks. In Treatment Period 2, an optional second ubrogepant dose or the participant's own acute medication could be used to rescue headaches that did not resolve within 2-24 h post initial ubrogepant dose. The primary objective evaluated the safety and tolerability of the concomitant use of ubrogepant and atogepant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 263 participants enrolled, 262 were treated in Treatment Period 1 (Safety Population 1) and 218 continued and were treated in Treatment Period 2 (Safety Population 2). The mean (standard deviation) number of ubrogepant use days in Treatment Period 2 was 6.6 (5.03) over the 12 weeks. In Treatment Periods 1 and 2, 49.6% and 43.1% of participants experienced a treatment-emergent adverse event (TEAE), respectively. The most common TEAEs (≥5%) in Treatment Period 1 and Treatment Period 2 were COVID-19 (8.4%, 3.2%), fatigue (6.5%, 1.4%), nausea (6.1%, 0.9%), decreased appetite (5.7%, 0.9%), and constipation (5.3%, 0.9%). In Treatment Period 2, no increase in the incidence and types of TEAEs in relation to the number of ubrogepant use days or doses taken were identified. During the whole treatment period, 9.9% of participants discontinued atogepant or ubrogepant treatment due to TEAEs. There was one serious TEAE in Treatment Period 1 (ureterolithiasis) and one in Treatment Period 2 (cervical myelopathy), and both were considered not related to study treatment by the study investigators.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The use of atogepant 60 mg QD for the preventive treatment of EM and ubrogepant 100 mg PRN for the acute treatment of migraine over the 12-week open-label concomitant use treatment period was safe and well tolerated. The overall safety results were consistent wit","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681698","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}

{"title":"Associations of comorbid headache disorders and depression with leisure-time physical activity among 14,088 adults in The Brazilian Longitudinal Study of Adult Health.","authors":"Arão Belitardo de Oliveira, Mario Fernando Prieto Peres, Juliane Prieto Peres Mercante, André R Brunoni, Yuan-Pang Wang, Maria Del Carmen B Molina, Lucas K Uchiyama, Paulo A Lotufo, Isabela M Benseñor, Alessandra C Goulart","doi":"10.1111/head.14868","DOIUrl":"https://doi.org/10.1111/head.14868","url":null,"abstract":"<p><strong>Background: </strong>While headache disorders are linked to low physical activity levels, the impact of depression on this relationship is unclear.</p><p><strong>Objective: </strong>To assess how single and comorbid diagnoses of migraine and tension-type headache (TTH) interact with depression and leisure-time physical activity (LTPA) levels in The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).</p><p><strong>Methods: </strong>In this cross-sectional analysis based on the ELSA-Brasil baseline data, the relationship of migraine, TTH (both assessed with the International Classification of Headache Disorders, Second Edition), and depression (assessed with the Clinical Interview Schedule-Revised) with LTPA levels (International Physical Activity Questionnaire) was investigated by employing linear regression models. Models were adjusted for sociodemographic, lifestyle, and clinical covariates, and interaction terms were created to examine additive effects of comorbid conditions.</p><p><strong>Results: </strong>Among 14,088 participants, 54.4% (7668/14,088) were female, prevalence rates were: TTH = 39.6% (5573/14,088), migraine = 27.0% (3806/14,088), depression = 0.7% (94/14,088), depression + TTH = 1.1% (148/14,088), and depression + migraine = 2.5% (356/14,088). The mean (standard deviation) LTPA levels across the groups were: no headache + no depression = 148.7 (183.0) min/week, TTH = 133.5 (170.1) min/week, migraine = 110.3 (154.8) min/week, depression = 76.5 (146.3) min/week, depression + TTH = 84.5 (127.7) min/week, and depression + migraine = 64.3 (123.2) min/week. Negative associations were found for depression (β = -55.1, 95% confidence interval [CI] -93.6 to -17.0; p = 0.005), migraine (β = -24.7, 95% CI -33.2 to -15.4; p < 0.001), and TTH (β = -15.5, 95% CI -23.1 to -7.6; p < 0.001) with LTPA. No interaction effect was observed for depression + TTH (β = 36.0, 95% CI -12.6 to 84.6; p = 0.147) and depression + migraine (β = 31.7, 95% CI -11.3 to 74.7; p = 0.149), indicating no additive effect of comorbid conditions on LTPA levels. After adjusting for headache attack frequency, only depression + migraine remained negatively associated with LTPA (β = -38.7, 95% CI -71.6 to -5.8; p = 0.021).</p><p><strong>Conclusions: </strong>Headache disorders and depression were independently and inversely associated with LTPA, with the strongest effects seen in depression alone or comorbid with migraine.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142618744","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}

{"title":"The safety and efficacy of onabotulinumtoxinA injections for children and adolescents with chronic migraine: A systematic review and meta-analysis.","authors":"Rebecca Lindsay, Amira Kalifa, Jonathan Kuziek, Marielle Kabbouche, Andrew D Hershey, Serena L Orr","doi":"10.1111/head.14798","DOIUrl":"10.1111/head.14798","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To qualitatively and quantitatively summarize the evidence for the use of onabotulinumtoxinA injections in children and adolescents with migraine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There are limited evidence-based treatment options for youth with migraine, especially youth with chronic migraine (CM). OnabotulinumtoxinA injections are an established evidence-based treatment for adults with CM. While several studies have assessed their safety and efficacy among adolescents with CM, there are no published systematic reviews summarizing the pediatric evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We carried out a systematic review, reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis, aiming to identify studies that included five or more children and adolescents aged ≤18 years with a diagnosis of migraine, who were treated with ≥50 units (U) of onabotulinumtoxinA and had outcomes assessed ≥4 weeks after one or more injection cycle. Both observational studies and randomized controlled trials (RCTs) were eligible for inclusion. Two investigators independently carried out the first (titles and abstracts) and second (full text) screening stages, as well as data extraction and quality appraisal. The American Academy of Neurology risk of bias grading scheme was used to assess study risk of bias. Studies with adequate data were pooled using random effects meta-analyses, and Hedge's g standardized mean differences with 95% confidence intervals (CIs) were generated to estimate the effect sizes of the continuous outcomes included. Studies lacking data required for meta-analysis were summarized qualitatively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We screened 634 studies and included 14 studies comprising 491 participants, of whom 489 had CM. Two studies were RCTs, 12 were observational uncontrolled studies, and all but one study included only youth with CM. Five Class IV observational uncontrolled studies were amenable to pooling in meta-analyses. After a mean of 2-2.6 injection cycles, headache frequency was shown to decrease significantly after treatment with onabotulinumtoxinA (Hedge's g = 0.97, 95% CI 0.58-1.35; p &lt; 0.0001), as did severity (Hedge's g = 1.24, 95% CI 0.55-1.94; p = 0.0005), with both estimates having a large effect size magnitude. A Class I parallel-group RCT of one injection series (155 U, 74 U, or placebo), powered to detect a change in 4 headache days per month, did not find outcome differences between the active and placebo treatment arms. A Class IV crossover RCT showed superiority of active (155 U) versus placebo injections. The remaining Class IV observational studies that were excluded from the meta-analyses all showed improved outcomes with onabotulinumtoxinA injections over time. No serious adverse events related to treatment occurred.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;OnabotulinumtoxinA injections have established safety for use in children and adolescents with CM and ar","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1200-1216"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916575","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}

{"title":"The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study.","authors":"Chunmei Zhao, Niti Shrestha, Hao Ren, Baohui Zhang, Ying Shen, Lan Meng, Dasheng Wu, Baoguo Wang, Bifa Fan, Fang Luo","doi":"10.1111/head.14814","DOIUrl":"10.1111/head.14814","url":null,"abstract":"<p><strong>Objective: </strong>To explore the efficacy and safety of 5% lidocaine-medicated plaster (LMP) in patients with trigeminal neuralgia (TN).</p><p><strong>Background: </strong>TN is an excruciatingly painful type of neuropathic facial pain. Anti-epileptics are the first-line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high-quality clinical studies have explored the effect and safety of LMP in patients with TN.</p><p><strong>Methods: </strong>The PATCH trial is an enriched enrollment with randomized withdrawal, double-blind, vehicle-controlled, parallel-group trial performed at five study centers. Eligible patients with TN received LMP during a 3-week initial open-label phase. Patients who met the response criteria entered the double-blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double-blind treatment phase, and treatment was continued in the remaining patients for up to 28 days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double-blind phase and the weekly mean pain severity in both the open-label phase and the double-blind phase of the study.</p><p><strong>Results: </strong>The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open-label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double-blind phase. In the double-blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double-blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log-rank p < 0.001). LMP also significantly reduced the weekly mean pain severity in the double-blind phase of the study (p = 0.007).</p><p><strong>Conclusions: </strong>LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add-on therapy in a multidrug treatment protocol.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1318-1328"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142080095","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}

{"title":"Cluster Analysis of Migraine-associated Symptoms (CAMS) in youth: A retrospective cross-sectional multicenter study.","authors":"Carlyn Patterson Gentile, Christina L Szperka, Andrew D Hershey","doi":"10.1111/head.14859","DOIUrl":"10.1111/head.14859","url":null,"abstract":"<p><strong>Objective: </strong>To conduct a retrospective cross-sectional multicenter study to validate the relationships between migraine-associated symptoms.</p><p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Discussion: </strong>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.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1230-1243"},"PeriodicalIF":5.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11560594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499073","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}

{"title":"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.","authors":"Carlyn Patterson Gentile, Andrew D Hershey, Christina L Szperka","doi":"10.1111/head.14858","DOIUrl":"10.1111/head.14858","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1217-1229"},"PeriodicalIF":8.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11560481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499071","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}