Objective: The aim of this study was to elucidate the adverse factors associated with brain arteriovenous malformation (BAVM)-related de novo headache after stereotactic radiosurgery (SRS) or microsurgery.
Background: There is a paucity of literature on posttreatment de novo headaches in initially headache-naïve patients who undergo treatment.
Methods: This retrospective cohort study analyzed patients aged 18 years or older who underwent SRS or microsurgery for a BAVM at our single center in Sichuan Province, China, between January 2010 and December 2019. Patients who did not present with headaches before treatment were included. Headache diagnosis and characteristics were performed according to the International Classification of Headache Disorders, 3rd edition criteria. The primary outcome was BAVM-related de novo headache after treatment. Statistical analysis was conducted on demographic, clinical, and radiographic characteristics to assess the distributions of the two groups of patients with and without posttreatment de novo headache. Subgroup analysis was further conducted on the SRS and microsurgery.
Results: Over the 10-year study period, we identified 194 patients with BAVM who presented without headache and who underwent SRS or microsurgery. Thirty-seven patients (19.1%) developed posttreatment de novo headache. In the SRS treatment cohort, statistically significant differences were detected between the headache and nonheadache subgroups with respect to the Spetzler-Martin (SM) grade (p = 0.018) and lesion diameter (p = 0.028). Multivariable logistic regression analysis confirmed that only the higher SM grade remained an independent adverse factor for de novo headache (adjusted odd ratio [OR] = 3.48, 95% confidence interval [CI] = 1.29-9.35, p = 0.013; high grade versus low grade BAVM). In the microsurgery treatment cohort, the lesion size in the de novo headache subgroup was significantly larger than that in the nonheadache subgroup, with a mean lesion diameter of 3.8 ± 0.3 cm versus 2.9 ± 0.2 cm (p = 0.024). Univariable logistic regression analysis revealed that only a larger diameter was significantly associated with increased odds of de novo headache (OR = 1.52, 95% CI = 1.04-2.21, p = 0.030; per 1 cm increase in diameter).
Conclusion: In the microsurgery treatment subgroup, a larger BAVM was associated with increased odds of de novo headache (per 1 cm increase); in the SRS treatment subgroup, grades III-V were associated with increased odds of de novo headache.
目的:探讨立体定向放射治疗(SRS)或显微外科手术后脑动静脉畸形(BAVM)相关从头头痛的相关不利因素。背景:关于headache-naïve患者最初接受治疗后复发性头痛的文献很少。方法:本回顾性队列研究分析了2010年1月至2019年12月在中国四川省单一中心接受SRS或显微手术治疗BAVM的18岁及以上患者。治疗前未出现头痛症状的患者也包括在内。根据国际头痛疾病分类第3版标准进行头痛诊断和特征。主要终点是治疗后与bavm相关的从头头痛。统计分析两组患者的人口学、临床和影像学特征,以评估有无治疗后头痛患者的分布。进一步对SRS和显微外科进行亚组分析。结果:在10年的研究期间,我们确定了194例没有头痛的BAVM患者,他们接受了SRS或显微手术。37例患者(19.1%)出现治疗后头痛。在SRS治疗队列中,头痛亚组和非头痛亚组在Spetzler-Martin (SM)分级(p = 0.018)和病变直径(p = 0.028)方面存在统计学差异。多变量logistic回归分析证实,只有较高的SM等级仍然是新发头痛的独立不利因素(调整奇比[OR] = 3.48, 95%可信区间[CI] = 1.29-9.35, p = 0.013;高级别vs低级别BAVM)。在显微手术治疗组中,新发头痛亚组的病变大小明显大于非头痛亚组,平均病变直径分别为3.8±0.3 cm和2.9±0.2 cm (p = 0.024)。单变量logistic回归分析显示,只有直径越大,从头开始头痛的几率增加(OR = 1.52, 95% CI = 1.04-2.21, p = 0.030;直径每增加1厘米)。结论:在显微手术治疗亚组中,较大的BAVM与新发头痛的几率增加相关(每增加1 cm);在SRS治疗亚组中,III-V级与新发头痛的几率增加相关。
{"title":"De novo headache after microsurgical resection or stereotactic radiosurgery of brain arteriovenous malformation.","authors":"Gui-Jun Zhang, Wei Wang, Jun-Feng Huo, Wei Dong, Liang-Wen Zhang","doi":"10.1111/head.70028","DOIUrl":"10.1111/head.70028","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to elucidate the adverse factors associated with brain arteriovenous malformation (BAVM)-related de novo headache after stereotactic radiosurgery (SRS) or microsurgery.</p><p><strong>Background: </strong>There is a paucity of literature on posttreatment de novo headaches in initially headache-naïve patients who undergo treatment.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed patients aged 18 years or older who underwent SRS or microsurgery for a BAVM at our single center in Sichuan Province, China, between January 2010 and December 2019. Patients who did not present with headaches before treatment were included. Headache diagnosis and characteristics were performed according to the International Classification of Headache Disorders, 3rd edition criteria. The primary outcome was BAVM-related de novo headache after treatment. Statistical analysis was conducted on demographic, clinical, and radiographic characteristics to assess the distributions of the two groups of patients with and without posttreatment de novo headache. Subgroup analysis was further conducted on the SRS and microsurgery.</p><p><strong>Results: </strong>Over the 10-year study period, we identified 194 patients with BAVM who presented without headache and who underwent SRS or microsurgery. Thirty-seven patients (19.1%) developed posttreatment de novo headache. In the SRS treatment cohort, statistically significant differences were detected between the headache and nonheadache subgroups with respect to the Spetzler-Martin (SM) grade (p = 0.018) and lesion diameter (p = 0.028). Multivariable logistic regression analysis confirmed that only the higher SM grade remained an independent adverse factor for de novo headache (adjusted odd ratio [OR] = 3.48, 95% confidence interval [CI] = 1.29-9.35, p = 0.013; high grade versus low grade BAVM). In the microsurgery treatment cohort, the lesion size in the de novo headache subgroup was significantly larger than that in the nonheadache subgroup, with a mean lesion diameter of 3.8 ± 0.3 cm versus 2.9 ± 0.2 cm (p = 0.024). Univariable logistic regression analysis revealed that only a larger diameter was significantly associated with increased odds of de novo headache (OR = 1.52, 95% CI = 1.04-2.21, p = 0.030; per 1 cm increase in diameter).</p><p><strong>Conclusion: </strong>In the microsurgery treatment subgroup, a larger BAVM was associated with increased odds of de novo headache (per 1 cm increase); in the SRS treatment subgroup, grades III-V were associated with increased odds of de novo headache.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"388-396"},"PeriodicalIF":4.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093017","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}
Pub Date : 2026-02-01Epub Date: 2026-01-30DOI: 10.1111/head.70038
Calli Cook, Marshall C Freeman, Jessica Ailani, Annika Ehrlich, Brian Grosberg, Marielle Kabbouche, Maureen Moriarty, Karissa Secora, Juliana VanderPluym, Brad Klein, Marius Birlea
Objectives: Discuss the current status of advanced practice providers (APPs) onboarding to headache medicine (HM) practices in the United States and present recommendations of the American Headache Society (AHS) APP Work Group to improve the onboarding process.
Background: A high demand for care, national shortage of specialists, and multiple advancements in HM have led to an increasing interest and presence of APPs of various backgrounds in the field, currently without a unifying onboarding process. Efforts to standardize and optimize the onboarding process for APPs in HM practices are necessary, to ensure high standards in quality of care.
Methods: The APP Work Group of the AHS Practice Management Committee developed comprehensive recommendations through literature review, survey of AHS members, and expert consensus. A modified Delphi protocol was used to establish key onboarding goals, definitions, and best practice recommendations.
Results: Recommendations are made regarding duration of onboarding, appropriate supervision, formal education and procedural skills, scope of practice, grading and documentation of competence, and reciprocal feedback.
Conclusion: Currently, there are no standard onboarding and training guidelines for APPs in the field of HM. We provide recommendations for a more systematic approach to help develop qualified providers and enhance their retention in HM practices.
{"title":"Towards a standardized process of onboarding advanced practice providers into headache medicine practices in the United States: Expert consensus from the American Headache Society practice management committee.","authors":"Calli Cook, Marshall C Freeman, Jessica Ailani, Annika Ehrlich, Brian Grosberg, Marielle Kabbouche, Maureen Moriarty, Karissa Secora, Juliana VanderPluym, Brad Klein, Marius Birlea","doi":"10.1111/head.70038","DOIUrl":"10.1111/head.70038","url":null,"abstract":"<p><strong>Objectives: </strong>Discuss the current status of advanced practice providers (APPs) onboarding to headache medicine (HM) practices in the United States and present recommendations of the American Headache Society (AHS) APP Work Group to improve the onboarding process.</p><p><strong>Background: </strong>A high demand for care, national shortage of specialists, and multiple advancements in HM have led to an increasing interest and presence of APPs of various backgrounds in the field, currently without a unifying onboarding process. Efforts to standardize and optimize the onboarding process for APPs in HM practices are necessary, to ensure high standards in quality of care.</p><p><strong>Methods: </strong>The APP Work Group of the AHS Practice Management Committee developed comprehensive recommendations through literature review, survey of AHS members, and expert consensus. A modified Delphi protocol was used to establish key onboarding goals, definitions, and best practice recommendations.</p><p><strong>Results: </strong>Recommendations are made regarding duration of onboarding, appropriate supervision, formal education and procedural skills, scope of practice, grading and documentation of competence, and reciprocal feedback.</p><p><strong>Conclusion: </strong>Currently, there are no standard onboarding and training guidelines for APPs in the field of HM. We provide recommendations for a more systematic approach to help develop qualified providers and enhance their retention in HM practices.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"502-510"},"PeriodicalIF":4.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093040","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}
Pub Date : 2026-02-01Epub Date: 2025-12-30DOI: 10.1111/head.70025
Nathaniel M Schuster, Mark S Wallace, Thomas D Marcotte, Dawn C Buse, Euyhyun Lee, Lin Liu, Michelle Sexton
Objective: To assess the efficacy of cannabis for the treatment of acute migraine.
Background: Preclinical and retrospective studies suggest cannabinoids may be effective in migraine treatment. However, there have been no randomized clinical trials examining the efficacy of cannabinoids for acute migraine.
Methods: In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to four separate migraine attacks, one each with vaporized (1) 6% Δ9-tetrahydrocannabinol (THC) (THC-dominant), (2) 11% cannabidiol (CBD) (CBD-dominant), (3) 6% THC + 11% CBD, and (4) placebo cannabis flower in a randomized order. Washout period between treated migraine attacks was ≥1 week. The primary endpoint was pain relief, and secondary endpoints were pain freedom and most bothersome symptom freedom, all assessed at 2-h post-vaporization.
Results: Ninety-two participants were enrolled and randomized, and 247 migraine attacks were treated. THC + CBD was superior to placebo at achieving pain relief (67.2% vs. 46.6%, odds ratio [95% confidence interval] 2.85 [1.22, 6.65], p = 0.016), pain freedom (34.5% vs. 15.5%, 3.30 [1.24, 8.80], p = 0.017), and most bothersome symptom freedom (60.3% vs. 34.5%, 3.32 [1.45, 7.64], p = 0.005) at 2 h, as well as sustained pain freedom at 24 h and sustained most bothersome symptom freedom at 24 and 48 h. THC-dominant was superior to placebo for pain relief (68.9% vs. 46.6%, 3.14 [1.35, 7.30], p = 0.008) but not pain freedom or most bothersome symptom freedom at 2 h. CBD-dominant was not superior to placebo for pain relief, pain freedom, or most bothersome symptom freedom at 2 h. There were no serious adverse events.
Conclusion: Acute migraine treatment with 6% THC + 11% CBD was superior to placebo at 2-h post-treatment with sustained benefits at 24 and 48 h.
目的:评价大麻治疗急性偏头痛的疗效。背景:临床前和回顾性研究表明大麻素可能有效治疗偏头痛。然而,目前还没有随机临床试验检验大麻素对急性偏头痛的疗效。方法:在这项随机、双盲、安慰剂对照、交叉试验中,患有偏头痛的成年人治疗多达四次偏头痛发作,每次发作按随机顺序分别使用(1)6% Δ9-tetrahydrocannabinol (THC) (THC优势)、(2)11%大麻二酚(CBD优势)、(3)6% THC + 11% CBD和(4)安慰剂大麻花。治疗后偏头痛发作的洗脱期≥1周。主要终点是疼痛缓解,次要终点是疼痛缓解和最麻烦的症状缓解,所有这些都在蒸发后2小时进行评估。结果:92名参与者被随机纳入,247例偏头痛发作得到治疗。THC + CBD在2小时疼痛缓解(67.2% vs. 46.6%,优势比[95%置信区间]2.85 [1.22,6.65],p = 0.016)、疼痛缓解(34.5% vs. 15.5%, 3.30 [1.24, 8.80], p = 0.017)、最令人烦恼的症状缓解(60.3% vs. 34.5%, 3.32 [1.45, 7.64], p = 0.005)、24小时持续疼痛缓解和24和48小时持续最令人烦恼的症状缓解方面优于安慰剂。thc优势组在疼痛缓解方面优于安慰剂组(68.9% vs. 46.6%, 3.14 [1.35, 7.30], p = 0.008),但在2小时时疼痛缓解或最令人烦恼的症状缓解方面优于安慰剂组。在2小时时,cbd优势组在疼痛缓解、疼痛缓解或最令人烦恼的症状缓解方面并不优于安慰剂。无严重不良事件发生。结论:6% THC + 11% CBD治疗急性偏头痛在治疗后2小时优于安慰剂,并在24和48小时持续获益。
{"title":"Vaporized cannabis versus placebo for acute migraine: A randomized, double-blind, placebo-controlled crossover trial.","authors":"Nathaniel M Schuster, Mark S Wallace, Thomas D Marcotte, Dawn C Buse, Euyhyun Lee, Lin Liu, Michelle Sexton","doi":"10.1111/head.70025","DOIUrl":"10.1111/head.70025","url":null,"abstract":"<p><strong>Objective: </strong>To assess the efficacy of cannabis for the treatment of acute migraine.</p><p><strong>Background: </strong>Preclinical and retrospective studies suggest cannabinoids may be effective in migraine treatment. However, there have been no randomized clinical trials examining the efficacy of cannabinoids for acute migraine.</p><p><strong>Methods: </strong>In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to four separate migraine attacks, one each with vaporized (1) 6% Δ9-tetrahydrocannabinol (THC) (THC-dominant), (2) 11% cannabidiol (CBD) (CBD-dominant), (3) 6% THC + 11% CBD, and (4) placebo cannabis flower in a randomized order. Washout period between treated migraine attacks was ≥1 week. The primary endpoint was pain relief, and secondary endpoints were pain freedom and most bothersome symptom freedom, all assessed at 2-h post-vaporization.</p><p><strong>Results: </strong>Ninety-two participants were enrolled and randomized, and 247 migraine attacks were treated. THC + CBD was superior to placebo at achieving pain relief (67.2% vs. 46.6%, odds ratio [95% confidence interval] 2.85 [1.22, 6.65], p = 0.016), pain freedom (34.5% vs. 15.5%, 3.30 [1.24, 8.80], p = 0.017), and most bothersome symptom freedom (60.3% vs. 34.5%, 3.32 [1.45, 7.64], p = 0.005) at 2 h, as well as sustained pain freedom at 24 h and sustained most bothersome symptom freedom at 24 and 48 h. THC-dominant was superior to placebo for pain relief (68.9% vs. 46.6%, 3.14 [1.35, 7.30], p = 0.008) but not pain freedom or most bothersome symptom freedom at 2 h. CBD-dominant was not superior to placebo for pain relief, pain freedom, or most bothersome symptom freedom at 2 h. There were no serious adverse events.</p><p><strong>Conclusion: </strong>Acute migraine treatment with 6% THC + 11% CBD was superior to placebo at 2-h post-treatment with sustained benefits at 24 and 48 h.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"365-376"},"PeriodicalIF":4.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12872409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145862783","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":"Comfort matters: A new strategy to ease injection pain during headache treatment procedures.","authors":"Hannah F J Shapiro","doi":"10.1111/head.70050","DOIUrl":"10.1111/head.70050","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040884","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}
Dawn C Buse, Lindsay A Videnieks, Karissa Charles, Killian Lozach, Kristina M Fanning, Talia A Guidi, Richard B Lipton
<p><strong>Objective: </strong>This study was undertaken to report rates of payer blocking of prescribed branded migraine medications in total and by race/ethnicity, income, and education, and to examine the relationship between payer blocking and emergency department and inpatient encounters for migraine-specific and all-cause reasons in a large US claims database.</p><p><strong>Background: </strong>Access to prescribed branded migraine medications can be challenging due to restrictive utilization management protocols and may be related to increased healthcare resource utilization. These barriers may disproportionately affect patients based on sociodemographic factors.</p><p><strong>Methods: </strong>This observational cohort study analyzed data from an integrated database containing electronic medical records, specialty pharmacy, and in-office dispensing datasets. Individuals with a migraine diagnosis who experienced payer blocking-defined as denial of prescribed branded migraine medications ≥2 times due to step therapy, prior authorization, or related restrictions-between January 1, 2019, and December 31, 2021, were included. Rates of payer blocking were reported for the total sample and by sociodemographic groups. Emergency department (ED) and inpatient encounter rates for migraine-specific and all-cause reasons were compared by payer blocking status. Differences were assessed using χ<sup>2</sup> tests with Bonferroni corrected α (p < 0.0018). Effect sizes were estimated using Cramer's V.</p><p><strong>Results: </strong>Among 7.7 million patients with ≥1 migraine-related prescription claim(s), 370,560 actively treated individuals met inclusion criteria for analysis. One in five (20.6%) experienced payer blocking. There were significant differences in the distribution of race/ethnicity, annual household income, and educational attainment categories across payer blocking status groups (p < 0.001 for all), with small effect sizes (Cramer's V = 0.014-0.034). Patients with a history of payer blocking had significantly higher rates of ED and inpatient encounters for both all-cause and migraine-specific reasons (p < 0.001 for all), although effect sizes were small. This pattern was consistent within racial/and ethnic groups, with significant differences observed for White patients both for migraine-related and all-cause ED and inpatient encounters, and Black/African American and Hispanic/Latino patients for migraine-related encounters (p < 0.001 for all).</p><p><strong>Conclusion: </strong>Payer blocking of branded migraine medications was fairly common, affecting one in five patients and was broadly associated with increased healthcare utilization. These findings suggest that payer blocking may disproportionately impact patients according to race/ethnicity, household income, and educational attainment. Although effect sizes were small, the outcomes may provide useful hypotheses for understanding and addressing healthcare disparities in migraine [Co
{"title":"Rates and healthcare resource utilization for people with branded acute and preventive migraine prescription medication order payer denials: An open, multi-source dataset, observational cohort study.","authors":"Dawn C Buse, Lindsay A Videnieks, Karissa Charles, Killian Lozach, Kristina M Fanning, Talia A Guidi, Richard B Lipton","doi":"10.1111/head.70026","DOIUrl":"10.1111/head.70026","url":null,"abstract":"<p><strong>Objective: </strong>This study was undertaken to report rates of payer blocking of prescribed branded migraine medications in total and by race/ethnicity, income, and education, and to examine the relationship between payer blocking and emergency department and inpatient encounters for migraine-specific and all-cause reasons in a large US claims database.</p><p><strong>Background: </strong>Access to prescribed branded migraine medications can be challenging due to restrictive utilization management protocols and may be related to increased healthcare resource utilization. These barriers may disproportionately affect patients based on sociodemographic factors.</p><p><strong>Methods: </strong>This observational cohort study analyzed data from an integrated database containing electronic medical records, specialty pharmacy, and in-office dispensing datasets. Individuals with a migraine diagnosis who experienced payer blocking-defined as denial of prescribed branded migraine medications ≥2 times due to step therapy, prior authorization, or related restrictions-between January 1, 2019, and December 31, 2021, were included. Rates of payer blocking were reported for the total sample and by sociodemographic groups. Emergency department (ED) and inpatient encounter rates for migraine-specific and all-cause reasons were compared by payer blocking status. Differences were assessed using χ<sup>2</sup> tests with Bonferroni corrected α (p < 0.0018). Effect sizes were estimated using Cramer's V.</p><p><strong>Results: </strong>Among 7.7 million patients with ≥1 migraine-related prescription claim(s), 370,560 actively treated individuals met inclusion criteria for analysis. One in five (20.6%) experienced payer blocking. There were significant differences in the distribution of race/ethnicity, annual household income, and educational attainment categories across payer blocking status groups (p < 0.001 for all), with small effect sizes (Cramer's V = 0.014-0.034). Patients with a history of payer blocking had significantly higher rates of ED and inpatient encounters for both all-cause and migraine-specific reasons (p < 0.001 for all), although effect sizes were small. This pattern was consistent within racial/and ethnic groups, with significant differences observed for White patients both for migraine-related and all-cause ED and inpatient encounters, and Black/African American and Hispanic/Latino patients for migraine-related encounters (p < 0.001 for all).</p><p><strong>Conclusion: </strong>Payer blocking of branded migraine medications was fairly common, affecting one in five patients and was broadly associated with increased healthcare utilization. These findings suggest that payer blocking may disproportionately impact patients according to race/ethnicity, household income, and educational attainment. Although effect sizes were small, the outcomes may provide useful hypotheses for understanding and addressing healthcare disparities in migraine [Co","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018208","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}
Kareem Joudi, Abigael Nsenga, Andrew R Williams, Sharon I Lee, Sadie Johnson, Eddie Irizarry, Benjamin Wolkin Friedman
Objective: We conducted a randomized study to determine if, among emergency department (ED) patients with acute posttraumatic headache, the combination of intravenous (IV) metoclopramide plus dexamethasone would result in less headache intensity during the 48 h after ED discharge than IV metoclopramide plus placebo.
Background: Intravenous metoclopramide can improve acute posttraumatic headache among ED patients, though this benefit is not sustained beyond the ED visit.
Methods: This was a randomized, double-blind, placebo-controlled, parallel group study of IV dexamethasone for acute posttraumatic headache. We enrolled patients who presented to two EDs in the Bronx, NY, with moderate or severe headache that met criteria for acute posttraumatic headache, per the International Classification of Headache Disorders, 3rd edition. All study participants received metoclopramide 10 mg IV. They also were randomized to receive dexamethasone 10 mg IV or placebo (normal saline). The primary outcome was absence of moderate or severe headache within 48 h of ED discharge and no use of analgesic or headache medication within that time. We also report frequency of sustained headache relief. It defined as obtaining and maintaining a headache intensity of mild or none, without the use of rescue medication, for 48 h.
Results: Over a 42-month period commencing in June 2021, 2220 patients were approached for participation and 162 were enrolled. At baseline, slightly more patients in the placebo arm reported severe versus moderate pain. No other baseline differences were noted. After accounting for age, sex, and baseline pain intensity, dexamethasone was not associated with the primary outcome (Adjusted odds ratio 1.11, 95% confidence interval [CI] 0.57, 2.19, p = 0.751). Sustained pain relief was reported by 10/77 (13.0%) of dexamethasone participants and 12/79 (15.2%) of placebo participants (95% CI for difference - 2.2%: -13.1, 8.7%).
Conclusion: Among ED patients with acute moderate or severe posttraumatic headache, one dose of IV dexamethasone did not improve headache outcomes.
目的:我们进行了一项随机研究,以确定急诊科(ED)急性创伤后头痛患者中,静脉注射(IV)甲氧氯普胺加地塞米松是否比静脉注射(IV)甲氧氯普胺加安慰剂在ED出院后48小时内的头痛强度更小。背景:静脉注射甲氧氯普胺可以改善急诊科患者的急性创伤后头痛,尽管这种益处在急诊科就诊后不能持续。方法:这是一项随机、双盲、安慰剂对照、平行组研究,静脉注射地塞米松治疗急性创伤后头痛。我们招募了在纽约布朗克斯的两个急诊室就诊的中度或重度头痛患者,这些患者符合急性创伤后头痛的标准,根据国际头痛疾病分类,第三版。所有的研究参与者都接受了甲氧氯普胺10mg IV。他们也随机接受了地塞米松10mg IV或安慰剂(生理盐水)。主要结局是ED出院后48小时内没有中度或重度头痛,并且在此期间没有使用止痛药或头痛药物。我们也报告持续头痛缓解的频率。它定义为在不使用抢救药物的情况下,获得并保持轻微或无头痛强度48小时。结果:从2021年6月开始的42个月期间,研究人员接触了2220名患者,其中162名患者入组。在基线时,安慰剂组报告严重疼痛的患者略多于中度疼痛。没有注意到其他基线差异。在考虑了年龄、性别和基线疼痛强度后,地塞米松与主要结局无关(调整优势比1.11,95%可信区间[CI] 0.57, 2.19, p = 0.751)。地塞米松参与者中10/77(13.0%)和安慰剂参与者中12/79(15.2%)报告了持续的疼痛缓解(95% CI差异- 2.2%:-13.1,8.7%)。结论:在急性中重度创伤后头痛的ED患者中,一剂量静脉地塞米松并不能改善头痛结局。
{"title":"IV dexamethasone as adjuvant therapy to metoclopramide for acute posttraumatic headache in the ED: A randomized controlled trial.","authors":"Kareem Joudi, Abigael Nsenga, Andrew R Williams, Sharon I Lee, Sadie Johnson, Eddie Irizarry, Benjamin Wolkin Friedman","doi":"10.1111/head.70027","DOIUrl":"https://doi.org/10.1111/head.70027","url":null,"abstract":"<p><strong>Objective: </strong>We conducted a randomized study to determine if, among emergency department (ED) patients with acute posttraumatic headache, the combination of intravenous (IV) metoclopramide plus dexamethasone would result in less headache intensity during the 48 h after ED discharge than IV metoclopramide plus placebo.</p><p><strong>Background: </strong>Intravenous metoclopramide can improve acute posttraumatic headache among ED patients, though this benefit is not sustained beyond the ED visit.</p><p><strong>Methods: </strong>This was a randomized, double-blind, placebo-controlled, parallel group study of IV dexamethasone for acute posttraumatic headache. We enrolled patients who presented to two EDs in the Bronx, NY, with moderate or severe headache that met criteria for acute posttraumatic headache, per the International Classification of Headache Disorders, 3rd edition. All study participants received metoclopramide 10 mg IV. They also were randomized to receive dexamethasone 10 mg IV or placebo (normal saline). The primary outcome was absence of moderate or severe headache within 48 h of ED discharge and no use of analgesic or headache medication within that time. We also report frequency of sustained headache relief. It defined as obtaining and maintaining a headache intensity of mild or none, without the use of rescue medication, for 48 h.</p><p><strong>Results: </strong>Over a 42-month period commencing in June 2021, 2220 patients were approached for participation and 162 were enrolled. At baseline, slightly more patients in the placebo arm reported severe versus moderate pain. No other baseline differences were noted. After accounting for age, sex, and baseline pain intensity, dexamethasone was not associated with the primary outcome (Adjusted odds ratio 1.11, 95% confidence interval [CI] 0.57, 2.19, p = 0.751). Sustained pain relief was reported by 10/77 (13.0%) of dexamethasone participants and 12/79 (15.2%) of placebo participants (95% CI for difference - 2.2%: -13.1, 8.7%).</p><p><strong>Conclusion: </strong>Among ED patients with acute moderate or severe posttraumatic headache, one dose of IV dexamethasone did not improve headache outcomes.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933011","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}
Abhijeet Jakate, Yan Weng, Ani Shkrodova, Ogert Fisniku, Ding Ding, Kayce Morton, Benjamin Maligalig, Pamela Garnick, Jing Liu, Mohamed H Shahin
Objective: This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.
Background: Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.
Methods: In this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.
Results: Geometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.
Conclusion: A single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.
{"title":"A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women.","authors":"Abhijeet Jakate, Yan Weng, Ani Shkrodova, Ogert Fisniku, Ding Ding, Kayce Morton, Benjamin Maligalig, Pamela Garnick, Jing Liu, Mohamed H Shahin","doi":"10.1111/head.70036","DOIUrl":"10.1111/head.70036","url":null,"abstract":"<p><strong>Objective: </strong>This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.</p><p><strong>Background: </strong>Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.</p><p><strong>Methods: </strong>In this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.</p><p><strong>Results: </strong>Geometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.</p><p><strong>Conclusion: </strong>A single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145916915","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}
Jessica Ailani, Rose Okonkwo, Elizabeth Johnston, Helen Hochstetler, Betzaida Martinez, Anthony Zagar, Robert A Nicholson, Bert B Vargas, E Jolanda Muenzel, Richard B Lipton
Objectives/background: This study was undertaken to evaluate patient reasons for nonadoption of migraine-preventive medications. Despite clear recommendations and eligibility criteria for migraine-preventive treatment by the American Headache Society and the availability of these treatments, many people with migraine are not taking appropriate preventive medications. Many are not seeking medical care in the first place, but even among those who are seeking medical care and have a diagnosis of migraine, the uptake of preventive medications remains low.
Methods: The OVERCOME (Observational Survey of the Epidemiology, Treatment, and Care of Migraine) study is an observational, longitudinal web-based survey conducted in more than 60,000 adults with migraine in the United States (US). The current analysis, a secondary post hoc analysis of the 2018-2020 baseline cross-sectional surveys, evaluated medication use in participants. In particular, the analysis investigates why some participants have never taken prescription medication for migraine prevention and examines how this group differs from those who are taking preventive medication, specifically in terms of disease severity and other patient-reported outcomes.
Results: Our findings revealed that among OVERCOME (US) participants who met criteria for migraine (n = 59,001), only approximately half (51.3%) had sought medical care for migraine in the previous 12 months, approximately one third (36.3%) had sought care and received a migraine diagnosis, and only 10% of participants had sought care, received a diagnosis of migraine, and were currently taking prescription medications for migraine prevention. Furthermore, among those who were eligible for migraine-preventive medication based on their headache frequency and associated disability (n = 22,249), 65.3% indicated they had never taken a preventive medication for migraine. The reasons for this were mostly medication-related (25.5% stated they were concerned about side effects, 23.3% said they did not like taking prescription medication, and 20.8% stated that their other medications worked well enough); however, there were also other reasons related to stigma, access, and communication with the health care provider that were noted by participants.
Conclusion: This study highlights an important need for patient education, especially as many of these individuals who had never taken medications to prevent migraine reported experiencing ≥15 monthly headache days (25.3%), severe interictal burden (43.3%), and severe migraine-related disability (53.1%). We believe that these results may be of interest to health care providers who see people with migraine and help them better understand and anticipate their patients' educational needs regarding migraine prevention.
{"title":"Reasons for patient reluctance to take preventive medications for migraine: Results of the OVERCOME (US) study.","authors":"Jessica Ailani, Rose Okonkwo, Elizabeth Johnston, Helen Hochstetler, Betzaida Martinez, Anthony Zagar, Robert A Nicholson, Bert B Vargas, E Jolanda Muenzel, Richard B Lipton","doi":"10.1111/head.70014","DOIUrl":"https://doi.org/10.1111/head.70014","url":null,"abstract":"<p><strong>Objectives/background: </strong>This study was undertaken to evaluate patient reasons for nonadoption of migraine-preventive medications. Despite clear recommendations and eligibility criteria for migraine-preventive treatment by the American Headache Society and the availability of these treatments, many people with migraine are not taking appropriate preventive medications. Many are not seeking medical care in the first place, but even among those who are seeking medical care and have a diagnosis of migraine, the uptake of preventive medications remains low.</p><p><strong>Methods: </strong>The OVERCOME (Observational Survey of the Epidemiology, Treatment, and Care of Migraine) study is an observational, longitudinal web-based survey conducted in more than 60,000 adults with migraine in the United States (US). The current analysis, a secondary post hoc analysis of the 2018-2020 baseline cross-sectional surveys, evaluated medication use in participants. In particular, the analysis investigates why some participants have never taken prescription medication for migraine prevention and examines how this group differs from those who are taking preventive medication, specifically in terms of disease severity and other patient-reported outcomes.</p><p><strong>Results: </strong>Our findings revealed that among OVERCOME (US) participants who met criteria for migraine (n = 59,001), only approximately half (51.3%) had sought medical care for migraine in the previous 12 months, approximately one third (36.3%) had sought care and received a migraine diagnosis, and only 10% of participants had sought care, received a diagnosis of migraine, and were currently taking prescription medications for migraine prevention. Furthermore, among those who were eligible for migraine-preventive medication based on their headache frequency and associated disability (n = 22,249), 65.3% indicated they had never taken a preventive medication for migraine. The reasons for this were mostly medication-related (25.5% stated they were concerned about side effects, 23.3% said they did not like taking prescription medication, and 20.8% stated that their other medications worked well enough); however, there were also other reasons related to stigma, access, and communication with the health care provider that were noted by participants.</p><p><strong>Conclusion: </strong>This study highlights an important need for patient education, especially as many of these individuals who had never taken medications to prevent migraine reported experiencing ≥15 monthly headache days (25.3%), severe interictal burden (43.3%), and severe migraine-related disability (53.1%). We believe that these results may be of interest to health care providers who see people with migraine and help them better understand and anticipate their patients' educational needs regarding migraine prevention.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911134","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}