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Background: Individuals with migraine frequently experience pre- and post-headache symptoms. This analysis aimed to characterize the relative frequency and burden of pre- and post-headache symptoms in people with migraine using data collected through the Chronic Migraine Epidemiology and Outcomes - International Study., Methods: This cross-sectional, observational, web-based survey was conducted in 2021-2022 in Canada, France, Germany, Japan, the United Kingdom, and the United States. Respondents who met modified International Classification of Headache Disorders, 3rd edition, criteria were offered the opportunity to participate. Information collected included migraine-related disability, depression/anxiety symptoms, cutaneous allodynia, activity limitations, and acute treatment optimization. Respondents indicated how often they had pre- or post-headache symptoms using a 5-point scale, ranging from 0 to 4, with a rating of 2 or higher classified as a pre- or post-headache symptom case. Modeling was used to examine relationships with monthly headache days (MHDs) and activity limitations during pre-headache and post-headache phases., Results: Among a total of 14,492 respondents, pre-headache symptoms were reported by 66.9%, while post-headache symptoms were reported by 60.2%. Both pre-headache and post-headache symptoms were reported by 49.5% of respondents, only pre-headache by 17.4%, only post-headache by 10.7%, and neither pre- nor post-headache symptoms by 22.4%. Compared with respondents who experienced only pre- or post-headache symptoms, respondents who experienced both pre- and post-headache symptoms had the highest rates of 4-7, 8-14, and ≥ 15 monthly headache days (23.1%, 14.1%, and 10.9%, respectively). Of respondents with both pre- and post-headache symptoms, 58.5% reported moderate-to-severe disability, 47.7% reported clinically significant symptoms of depression, 49.0% reported clinically significant symptoms of anxiety, and 63.8% reported cutaneous allodynia with headache (ASC-12). Moderate-to-severe activity limitations were reported during the pre-headache (29.5%) and post-headache phases (27.2%). For all outcomes modeled, after controlling for covariates, having pre-headache symptoms, post-headache symptoms, or both were associated with worse outcomes than having neither., Conclusions: Pre- and post-headache phases of migraine are common, carry unrecognized burden, and may be a target for treatment., (© 2023. The Author(s).)

Objective: We investigated adult-onset epilepsy as a risk factor for the development of substance use disorder (SUD) by comparing the rate of SUD diagnosis among adults diagnosed with epilepsy with presumably healthy controls with lower extremity fractures (LEF). For additional comparison, we investigated the risk for adults with migraine only. Epilepsy and migraine are both episodic neurological disorders and migraine is frequently comorbid with epilepsy., Methods: We conducted a time-to-event analysis using a subset of surveillance data of hospital admissions, emergency department visits, and outpatient visits in South Carolina, USA from January 1, 2000, through December 31, 2011. Individuals aged 18 years or older were identified using the International Classification of Disease, 9thRevision Clinical Modification (ICD-9) with a diagnosis of epilepsy (n = 78,547; 52.7% female, mean age 51.3 years), migraine (n = 121,155; 81.5% female, mean age 40.0 years), or LEF (n = 73,911; 55.4% female, mean age 48.7 years). Individuals with SUD diagnosis following epilepsy, migraine, or LEF were identified with ICD-9 codes. We used Cox proportional hazards regression to model the time to SUD diagnosis comparing adults diagnosed with epilepsy, migraine, and LEF, adjusting for insurance payer, age, sex, race/ethnicity, and prior mental health comorbidities., Results: Compared to LEF controls, adults with epilepsy were diagnosed with SUD at 2.5 times the rate [HR 2.48 (2.37, 2.60)] and adults with migraine only were diagnosed with SUD at 1.12 times the rate [HR 1.12 (1.06, 1.18)]. We found an interaction between disease diagnosis and insurance payer, with hazard ratios comparing epilepsy to LEF of 4.59, 3.48, 1.97, and 1.44 within the commercial payer, uninsured, Medicaid, and Medicare strata, respectively., Significance: Compared to presumably healthy controls, adults with epilepsy had a substantially higher hazard of SUD, while adults with migraine only showed a small, but significant, increased hazard of SUD., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: To systematically review the literature assessing associations between TMDs and primary headaches., Methods: Using validated clinical criteria, studies on TMDs and primary headaches published up to January 10, 2023 were identified using six electronic databases. This review adhered to the PRISMA 2020 guidelines and 27-item checklist and is registered on PROSPERO (CRD42021256391). Risk of bias was evaluated using the National Institutes of Health Quality Assessment Toolkits for Observational Cohort and Cross-Sectional Studies., Results: Two independent investigators rated 7,697 records against the primary endpoint and found 8 records meeting the eligibility requirements. Migraine was found to be the most common primary headache related to TMDs (61.5%), followed by episodic tension-type headache (ETTH; 38.5%). A moderate association was found for mixed TMDs with migraine and ETTH, with a large sample size and multiple studies included (n = 8). A very low-quality association was found for myalgia-related TMDs with migraine and ETTH (included studies, n = 2)., Conclusion: The association between TMDs and primary headaches is of great interest given the possible effectiveness of TMD management in reducing headache intensity/frequency in patients with TMDs and headache comorbidity. A moderate association was found for mixed TMDs with primary headaches, in particular migraine and ETTH. However, owing to the overall moderate certainty of evidence of the present findings, further longitudinal studies with larger samples investigating possible associated factors and using accurate TMD and headache category assignment are needed.

Between 2016 and 2017, several U.S. Diplomats in Havana, Cuba, experienced perplexing vestibular and neurological symptoms attributed to an unknown source. They presented with significant vestibular and headache symptoms similar to individuals who experience vestibular migraine (VM). As such, we hypothesize that VM may be a possible explanation for the Havana cohort's presenting symptoms. To evaluate this hypothesis, we compared symptoms reported by the affected individuals in Havana, Cuba, to symptoms reported by corresponding patients from a tertiary academic neurotology clinic with a chief complaint of vertigo or disequilibrium, who met the International Classification of Headache Disorders criteria for VM. The prevalence of the Havana subjects experiencing various symptomatic domains was compared with the VM cohort, leading to 26 unique domains and statistical comparisons between the cohorts. Of the 26 domains compared between the two cohorts, 18 were not significantly different. This included the two most important components of meeting criteria for VM, namely the co-existence of headache and vestibular symptoms. On regression analysis, the only feature which kept its significant difference between the two cohorts was acute intense head pressure (P = 0.007). The domains with similar occurrence ratios included dizziness, headache, light sensitivity, hearing reduction, and tinnitus. In other words, multiple headache and vestibular symptoms, consistent with VM criteria, were similar between the two cohorts. The considerable similarities across various domains between VM patients and Havana subjects could be due to migraine as a possible common etiology for both groups. We propose VM as a potential etiology for the symptomatology in the U.S. diplomats in Cuba., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper, (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: The objectives of this study were to determine the rates of nausea, phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs., Background: The MBS has emerged as an important coprimary efficacy endpoint in clinical trials of acute treatments for migraine, as recommended by the Food and Drug Administration. The current understanding of how persons with migraine designate an associated symptom as the most bothersome has been assessed primarily in the context of randomized trials., Methods: Respondents (n = 95,821) in the cross-sectional, observational Migraine in America Symptoms and Treatment (MAST) study were adults (aged ≥18 years) recruited from a US nationwide online research panel. A validated diagnostic screener identified 15,133 individuals who met modified International Classification of Headache Disorders (ICHD)-3 beta criteria for migraine and reported at least 1 monthly headache day (MHD) over the previous 3 months. The survey ascertained sociodemographic variables, headache-related disability, MHDs, cutaneous allodynia, medication overuse, a migraine symptom severity score, pain interference, noncephalic pain, anxiety and depression symptoms, visual aura over the previous year, and acute treatment optimization. The current analysis is based on respondents who also completed a 6-month follow-up assessment that included questions about their most bothersome headache symptom., Results: A total of 7518 respondents completed the 6-month follow-up, and 6045 met inclusion criteria and were included in the analysis. The mean age of respondents was 47 (SD 13.4) years, 76.0% (4596/6045) were women, and 84.8% (5103/6017) were white. Among all respondents, 64.9% reported all 3 migraine symptoms. The MBS was photophobia in 49.1% (2967/6045), nausea in 28.1% (1697/6045), and phonophobia in 22.8% (1381/6045). Respondents reporting photophobia as the MBS were more likely to be men, to be obese, and to report visual aura. Those reporting nausea as the MBS were more likely to be women, to have lower incomes, and to report lower levels of treatment optimization. Respondents reporting phonophobia as the MBS were more likely to have cutaneous allodynia and less likely to have visual aura., Conclusion: Most people with migraine in the MAST observational study reported all 3 cardinal symptoms of nausea, photophobia, and phonophobia. As in clinical trials, the most common MBS was photophobia. Patient profiles differed among the groups defined by their MBS., (© 2019 Promius Pharma. Headache: The Journal of Head and Face Pain published by Wiley Periodicals, Inc., on behalf of American Headache Society.)

Introduction: Abdominal migraine (AM) is uncommon and understudied. Our objective was to investigate the diagnosis and treatment of children and adolescents with AM and compare with that of pediatric gastroenterologists and neurologists., Patients and Method: All AM cases (1-18 years) from a USA hospital with diagnosis of abdominal migraine or its variants (ICD-9 346.2 or IC-10 G43.D, G43.D0, G43.D1) between 2011 and 2017 were reviewed. Information on diagnosis, interval from onset of symptoms, diagnostic criteria, diagnostic tests, treatment, and outcome were analyzed., Results: 69 medical records were identified. The mean age at diagnosis was 9.7 years, and 48% of patients were female. 50/69 (72.4%) patients were exclusively treated by a pediatric gastroenterologist and 10/69 (14.5%) exclusively by a pediatric neurologist. 6/69 (8.7%) were initially evaluated by gas troenterology and referred to neurology, and 2/69 (2.9%) were initially evaluated by neurology and then referred to gastroenterology. 3/10 (30%) of the AM diagnosed by neurologists did no report ab dominal pain (AP), however, all diagnoses made by gastroenterologists did (p = 0.0035). 5/50 (10%) of the gastroenterology medical records and no neurology medical records mentioned Rome criteria., Conclusions: Most of the children were diagnosed by pediatric gastroenterologists. Gastroenterolo gists rarely use the Rome criteria. Patients evaluated by neurologists are frequently diagnosed with AM even without AP (a criterion that is required for its diagnosis). Education is recommended for the correct and timely diagnosis of AM.

Background: Cutaneous allodynia is a common clinical feature of migraine that has been associated with reduced efficacy of acute migraine treatments and an increased risk of disease progression., Objective: Identify factors associated with allodynia in a sample of adults with migraine., Methods: An online survey panel was used to identify adults with migraine who averaged at least 1 monthly headache day over the previous 3 months. Data on sociodemographics, headache frequency, headache pain intensity, migraine symptom severity, medication use, depression and anxiety, and cutaneous allodynia (via the Allodynia Symptom Checklist) were obtained. Binary logistic modeling predicted the presence of allodynia. Odds ratios and 95% confidence intervals (CI) were calculated., Results: In total, 15,133 individuals with migraine met the eligibility criteria. Mean age was 43.1 years, 73.0% were female, and 81.0% were Caucasian. Allodynia was present in 39.9%. The fully adjusted model, controlling for sociodemographics and headache features, demonstrated that allodynia was significantly associated with a higher migraine symptom severity score (odds ratio 1.17, confidence interval 1.15, 1.19) and more severe pain intensity (odds ratio 1.11, confidence interval 1.08, 1.14); probable depression and/or anxiety (odds ratio 1.83, confidence interval 1.67, 2.00); and overuse of acute medication (odds ratio 1.23, confidence interval 1.09, 1.38). A higher number of monthly headache days increased the likelihood of allodynia, but the effect was attenuated in the fully adjusted model., Conclusion: In a representative sample of US adults with migraine, there were significant associations between allodynia and headache frequency and intensity, anxiety and/or depression, symptom severity, and acute medication overuse.

Background: Though nausea is a cardinal feature of migraine, its influence on migraine progression has not been evaluated. This article aims to evaluate persistent frequent headache-related nausea (PFN) in persons with episodic migraine (EM) as a predictor of new onset chronic migraine (CM)., Methods: This prospective cohort study uses data from the 2007 and 2008 American Migraine Prevalence and Prevention study surveys to identify subgroups with episodic International Classification of Headache Disorders, 2nd edition defined migraine and either PFN or no or low frequency nausea (NLFN). PFN was defined by the presence of nausea ≥ half the time in both 2007 and 2008. NLFN was defined by nausea that was present

Background: The evidence for an association between migraine and breast cancer risk is inconclusive. While female sex hormones have been proposed as one underlying mechanism, data on sex hormone levels in migraineurs are sparse., Methods: We prospectively evaluated the association between migraine and breast cancer risk among 115378 Nurses' Health Study II participants using Cox proportional hazards models. Differences in endogenous sex hormone levels according to migraine status were assessed among 2034 premenopausal women using linear regression. We performed a meta-analysis of studies investigating the association between migraine and invasive breast cancer risk published through October 2013. All statistical tests were two-sided., Results: Seventeen thousand six hundred ninety-six women (15.3%) reported a physician's diagnosis of migraine at baseline. Over 20 years of follow-up, 833 in situ and 3091 invasive breast malignancies occurred. Migraine was not associated with total (hazard ratio [HR] = 0.96, 95% confidence interval [CI] = 0.88 to 1.04), in situ (HR = 0.97, 95% CI = 0.82 to 1.15), or invasive breast cancer risk (HR = 0.95, 95% CI = 0.87 to 1.04). Endogenous sex hormone levels did not differ according to migraine status. In the meta-analysis, migraine was associated with a lower risk of breast cancer overall (pooled risk ratio [RR] = 0.84, 95% CI = 0.73 to 0.98). However, this inverse association was apparent only among case-control studies (pooled RR = 0.72, 95% CI = 0.66 to 0.79), and not among cohort studies (pooled RR = 0.98, 95% CI = 0.87 to 1.10)., Conclusion: In this large cohort study, migraine was not associated with breast cancer risk or differences in endogenous sex hormone levels. While case-control studies suggest an inverse association between migraine and breast cancer risk, prospective cohort studies do not support an association in pooled analyses., (© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Background: Elevated blood pressure (BP) and headache have long been linked in the medical literature, although data on association are conflicting. We used previously collected data to address these related aims: (1) using the National Hospital Ambulatory Medical Care Survey (NHAMCS), we determined whether elevated BP is more likely in patients who present to an emergency department (ED) with headache than in patients who present with other complaints; (2) using data collected in 3 ED-based migraine clinical trials, we determined the association between improvement in headache pain and improvement in BP among patients who present to an ED with migraine and elevated BP; (3) using the data from the migraine clinical trials, we also determined if an elevated baseline BP identifies a group of patients less likely to respond to standard migraine treatment., Methods: We analyzed 2 distinct data sets. The first, NHAMCS, is a national probability sample of all US ED visits. The second is a compilation of data gathered during 3 ED-based migraine randomized controlled trials. We defined elevated BP as follows: moderate elevation-systolic BP (SBP) ≥150 mm Hg or diastolic BP (DBP) ≥95 mm Hg; marked elevation-SBP ≥165 mm Hg or DBP ≥100 mm Hg; and severe elevation-SBP ≥180 mm Hg or DBP ≥110 mm Hg. We report the association between headache and elevated BP in NHAMCS using odds ratios (ORs) with 95% confidence intervals (CI). We report the correlation coefficient and r(2) for the association between improvement in BP and improvement in headache pain in our clinical trials data set. Finally, using our clinical trials database, we determined the influence of elevated BP at baseline on response to migraine medication by constructing a linear regression model in which the dependent variable was improvement in 0 to 10 pain score between baseline and 1 hour, and the primary predictor variable was presence or absence of elevated BP at baseline., Results: Headache was the primary complaint in 3.7% (95% CI, 3.4-4.0%) of all US ED visits, corresponding to 4.8 million (95% CI, 4.2-5.4 million) patient visits. Among US ED patients, those with headache were more likely than patients with other chief complaints to have markedly (OR, 1.37; 95% CI, 1.16-1.61) or severely elevated BP (OR, 1.49; 95% CI, 1.17-1.90). In our clinical trials data set of patients with migraine with moderately elevated BP, there was no correlation between improvement in pain score and improvement in SBP (r = -0.07, r(2) = 0, P = .465) or DBP (r = -0.03, r(2) = 0, P = .75). Similarly, there was no correlation between improvement in headache and improvement in BP among patients with migraine with markedly elevated BP (for SBP, r = -0.19, r(2) = 0.04, P = .89; for DBP, r = -0.02, r(2) = 0, P = .87), nor among patients with severely elevated BP (for SBP, r = 0.06, r(2) = 0, P = .81; for DBP, r = 0.03, r(2) = 0, P = .90). Patients with moderately elevated BP had slightly less improvement in their 0 to 10 pain score than patients with BPs below this cutoff (-0.6; 95% CI, -1.2 to -0.1; P = .03). This was more pronounced among patients with markedly elevated BP (-0.9; 95% CI, -1.7 to -0.2)., Conclusions: Although there is an association between elevated BP and headache among patients presenting to an ED, improvement in headache is not associated with improvement in BP., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To examine the pattern and extent to which other physical conditions are comorbid with migraine and other headaches in youth in a representative sample of the US population., Study Design: The National Comorbidity Survey-Adolescent Supplement is a face-to-face survey of adolescents aged 13-18 years in the continental US. Sufficient information to assess the International Headache Society's criteria for migraine with and without aura over the past 12 months was available in the diagnostic module. A caretaker/parental self-administered report was used to assess a broad range of other physical conditions. The sample for these analyses was 6843 adolescents with systematic caretaker/parent reports., Results: Adolescents with any headaches reported higher rates of other neurologic conditions, including epilepsy (OR, 2.02; 95% CI, 1.04-3.94), persistent nightmares (OR, 2.28; 95% CI, 1.34-3.87), and motion sickness (OR, 1.6; 95% CI, 1.07-2.4), as well as abdominal complaints (OR, 2.36; 95% CI, 1.59-3.51). Asthma (OR, 2.22; 95% CI, 1.26-3.92) and seasonal allergies (OR, 1.66; 95% CI, 1.12-2.48) were more common in adolescents with migraines than in adolescents with nonspecific headaches., Conclusion: Adolescent migraine is associated with inflammatory conditions such as asthma and seasonal allergies, as well as with epilepsy, persistent nightmares, and motion sickness. Our findings suggest that comorbid medical conditions should be evaluated comprehensively in determining treatment options in youth with headache. Such comorbidity also could be an important source of the clinical and etiologic heterogeneity in migraine., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Background: Though triptans are considered the standard of acute therapy for migraine attacks with headache-related disability, they are used by the minority of potentially eligible persons. Understanding the socio-demographic and headache features that predict triptan use may help to clarify barriers to optimal treatment., Objective: To assess the sociodemographic and headache features associated with triptan use in a US population sample of persons with episodic migraine., Methods: The American Migraine Prevalence and Prevention Study (AMPP) is a longitudinal study conducted in a representative sample of US headache sufferers. Episodic migraineurs (n = 11,388) who provided treatment data in 2005 were included in the current analyses.We assessed factors associated with triptan use through univariate and multivariate analyses. Multivariate analyses were adjusted for sociodemographic factors, headache-related disability, cutaneous allodynia, depression, and preventive headache medication use., Results: Among persons with episodic migraine, 18.31% reported current use of triptans for acute headache treatment. In univariate analyses, triptan use was most common in midlife (ages 30-59), among females, and was more common in Caucasians than in African Americans. Triptan use increased with headache frequency, headache-related disability and allodynia, but decreased among persons with depression. In multivariate analyses, female gender, Caucasian race, age 40-49, higher levels of education (college or higher), annual household income of ≥$40,000, having health insurance, the presence of cutaneous allodynia, greater headache-related disability, and preventive medication use for migraine were significantly associated with triptan use., Conclusions: Less than 1 in 5 persons with migraine in the United States who were respondents to this survey used triptans for acute headache treatment over the course of a year. Several markers of severe headache, including disability and allodynia,were associated with increased triptan use. Groups less likely to get triptans included males, African Americans, older adults, and the uninsured. Predictors of use provide insight into groups with unmet treatment needs.

Objective: Our objective was to demonstrate that, despite recognition by both the gastroenterology and headache communities, abdominal migraine (AM) is an under-diagnosed cause of chronic, recurrent, abdominal pain in childhood in the USA., Background: Chronic, recurrent abdominal pain occurs in 9-15% of all children and adolescents. After exclusion of anatomic, infectious, inflammatory, or other metabolic causes, "functional abdominal pain" is the most common diagnosis of chronic, idiopathic, abdominal pain in childhood. Functional abdominal pain is typically categorized into one, or a combination of, the following 4 groups: functional dyspepsia, irritable bowel syndrome, AM, or functional abdominal pain syndrome. International Classification of Headache Disorders--(ICHD-2) defines AM as an idiopathic disorder characterized by attacks of midline, moderate to severe abdominal pain lasting 1-72 hours with vasomotor symptoms, nausea and vomiting, and included AM among the "periodic syndromes of childhood that are precursors for migraine." Rome III Gastroenterology criteria (2006) separately established diagnostic criteria and confirmed AM as a well-defined cause of recurrent abdominal pain., Methods: Following institutional review board approval, a retrospective chart review was conducted on patients referred to an academic pediatric gastroenterology practice with the clinical complaint of recurrent abdominal pain. ICHD-2 criteria were applied to identify the subset of children fulfilling criteria for AM. Demographics, diagnostic evaluation, treatment regimen and outcomes were collected., Results: From an initial cohort of 600 children (ages 1-21 years; 59% females) with recurrent abdominal pain, 142 (24%) were excluded on the basis of their ultimate diagnosis. Of the 458 patients meeting inclusion criteria, 1824 total patient office visits were reviewed. Three hundred eighty-eight (84.6%) did not meet criteria for AM, 20 (4.4%) met ICHD-2 formal criteria for AM and another 50 (11%) had documentation lacking at least 1 criterion, but were otherwise consistent with AM (probable AM). During the observation period, no children seen in this gastroenterology practice had received a diagnosis of AM., Conclusion: Among children with chronic, idiopathic, recurrent abdominal pain, AM represents about 4-15%. Given the spectrum of treatment modalities now available for pediatric migraine, increased awareness of cardinal features of AM by pediatricians and pediatric gastroenterologists may result in improved diagnostic accuracy and early institution of both acute and preventative migraine-specific treatments., (© 2011 American Headache Society.)

Objective: To examine the association between migraine and cardiovascular diseases during pregnancy. Design US population based case-control study., Setting: Nationwide inpatient sample, from the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality. Population 18,345,538 pregnancy related discharges from 2000 to 2003., Main Outcome Measures: Diagnosis of migraine, as identified by ICD-9 codes 346.0 and 346.1. Stroke and other vascular diseases were identified by using standard ICD-9 codes., Results: From the hospital discharges with a pregnancy discharge code, 33 956 migraine codes were identified: 185 per 100 000 deliveries. Diagnoses that were jointly associated with migraine codes during pregnancy (excluding pre-eclampsia) were stroke (odds ratio 15.05, 95% confidence interval 8.26 to 27.4), myocardial infarction/heart disease (2.11, 1.76 to 2.54), pulmonary embolus/venous thromboembolism (3.23, 2.06 to 7.07), and hypertension (8.61, 6.43 to 11.54), as well as pre-eclampsia/gestational hypertension (2.29, 2.13 to 2.46), smoking (2.85, 2.53 to 3.21), and diabetes (1.96, 1.64 to 2.35). However, migraine was not associated with several non-vascular diagnoses (pneumonia, transfusions, postpartum infection or haemorrhage)., Conclusions: In this large, population based sample of pregnant women admitted to hospital, a strong relation existed between active peripartum migraine and vascular diagnoses during pregnancy. Because these data do not allow determination of which came first, migraine or the vascular condition, prospective studies of pregnant women are needed to explore this association further.

Objective: To evaluate the disability profile and patterns of treatment and health care use for chronic migraine (CM) in the general population, in contrast to episodic migraine., Methods: We identified 24,000 headache sufferers, drawn from more than 165,000 individuals representative of the US population. This sample has been followed up with annual surveys using validated questionnaires for the diagnosis of episodic migraine and CM. As a part of the survey, subjects were asked to report the specific medications currently used for their most severe headaches, as well as level of satisfaction with treatment., Results: Our sample consisted of 520 individuals with CM and 9,424 with episodic migraine. Over a 3-month period, more than half of the individuals with CM missed at least 5 days of household work, compared with 24.3% of those with episodic migraine (p < 0.001). Reduced productivity in household work for at least 5 days over 3 months was reported by 58.1% and 18.2% (p < 0.001); at least 5 days of missed family activities was reported by 36.9% and 9.5% (p < 0.001). The majority of the CM sufferers (87.6%) had previously sought care to discuss their headaches with a health professional. Migraine-specific acute treatments were used by 31.6% of respondents with CM and 24.8% with episodic migraine. Around 48% of the individuals with CM were satisfied with their acute therapies. Just 33.3% of those with CM were currently using preventive medications., Conclusion: Chronic migraine (CM) is more disabling than episodic migraine in the population. Although most individuals with CM sought medical care for this disorder, the majority did not receive specific acute or preventive medications.

Objectives: Assess the relationship between migraine frequency and health utility., Methods: Patients aged >/=18 years diagnosed with episodic migraine were enrolled at three US sites representing varied models of health-care delivery. All subjects completed a questionnaire that included demographic and clinical information, a migraine-specific disability questionnaire, and the Health Utilities Index Mark 3 (HUI3). The HUI3 is a generic health status and health-related quality-of-life measure. HUI3 health status data are translated into utility scores anchored by 0 (dead) and 1 (perfect health)., Results: The study enrolled 150 patients. The mean age was 44 years and 87% were female. Mean (+/-SD) monthly migraine frequency was 4.4 +/- 3.6, with 34% reporting 6 migraines per month. The mean (+/-SD) HUI3 score was 0.62 +/- 0.26. After controlling for study center, demographics, comorbidities, migraine characteristics, and level of migraine disruptiveness, migraine frequency was found to be significantly (P < 0.05) and negatively associated with HUI3 scores. Subjects with >6 migraines per month had an adjusted mean HUI3 score of 0.41; the corresponding mean for those reporting

Objective: To evaluate prospectively the efficacy and safety of almotriptan 12.5 mg as compared to placebo when administered within 1 hour of headache pain onset for the acute treatment of 3 migraine headaches., Background: Although clinical trials have reported improved outcomes when triptans were used early or to treat mild pain, acceptance of this treatment strategy has been hampered by both efficacy and tolerability issues., Methods: In this multicenter, double-blind, placebo-controlled, parallel-group trial, patients with IHS-migraine were randomized in a 1:1 ratio to treat 3 consecutive migraine attacks with either almotriptan 12.5 mg or placebo. Patients were instructed to take their study medication at the first sign of headache pain of any intensity, within 1 hour of onset, and to record their symptoms at multiple time points during their headaches using a personal digital assistant. Clinical trial efficacy results for the first study headache and safety data for the entire study are presented., Results: A total of 378 patients were randomized, 189 to each group; 162 almotriptan-treated patients, and 155 placebo-treated patients were evaluable for efficacy. Almotriptan treatment, compared to placebo, resulted in a significantly greater proportion of patients achieving 2-hour pain free (37.0% vs 23.9%, P= .010), 2-hour pain relief (72.3% vs 48.4%, P < .001) and sustained pain free (24.7% vs 16.1%, P= .040). Significant differences in pain free (P= .026) and pain relief (P= .019) between almotriptan and placebo also were observed at 1 hour. At 2 to 4 hours and 4 to 24 hours after treatment, the mean intensity of phonophobia and photophobia were significantly lower in the patients treated with almotriptan compared to the placebo-treated patients. A greater proportion of patients treating with almotriptan versus placebo reported normal functionality within 2 hours postdose (54.4% vs 38.1%, P= .007) and 4 hours postdose (74.5% vs 54.3%, P < .001). The percentage of patients experiencing 1 or more treatment-emergent adverse events (AE) was 9.8% for almotriptan and 6.4% for placebo. The only treatment-emergent AEs that occurred with a frequency of at least 1% (equivalent to 2 or more patients) in the almotriptan and placebo groups, respectively, were somnolence (1.1% and 2.3%), nausea (1.1% and 1.7%), vomiting (1.1% and 0.6%), and fatigue (1.1% and 0%)., Conclusion: Treatment with almotriptan within 1 hour of migraine onset resulted in significantly better clinical outcomes than placebo and tolerability similar to placebo. Acute medications, such as almotriptan, that are both effective and well tolerated may encourage patients to access acute treatment earlier.

Background: Case descriptions suggest IBS patients are more likely to have other disorders, including migraine, fibromyalgia, and depression. We sought to examine the prevalence of these conditions in cohorts of people with and without IBS., Methods: The source of data was a large U.S. health plan from January 1, 1996 though June 30, 2002. We identified all people with a medical claim associated with an ICD-9 code for IBS. A non-IBS cohort was a random sample of people with an ICD-9 code for routine medical care. In the cohorts, we identified all claims for migraine, depression, and fibromyalgia. We estimated the prevalence odds ratios (PORs) of each of the three conditions using the Mantel-Haenszel method. We conducted quantitative sensitivity analyses to quantify the impact of residual confounding and in differential outcome identification., Results: We identified 97,593 people in the IBS cohort, and a random sample of 27,402 people to compose the non-IBS comparison cohort. With adjustment, there was a 60% higher odds in the IBS cohort of having any one of the three disorders relative to the comparison cohort (POR 1.6, 95% CI 1.5 - 1.7). There was a 40% higher odds of depression in the IBS cohort (POR 1.4, 95% CI 1.3 - 1.4). The PORs for fibromyalgia and migraine were similar (POR for fibromyalgia 1.8, 95% CI 1.7 - 1.9; POR for migraine 1.6, 95% CI 1.4 - 1.7). Differential prevalence of an unmeasured confounder, or imperfect sensitivity or specificity of outcome detection would have impacted the observed results., Conclusion: People in the IBS cohort had a 40% to 80% higher prevalence odds of migraine, fibromyalgia, and depression.

Patent foramen ovale (PFO) has been linked to ischemic strokes of undetermined cause (cryptogenic strokes). PFO-a remnant of fetal circulation when the foramen ovale does not seal after birth-can permit microemboli to escape the pulmonary filter into the intracranial circulation, causing stroke. Coexistent atrial septal aneurysm, pelvic deep vein thrombosis and inherited clotting factor deficiencies could potentiate stroke risk in patients with PFO. Transcatheter PFO closure, a minimally invasive procedure, is one technique used to prevent recurrent cerebrovascular events. A connection between PFO and migraine headache has been conceptualized from retrospective evidence of reduced migraine frequency and severity after PFO closure; however, prospective randomized trials are needed to verify the efficacy of PFO closure on migraine prevention. In this review we discuss embryologic origins, diagnostic techniques and treatment options for prevention of paradoxical embolism thought to be related to PFO, and the relation of PFO to cryptogenic stroke and migraine.

Objective: To examine the direct medical costs associated with migraine, when diagnosed alone and in conjunction with anxiety and/or depression in adults and children., Background: Migraine is a common disorder that can often be accompanied by comorbid anxiety and/or depression. Given the prevalence of migraine and the likelihood for comorbid conditions, it is not surprising that migraine is extremely costly for society., Methods: Migraine cohorts were identified in a 1999-2000 database capturing inpatient, outpatient, and prescription drug services from approximately 45 large employers. Four cohorts of adults (migraine only, migraine and anxiety, migraine and depression, migraine and both conditions), and two cohorts of children (migraine only, migraine and anxiety and/or depression), were compared to respective "healthy" cohorts. t-statistics were used to capture differences in costs between the migraine cohorts and the healthy cohorts whereas ANOVA was used to test for differences in costs between subgroups of migraine sufferers., Results: Compared to nonmigraineurs, adults and children with migraine had significantly higher total direct medical costs in all examined categories (P < .0001) (7,089 US Dollars vs US Dollars adults; 4,272 US Dollars vs 1,400 US Dollars children). For adults, the presence of depression and/or anxiety along with migraine equated to significantly greater total direct medical costs when compared to their matched healthy cohorts (P < .0001) (12,642 US Dollars vs 5,179 US Dollars anxiety; 11,290 US Dollars vs 3,135 US Dollars depression). Children with migraine and either anxiety or depression (or both) incurred an average of 9,875 US Dollars in total direct medical costs as compared with only 1,165 US Dollars for healthy comparators. For children and adults, the presence of comorbid anxiety or depression was associated with significantly higher medical costs when compared to migraine alone (P < .0001)., Conclusions: This analysis quantifies the economic impact of a migraine diagnosis for both adults and children. The results of this analysis demonstrate that individuals identified as migraineurs have significantly higher medical costs than healthy comparators, with or without comorbid anxiety and/or depression. This study also suggests that clinicians should be aware that while proper treatment of migraine with effective acute and prophylactic therapy is important, attention must also be directed to comorbid conditions.

In evaluating the cardiovascular risks of triptans (5-HT(1B/1D) agonists) for the treatment of migraine, the possible relationship between migraine and cardiovascular disease warrants careful assessment. The vascular nature of migraine is compatible with the possibility that migraine is a manifestation of cardiovascular disease or is linked to cardiovascular disease via a common mechanism. If so, then migraine itself--independent of the use of triptans--may be associated with an increased risk of cardiac events. This article considers the epidemiologic literature pertinent to evaluating the association of migraine with coronary heart disease. The research reviewed herein fails to support an association between migraine and coronary heart disease. First, data from several large cohort studies show that the presence of migraine does not increase risk of coronary heart disease. Furthermore, although migraineurs are generally more likely than nonmigraineurs to report chest pain, the presence of chest pain in most studies did not predict serious cardiac events such as myocardial infarction. That the gender- and age-specific prevalence of migraine does not overlap with that of coronary heart disease is also consistent with a lack of association between migraine and atherosclerotic cardiovascular disease. While migraine appears not to be associated with coronary heart disease, preliminary evidence suggests a possible link of migraine with vasospastic disorders such as variant angina and Raynaud's phenomenon. These results warrant further investigation in large prospective studies.

Study Objective: The practice patterns of US emergency departments in the treatment of patients with isolated benign headache have been recently described. How treatment varies among EDs has not been reported. To assess institutional variability in the pharmacotherapy of patients with benign headache, we describe and analyze the practice patterns of 3 US EDs., Methods: This health records survey included a cohort sample of consecutive adult patients aged 16 to 65 years treated with parenteral medication for isolated benign headache at 3 nonaffiliated US EDs: a large, group-model health maintenance organization, a tertiary-care academic center, and a rural community hospital. Patients who underwent a diagnostic search for intracranial pathology, who had any nonheadache secondary diagnosis, or who had coexistent trauma, fever (temperature of > or =38.0 degrees C [100.4 degrees F]), or known pregnancy were excluded from study analysis. Demographic, clinical, and pharmacotherapeutic variables were collected for each ED visit. Descriptive analyses were performed; comparisons were made with t tests., Results: Of the 490 eligible patients treated during the 4-month study period, the mean age was 36.4 years, and 374 (76%) were women. During their 629 visits, 364 (58%) received a migraine diagnosis, and 258 (41%) received a nonspecific headache diagnosis. Polypharmacy was common: 515 (82%) received 2 or more medications, and 154 (25%) received 3 or more medications. Pharmacotherapy varied greatly among the EDs. Use of opioid agonists showed the widest variation (16% to 72%), although use of dihydroergotamine (5% to 16%), prochlorperazine (32% to 59%), and adjunct diphenhydramine with prochlorperazine (42% versus 88%) also varied., Conclusion: Great institutional variability exists among US EDs in the parenteral treatment of patients with isolated benign headache.

Typical drug development includes few studies to find the right dose/dosing regimen and several other bridging studies evaluating various prognostic factors (e.g.: co-administration of other drugs, organ failure). The drug sponsors and the regulators use this information to formulate labeling instructions for safe and effective use of the drug. In the current article, modeling and simulation are proposed as tools to integrate the knowledge from the effectiveness/safety studies and the bridging studies. Simulations allow exploring the impact of various prognostic factors on the effectiveness and safety. The concept is exemplified using the new drug application of an anti-migraine drug. The exercise aids in integrating all the knowledge across the drug development to suggest rationale dosing strategies; effectively communicating the impact of the prognostic factors to the clinicians/regulators; and protect against any intellectual losses due to development team changes.

Background: Adults with chronic daily headache often describe a transformation from episodic migraine and partial retention of migrainous features. Although chronic daily headache has not been investigated as carefully in the pediatric population, one study showed a predominance of coexisting daily headache and episodic migraine, without a clear history of transformation., Objective: To identify the clinical features of chronic daily headache in children and adolescents, to evaluate the efficacy of current headache classification criteria, and to compare the features of coexistent daily and episodic headaches so as to determine whether they represent separate syndromes or different stages in the "transformation" process., Design: We surveyed 189 consecutive patients, 18 years of age or younger, who presented for initial evaluation of daily or near daily headache at one of 9 tertiary headache clinics. Data were collected in semistructured interviews employing a standard questionnaire and analyzed using Statistical Analysis Systems and Stata statistical software computer programs., Results: Of the patients enrolled, 70% were female and 87% were white. Mean age was 13.0 +/- 3.1 years. Male gender was associated with a higher degree of reported disability. A family history of headache (typically migraine) was described in 79%. Use of nonsteroidal anti-inflammatory drugs 5 days per week or more was reported by 44% of patients. The International Headache Society (IHS) criteria failed to classify 64% of patients and criteria proposed by Silberstein et al failed to classify 31% of patients. Participating physicians misclassified patients according to criteria of the IHS and Silberstein et al in one third of cases. Nearly one quarter of patients reported two separate headache types with distinguishing characteristics. "Baseline" headache was present 27.3 +/- 4.1 days per month with a mean pain intensity of 5.9 +/- 2.1 on a 10-point scale. Superimposed episodic headache occurred 4.7 +/- 3.8 days per month with a mean pain intensity of 8.4 +/- 1.4, and was more often accompanied by other migrainous symptoms. After logistic regression to control for pain intensity, the only statistically significant difference between the two headache types was a lower prevalence of tension-type head pain with the superimposed headache., Conclusions: Our data suggest that rather than having two coexistent headache types, children and adolescents with chronic daily headache have a single syndrome that, in many cases, will paroxysmally worsen and gather migrainous features.

Objective: To determine whether there are any differences in health-related quality of life between patients with migraine and those with transformed migraine., Background: There are no published reports comparing the health-related quality of life between patients with migraine and patients with transformed migraine., Methods: We conducted a retrospective analysis examining the health-related quality of life of patients with transformed migraine and migraine seen at a specialty headache clinic. Data collected included the Short Form-36 (SF-36) and the Migraine Disability Assessment questionnaires as well as demographic information. Both of these forms are part of the initial evaluation at the headache clinic. A t test with Bonferroni correction was used to test for significant differences in the SF-36 domains between the groups., Results: Data were collected for 90 patients, 46 with transformed migraine and 44 with migraine. There were no significant differences between groups with respect to sex, race, or age. Over the last 90 days prior to their first visit, patients with transformed migraine reported having a headache an average of 69 days compared with patients with migraine who averaged 18 days with headache (P<.05). Compared with patients with migraine, patients with transformed migraine had statistically (P<.05) and clinically significant (difference >5 points) lower mean scores on seven of the eight SF-36 domains and both the mental and physical summary scores of the SF-36., Conclusions: The results of this study suggest that patients with transformed migraine have a lower health-related quality of life than patients with migraine. These findings indicate that the headache chronicity associated with transformed migraine has a significant influence on quality of life. The results highlight the importance of effective management of headaches to avoid the progression of migraine to the more disabling transformed migraine.

Objective: To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness)., Methods: Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation., Results: The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 +/- 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach alpha =.92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics., Conclusions: These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life.

Objective: This study reports on the influence of migraine and comorbid depression on health-related quality of life (HRQoL) in a population-based sample of subjects with migraine and nonmigraine controls., Methods: Two population-based studies of similar design were conducted in the United States and United Kingdom. A clinically validated, computer-assisted telephone interview was used to identify individuals with migraine, as defined by the International Headache Society, and a nonmigraine control group. During follow-up interviews, 389 migraine cases (246 US, 143 UK) and 379 nonmigraine controls (242 US, 137 UK) completed the Short Form (SF)-12, a generic HRQoL measure, and the Primary Care Evaluation of Mental Disorders, a mental health screening tool. The SF-12 measures HRQoL in two domains: a mental health component score (MCS-12) and a physical health component score (PCS-12)., Results: In the United States and United Kingdom, subjects with migraine had lower scores (p < 0.001) on both the MCS-12 and PCS-12 than their nonmigraine counterparts. Significant differences were maintained after controlling for gender, age, and education. Migraine and depression were highly comorbid (adjusted prevalence ratio 2.7, 95% CI 2.1 to 3. 5). After adjusting for gender, age, and education, both depression and migraine remained significantly and independently associated with decreased MCS-12 and PCS-12 scores. HRQoL was significantly associated with attack frequency (for MCS-12 and PCS-12) and disability (MCS-12)., Conclusions: Subjects with migraine selected from the general population have lower HRQoL as measured by the SF-12 compared with nonmigraine controls. Further, migraine and depression are highly comorbid and each exerts a significant and independent influence on HRQoL.

Migraine, a common disorder of uncertain pathogenesis, is linked to ischemia in a variety of ways. In some cases the relationship is coincidental. In others, migraine may be causally related to stroke, although the mechanism of migrainous stroke, if not due to arterial dissection, is unclear. In young women, additional risk factors for stroke such as cigarette smoking, use of combined oral contraceptives and anticardiolipin antibody immunoreactivity may potentiate migraine, especially migraine with aura, as a stroke risk factor. The complexity of the relationship is highlighted in certain genetic conditions such as cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy and mitochondrial encephalopathy with lactic acidosis and stroke in which migraine and stroke are both prominent clinical features.

Based on reports of headache in arteriovenous malformations and epilepsy, one would predict that the prevalence of migraine headache in the Sturge-Weber syndrome would be higher than in the general population. A questionnaire designed to determine the prevalence and type of headache by IHS criteria was sent to the 500 members of the Sturge-Weber Foundation. The average age of the patients in this sample (71 patients) was 15 years. The sex ratio was approximately one to one. Headache meeting IHS criteria for migraine occurred in 28% (equally among males and females) compared to 17% in females and 5% in males in the general population. Neurologic deficits occurred in 58% during migraine. The prevalence of migraine in children under the age of 10 (31%) was higher than that reported in the general population (5%) and the age of onset was younger. The mechanism of migraine headache in Sturge-Weber syndrome may be similar to that found in epilepsy and vascular malformations.

Migraine epidemiology presents methodological challenges, partially simplified by the use of the new International Headache Society (IHS) Classification. Most previously published migraine studies were clinic-based, which introduces bias since less than 5% of migraineurs consult specialists. A series of population-based studies of migraine prevalence and incidence, based on the new operational IHS criteria, are now available and are reviewed, along with the migraine personality, comorbid psychiatric conditions and neuropsychological impairment. Migraine headaches are now divided into those with aura (classic migraine) and those without aura (common migraine). Headache occurs in about 91% of men and 96% of women, migraine occurs in about 6% of men and 18% of women (one-year prevalence). Migraine is most common in the third decade of life and in lower socioeconomic groups. It is associated with an increased prevalence of depression and panic attacks.

Information about headache was collected from a nonclinical sample of 451 women, aged 15 to 44, in 12 major U.S. cities. Questions were asked in regard to the presence in the past year of headache, and of the following characteristic symptoms of migraine: unilateral location, throbbing quality, visual aura, vomiting, and severity sufficient to affect daily activities. Twenty-three percent of the women had headaches with two or more of these characteristics. The frequency of such symptoms was significantly greater in women who smoked or formerly had smoked cigarettes, in women with lower incomes and poor education, and in women with a history of hypertension, stomach ulcer, fainting, and a variety of emotional complaints. The frequency of reported symptoms of migraine did not vary significantly according to age, race, marital status, use of oral contraceptives, or number of living children. These findings do not support the commonly held clinical impression that migraine is uncommon among blacks or among the poorly educated.