Recognition and therapeutic management of migraine in 2004, in France: results of FRAMIG 3, a French nationwide population-based survey

OBJECTIVE: To evaluate the proportion of migraineurs who are self-aware of their disease in France, to determine the factors (disability, quality of life, psychiatric comorbidities, and medical consultation) that may promote self-awareness of migraine, and to assess the influence of these factors on migraine attacks. BACKGROUND: New recommendations for migraine diagnosis and medical management were released in 2003 by the French medicoeconomic evaluation service (ANAES). In addition, the revised classification of headache disorders recently issued by the International Headache Society includes probable migraine as a form of migraine. However, strict and probable migraine now appear to be part of the same spectrum of disease. METHODS: Subjects with migraine (strict or probable) according to the revised classification were identified by a postal questionnaire from a large representative sample of the French adult population. Migraine-related disability was assessed using the MIDAS questionnaire, anxiety and depression by the Hospital Anxiety and Depression scale (HADS), and health-related quality of life (HRQoL) by the 8 concepts of the Short-Form 12 (SF-12) questionnaire. Migraine management was assessed according to the use of recommended or nonrecommended treatments, and treatment efficacy according to the set of 4 questions designed by the ANAES. RESULTS: Of the 10,532 subjects interviewed, 1,179 subjects (21.3%) were identified as migraineurs. Sixty percent of all migraine subjects were not self-aware that they had migraine. Medical consultation, duration of migraine history, severe intensity of attacks, impact on daily living, and female gender promoted self-awareness of migraine. On the other hand, HRQoL and anxiety and depression scores were not different between subjects self-aware or not self-aware of migraine. Only 20% of all migraine subjects were medically followed-up. Quality of the first medical consultation appears determinant for continued consulting. Subjects self-aware of migraine more frequently used recommended acute treatments of migraine, which proved more effective than nonrecommended treatments as assessed according to the ANAES set of questions. CONCLUSIONS: Migraine medical diagnosis and follow-up remain low in France. Careful medical consultation is a prime factor for migraine subject self-awareness of migraine, continued consultation, and use of recommended medications for the treatment of migraine attacks.     

Negative impact of episodic migraine on a university population: quality of life, functional impairment, and comorbid psychiatric symptoms

(Headache 2011;51:581‐589) Background.— Migraine is associated with significant negative impact, including reduced quality of life, impaired functioning, and comorbid psychiatric disorders. However, the impact of migraine on university students is understudied, despite their high prevalence of migraine and psychiatric disorders and their frequent use in research studies. Objectives.— The aim of this cross‐sectional study was to evaluate the impact of migraine among college students on quality of life, functional impairment, and comorbid psychiatric symptoms. Methods.— Three hundred and ninety‐one students (76.73% female, mean age = 19.43 ± 2.80 years) completed well‐validated measures of migraine and migraine‐related disability, quality of life, and comorbid psychiatric symptoms. They also quantified impairment in school attendance and home functioning and reported the number of medical visits during the preceding 3 months. Results.— One hundred and one (25.83%) met conservative screening criteria for episodic migraine; their mean score on the Migraine Disability Assessment Questionnaire was 9.98 ± 12.10. Compared to those not screening positive for migraine, the migraine‐positive group reported reduced quality of life on 5 of 6 domains, as well as a higher frequency of missed school days (2.74 vs 1.36), impaired functioning at home (2.84 vs 1.21 days), and medical visits (1.86 vs 0.95). They also reported more symptoms of both depression and anxiety than controls, although differences in functional impairment remained after controlling for these comorbid psychiatric symptoms. These differences were highly statistically significant and corroborated by evidence of clinically significant impairment; the corresponding effect sizes were modest but non‐trivial. Conclusions.— Episodic migraine is associated with negative impact in numerous domains among university students. These findings replicate and extend those of studies on other samples and have implications for future research studies with this population.     

Loss of Productivity and Quality of Life in Migraine Sufferers Among French Workers: Results From the GAZEL Cohort

To assess the burden of migraine, we compared the productivity and the perceived health of 991 migraine sufferers (IHS criteria), 1004 other-headache sufferers, and 1757 nonheadache sufferers randomly chosen among volunteers from employees of the French national gas and electricity company. The extent of absenteeism was collected independently from the study subjects during a 4-year period. Performance at work was self-assessed at the end of the followup. The study subjects also completed the Short-Form 36 Health Survey Questionnaire (SF36) and the Spielberger anxiety scale. The number of workdays lost due to migraine was not statistically different between the migraine and control groups, after adjustment for age, sex, and number of health impairments other than headaches. Performance was found to be greatly reduced in migraineurs. The quality of life was poorer and the anxiety level was higher in the migraine group than in the nonheadache group. There was no difference between migraineurs and other-headache sufferers for any variable. The lack of difference in absenteeism between migraineurs and nonheadache subjects calls into question prior research based on self-report. Moreover, it also calls into question the economic impact of migraine due to its indirect costs found in previous studies without e control group. We found that the burden of migraine may be considered mainly in terms of reduced quality of life.     

The specific disease burden of neuropathic pain: results of a French nationwide survey

We report the first nationwide survey of the impact of neuropathic pain, as opposed to nonneuropathic pain, on quality of life and health care utilization in the French general population. A postal questionnaire was sent to a representative sample of 4554 respondents from an initial nationwide survey of 30,155 subjects with or without chronic pain. It included pain characteristics (Neuropathic Pain Symptom Inventory, DN4), quality of life (Medical Outcomes Short Form 12, SF-12), sleep, anxiety/depressive symptoms (Hospital Anxiety and Depression Scale) and health care utilization. In total, 3899 (85.6%) questionnaires were returned, 3816 (97.9%) could be assessed and 3165 subjects (82.9%) confirmed their pain status. Subjects reporting pain and neuropathic characteristics based on the DN4 displayed a higher degree of impairment of all dimensions relating to quality of life and sleep and had higher anxiety/depression scores than those reporting pain without neuropathic characteristics and those without pain (P < .01). They also made greater use of health care facilities, particularly as concerned neurological treatments and visits to neurologists (21% vs 9%; P < .01). Multivariate analyses showed that the neuropathic characteristics of pain made an independent contribution to quality-of-life impairment (P < .0001 and P = .0005 for the physical and mental scores of the SF-12 respectively). Our study indicates that the disease burden of chronic pain depends on the nature of the pain, independently of its intensity and duration.     

The epidemiology of headache in Germany: a nationwide survey of a representative sample on the basis of the headache classification of the International Headache Society

This study presents the first account of the prevalence of headache syndromes, defined according to the International Headache Society criteria, in a large representative sample of the German population; 5000 persons representative of the total population were selected from 30,000 households. Subjects were requested to answer a questionnaire about headache occurrence during their lifetime. The completion rate was 81.2%. Seventy-one point four percent ( n = 2902) reported a history of headache. Twenty-seven point five percent fulfilled the criteria for migraine. Thirty-eight point three percent ( n = 1557) met the criteria for tension-type headache and 5.6% ( n = 229) did not fulfil criteria for either migraine or tension-type headache. Significant correlations were found between the prevalence of the different headache syndromes and sociodemographic variables such as sex, age and place of residence. The prevalence of headache did not exhibit any significant differences between the various länder (states or regions) of Germany. When extrapolated to the total population these results reveal that 54 million people in Germany suffer from headache at least occasionally or persistently. These findings suggest that the magnitude of the neurological disorders, migraine and tension-type headache, is seriously underestimated and thus constitutes a major contemporary health problem.     

Development and validation of the Headache Needs Assessment (HANA) survey

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.     

Measuring the Functional Status and Well-Being of Patients with Migraine Headache

SYNOPSIS
Objective: Compare adult migraineurs' health related quality of life to adults in the general U.S. population reporting no chronic conditions, and to samples of patients with other chronic conditions. Methods: Subjects (n=845) were surveyed 2–6 months after participation in a placebo-controlled clinical trial and asked to complete a questionnaire including the SF-36 Health Survey, a migraine severity measurement scale and demographics. Results were adjusted for severity of illness and comorbidities. Scores were compared with responses to the same survey by the U.S. sample and by patients with other chronic conditions. Results: Response rate was 67%. After adjustment for comorbid conditions, SF-36 scale scores were significantly (P 0.001 ) lower in migraineurs, relative to age and sex-adjusted norms for the U.S. sample with no chronic conditions. Some health dimensions were more affected by migraine than other chronic conditions, while other dimensions were less affected by migraine. Measures of bodily pain, role disability due to physical health and social functioning discriminated best between migraineurs, the U.S. sample, and patients with other chronic conditions. Patients reporting moderate, severe and very severe migraines scored significantly (P £ 0.001 ) lower on five of the eight SF-36 scales than the U.S. sample. Conclusions: Migraine has a unique, significant quality of life burden.     

MIG ACCESS: a population-based, nationwide, comparative survey of access to care in migraine in France

A national control-matched survey was conducted in France to evaluate the access of migraineurs to health care. A validated IHS criteria-based diagnostic procedure for screening was conducted in adults drawn from a sample of 6,000 house holds. A group of 650 subjects fulfilling the IHS criteria for migraine were matched by sex, age and activity status with a group of non-headache, non-migraine controls. Response rates were 87% and 82% for the migraineurs and the controls, respectively. The comparability of the groups was demonstrated by the absence of statistical differences between either respondents versus non-respondents or migraineurs versus controls for sex, age and occupation. The 3-month prevalence of migraine was estimated at 13% (95% CI: 12–14). The health care consumption of migraineurs was not higher than that of the controls. Migraineurs rarely consult for headaches and seem to content themselves with their routine analgesic treatment. They believe, however, that improvement in their condition is possible and discuss this with their physicians. This ambivalent attitude mainly reflects a fatalistic outlet which may constitute the major obstacle of an improved management of migraine.     

Topiramate Treatment of Chronic Migraine: A Randomized, Placebo-Controlled Trial of Quality of Life and Other Efficacy Measures

Objective.— To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double‐blind, placebo‐controlled, multicenter clinical trial. Background.— We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated. Methods.— Variables analyzed included between‐treatment group differences in percent responders, change in the mean monthly rate of total headache days and headache‐free days, change in average and worst daily headache severity, change in the mean monthly use of acute headache medications, and absolute change and percent change in a headache index. Additional analyses included evaluation of changes in: the associated symptoms of photophobia, phonophobia, and nausea; Migraine‐Specific Quality of Life Questionnaire scores; Migraine Disability Assessment Scale scores; and Physician's and Subjects Global Impression of Change. Results.— The intent‐to‐treat population consisted of 306 patients (topiramate, n = 153; placebo, n = 153). Categorical responder rates of reductions in mean monthly migraine/migrainous days for topiramate‐ vs placebo‐treated subjects were as follows: for ≥25% reduction: 68.6% vs 51.6% (P = .005); ≥50%: 37.3% vs 28.8% (P = .093); and ≥75%: 15.0% vs 9.2% (P = .061). The decrease in mean monthly total headache days and headache‐free days for topiramate vs placebo treatment was 5.8 vs 4.7 days (P = .067). Compared with placebo, topiramate treatment resulted in statistically significant mean improvements in the Role Restrictive (P = .028) and Emotional Function (P = .036) domains of the Migraine‐Specific Quality of Life Questionnaire, in the worst daily severity of migraine (P = .016), severity of photophobia (P = .032), frequency of vomiting (P = .018), photophobia (P = .038), phonophobia (P = .010), unilateral pain (P = .015), pulsatile pain (P = .023), and pain worsened because of physical activity (P = .047). In addition, there were trends observed (favoring topiramate) in average daily severity of migraine (P = .077), acute headache medication use (P = .127), severity of nausea (P = .098), frequency of nausea (P = .166), the Role Preventive domain of the Migraine‐Specific Quality of Life Questionnaire (P = .061), and severity of phonophobia (P = .062). Conclusions.— In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events.     

Quality of sleep, fatigue and daytime sleepiness in migraine— a controlled study

The objective of this study was to evaluate whether the quality of sleep and the degree of fatigue and daytime sleepiness are related to migraine. We investigated 489 subjects comprising 97 patients with eight or more, 77 patients with five to seven and 196 patients with one to four migraine days per month, and 119 migraine-free controls with fewer than six headache days per year. The patients were recruited via articles in newspapers not stressing the subject of the study. All participants underwent a semistructured interview and completed the Pittsburgh Sleep Quality Index (PSQI), the Fatigue Severity Scale (FSS), the Epworth Sleepiness Scale (ESS) and the Self-rating Depression Scale and the Self-rating Anxiety Scale. For statistical analysis we used two way manova s, post hoc univariate two-way anova s and Hochberg's GT2 tests as well as three-way mixed design anova s. The PSQI total score was highest in patients with frequent migraine (5.9 ± 4.3) and lowest in controls (4.3 ± 2.5, P  = 0.04). Four subscores of the PSQI showed similar statistically significant differences. The FSS and ESS scores did not differ in the four study groups. Analysing depression and anxiety revealed a significant impact on PSQI, FSS and ESS, but did not demonstrate interactions with migraine, thus suggesting that the impact of migraine is similar in patients without and with psychiatric comorbidity. In conclusion, the quality of sleep is decreased in patients with migraine, whereas fatigue and daytime sleepiness do not differ from healthy controls. The decreased quality of sleep in migraineurs is also a consequence of migraine itself and cannot be explained exclusively by comorbidity with depression or anxiety.     

Migraine without aura and migraine with aura are distinct clinical entities: a study of four hundred and eighty-four male and female migraineurs from the general population

The clinical characteristics of migraine without aura (MO) and migraine with aura (MA) were compared in 484 migraineurs from the general population. We used the criteria of the International Headache Society. The lifetime prevalence of MO was 14.7% with a M:F ratio of 1:2.2; that of MA was 7.9% with a M:F ratio of 1:1.5. The female preponderance was significant in both MO and MA. The female preponderance was present in all age groups in MA, but was first apparent after menarche in MO, suggesting that female hormones are an initiating factor in MO, but not likely so in MA. The age at onset of MO followed a normal distribution, whereas the age at onset of MA was bimodally distributed, which could be explained by a composition of two normal distributions. The estimated separation between the two groups of MA was at age 26 years among the females and age 31 years among the males. The observed number of persons with co-occurrence of MO and MA was not significantly different from the expected number. The specificity and importance of premonitory symptoms are questioned, but prospective studies are needed. Bright light was a precipitating factor in MA, but not in MO. Menstruation was a precipitating factor in MO, but not likely in MA. Both MO and MA improved during pregnancy. The clinical differences indicate that MO and MA are distinct entities.     

Attitudes and burden of disease among self-considered migraineurs--a nation-wide population-based survey in Sweden

The authors have earlier reported a 1-year prevalence of 13.2 +/- 1.9% for migraine in Sweden. This is a subsequent extensive postal survey of the burden of disease and attitudes among migraineurs in a sample (n = 423, 23% men and 77% women, aged 18-74 years) randomly recruited from all main regions of the country, representative of adults in the general Swedish population with self-considered migraine. Results are presented only from participants who after analysis of symptoms were found to fulfil the International Headache Society's migraine criteria. In order to assess headache duration open-mindedly, the strict time criterion 4-72 h was deliberately disregarded as an inclusion criterion. Individuals who did not consider themselves to have migraine were excluded. Less than half of the group (45%) had received a diagnosis of migraine from a physician. Accordingly, a large number of individuals that would not have come to attention in a clinic-based study have been included. The mean attack frequency was 1.3 per month, and the number of attacks per year in Swedish adults is approximately 10 million. A minority (27%) of sufferers have a majority (68%) of all attacks. The mean attack duration was 19 h. A considerable number of individuals reported attacks < 4 h (15.8%) or > 72 h (6.4%). Less than half of the individuals recovered completely between the attacks. Despite this, only every fourth (27%) participant was currently consulting a physician (6% regularly; 21% occasionally). Most of the migraineurs reported absence from school or work, a negative influence of migraine on the most important aspects of life, and an interest in testing other treatments for migraine during the last year. Of those (n = 231) migraineurs who had consulted a physician, about 60% were satisfied with information given or treatment offered. This implies, however, that there is still room for improvement in the management of migraine in Sweden.     

Assessment of migraineurs referred to a specialist headache clinic in Singapore: diagnosis, treatment strategies, outcomes, knowledge of migraine treatments and satisfaction

This study aimed to compare (i) migraineurs' diagnosis, treatment strategies and satisfaction when treated by community care physicians (CCPs) and at the specialist headache clinic; (ii) migraineurs' knowledge of migraine treatments and outcomes at baseline and at 3 months' interval. Thirty-eight patients were interviewed at baseline visit and 3 months after neurologist consultation, using a survey form which consisted of a series of self-designed questions, the MIDAS questionnaire and the SF-36 Health Survey. More patients were informed of the diagnosis of migraine by the neurologist than by CCPs. Compared with CCPs, the neurologist was more likely to employ preventive therapies, prescribe triptans and ask patients to keep a headache diary. Patients' number of days with headaches in the last 3 months, pain intensity, MIDAS score and five out of the eight SF-36 domain scores were significantly improved at the 3 months' interval (P<0.05) compared with baseline at the specialist headache clinic. More patients recognized migraine-specific therapies and reported satisfaction with treatment after the neurologist consultation. This is the first study detailing significant improvements in patients' clinical outcomes, knowledge of migraine treatments and satisfaction after consultation at a specialist headache clinic in Singapore.     

Impact of monthly headache days on migraine-related quality of life: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study

Objective

To characterize the direct impact of monthly headache days (MHDs) on health-related quality of life (HRQoL) in people with migraine and the potential mediating effects of anxiety, depression, and allodynia.

Background

Although the general relationship between increased migraine frequency (i.e., MHDs) and reduced HRQoL is well established, the degree to which reduced HRQoL is due to a direct effect of increased MHDs or attributable to mediating factors remains uncertain.

Methods

Cross-sectional baseline data from participants with migraine who completed the Core and Comorbidities/Endophenotypes modules in the 2012–2013 US Chronic Migraine Epidemiology and Outcomes (CaMEO) study, a longitudinal web-based survey study, were analyzed. The potential contribution of depression, anxiety, and/or allodynia to the observed effects of MHDs on HRQoL as measured by the Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ) was evaluated.

Results

A total of 12,715 respondents were included in the analyses. The MSQ domain scores demonstrated progressive declines with increasing MHD categories (B = −1.23 to −0.60; p < 0.001). The observed HRQoL decrements associated with increasing MHDs were partially mediated by the presence of depression, anxiety, and allodynia. The MHD values predicted 24.0%–32.4% of the observed variation in the MSQ domains. Depression mediated 15.2%–24.3%, allodynia mediated 9.6%–16.1%, and anxiety mediated 2.3%–6.0% of the observed MHD effects on the MSQ.

Conclusions

Increased MHD values were associated with lower MSQ scores; the impact of MHDs on the MSQ domain scores was partially mediated by the presence of depression, anxiety, and allodynia. MHDs remain the predominant driver of the MSQ variation; moreover, most of the variation in the MSQ remains unexplained by the variables we analyzed. Future longitudinal analyses and studies may help clarify the contribution of MHDs, comorbidities, and other factors to changes in HRQoL.     

Priority acute and preventive migraine treatment benefits: Results of the Migraine Clinical Outcome Assessment System (MiCOAS) qualitative study of people living with migraine

Background

There is renewed emphasis on including patients in determining, defining, and prioritizing outcomes for migraine treatment.

Objectives

To obtain insights directly from people living with migraine on their priorities for treatment.

Methods

A total of 40 qualitative interviews were conducted as part of the Migraine Clinical Outcome Assessment System project, a United States Food and Drug Administration grant-funded program to develop a core set of patient-centered outcome measures for migraine clinical trials. Interviews included a structured exercise in which participants rank-ordered pre-defined lists of potential benefits for acute and preventive migraine therapy. The 40 study participants who reported being diagnosed with migraine by a clinician ranked the benefits and explained their rationale.

Results

Study participants consistently ranked either pain relief or absence of pain as their top priority for acute treatment. Relief/absence of other migraine symptoms and improved functioning were also prioritized. For preventive treatment, participants prioritized reductions in migraine frequency, symptom severity, and attack duration. Few differences were found between participants with episodic migraine and those with chronic migraine. However, participants with chronic migraine ranked “increased predictability of attacks” much higher than those with episodic migraine. Participants' rankings were influenced by prior expectations and experiences of migraine treatments, which caused many participants to deprioritize desired benefits as unrealistic. Participants also identified several additional priorities, including limited side-effects and reliable treatment efficacy in both acute and preventive treatments.

Conclusion

The results showed the participants prioritized treatment benefits aligned with existing core clinical outcomes used in migraine research, but also valued benefits that are not typically assessed, such as predictability. Participants also deprioritized important benefits when they believed treatment was unlikely to deliver those outcomes.