2000 Wolfe Award. Sumatriptan for the range of headaches in migraine sufferers: results of the Spectrum Study

BACKGROUND: Migraineurs experience a spectrum of headaches: migraine, migrainous, and episodic tension-type as defined by the International Headache Society (IHS). OBJECTIVE: To evaluate the effectiveness of sumatriptan, 50-mg tablets, in treating the spectrum of headaches in IHS-diagnosed migraineurs. DESIGN/METHODS: Migraineurs with severe disability (Headache Impact Questionnaire score 250 or greater) were enrolled in a randomized, double-blind, placebo-controlled, crossover study. Patients treated up to 10 headaches with sumatriptan, 50 mg, or placebo (4:1). Headache features, recorded prior to treatment, were used to classify each headache using IHS criteria. Headache response (moderate or severe pain reduced to mild or no pain) and pain-free response were recorded at 2 and 4 hours postdose (primary endpoint). Because patients treated multiple attacks, statistical methods controlling for within-subject correlation were used. RESULTS: Two hundred forty-nine migraineurs treated 1576 moderate or severe headaches: migraine (n = 1110), migrainous (n = 103), and tension-type (n = 363). Sumatriptan was superior to placebo for headache response 4 hours postdose (primary endpoint) across all headache types (migraine, 66% versus 48%; P<.001; migrainous, 71% versus 39%; P<.01; tension-type, 78% versus 50%, P<.001). Sumatriptan was also superior to placebo for pain-free response 4 hours postdose for migraine (41% versus 24%, P<.001) and tension-type headaches (56% versus 36%, P =.001). Sumatriptan provided superior pain-free response 2 hours postdose for migraine (18% versus 7%, P<.0001) and tension-type headache (28% versus 14%, P =.0005) compared with placebo. CONCLUSION: Sumatriptan, 50-mg tablets, are effective for the full spectrum of headaches experienced by patients with disabling migraine due to a sumatriptan-responsive mechanism.     

Prevalence and Burden of Headache and Migraine in Germany

Objective.— To determine prevalence and burden of headache and migraine in the general population in Germany including patterns of healthcare and medication use.
Methods.— Telephone interviews were conducted on a representative sample of the general population in Germany aged ≥18 years (n = 7341). Migraine was diagnosed according to the International Headache Society criteria.
Results.— One-year prevalence was: headache 60.2%, migraine 10.6%, nonmigrainous severe headache 24.7% (women 66.6%, 15.6%, and 27.1%; men 53.0%, 5.3%, and 22.2%). Approximately 60% of headache sufferers reported severe headaches, 30% of which were migrainous. Migraineurs reported more often frequent headaches, disability, use of analgesics, and medical consultation than individuals with nonmigrainous severe headaches. Only 42% of migraineurs had consulted a physician and the majority relied exclusively on over-the-counter medication.
Conclusion.— Migraine accounts for a great part of the healthcare impact of headaches in Germany. However, the majority of migraineurs do not seek medical care and may not be optimally treated.     

Prevalence and diagnosis of migraine in patients consulting their physician with a complaint of headache: data from the Landmark Study

CONTEXT: Headache experts have suggested that to improve the recognition of migraine, patients with a stable pattern of episodic, disabling headache and a normal physical exam should be considered to have migraine in the absence of contradictory evidence. The premise upon which this approach is based-that is, that episodic, recurrent primary headache in the clinic is usually migraine-has not been evaluated in prospective clinical studies. OBJECTIVES: To (1) evaluate the diagnoses of patients consulting their physician with primary episodic headache and (2) compare clinic diagnoses and patient self-diagnoses with International Headache Society (IHS) headache diagnoses assigned on the basis of longitudinal data from patient diaries. DESIGN: Prospective, open-label study. During the screening visit, patients self-reported a headache diagnosis and then were assigned a headache diagnosis by their physician following his or her customary practice. Patients with a new physician diagnosis of migraine or nonmigraine primary headache were given diaries to record headache symptoms for up to 3 months or 6 attacks. Members of an expert panel, unaware of the clinic diagnosis, used diary data to assign a headache diagnosis to each attack and to each patient. SETTING: One hundred twenty-eight (128) practices in 15 countries including the United States. PATIENTS: A total of 1203 male and female patients between 18 and 65 years of age who consulted their physician with headache as a primary or secondary complaint. RESULTS: Overall, 94% of patients with a physician diagnosis of nonmigraine primary headache or a new clinic diagnosis of migraine had IHS-defined migraine (76%) or probable migraine (migrainous) (18%) headache on the basis of longitudinal diary data. A new clinic diagnosis of migraine was almost always correct: 98% of patients with a clinic diagnosis of migraine had IHS-defined migraine (87% of patients) or probable migraine (11% of patients) headache on the basis of longitudinal diary data. On the other hand, review of diaries of patients with a clinic diagnosis of nonmigraine revealed that 82% of these patients had IHS-defined migraine (48%) or probable migraine (34%) headache. Altogether, one in four patients (25%) with IHS-defined migraine according to longitudinal diary data did not receive a clinic diagnosis of migraine. CONCLUSIONS: These findings support the diagnostic approach of considering episodic, disabling primary headaches with an otherwise normal physical exam to be migraine in the absence of contradictory evidence. If in doubt of diagnosis or when assigning a nonmigraine diagnosis, strong consideration should be given to the use of a diary to confirm primary headache diagnosis.     

Quality of Life and Productivity in Nurses Reporting Migraine

A random sample survey was conducted to determine the prevalence of migraine in nurses and to study its effect on quality of life and productivity. Of the 10 000 nurses sampled, 2949 returned the questionnaire for a response rate of 29.5%. The majority (99%) of respondents were employed and worked in hospitals (60%). According to the International Headache Society (IHS) criteria, 17% of the sample (n=495) were classified as having migraine. An additional 25% (n=750) suffered severe headaches but did not meet IHS criteria for migraine, and the remaining 58% (n=1704) were classified as not having either migraine or severe headaches. The migraineurs had significantly reduced work productivity and quality of life compared to both the severe headache and the nonmigraine nonsevere headache groups. This study will increase awareness and sensitivity of the profession to its colleagues who are migraine sufferers.     

Migraine Disability Awareness Campaign in Asia: Migraine Assessment for Prophylaxis

Objectives.— This study aimed to survey the headache diagnoses and consequences among outpatients attending neurological services in 8 Asian countries. Methods.— This survey recruited patients who consulted neurologists for the first time with the chief complaint of headache. Patients suffering from headaches for 15 or more days per month were excluded. Patients answered a self‐administered questionnaire, and their physicians independently completed a separate questionnaire. In this study, the migraine diagnosis given by the neurologists was used for analysis. The headache symptoms collected in the physician questionnaire were based on the diagnostic criteria of migraine proposed by the International Classification of Headache Disorders, second edition (ICHD‐2). Results.— A total of 2782 patients (72% females; mean age 38.1 ± 15.1 years) finished the study. Of them, 66.6% of patients were diagnosed by the neurologists to have migraine, ranging from 50.9% to 85.8% across different countries. Taken as a group, 41.4% of those patients diagnosed with migraine had not been previously diagnosed to have migraine prior to this consultation. On average, patients with migraine had 4.9 severe headaches per month with 65% of patients missing school, work, or household chores. Most (87.5%) patients with migraine took medications for acute treatment. Thirty‐six percent of the patients had at least one emergency room consultation within one year. Only 29.2% were on prophylactic medications. Neurologists recommended pharmacological prophylaxis in 68.2% of patients not on preventive treatment. In comparison, migraine prevalence was the highest with ICHD‐2 “any migraine” (ie, migraine with or without migraine and probable migraine) (73.3%) followed by neurologist‐diagnosed migraine (66.6%) and ICHD‐2 “strict migraine” (ie, migraine with or without aura only) (51.3%). About 88.6% patients with neurologist‐diagnosed migraine fulfilled ICHD‐2 any migraine but only 67.1% fulfilled the criteria of ICHD‐2 strict migraine. Conclusions.— Migraine is the most common headache diagnosis in neurological services in Asia. The prevalence of migraine was higher in countries with higher referral rates of patients to neurological services. Migraine remains under‐diagnosed and under‐treated in this region even though a high disability was found in patients with migraine. Probable migraine was adopted into the migraine diagnostic spectrum by neurologists in this study.     

The effects of a sensitisation campaign on unrecognised migraine: the Casilino study

A striking feature of migraine is the difference between the estimated migraine prevalence and the actual number of migraineurs consulting their general practitioners (GPs). We investigated the impact of a sensitisation campaign on migraine in a large cohort of patients, living in a district of Rome. The study involved 10 GPs and a population of about 12 000 people, contacted by mail and posters located in GP clinics. Both the letter and poster stressed the impact of headache on quality of life and included the Italian version of the three-item Identification of Migraine (ID Migraine) screening test, consisting of questions on disability, nausea and photophobia. If the subjects suffered from headaches, they were invited to contact their GPs for a visit and a free consultation with a headache expert. By means of this sensitisation campaign, 195 headache patients consulted their GPs. Ninety-two percent of them (n=179) were migraineurs; 73% of them had never consulted a physician for headache. The ID Migraine test had a sensitivity of 0.92 (95% CI 0.86–0.95), a specificity of 0.75 (95% CI 0.47–0.91) and a positive predictive value (PPV) of 0.97 (95% CI 0.93–0.99) for a clinical diagnosis of migraine, according to the International Headache Society (IHS) criteria. This study confirms that a large number of migraine patients never see a doctor for their headache. This awareness campaign is likely to identify the severest cases of undiagnosed migraineurs. However, mailing campaigns do not seem to be so effective in bringing undiagnosed migraine patients into the primary care setting, and more efficient strategies have to be planned.     

Evolution of migraine after a 10-year follow-up

OBJECTIVE: To assess the evolution of headaches in a workplace cohort over a 10-year period. BACKGROUND: Migraine headaches are associated with significant handicap in everyday activities and poor quality of life. The prevalence of migraine shows a bell-shaped age distribution with a peak during the third and fourth decades. However, there is little longitudinal data available on the natural history of this condition. A prospective health survey undertaken in a large workplace cohort since 1989 provides an opportunity to assess the evolution of migraine and other headache syndromes over a 10-year period. METHODS: A sample of 2500 subjects who reported regular headaches was chosen at random from those with headache identified in a cohort of 46,244 employees of the French national power company aged between 35 and 50 years in 1989 participating in a yearly health survey. In 1993, all subjects were sent a headache questionnaire to complete and return. In 2003, an identical questionnaire was sent to all subjects who had returned exploitable data in 1993. Headache diagnosis was assigned retrospectively using the International Headache Society (IHS) criteria to migraine (IHS categories 1.1 and 1.2), migrainous disorder (IHS category 1.7), or other episodic headaches. RESULTS: Of 2500 subjects sampled, 2051 (82%) returned exploitable data for the first questionnaire in 1993. In 2003, 1250 (61%) of these provided a second data set. In 1993, 623 (30.4%) of subjects fulfilled diagnostic criteria for migraine. However, only 37% of these retained the diagnosis 10 years later. In contrast, the proportion of subjects with other forms of episodic headache rose from 23.7% to 31.6%. In 2003, 9.5% of the sample were headache-free. Retention or acquisition of a diagnosis of migraine was more common in women than in men, and age was associated with evolution to a less severe headache syndrome. In those subjects who continued to have headaches, frequency and severity were lower at the second assessment. CONCLUSIONS: Only a minority of subjects diagnosed with migraine or migrainous disorder retain the diagnosis 10 years later, with most subjects evolving to a less disabling headache type.     

Allodynia in Migraine: Association With Comorbid Pain Conditions

Background.— Cutaneous allodynia (CA) in migraine is a clinical manifestation of central nervous system sensitization. Several chronic pain syndromes and mood disorders are comorbid with migraine. In this study we examine the relationship of migraine‐associated CA with these comorbid conditions. We also evaluate the association of CA with factors such as demographic profiles, migraine characteristics, and smoking status that may have an influence on the relationships of CA to pain and mood. Methods.— Data are from a cross‐sectional multicenter study of comorbid conditions in persons seeking treatment in headache clinics. Diagnosis of migraine was determined by a physician based on the International Classification of Headache Disorders‐II criteria. Participants completed a self‐administered questionnaire ascertaining sociodemographics, migraine‐associated allodynia, physician‐diagnosed comorbid medical and psychiatric disorders, headache‐related disability, current depression, and anxiety. Results.— A total of 1413 migraineurs (mean age = 42 years, 89% women) from 11 different headache treatment centers completed a survey on the prevalence of comorbid conditions. Aura was reported by 38% and chronic headache by 35% of the participants. Sixty percent of the study population reported at least one migraine‐related allodynic symptom, 10% reported ≥4 symptoms. Symptoms of CA were associated with female gender, body mass index, current smoking, presence of aura, chronic headaches, transformed headaches, severe headache‐related disability, and duration of migraine illness from onset. The prevalence of self‐reported physician diagnosis of comorbid pain conditions (irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia) and psychiatric conditions (current depression and anxiety) was also associated with symptoms of CA. Adjusted ordinal regression indicated a significant association between number of pain conditions and severity of CA (based on symptom count). Adjusting for sociodemographics, migraine characteristics, and current depression and anxiety, the likelihood of reporting symptoms of severe allodynia was much higher in those with 3 or more pain conditions (odds ratio = 3.03, 95% confidence interval: 1.78‐5.17), and 2 pain conditions (odds ratio = 2.67, 95% confidence interval: 1.78‐4.01) when compared with those with no comorbid pain condition. Conclusion.— Symptoms of CA in migraine were associated with current anxiety, depression, and several chronic pain conditions. A graded relationship was observed between number of allodynic symptoms and the number of pain conditions, even after adjusting for confounding factors. This study also presents the novel association of CA symptoms with younger age of migraine onset, and with cigarette smoking, in addition to confirming several previously reported findings.     

Migraine headaches in adolescents: a student population-based study in Monreale

We assessed the prevalence of migraine headaches in an epidemiological survey of an 11 to 14-year-old student population. Migraine headaches were classified on the basis of questionnaires and neurological examination using the operational diagnostic criteria of the International Headache Society. Prevalence of migraine without aura (IHS code 1.1) was 2.35%; that of migraine with aura (IHS code 1.2) was 0.62%. Migraine without aura was equally distributed among males and females, whereas migraine with aura was preponderant in the female cohort. The prevalence of migraine headaches in males was constant through the ages studied, whereas the prevalence of migraine headaches in females reached a peak at age 12 and plateaued over the following two years. Although the new IHS classification criteria of migraines are reliable and exhaustive, some subcriteria may not be valid in a juvenile population. For instance, the duration of the pain in young migraineurs is often briefer than in adults, and the intensity of pain was almost always described as moderate or severe. Therefore, in order to increase the reliability and comprehensiveness of the IHS classification, minor modifications should be made.     

Migraine without aura and migrainous disorder in children; International Headache Society (IHS) and revised IHS criteria

The widely used criteria of the IHS to define migraine without aura in children are highly specific but show poor sensitivity, with a large percentage of headaches being classified as migrainous disorder (MD). The objective of this study was to assess how many headache patients in a series of children met the diagnostic criteria of the IHS for migraine without aura or MD and to determine the changes required to convert the greatest number of MD into migraine without aura, without affecting classification of the remaining headache types. A prospective study was undertaken of 131 patients under 15 years old referred to our centre for headache. Patients were classified according to the IHS criteria and according to a modification of these criteria consisting of: (1) reduction of minimum time required for classification into migraine without aura from 2 h to 1 h; (2) acceptance of bifrontal location in addition to hemicranial; (3) acceptance of either phonophobia or photophobia as valid criteria instead of requiring presence of both. Using the IHS criteria, 51 (39%) children were diagnosed as having migraine without aura and 26 (20%) as having MD. According to our revised IHS criteria, 68 (52%) were diagnosed as migraine without aura and nine (7%) as MD. When the three modified criteria were applied, three tension headaches and one unclassifiable headache changed category. When only reduced duration and bifrontal location were applied, none of the headaches other than MD changed category. Application of two modifications to the IHS criteria--reduction in duration of headache to 1 h and acceptance of bifrontal location--increased sensitivity without reducing specificity in classifying migraine without aura in children.     

Responsiveness of non-IHS migraine and tension-type headache to sumatriptan

In a long-term efficacy and satiety study, 424 patients were treated with sumatriptan (6 mg sc) for 1,904 migraine attacks. The patients were diagnosed with migraine based on IHS criteria but individual migraine attacks treated in the study were physician diagnosed; not necessarily required to meet IHS criteria. A re-analysis of the treatment response to open label sumatriptan (6 mg sc) indicated that 43 patients had treated at least one migraine that fulfilled IHS criteria for tension-type headache. Analysis of this population revealed they treated 232 headaches. Of these headaches, 114 were classified per IHS criteria as migraine; 76 as tension-type; and 42 as. non-IHS migraine (not classifiable as IHS migraine or IHS tension-type headache). Of the 114 migraines a positive response to sumatriptan occurred in 109 (96%) cases; of the 76 tension-types, 73 responded to sumatriptan (97%); of the 42 non-IHS migraine, 40 (95%) responded to sumatriptan. An equivalent response to sumatriptan among three diagnostic groups of headache supports the concept of a common biologic mechanism involving 5HT₁ receptors that spans a range of clinical presentations.     

Migraine prevalence: a literature review

Worldwide epidemiological studies provide estimates of migraine prevalence. The International Headache Society (IHS) diagnostic criteria have permitted more reliable and generalizable study estimates. In this review, recent population-based reports of IHS-defined migraine are discussed to update the current epidemiological literature, to highlight methodological challenges, and to encourage greater public awareness of this frequently undiagnosed disabling disorder.     

The Burden of Headache in Neurology Outpatient Clinics in Turkey

Background and Aim: The aim of the study was to investigate the burden of headache in neurology outpatient clinics (NOCs) regardless of their primary complaint. Methods: Patients presenting for their routine appointments in 41 NOCs were screened during the course of 1 week. All eligible subjects (n = 3682; 61.9% female, mean age 45.2 ± 16.5 years) were evaluated by a neurologist for the headache diagnosis and some demographic characteristics. Results: Of all patients, 66.4% reported headache, and in 35.1% headache was the primary cause for admitting to the NOC. Of 3682 patients, 917 (24.9%) were diagnosed as migraine according to International Headache Society (IHS) criteria. Thirty‐three and nine‐tenths percent of all patients admitted and 56% of the migraineurs according to IHS had severe headaches. As the headache severity increases, the ratio of the patients admitted with headache as the primary complaint increases significantly. The distribution of burden and other characteristics of headache did not differ in seven geographic regions and 41 different centers. Conclusion: Headache complaint caused at least 1/3 of all neurological outpatient visits in Turkey and 2/3 of all patients admitted to NOC had headache. Of these patients, 1/4 had migraine according to IHS with substantial disability and severity level. ?     

One-year prevalence of migraine in Sweden: a population-based study in adults

A randomly selected sample of 1668 individuals (782 women and 886 men) aged 18-74 years was interviewed by telephone using a standardized questionnaire including the International Headache Society (IHS) criteria for migraine. The survey was performed by SIFO, the national public opinion poll agency. The results obtained demonstrate that 21% of the Swedish population had suffered from severe headaches during the past year. A majority of these headache sufferers (61%) fulfilled the IHS-criteria for migraine. The 1-year prevalence of migraine in Sweden was found to be 13.2 +/- 1.9% (16.7% among women and 9.5% among men). The prevalence of migraine in this Swedish population did not differ between the northern, middle and southern part of Sweden, or between urban and rural areas or different income groups. Only about half (49%) of the migraineurs had been diagnosed by a physician. Among the individuals who fulfilled the IHS criteria for migraine the mean attack-frequency was 1.3 per month and the mean attack-duration was 19 h. If the duration of the attack was disregarded as a strict criterion for migraine (attacks < 4 h and > 72 h were included), the prevalence increased to 17.0 +/- 1.9% without affecting the sex distribution. With this amendment, 92% of those who considered their headaches to be migraine or migraine-like in fact fulfilled the alternative criteria for migraine. However, only 76% of those who believed that they had migraine or migraine-like headaches fulfilled the strict IHS criteria for migraine. An extension of the time window from 4 to 72 h may be reasonable both from a pragmatic and from a rational clinical point of view.