An assessment of the burden of migraine using the willingness to pay model.

Willingness to pay methods measure treatment preferences and also measure the burden of illness in economic terms. We used a contingent valuation method to measure migraine sufferers' willingness to pay (WTP) for acute medication for their most severe headache attacks, based on various profiles of treatment benefits and the characteristics of the migraine sufferer. Subjects were identified from a population-based database of migraine sufferers, previously recruited by random digit dialing. Telephone interviews (n = 1428) were used to gather demographic and headache characteristics. Subjects who met the International Headache Society criteria for migraine with or without aura and satisfied the other inclusion criteria based on telephone interview (n = 312) were invited to participate in a mailed questionnaire study. The questionnaire was mailed to the 310 subjects who agreed to participate and 201 (65%) surveys were returned. The survey included questions on the demographics, the migraine characteristics, and the psychological disposition of the respondents. WTP for an acute migraine treatment with 14 different hypothetical treatment profiles was explored. Responders and non-responders to the survey were generally similar. The newly designed WTP questionnaire had high internal consistency (Cronbach's alpha 0.90) and test-retest reliability (Spearman's correlation coefficients 0.71-0.77). Study subjects were willing to pay a median price of US 5 dollars for a migraine treatment that provided complete relief in 30 min and worked 100% of the time, with no side-effects and no headache recurrence. Median WTP decreased as treatment attributes deviated from this ideal. For example, WTP declined to a median of US 1 dollar for complete relief in 2 h and to US 0.25 dollars for complete relief in 4 h. All of the medication attributes powerfully influenced WTP. Several variables predicted WTP including current payment for medication, MIDAS (Grade III), and those with headaches of long duration. Subjects who employed a greater number of coping skills were less willing to pay. Patient demographics and migraine severity predict WTP, but treatment attributes were also important. As treatment improves, WTP for migraine medications is likely to increase.

Epidemiology of migraine.

Migraine is a highly prevalent headache disorder that has a substantial impact on the individual and society. Over the past decade, substantial advances in research have increased understanding of the pathophysiology, diagnosis, epidemiology, and treatment of the disorder. This article reviews data on the epidemiology and impact of migraine. It also highlights the increased awareness of migraine, citing examples from the popular media and the Internet.

Migraine, quality of life, and depression: a population-based case-control study.

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.

Treatment of severe, disabling migraine attacks in an over-the-counter population of migraine sufferers: results from three randomized, placebo-controlled studies of the combination of acetaminophen, aspirin, and caffeine.

OBJECTIVE: To examine the benefits of acetaminophen, aspirin, and caffeine (AAC) in the treatment of severe, disabling migraine attacks, in a population of migraine sufferers for whom over-the-counter (OTC) medications are appropriate. BACKGROUND: Subjects (n = 1220) who met the International Headache Society criteria for migraine with or without aura were included in three independent clinical studies. DESIGN/METHODS: Post-hoc analysis of 172 subjects who met the criteria for severe, disabling migraine reported a history of migraine attacks characterized by at least severe pain and severe disability, and treated attacks with severe pain and at least severe disability. Subjects who usually vomited with 20% or more of their migraine attacks, and those with incapacitating disability (subjects who required bed rest for more than 50% of their attacks) were not eligible for enrollment. RESULTS: From 1 h and continuing through 6 h postdose, the proportion of responders was significantly greater (p< or =0.01) for AAC than placebo. The pain intensity difference from baseline was significantly greater (p< or =0.05) for AAC than placebo from 0.5 h through 6 h. The proportion of subjects reporting improvement in functional disability, photophobia, and phonophobia was significantly greater for AAC than placebo from 2 h through 6 h postdose. CONCLUSIONS: The nonprescription combination of AAC was well tolerated and effective.

Treatment of menstruation-associated migraine with the nonprescription combination of acetaminophen, aspirin, and caffeine: results from three randomized, placebo-controlled studies.

This retrospective study sought to examine the benefits of the nonprescription combination of acetaminophen, aspirin, and caffeine (AAC; Excedrin Migraine, Bristol-Myers Squibb Company, New York, New York) for the treatment of menstruation-associated migraine compared with migraine not associated with menses. Data were derived from 3 double-masked, randomized, placebo-controlled, single-dose trials enrolling subjects who met the International Headache Society's diagnostic criteria for migraine with or without aura. Subjects with incapacitating disability (attacks requiring bed rest >50% of the time) and those who usually experienced vomiting > or =20% of the time were excluded. Retrospective analysis of the 1220 subjects included in the efficacy-evaluable data set indicated that 185 women treated menstruation-associated migraine, 781 women treated migraine not associated with menses, and 1 woman provided no information regarding menstrual status. At baseline and at 0.5, 1, 2, 3, 4, and 6 hours postdose, subjects assessed the intensity of headache pain, functional disability, nausea, photophobia, and phonophobia. Pain intensity, nausea, photophobia, and phonophobia were rated on a 4-point scale ranging from 0 = none to 3 = severe; functional disability was rated on a 5-point scale ranging from 0 = none to 4 = incapacitating. For both menstruation-associated migraine and migraine not associated with menses, the proportion of subjects with pain intensity reduced to mild or none (responders) was significantly greater with AAC than with placebo at all postdose time points from 0.5 through 6 hours (P< or =0.05), with no statistically significant difference in treatment effect between menstruation-associated migraine and migraine not associated with menses at any postdose time point. Migraine characteristics such as photophobia, phonophobia, and functional disability were significantly improved in AAC-treated subjects at all time points from 1 through 6 hours (P< or =0.01) in both the menstruating and nonmenstruating groups. Significant relief from nausea was experienced in both menstruation-associated migraine and migraine not associated with menses, but relief appeared earlier in the AAC nonmenstruating subjects (2 hours postdose, P< or =0.01) than in the menstruating subjects (6 hours postdose, P< or =0.05). Beginning at 3 hours postdose, significantly fewer subjects treated with AAC required rescue medication (P< or =0.05) for menstruation-associated migraine (AAC 6%, placebo 15%) and migraine not associated with menses (AAC 7%, placebo 14%). The most commonly used rescue medications in both the menstruating and nonmenstruating groups were nonsteroidal anti-inflammatory drugs, prescription combination analgesics/narcotics, and prescription migraine preparations. AAC was well tolerated in both menstruation-associated migraine and migraine not associated with menses; in general, adverse experiences were similar in both groups. The proportion of subjects who had 1 or more adverse experiences was significantly higher among those receiving AAC than among those receiving placebo (menstruation-associated migraine: AAC 26.4%, placebo 12.6%, P = 0.025; nonmenstruation-associated migraine: AAC 18.6%, placebo 11.4%, P = 0.005). Adverse experiences were similar in type and severity to those previously associated with single doses of acetaminophen, aspirin, or caffeine. Thus the nonprescription combination of AAC was highly effective in treating the pain, disability, and associated symptoms of both menstruation-associated migraine and migraine not associated with menses.