Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial.

OBJECTIVE: To determine if the addition of preventive drug treatment (ß blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine. DESIGN: Randomised placebo controlled trial over 16 months from July 2001 to November 2005. SETTING: Two outpatient sites in Ohio, USA. PARTICIPANTS: 232 adults (mean age 38 years; 79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment. INTERVENTIONS: Addition of one of four preventive treatments to optimised acute treatment: ß blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus ß blocker (n=69). MAIN OUTCOME MEASURE: The primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores. RESULTS: Mixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined ß blocker and behavioural migraine management (-3.3 migraines/30 days, 95% confidence interval -3.2 to -3.5), but not the addition of ß blocker alone (-2.1 migraines/30 days, -1.9 to -2.2) or behavioural migraine management alone (-2.2 migraines migraines/30 days, -2.0 to -2.4), improved outcomes compared with optimised acute treatment alone (-2.1 migraines/30 days, -1.9 to -2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined ß blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus ß blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16. CONCLUSION: The addition of combined ß blocker plus behavioural migraine management, but not the addition of ß blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined ß blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine. TRIAL REGISTRATION: Clinical trials NCT00910689.

Do psychiatric comorbidities influence headache treatment outcomes? Results of a naturalistic longitudinal treatment study.

This study examined if the presence of one or more psychiatric disorders influences headache treatment outcomes in patients in headache specialty treatment centers. Using a naturalistic, longitudinal design, 223 patients receiving preventive therapy for headache disorders completed 30-day daily diaries that assessed headache days/month and severity at acute therapy baseline and 6-month evaluation and also provided data on headache disability and quality of life at acute therapy baseline, preventive therapy initiation, preventive therapy adjustment, and 6-month evaluation visits. Psychiatric diagnoses were determined using the Primary Care Evaluation for Mental Disorders (PRIME MDs). Of the 223 patients, 34% (n = 76) had no psychiatric disorder, 21% (n = 46) were diagnosed with Depression-Only; 13% (n = 29) were diagnosed with Anxiety-Only; and 32% (n = 72) were diagnosed with Depression-and-Anxiety. Prior to initiating new preventive therapy, patients with one or more psychiatric disorders reported more frequent and disabling headaches and poorer life quality compared to patients with no psychiatric disorders. Rates of improvement in headache days/month, disability, and quality of life were significant and comparable across the four groups. Contrary to clinical wisdom, patients with psychiatric disorders respond very favorably to contemporary headache treatments administered in headache specialty treatment centers.

Race differences in adherence to headache treatment appointments in persons with headache disorders.

PURPOSE: This research characterized patterns and predictors of adherence to headache treatment appointments in patients presenting at headache specialty treatment clinics throughout Ohio. BASIC PROCEDURES: Participants were 186 patients (118 white, 68 African Americans, 89% female) in headache treatment clinics in Cincinnati, Cleveland, Columbus and Toledo, OH. The study used a naturalistic longitudinal cohort design and assessed patients during four treatment visits (pretreatment, one-month follow-up, two-month follow-up and six-month follow-up). During the 30 days prior to initiating new headache treatments, patients used a daily diary to record data on headache severity, frequency and disability; headache treatment locus of control and headache management self-efficacy; social support; and demographic characteristics. The Primary Care Evaluation for Mental Disorders interview was administered to all patients at pretreatment to screen for psychiatric diagnoses. Patient attendance at the four treatment appointments was used to create a dichotomous measure of treatment appointment adherence (i.e., 0 = completed treatment; 1 = terminated treatment prematurely). MAIN FINDINGS: African Americans were more likely to be diagnosed with depression than whites and were more likely to prematurely terminate their headache treatment appointments regardless of their socioeconomic status (SES). White patients with SES values above the median reported the lowest rate of premature treatment termination. PRINCIPAL CONCLUSIONS: Higher SES enables whites (but not African Americans) to attend all headache treatment appointments. Interventions that enable African-American headache patients to complete their prescribed headache treatments are urgently needed.

Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.

CONTEXT: Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy. OBJECTIVE: To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine. DESIGN, SETTING, AND PARTICIPANTS: Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack. INTERVENTIONS: Patients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain. MAIN OUTCOME MEASURES: Primary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptan-naproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptan-naproxen sodium and each monotherapy. RESULTS: Sumatriptan-naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptan-naproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptan-naproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptan-naproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptan-naproxen sodium and sumatriptan monotherapy. CONCLUSION: Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2).

Factors associated with migraine-related quality of life and disability in adolescents: a preliminary investigation.

OBJECTIVES: This study examined factors associated with impaired quality of life and functioning in a sample of treatment-seeking adolescent migraineurs. Subjects.-The 37 participants were 51.4% female, and averaged 14.3 years of age and 4.1 migraines per month for the previous 36 months. PROCEDURE: The Migraine-Specific Quality of Life Questionnaire, questionnaire items inquiring about missed activities, and headache diary recordings of missed and impaired activity time served as dependent measures. Variables studied were age; gender; migraine frequency, duration, and severity; presence of nausea, photophobia, or phonophobia; and number of visits to an emergency department in the previous year. RESULTS: Three hierarchical forward regressions and one logistic regression, controlling for age and gender, revealed that the presence of nausea and at least one emergency department visit predicted poorer quality of life and a greater number of missed activities in these adolescent migraineurs. The presence of migraine-related missed activity hours from headache diaries was predicted by being male, having higher combined photophobia and phonophobia sensitivity scores, as well as more frequent and severe migraines. Greater impairment was predicted by having longer average duration attacks. CONCLUSIONS: These preliminary findings suggest that the continued development of effective treatment approaches to alleviate pain, suffering, and disability in adolescent migraineurs is required. In particular, evidence for the impact of nausea and sensitivities suggests that they may be important targets for treatment. As well, adolescent migraineurs with a history of a visit to an emergency department in the previous year likely experience greater individual and family distress, more disability, and poorer quality of life that require thoughtful, comprehensive treatment to prevent the development of more severe headache difficulties.

Treating chronic tension-type headache not responding to amitriptyline hydrochloride with paroxetine hydrochloride: a pilot evaluation.

CONTEXT: In some individuals, chronic tension-type headache fails to respond to tricyclic antidepressant medications that often serve as first-line therapy. OBJECTIVE: To evaluate the clinical efficacy of paroxetine hydrochloride for chronic tension-type headache not responding to amitriptyline hydrochloride. DESIGN AND SETTING: Open-label trial of paroxetine conducted at 2 outpatient sites in Ohio. PARTICIPANTS AND INTERVENTION: Thirty-one adults (mean age, 37 years; 20 women) with chronic tension-type headache (mean, 25 headache days per month) who had failed to respond (less than 30% improvement) to treatment with either amitriptyline (n = 13) or matched placebo (n = 18). All participants were treated with paroxetine (up to 40 mg per day) in a 9-month protocol. OUTCOME MEASURES: Monthly headache index calculated as the mean of pain ratings (0 to 10 scale) recorded by participants in a diary 4 times per day, number of days per month with at least moderate pain (pain rating of 5 or greater), and analgesic medication use. RESULTS: In patients who had not responded to amitriptyline, paroxetine failed to reduce chronic tension-type headaches or analgesic medication use. In patients who had not responded to placebo, paroxetine produced modest reductions in chronic tension-type headaches and analgesic use. CONCLUSIONS: We found no evidence that chronic tension-type headaches that failed to respond to tricyclic antidepressant therapy with amitriptyline improved when subsequently treated with paroxetine. More support was found for the efficacy of paroxetine in patients with chronic tension-type headaches who had failed to respond to placebo.

Perceptions and needs of patients with migraine: a focus group study.

OBJECTIVE: This study's purpose was to identify the areas that people find most difficult in living with migraines and, in that regard, what kinds of assistance would be most helpful to them and to other people who have migraine headaches. STUDY DESIGN: Four focus groups, each consisting of 4 to 8 participants, were held. Discussions, which were recorded and organized according to category and theme, focused on problems in living with migraines and effective treatment of migraines. POPULATION: Participants were 24 people who had been experiencing 1 to 2 migraines a month, each lasting 1 to 2 days, for at least 6 months. RESULTS: Five themes emerged: (1) impact on family, (2) misunderstanding by others, (3) effect on work, (4) physician care issues, and (5) issues related to medical insurance and drug companies. A majority of participants identified early treatment as the most important consideration for new migraine sufferers. Many participants preferred to have a relationship with their physicians in which they developed a treatment plan together rather than receiving generic educational materials. CONCLUSIONS: Results suggest that patients are interested in understanding their migraines and securing relevant information in addition to obtaining pain relief. Patients desired collaborative relationships with their physicians and a team approach to treatment. Suggestions for physicians who treat patients who have migraines are reviewed.