OBJECTIVE: To determine if the addition of preventive drug treatment (beta 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: beta blocker (n = 53), matched placebo (n = 55), behavioural migraine management plus placebo (n = 55), or behavioural migraine management plus beta 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 beta blocker and behavioural migraine management (-3.3 migraines/30 days, 95% confidence interval -3.2 to -3.5), but not the addition of beta 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 beta blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus beta 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 beta blocker plus behavioural migraine management, but not the addition of beta blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined beta blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine. TRIAL REGISTRATION: ClinicalTrials.gov NCT00910689.
Reproduced with permission from the BMJ Publishing Group.

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