Propranolol in the Prophylaxis of Migraine

SYNOPSIS
This 34-week, placebo-controlled, single crossover study with a double-blind randomized treatment sequence evaluated the effects of propranolol as a prophylactic agent in individualized doses ranging from 60–320 mg/day given to 62 patients who had common and/or classic migraine. Variables reflecting efficacy were the frequency, severity, and persistency of acute migraine attacks expressed as Headache Unit Index (HUI) and the therapeutic medication required for acute attacks during the study expressed as the Relief Medication Unit Index (RMUI). Both HUI and RMUI were significantly reduced from baseline after the six weeks of propranolol titration (p<0.0001) reflecting fewer and/or less severe headaches. During the crossover treatment periods, propranolol, in comparison with placebo, was significantly more effective in the reduction of HUI (p<0.01) and RMUI (p<0.05). Data at the end of the dose finding (titration) period were analyzed separately for patients whose final prescribed doses were 60-240 mg or 320 mg/day propranolol. Significant reductions in HUI and RMUI (p< 0.0001) were shown at this time at each dose level. At all dose levels, propranolol was well tolerated. This was the first study in which the propranolol dose for migraine extended above the usual recommended 240 mg/day, i.e., up to 320 mg/day. This higher dose was administered if the drug had been well tolerated, even if only one headache in 2 weeks occurred at lower doses. The data suggest that there is an option to prescribe propranolol at higher doses as a preventive measure, thus reducing the need for ancillary medications.