Propranolol in the Prophylaxis of Migraine

Abstract

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.

Long-Acting Propranolol in Migraine Prophylaxis: Results of a Double-Blind, Placebo-Controlled Study

“…Similar results were reported using either the conventional formulation at identical dosages (2,4) or the long action preparation (8). Although significant, the fall was only moderate and did not necessitate any withdrawal of treatment.…”

“…This 1 3 Tiredness 5 5 3 2 Wheezing 1 Dyspnea 3 3 1 Dyspepsia 1 3 1 Diarrhea 2 1 1 Constipation 1 5 2 2 Insomnia 3 3 2 2 Dreams ----Hallucinations ----Depression 2 3 2 Impotence 1 Dizziness 2 1 1 1 Headache 1 1 1 Rash 1 Nausea 1 Eye troubles 1 has already been reported with the conventional formulation (3,4,12). This 1 3 Tiredness 5 5 3 2 Wheezing 1 Dyspnea 3 3 1 Dyspepsia 1 3 1 Diarrhea 2 1 1 Constipation 1 5 2 2 Insomnia 3 3 2 2 Dreams ----Hallucinations ----Depression 2 3 2 Impotence 1 Dizziness 2 1 1 1 Headache 1 1 1 Rash 1 Nausea 1 Eye troubles 1 ...…”

“…Propranolol is a drug of choice among the prophylactic drugs available for migraine, and its efficacy is now well established (1)(2)(3)(4). Over 50 trials using the conventional formulation have been published, either against placebo or propranolol has been used as the reference drug for assessing other medications.…”

EFNS guideline on the drug treatment of migraine – revised report of an EFNS task force

“…Betablockers are clearly effective in migraine prophylaxis and very well studied in a lot of placebo-controlled, randomized trials. The best evidence has been obtained for metoprolol [87][88][89][90][91] and propranolol [87,88,[92][93][94][95][96][97][98]. Also, bisoprolol [91,99], timolol [93,100], and atenolol [101] might be effective but evidence is less convincing compared with propranolol and metoprolol.…”

EFNS guideline on the drug treatment of migraine – report of an EFNS task force

“…Betablockers are clearly effective in migraine prophylaxis and very well studied in a lot of placebo-controlled, randmized trials. The best evidence has been obtained for the selective betablocker metoprolol [69][70][71][72][73] and for the non-selective betablocker propranolol [69,70,[74][75][76][77][78][79][80]. Moreover, bisoprolol [73,81], timolol [75,82], and atenolol [83] might be effective, but evidence is less convincing compared with propranolol and metoprolol.…”