Methods | Multicentre, randomised, double-blind, parallel-group, double-dummy. Single oral dose Each participant treated three migraine attacks. Medication taken when migraine headache pain of moderate or severe intensity, provided it was within 6 hours of headache onset, and participants had been free from any previous migraine attack for at least 24 hours Assessments at 0 and 2 hours. If pain not controlled, participants encouraged to wait 2 hours before taking rescue medication Patients returned to study centre after treating first attack, and were then given medication and diary cards for treating two further attacks |
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Participants | Aged 18-65 years, meeting IHS criteria for migraine with and without aura. At least 12-month history of migraine, with age of onset before 50 years and one to six attacks per month of moderate to severe intensity, for three months prior to inclusion in study Excluded participants with basilar, ophthalmoplegic or hemiplegic migraine, and those with non-migraine headache on more than 10 days per month for preceding 6 months Approximately half of participants in each treatment arm had previously been treated with acetylsalicylic acid plus metoclopramide, with ‘good’ or ‘fair’ response reported in roughly 55% of participants in each group Approximately 80% of participants had previously received or were currently receiving acetylsalicylic acid or NSAIDs alone, with ‘good’ or ‘fair’ response reported in approximately 45% of participants in both groups N = 666 M = 100, F = 566 Mean age 41 years |
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Interventions | Acetylsalicylic acid 900 mg plus metoclopramide 10 mg, n = 340 Zolmitriptan 2.5 mg, n = 326 |
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Outcomes | Headache response at 2 hours in all three attacks Pain-free at 2 hours after first dose in all three attacks Relief of migraine-associated symptoms (nausea, vomiting, photophobia, phonophobia) PI: standard 4-point scale Use of escape medication Headache recurrence Adverse events PGE: standard 4-point scale Time to onset of meaningful migraine relief |
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Notes | Oxford Quality Scale: R2, DB2, W1. Total = 5. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Computer-generated randomisation list” |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Yes | Double-dummy design |