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. Author manuscript; available in PMC: 2014 Sep 13.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008041. doi: 10.1002/14651858.CD008041.pub2
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
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
Interventions Acetylsalicylic acid 900 mg plus metoclopramide 10 mg, n = 340
Zolmitriptan 2.5 mg, n = 326
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
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