Methods | Multicentre, randomised, double-blind, placebo-controlled, three-fold cross-over, double-dummy. Single oral dose per attack. Each participant treated three migraine attacks with different treatments Medication taken when migraine headache pain of moderate or severe intensity Assessments at 0, 0.5, 1, 1.5, 2 and 24 hours. If pain not controlled, participants encouraged to wait 2 hours before taking rescue medication Participants instructed to leave a minimum of 48 hours between consecutive study treatments to ensure that new attack and not migraine recurrence was being treated |
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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 one to six attacks per month N = 312 M = 59, F = 253 Mean age 38 years |
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Interventions | Effervescent acetylsalicylic acid 1000 mg, n = 222 Ibuprofen 400 mg, n = 212 Sumatriptan 50 mg, n = 226 Placebo, n = 222 |
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Outcomes | Pain intensity at 0.5, 1, 1.5 and 2 hours Nausea, vomiting, photophobia and phonophobia at same time points Global assessment of medication on 4-point categorical scale Use of ‘escape medication’ Time when headache disappeared Recurrence within 24 hours Adverse events |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Treatment was assigned by a predetermined randomisation code” |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Yes | Double dummy design |