Methods | Multicentre, randomised, double-blind, three-arm, parallel-group, double-dummy. Single oral dose 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 asked to wait 2 hours before taking rescue medication |
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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 = 433 M = 66, F = 367 Mean age 42 years |
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Interventions | Effervescent acetylsalicylic acid 1000 mg, n = 146 Sumatriptan 50 mg, n = 135 Placebo, n = 152 |
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Outcomes | Headache relief at 1 and 2 hours Pain-free at 2 hours 24-hour sustained relief Adverse events Remission of associated symptoms: nausea, photophobia, phonophobia Overall impression of study medication Need for rescue medication |
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Notes | Oxford Quality Score: 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 | “Matching effervescent or tablet placebo” |