Methods | Multicentre, randomised, double-blind, parallel-group, double-dummy. Single oral dose per attack. Participants treated up to three migraine attacks Assessments at 0 and 2 hours. If pain not controlled, participants asked to wait 2 hours before taking rescue medication Participants instructed to leave minimum interval of 48 hours between consecutive study treatments to ensure adequate washout |
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Participants | Aged 18-65 years, meeting IHS criteria for migraine. At least 12-month history of migraine, with one to six attacks per month of moderate or severe intensity Excluded participants with need for continuing migraine prophylaxis N = 358 (355 analysed for at least one attack) M = 72, F = 283 Mean age = 41 years |
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Interventions | Aspirin 900 mg plus metoclopramide 10 mg, n = 183 Sumatriptan 100 mg, n = 172 |
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Outcomes | Headache relief at 2 hours PI: 4-point scale Presence of nausea, vomiting, photophobia, phonophobia Functional disability Headache recurrence at 48 hours Use of rescue medication PGE: 4-point scale Adverse events |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not described |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Double dummy design |