| Methods | Multicentre, randomised, double-blind, three parallel groups. Single oral dose per attack. Two attacks treated Medication taken when migraine headache pain of moderate or severe intensity Assessments at 0 and 2 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 or without aura. At least 12-month history of migraine, with two to six attacks per month during three months prior to study N = 421 (385 experienced ≥1 attack and analysed for efficacy) M = 94, F = 327 Mean age = 39 years |
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| Interventions | Lysine acetylsalicylate 1620 mg (equivalent to 900 mg aspirin) plus metoclopramide 10 mg, n = 137 Sumatriptan 100 mg, n = 122 Placebo, n = 126 |
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| Outcomes | Headache relief at 2 hours PI: 4-point scale Pain-free at 2 hours 24-hour sustained relief Headache recurrence at 24 hours Relief of nausea and vomiting Use of rescue medication PGE: 4-point scale Adverse effects |
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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 |
Yes | Double dummy design |