Methods | Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single oral dose per attack. Participants treated two migraine attacks 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 for three months prior to inclusion in study. Prophylaxis permitted if stable for ≥3 months Excluded participants whose migraine headache was never accompanied by nausea or vomiting N = 266 (250 analysed for efficacy, 16 did not take medication) M = 46, F = 220 Mean age 37 years |
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Interventions | Lysine acetylsalicylate 1650 mg (equivalent to 900 mg aspirin) plus metoclopramide 10 mg, n = 126 Placebo, n = 124 |
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Outcomes | Headache relief at 2 hours Pain-free at 2 hours PI: 4-point scale Presence of nausea and vomiting Headache recurrence at 24 hours PGE: 4-point scale Use of rescue medications |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not described |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Not described |