Methods | Multicentre, randomised, double-blind, double-dummy, parallel-group. Single oral dose Each participant to treat two attacks, as soon as intensity was moderate or severe Assessmnets at 0, 2 and 24 hours If pain not controlled, participants encouraged 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 moderate or severe attacks per month. Prophylaxis permitted if stable for ≥3 months N = 296 randomised (268 took study medication) M = 47, F = 249 Mean age 37 years |
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Interventions | Calcium carbasalate 1145 mg (equivalent to 900 mg aspirin) plus metoclopramide 10 mg, n = 136 Ergotamine 1 mg plus metoclopramide 10 mg, n = 132 | |
Outcomes | Headache relief at 2 hours Pain-free after 2 hours Relief of nausea PGE: 4-point scale Headache recurrence within 24 hours Use of rescue medication 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? | Yes | Predetermined randomisation list |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Yes | Double-dummymethod, using tablet and sachet |