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. Author manuscript; available in PMC: 2014 Sep 13.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008041. doi: 10.1002/14651858.CD008041.pub2
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
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
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
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