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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, 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
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
Interventions Aspirin 900 mg plus metoclopramide 10 mg, n = 183
Sumatriptan 100 mg, n = 172
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
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