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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Feb 15;2:CD009665. doi: 10.1002/14651858.CD009665
Methods Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat single attack
Medication administered when migraine headache pain was of moderate or severe intensity
Assessments at 30, 60, 90, and 120 minutes after dosing
Rescue medication was available after 30 minutes if there was no response to the study treatment
Participants To be eligible for entry, participants were required to have a history of migraine (1 to 6 headaches a month) with or without aura as defined by the IHS (1988)
No narcotic analgesics or ergotamine within the previous 24 h, or aspirin within the previous 6 h before study treatment
N= 51 (50 for efficacy)
M 7, F 43 (86%)
Mean age 41 years
Without aura 74%
Interventions Sumatriptan 4 mg, n = 28
Placebo, n = 23 (22 for efficacy)
Outcomes Only 30 minute efficacy outcomes reported
Adverse events
Notes Oxford Quality Score: R1, DB2, W1. Total = 4.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias)
All outcomes
Low risk Matching placebo
Study size High risk Treatment groups <50 participants