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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, cross-over design. Single dose to treat each of 2 successive attacks
Assessments at 1 and 2 h after dosing.
Second dose of study medication available after 2 h for participants not completely free from headache, or experiencing recurrence of headache within 24 h
Rescue medication (non-ergotamine) was available 1 h after second injection if symptom relief remained inadequate
Participants Aged 18 to 65, with GP diagnosed migraine. At least 6-month history of migraine (untreated severity ≥ moderate) with an average of 1 to 6 attacks per month
Participants were excluded if they had previously used sumatriptan or were currently using migraine prophylactic agents
N = 230 (209 treated both attacks)
M 20, F 189 (90%)
Mean age 44 years
Post-treatment headache diagnosis revealed that ≥ 90% of treated attacks met IHS criteria for migraine (1988) with or without aura
Without aura 65%
Approximately 1% of participants had mild baseline pain intensity when study medication was administered
Interventions Sumatriptan 6 mg, n = 209
Placebo, n = 209
Outcomes Adverse events
Notes Oxford Quality Score: R1, DB1, W0. Total = 2.
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
Unclear risk Not reported
Study size Low risk Treatment groups > 200 participants