Skip to main content
. 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, and 120 minutes after dosing
An open 3 mg injection of sumatriptan was available after 30 minutes if headache had not improved to no worse than mild
Rescue medication (not containing ergotamine or dihydroergotamine) was available after 60 minutes if relief remained inadequate
Participants Aged 18 to 60 years, meeting IHS criteria for migraine (1988) with or without aura.
At least 1-year history of migraine (untreated severity ≥ moderate) with 1 to 6 attacks per month
No use of ergotamine or morphine-containing preparations within 24 h, or analgesics within 6 h of study treatment
The use of prophylactic therapy, provided it did not contain ergotamine, was allowed
N = 685 (672 for efficacy)
M 165, F 520 (76%)
Mean age 40 years
Without aura 76%
Interventions Sumatriptan 1 mg, n = 170
Sumatriptan 2 mg, n = 171
Sumatriptan 3 mg, n = 172
Placebo, n = 172
Outcomes Efficacy data only reported for 30 minutes
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB1, W1. Total = 3.
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 Unclear risk Treatment groups 50 to 200 participants