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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 up to 3 successive attacks
Medication administered at the first sign of headache pain
Assessments at 1, 2, 3, 4, 6, 8, and 24 hours after dosing
Second injection available to participants after 2 h to treat recurrence of headache or if the response to the initial injection had been inadequate
Rescue medication (non-ergotamine) was permitted 2 h after the second injection
Participants Aged 18 to 65, at least 6-month history of migraine (diagnostic criteria equivalent to IHS 1988) without aura
Frequency of 1 to 6 attacks per month in the past 12 months, characterised by slow developing headache (the time interval between onset of mild headache and development of moderate or severe headache had to be consistently greater than 1 hour)
N = 349
M 62, F 287 (82%)
Mean age 40 years
100% without aura
Interventions Sumatriptan 6 mg, n = 136
Placebo, n = 113
Outcomes Serious 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