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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. Single dose to treat each of 4 consecutive attacks (3 with sumatriptan, 1 with placebo)
Medication administered when migraine headache pain was of moderate or severe intensity
Assessments at 0.5, 1, and 1.5 h after dosing
Rescue medication available after 1.5 h
Participants Aged 18 years or over, meeting IHS criteria for migraine (1988) with or without aura.
At least 1-year history of migraine (untreated severity ≥ moderate)
No ergotamine or analgesics containing opioid derivatives within 24 h, or simple analgesics or antiemetics within 6 h of taking study medication
Each treatment separated by a pain-free interval of at least 24 h
N = 170 (of which 120 treated all 4 attacks)
M 15, F 155 (91%)
Mean age 41 years
Proportion with/without aura not reported
Interventions Sumatriptan 6 mg, n = 166 (128 treating first attack with moderate or severe baseline pain intensity)
Placebo, n = 144 (42 treating first attack with moderate or severe baseline pain intensity)
Outcomes Headache relief (at 1 h)
Pain-free (at 1 h)
24 h sustained headache relief
24 h sustained pain-free
Improvement in nausea, vomiting, photophobia, and phonophobia at 1 h
Improvement in functional disability at 1 h
Use of rescue medication
Adverse events
Withdrawals
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 Placebo injections designed to match the active dose
Study size High risk Treatment group 50 to 200 participants, placebo group < 50 participants