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. Author manuscript; available in PMC: 2014 Sep 11.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Nov 10;(11):CD008040. doi: 10.1002/14651858.CD008040.pub2
Methods Multicentre, R, DB, PC, parallel-group
Single attack treated with a single dose of study medication. Medication taken when pain was moderate or severe. Rescue medication after 2 h if necessary
Assessments at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 h
Participants Episodic migraine ± aura (IHS 2004). Age ≥ 18 years. History of 0.5 to 6 attacks/month in past year and previous treatment with OTC medication. Untreated severity ≥ moderate. Excluded: require bedrest for > 50%, or vomiting with > 20% of attacks
N = 346
M 58, F 288
Mean age 39 years
22% with aura
Interventions Paracetamol 1000 mg, n = 177
Placebo, n = 169
Prophylactic medication continued unchanged
Outcomes Pain-free at 2 h
Headache relief at 1 h and 2 h
Relief of nausea, photophobia, phonophobia, functional disability
Use of rescue medication Adverse events Withdrawals
Notes Oxford Quality Score: R2, DB2, W1. Total = 5
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “computer-generated randomization code”
Allocation concealment? Yes “blister cards with winged 2-piece code label including treatment assignment according to sponsor-generated randomization code”
Blinding?
All outcomes
Yes “tablets identical in shape, size and color”