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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, parallel-group
Three attacks treated with same medication. Second dose of sumatriptan or placebo paracetamol + domperidone allowed after 2 h if necessary. Rescue medication after 4 hours if necessary
Participants Migraine ± aura (diagnostic criteria not reported). Aged 20 to 65 years. Duration of condition ≥ 1 year. Frequency ≥ 1 every 8 weeks. Excluded: prophylactic treatment within 2 weeks, IHD, chronic analgesic use for other condition
N = 607
M 98, F 509
Mean age 39 years
Interventions Paracetamol + metoclopramide 1000/10 mg, n = 302
Sumatriptan 100 mg, n = 305
Outcomes Headache relief at 2 h
24 h sustained relief
Relief of nausea, vomiting, photophobia/phonophobia
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
Allocation concealment? Yes Investigators provided with a sealed envelope for each patient - to be returned unopened at the end of the trial, or patient discontinued from trial
Blinding?
All outcomes
Yes Each active treatment had a matched placebo tablet (triple dummy)