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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 single attack
Medication administered when migraine headache pain was of moderate to severe intensity
Assessments at 10, 20, 30, 60, 90, 120, 180, and 240 minutes after dosing
Rescue medication (excluding ergotamine-containing therapy) was available after 4 h for inadequate relief of symptoms
Participants Aged 18 to 55 years, meeting IHS criteria for migraine (1988) with or without aura.
At least 1-year history of migraine (untreated severity ≥ moderate) with an average of 1 to 6 attacks per month
Participants were excluded if they had previously received subcutaneous sumatriptan Migraine prophylactic therapy stopped at least 2 weeks before the administration of study treatment
No ergotamine-containing preparations within 24 h, or analgesics within 6 h of receiving study medication
N = 335
M 47, F 288 (86%)
Mean age 38 years
Without aura 89%
Interventions Sumatriptan 6 mg, n = 47
Naratriptan 0.5 mg, n = 60
Naratriptan 1 mg, n = 55
Naratriptan 2.5 mg, n = 42
Naratriptan 5 mg, n = 34
Naratriptan 10 mg, n = 34
Placebo, n = 63
Outcomes Headache relief (at 1 and 2 h)
Pain-free (at 2 h)
Improvement in nausea, vomiting, and photo/phonophobia at 2 h
Presence of functional disability at 2 h
Use of rescue medication
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 High risk Some treatment groups 50 to 200 participants, others <50 participants