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 |
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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% |
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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 |
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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 |
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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 |