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 |
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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 |
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Interventions | Paracetamol + metoclopramide 1000/10 mg, n = 302 Sumatriptan 100 mg, n = 305 |
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Outcomes | Headache relief at 2 h 24 h sustained relief Relief of nausea, vomiting, photophobia/phonophobia Use of rescue medication Adverse events Withdrawals |
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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) |