Methods | R, DB, DD, AC, cross-over Two attacks treated with single doses of each of two study medications. Medication taken when pain was moderate or severe. Rescue medication after 4 h if necessary Severity assessed at 0, 1, 2, 4, 24, 48, 72 h |
|
Participants | Migraine ± aura (diagnostic criteria not reported). Aged 18 to 65 years. Duration of condition > 1 year. Frequency ≥ 2 every 12 weeks. Prophylactic therapy (pizotifen, clonidine, β-blockers, calcium channel blockers) allowed if stable for ≥ 3 months and kept constant N = 161 (120 took both treatments and analysed for efficacy) M 9, F 111 Mean age 43 years |
|
Interventions | Paracetamol + domperidone 1000/20 mg + placebo Sumatriptan 50 mg + placebo |
|
Outcomes | Headache relief at 2 h Presence of nausea and vomiting Adverse events Withdrawals |
|
Notes | Oxford Quality Score: R1, DB2, W1. Total = 4 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not described |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Yes | “matching placebos” |