S2BL99.
Methods | Multicentre, randomised, double‐blind, double‐dummy, parallel‐group. Single dose to treat each of up to 3 attacks. Assessments at 30, 60, and 120 minutes after dosing Second dose of study medication available to treat headache recurrence between 2 and 24 h (second dose could not be taken if the first dose was not effective Rescue medication available after 2 h if response to initial treatment was inadequate |
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Participants | Aged 18 to 65, at least 1‐year history of migraine (diagnostic criteria equivalent to IHS 1988) with or without aura, and a frequency of 1 to 6 attacks (untreated severity moderate or severe) per month in the past 12 months No treatment with monoamine oxidase inhibitors or serotonin reuptake inhibitors during the course of the study N = 255 M 52, F 203 (80%) Mean age 43 years Proportion with/without aura not reported |
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Interventions | Sumatriptan 6 mg, n = 125 (122 with moderate or severe baseline pain intensity for attack 1) Oral effervescent acetylsalicylic acid (ASA) 1000 mg + metoclopramide (MCP) 10 mg, n = 130 (125 with moderate or severe baseline pain intensity for attack 1) |
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Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 1 and 2 h) Improvement in nausea and vomiting (at 1 and 2 h) Use of rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4. | |
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 | Low risk | Double‐dummy |
Study size | Unclear risk | Treatment groups 50 to 200 participants |