Skip to main content
. 2012 Feb 15;2012(2):CD009665. doi: 10.1002/14651858.CD009665

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
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
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)
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
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