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. 2014 Dec 11;2014(12):CD009281. doi: 10.1002/14651858.CD009281.pub3

Peroutka 2004.

Methods Single‐centre, randomised, double‐blind, placebo‐controlled, 3‐period cross‐over study
Single oral dose administered at the onset of moderate or severe pain
Duration: 24 h, with assessments at baseline, 1, 6, and 24 h post dose
Participants Acute migraine attack without aura, in accordance with IHS criteria, with a history of ≥ 12 months
Participants were 18 to 60 years of age
N = 72 enrolled (52 treated first attack, 46 treated second attack, 39 treated the third attack); treated a total of 134 attacks
M 10, F 62
Mean age 45 years
Interventions Numbers of attacks treated:
Diclofenac sodium softgel 100 mg + caffeine 100 mg, n = 43
Diclofenac sodium softgel 100 mg, n = 46
Placebo, n = 45
Outcomes Headache relief at 1 h
Withdrawals and dropouts
Serious adverse events
Notes Oxford Quality Score: R1, DB1, W1. Total = 3/5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method used to generate random sequence not described
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Method not described
Size High risk < 50 participants in relevant treatment arms