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 |
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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 |
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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 |
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Outcomes | Headache relief at 1 h Withdrawals and dropouts Serious adverse events |
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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 |