Schachtel 1991a.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study Single oral dose after onset of relatively severe throat pain (> 66 mm on 100 mm VAS). Duration: 2 h, with assessments at baseline, 15, 30, 45, 60, 90, and 120 minutes post dose |
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Participants | Acute sore throat, with a score of ≥ 4 on 12‐point tonsillopharyngitis assessment and pain intensity > 66/100 on VAS Participants at least 18 years of age N = 210 (207 for efficacy) M 69, F 138 Mean age 30 years |
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Interventions | Aspirin 800 mg + caffeine 64 mg, n = 70 for efficacy Aspirin 800 mg, n = 68 for efficacy Placebo, n = 69 for efficacy No "cold medication", mood‐altering drugs, or alcohol within 8 h, or caffeine‐containing medication or beverages within 12 h of dosing |
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Outcomes | PI: 100 mm VAS PR: 6‐point categorical scale (from 'no relief' to 'complete relief') Withdrawals and dropouts |
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Notes | Oxford Quality Score: R2, DB1, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation code |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method not described |
Size | Unclear risk | 50 to 200 participants in relevant treatment arms |