Coudreuse 2010.
Methods | R, DB, PC, multicentre, parallel group Plaster applied daily for 7 days PI assessed twice daily over 3 days, then day 7. Overall treatment efficacy and tolerability assessed on days 3, 7 |
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Participants | Ankle sprain (< 48 hours) with lateral external ligament involvement
PI on movement ≥ 50/100, oedema ≥ 20 mm difference between ankles N = 240 (233 for analysis) M 148, F 86, 6 unknown |
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Interventions | DHEP/hep, n = 120
Placebo, n = 120 Rescue medication: paracetamol to maximum 4 g daily No other treatments allowed |
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Outcomes | Global efficacy at 7 days: 4‐point scale (responder = "excellent" or "good") Mean change in PI on movement at 6 hours and 7 days Mean change in oedema at 3 and 7 days Tolerability Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | "sealed envelopes" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Appearance and odour identical for all plasters |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis, < 5% excluded for missing data, equal between groups |
Size | Unclear risk | 50 to 200 participants per treatment arm |