Li 2013.
Methods | R, DB, PC, multicentre, parallel groups Plaster applied x 2 daily for 7 days PI assessed daily, overall treatment efficacy and tolerability assessed at 7 days |
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Participants | Mild or moderate ankle or knee sprain, muscle strain or contusion (< 72 hours), PI ≥ 50/100
N = 384 M 144, F 240 Mean age 42 years |
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Interventions | DHEP plaster, x 2 daily, n = 192
Placebo plaster, x 2 daily, n = 192 Rescue medication: paracetamol to maximum 2 g daily |
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Outcomes | ≥ 50% reduction in PI at 7 days Overall treatment efficacy: 5‐point scale (responder = "good" or "excellent") Overall tolerability: 5‐point scale (responder = "good" or "excellent") Rescue medication 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 | Method not fully described: "sealed envelopes", "concealed from investigators and participants" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical in texture, size, color and odor" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals 2%. Methods states LOCF, but appears to describe BOCF for withdrawals |
Size | Unclear risk | 50 to 200 participants per treatment arm |