Hoffmann 2012.
Methods | R, DB, PC, multicentre, parallel group Plaster applied x 1 daily (minimum of 20 consecutive hours of application per day) for 14 days PI assessed daily, overall efficacy assessed at 7 and 14 days |
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Participants | Unilateral, mild to moderate muscle contusion of upper or lower limb (< 72 hours), PI ≥ 50/100, superficial haematoma ≤ 10 x 14 cm at injured site N = 354 M 126, F 228 Mean age 39 years |
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Interventions | DHEP/hep plaster, x 1 daily, n = 121
DHEP plaster, x 1 daily, n = 115
Placebo plaster, n = 118 Rescue medication: paracetamol 500 mg (no limit reported) |
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Outcomes | PGE: 5‐point scale (responder = excellent or good) at 14 days Mean reduction in PI at 3 and 8 days Rescue medication Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported |
Allocation concealment (selection bias) | Unclear risk | Method not reported: "Medication packed and labelled in order to render all participants and personnel fully blinded to treatment administered" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Indistinguishable regarding appearance, shape, colour, size and odour" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No responder analysis reported, and imputation method not mentioned |
Size | Unclear risk | 50 to 200 participants per treatment arm |