Mahler 2003.
Methods | R, DB, AC, parallel groups Gel applied with gentle massage to affected area 3 times daily, without occlusion, for 10 days Assessed at baseline, 3, 10 days in clinic and daily patient diary |
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Participants | First‐degree ankle or knee sprains, first‐degree muscle strains and mild‐to‐moderate contusions n = 100 M 69, F 31 Mean age 32 years Mean baseline pain with activity ≥ 65 mm |
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Interventions | DHEP lethicin gel, 3 x 5 g (= 65 mg) daily, n = 52 DHEP gel, 3 x 5 g (= 65 mg) daily, n = 48 All participants treated with ice at site of inflammation for first 48 hours, but no immobilisation allowed Rescue medication: paracetamol 500 mg if strictly necessary |
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Outcomes | PGE: 4‐point scale (responder = "good" or "excellent") Pain on movement: 100‐mm VAS (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated randomization list" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Pharmaceutically inert colouring agents added to reference formulation so that gels were indistinguishable |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in responder analysis |
Size | High risk | < 50 participants in each treatment arm |