González de Vega 2013.
Methods | R, DB (for gels), SB (for ointment), AC, multicentre, parallel groups 2 g (˜ 6 cm of gel) applied over injured area x 3 daily for 14 days Assessments at 0, 4, 7, 14 days of treatment, and day 42 follow‐up |
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Participants | Grade I or II ankle sprain (< 24 hours) with lateral external ligament involvement, PI on weight bearing ≥ 30/100 N = 449 M = 308, F = 112 (for analysis) Mean age 28 years |
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Interventions | Traumeel gel, 3 x 2 g daily, n = 140 Traumeel ointment, n = 143 (not analysed in this review) Diclofenac gel 1%, 3 x 2 g daily, n = 137 Rescue medication: paracetamol to maximum 2 g daily |
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Outcomes | Pain‐free on day 7 Global efficacy: 5‐point scale (responder = "good" and "very good") on day 14 Normal function on day 14: yes or no (responder = "yes") Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2 (gels), 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) | Low risk | Central allocation, kits assigned in order received, and used envelopes (no further details) |
Blinding (performance bias and detection bias) All outcomes | Low risk | For gel comparison: "identical containers" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Used LOCF. Most withdrawals due to early recovery (within 14 days), approximately equal between groups |
Size | Unclear risk | 50 to 200 participants per treatment arm |