Aoki 1984.
Methods | R, DB, PC, AC, parallel groups Gel applied to affected area 3 or 4 times daily, with no occlusion for 7 days Assessment at baseline, 3, 7 days |
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Participants | Acute orthopaedic trauma (contusion, distortion, fracture, < 7 days) N = 252 (203 analysed for efficacy) M 98, F 105 Age range 8 to 86 years, 13% younger than 20 years Baseline pain mild in 35% Exclusions: 23 protocol violations, 26 reasons "not related" to drug. Equally distributed between groups |
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Interventions | Piroxicam gel 0.5%, 1 g 3 to 4 x daily, n = 84 Indomethacin gel 1%, 1 g 3 to 4 x daily, n = 84 Placebo gel, n = 84 No other medication or initiation of physical therapy allowed |
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Outcomes | PGE: 5‐point scale (responder = "better" and "much better") Adverse events Withdrawals and exclusions |
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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 | Not described |
Allocation concealment (selection bias) | Low risk | "key code sealed until end of study" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Gels in "identical tubes" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | > 10% withdrawals "unrelated to treatment" and for "protocol violations". No further details, but no significant differences between groups |
Size | Unclear risk | 50 to 200 participants per treatment group |