Sugioka 1984.
Methods | R, DB, AC, parallel groups Gel applied to affected area 3 to 4 times daily, without occlusion, for 14 days Assessed at baseline, 7, 14 days |
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Participants | Non‐traumatic diseases of muscle or tendon N = 366 (340 analysed for efficacy) M 115, F 202 (completers) Age range 12 to 84 years (most 30 to 70) Baseline pain on movement "none" or "mild" in about 1/3 of participants Exclusions for protocol violations: 8 piroxicam, 18 indomethacin |
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Interventions | Piroxicam gel 0.5%, 3 to 4 x 1 g daily, n = 183 Indomethacin gel 1%, 3 to 4 x 1 g daily, n = 183 No concomitant anti‐inflammatory or analgesic drug, including steroids, or initiation of physical therapy allowed |
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Outcomes | PGE: 5‐point scale (responder = "better" or "much better") Pain on movement: 4‐point scale (responder = "reduced" or "disappeared") |
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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 and retained until end of study |
Blinding (performance bias and detection bias) All outcomes | Low risk | "both packages were of the same appearance and indistinguishable", and investigators did not see contents |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All relevant participants included in analysis |
Size | Unclear risk | 50 to 200 participants per treatment arm |