Chatterjee 1977.
Methods | R, DB, PC, parallel groups Cream applied to site of injury 3 times daily for 6 days Assessment at baseline, 2, 6 days |
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Participants | Soft tissue injuries (recent) N = 51 M/F not reported Age not reported Baseline pain on passive movement moderate or severe in all but 3 participants |
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Interventions | Benzydamine HCl cream 3%, 3 x daily, n = 25 Placebo cream, n = 25 (5 active, 6 placebo participants also received ultrasound) No other topical agent allowed |
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Outcomes | Pain on passive movement: 4‐point scale (responder = "absent" or "slight") Tenderness with pressure: 4‐point scale (responder = "absent" or "slight") 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) | Low risk | "predetermined randomised schedule" |
Allocation concealment (selection bias) | Low risk | Sealed copy of schedule held by investigator and duplicate copy kept by clinical trial co‐ordinator. Looked at only in event of adverse reaction (not necessary) |
Blinding (performance bias and detection bias) All outcomes | Low risk | "indistinguishable .... in appearance and consistency" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2% lost to follow‐up, no withdrawals due to adverse events. Responder analysis |
Size | Unclear risk | < 50 participants per treatment arm |