Kiss 2001.
Methods | This was a randomised controlled trial. | |
Participants |
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Interventions | A: mometasone furoate 0.05% ointment B: placebo once daily These were taken for 5 weeks. |
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Outcomes |
Outcomes of the trial 1) Clinical score of phimosis |
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Notes | Setting: children's hospital Country: Hungary Funding source: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | There was no description of the process of randomisation. |
Allocation concealment (selection bias) | Unclear risk | There was no description of the allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | There was no description of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 boys were lost to follow up ‐ 3 in whom clinically suspected penile LS was not confirmed by pathological examination. There was no significant difference in the withdrawal rate between the treatment and control groups. |
Selective reporting (reporting bias) | Low risk | A change in the clinical score of phimosis and adverse drug reactions was reported. |
Degree of certainty that the participants have LS | Low risk | All penile LS cases underwent circumcision, and those that could not be proven by biopsy were excluded. |
Baseline assessment of the participants | Unclear risk | This was not performed. |
Drug identity, source, dose, duration of treatments, and adequacy of instructions | Low risk | The treatments were standardised. |
Description and standardisation of outcome measures | Low risk | Phimosis was graded 1 to 4. |
Discontinuation of previous treatments | Unclear risk | There was no relevant description. |
Permission or standardisation of concomitant treatments | Unclear risk | There was no relevant description. |
Use and appropriateness of statistical analyses where tabulated data could not be extracted from the original publication | Unclear risk | Student's t‐test was used to compare the scores before and after treatments, but Wilcoxon signed rank test should have been used. |