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. 2011 Dec 7;2011(12):CD008240. doi: 10.1002/14651858.CD008240.pub2

Kiss 2001.

Methods This was a randomised controlled trial.
Participants
  • 40 boys with penile lichen sclerosus

Interventions A: mometasone furoate 0.05% ointment
B: placebo once daily
These were taken for 5 weeks.
Outcomes Outcomes of the trial
1) Clinical score of phimosis
Notes Setting: children's hospital
Country: Hungary
Funding source: not reported
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.