Sideri 1994.
Methods | This was a randomised controlled trial. | |
Participants |
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Interventions | A: testosterone propionate 2% B: placebo (petrolatum ointment) These were taken for 1 year. |
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Outcomes |
Outcomes of the trial 1) Symptoms 2) Gross appearance 3) Histological changes |
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Notes | Setting: university hospital Country: Italy 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 | Low risk | Neither the investigator nor the participants knew which medicine was being applied. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There was no description of withdrawal or dropout. |
Selective reporting (reporting bias) | Low risk | Improvement in symptoms, gross appearance, and adverse drug reactions were reported. |
Degree of certainty that the participants have LS | Low risk | LS was proven by biopsy. |
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 | Unclear risk | Although a scoring system was used to assess clinical and symptomatic status, no relevant details were provided. |
Discontinuation of previous treatments | Low risk | All participants received an initial 2‐week course of topical antibiotic‐corticosteroid cream before allocation, then they were randomised to the testosterone and placebo groups. |
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 | Low risk | We extracted tabulated data from the trial. |
VAS= visual analogue scale PR=pruritus BP= burning/pain