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

Sideri 1994.

Methods This was a randomised controlled trial.
Participants
  • 58 women with histologically confirmed vulval LS

Interventions A: testosterone propionate 2%
B: placebo (petrolatum ointment)
These were taken for 1 year.
Outcomes Outcomes of the trial
1) Symptoms
2) Gross appearance
3) Histological changes
Notes Setting: university hospital
Country: Italy
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 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