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. 2012 Oct 17;2012(10):CD003584. doi: 10.1002/14651858.CD003584.pub2

Fischbein 1992.

Methods This was a RCT.
Participants The treatment setting was multicentre.
 There were 189 participants in the original sample (fungal skin infection across multiple sites (tinea pedis data were separated out)).
The total evaluable sample was 53 participants (group 1 = 27 participants; group 2 = 26).
Exclusion criteria of the trial
  • No systemic or topical antifungals taken 3 days before the study


It was unclear what the unit of analysis was; the trial authors did not respond to requests for clarification.
Interventions
  • Group 1: fluconazole 50 mg once daily for an average period of 4 weeks

  • Group 2: ketoconazole 200 mg once daily for an average of 4 weeks

Outcomes Primary outcomes of the trial
  1. Cure, demonstrated by negative results on microscopy and no growth of dermatophyte in culture


Secondary outcomes of the trial
  1. Clinical signs and symptoms: exudation, erythema, vesicles, desquamation, maceration, fissuring

  2. Adverse events: reported for multiple sites on the body

Notes The source of funding was not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: The method of randomisation was not reported.
Allocation concealment (selection bias) Unclear risk Comment: The authors did not report how allocation was concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "...double‐blind." "Fluconazole was supplied as 50‐mg capsules and ketoconazole as identical appearing 200‐mg capsules."
Comment: Participants received the same capsule regimen and number of capsules. Whilst it was not specifically stated that participants were blinded, the study was reported to be 'double‐blind'. Therefore, we judged that the participants were likely to be blinded and so at low risk of bias.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: There was no report regarding who allocated treatment or provided medication. It is not clear from the report whether the treatment provider was blinded in this 'double‐blind' study; therefore, we judged this to be at unclear risk.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: Participants were assessed in the same manner; however, it was not reported if the outcome assessor was blinded. Therefore, we judged this to be at unclear risk.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: This domain was judged to be at high risk of bias; sites of infection were reported in the analysis whilst participants were randomised. Several sites were not analysed due to baseline exclusions; alternative treatments were administered; and there was a lack of mycological and clinical data resulting in an overall potential for bias.
Selective reporting (reporting bias) Low risk Comment: The study protocol was not available. However, the outcomes stated in the methods of the report were all described in the results and discussion.
Other bias Low risk Quote: "The evaluable treatment groups were well matched in terms of baseline demographic characteristics, duration of present infection and the mean total signs and symptoms at baseline." 
Comment: The baseline demographics appeared to be equal. Multiple sites were investigated. The trial appeared to be free from other sources of potential bias.