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

Smith 2001.

Methods This was an open‐label RCT.
Participants The treatment setting was multicentre.
There were 27 participants in the initial sample.
The total evaluable sample was 17 participants (group 1 = 10 participants; group 2 = 7 participants).
Exclusion criteria of the trial
  • Negative culture

  • Minimum level of clinical disease

  • Systemic antifungal therapy within 6 weeks of screening

  • Topical therapy within 2 weeks of screening

  • HIV‐Participants

Interventions
  • Group 1: terbinafine 250 mg once daily for 2 weeks

  • Group 2: terbinafine 250 mg once daily for 4 weeks

Outcomes Primary outcomes of the trial
  1. Cure, demonstrated by negative results on microscopy and culture


Secondary outcomes of the trial
  1. Clinical disease score reported, based on erythema, pruritus, scaling of the skin, pustules, incrustation, vesiculation

  2. Adverse events

Notes Pharmaceutical involvement of the co‐authors was declared; however, funding was not addressed.
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 High risk Quote: "...open label."
Comment: Participants were not blinded; they were aware of which treatment arm they were allocated.
Blinding (performance bias and detection bias) 
 All outcomes High risk Comment: There was no report regarding who allocated treatment/provided medication.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "...open label."
Comment: The outcome assessors were not blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "27 HIV‐positive participants were enrolled in the study... ten participants subsequently were excluded because of negative initial culture results (n = 9) or loss to follow up (n = 1)."
Comment: Those lost to follow up or excluded were accounted for. The attrition rate was 37%. An intention‐to‐treat analysis was done.
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 High risk Quote: "There were no differences in baseline demographics or disease characteristics except for the duration of target infection. The mean duration was less than half as long for the 2‐week group compared to the 4‐week group (151 weeks versus 376 weeks)."
Comment: The duration of infection at baseline was substantially different for the 2 groups.