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

Savin 1990a.

Methods This was a RCT.
Participants The trial was conducted across 2 treatment centres.
 There were 50 participants in the initial sample (moccasin type tinea pedis).
 The total evaluable sample was 41 participants (group 1 = 23 participants; group 2 = 18 participants).
Exclusion criteria of the trial
  • Any radiotherapy, treatment with cytostatic or immunosuppressant drugs, antibiotics, antifungals, antivirals or antiparasitics within 2 weeks prior to the study

Interventions
  • Group 1: terbinafine 125 mg taken twice daily for 6 weeks

  • Group 2: placebo taken twice daily for 6 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: erythema, scaling, vesiculation, pustules, pruritus

  2. Adverse events: number of participants (number of events)

Notes This was funded in part by a pharmaceutical company ‐ Sandoz Pharmaceuticals Corp.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Participants were randomly allocated to active or placebo group."
Comment: The method of randomisation was not reported.
Allocation concealment (selection bias) Unclear risk Comment: There was no mention of allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Participants were randomly allocated to active (oral terbinafine 125mg) or placebo groups and were treated in double‐blind fashion twice daily for a period of 6 weeks."
Comment: Whilst it was not specifically stated how the participants were blinded, it was judged to be sufficient that the study was reported "double blind"; therefore, this domain was judged to be at low risk.  
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Comment: It was not clear from the report whether the treatment provider was blinded in this "double blinded" study. Therefore, it was judged to be at unclear risk.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: It was not clear from the report whether the outcome assessor was blinded in this "double blinded" study; therefore, it was judged to be at unclear risk.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Two participants who began treatment with placebo had negative cultures [and were] therefore excluded." "There were seven drop outs: four participants lost to follow up (two treated with terbinafine, two with placebo), one participant due to elevated liver function tests (placebo) and another [due to] concurrent treatment with antibiotics (placebo)."
Comment: Exclusions were reported. The final analysis was undertaken in 41 of the participants who were initially recruited (50 participants), representing an attrition rate of 18%.
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 Comment: The study appeared to be free from other sources of bias.