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
|
|
Interventions |
|
|
Outcomes |
Primary outcomes of the trial
Secondary outcomes of the trial
|
|
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. |