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. 2017 Jul 14;2017(7):CD010031. doi: 10.1002/14651858.CD010031.pub2

Walsoe 1990.

Methods Design: double‐blind RCT
Participants Number of participants randomised: 20
Sex: not stated for toenail subgroup (both sexes included)
Mean age: not stated
Number included in analysis: 20
Number completing treatment: 20
Inclusion criteria
Type/location/characteristics of infection: toenail or fingernail onychomycosis caused by T rubrum or T mentagrophytes
Duration of infection: not stated
Exclusion criteria: antimycotic therapy within 1 month of start of study, pregnancy or serious concurrent disease
Washout period: not explicitly stated, by participants with antimycotic therapy within 1 month of start of study were excluded
Setting: not stated, study authors are all from Copenhagen
Comorbidities: not stated
Interventions
  1. 100 mg itraconazole daily for 6 months

  2. 500 mg griseofulvin daily for 6 months

Outcomes Duration of follow‐up: 12 months
Outcomes measured: cure (defined as clinical and mycological cure), marked improvement (defined as positive microscopy and negative culture), and improvement (50% clinical improvement compared to baseline and positive mycology)
Safety and tolerability: side effects reported
Source of funding No information available
Conflict of interest No conflict of interest identified
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "double‐blind study ... randomised basis"
Comment: method not stated
Allocation concealment (selection bias) Unclear risk Quote: "double‐blind study ... randomised basis"
Comment: method not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "[f]or each patient, 12 boxes were prepared, each containing blister packs"
Comment: blister packs were used, but it was not clear whether any visual differences remained between treatments
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "double‐blind study ... randomised basis"
Comment: method not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants included in analysis
Selective reporting (reporting bias) Low risk All results presented as set out in the Methods. All prespecified outcomes appear to be reported.
Other bias Low risk No other risks of bias identified