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

Won 2007.

Methods Design: open‐label, randomised study
Participants Number of participants randomised: 72
Sex: 50% male
Mean age: 45.8 years (range 17‐70)
Number included in analysis: 49
Number completing treatment: assumed 49 (no discontinuations reported)
Inclusion criteria: unclear
Type/location/characteristics of infection: distal or distolateral subungual toenail onychomycosis, not more than 75% involvement of nail plate, confirmed by microscopy or culture
Duration of infection: not specified
Exclusion criteria: any systemic disease
Washout period: 1 month for topical antifungal therapies or topical steroids, 2 months for systemic antifungal therapy
Setting: 2 research centres in Seoul, Korea
Comorbidities: not stated
Interventions
  1. Itraconazole (400 mg/d) for 1 week in every 4 of 12 weeks

  2. Terbinafine (250 mg/d) for 12 weeks

Outcomes Duration of follow‐up: 96 weeks
Outcomes measured: mycological cure, clinical cure, adverse events, subject acceptance
Safety and tolerability: adverse events reporting, measurement of alanine aminotransferase, aspartate aminotransferase and gamma‐glutamyl transpeptidase
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: "[p]articipants were randomly selected" to their treatment group
Comment: no method is given
Allocation concealment (selection bias) Unclear risk Quote: "[p]articipants were randomly selected" to their treatment group
Comment: method not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: blinding is not mentioned in this study, and participants were given 300 mg of itraconazole daily for 1 week every 4 weeks or 250 mg terbinafine daily for 12 weeks. Because of these factors, it is possible that blinding could have been broken.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: blinding is not mentioned in this study
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: because the nail involvement was statistically different between groups, 21 of the initial 70 randomised participants were excluded, and the outcome data are unavailable. No systemic differences between withdrawals between groups
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

AE: adverse event; ALP: alkaline phosphatase; ALT: alanine transaminase; AST: aspartate transaminase; CBC: complete blood count; ECG: electrocardiogram; GGT: gammaglutamyl transferase; GI: gastrointestinal; IIT: itraconazole‐itraconazole‐terbinafine (3 pulses total); ITT: intention‐to‐treat; KOH: potassium hydroxide; LFT: liver function test; NA: not applicable;RCT: randomised controlled trial; RFT: renal function test; TRIPA: trichophytin antigen; TTT: terbinafine × 3 pulses.