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 |
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Interventions |
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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 |
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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.