Kejda 1999.
| Methods | Design: open‐label, randomised, parallel‐group study | |
| Participants | Number of participants randomised: 61 Sex (M/F): 27/34 Mean age: 47 years Number included in analysis: 51 Number completing treatment: 61 (10 in the itraconazole group received an additional pulse and were not included in efficacy analysis) Inclusion criteria: distal and lateral subungual onychomycosis with ≥ 50% nail plate involvement; positive KOH test or positive culture; mycologic examination anonymous for the clinician; mycologic evaluation at baseline then every 3rd mo for 9mo after treatment; and lab blood parameters within normal limits. Type/location/characteristics of infection: positive onychomycosis of the toenails Duration of infection: not stated Exclusion criteria: systemic antimycotic therapy within 3 months prior; use of any antifungal agent during trial (incl top); pregnancy/breastfeeding/lack of reliable contraception; use of cisapride, astemizole, terfenadine, simvastatin, lovastatin, phenytoin, triazolam, or rifampin; serious diseases affecting the liver or kidneys; or psoriasis Washout period: not stated Setting: Czech Republic Comorbidities: not stated |
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| Interventions |
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| Outcomes | Duration of follow‐up: every 3rd month for 9 months after treatment Outcomes measured: affected nails/participants, global clinical parameter, KOH test, culture Safety and tolerability assessed by: reported adverse effects (cephalgia, exanthem, urticaria, diarrhoea, fatigue, dyspepsia, bloating, gryphosis of mycotic nails, obstipation, weight gain, flatulence, myositis) |
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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: "[a] total of 61 patients were randomly assigned treatment and entered into the study." "Patients were similar in gender and age." Comment: method of random sequence generation not stated. Baseline characteristics similar between treatment groups |
| Allocation concealment (selection bias) | Unclear risk | Quote: "[a] total of 61 patients were randomly assigned treatment and entered into the study." Comment: method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "[t]his open, randomised, parallel‐group study represents a comparative clinical evaluation of therapeutic efficacy and tolerability of oral itraconazole pulse therapy (400 mg twice daily, 1 week/month, 3 pulses) and continuous terbinafine therapy (250 mg/day, 98 days)." Comment: participants and personnel likely unblinded as study states that it was an open study. Hence, there is a high risk of performance bias, especially as one treatment was pulse therapy and the other was continuous. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "[o]pen". "Patients were evaluated every third month for 9 months after treatment". Comment: outcome assessors likely unblinded as study states that it was an open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "[a] total of 61 patients were randomly assigned treatment and entered into the study. In the itraconazole arm, 10 patients received an additional pulse and were not included in the efficacy analysis." Comment: all dropouts explained and accounted for. Sufficient data provided for ITT 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 clear other bias seen |