Ranawaka 2016.
Methods | Design: randomised, double‐blind, comparative study | |
Participants | Number of participants: 90 Sex: not stated (both sexes included) Mean age: 47.6 years (range 20‐80) Number included in analysis: 57 Number completing treatment: 57 Inclusion criteria: outpatients with a clinical diagnosis of onychomycosis of finger or toenails caused by non‐dermatophytes and proven by culture Duration of infection: 1 month‐20years Exclusion criteria: pregnant women, breastfeeding mothers, patients with known renal or liver impairment, congestive cardiac failure Setting: dermatology clinic at the General Hospital Chillaw, Sri Lanka and Base Hospital Homagama, Sri Lanka Comorbidities: not stated |
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Interventions |
In divided doses for 7 days per month (1 week on and 3 weeks off monthly pulses). 2 pulses were prescribed for fingernails and 3 pulses for toenails |
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Outcomes | Clinical and mycological cure. Clinical cure was defined as complete absence of all the clinical signs of onychomycosis. Mycological cure was defined as negative direct microscopy and culture | |
Source of funding | No information available | |
Conflict of interest | Authors did not declare any conflict of interest | |
Notes | Data for toenails only provided after communication with the lead author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: the treatment options were documented separately and packed in covered opaque envelopes consecutively numbered according to the randomisation schedule as to have a ratio of 1:1 |
Allocation concealment (selection bias) | Low risk | Quote: "[t]he allocation sequence was concealed from the researcher enrolling and assessing the participants" Comment: allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "[t]he participants and the investigator (outcome assessor) were blind to the type of therapy " Comment: participants and personnel were blinded to therapy |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "[t]he participants and the investigator (outcome assessor) were blind to the type of therapy. Same investigator performed clinical assessment on all the participants at each visit until cure" Comment: outcome assessment was blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some differences in loss to follow‐up (7/43 in itraconazole and 14/47 in terbinafine defaulted to other treatments before the end of the trial) |
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 biases identified |