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

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
Interventions
  1. 400 mg itraconazole

  2. 500 mg terbinafine


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
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