Arenas 1995.

Methods	Design: open‐label comparative randomised trial
Participants	Number of participants randomised: 53 Sex: not stated (both sexes included) Mean age: 39 years Number included in analysis: 43 Number completing treatment: 40 Inclusion criteria: age > 18 years, onychomycosis Type/location/characteristics of infection: distal or lateral subungual onychomycosis diagnosed by physical examination, KOH smear and culture Duration of infection: 3 months to 26 years Exclusion criteria: abnormal haematology, blood chemistries, urinalysis, liver tests; onychomycosis caused by resistant fungi; pregnancy or lactation; treatment for gastric hyperacidity; psoriasis, other serious conditions. Withdrawal criteria: serious adverse effects, development of severe disease not associated with the treatment, non‐cooperative participants, voluntary withdrawal Washout period: 3 months for antimycotic treatment Setting: hospital dermatology department in Mexico Comorbidities: not stated
Interventions	Itraconazole 200 mg once daily for 3 months Terbinafine 250 mg for 3 months
Outcomes	Duration of follow‐up: 9 months Outcomes measured: % of nail involvement, nail abnormalities, nail changes, nail growth, participant's evaluation of treatment, doctor's evaluation of treatment (cure vs improvement) Safety and tolerability assessed by: reporting of adverse events, LFTs
Source of funding	Janssen Pharmaceutical assisted in data management and statistical analyses
Conflict of interest	Clear disclosure of pharmaceutical industry involvement. No details regarding individual author conflict of interest statements provided
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "[p]atients were randomly assigned to one of the two treatment groups." Comment; method of sequence generation not stated
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "[c]omparative, open, and prospective study" Comment: participants and personnel not blinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "[c]omparative, open and prospective study" Comment: no mention that outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "[i]n the itraconazole treatment group 3 patients dropped out for unknown reasons and 1 patient withdrew because of headache; 23 [of 27 randomised] finished the follow‐up period." "In the terbinafine treatment group 7 patients dropped out for unknown reasons and 2 patients because of … adverse events; 17 patients [of 26 randomised] finished the follow‐up period." Comment: all participants that entered the study are accounted for.
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