Gupta 2001b.

Methods	Design: single‐blinded RCT
Participants	Number of participants randomised: 59 Sex (M/F): 48/11 Mean age: 68 years Number included in analysis: 59 Number completing treatment: 56 Inclusion criteria: age > 18 years Type/location/characteristics of infection: toenail onychomycosis caused by S brevicaulis spp Distal and lateral onychomycosis, moderate‐severe disease of target nail Duration of infection: not stated Exclusion criteria: allergy to any of the drugs in the study, medications known to interact with study medications, immunocompromise, pregnancy and lactation Washout period: 6 months for oral and 2 weeks for topical Setting: USA and Canada (multicentre) Comorbidities: not stated
Interventions	Griseofulvin 600 mg twice daily  for 12 months Ketonconazole 200 mg daily for 4 months Itraconazole pulse therapy for 3 pulses (each pulse = 200 mg twice daily for 1 weeks with 3 weeks off between pulses) Terbinafine daily for 12 weeks Fluconazole 150 mg daily for 12 weeks
Outcomes	Duration of follow‐up: 12 months Outcomes measured: clinical cure, mycological cure Safety and tolerability assessed by: side effects, LFTs, CBC, RFTs
Source of funding	Study is stated to be non‐industry‐sponsored
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: "[e]ligible patients with onychomycosis due to S. brevicaulis were randomly divided to receive treatment with griseofulvin, ketoconazole, itraconazole, terbinafine and fluconazole". "At baseline, for the 5 treatment groups, there was no significant difference in the mean age of the patients or mean severity of disease". Comment: no method of random sequence generation stated. Baseline characteristics between groups appear similar from the text, but no tabulated data provided
Allocation concealment (selection bias)	Unclear risk	Quote: "[e]ach consecutive patient who fulfilled the inclusion criteria was considered for the study". Comment: no method of allocation concealment stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "[s]ingle‐blinded", "Treatment with the oral agents was given as follows: griseofulvin 600 mg twice daily for 12 months, ketoconazole 200 mg daily for 4 months, itraconazole 3 pulses with each pulse consisting of 200 mg twice daily for 1 week on, 3 weeks off, terbinafine 250 mg daily for 12 weeks, and fluconazole 150 mg/day for 12 weeks." Comment: study states that it is single‐blinded, but does not state any methods for blinding participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "[s]ingle‐blinded", "When the patients were seen at the follow‐up, at month 12 from the start of treatment, the efficacy parameters were CC (clinical cure) and MC (mycological cure)". Comment: study states that it is single‐blinded, but does not state any methods for blinding outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "[i]n this study a total of 59 patients with S. brevicaulis onychomycosis of the toes were evaluated". "Patients were randomised to the following groups: griseofulvin (11 patients), ketoconazole (12 patients), itraconazole (12 patients), terbinafine (12 patients) and fluconazole (12 patients)." Comment: low risk of attrition bias as outcomes for all randomised participants reported, with no exclusions
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