Goodfield 1992.

Methods	Design: parallel group RCT
Participants	Number of participants randomised: 112 (99 toenail) Number included in analysis: 85 Sex (M/F): 55/30 Mean age: 44 years (range 19‐78) Number completing treatment: not clear Inclusion criteria: mycological and clinical evidence of dermatophyte infection of fingernails and toenails Type/location/characteristics of infection: toenail and fingernail infections (worst affected nail selected for assessment) Duration of infection: not stated Exclusion criteria: renal/hepatic/GI disease, psoriasis, yeast infection of nails, pregnancy, lactation Washout period: not stated Setting: 8 dermatology centres in UK Comorbidities: not stated
Interventions	Placebo once daily (12 weeks) Terbinafine 250 mg/day once daily (12 weeks)
Outcomes	Duration of follow‐up: 36 weeks after treatment Outcomes measured: mycological cure = negative microscopy and culture, clinical cure Safety and tolerability assessed by: adverse event reporting, biochemical and haematological variables
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)	Low risk	Quote: "[p]atients … were randomised (with random tables of Fisher and Yates)" Comment: method of random sequence generation adequate to minimise selection bias
Allocation concealment (selection bias)	Unclear risk	Quote: "[p]atients were randomised in a double‐blind, placebo controlled parallel group comparison." Comment: method of allocation concealment not stated
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "[p]atients were randomised in a double‐blind, placebo controlled parallel group comparison." Comment: states double‐blinded, but no method stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "[p]atients were seen at monthly intervals throughout the treatment period. At each visit the mycological, biochemical and haematological investigations were repeated; compliance and the occurrence of side effects were ascertained, and the target nail was examined clinically." Comment: no mention of outcome assessor blinding method
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "[o]ne hundred and twelve patients were enrolled into the study, 99 with toenail infection." Comment: data provided for both ITT analysis and per protocol analysis (Table II)
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