Table 4.

Summary of studies included for review

Study [ref]	Design	Subjects n (males)	Age Mean (SD)	Intervention	Assessment (weeks)	Outcome measures Safety	Outcome measures Efficacy
Pollak [44]	Case series	77 (N/R)	N/R	Active Intervention: 250 mg oral terbinafine once daily for 12 weeks	0, 6, 12, 18, 24, 30, 36, 48, 72	Participant and investigator-reported adverse events. Severity (mild, moderate, severe, life-threatening) and likelihood of adverse event related to treatment (yes, no, uncertain) determined by investigator	Not assessed
				Control : no control
Albreski [45]	RCT	52 (51)	71.42 (6.21) years	Active Intervention: 200 mg of oral itraconazole twice daily for one week over three consecutive months	0, 2, 10, 32	Investigator-reported adverse events and likelihood that any adverse events were related to drug therapy	Not assessed
				Control: Toenail trimming, cleaning and soaking for 4 months.
Brenner [43]	Case series	49 (36)	63.8 (12.0)years	Active Intervention: Daily topical application of Ciclopirox 8% nail lacquer with mechanical debridement every eight weeks for 48 weeks.	0, 8, 16, 24, 32, 40, 48	Participant and investigator-reported adverse events. Severity and likelihood of adverse event related to treatment determined by investigator.	Mycological cure: negative results on microscopy (KOH) and fungal culture. Clinical cure: ≥ 90% improvement (from baseline) in diseased nail. Complete cure: mycological cure plus clinical cure.
				Control: no control
Farkas [46]	Case series	89 (47)	55.7 (11.7) years	Active intervention: 250 mg oral terbinafine once daily for 12 weeks.	0, 4, 8, 12, 24, 36, 48	Self-reported adverse event (severity was scored as mild, moderate or severe) and the likelihood of any adverse events being related to the intervention (non, unlikely, possible, probably, certain)	Mycological cure: negative results on microscopy and fungal culture of samples taken from the target toe nail. Clinical cure: 100% clearing of the target toenail. Complete cure: mycological cure plus clinical cure
				Control: no control
Gupta [42]	RCT	70 (34)	60.67 (1.52) years	Active intervention: 200 mg oral itraconazole twice daily for one week of three consecutive months	0, 1, 6, 12,24, 36, 48, 60, 72	Self-reported adverse event and the likelihood of any adverse events being related to the intervention	Mycological cure: negative results on microscopy and fungal culture. Clinical cure: ≤ 10% nail plate involvement. Effective cure: mycological cure plus either clinical cure.
				Control: 250 mg oral terbinafine daily for 12 weeks.
Sadighha [41]	Case series	13 (N/R)	50-73 years	Active intervention: 200 mg oral itraconazole twice daily for one week of four consecutive months	0, 26	Not assessed	Complete cure: negative mycological culture and resolution of nail deformity.
				Control: no control

RCT = Randomised controlled trial

N/R = not reported

all studies, except that by Farkas and colleagues [46] assessed people with Type 2 diabetes. Farkas and colleagues did not find any significant differences in the treatment outcomes for patients with Type 1 and Type 2 diabetes, the pooled results from this study were considered in this review