Table 4 Summary of studies included for review

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