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Table 4 Summary of studies included for review

From: Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic 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    
  1. RCT = Randomised controlled trial
  2. N/R = not reported
  3. 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