The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis

Objective: To determine whether adding aggressive clebridement to oral terbinafine for treating toenail onychomycosis impacts patient-reported outcomes (PROs). Materials and methods: A total of 504 patients were randomized to receive 12 weeks of terbinafine 250 mg/day with or without debridement, with an additional 36-week follow-up. The OnyCOE-tTm, a validated disease-specific PRO questionnaire, was completed at baseline and weeks 6, 12, 24, and 48. It included six multiitem scales (symptom frequency, symptom bothersomeness, appearance problems, physical activities problems, stigma, and treatment satisfaction), and one single-item scale: overall problem. Longitudinal analysis of change was conducted to assess treatment effect. Repeated-measures models adjusted for visit, age, sex, baseline scores, severity and duration of infection; treatment interactions were also tested. Results: Symptom frequency and treatment satisfaction significantly improved in the terbinafine + debridement group compared with terbinafine alone (p=0.0395 and p=0.0077, respectively). Age and sex were often significant explanatory variables, and further analysis of change scores at 12 weeks revealed that females treated with terbinatine + debriclement reported significantly less improvement in the physical activities problems (P=0.0021) and overall problem (p=0.0112) scores. Conclusions: Aggressive debridement, when used as an adjunct therapy with oral terbinafine, improved treatment satisfaction and reduced symptom frequency. The observed sex differences warrant further investigation.