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

• Published in: The Journal of dermatological treatment 2007, Vol.18 (1), p.46-52
• Main Authors: Potter, Lori P., Mathias, Susan D., Raut, Monika, Kianifard, Farid, Landsman, Adam, Tavakkol, Amir
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antifungal Agents - therapeutic use; Biological and medical sciences; Boston; Debridement; Debridement - methods; Female; Foot Dermatoses - drug therapy; Foot Dermatoses - surgery; Human mycoses; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Mycoses; Mycoses of the skin; Nails; Naphthalenes - therapeutic use; onychomycosis; Onychomycosis - drug therapy; Onychomycosis - surgery; Pharmacology. Drug treatments; PRO; Prospective Studies; quality of life; San Francisco; Skin, nail, hair, dermoskeleton; Surveys and Questionnaires; terbinafine; Treatment Outcome
• ISSN: 0954-6634; 1471-1753
• DOI: 10.1080/09546630600965004

Objective: To determine whether adding aggressive debridement 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 multi-item 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 terbinafine + debridement 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.