title: The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis.
abstract: OBJECTIVE
  To determine whether adding aggressive debridement to oral terbinafine for treating toenail onychomycosis impacts patient-reported outcomes (PROs).
  
  
  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-t, 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, 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.
authors: Ovation Research Group. San Francisco, CA, USA.
authors: Lori P
authors: LP
authors: Potter
authors: Susan D
authors: SD
authors: Mathias
authors: Monika
authors: M
authors: Raut
authors: Farid
authors: F
authors: Kianifard
authors: Adam
authors: A
authors: Landsman
authors: Amir
authors: A
authors: Tavakkol
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D001900:Boston; D003646:Debridement / Q000379:methods; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009262:Nails; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000188:drug therapy* / Q000601:surgery; D011446:Prospective Studies; D012495:San Francisco; D011795:Surveys and Questionnaires; D000077291:Terbinafine; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine