Background: Although otomycosis is a disease spread throughout the world, there are only a few of studies about it.Objective: We aimed to evaluate the clinical efficacy of terbinafine hydrochloride spray (THS) in combination with 3% boric acid alcohol (3% BAA) ear drops compared to 3% BAA ear drops in otomycosis. Methods: This was a randomised, parallel-group, double-blind study involving 320 patients of both sexes aged 18 years or older. Results: The clinical cure rate was higher (p = .01) with THS in combination with 3% BAA ear drops than with 3% BAA ear drops alone. The change of mean total symptom score was significant with THS in combination with 3% BAA ear drops (p = .035). No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving THS in combination with 3% BAA ear drops and those receiving only 3% BAA ear drops. Resolution rates of pruritus, otorrhea, aural fullness, tinnitus and hypoacusis (p = .005, p = .004, p = .002, p = .001, p = .004, respectively) was higher with THS in combination with 3% BAA ear drops, as was eradication (p = .001). There were seven mild adverse events, three with the THS in combination with 3% BAA ear drops (not related to the treatment) and four when 3% BAA was administered alone (not related to the treatment).Conclusions: THS in combination with 3% BAA ear drops is a more effective treatment for otomycosis than 3% BAA ear drops alone. The THS in combination with 3% BAA ear drops also has an excellent safety profile.Significance: To provides a safe and effective method for treating otomycosis.
RCT Entities:
Background: Although otomycosis is a disease spread throughout the world, there are only a few of studies about it.Objective: We aimed to evaluate the clinical efficacy of terbinafine hydrochloride spray (THS) in combination with 3% boric acid alcohol (3% BAA) ear drops compared to 3% BAA ear drops in otomycosis. Methods: This was a randomised, parallel-group, double-blind study involving 320 patients of both sexes aged 18 years or older. Results: The clinical cure rate was higher (p = .01) with THS in combination with 3% BAA ear drops than with 3% BAA ear drops alone. The change of mean total symptom score was significant with THS in combination with 3% BAA ear drops (p = .035). No differences were found in the percentage of patients reporting resolution of otalgia between patients receiving THS in combination with 3% BAA ear drops and those receiving only 3% BAA ear drops. Resolution rates of pruritus, otorrhea, aural fullness, tinnitus and hypoacusis (p = .005, p = .004, p = .002, p = .001, p = .004, respectively) was higher with THS in combination with 3% BAA ear drops, as was eradication (p = .001). There were seven mild adverse events, three with the THS in combination with 3% BAA ear drops (not related to the treatment) and four when 3% BAA was administered alone (not related to the treatment).Conclusions: THS in combination with 3% BAA ear drops is a more effective treatment for otomycosis than 3% BAA ear drops alone. The THS in combination with 3% BAA ear drops also has an excellent safety profile.Significance: To provides a safe and effective method for treating otomycosis.