Efficacy and safety of terbinafine hydrochloride spray and 3% boric acid alcohol ear drops in otomycosis

Abstract

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.

Keywords:

• Otomycosis
• terbinafine hydrochloride spray
• 3% boric acid alcohol ear drops
• topical treatment

Disclosure statement

The authors have no financial relationships and conflicts of interest to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was supported by funds from the Key Technology Research and Development Program of Shandong [grant no. 2019GSF108257 to Jie Han and 2018GSF118192 to Zhiyong Yue]. Funding agencies have no role in research design or manuscript writing.