Eradicating Otomycosis with Terbinafine Solution: Basic and Clinical Investigation.

BACKGROUND

Otomycosis still remains intractable in clinical practice, likely because topical antifungal agents lack efficacy or are potentially toxic to the inner ear end organs.

OBJECTIVES

The aim of this study was to investigate whether terbinafine solution is a potential candidate for treating intractable otomycosis in humans. In addition, the toxic effect on the inner ear was also assessed by animal models treated with terbinafine.

METHODS

Guinea pigs were instilled with 0.1 mL terbinafine (10 and 25 mg/mL) in the left round window membrane. At 2 weeks after treatment, all animals underwent an inner ear test battery and were then sacrificed for morphological study. Clinically, 20 patients with otomycosis were treated with terbinafine solution at a dosage of 0.4 mg.

RESULTS

All terbinafine-treated animals showed intact inner ear function when total dosage of terbinafine was <2.5 mg, which was further confirmed by morphological study. Subsidence of otomycosis was achieved in all 20 patients 1 week after treatment with terbinafine (0.4 mg) without untoward effect. No evidence of recurrence was noted 1 year after treatment.

CONCLUSION

The paucity of inner ear toxicity of terbinafine even at a dosage of 2.5 mg was identified in guinea pig models morphologically and physiologically. Topical application of terbinafine solution at a dosage of 0.4 mg may be a potential treatment for otomycosis in humans.