A randomized controlled clinical trial on efficacy of topical clotrimazole vs. topical fluconazole vs. topical application of gentian violet in the treatment of otomycosis conducted in a tertiary health care centre
Abstract Background Otitis externa can be caused by an infectious agent (bacterial, fungal, or viral), trauma, or an allergy. Otomycosis is fungal otitis externa. It is prevalent in hot and humid weather and a common entity in any ENT outpatient clinic in India. Aspergillus and Candida are the commo...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2025-08-01
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| Series: | The Egyptian Journal of Otolaryngology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43163-025-00877-5 |
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| Summary: | Abstract Background Otitis externa can be caused by an infectious agent (bacterial, fungal, or viral), trauma, or an allergy. Otomycosis is fungal otitis externa. It is prevalent in hot and humid weather and a common entity in any ENT outpatient clinic in India. Aspergillus and Candida are the common causative organisms. The overall incidence of otomycosis has increased due to the widespread use of topical and systemic antibiotics and steroids. Materials and methods A randomized control trial was performed on 100 adult individuals suffering from otomycosis presenting to the ENT outpatient clinic in a medical college in Mumbai. Inclusion criteria were adult individuals diagnosed with otomycosis. Patients with otitis media and patients who had previously undergone ear surgery were excluded from this study. Patients were randomly assigned among 3 groups: Group 1 (33 subjects) received clotrimazole ear drops, two drops thrice a day; Group 2 (33 subjects) received fluconazole, two drops thrice a day; and Group 3 (34 subjects) received topical gentian violet solution applied once a week by a member of the ENT team. Patients were called for follow-up after 1 week and, if required, every week thereafter until all the symptoms were resolved. Each symptom was evaluated using a visual analogue scale (VAS) ranging from 1 to 10. Posttreatment scores were obtained by a blinded data collector and compared to previous scores among the three groups. Forty-six men and 54 women participated in this clinical trial. Results Clotrimazole was equally efficacious as fluconazole, whereas gentian violet was not as efficacious in the treatment of earache and ear discharge due to otomycosis. Clotrimazole was more efficacious than fluconazole, which in turn was more efficacious than gentian violet for the treatment of itching in the ear due to otomycosis. Patients receiving clotrimazole were cured fastest among the three groups. Conclusion Among clotrimazole, fluconazole, and gentian violet, clotrimazole was most efficacious in improving the symptoms of earache, ear discharge, ear itching, and ear block. It is recommended as the first-line drug of choice. Fluconazole was equally efficacious in relieving earache and ear discharge; however, it had to be used for a longer duration. |
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| ISSN: | 2090-8539 |