Prasun Mishra*, Sheenu Sachdeva, Maitri Kaushik and Deeksha Agrawal
Department of ENT Bharati Vidyapeeth Medical College, Pune, India
Received: 06 September, 2017; Accepted: 26 September, 2017; Published: 27 September, 2017
Dr. Prasun Mishra, Departmenrt of ENT Bharati Vidyapeeth Medical College, Pune, India, Tel: +91 020 40555555; Extn: 277; Fax: 24371116; E-mail:
Mishra P, Sachdeva S, Kaushik M, Agrawal D (2017) Otomycosis treatment: Topical Drops versus Cream – A prospective randomized study. Arch Otolaryngol Rhinol 3(3): 106-108. DOI: 10.17352/2455-1759.000059
© 2017 Mishra P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Otomycosis; 1%clotirmazole; Cream; drops
Introduction: Otomycosis, is one of the most common conditions encountered in a ENT practice. Difference of opinion does exist regarding ideal treatment modality.
Aim: Compare the treatment efficacy of 1% Clotrimazole drops with 1% Clotrimazole Cream in management of otomycosis.
Method: Randomized control study was performed over 3 months. 60 patients, clinically diagnosed with otomycosis were included in study. Patients were randomly allotted to treatment arms of either 1% clotirmazole drops or 1% clotirimazole cream. Improvement in symptoms of pain, pruritis and blocked sensation on one and two weeks follow up was recorded. External auditory canal was evaluated for improvement in otomycotic debris. All patients were asked the opinion about preferred modality of treatment.
Results: When compared to the symptoms on day one at day 07, the change in symptoms in both the groups was significant (p<0.05). Significant difference was also noted for the improvement in otomycotic debris in both the groups. The group with cream had significantly more blocked sensation. On second week follow up, significant improvement was noted for all the symptoms and otomycotic debris. 45 out of 60 patients preferred using cream.
Conclusion: 1% topical clotrimazole and cream are equally effective in management of otomycosis.
Otomycosis, also known as fungal otitis externa is one of the most common conditions encountered in a general ENT practice. Wide spread use of steroid and antibiotic drops or prior otologic procedures have led to increase in prevalence of this condition [1,2]. Prevalence of this condition is more in tropical and subtropical humid climates. A high prevelance rate of 9% has been mentioned for otomycois amongst patients presenting with otitis externa . The common organism that cause otomycosis are Aspergillus fumigatus, Aspergillus Aspergillus niger, Candida albicans of which aspergillus Niger is found to be predominant [4,5].
Though this condition is not fatal it does presents a challenge for otolaryngologists for it often needs long-term treatment and follow-up. It also tends to recurr quiet often . Difference of opinion does exists regarding ideal treatment modality of otomycosis. Treatment options for otomycosis commonly include elimination of predisposing factor, thorough cleaning of the canal, use of topical antifungals.
Studies show clotrimazole as one of the most effective agents for management of Otomycosis, with reported efficacy rate of 95% to 100 %. It is available as powder, lotion, and solution and is considered free of ototoxic effects . Commonly topical Clotrimazole drops are used 2- 3 times a day for 7-10 days or till cure. Putting drops so frequently for long is definitely cumbersome especially for office class patients. Some studies have suggested use of Clotrimazole cream for this purpose however there is a dearth of comparative randomized data. Thus in this study the aim was to compare the treatment efficacy of 1% Clotrimazole drops with 1% Clotrimazole Cream.
This was randomized control study performed over a period of 3 months. Inclusion criteria consisted of all consenting patients with otomycosis. Patients with chronic otitis media, mastoidectomy cavity, uncontrolled diabetes and those using hearing aids were excluded from study. Diagnosis of otomycosis was based on clinical feature and otoscopy finding of matted hyphae, spores, or curdy precipitate in the external auditory canal. Patient were told to rate the symptoms as per visual analogue scale (VAS). The symptoms were pain, blocked sensation and pruritis. A proper suction clearance of the external canal was done by otoendoscopy or otomicroscopy.
Using computer generated random number table patients were allotted to either of the two groups. Group A consisted of 1% Clotrimazole drops and group B comprised of 1% Clotrimazole cream.
Group A patients were instructed to instill 1% Clotrimazole drops three drops three times a day and to review in opd after a week. For group B patients, 1% Clotrimazole cream was filled in 2 ml syringe and external auditory canal was filled with this cream under endoscopic guidance. Cotton was placed in EAC and patient was told to review in outpatient department after a week. During follow up the symptoms were evaluated again and EAC was examined. Patient was considered treated when there was no evidence of residual fungal debris. If during the first visit patient had evidence of otomycosis, the treatment was repeated and patient reviewed again after a week.
After cure all the patients were asked a standard question. “If the results are same will they prefer one time instillation of cream or topical drops which needs to be instilled daily three times”. The answer was noted.
Requisite statistical tests were applied on the results. Fishers’s Exact Test was used for comparing the symptom change between two groups. McNemar’s test was used for Intra group symptom improvement. P value <0.05 was considered as significant difference.
Total 60 patients formed the study group with 30 in each group. Gender wise distribution in both the group was almost equal figure 1.
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