Abstract
To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment in the treatment of otomycosis. This randomized controlled trial included 90 patients who presented to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and were clinically diagnosed as a case of otomycosis via otoscopy. The external auditory canal of the patient was cleared of fungal debris via suction before treatment. In Group A, the ear canal was filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B 10% pyodine-soaked gel foam was placed in the external auditory canal. The patients were followed up on post-treatment days 7 and 14. The results showed that out of 90 patients with otomycosis, the left ear was affected in 50(55.6%) patients and the right ear in 40(44.4%). 8(8.9%) of 90 patients had controlled preexisting diabetes mellitus. On the 7th post-treatment follow-up day, 17 (41.5%) patients in Group A and 28(66.7%) patients in Group B showed no fungal spores. Other symptom resolution was also comparable in both groups. At the 14th day follow-up 33(80.5%) patients in Group A and 38(92.7% patients in Group B showed no fungal hyphae on otoscopy. In terms of treatment response 19(46.34%) patients in Group A and 21(51.21%) patients in Group B showed good treatment response at the end of 2nd post-treatment week with a p-value of 0.798. yodine-soaked gel foam placement in the external auditory canal is a safe and effective method for the treatment of otomycosis with the efficiency of this method comparable to a single topical clotrimazole ointment application.
Keywords: Otomycosis, Clotrimazole ointment, Pyodine (povidone iodine)
Introduction
Otomycosis, external auditory canal fungal infection is a recurrent and prevalent condition affecting 9% [1, 2] to 27.2% of patients worldwide [3]. The use of topical antibiotics, humid conditions, and trauma to the external auditory canal are well-recognized risk factors for this disease [4]. Aspergillus niger (60–90%), and Candida species (10–40%) are the most commonly isolated pathogens in patients with otomycosis [5]. Otomycosis presents with bothersome symptoms such as pruritis, watery ear discharge, otalgia, and ear blockage which significantly impairs the patient’s quality of life [6].
Therapeutic approaches for fungal ear infections include aural toilet, withholding topical antibiotics, starting topical antifungals, and enhancing patient well-being and cleanliness Multiple treatment options are available for the treatment of otomycosis but the recurrence rate of the disease is high. While several antifungal agents have been employed for its treatment, due to a lack of efficacy comparison it is difficult to select an appropriate option [7].
The choice of therapy plays an important role in achieving rapid symptom resolution and complete fungal eradication. Clotrimazole, a conventional antifungal agent, has been widely employed, but its efficacy is not always optimal. For topical treatment compliance of the patient and proper application of medication is also an important factor affecting the efficacy of the drug. Conversely, the utilization of pyodine-soaked Gelfoam is a novel approach that offers several advantages, including sustained drug release better drug penetration, and decreased risk of resistance as in the case of antifungals [8].
Due to reduced compliance of the patients and ineffective technique of using topical antifungal otomycosis has a high rate of treatment failure and recurrence. Topical clotrimazole drops and povidine iodine solution have been compared for their efficacy in the past but a single topical application has not been compared until now. In this pursuit, we present a rigorous and comprehensive clinical trial designed to evaluate the comparative efficacy of two distinct treatment modalities: pyodine-soaked Gelfoam and a single topical application of 1% clotrimazole. The rationale behind this study is to address the escalating concerns regarding treatment-resistant otomycosis, as well as the need for cost-effective and practical solutions.
By addressing the question of which treatment is superior, this study endeavors to optimize the management of otomycosis, ensuring better patient outcomes and reduced healthcare costs.
Materials and Methods
A randomized controlled study was done in the ENT Department of Benazir Bhutto Hospital Rawalpindi over a period of 7 months from May 2023 to December 2023.Individuals with a clinical otomycosis diagnosis were recruited for the study. Individuals with active Chronic suppurative otitis media, mastoid cavities, external auditory canal abnormalities, and hearing aids were excluded from the study. A sample size of 90 patients was calculated and participants were selected from the ENT clinic of Benazir Bhutto Hospital. This study was conducted following the ethical principles outlined in the Declaration of Helsinki. Ethical approval was obtained from the Institutional Review Board (IRB) of Benazir Bhutto Hospital. All participants were provided with detailed information about the study, including its purpose, procedures, potential risks, and benefits. Written informed consent was obtained from each participant before enrollment in the study. Participants were randomly assigned to either [Group A] or [Group B] using the lottery method. Each participant drew a lot from a container that held an equal number of slips, with each slip corresponding to one of the study groups.This method ensured that the assignment of participants to the intervention groups was purely random and unbiased. Double blinding was also ensured to minimize bias. Complete history was taken from the patients and the ear canal was assessed by otoscopy. The aural toilet of all patients was done via suctioning of the ear canal. In Group A patient’s ear canal was filled with 1% clotrimazole ointment by using an Intravenous catheter and syringe In Group B 10% pyodine solution-soaked gel foam was placed in the external auditory canal (Fig. 1).
Fig. 1.
Endoscopic view of external auditory canal pretreatment. Pretreatment endoscopic view of ear canal of patients allocated in study showing fungal hyphae and exudate in ear canal
Follow-up of patients was done on the 7th and 14th post-treatment days otoscopy was performed and post-treatment symptom resolution and ear canal condition were assessed. Patients were allocated into three groups based on their clinical outcomes.
Good Response
Patients with a dry external auditory canal and tympanic membrane intact [9].
Partial Response
Patients with scanty discharge but not completely dry external auditory canal.
No Response
Patients with unusually high external auditory canal Exudation.
Statistical Analysis
The primary outcome measure was the efficacy of the treatment, assessed through clinical improvement in otomycosis symptoms. Baseline characteristics of participants in both groups were summarized using descriptive statistics. Continuous variables were expressed as means ± standard deviations, while categorical variables were presented as frequencies and percentages.
Independent samples t-tests and chi-square tests were used to compare baseline characteristics and symptoms outcome after treatment between the two treatment groups to ensure comparability. All statistical analyses were performed using SPSS version 23, and p-values less than 0.05 were considered statistically significant (Fig. 2).
Fig. 2.
Flowchart of participants in study. Flowchart showing the study methodology and randomization
Results and Analysis
In this study, a total of 90 patients with otomycosis were included in two treatment groups. 45 patients were included in each group. Out of 90 patients, 46(51.1%) were male and 44 (48.9%) were female with a mean age of 37.48 ± 14.252. 45(50%) of patients were in the age group of 31–50 years. The Baselines characteristics of patients included in both groups are shown in Table 1.
Table 1.
Demographic data of study participants
| Characteristics | Group A (N = 45) | Group B (N = 45) |
|---|---|---|
| Gender | ||
| Male | 24(53.3%) | 22(48.8%) |
| Female | 21(46.6%) | 23(51.1%) |
| Age Distribution | ||
| Upto 30 years | 13(28.8%) | 17(37.7%) |
| 31–50 years | 22(48.8%) | 23(51.1%) |
| > 50 years | 10(22.2%) | 5(11.1%) |
| Affected Ear | ||
| Left | 27(60%) | 23(51.1%) |
| Right | 18(40%) | 22(48.8%) |
| Color of Spores | ||
| White | 12(26.6%) | 14(31.1%) |
| Black | 32(71.1%) | 31(68.8%) |
| Green | 1(2.2%) | 0(0%) |
| History of DM | ||
| Yes | 6(13.3%) | 2 (4.4%) |
| No | 39(86.6%) | 43(95.6%) |
The demographic profile of participants included in the study in both groups is shown with age and gender distribution, disease laterality, color of fungal spores and history of DM
The disease affected the left ear in 50(55.6%) patients and the right ear in 44(48.9%). 8(8.9%) out of 90 patients had preexisting diabetes mellitus. 8 out of 90 patients lost follow-up during the study.
Fungal spores seen on otoscopy were black in 63 out of 90 patients. Fungal culture revealed Aspergillus niger in 60 (66.6%) patients followed by candida in 25(27.7%) patients and no growth in 5 patients (Fig. 3).
Fig. 3.
Frequency of fungus on culture. Bar chart showing the prevalence of the type of fungus in study population with Aspergillus being the most common
The most common presenting symptom was pruritus in 62 out of 90 patients Table 2 shows the frequency of pretreatment clinical symptoms in group A and B.
Table 2.
Pretreatment symptoms of patients in both groups
| Pretreatment Symptoms | Group A | Group B |
|---|---|---|
| Pruritis | ||
| Yes | 32(71.1%) | 33(73.3%) |
| No | 13(28.8%) | 12(26.6%) |
| Otalgia | ||
| Yes | 19(42.2%) | 25(55.5%) |
| No | 26(57.7%) | 20(44.4%) |
| Watery Ear Discharge | ||
| Yes | 17(37.7%) | 13(28.8%) |
| No | 28 (62.2%) | 32(71.1%) |
| Ear Blockage | ||
| Yes | 25(55.5%) | 19(42.2%) |
| No | 20(44.4%) | 26(57.7%) |
This table lists the symptoms experienced by patients before treatment. The symptoms recorded include pruritis, otalgia, watery ear discharge, and ear blockage. The number and percentage of patients experiencing each symptom are indicated under the “Yes” column, while those not experiencing the symptoms are indicated under the “No” column
The most common pretreatment sign was canal erythema in 46 out of 90 patients. Table 3 shows the examination findings in Group A and B patients. As depicted in the table below all the variables have comparable results in groups A and B on the 7th post-treatment day with p-value > 0.05. On the 14th post-treatment day, all of the post-treatment signs have comparable results in both groups with no significant p-value.
Table 3.
Profile of clinical signs and symptoms pre and post treatment
| Pretreatment Clinical Signs | Post Treatment 7th Day | Post Treatment 14th Day | ||||||
|---|---|---|---|---|---|---|---|---|
| Group A | Group B | Group A | Group B | P value | Group A | Group B | P value | |
| Fungal Spores | ||||||||
| Yes | 45(100%) | 45(100%) | 24(58.5%) | 14(33.3%) | 0.065 | 8(19.5%) | 3(7.3%) | 0.269 |
| No | 0(0%) | (0%) | 17(41.5%) | 28(66.7%) | 33(80.5%) | 38(92.7%) | ||
| EAC Edema | ||||||||
| Yes | 22(48.8%) | 11(24.4%) | 17(41.5%) | 8(19.1%) | 0.078 | 9(21.9%) | 5(21.2%) | 0.502 |
| No | 23(51.1%) | 34(75.5%) | 24(58.5%) | 34(80.9%) | 32(78.1%) | 36(87.8%) | ||
| TM Congestion | ||||||||
| Yes | 15(33.3%) | 12(26.6%) | 12(29.3%) | 8(19.1%) | 0.276 | 6(14.6%) | 4(9.7%) | 0.500 |
| No | 30(66.6%) | 33(73.3%) | 29(70.7%) | 34(80.9%) | 35(85.4%) | 37(90.3%) | ||
| Canal Erythema | ||||||||
| Yes | 24(53.3%) | 22(48.8%) | 25(60.9%) | 22(52.4%) | 0.430 | 16(39.0%) | 17(41.5%) | 0.822 |
| No | 21(46.6%) | 23(51.1%) | 16(39.1%) | 20(47.6%) | 25(61.0%) | 24(58.5%) | ||
| Tragal Tenderness | ||||||||
| Yes | 10(22.2%) | 7(15.5%) | 2(4.8%) | 2(4.8%) | 0.980 | 1(2.5%) | 0(0%) | 0.314 |
| No | 35(77.7%) | 38(84.4%) | 39(95.2%) | 40(95.2%) | 40(97.5%) | 41(100%) | ||
| Purulent Discharg e | ||||||||
| Yes | 11(24.4%) | 15(33.3%) | 1(2.4%) | 4(9.5%) | 1.840 | 0(0%) | 1(2.4%) | 0.314 |
| No | 34(75.5%) | 30(66.6%) | 40(97.65%) | 38(90.5%) | 41(100%) | 40(97.6%) | ||
This table details the clinical signs observed in patients before and after treatment on 7th and 14th post treatment day. The signs include fungal spores, EAC edema, TM congestion, canal erythema, tragal tenderness, and purulent discharge. The number and percentage of patients exhibiting each sign are listed under the “Yes” column, and those not exhibiting the signs are listed under the “No” column. Comparison of patients in Group A and B posttreatment along with p values is shown
As the study population includes 8 diabetic patients to study the treatment efficacy among broader patients population. To eliminate bias we performed a subgroup analysis to compare treatment response among diabetic and nondiabetic patients. Mann-Whitney U test was performed. The results indicated that there was no significant difference between the treatment response of diabetics and nondiabetic patients with U = 219.000000, Z= -1.222803 and p = 0.221404.
Over all treatment response in both groups also as no significant difference with a P value of 0.798. Figure 4 shows 14th post treatment day response among both groups.
Fig. 4.
14th day post treatment response among both groups. Line graph comparing the overall treatment response between Group A (clotrimazole application) and Group B (pyodine solution application) on the 14th post-treatment day
Discussion
Otomycosis, fungal otitis externa is a commonly encountered disease in ENT clinics constituting almost 30% of ear infections [10] and it can pose challenges for both patients and otolaryngologists. The primary goal of management is not only to treat the fungal infection but also to relieve the associated symptoms and clinical signs.
Conditions such as mastoidectomy cavities, chronic suppurative otitis media, and immunosuppression are established risk factors for otomycosis development. In this study, we intentionally excluded individuals with these underlying conditions to investigate other potential contributing factors to otomycosis.In this study, we intentionally excluded individuals with these underlying conditions to investigate other potential contributing factors to otomycosis.
The initial step in otomycosis treatment involves addressing precipitating factors. Following this, it is recommended to perform local cleaning and apply an antifungal agent, either through topical or systemic administration [11]. There are varying approaches reported in the literature, with some studies proposing the use of ear drops tds or qid for 1 week to increase ear canal acidity as an effective treatment. Alternatively, some suggest the daily filling of an antifungal solution into the ear [12].
Considering the demographics of otomycosis, prior studies have reported variations in the gender distribution of affected individuals. In our study, we found an equal prevalence in both sexes with 30–40-year age group are most commonly affected.
Clotrimazole, a commonly used antifungal agent from the azole group, is often employed in otomycosis treatment. It is frequently combined with topical antibiotics or steroids. The drug has demonstrated effectiveness in numerous studies, with a cure in most cases [13].
In line with Munguia and Daniel’s findings [14], azole antifungals have the highest efficacy in treating otomycosis, with nystatin and tolnaftate considered as the next most effective option. In our study, topical clotrimazole was applied to patients diagnosed with otomycosis. Clotrimazole, an imidazole derivative, is a broad-spectrum antifungal agent. Clotrimazole acts by disrupting the fungal cell membrane and interfering with ergosterol synthesis. This dual mechanism increases membrane permeability, causing leakage of cellular components and reduced fungal growth. Clotrimazole’s efficacy in treating fungal infections, including otomycosis, is attributed to its ability to weaken and ultimately kill fungal cells [15]. Furthermore, clotrimazole preparations have demonstrated safety and no evidence of apparent damage to ear or hearing functions in guinea pigs [16].
Haq et al. in a study suggested that the use of clotrimazole in the management of otomycosis not only relieves its symptoms but also reduces the chances of recurrent disease [6]. As repeated daily application is difficult for the patients and results in reduced compliance single-dose application was studied.
Referring to a study conducted by Chavan et al. single-dose topical application of clotrimazole was done and 91.0% of patients recovered from the disease at 1-month follow-up with only 9.0% having the persistent disease [17].
In our study, 1% clotrimazole cream was applied topically to the external ear canal in a single visit. This approach offers greater convenience compared to using topical drops since it does not rely on the patient’s compliance or requires multiple visits to the aural toilet.
Van Hasselt et al. conducted a study with a similar focus [18]and utilized a single instillation of silver nitrate gel for otitis externa treatment and found that it was cost-effective and less time-consuming.
As a result, the application of 1% clotrimazole in the external auditory meatus at a single visit after local cleaning is considered a sufficient and cost-effective treatment approach.
Povidone iodine on the other hand is easily accessible and demonstrated to be efficient in treating chronic suppurative otitis media, a risk factor for the development of otomycosis. Povidone iodine is chemically stable, and cost-effective, and has not yet shown signs of bacterial or fungal resistance [19]. The appearance of resistant organisms is a growing concern with the indiscriminate use of topical antibiotics and antimicrobials. Povidone iodine addresses this issue as there are no reported cases of resistance to date. This feature is particularly significant in developing countries, where affordable and effective medications without ototoxicity are essential.
A study by Mofatteh et al. [20] involving 204 otomycosis Patients was observed to assess the differences in recovery rates when using topical Betadine (povidone-iodine) in comparison to clotrimazole. The authors stated that the effectiveness of povidone-iodine and clotrimazole was comparable to otomycosis treatment.
A study was conducted by JweryAK and the efficacy of clotrimazole, acetic acid, and povidone-iodine was compared among patients with otomycosis it was concluded that 97.5% of patients of the Clotrimazole group, 72.5% of the acetic acid group and 52.5% of povidone-iodine group showed response to the treatment option with a p-value of 0.00001 [21].
The study’s findings introduced the concept of grading otomycosis based on its signs, a novel approach in the literature. The signs and symptoms for each drug were compared before and after treatment, and the analysis showed that both the povidone-iodine and Clotrimazole groups had improvements in post-treatment signs and symptoms, with both exhibiting a residual fungal disease rate of 12.2%. Thus, povidone iodine exhibited a cure rate comparable to Clotrimazole.
Conclusion
In summary, both Clotrimazole and povidone-iodine showed improvements in symptoms post-treatment and demonstrated comparable efficacy in treating otomycosis. Povidone-iodine can be used as a suitable alternative to traditional antifungal treatments for otomycosis management. This study also introduced the concept of grading otomycosis based on signs, symptoms, and response assessment. Traditional antifungal treatments often require multiple administrations per day, with their efficacy dependent on patient compliance and the mode of application. However, with this novel treatment strategy, compliance is less likely to be a concern.
It is important to note the limitation of this study due to the small sample size, which may affect the generalizability of the findings. Further research with larger sample sizes is needed to confirm these results and establish more robust conclusions.
Acknowledgements
Not applicable.
Author Contributions
Concept: ZS; design: ZS; definition of intellectual content: ZS, AHA; literature search: ZS; data acquisition: ZS; manuscript preparation ZS, MA manuscript editing: ZS, NR ; manuscript review: ZS, AHA, MA, NR.
Funding
We verily state that this study is not funded by any source(s).
Data Availability
The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. To ensure transparency and reproducibility, we have made patients’s data publicly available at clinical trial.gov. Any additional data that support the findings of this study are available from the corresponding author, Zuneera Shabbir, upon reasonable request, subject to any ethical or privacy restrictions.
Declarations
Ethical Approval and Consent to Participate
Ethical approval for this research was obtained from RMU clinical trail unit under protocol number CTU/06/2023/002/RMU. All participants were provided with detailed information regarding the study’s purpose, procedures, potential risks, and benefits. Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were assured of the confidentiality of their data and their right to withdraw from the study at any time without any repercussions.
Consent for Publication
All participants provided consent for the publication of their data and accompanying images. Written informed consent was obtained from each participant guardian prior to publication. Participants were informed that their personal data would be anonymized and that they could withdraw consent at any time before publication without any consequences.
Informed Consent
All patients were informed about the nature of the project and their verbal and written consent was taken for participation in our study.
Human and Animal Participants
Humans were involved in this particular research.
Conflict of Interest
There exists no conflict of interest among all authors. The manuscript has been read and approved by all the authors, the requirements for authorship as stated earlier in this document have been met, and each author believes that the manuscript represents honest work.
Footnotes
Publisher’s Note
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. To ensure transparency and reproducibility, we have made patients’s data publicly available at clinical trial.gov. Any additional data that support the findings of this study are available from the corresponding author, Zuneera Shabbir, upon reasonable request, subject to any ethical or privacy restrictions.