Abstract
Chronic suppurative otitis media is a prolonged and chronic condition. It is a prevalent bacterial infection in the field of otolaryngology that has substantial consequences. Prior to surgical intervention, it is crucial to implement medical treatment to make the ears dry in cases of chronic suppurative otitis media. The goal is to determine the most suitable agent for aural toileting in individuals with chronic suppurative otitis media by evaluating the outcomes of irrigation of acetic acid and gentian violet and determining the most suitable treatment. A randomized controlled study was done on 100 patients in a tertiary care center with a tubotympanic type of CSOM in the active phase. Patients were divided into 2 groups and toileting and irrigation were done with acetic acid in one group and with gentian violet in the other for 3 weeks. The comparison of treatment outcomes between the groups revealed a statistically significant difference, with acetic acid demonstrating superior treatment results compared to gentian violet. This was further confirmed by a statistically significant difference between the two groups in otologic scores at different time points, as a result of a considerably greater fall in scores in the acetic acid group. Regular antiseptic auditory cleaning and irrigation can help manage chronic suppurative otitis media. The process of healing is facilitated by modifying the pH of the ear canal, reducing inflammation, destroying biofilms, and removing exudates. Acetic acid appears to be more effective than gentian violet in treating the condition. Therefore, acetic acid alone or in conjunction with antibiotic ear drops, can be used for the treatment of chronic suppurative otitis media.
Keywords: Chronic suppurative otitis media, Tubotympanic type, Acetic acid, Gentian violet
Introduction
Chronic otitis media is a long-lasting and gradually developing condition. It is a prevalent bacterial infection that has substantial economic and individual consequences [1].
Prior to surgical intervention, it is crucial to implement medical care for the treatment of chronic suppurative otitis media to make the ears dry. Bacterial biofilms are agglomerations of bacteria that adhere to a surface which are encased in a matrix and are believed to have a key function in chronic illnesses [2]. Biofilm also plays a role in the pathophysiology of CSOM which accounts for the reported drug resistance [3].
Aural toileting is an essential part of medical management for chronic suppurative otitis media [4].
The understanding that persistent otolaryngological bacterial infections are associated with biofilms has driven the advancement of novel approaches for the investigation, prevention, and treatment of biofilms [5].
Physically eliminating or disturbing the bacterial biofilm is an effective method for treating this persistent illness, but it is often not possible to do so in a clinical setting [6]. Thus, several techniques are now being explored for destabilizing biofilm.
This study aims to determine the most suitable medical treatment method for individuals with chronic suppurative otitis media by evaluating the effectiveness of aural toileting using either acetic acid or gentian violet in managing chronic discharging ears.
Materials and Methodology
This randomized controlled study was carried out at the Department of Otorhinolaryngology and Department of General Medicine of a tertiary care hospital on 100 patients between April 2024 and May 2024 following Institutional Ethical Committee approval.
Inclusion Criteria
Individuals with tubotympanic chronic suppurative otitis media with active ear discharge.
Individuals between the ages of 18 years to 60 years belonging to both genders.
Exclusion Criteria
Individuals with atticoantral type of chronic suppurative otitis media.
Individuals in quiescent and inactive stages of chronic suppurative otitis media.
Individuals with concurrent otitis externa or otomycosis.
Individuals with a recent history of oral or systemic antibiotic therapy.
Individuals with a history of hypersensitivity reaction to acetic acid or gentian violet.
Individuals with uncontrolled diabetes mellitus.
Clinically unstable patients.
Sample Size
The sample size was estimated by using nMaster software Version 2.0 by applying the following details in the below sample size formula for two proportion comparisons.
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Based on the study “Efficacy of combination of acetic acid and ciprofloxacin eardrops versus only ciprofloxacin eardrops in achieving dry ears in chronic suppurative otitis media” by Basavaraju K.P et al [7], P1 and P2 were assigned values of 0.906 and 0.452 respectively, with an alpha of 0.05 (2 sided) and power of 99%, the sample size was estimated to be 34 samples per sample group. In order to increase the efficacy of the study, 50 samples were used in each group and thus total sample size was 100 patients.
Procedure
Informed consent was obtained. A thorough history and clinical examination were done. Duration of ear discharge, whether the discharge is foul smelling or blood-stained, the tympanic membrane’s status and quadrant of the perforation, and the presence of middle ear mucosal inflammation were noted. Patients fulfilling the inclusion and exclusion criteria were selected and randomized by computer generated block randomization method and allocated into two groups. In the first group, aural toileting was done with acetic acid, and in the other group, gentian violet was used and patients were followed up (Fig. 1).
Fig. 1.
Consolidated standards of Reporting trials (CONSORT) Flow diagram of the randomized controlled trial through various stages
Patients were instructed to review six days a week for three weeks. Both groups had a meticulous cleaning of the EAC and middle ear cavity using a suction tube. In one group, patients’s external auditory canal was flushed with 5 ml of 1.5% acetic acid, while in the other group, gentian violet ear wick was prepared and placed in the external auditory canal. The patients and their attendants were given instructions on how to administer acetic acid drops in one group and how to insert the gentian violet wick in the other group, and were advised to practice self-irrigation at home at night. The patients were also clearly instructed to avoid the entry of water into the ears and to avoid ear probing. The type and amount of discharge were noted and the otologic symptom score was calculated (Table 1) [8].
Table 1.
Otologic symptom score [8]
| Signs/symptoms | Score 0 | Score 1 | Score 2 | Score 3 |
|---|---|---|---|---|
| Amount of discharge | Absence of discharge | Discharge restricted to middle ear | Discharge entering external auditory canal | Complete filling of external auditory canal with discharge |
| Type of discharge | Not present | Mucoid discharge | Mucopurulent discharge | Purulent discharge |
After three weeks, the treatment was stopped. The efficacy of the treatment was determined by evaluating the changes in the scores of otologic symptoms during the visit on day 14. The classification was separated into three distinct categories: The term “Success” is used to describe cases where the otologic symptom score was less than three on day 21. The term “Improvement” is used when the otologic symptom score ranged from three to four on day 21, but with a decrease from the baseline score. “Treatment failure” is defined as the lack of any change or an increase in the initial score on day 21. In patients with treatment failure, oral and topical antibiotics were started.
The data was collected and analyzed with IBM SPSS Statistics, Version 29. Descriptive statistics, frequency analysis, and percentage analysis were employed to characterize the data. Categorical variables were examined using these methods, while continuous variables were assessed using the mean and standard deviation. The Independent sample t-test was employed to determine the significant distinction between the bivariate samples in Independent groups. The Chi-Square test was employed to determine the significance of qualitative categorical data. In the statistical techniques mentioned above, a p-value less than 0.05 is regarded as statistically significant.
Results
40% of the study population consisted of patients aged 41–50 years, making them the largest age group in this study.31% of the patients fell within the age range of 31–40 years, 16% were in the age range of 21–30 years, and 13% were in the age range of 51–60 years. The study population had a majority of females, accounting for 54%, while males accounted for 46%. (Table 2).
Table 2.
General characteristics of the population
| Characteristics | Frequency | Percentage |
|---|---|---|
| Age | ||
| 21–30 yrs | 16 | 16.0 |
| 31–40 yrs | 31 | 31.0 |
| 41–50 yrs | 40 | 40.0 |
| 51–60 yrs | 13 | 13.0 |
| Gender | ||
| Female | 54 | 54.0 |
| Male | 46 | 46.0 |
| Total | 100 | 100.0 |
The age and gender distribution in the two groups were analyzed and found to be statistically insignificant(Tables 3 and 4). This indicates that the patient profiles in both groups were similar and will not affect the assessment of which treatment group had superior results.
Table 3.
Crosstabulation between the age and the acetic acid and gentian violet groups
| Groups | Total | ||||
|---|---|---|---|---|---|
| Acetic acid | Gentian violet | ||||
| Age | 21–30 yrs | Count | 9 | 7 | 16 |
| % | 18.0% | 14.0% | 16.0% | ||
| 31–40 yrs | Count | 12 | 19 | 31 | |
| % | 24.0% | 38.0% | 31.0% | ||
| 41–50 yrs | Count | 24 | 16 | 40 | |
| % | 48.0% | 32.0% | 40.0% | ||
| 51–60 yrs | Count | 5 | 8 | 13 | |
| % | 10.0% | 16.0% | 13.0% | ||
| Total | Count | 50 | 50 | 100 | |
| % | 100.0% | 100.0% | 100.0% | ||
| Mean | 40.5 | 40.9 | |||
| SD | 7.6 | 9.2 | |||
| Chi-Square Tests | |||||
| Value | df | p-value | |||
| Pearson Chi-Square | 4.123a | 3 | 0.248 | ||
Table 4.
Crosstabulation between gender and acetic acid and gentian violet groups
| Crosstab | |||||
|---|---|---|---|---|---|
| Groups | Total | ||||
| Acetic acid | Gentian violet | ||||
| Gender | Female | Count | 28 | 26 | 54 |
| % | 56.0% | 52.0% | 54.0% | ||
| Male | Count | 22 | 24 | 46 | |
| % | 44.0% | 48.0% | 46.0% | ||
| Total | Count | 50 | 50 | 100 | |
| % | 100.0% | 100.0% | 100.0% | ||
| Chi-Square Tests | |||||
| Value | df | p-value | |||
| Pearson Chi-Square | .161a | 1 | 0.688 | ||
A statistically significant difference was found when the treatment outcomes of the two groups were compared. (Table 5). The superior treatment outcome of the acetic acid group compared to gentian violet was the reason for this (Graph 1).
Table 5.
Cross tabulation between the different results of improvement and acetic acid & gentian violet group
| Crosstab | |||||
|---|---|---|---|---|---|
| Groups | Total | ||||
| Acetic acid | Gentian violet | ||||
| Result of treatment | Failure | Count | 1 | 27 | 28 |
| % | 2.0% | 54.0% | 28.0% | ||
| Improvement | Count | 10 | 17 | 27 | |
| % | 20.0% | 34.0% | 27.0% | ||
| Success | Count | 39 | 6 | 45 | |
| % | 78.0% | 12.0% | 45.0% | ||
| Total | Count | 50 | 50 | 100 | |
| % | 100.0% | 100.0% | 100.0% | ||
| Chi-Square Tests | |||||
| Value | df | p-value | |||
| Pearson Chi-Square | 50.158a | 2 | 0.0005 | ||
Graph 1.
Comparison of treatment results between the two groups
The otologic symptom scores were compared amongst the two groups at different time points, and the mean and standard deviation were obtained (Table 6). The mean score of the acetic acid group decreased from 4.3 on day 0 to 1.7 on day 21, whereas with gentian violet, it only decreased from 4.7 on day 0 to 4.0 on day 21 (Graph 2).
Table 6.
Mean and standard deviation of otologic symptom scores in the two groups
| Otologic symptom score | ||||
|---|---|---|---|---|
| Groups | N | Mean | SD | |
| Day 0 | Acetic acid | 50 | 4.3 | 1.0 |
| Gentian violet | 50 | 4.7 | 1.0 | |
| Day 7 | Acetic acid | 50 | 3.4 | 1.1 |
| Gentian violet | 50 | 4.5 | 1.1 | |
| Day 14 | Acetic acid | 50 | 2.8 | 1.1 |
| Gentian violet | 50 | 4.3 | 1.3 | |
| Day 21 | Acetic acid | 50 | 1.7 | 1.2 |
| Gentian violet | 50 | 4.0 | 1.5 | |
Graph 2.
Comparison of otologic symptom scores between the two groups on Day 0, 7, 14 and 21
The otologic scores of the two groups were compared on days 0, 7, 14, and 21. The score values for the acetic acid group declined more compared to the gentian violet group, and this difference in the score values was statistically significant on days 7, 14, and 21 (Table 7). Therefore, it can be inferred that acetic acid was more effective in alleviating the condition.
Table 7.
Independent samples test to calculate the difference between otologic scores in the two groups on Day 0,7,14 and 21
| Independent samples test | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Levene’s test for equality of variances | t-test for equality of means | |||||||||
| F | Sig. | t | df | p-value | Mean difference | Std. error difference | 95% confidence interval of the difference | |||
| Lower | Upper | |||||||||
| Day 0 | Equal variances assumed | 0.908 | 0.343 | 1.803 | 98 | 0.075 | − 0.3600 | 0.1997 | − 0.7563 | 0.0363 |
| Day 7 | Equal variances assumed | 0.090 | 0.765 | 4.713 | 98 | 0.0005 | -1.0200 | 0.2164 | -1.4495 | − 0.5905 |
| Day 14 | Equal variances assumed | 6.068 | 0.016 | 6.426 | 98 | 0.0005 | -1.5200 | 0.2365 | -1.9894 | -1.0506 |
| Day 21 | Equal variances assumed | 5.042 | 0.027 | 8.450 | 98 | 0.0005 | -2.3400 | 0.2769 | -2.8895 | -1.7905 |
Discussion
Chronic Suppurative Otitis Media is a condition characterized by a continuous or recurring discharge from the ear over a period of 3–6 weeks. This discharge occurs through tympanic membrane perforation and is caused by long-term middle ear and mastoid cavity inflammation [9]. Medical treatment is necessary for converting a discharging ear to a dry ear before proceeding with surgical treatment.
The complete range of medical care for this condition includes regular cleaning of the ear, the use of antiseptic medications applied directly to the affected area, and the administration of antibiotics either through topical application or by taking them orally.
Several studies have indicated that topical antiseptics can be just as effective as topical antibiotics in treating otorrhoea. Acetic acid has been extensively used as an antibacterial agent in several domains. It has been employed to eliminate food-borne pathogenic bacteria, hinder the growth of Escherichia coli, and address ear infections, as indicated by numerous prior investigations [10]. The efficacy of acetic acid is derived from the capacity to lower pH in the ear and inhibit the proliferation of microorganisms [11]. Gentian violet has anti-inflammatory qualities that help reduce inflammatory exudates, resulting in dryness in the affected area. It has been used to address chronic secretory otitis externa [12].
The process behind toileting and irrigation seems to be the elimination of inflammatory exudates, removal of the biofilm, and shift of pH in the medium of the ear canal causing protein denaturation and thus disrupting bacterial growth [13]. Additionally, it aids in the eradication of biofilms. Biofilms are thought to be the main reason for recalcitrant chronic suppurative otitis media, which also explains the resistance to antibiotics [3]. At present, biofilms are regarded as a critical component of persistent infections [14].
In this study, 100 patients were randomized and divided into two groups. The age and gender distribution were compared between the two groups through chi-square tests which were statistically insignificant(Tables 3 and 4). This confirmed that the two groups’ participant profiles were comparable and would not have an impact on the study’s findings. Otologic symptom scores were calculated at the start of the study, on days 7,14, and 21 to assess the effect of the treatment on the condition.
In the acetic acid group, on day 21, one patient did not have any improvement (2%), while ten patients (20%) had improvement of the condition and the treatment was successful in thirty-nine patients (78%) where the otologic symptom score decreased to less than three. In contrast, in the gentian violet group, twenty-seven patients (54%) had treatment failure, seventeen patients (34%) had improvement in symptoms, and six patients (12%) had a successful treatment outcome on day 21 (Table 5). The treatment results were compared between the two groups and the chi-square test was found to be statistically significant.
The otologic symptom scores were analyzed in both groups and the mean otologic symptom score in the acetic acid group was found to be 4.3 at the start of the treatment period which decreased to 3.4 on day 7, 2.8 on day 14 and was 1.7 at the end. Whereas in the gentian violet group, the mean otologic score was 4.7 at the start of the treatment and only decreased slightly to 4.5 on day 7, 4.3 on day 14, and 4.0 at the end of the treatment (Table 6).
The Independent sample test was done to assess the difference in otologic symptom scores between the two groups at various points of the study and a high statistically significant difference was found on days 7, 14, and 21 (Table 7). This was due to a significantly greater decrease in the acetic acid group’s scores indicating its efficacy compared to the gentian violet group where there was only a minor reduction in the scores.
The study found that acetic acid effectively treated and converted the ear dry in 78% of the patients, resulted in improvement in 20% of the patients, and had no effect in 2% of the patients. On the other hand, gentian violet achieved a positive outcome in 12% of patients, showed some improvement in 34% of patients, and had no effect in 54% of patients. Therefore, acetic acid proved to be a far more potent agent in fighting the condition. This was similar to a study done by Gupta C et al., where the dry ear was achieved in 84% of the patients within an average of 27.3 days [15]. In another study by Nazir riaz et al., the effectiveness of using acetic acid toiletting in controlling CSOM was 89.55%, whereas the effectiveness of systemic antibiotics was 68.66% [16]. The current study demonstrates the efficacy of acetic acid, which is further corroborated by Eason et al. Their findings indicated that locally applied antiseptics and antibiotics were equally effective.
In a study done by arslan akhtar et al., the effectiveness of acetic acid and ciprofloxacin ear drops in curing ear discharge after two weeks of treatment was noted [17]. The difference in decreasing and resolving the ear discharge was found to be highly statistically significant with a p-value < 0.0001. This was comparable with our study where the difference in otologic symptom scores was compared between the two groups and was found to be highly statistically significant (p-value of 0.0005), indicating the greater decline in otologic scores due to resolution of discharge in the acetic acid group.
In the gentian violet group in this study, only 12% of the patients had a resolution of ear discharge. This was in contrast to a study by Kayama C et al., where gentian violet was used in refractory discharging ears infected with methicillin-resistant Staphylococcus aureus with or without Pseudomonas aeruginos, and there was resolution of the disease in 90% of the patients [18].
The resolution rate of otorrhoea in the acetic acid group (78%) was comparable with that of a study done by Kanakarajulu B et al., where otorrhoea resolution was achieved in 88% of the patients treated with acetic acid irrigation whereas it was achieved only in 52% of the patients treated with topical and systemic antibiotics [19].
Acetic acid yielded superior results and enhanced outcomes. This highlights the efficacy of the medicine, however, it might also have been influenced by the delivery of the drug through flushing, which increases the likelihood of removal of the biofilm layer. Neither group reported any side effects due to the installation of the medication.
The benefits of this treatment are significant from a socioeconomic perspective. The cost of this therapy is relatively inexpensive in comparison to antibiotic treatment. Thus irrigation agents like acetic acid can be used either alone or in conjunction with antibiotic ear drops to treat chronic suppurative otitis media.
Conclusion
Regular auditory cleaning and irrigation using antiseptic agents can be an effective option for managing chronic suppurative otitis media (CSOM). It is both safe and cost-effective, with no adverse effects. The modification of the pH in the ear canal and the reduction of inflammation are the contributing factors that facilitate the healing process, together with the destruction of the biofilm and the elimination of exudates. Acetic acid appears to be a superior drug for achieving greater resolution of the condition when compared to gentian violet. Hence, in instances of Chronic suppurative otitis media, it could be prudent to consider treating it with agents such as acetic acid either on its own or in combination with antibiotic ear drops.
Declarations
Ethical Approval
As per university standards written ethical approval has been collected and preserved by the author(s).
Consent for Publication
As per university standards, Participants’ written consent has been collected and preserved by the author(s).
Competing Interests
The authors have declared that no competing interests exist.
Footnotes
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