Inflammatory conditions in the external and middle ear are responsible for most ear discharges. It affects people of all age groups, but commonly, it is a condition of children.[1],[2] These include acute and chronic otitis externa, acute otitis media, chronic suppurative otitis media (CSOM) with or without cholesteatoma, and malignant otitis externa.[3],[4],[5] It is one of the most common infective conditions seen in all the age groups. It occurs due to chronic infection of the middle ear resulting in persistent otorrhea, hearing loss, and mental disturbance if not managed on time.[6],[7] Pus culture in CSOM shows multiple aerobic and anaerobic organisms.[8],[9],[10] Treatment options include the following: dry mopping, topical antiseptics or antibiotics, and sometimes combined with steroids and systemic antibiotics.[11] Many topical antibiotics have been used. Drug sensitivity patterns show that ciprofloxacin (quinolones) is active against most of the isolates, followed by amikacin, gentamicin, and other penicillins and cephalosporins.[12],[13]

This study aimed to compare the effectiveness of topical versus combined (systemic plus topical) therapy in ciprofloxacin-sensitive CSOM (tubotympanic) and to find the bacteriological profile for ear discharge by taking the ear swab for culture and sensitivity.

Study design

This was a hospital-based prospective randomized control study carried out over a period of 18 months.

Participants

A total of 100 patients of age ≥20 years with clinically diagnosed CSOM (tubotympanic type) were enrolled in this study. After culture and sensitivity report, the recruited patients were allotted to their respective groups by simple random sampling method as:

These patients were received 1 week of treatment and followed up on day 3 and day 7.

Inclusion criteria

Exclusion criteria

Materials

Statistical methods

Suitable statistical significance test was used for statistical analysis along with SPSS version 22, IBM SPSS Statistics Inc., Chicago, Illinios, USA) software package.

Procedure

At the first visit of each patient, a pretested pro forma was used to record the relevant information of each individual included in the study.

The aural discharge was collected with a conventional sterile swab preventing contact with the external auditory meatus using a sterilized aural speculum. The specimens were immediately transported to the microbiology test laboratory. The samples were put into blood agar (enriched medium) and MacConkey agar (differential medium) and incubated for 24 h.

The primary colony of the cultured bacteria was identified by Gram stain and biochemical tests. Culture and sensitivity of isolates were determined by the Kirby–Bauer disk diffusion method.

Each patient was then randomly assigned to a study group. In Group A, ciprofloxacin (0.3%) ear drops (3 drops) was used thrice a day for 7 days in the affected ear. In Group B, a combination of topical ciprofloxacin (0.3%) (3 drops) thrice a day and tablet ciprofloxacin (500 mg) twice a day were administered for 7 days.

Patients were advised dry mopping and also to prevent water entry into the affected ear before instilling the ear drops. The right technique of instilling with intermittent tragal pressure was advised.

The following criteria were used for assessing the results:-

Ethical Clearance

Ethical approval for this study ( Institutional Ethical Committee MMC/IEC/2020/64) was provided by ethical committee of Muzaffarnagar Medical College , Muzaffarnagar (U.P) on 27 January 2020.

One hundred patients with clinically diagnosed CSOM were included in the study. Patients were divided into two groups: Group A (50 patients) were given ciprofloxacin (0.3%) ear drops (3 drops) thrice a day for 7 days in the affected ear and Group B (50 patients) were given a combination of topical ciprofloxacin (0.3%) (3 drops) thrice a day and tablet ciprofloxacin (500 mg) twice a day for 7 days. Both male and female participants were selected: 55 males and 45 females.

Patients with unilateral ear discharge were included in this study. It was found that 52 patients had ear discharge in the right ear and 48 patients had ear discharge in the left ear. After taking a swab from ear discharge, culture and sensitivity were done to rule out ciprofloxacin-sensitive organisms, results of which are shown in [Table 1].

Patients with different types of perforation were included in the study out of which 3 patients had small central perforation, 13 patients had moderate central perforation, and 84 patients had large central perforation. The resolution of discharge in both the groups is shown in [Table 2]. It can be inferred from the results of Chi-square test that there was a significant difference of resolution of discharge in both the groups.

The results of Chi-square test (χ2) [Table 3] were used to compare two groups in terms of resolution of discharge on 3rd day. It was observed that there was no significant difference between the two groups in terms of resolution of discharge (P = 0.65).

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The Chi-square test (χ2) [Table 4] was used to compare the two groups in terms of resolution of discharge on 7th day. It was observed that there was no significant difference between the two groups in terms of resolution of discharge (P = 0.65).

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The results of adverse effects in both the groups showed that a total of 13 complained of adverse effects to the drugs prescribed [Table 5]. Out of which, 2 patients were in Group A taking topical ciprofloxacin ear drops, whereas 11 patients were in Group B staking combined oral and topical ciprofloxacin. In Group A, two patients developed fungal overgrowth with none had complained of vertigo and gastrointestinal upset, whereas in Group B, one patient developed fungal overgrowth, seven patients complained of gastrointestinal upset, and three patients developed vertigo.

CSOM is a disease with worldwide prevalence having potentially serious long-term effects. It is a disease well known for its recurrence and persistence, despite treatment. The study of the organisms commonly associated with CSOM and their antibiotic sensitivity is necessary to enable the otologist to plan a general pattern of treatment for the patients with the discharging ear, presenting certain characteristic features, as this infection is characterized by its chronicity.

In this study, 55 (55%) were male and 45 (45%) were female, which is similar to the findings of Arya and Mohapatra (1966).[14]

In this study, otorrhea was observed in the left ear 48 (48%) and in the right ear 52 (52%), which was different from the studies conducted in South Africa by Tiedt NJ et al showed difference in the distribution of bacteriology, indicating that separate pus specimens need to be taken in bilateral disease.[15]

The most predominant bacteria found in this study were Staphylococcus (45%), which correlated with the studies of Loy AHC,[16] Ettehad GH,[17] Ahmad S,[18] Prakash R,[19] and Gurov AV.[20] Some studies differ from this were Aslam MA[21] and Deb T,[22] they showed Pseudomonas was the most predominant and, Sharma M[23] and Chirwa M[24] showed Proteus species was the most predominant. This could be attributed to effect of climate and variation of organisms in different communities and localities and different study sites which are either hospital or community based.

In this comparative study of two groups, the success rate of treatment in Group A was 41%, whereas in Group B was 43%. In the absence of any systemic disease, topical treatment alone constitutes the mainstay of treatment, finding no evidence that systemic antibiotics alone or in combination with topical preparations improve treatment outcomes compared with topical antibiotics alone. Another character of topical delivery system is the absence of systemic effects. Because no systemic delivery of topically administered agents occurs, the normal flora in the respiratory and gastrointestinal tracts is not exposed to antibiotics. Topical antibiotics reduces the cost of treatment. These findings were correlated with previous studies of Renukananda GS and Sharma M.

Out of 100 patients, 2 patients in Group A complained of adverse effects whereas 11 patients in Group B.

According to our findings, it was concluded that empirical treatment with topical ciprofloxacin alone was as effective as combined oral and topical ciprofloxacin and that the inclusion of oral drug did not have any additional beneficial effect, but the cost-effectiveness is a major concern in low socioeconomic population.

As cost-effectiveness is less in topical ciprofloxacin as compared to combined oral and topical ciprofloxacin, in rural population, topical ear drops alone can be used as a sole agent in the first-line management of discharging CSOM.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.