Open Access

Serous otitis media: Clinical and therapeutic considerations, including dexamethasone (C22H29FO5) intratympanic injection

  • Authors:
    • Cristian Mârțu
    • Sebastian Cozma
    • Bogdan Cobzeanu
    • Doina Vesa
    • Corina Butnaru
    • Dragoș Bularda
    • Adeline Cumpătă
    • Luminița Rădulescu
  • View Affiliations

  • Published online on: December 7, 2021     https://doi.org/10.3892/etm.2021.11048
  • Article Number: 125
  • Copyright: © Mârțu et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )
Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )


Abstract

Serous otitis media (SOM) occurs in children and constitutes one of the most significant causes of hearing loss in young age, posing as an important risk factor for long‑term hearing loss. SOM is underdiagnosed, most frequently in infants, or the appointment to the ENT doctor is delayed due to non‑acute symptomatology. The aim of the present study was to assess 285 patients with SOM diagnosed within a two‑year span. The etiology and pathology of hearing loss in patients with different age groups were examined. The importance of a clinical examination and tympanometry was emphasized as absolutely necessary for a correct diagnosis. Treatment targeted Eustachian Tube permeabilization for satisfactory long‑term middle ear aeration. Nasal drops with vasoconstrictor drugs (phenylephrine) and disinfectant (colloidal silver 1%) were commonly used, but some patients also benefitted from dexamethasone intratympanic injection. Patients were evaluated at the end of the treatment and follow‑up occurred at one month, one year and three years later.

Introduction

Serous otitis media (SOM) is a common inflammatory process of the middle ear, frequent in early childhood. It is commonly accompanied by mild to moderate hearing loss (HL), alongside a sensation of pressure in the ear that infants cannot always describe or indicate. The functional deficiencies of the auditory organ, especially if it is bilateral, can have an important influence in the development of a small child. SOM is defined as the presence of fluid (effusion) in the middle ear, with no signs or symptoms of acute ear infection (1,2). This is usually due to Eustachian tube dysfunction.

The presence of serous fluid in the middle ear acts like a barrier in sound conduction, accompanied by a decrease in the efficiency of transmitting sound to the middle ear (ear drum and ossicles) (1). If we consider SOM to be a continuous dynamic process, there are several factors that influence and transform the character of the effusion such as time, the body's reaction and repeated infections. There are different stages of serous otitis, varying from tubotympanic catarrh, acute serous otitis, chronic serous otitis or progression to fibro-adhesive otitis (3).

From a functional point of view, the final stage of these conditions can be hearing impairment. Regarding the impact and importance of this condition, in the USA, 2.2 million episodes of common serous otitis are diagnosed annually, with a cost of $4 billion (3).

In fact, indirect costs are much higher, because the average serous otitis is usually asymptomatic, and many episodes remain undetected, including children with hearing impairments and reduced school performance (3).

There are many risk factors associated with SOM development. Some are related to inflammatory and immune reactions against rhinopharyngeal infections leading to cytokine production and the secretion of an exudate rich in protein and inflammatory mediators, allergy, genetic conditions, pollutants, biofilm formation and persistence, and gastro-esophageal reflux (4).

Different treatment options are available, including medical treatment (anti-inflammatory, antihistaminic, mucolytic, antibiotic), mechanic inflation through the Eustachian tube (Politzer maneuver), surgery (intratympanic injections and grommet placement), with various results, being also influenced by the individual particularity of the pathology and patient (4).

The aim of the study was to investigate the frequency of SOM by age groups, in relation with different possible etiopathogenic causes, considering early and correct diagnosis, as well as obtaining optimal therapeutic results.

Patients and methods

Patient characteristics

The present study was conducted on 285 patients diagnosed with SOM that were hospitalized in the ENT Department, Clinical Rehabilitation Hospital and the ENT Department, ‘Sf. Andrei’ Emergency Hospital Galati (Galati, Romania), over a period of two years (2016-2017) and followed up for a minimum of three years after initial management.

Each patient underwent general ENT evaluation that included audiometry and tympanometry with an Interacoustics AA222 AudioTraveller (SC Sonorom SRL). This study was approved by the Ethics Committee of ‘Grigore T. Popa’ University of Medicine and Pharmacy (Iasi, Romania). Written informed consent was obtained from all patients and/or guardians prior to publication.

Inclusion and exclusion criteria

The design of the study was based on a retrospective analytical investigation with etiopathogenesis analysis of all patients.

Inclusion criteria were patients with type B tympanogram and positive otomicroscopic image of SOM. Exclusion criteria were patients with atelectatic ear pathology, otosclerosis, acute or chronic suppurative otitis media, external otitis, or foreign bodies in the external ear canal. Patients referred for grommet insertion or failing to return for follow-up were also excluded.

Methods

The treatment for SOM included nasal drops with decongestant drugs up to 3 times a day. Phenylephrine was commonly used for short periods (3-5 days) in acute episodes and colloidal silver 1% solution. In some patients, this treatment was inefficient, with SOM persistence for more than 3 months; for this situation, intratympanic dexamethasone (DXM) (ITD) injection treatment was performed under sedation (for the majority of cases), with the placement of 0.5 ml/4 mg/mm DXM directly into the antero-inferior quadrant of the tympanic membrane through a small tympanotomy. The procedure was performed during day hospitalization, with patients leaving the hospital 3 h after the ITD placement.

Results

SOM and various parameters

Results showed a higher frequency of SOM in female patients (58.6%), but without any explanation regarding sex preference.

Out of the total number of patients, 59.3% of the SOM cases were bilateral and 40.7% of cases were unilateral (Fig. 1).

In regards to the patients with SOM, 220 patients (77.2%) were between 2 and 14 years; 53 patients (18.6%) were in the age range of 15-30 years, while 12 patients (4.2%) were over 31 years of age (Fig. 2).

Most patients claimed HL as first symptom (58.57% bilateral, 30% unilateral); in small children, this was reported by the parents, or educators. Other local symptoms included ear fullness with autophony (20%), mild otalgia (33%), tinnitus (2.85%) and mild dizziness (15.7%) (Fig. 3).

Recorded symptoms associated with SOM were nasal obstruction with oral breathing (44.2%), rhinorrhea (8.5%), dysphagia (4.3%), cough (2.85%) and hyponasality (15.7%) (data not shown).

Physical examinations

Through the physical examination of the children, retrostilian, submandibular and laterocervical adenopathies were observed. The nodes were elastic, painless and mobile with an average diameter of 3x1cm. Other patients had nasal pyramid dysmorphism.

The otoscopic diagnosis (in 97.15% of cases, the aspect of the tympanic membrane was modified) was more evident in adults than in children. In adults, the presence of liquid with or without air bubbles was most often observed behind a slightly retracted eardrum (10% of cases). In children, the observation of fluid level was exceptional.

Audiometric testing was performed on children >5 years of age. Audiometric results showed bilateral conductive HL in 34.37% of patients, unilateral conductive HL in 37.53% of patients, 24% showed bilateral mixed HL and 4.1% showed unilateral mixed HL and conductive HL in the contralateral ear. HL was greater at low frequencies, in most cases around 30-40 dB.

Treatment methods

In 208 patients (73%), SOM healed within 3 months, with just local nasal treatment and ET permeabilization methods: ET anemizations, mechanical exercises (positive pressure in the rhinopharynx). In 40 cases (14%), nasal decongestant and disinfectant drops were accompanied by antihistaminic short-time treatment (loratadine, levocetirizine) and mucolytic (active substance acetylcysteine) treatment (Fig. 4).

In 37 cases (13%), SOM did not resolve unless transtympanic aspiration of the sero-mucous fluid was performed under sedation and corticosteroid medication (DXM) was placed in the tympanic cavity (Fig. 4).

Tympanic membrane perforation usually healed primarily between 5 and 10 days. There were no cases of persistent tympanic membrane perforation, and audiometric testing at 1 month showed improvement of hearing thresholds. Follow-up was performed at one and three years. Most of the patients showed full recovery, however, a group of 23 patients (8%) showed recurrent SOM and needed further treatment.

Discussion

The study followed the frequency of SOM by age groups in parallel with its possible etiopathogenesis. Regarding children (aged <14 years), there was an increased frequency of 52% in younger children (2-6 years of age) and only 25.2% in older children (7-14 years of age).

Data from literature confirm this fact. It is reported that 90% of children have severe serous otitis before school age (5). The frequency of common SOM episodes is particularly high, averaging about four episodes per year (6).

In the first year of life, >50% of children have SOM which can reach >60% by the age of 2(7). One out of eight children aged five to six, in preschool, have fluid in one or both ears (8).

Most episodes of SOM heal spontaneously within 3 months, but 30-40% of children have repeated episodes and 5-10% have SOM lasting over a year or more (1,5,9).

The etiopathogenic factors, according to the medical files of the patients (anamnesis and personal medical history), most commonly incriminated in the age group 2-14 years were acute and chronic adeno-amygdalitis 83.18% (183 out of 220 patients), acute and chronic rhinosinusitis 51.81% (114 patients out of 220), septal deviations and inferior turbinate hypertrophy 32.72% (72 out of 220 patients).

Most factors for the 15- to 30-year age group were: acute and chronic adeno-amygdalitis 77.35% (41 out of 53 patients), acute and chronic rhinosinusitis 69.81% (37 out of 53 patients), septal deviations and turbinate hypertrophy, especially posteriorly 73.58% (39 out of 53 patients).

Patients in the latter age group presented septum deviation and chronic hypertrophic rhinitis 83.33% (10 out of 12 patients), rhinosinusitis allergy 33.33% (4 out of 12 patients), chronic otitis media 25% (3 out of 12 patients), acute untreated rhinopharyngitis 25% (3 out of 12 patients) and rhinopharyngeal carcinoma 16.66% (2 out of 12 patients).

An increased frequency in symptomatology was observed during the spring period (40% of cases) and the months with increased incidence of SOM were March, April, May, September and October. An explanation can be the increased frequency of viral rhinopharyngeal inflammation, considerable temperature variations and sudden changes in atmospheric pressure.

Patient origin was recorded and a higher percentage of SOM was observed in socio-economically deprived urban neighborhoods (42.45%, 121 patients), compared to rural areas (26.66%, 76 patients) and 30.87% in urban areas. This could be explained by a lower medical addressability, crowded dwellings and increased exposure to risk factors, such as passive smoking.

According to literature, the average duration of a SOM episode is 17 days (6). Common symptomatology is discrete and minimal eardrum changes were observed (10).

If the SOM persists for >3 months (present in 25% of cases), symptoms such as HL, vestibular dysfunction, poor school performance and ear fullness or behavioral changes may occur (11). SOM can transform into acute suppurated otitis, which needs antibiotic treatment in order to avoid further complications (12,13).

Patients included in the study had associated symptoms as well, such as nasal obstruction with oral breathing, rhinorrhea, dysphagia, cough, hyponasality, increased frequency of retrostilian, submandibular, laterocervical adenopathy and sometimes nasal pyramid dysmorphism. For a correct diagnosis, an audiometric examination was essential and could be performed on children after the age of 5.

The audiometric examination should be completed with tympanometry. This technique has the advantage of objectifying the variations of acoustic impedance. Tympanometry is a non-invasive technique that can be achieved in young children and usually a B- or C-type curve is recorded in SOM.

This examination is especially useful in young children, where otoscopy is often difficult or inconclusive. Another advantage of tympanometry is the possibility of observing the dynamic of middle ear pathology. Performed routinely, tympanometry would allow a greater detection of SOM.

Targeted treatment is needed for rhinopharyngeal disobliteration and ET permeabilization in order to establish normal anatomic and physiologic conditions, hearing improvement and the prevention of recurrences and development of chronic condition of the middle ear (chronic SOM, atelectatic ear, cholesteatoma).

Vasoconstrictor and nasal disinfectants, such as Phenylephrine and Colloidal Silver, were used after nasal secretions were aspirated or eliminated by correct nose blowing. Most of the patients that presented with fresh symptomatology onset benefited from decongestant substances at the rhinopharyngeal tubal orifices applied by cotton swabs (34% of cases).

Nasal mucosa hypertrophy is influenced by local anatomical mechanical obstruction and inflammation, air quality and allergic terrain of the child. Although studies show a limited efficacy of antihistaminic medication in ET function prognosis (14,15), in some cases it may be effective in nasal decongestion and ET permeabilization (especially in patients with allergic conditions) (16). In select cases, before initiating transtympanic function treatment protocol (performed under sedation during continuous hospitalization), antihistaminic drugs were used 5-7 days with some favorable results (6% of cases).

Second-generation H (1)-antihistamines (loratadine or levocetirizine) have high selectivity for H (1)-receptors with improved efficacy and minimal side effects compared to first-generation molecules and can provide improvement of ET mechanics (16).

After ITD, some of the patients complained about ear fullness 26.31% (75 patients), sometimes light dizziness 10.87% (31 patients) and discrete ear discharge 19.65% (56 patients). Symptoms can persist several hours and are related to the presence of the liquid in the middle ear. Myringotomy healed in all patients.

DXM has been used due to good local dispersion with the ability to inhibit inflammation and reduce edema, satisfactory absorption in the middle ear and no side effects locally and generally. Previous findings also found DXM to be effective in the reduction of granulation tissue, more than antibiotic therapy alone (17). Mucosal hypertrophy reduction and possible permeabilization improvement through ET is expected.

SOM is a disorder found more commonly in childhood, with recurrent episodes and a higher frequency of viral rhinopharyngeal infections.

Most frequent etiopathogenic factors were found to be ET dysfunction, infection, and allergy.

SOM can be relatively asymptomatic with uni- and even bilateral conductive HL. An audiometric examination is indispensable in adults and children.

Surgical interventions for associated diseases can indirectly treat SOM and the inherent ear affliction. The General Practitioner is familiar with SOM, as well as its treatment. SOM is especially frequent in school-aged children. If not treated, it can lead to repeated episodes of SOM and other complications in time.

Upper respiratory tract mucosa inflammation and edema should be addressed by complex medical treatment (vasoconstrictor, disinfectant, corticosteroid, mucolytic, antihistaminic), although sometimes SOM has to be addressed by myringotomy. The placement of DXM in the middle ear is an effective method for localized corticosteroid drug delivery with minimal local and general side effects.

Acknowledgements

Professional editing, linguistic and technical assistance were performed by Irina Radu, Individual Service Provider.

Funding

Funding: No funding was received.

Availability of data and materials

All data and materials supporting the results of the present study are available in the published article.

Authors' contributions

All authors contributed to the acquisition of the data and critical revision of manuscript for important intellectual content. CM contributed to the design of the study, data analysis and edited the manuscript. SC contributed to the design of the study and data acquisition. BC analyzed and interpreted the data. DV designed the study, provided archive data and wrote the main manuscript text. CB contributed to the data analysis and to the design of the study. DB contributed to the data acquisition and data interpretation. AC provided archive data, contributed to data acquisition and edited the manuscript. LR contributed to the data analysis, data interpretation and edited the manuscript. All authors read and approved the final version of the manuscript. CM and BC are responsible for confirming the authenticity of raw data.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of ‘Grigore T. Popa’ University of Medicine and Pharmacy (Iasi, Romania)- Nr.4/13.09.21. Written informed consent was obtained from all the patients and/or guardians prior to publication.

Patient consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

References

1 

Kocygit M, Ortekin SG, Cakabay T, Ozkaya G, Bezgin SU and Adali MK: Frequency of serous otitis media in children without otolaryngological symptoms. Int Arch Otorhinolaryngol. 21:161–164. 2017.PubMed/NCBI View Article : Google Scholar

2 

Stool SE, Berg AO, Berman S, Carney CJ, Cooley JR, Culpepper L, Eavey RD, Feagans LV, Finitzo T, Friedman E, et al: Managing otitis media with effusion in young children. American Academy of Pediatrics the Otitis Media Guideline Panel. Pediatrics. 94:766–773. 1994.PubMed/NCBI

3 

Shekelle P, Takata G, Chan LS, Mangione-Smith R, Corley PM, Morphew T and Morton S: Diagnosis, natural history, and late effects of otitis media with effusion. Evid Rep Technol Assess (Summ). 55:1–5. 2002.PubMed/NCBI View Article : Google Scholar

4 

Gates GA, Avery CA, Prihoda TJ and Cooper JC Jr: Effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chronic otitis media with effusion. N Engl J Med. 317:1444–1451. 1987.PubMed/NCBI View Article : Google Scholar

5 

Tos M: Epidemiology and natural history of secretory otitis. Am J Otol. 5:459–62. 1984.PubMed/NCBI

6 

Mandel EM, Doyle WJ, Winther B and Alper CM: The incidence, prevalence and burden of OM in unselected children aged 1-8 years followed by weekly otoscopy through the ‘common cold’ season. Int J Pediatr Otorhinolaryngol. 72:491–499. 2008.PubMed/NCBI View Article : Google Scholar

7 

Casselbrant M and Mandel EM: Epidemiology. In: Rosenfeld RM, Bluestone CD, Eds: Evdence-based otitis media, cd 2, Hamilton, Ontario, BC Decker, 147-162, 2003.

8 

Martines F, Bentivegna D, Di Piazza F, Martinciglio G, Sciacca V and Martines E: The point prevalence of otitis media with effusion among primary school children in Western Sicily. Eur Arch Otorhinolaryngol. 267:709–714. 2010.PubMed/NCBI View Article : Google Scholar

9 

Williamson IG, Dunleavey J, Bain J and Robinson D: The natural history of otitis media with effusion--a three-year study of the incidence and prevalence of abnormal tympanograms in four South West Hampshire infant and first schools. J Laryngol Otol. 108:930–934. 1994.PubMed/NCBI View Article : Google Scholar

10 

Bhutta MF, Thornton RB, Kirkham LS, Kerschner JE and Cheeseman MT: Understanding the aetiology and resolution of chronic otitis media from animal and human studies. Dis Model Mech. 10:1289–1300. 2017.PubMed/NCBI View Article : Google Scholar

11 

Rosenfeld RM, Schwartz SR, Cannon CR, Roland PS, Simon GR, Kumar KA, Huang WW, Haskell HW and Robertson PJ: Clinical practice guideline: Acute otitis externa. Otolaryngol Head Neck Surg. 150 (Suppl 1):S1–S24. 2014.PubMed/NCBI View Article : Google Scholar

12 

Butnaru C, Serban R, Martu C, Lungu A, Doroftei EA, Cobzeanu B and Cozma S: Otitis media complications proceedings of national Ent. Head and Neck Surgery Conference. 102–106. 2019.

13 

Serban R, Butnaru C, Stefanescu H, Martu C, Cozma S and Radulescu L: Complications of otomastoiditis in children. Conference: National ENT, head and neck surgery national ent. Head And Neck Surgery Conference. 312–315. 2017.

14 

Vanneste P and Page C: Otitis media with effusion in children: Pathophysiology, diagnosis, and treatment. A review. J Otol. 14:33–39. 2019.PubMed/NCBI View Article : Google Scholar

15 

Norman G, Llewellyn A, Harden M, Coatesworth A, Kimberling D, Schilder A and McDaid C: Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: A health technology assessment. Clin Otolaryngol. 39:6–21. 2014.PubMed/NCBI View Article : Google Scholar

16 

Ma Y, Liang M, Tian P, Liu X, Dang H, Chen Q, Zou H and Zheng Y: Eustachian tube dysfunction in patients with house dust mite-allergic rhinitis. Clin Transl Allergy. 10(30)2020.PubMed/NCBI View Article : Google Scholar

17 

Paksoy M, Altin G, Eken M and Hardal U: Effectiveness of intratympanic dexamethasone in otitis media with effusion resistant to conventional therapy. Indian J Otolaryngol Head Neck Surg. 65 (Suppl 3):S461–S467. 2013.PubMed/NCBI View Article : Google Scholar

Related Articles

Journal Cover

February-2022
Volume 23 Issue 2

Print ISSN: 1792-0981
Online ISSN:1792-1015

Sign up for eToc alerts

Recommend to Library

Copy and paste a formatted citation
x
Spandidos Publications style
Mârțu C, Cozma S, Cobzeanu B, Vesa D, Butnaru C, Bularda D, Cumpătă A and Rădulescu L: Serous otitis media: Clinical and therapeutic considerations, including dexamethasone (C<sub>22</sub>H<sub>29</sub>FO<sub>5</sub>) intratympanic injection. Exp Ther Med 23: 125, 2022
APA
Mârțu, C., Cozma, S., Cobzeanu, B., Vesa, D., Butnaru, C., Bularda, D. ... Rădulescu, L. (2022). Serous otitis media: Clinical and therapeutic considerations, including dexamethasone (C<sub>22</sub>H<sub>29</sub>FO<sub>5</sub>) intratympanic injection. Experimental and Therapeutic Medicine, 23, 125. https://doi.org/10.3892/etm.2021.11048
MLA
Mârțu, C., Cozma, S., Cobzeanu, B., Vesa, D., Butnaru, C., Bularda, D., Cumpătă, A., Rădulescu, L."Serous otitis media: Clinical and therapeutic considerations, including dexamethasone (C<sub>22</sub>H<sub>29</sub>FO<sub>5</sub>) intratympanic injection". Experimental and Therapeutic Medicine 23.2 (2022): 125.
Chicago
Mârțu, C., Cozma, S., Cobzeanu, B., Vesa, D., Butnaru, C., Bularda, D., Cumpătă, A., Rădulescu, L."Serous otitis media: Clinical and therapeutic considerations, including dexamethasone (C<sub>22</sub>H<sub>29</sub>FO<sub>5</sub>) intratympanic injection". Experimental and Therapeutic Medicine 23, no. 2 (2022): 125. https://doi.org/10.3892/etm.2021.11048