|Year : 2013 | Volume
| Issue : 3 | Page : 114-117
Efficacy of mometasone nasal spray in the treatment of otitis media with effusion in the pediatric age group: A preliminary study
Shalini Sandeep Menon, Abdul Rahman, Ramaswamy Balakrishnan, Dipak Ranjan Nayak, Kailesh Pujary
Department of Otolaryngology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India
|Date of Web Publication||2-Sep-2013|
Kasturba Medical College, Manipal University, Manipal - 576 104, Karnataka
Source of Support: None, Conflict of Interest: None
Aims: To study the efficacy of mometasone furoate monohydrate topical nasal spray in the treatment of otitis media with effusion (OME) in children aged between 4 and 15 years. Thus, by comparative analysis of results, at 0 and 6 weeks of using mometasone nasal spray, its efficacy in improving the clinical and audiological status of children with OME is assessed. Materials and Methods: A prospective, clinical study carried out on 22 children aged between 4 and 15 years who had attended our Department of Otolaryngology in a tertiary care hospital from January 2008 to May 2009. Results: The efficacy of mometasone furoate monohydrate topical nasal spray in the resolution of middle ear fluid in children aged between 4 and 15 years with OME in this study group was observed to be significant (52.7%). A significant improvement in the overall symptoms was seen in the treatment group. There was good improvement in the audiological status also. Conclusion: Topical steroids can be an alternative to surgery in controlling OME. However, these results are only short-term; a long-term follow-up is necessary. Topical intranasal mometasone furoate therapy can be considered a good therapeutic option to OME. Nasal administration of this steroid is safe, reproducible, easily performed, and well tolerated by pediatric patients.
Keywords: Impedance audiometry, Mometasone furoate, Otitis media with effusion
|How to cite this article:|
Menon SS, Rahman A, Balakrishnan R, Nayak DR, Pujary K. Efficacy of mometasone nasal spray in the treatment of otitis media with effusion in the pediatric age group: A preliminary study. Indian J Otol 2013;19:114-7
|How to cite this URL:|
Menon SS, Rahman A, Balakrishnan R, Nayak DR, Pujary K. Efficacy of mometasone nasal spray in the treatment of otitis media with effusion in the pediatric age group: A preliminary study. Indian J Otol [serial online] 2013 [cited 2019 Apr 22];19:114-7. Available from: http://www.indianjotol.org/text.asp?2013/19/3/114/117476
| Introduction|| |
Otitis media with effusion (OME) is a common otological condition of childhood.  The etiology of OME is uncertain, low grade infection, poor Eustachian tube More Details function, adenoidal infection or hypertrophy and pharyngeal reflux have all been implicated. The condition is the most common cause of acquired hearing loss in children. This may negatively affect language development.  Conventional medical therapy has been tried for OME including antibiotics, decongestants, antihistamines, and a combination of these agents. Failure of the medical treatment of the middle ear effusion potentiates the need for a myringotomy and ventilation tube insertion.
Some authors have suggested the use of corticosteroids in the treatment of middle ear effusion. There has been no consensus on this issue. Short-term use of systemic steroids provides a temporary improvement. , The long-term use of systemic steroids is not appropriate in children due to the adverse effects.  Topical intranasal steroids are relatively safe as the glucocorticoid is rapidly degraded in the nasal mucosa to less active metabolites and any unchanged drug that is absorbed is metabolized through the liver.  The systemic adverse effects are therefore less likely while the desired antiinflammatory effects may be similar. 
In this study, mometasone furoate monohydrate topical nasal spray was used in the treatment of OME in children aged between 4 and 15 years. The efficacy of the topical steroid spray in improving the clinical and audiological status of children with OME is assessed.
| Materials and Methods|| |
A prospective clinical study was carried out from January 2008 to May 2009 on 22 children who were evaluated in the Department of Otolaryngology of a tertiary care hospital and had been diagnosed to have OME.
Twenty-two children were grouped into two groups, that is, a younger age group aged between 4 and 8 years as 'A" and older children aged between 9 and 15 years as "B." Each ear was evaluated separately. The children included in the study had features of OME by otoscopic/otomicroscopic examination with a Type B tympanogram and conductive hearing loss on audiometry. Children excluded from the study were those with:
All the patients received intranasal mometasone furoate monohydrate nasal spray 100 mcg/day, one spray in each nostril once a day for 6 weeks by the technique of neck flexion while dispensing from a vertically held bottle in order to direct the spray toward the posterior nasal cavity. Assessment of each patient included a history, a symptom questionnaire, clinical examination, an otoscopy/otomicroscopic examination, a tympanogram, and in older children a pure tone audiogram (PTA). All the patients were assessed at 0 and 6 weeks.
- Previous history of use of systemic or intranasal steroids
- Previous history of surgery for these illnesses
- Sensorineural hearing loss
- Active upper respiratory tract infection in the preceding 2 weeks or history of allergic rhinitis
- History of immunodeficiency
- Hypersensitivity to mometasone furoate monohydrate
- Systemic and local contraindication against steroids and
- Craniofacial anomaly
The symptom questionnaire was filled in at the initial enrollment and after 6 weeks. It consisted of a parental assessment of patient's hearing loss, nasal obstruction, nasal discharge, snoring/mouth breathing, and recurrent upper respiratory tract infections. The symptoms were scored as "0-10" according to the severity of each. Subsequently, the scores of each patient were added up and the overall score was used for comparison at the end of the study. Each symptom was also compared separately between the two evaluations. The ears were examined separately by otoscopy/otomicroscopic examination for the tympanic membrane appearance. The mobility was assessed by pneumatic otoscopy.
Tympanometry and pure tone audiometry was done by an audiologist in a standardized room by Grayson-Steadler GSI-61 clinical audiometer and tympanometry. A Jerger type B flat tympanogram was considered to support diagnosis of OME.
| Results|| |
A total of 22 patients were taken up for the study. Fifteen patients (68%) were in the age group 5-8 years, that is, "A" group and remaining seven patients were in the 9-15 years age group, that is, "B" group. There were 10 male and 12 female patients.
Symptom score of patients shows a difference of 127 between 0 and 6 weeks when calculated with the above mentioned scoring as shown in [Figure 1] and [Figure 2]. These patients were then subjected to hearing evaluation by PTA and impedance audiogram, performed at 0 and 6 weeks of receiving mometasone nasal spray.
When the PTA was analyzed pre- and post-treatment, a mean improvement of 9.4 dB in the AB gap was observed (P value = 0.029). Similarly, with the impedance audiogram, 'B' curve was demonstrated in 36 out of 44 ears (81.81%). Among these, 12 (36) became 'A' type and 7 (36) became 'C' type after treatment with a 52.7% clearance of middle ear fluid (P value = 0.0004) as depicted in [Figure 1] and [Figure 2]. This was considered as significant.
| Discussion|| |
The treatment of OME is still unclear due to its multifactorial pathogenesis.  Insertion of tympanostomy tubes with or without adenoidectomy is an universally accepted modality in the treatment/control of persisting middle ear effusion.  However, this procedure may cause complications such as tympanic membrane perforations, aural discharge, sclerotic changes over the membrane, hearing loss, and rarely, cholesteatoma. The role of corticosteroids is controversial. When compared with systemic steroids, topical steroids have limited adverse effects. They exert their anti-inflammatory effect locally on the nose, nasopharynx and eustachian tube. , Corticosteroids have a direct anti-inflammatory action in the middle ear and eustachian tube by preventing the synthesis of inflammatory mediators, increase in surfactant in the eustachian tube, and shrinkage of peritubal lymphatics allowing for better tubal function. In addition, the decrease in the viscosity of middle ear fluids, amelioration of allergic diathesis, and upregulation of transepithelial sodium transport in the middle ear epithelium promotes removal of middle ear fluid.  However, the mode of action of intranasal steroids is complex. It is not known whether they penetrate the nasal mucosa. But their low systemic activity supports the concept of local action on nasal mucosa.  They influence a variety of inflammatory cells and their mediators such as epithelial cells, lymphocytes, basophils, mast cells, and Langerhan cells. A reduced influx of mediator cells may explain some of the effects of intranasal corticosteroids on rhinitis symptoms but it cannot explain all of the effects because intranasal steroids also reduce the early phase sneezing and rhinorrhea after an allergen challenge outside the pollen season. In this situation, the number of surface mast cells/basophils is very low, as it is in the absence of allergic rhinitis. The data on efficacy of intranasal steroids for persistent OME are limited with few published studies. , The overall beneficial effects with intranasal steroids were notable but transient.
This study demonstrated the outcome of intranasal mometasone furoate nasal spray in the treatment of OME on 22 children aged between 4 and 15 years. There was an overall improvement in the symptom score of 30.9% after treatment. A previous study by Berlucchi et al.,  evaluated the efficacy of mometasone nasal spray in decreasing the adenoid size and in reducing the severity of nasal obstruction, which was 77.7% in the study group. The role of mometasone nasal spray as a single modality of treatment in OME has not been adequately evaluated. Mometasone nasal spray is safe and well tolerated. After intranasal administration, it undergoes extensive first pass metabolism. As a result, the systemic concentrations are below quantifiable limits suggesting a negligible risk of adverse events. Ratner et al.,  studied the long-term safety and efficacy of mometasone nasal spray in children. They concluded that 100 μg of mometasone furoate nasal spray once daily for one year was well tolerated in children of age group 6-11 years with negligible systemic exposure and no evidence of suppression of hypothalamic-pituitary-adrenal axis or ocular changes. Among the several steroid nasal sprays, mometasone furoate was preferred in our study because it does not cause any adverse tissue changes in the nasal mucosa of patients with no effect on growth in children and no effect on hypothalamic-pituitary-adrenal axis. The systemic availability of drug after topical application is lower than other steroids. ,,,
Yaman et al.,  investigated the dose-related effectiveness of corticosteroids in the treatment of OME by using objective measurement techniques of tymapanometry and cytokine measurement. The study confirmed the short-term beneficial effect of systemic steroids on the resolution of OME in a rat model. Similarly, Schwartz et al.,  reported the results of 40 children treated with steroid spray either initially or following cross over with 70% showing resolution of OME via pneumo-otoscopy and 64% via tympanometry. Shapiro et al.,  in 1982 compared dexamethasone nasal spray with a placebo in a blinded study of 45 children with persistent Eustachian tube dysfunction for a minimum of 4 weeks. In the first 3 weeks, dexamethasone showed more efficacies than the placebo but in the third week there was no difference between the two. Cengel and Akyol  conducted prospective, controlled, randomized study in children (3-15 years) using intranasal mometasone furoate monohydrate 100 mcg/day. They found the resolution of OME in the study group, that is, 42.2% was significantly higher than in the control group, that is, 14.5% (P < 0.001). They concluded that mometasone nasal spray can significantly reduce the adenoid hypertrophy and eliminate the obstructive symptoms.
In our study, at 0 weeks, 30 (44) ears showed AB gap >20 dB loss, that is, 68.18%. After 6 weeks of treatment 17 (30) ears showed significant closure (>10 dB) in A-B gap, that is, 56.67% improvement. The mean improvement in the AB gap was 29.4 dB. The impedance audiogram showed 'B' curve in 36 (44) ears (81.81%), 'A' type in 5 (44) ears (11.36%), and 'C' type in 3 (44) ears (6.81%) at 0 week of study. After 6 weeks, impedance audiogram demonstrated an 'A' type curve in 18 (44) ears (40.91%), 'B' type in 18 (44) ears (40.91%), and 'C' type in 8 (44) ears (18.18%). After treatment with 6 weeks of mometasone furoate nasal spray, a 52.7% of ears showed clearance of fluid, which was statistically significant (P value = 0.0004). Therefore, the 52.7% recovery rate without any other medication given simultaneously is significant. There is no consensus in literature regarding the duration and dosage of steroid nasal spray especially in children. The dose used in our study is equal to that used in allergic rhinitis in the prescription of the drug. The safety of use for one year of topical steroids in children has been documented. Therefore, long-term topical nasal steroids can be used in the routine dose for OME.
Our study concerns the short-term follow up of patients, which demonstrated efficacy of the topical steroid treatment in the control of OME. It does not give its reliability of long-term control. The effects of the drug in the control of OME must be studied.
| Conclusion|| |
Corticosteroids have a potential role in the treatment of OME. Topical intranasal steroids are safer than systemic preparations. The efficacy of mometasone furoate topical nasal spray in the resolution of middle ear fluid in children aged between 4 and 15 years with OME was observed to be significant and comparable with previous studies. There was a good improvement in the audiological status of these children. Thus, topical nasal steroid can be considered a viable alternative to surgery in controlling OME. These results have been observed in the short-term. A long-term follow up is necessary to assess whether the effects are permanent or temporary.
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[Figure 1], [Figure 2]