Effect of Topical Intranasal Steroid in Management of Otitis Media with Effusion

Transcription

1 Med. J. Cairo Univ., Vol. 85, No. 2, March: , Effect of Topical Intranasal Steroid in Management of Otitis Media with Effusion MEDHAT M. SHARSHAR, M.D. The Department of ENT, Hearing and Speech Institute, Imbaba, Giza Abstract Objective: To evaluate the effectiveness of using topical nasal steroids in comparison with oral steroids in the treatment of Otitis Media with Effusion (OME) in children. Methods: One hundred (100) patients were included in the study, they were divided into two equal groups, Group A received intranasal mometasonefuroate monohydrate spray once daily for 6 weeks, and Group B received oral steroids in tapering doses over 2 weeks for 6 weeks, plus systemic antibiotics, nasal decongestants, and mucolytics for both groups, tympanogram was done every 2 weeks for all patients. Results: Highly significant improvement (p<0.01) of OME regarding symtoms, signs, and tympanometric results, occurred in each group alone at the end of the study, with no significant difference (p>0.05) in improvement between the two groups, although oral steroids (Group B) gave better results. Conclusion: Both topical intranasal and oral steroids are effective medical therapy in the treatment of OME in children with no significant difference between the two methods. Key Words: Otitis media with effusion Nasal steroids Tympanometry. Introduction OTITIS Media with Effusion (OME) isdefined by the presence of Middle Ear Effusion (MEE) behind an intact Tympanicmembrane (TM) without signs or symptoms of acute infection. OME may occur spontaneously because of poor Eustachian tube function or asan inflammatory response following Acute Otitis Media (AOM). About 80% of children may experience one episode or more of OME by age of 3 years. OME is also characterized by a high rate of recurrence, a recurrence rate of 50% was found within 24 months [1]. Many patients with OME require no specific treatment. The most common medical treatment Correspondence to: Dr. Medhat M. Sharshar, The Department of ENT, Hearing and Speech Institute, Imbaba, Giza options include the use of decongestants, mucolytics, steroids, antihistamines, antibiotics, and autoinflation. Surgical treatment options include grommet insertion, myringotomy (tympanocentesis, i.e. surgical incision of the eardrum, with or without aspiration of fluid from the middle ear cavity) and adenoidectomy. The optimal treatment strategy remains controversial, there being wide international variability in clinical practice. Antibiotic treatment has a negligible effect on the long-term resolution of MEE [2]. The effect of systemic and topical intranasal steroids on otitis media with effusion in children has been the subject of randomized and controlled clinical trials, systemic steroids, may be able to gain access to the middle ear, however both short term and long term complications from systemic steroids are well known to otolaryngologists. Topical intranasal steroids may be safer than systemic preparations because the glucocorticoid is rapidly degraded in the nasal mucosa to less active metabolites and any unchanged drug that is absorbed is metabolized in the first pass through the liver, systemic adverse effects are therefore less likely, while the desired anti-inflammatory effects may be similar [3]. Patients and Methods This study was conducted on (100 children) suffering from otitis media with effusion. Patients were selected from those attending E.N.T clinics in Hearing and Speech Institute in the period from October 2011 to March Children who have taken systemic or topical intranasal steroids in the previous 3 months, children who previously underwent operative procedures for treatment of their OME and children who are suffering from symptoms of adenoid hypertrophy are excluded. 761

2 762 Effect of Topical Intranasal Steroid in Management of Otitis Media with Effusion All patients had been subjected to the following diagnostic work up including medical history eg diminution of hearing, tinnitus, earache and ear examination also audiological evaluation by tympanometry and pure tone. Children meeting entry criteria were divided into two equal groups: - Group A (50 children) received topical intranasal mometasonefuroate, once a day for 6 weeks 50 gg (one puff) in each nostril (total daily dose 1 00µ g). - Group B (50 children) received oral prednisolone in syrup form 1mg/kg/day in devided doses in tapering doses over 2 weeks for 6 weeks. In addition, both groups received systemic antibiotics for 10 days and nasal decongestants for 5 days. All patients were evaluated at 0, 2, 4 and 6 weeks. The assessment of each patient included history, a symptom questionnaire, otoscopic examination, a tympanogram, and a pure tone audiogram (above the age of 6 years). At the follow-up visits (every two weeks) subjective improvement of the symptoms, otoscopic examination findings was recorded as well as the tympanometry evaluation. Patients considered improved as follow: Resolution or cure of bilateral glue ear (B/B tympanogram) was defined by complete bilateral clearance (A/A tympanogram) at any stage. Partial improvement was defined by (C tympanogram). Results The present study included 100 patients (children) aged from 3-10 years old, the gender composition was male 65% and female 35% divided into 2 equal groups (Group A & Group B) in a comparative study between the use of oral steroids and topical nasal steroids in the treatment of otitis media with effusion. Group (A) received intranasal mometasonefuroate monohydrate 100mcg/day, one spray in each nostril once a day for 6 weeks, and Group (B) received oral prednisolone in tapering doses over 2 weeks for 6 weeks. Highly significant improvementof OME regarding symtoms, signs, and tympanometric results, occurred within each group at the end of the study, with no significant difference in improvement between the two groups, yet, oral steroids (Group B) gave better results. There was no significant difference between Group A and Group B as regards improvement of hearing impairment at all stages of the study, but high significant difference between both groups was found at stage 2 (after 4 weeks) (Table 1), although high significant improvement of hearing occurred within each group separately at the end of the study, with no significant improvementin Group A after 2 weeks and after 6 weeks in Group B. Regarding earache and tympanic membrane appearance there was no significant difference between Group A and Group B at all stages of the study, within each group separately there was a highly significant improvement after 2 weeks in both groups, the overall results showed a highly significant improvement within each group separately. No significant difference between Group A and Group B as regards improvement of tympanic membrane retraction at all stages of the treatment. Within each group separately, there was no significant improvement in both groups after 2 weeks, and in Group A after 4 weeks, but a highly significant imprevement occurred in Group B after 4 weeks and in both groups after 6 weeks. Regarding the tympanogram results, there was no significant difference between Group A and Group B at all stages of the study (Table 2). Within each group separately there was a highly significant improvement of tympanometric results in both groups at all stages of the study except at the 1 st stage (after 2 weeks), there was a significant improvement in Group A. Table (1): Comparison between both groups as regards hearing impairment at different time measurements. Hearing impairment at Group A Group B N % N % χ 2 p- value Start of treatment: Positive Negative NS After 2 weeks: Positive Negative NS After 4 weeks: Positive Negative HS After 6 weeks: Positive Negative NS

3 Medhat M. Sharshar 763 Table (2): Comparison between both groups as regards tympanogram at different time measurements. Tympanogram at Group A Group B N % N % χ 2 p- value Start of treatment: Effusion Partial improvement NS Improvement After 2 weeks: Effusion Partial improvement NS Improvement After 4 weeks: Effusion Partial improvement NS Improvement After 6 weeks: Effusion Partial improvement NS Improvement Discussion Otitis Media with Effusion (OME), or 'glue ear', is characterized by an accumulation of fluid in the middle ear, in the absence of acute inflammation. It is an important and common problem. The present study included 100 patients (children) divided into 2 equal groups (Group A & Group B) in a comparative study between the use of oral steroids and topical nasal steroids in the treatment of otitis media with effusion within 6 weeks. Group (A) received intranasal mometasonefuroate monohydrate 100mcg/day, one spray in each nostril once a day for 6 weeks, and Group (B) received oral prednisolone in tapering doses over 2 weeks for 6 weeks. In addition, both groups received systemic antibiotics, nasal decongestants, and mucolytics. Highly significant improvement (p<0.01) of OME regarding symtoms, signs, and tympanometric results, occurred in each group alone at the end of the study, with no significant difference ( p>0.05) in improvement between the two groups, yet, oral steroids (Group B) gave better results. This indicates the effectiveness of both oral and topical steroids in treatment of otitis media with effusion. Tracy et al., [3] reported a trial on 61 children with persistent middle ear effusion, were randomized into three treatment groups: (1) Prophylactic antibiotics; (2) Prophylactic antibiotics plus intranasal beclomethasone and (3) Prophylactic antibiotics plus intranasal placebo. Patients were evaluated with tympanogram, otoscopic examination, and symptom questionnaire at 0, 4, 8, and 12 weeks. The beclomethasone plus antibiotics group improved all three measures more rapidly than the antibiotics-alone and placebo nasal spray plus antibiotics groups and concluded that intranasal beclomethasone may be a useful adjunct to prophylactic antibiotic treatment of chronic middle ear effusion. Christopher et al., [4] in a systematic review concluded that steroids alone or combined with an antibiotic lead to a quicker resolution of OME in the short term. Cengel et al., [5] reported a clinical study on a total of 122 children were enrolled into the study and control groups. The study group received intranasal mometasonefuroate monohydrate 100 mcg/day, one spray in each nostril once a day for 6 weeks. The control group was followed-up without any treatment. No other medication was allowed during the study in either group. Resolution of OME in the study group (42.2%) was significantly higher than that in the control group (14.5%). Forty-five patients (67.2%) with adenoid hypertrophy in the study group showed significant decreases in adenoid size according to the endoscopic evaluation compared to the control group. A significant improvement in obstructive symptoms was seen in the treatment group. These results indicated that nasal mometasonefuroate monohydrate treatment can significantly reduce adenoid hypertrophy and obstructive symptoms and a useful alternative to surgery, at least in the short term, for otitis media with effusion. Behrooz Barati et al., [6] conducted a randomized, prospective clinical trial using amoxicillin and a decongestant for both groups and nasal beclomethasone spray only for case group and finally concluded that the administration of nasal beclomethasone spray as an adjuvant for the treatment of OME not only improved the results treatment but also increased the resolution of symptoms and the patients' quality of hearing.

4 764 Effect of Topical Intranasal Steroid in Management of Otitis Media with Effusion It is hypothesised that steroids could clear effusions by: (A) Stabilizing membrane phospholipid breakdown and thus preventing the formation of arachidonic acid and associated inflammatory mediators; (B) Shrinking peri-tubal lymphoid tissue; (C) Enhancing secretion of eustachian tube surfactant; and (D) Reducing middle ear fluid viscosity [7]. Topical intranasal steroids may be safer than systemic preparations because the glucocorticoid is rapidly degraded in the nasal mucosa to less active metabolites and any unchanged drug that is absorbed is metabolized in the first pass through the liver [3]. Systemic adverse effects are therefore less likely, while the desired anti-inflammatory effects may be similar. Systemic steroids, however, may be able to gain access to the middle ear, while topical intranasal steroids would not be expected to reach the middle ear but may modulate eustachian tube function. Although long term or frequent courses of oral steroids are associated with important adverse effects, repeated short courses of prednisolone (median of four courses in a year) in children with asthma were shown to be safe and not associated with any lasting effects on bone metabolism or mineralization or adrenal function [9]. Kuo et al., [10] said that treatment of OME is still a controversial issue, the conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms. There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few studies have investigated topical intranasal steroids for OME treatment, and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation. In our study, both topical and systemic steroids gave a high significant improvement regarding symptoms, signs, and tympanometric results in OME at the end of the study (after 6 weeks), yet, systemic steroids gave better results. So both topical intranasal and systemic steroids administration are considered effective treatments of OME in children, however, comlications of sysemic steroids can be avoided by using topical steroids. Conclusion: Both topical intranasal and oral steroids are effective adjunctive treatment for otitis media with effusion in children in the short term, yet, oral steroids are more effective. In our study, one hundred (100) children that fulfilled the inclusion criteria divided into 2 equal groups, Group A received topical intranasal steroids and Group B received oral steroids. The results showed improvement in the average tympanogram results in 17 patients from Group A, and 21 patients from Group B after treatment. From these findings, it is concluded that both topical intranasal and systemic steroids are effective in treatment of OME in children but without significant difference, so oral steroid complications could be avoided by using local steroid spray. References 1- TEELE D.W., KLEIN J.O. and B. ROSNER: Epidemiology of otitis media during the first seven years of life in children in greater Boston: A prospective cohort study. J. Infect. Dis., 160 (1): p.83-94, ROSENFELD R.M. and D. KAY: Natural history of untreated otitis media. Laryngoscope, 113 (10): p , TRACY J.M., DEMAIN J.G., HOFFMAN K.M. and GOETZ D.W.: Intranasal beclomethasone as an adjunct to treatment of chronic middle ear effusion. Annals of Allergy, Asthma andimmunology, 80: , CHRISTOPHER C., BUTLER B.A. and JUDITH H.: Steroids for otitis media with effusion, Arch. Pediatr. Adolesc. Med., 155: 641-7, CENGEL S. and AKYOL M.U.: The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy, International Journal of Pediatric Otorhinolaryngology, 70: , BEHROOZ BARATI, MOHAMMAD REZA OMRANI, AHMAD REZA OKHOVAT, ROYA KELISHADI, MUS- TAFA HASHEMI, AKBARHASSANZADEH, MOJTA- BA ABTAHI, NAVID OMIDIFAR and HANIF OKHO- VAT: Effect of nasal beclomethasone spray in the treatment of otitis media with effusion, J. Res. Med. Sci., April, 16 (4): , DUCHARME F.M., CHABOT G., POLYCHRONAKOS C., GLORIEUX F. and MAZER B.: Safety profile of frequent short courses of oralglucocorticoids in acute pediatric asthma: Impact on bonemetabolism, bone density, and adrenal function. Pediatrics, 111 (2): , KUO C.L., WANG M.C., CHU C.H. and SHIAO A.S.: New therapeutic strategy for treating otitis media with effusion in postirradiated nasopharyngeal carcinoma patients. J. Chin. Med. Assoc., 75 (7): [PubMed], 2012.

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