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Intranasal beclomethasone as an adjunct to treatment of chronic middle ear effusion
J M Tracy1, J G Demain, K M Hoffman
1Department of Allergy-Immunology, Wilford Hall Medical Center, Lackland AFB, Texas, USA.
Insights
Topical intranasal beclomethasone, when combined with antibiotics, offers a faster resolution for chronic middle ear effusions in children. This combination therapy improved middle ear pressures and effusion resolution more effectively than antibiotics alone.
Area of Science:
- Pediatrics
- Otolaryngology
- Pharmacology
Background:
- Chronic middle ear effusion (CME) affects 10-50% of children post-otitis media, leading to hearing loss and developmental issues.
- Current treatments for CME include prophylactic antibiotics and tympanostomy tubes.
Purpose of the Study:
- To evaluate the efficacy of topical intranasal beclomethasone as an adjunct to prophylactic antibiotic therapy for chronic middle ear effusion.
- To assess the impact on middle ear effusion resolution and related symptoms.
Main Methods:
- A double-blind, placebo-controlled, randomized study involving 61 children (aged 3-11) with persistent middle ear effusion.
- Three groups: antibiotics alone, antibiotics plus intranasal beclomethasone, and antibiotics plus intranasal placebo.
- Evaluations included tympanometry, otoscopy, and symptom questionnaires over 12 weeks.
Main Results:
- The beclomethasone plus antibiotics group showed more rapid improvement in middle ear pressures and symptoms within the first 8 weeks.
- Significantly improved middle ear pressures were observed in the beclomethasone group over 12 weeks.
- Resolution of chronic middle ear effusions was more frequent in the beclomethasone group.
Conclusions:
- Intranasal beclomethasone may serve as a beneficial adjunct to prophylactic antibiotic treatment for chronic middle ear effusion.
- The study suggests a potential role for nasal steroids in managing persistent middle ear effusions.
Background:
Following otitis media, 10% to 50% of children develop residual middle ear effusion with concurrent hearing loss and potential cognitive, behavioral, and language impairment. Prophylactic antibiotics and tympanostomy tubes are currently recommended treatments for chronic middle ear effusion.
Objective:
In a double-blind, placebo-controlled, randomized study of chronic middle ear effusion, we assessed the effectiveness of topical intranasal beclomethasone as an adjunct to prophylactic antibiotic therapy.
Methods:
Sixty-one children, aged 3 to 11 years with persistent middle ear effusion greater than 3 months, were randomized into three treatment groups: (1) prophylactic antibiotics; (2) prophylactic antibiotics plus intranasal beclomethasone (336 micrograms/day); and (3) prophylactic antibiotics plus intranasal placebo. Patients were evaluated with aeroallergen skin tests at entry; and tympanogram, otoscopic examination, and symptom questionnaire at 0, 4, 8, and 12 weeks.
Results:
While middle ear pressures, otoscopic examinations, and symptom scores were improved for each treatment group over 12 weeks of therapy, the beclomethasone plus antibiotics group improved all three measures more rapidly than the antibiotics-alone and placebo nasal spray plus antibiotics groups over the first 8 weeks. Only the beclomethasone group significantly improved left (P = .004) and right (P = .01) middle ear pressures over 12 weeks. Resolution of chronic middle ear effusions was more frequent in the beclomethasone group (P < or = .05 at 4 and 8 weeks). No difference in response to nasal steroids was observed between atopic and nonatopic subjects.
Conclusions:
We conclude that intranasal beclomethasone may be a useful adjunct to prophylactic antibiotic treatment of chronic middle ear effusion.
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