Purpose of the Study
Following otitis media, 10% to 50% of children develop residual middle ear effusions. Prophylactic antibiotics and tympanotomy tubes are currently recommended treatments. The purpose of this study was to assess the effectiveness of topical intranasal beclomethasone as an adjunct to prophylactic antibiotic therapy.
Sixty-one children aged 3 to 11 years with persistent middle ear effusion >3 months were recruited from a military dependant population referred to the Wilford Hall Medical Center Pediatric Chronic Ear Clinic between October 1991 and June 1992.
The study used a double-blind, placebo-controlled, randomized design. The subjects were randomized into three 12-week treatment groups: 1) prophylactic antibiotics; 2) prophylactic antibiotics plus intranasal beclomethasone (336 μg/day); and 3) prophylactic antibiotics plus intranasal placebo. At entry, patients were evaluated with aeroallergen skin tests, a tympanogram, otoscopic examination, and symptom questionnaire. These same evaluations were performed at 4, 8, and 12 weeks.
Fifty-nine subjects completed the study. The three treatment groups were not statistically different in any characteristic (age, sex, atopy, family history of allergy, history of tympanostomy tubes, presence of smokers at home, enrollment in day care, antibiotic treatment at entry, history of penicillin sensitivity, or intercurrent illnesses during treatment.) The frequency of atopy in the patient population was 24%. The beclomethasone plus antibiotics group improved in all three measures (tympanometry, otoscopic examination, and symptom scores) more rapidly than the antibiotic alone and placebo nasal spray plus antibiotic groups over the first 8 weeks. At 12 weeks, the differences among groups were no longer significant for tympanometry and otoscopic examination but the difference in symptom scores remained significant comparing antibiotics plus beclomethasone and antibiotics alone (P = .015). Over the entire 12 weeks, only the antibiotics plus beclomethasone nasal spray group had significantly improved both right and left mean middle ear pressures (right,P = .010, left P = .004). No difference in response to nasal steroids was observed between atopic and nonatopic subjects.
Intranasal beclomethasone may be a useful adjunct to prophylactic antibiotic treatment of chronic middle ear effusion.
From this study it seems that although intranasal steroids may be a useful adjunct to prophylactic antibiotics in the treatment of chronic middle ear effusion, over the long term the differences become less remarkable. Middle ear disease tends to improve with time no matter what the treatment but intranasal steroids should certainly be considered for more stubborn cases. With the current emphasis on using less prophylactic antibiotic, it would be very helpful to see another study using intranasal steroid without antibiotic in one of the treatment groups.