INTRANASAL BECLOMETHASONE AS AN ADJUNCT TO TREATMENT OF CHRONIC MIDDLE-EAR EFFUSION

Background: Following otitis media, 10% to 50% of children develop res idual middle ear effusion with concurrent hearing loss and potential c ognitive, behavioral, and language impairment. Prophylactic antibiotic s and tympanostomy tubes are currently recommended treatments for chro nic middle ear effusion. Objective: In a double-blind, placebo-control led, randomized study of chronic middle ear effusion, we assessed the effectiveness of topical intranasal beclomethasone as an adjunct to pr ophylactic antibiotic therapy. Methods: Sixty-one children, aged 3 to 11 years with persistent middle ear effusion greater than 3 months, we re randomized into three treatment groups: (1) prophylactic antibiotic s; (2) prophylactic antibiotics plus intranasal beclomethasone (336 mu g/day); and (3) prophylactic antibiotics plus intranasal placebo. Pat ients were evaluated with aeroallergen skin tests at entry; and tympan ogram, otoscopic examination, and symptom questionnaire at 0, 4, 8, an d 12 weeks. Results: While middle ear pressures, otoscopic examination s, and symptom scores were improved for each treatment group over 12 w eeks of therapy, the beclomethasone plus antibiotics group improved al l three measures more rapidly than the antibiotics-alone and placebo n asal spray plus antibiotics groups over the first 8 weeks. Only the be clomethasone group significantly improved left (P = .004) and right (P = .01) middle ear pressures over 12 weeks. Resolution of chronic midd le ear effusions was more frequent in the beclomethasone group (P less than or equal to .05 at 3 and 8 weeks). No difference in response to nasal steroids was observed between atopic and nonatopic subjects. Con clusions: We conclude that intranasal beclomethasone may be a useful a djunct to prophylactic antibiotic treatment of chronic middle ear effu sion.