title: Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial.
abstract: In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children.
mesh_terms: D002648:Child; D002675:Child, Preschool; D002744:Chlorpheniramine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010034:Otitis Media with Effusion / Q000188:drug therapy*; D010349:Patient Compliance; D011897:Random Allocation
chemical_list: D004338:Drug Combinations; C001941:chlorpheniramine, ephedrine drug combination; D002744:Chlorpheniramine; D004809:Ephedrine