Oral decongestant in acute otitis media. Results of a double-blind trial

In order to investigate the influence of an orally administered decongestant, norephedrine, upon the clinical course of acute otitis media and tubal function, a double-blind trial was performed in Copenhagen in December, 1976–February, 1977, in which 93 patients, aged 6 months to 10 years, with 135 ears with acute otitis media, were treated either with norephedrine or placebo in a randomized order. Most other treatment was avoided except for pain-relieving baby aspirins. The effect of norephedrine seemed to be no other than that of placebo. Because of this inefficacy of norephedrine the authors have, therefore, a material of patients with acute otitis media where the main treatment was pain-relieving aspirin. The use and abuse of antibiotics in the treatment of this disease are discussed, and the authors stress the necessity of performing controlled studies of the efficacy of antibiotics in acute otitis media, since such studies do not exist.