Trial of three-day and ten-day courses of amoxycillin in otitis media.

Abstract

A randomised double-blind controlled trial compared three-day and 10-day courses of amoxycillin (25 mg/kg daily) in children with otitis media. Seventeen doctors from five centres admitted 84 children between the ages of 2 and 10 years. Symptoms and signs were measured on admission to the trial, on day 3, and on day 15. Mothers' observations were recorded daily for 10 days. Audiograms were performed at four and 12 weeks after the end of the trial. The treatment groups showed little difference in the speed of resolution of symptoms and signs, the numbers of primary treatment failures, or the frequency of recurrent ear infections. There were no complications in either group.Most children with otitis media can probably be successfully and safely treated with no more than a three-day course of amoxycillin providing their progress is reviewed about the fifth or sixth day after treatment started. This policy could save over £1 million annually in antibiotic costs.

Treatment of Acute Otitis Media With a Shortened Course of Antibiotics

“…48,53,54,57,60,69,70,73 Cointervention was permitted in 38% of trials, usually with analgesics and decongestants. [46][47][48]50,51,53,57,59,[64][65][66] In 2 trials, myringotomy had been conducted in early treatment failures. 48,59 Concurrent use of a second antibiotic was seen in 1 trial.…”

“…48,59 Concurrent use of a second antibiotic was seen in 1 trial. 61 A check for compliance with antibiotic administration was carried out in half of the trials 26,46,48,[52][53][54][57][58][59]62,67,70,72,73 ; substantial noncompliance was noted in 3 trials in 2 publications, contributing to the withdrawal of patients.…”

“…Secondary outcomes were assessed at 30 to 40 days and 3 months following trial entry. 26,46,53,58 The ceftriaxone trials were conducted in the United States or Israel. A diagnosis of AOM was made using clinical and tympanometric criteria.…”

“…Although the majority of trials excluded comorbid conditions, only 31% excluded children with chronic or recurrent OM. 46,53,55,56 In all trials, diagnosis of AOM was made according to the presence of signs and symptoms. Tympanometry 58 and tympanocentesis 26,49,54 were not commonly performed.…”

“…26,47,49,[53][54][55][56][57][58] Ten trials in 8 publications defined a satisfactory outcome as the resolution or improvement of signs and symptoms, including middle ear effusion. 26,46,49,[54][55][56][57][58] Three trials in 2 publications regarded persistent effusion as a treatment failure. 47,53 One thousand children were evaluated at 8 to 19 days after treatment was begun, 53,58 and 462 children were evaluated at both 8 to 19 days and 20 to 30 days after entry into trial.…”