Two versus seven days penicillin treatment for acute otitis media. A placebo controlled trial in children
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A two-day penicillin-V treatment for acute otitis media is as effective as a seven-day course. This shortened duration may significantly reduce antibiotic use in children without increasing complications.
Area of Science:
- Pediatrics
- Infectious Diseases
- Otolaryngology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Standard treatment often involves a 7-10 day course of antibiotics, contributing to antibiotic resistance.
- Optimizing AOM treatment duration is crucial for effective management and antimicrobial stewardship.
Purpose of the Study:
- To compare the efficacy of a 2-day versus a 7-day course of penicillin-V for treating acute otitis media in children.
- To evaluate the impact of treatment duration on clinical outcomes and symptoms.
- To explore a novel, shorter treatment strategy for AOM.
Main Methods:
- A double-blind, placebo-controlled trial involving 103 children aged 1-10 years.
- Participants received either 2 days or 7 days of penicillin-V (55 mg/kg/day).
- Outcomes assessed included earache, tympanic membrane healing, tympanometry, fever, and cold symptoms.
Main Results:
- No significant differences were observed between the 2-day and 7-day treatment groups for earache, tympanic membrane healing, tympanometry, fever, or cold symptoms.
- A satisfactory disease course was achieved in 71% of the 2-day group versus 76% of the 7-day group (p > 0.1).
- The additional 5 days of penicillin provided only a marginal benefit.
Conclusions:
- A 2-day course of penicillin-V is a viable and effective treatment duration for acute otitis media in children.
- Shortened antibiotic courses can significantly reduce penicillin consumption.
- A new treatment approach involving watchful waiting, a 2-day antibiotic course, and myringotomy for refractory cases is proposed to decrease antibiotic use by approximately 85% without increasing risks.
Abstract:
103 children between 1 and 10 years of age participated in a double-blind placebo-controlled trial testing the effect of penicillin-V, 55 mg/kg/day, for two days versus seven days in acute otitis media. No significant differences could be demonstrated with regard to earache, healing of the tympanic membrane, tympanometry, fever or common cold symptoms. 76% in the group treated for seven days had a satisfactory course of the disease, compared to 71% in the group treated for two days (p greater than 0.1). In spite of the relatively small number of patients, it is concluded that the effect of penicillin for additional five days in acute otitis media after the initial treatment for two days, can at most be marginal. The advantages of a shortened treatment period are several; the authors have outlined a new treatment modality, consisting of masterful inactivity for 8-12 hours, penicillin-V for two days, and myringotomy in refractory cases, after a new evaluation by the otologist. We believe hereby to be able to reduce penicillin consumption in children with acute otitis media to about 15% of the previous level, without increasing the risk of serious complications.