In summary, patients who received antibiotics:

Benefits in NNT

    24.6% higher rate of complete resolution within 2-3 months
    1 in 5 were helped (complete resolution of effusion at 2-3 months)

Harms in NNT

    5% higher rate of adverse events
    1 in 20 were harmed (diarrhea, vomiting, rash)

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Source: Venekamp RP, Burton MJ, van Dongen TMA, van der Heijden GJ, van Zon A, Schilder AGM. Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev. 2016;(6):CD009163.

Study Population: 3663 children with otitis media with effusion seen in primary care and specialty offices and enrolled in 25 randomized controlled trials

Efficacy Endpoints: Resolution of OME by tympanometry or otoscopy

Harm Endpoints: Medication adverse events (e.g. diarrhea, vomiting, rash)

Narrative: Otitis media with effusion (OME), one of the most common diseases in early childhood, is a self-limited illness1 with an estimated recurrence rate of 50% within 24 months.2 OME is characterized by an accumulation of fluid in the middle ear without symptoms or signs of acute infection.3 In most cases OME causes mild hearing impairment for a short period. OME in the pediatric population can lead to diminished hearing which in theory could hinder early learning. Some studies have shown an association with adult hearing loss as well.4 In one study, for instance, OME and recurrent otitis media before the age of 3 were weakly associated with worse classroom concentration, mathematical skills, oral performance and reading skills.5

OME can be managed surgically (ventilation tubes, adenoidectomy) or medically (antibiotics, antihistamines, decongestants). The American Academy of Pediatrics 2019 advises against the use steroids, antihistamines and antibiotics in the management of OME but recommends surgical management for children with OME for more than 3 months and hearing deficits.6

The systematic review discussed here7 is an update from a previous Cochrane review in 2012,8 and reports meta-analyzed data collected from 3258 children from 23 trials. Seven were open-label, three were investigator-blinded, and 15 were double-blinded randomized controlled trials. The subjects’ mean age was 4.7 years, and 54% were boys.

Tympanometry, alone or in combination with otoscopy, was used to define OME and to monitor its resolution. Several antibiotics were used in the study but the commonly used included amoxicillin, amoxicillin/clavulanate potassium, trimethoprim-sulfamethoxazole. Duration of treatment varied, but was 10-14 days or four weeks in the majority of studies.

The primary outcome was complete resolution of OME at 2-3 months post-randomization. Data from six trials (523 children, with 484 (93%) included in the analysis) showed children treated with oral antibiotics were more likely to have complete resolution of OME at 2-3 months, relative risk [RR] 2.0, 95% confidence interval [CI], 1.6-2.5; absolute risk difference [ARD]: 24.6%; Number-needed-to-treat [NNT] 5; moderate quality evidence. When resolution of symptoms at 2-4 weeks was examined in data from 14 trials (n=2253, of whom 2091, or 93%, were included in the analysis), results were similar: RR 2.0, 95% CI, 1.5-2.7; ARD: 20%; NNT 5; low quality evidence.

A second primary outcome was adverse medication effects, specifically diarrhea, vomiting, or rash. Data from five trials (n=775, of whom 742, or 96%, were included in the analysis) showed children treated with oral antibiotics were more likely to experience adverse effects, RR 2.2, 95% CI 1.3-3.6; ARD: 20%; NNH 5; low quality evidence). None of the trials reported on long-term adverse effects of antibiotics such as bacterial resistance.

Two studies reported on hearing level based on speech recognition threshold with no differences at 4 weeks. No trials reported on language, speech, or cognitive development.

Caveats: Several caveats must be considered. Some of the studies included were limited by potential risk of bias, and there was inconsistency of effects across trials. Therefore, the Cochrane systematic review rates the quality of evidence for the primary outcome (resolution of OME at 2-3 months) as moderate and for the secondary outcomes of resolution of OME at 2-4 weeks as low. Critically, no trials reported data on language and speech development or cognitive development, theoretically the long term complications treatment of OME aims to prevent.

Similarly, several studies show the use of tympanostomy tubes in children with persistent middle-ear effusion results in short-term improvements in hearing, when compared with watchful waiting.9 However, as with antibiotics there is no evidence of a sustained or long term benefit on hearing., and no data showing improvements in cognitive or developmental outcomes.

Based on this evidence we rate the administration of antibiotics for OME as Red ( harm outweigh benefits). Based on the apparent success of antibiotics in reducing effusion this may seem incongruous., however, the AAP 2019 guideline also recommends against antibiotic use for OME, using logic we agree with: existing data demonstrate no long-term or patient oriented benefit, despite finding clinically meaningful harms. In short, while more patients in the antibiotic group may experience short term resolution of OME, the absence of any data showing impact on the target outcomes of language, speech, and cognitive goals points to a need for further research focusing on patient-centered endpoints.

Finally, long-term considerations such as antibiotic compliance, cost of treatment, recurrence of OME ( 50% recuurence within the first 24 months)2, and development of antibiotic resistance10 should be considered before prescribing antibiotics for this or any other self-limiting disease.

The original manuscript was published in Academic Emergency Medicine as part of the partnership between TheNNT.com and AEM.

Author: Kelvin Kwofie, MD; Allan B. Wolfson, MD
Supervising Editors: Shahriar Zehtabchi, MD

Published/Updated: April 5, 2021

  1. The Title Bar

    The title bar is color-coded with our overall recommendation.

    • Green: Benefits outweigh risks.
    • Yellow: Unclear risk/benefit profile.
    • Red: Benefits do not outweigh risks.
    • Black: Obvious harms, no clear benefits.
  2. Tip content...