In Summary, for those who took the antibiotics:

Benefits in NNT

  • 100% saw no benefit (reduction of serious complications: mastoiditis, meningitis, hearing loss)
  • 100% saw no benefit (reduced late recurrence)
  • 100% saw no benefit (pain reduction after 24 hours)
  • 6% had reduced pain (after 2-7 days)
  • None had fewer serious complications
  • None had less disease recurrence
  • None had less pain after 24 hours
  • 1 in 16 were helped (pain reduction after 2-7 days)

Harms in NNT

  • 11% were harmed (diarrhea)
  • 1 in 9 were harmed (diarrhea)

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Source: Sanders S, Glasziou PP, DelMar C, Rover sMM. Antibiotics for acute otitis media in children. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000219. DOI: 10.1002/14651858.CD000219.pub2.
Turck D, Bernet JP, Marx J, et al. Incidence and risk factors of oral antibiotic-associated diarrhea in an outpatient pediatric population. J Pediatr Gastroenterol Nutr 2003;37:22-26.

Efficacy Endpoints: Serious complications (mastoiditis, meningitis, hearing loss), disease recurrence, pain

Harm Endpoints: Adverse medication effects

Narrative: This review included 15 trials (n = 4199 children) of which 10 (n = 2928) compared antibiotics with placebo in patients with acute otitis media. Amoxicillin and penicillin were the most commonly used antibiotics, and the duration of therapy was typically in the range of 7 to 10 days. There was one documented case of mastoiditis in a penicillin-treated patient. Of interest to both physician and patient, 78% of patients in the placebo and treatment groups had complete recovery by 2 to 7 days, which speaks to the self-limited nature of this disease process.

Two trials compared immediate antibiotic administration with a “watchful waiting” approach, while two other trials compared it to the approach of administering a prescription to be filled if symptoms persisted beyond 48 hours. Pain scores were the same at 3 to 7 days for those patients given immediate antibiotics versus subjects allocated to the observational treatment strategies.

While adverse events like rashes and allergic reactions can be caused by antibiotic use, the most commonly reported side effect is diarrhea. The gastrointestinal harms reported in the Cochrane Review seem to substantially underestimate the true effect that antibiotics have in this regard, so harm rates are calculated using one of the best (and most widely cited) observational studies assessing the risk of antibiotic-associated diarrhea in a pediatric outpatient setting. In this prospective study, there were 650 subjects. The overall incidence of diarrhea was 11%, with a mean duration of illness of 4 days. Augmentin was the highest risk antibiotic, with an associated 23% diarrhea rate.

Caveats: These trials were all performed in high-income settings where complications from otitis media are relatively rare. There is limited data to guide treatment of this disease in a non-industrialized setting. The rather modest benefits realized by antibiotic usage seem to be most pronounced in those age < 2 years.

Author: Ashley Shreves, MD

Published/Updated: August 22, 2010

  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.
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