Acute Otitis Media: Treat or Not?

From Medscape Pediatrics > Viewpoints

William T. Basco, Jr., MD

A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media

Tähtinen P, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohala A
N Engl J Med. 2011;364:116-126
Study Summary

Tähtinen and coworkers evaluated the efficacy of antibiotic treatment for acute otitis media (AOM) in a group of Finnish children 6-35 months old. Children were generally healthy and met 3 criteria for diagnosis of AOM:

* Middle ear fluid detected by pneumatic otoscopy as evidenced by at least 2 of the following: a bulging tympanic membrane, decreased mobility of the tympanic membrane, abnormal color or opacity (not due to scarring), or air-fluid levels;
* Erythema of the tympanic membrane; and
* Presence of acute symptoms, such as fever, ear pain, or respiratory symptoms.

The study was a randomized, double-blind, placebo-controlled trial not sponsored by a pharmaceutical group.
The study drug was amoxicillin-clavulanate, dosed at 40 mg/kg/day (amoxicillin component) and given over 7 days.
The placebo preparation had similar taste and color.
Parents recorded daily symptoms, drug administration, missed school or daycare, missed parental work, and adverse events associated with taking the medication.

Parents were allowed to administer oral analgesics and antipyretics along with analgesic ear drops and decongestant nose drops or sprays.
Enrollment day was day 1, and follow-up visits took place on day 3 and day 8, the end of treatment.
Parents were to contact the investigators at any time if their child's condition worsened.
Study physicians were allowed to switch children to a rescue preparation if deemed necessary during a follow-up visit.
The primary outcome was time to treatment failure.
Treatment failure could be evidenced by one of the following criteria:

* Failure to improve by day 3;
* Worsening overall condition at any point;
* Worsening otoscopic findings;
* Perforation of the tympanic membrane;
* Development of a complication of AOM, such as mastoiditis; and
* Parental discontinuation of the study drug for any reason.

A total of 319 children were enrolled in the study, 161 of whom received the active compound and 158 of whom received placebo.
The mean age of the children was 3 years, and the groups did not differ in frequency of previous AOM, receipt of vaccines, or current symptoms.
Children who received placebo were more likely to be afebrile (70.9% vs 60.2%) compared with children who assigned to the intervention arm.
Study children had 94% adherence to study medication administration.

Overall, treatment failure was much higher in the placebo group (44.9%) than in the intervention group (18.6%, P < .001).
This difference between groups was already apparent at the day 3 visit.
Treatment with study compound resulted in a 62% reduction in the risk for treatment failure (95% confidence interval, 0.25-0.59).
The number needed to treat to avoid 1 treatment failure was 3.8 children.
Each of the independent contributors to "treatment failure" occurred less frequently in the treatment group than in the placebo group.
Rescue treatment was administered to 6.8% of intervention-arm children and 33.5% of placebo-arm children.
No differences in use of analgesics or antipyretics were found between the groups.
Treatment-arm children missed fewer daycare and the parents of these children missed fewer work days; both differences were significant.
Diarrhea, the most common adverse event, was almost twice as common in the treatment group (47.8% vs 26.6%), but none of the treatment-group children stopped antibiotics because of diarrhea.
The investigators concluded that amoxicillin-clavulanate was superior to placebo for the treatment of AOM.

Abstract