In children with certain otitis media, antibiotics resolve symptoms more quickly than watchful waiting

Two new studies provide solid evidence that antibiotic treatment produces faster resolution of otitis media (OM) symptoms than watchful waiting in children up to 35 months old.

A strategy of “watchful waiting” had been endorsed in 2004 by the American Academy of Pediatrics and the American Academy of Family Physicians for children in this age group with “nonsevere” acute OM after reports of spontaneous improvement of symptoms in clinical trials.

Investigators from Pittsburgh, Pennsylvania, and Turku, Finland, put this clinical question to the test in separate studies.

University of Pittsburgh researchers enrolled 291 children aged 6 to 23 months who had acute (onset within 48 hours) OM diagnosed on the basis of 3 criteria: 1) a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale-a 0 to 14 scale, with higher scores indicating more severe symptoms; 2) middle-ear effusion; and 3) bulging of the tympanic membrane.

The children were randomized to placebo or amoxicillin-clavulanate (total dose, 90 mg/kg of amoxicillin; 6.4 mg/kg of clavulanate) for 10 days.

The percentage of children with sustained resolution of symptoms (a score of 0 or 1 on the AOM-SOS) was superior in the treatment group versus the placebo group (P=.04 for overall comparison).

At day 2, 20% in the treatment group had sustained resolution of symptoms versus 14% in the placebo group. This difference between groups remained until the day-7 visit, when 67% versus 53% had sustained resolution of symptoms in the treatment and placebo groups, respectively.

Middle-ear effusion was significantly less likely at days 21 to 25 among children receiving amoxicillin-clavulanate (P=.05).

The Finnish group enrolled 319 children 6 to 35 months old with acute symptoms of OM and tympanic membrane findings that included acute inflammatory signs. Participants were randomized to amoxicillin-clavulanate (dose, 40 mg/kg/day of amoxicillin; 5.7 mg/kg/day of clavulanate) or placebo for 7 days. Treatment failure, the primary outcome, occurred in 18.6% of the treatment group and 44.9% of the placebo group (P<.001).

Treatment failure already was less frequent in the amoxicillin-clavulanate group by the first visit (at day 3), and the difference in treatment failure between the 2 groups increased until the last visit at day 8.

Diarrhea affected 47.8% of the amoxicillin-clavulanate group and 26.6% of the placebo.

To reduce the risk of the emergence of antibiotic resistance, the Pittsburgh researchers suggest restricting antibiotic treatment to children whose illness is diagnosed using stringent criteria such as the ones used to enroll patients in this study.

The Finnish investigators suggest looking for clinical characteristics to identify those children who may benefit most from antimicrobial treatment for acute OM.

Hoberman A, Paradise JL, Rockette HE, et al. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011;364(2):105-115.

Tahtinen PA, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohola A. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med. 2011;364(2):116-126.