Despite limited evidence for clinical efficacy, antibiotics are commonly prescribed for young children who have acute otitis media. Several European researchers now advocate that antibiotic therapy be limited to children who are at special risk for complications or prolonged symptoms. Most studies on which these recommendations are based concern children older than two years. Damoiseaux and colleagues compared the efficacy of amoxicillin with that of placebo in the treatment of acute otitis media in children younger than two years.

Fifty-three general practices in the Netherlands participated in the study. Children six months to two years of age with signs and symptoms characteristic of acute otitis media as defined by Dutch guidelines, including pain and systemic upset as well as documented changes in the appearance of the tympanic membrane, were eligible for the study. Children with a history of recent use of antibiotics, allergy to amoxicillin, compromised immunity or craniofacial deformities were excluded from the study. All participating physicians were trained to classify acute otitis media according to a standard reference slide set. Children who met the inclusion criteria were randomized to receive amoxicillin suspension (40 mg per kg per day) in three divided doses or an identical placebo for 10 days. In accordance with common practice in the Netherlands, the children also received decongestant nasal drops and could be given acetaminophen to relieve pain and fever. Physicians gathered data at the initial visit and on days 4 and 11. Parents kept a symptom diary for 10 days to record medication use, symptoms and any suspected adverse effects of treatment. A researcher visited all patients at home six weeks after treatment to collect information and perform otoscopy and tympanometry. The primary outcome was persistent symptoms after four days. Secondary outcomes included persistent fever, earache, crying, irritability and no improvement in the appearance of the tympanic membrane after 11 days.

A total of 240 children were randomized to one of the study groups. Those in the treatment group were more likely to have recurrent otitis media, to attend day care and to be exposed to parental smoking than children receiving the placebo, but in other respects, the two groups were comparable. Diaries and medication review indicated that compliance with therapy was greater than 80 percent. Symptoms persisted until at least day 4 in 59 percent of the treatment group compared with 72 percent of those receiving the placebo. This difference remained significant even after adjustment for significant variables such as recurrence, day care attendance and parental smoking. The median duration of fever was two days in the treatment group and three days in the control group. Similarly, the median time to cessation of pain or crying was eight days in the treatment group and nine days in the control group. Children in the treatment group took an average of 1.7 doses of analgesic in the first three days and 2.3 doses during the 10 days of therapy. Children in the control group took 2.5 doses of analgesic in the first three days and 4.1 doses during the 10-day treatment period. The incidence of recurrent otitis media or effusion, use of antibiotics and need for specialty referral did not differ between groups during the six-week follow-up period. Adverse effects were not common, but diarrhea attributed to treatment was reported on day 4 in 17 percent of the treatment group and in 10 percent of the control group.

The authors conclude that early symptom resolution was more common with amoxicillin therapy but that the benefit was not sufficient to recommend its routine use in every child with acute otitis media. They calculate that seven to eight children require treatment for one to have improved symptoms at day 4. Therefore, they suggest an initial approach of therapy with analgesics and watchful waiting, reserving antibiotic use for children at risk of prolonged or serious consequences from otitis media. The authors admit that this approach is controversial and that more research is needed to identify optimal treatment of this common condition.