ASPEN, COLO. — A Dutch meta-analysis addressing the long-controversial issue of antibiotics for acute otitis media tops one expert's list of the most important studies in the field of pediatric infectious diseases during the past year.
The Dutch study earned No. 1 status because it was rigorously well conducted and provided the last key piece of missing information needed to make a fully informed decision about whether to prescribe antibiotics for this common condition, Dr. Michael Radetsky explained at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.
“This is it. No further information will ever come out in the future that will help you in your decision making,” said Dr. Radetsky, a pediatric infectious diseases consultant at the University of New Mexico, Albuquerque.
Maroeska Rovers, Ph.D., and colleagues at Wilhelmina Children's Hospital, Utrecht, the Netherlands, scoured the world literature and found 10 randomized, placebo-controlled clinical trials that met their quality standards and addressed the issue of antibiotics for acute otitis media in children up to age 12 years. They contacted the principal investigators, got their raw data, and recalculated the results using advanced statistical methods.
Their conclusion? Antibiotics are in fact useful—but only in two specific settings: in children with acute otitis media and otorrhea, and in children less than age 2 years with bilateral disease (Lancet 2006;368:1429-35).
The number of children fitting either such description who would need to be treated with antibiotics in order for one additional child to obtain benefit was three to four, which Dr. Radetsky deemed “very reasonable.” However, the degree of clinical benefit in terms of reduction of pain and/or fever at 3–7 days was modest, he added at the conference, also sponsored by the University of Colorado.
Coupling the Dutch findings with those from earlier studies in the United Kingdom and United States that demonstrated the efficacy and practicality of deferred antibiotics, Dr. Radetsky said that the paradigm for office-based treatment should be to defer antibiotics, with a prescription handed to the parent to be filled only if the child doesn't improve in the next day or 2.
And while deferred antibiotics should be the default position, there is a role for immediate antibiotic therapy in the two specific settings identified by the Dutch pediatricians. In addition, Dr. Radetsky said, there is solid evidence from earlier studies that standard-dose amoxicillin is the drug of choice (Pediatrics 2006;117:1087-94) and that 5 days of treatment are as good as 10 (JAMA 1998;279:1736-42).
Sharing the podium with the Dutch acute otitis media study were the following runners-up:
▸ Once- vs. twice-daily amoxicillin for streptococcal pharyngitis. Dr. Herbert W. Clegg of Estover Pediatrics, Charlotte, N.C., and his coinvestigators there and at University of Minnesota, Minneapolis, randomized 652 children aged 3–18 years to 10 days of once- or twice-daily amoxicillin. The dosing was weight adjusted. Patients who weighed less than 40 kg got either 375 mg twice daily or 750 mg once daily. Those weighing more than 40 kg received 500 mg twice daily or 1 g once daily.
Microbiologic failure was defined as culture-proven infection with or without symptoms, and by the same M-type microorganism as at baseline. Rates were similar in the two study arms at 15%–20%. Likewise, clinical recurrence rates weren't significantly different at 8% and 10% in the two groups (Pediatr. Infect. Dis. J. 2006;25:761-7).
▸ Antibiotics for acute purulent rhinitis. Investigators at the University of Auckland (New Zealand) conducted a meta-analysis of seven high-quality randomized, placebo-controlled, blinded clinical trials and concluded antibiotic therapy conferred a statistically significant—albeit modest—18% increased relative likelihood of symptomatic benefit in terms of the amount of purulent discharge present at days 5–8. But the number needed to treat in order to benefit 1 patient, which was estimated at 7–15, overlapped the number needed to harm, which was 12–78 (BMJ 2006;333:279-81).
It's never a good situation when those two numbers overlap, Dr. Radetsky said. Moreover, there's no way to predict which patients might benefit from antibiotics.
“So don't do it,” he urged. “But if you must do it, if you're going to cave in to pressure—if the mother is weeping, the father is hitting his head against the wall, the child can't get back into day care—you know how it is—then please only do it for 3–5 days.”
▸ Use of C-reactive protein and WBC to distinguish bacterial from viral infections. Investigators at Turku (Finland) University Hospital reviewed their long-term experience and concluded that a single result using either test is of only limited clinical value in making a distinction between bacterial and viral infections.