Article

Resolving design problems in equivalency trials

Center for International Health and Development, Boston University School of Public Health, Boston, Massachusetts, USA.
Journal of Pediatrics (Impact Factor: 3.74). 08/2006; 149(1):12-6. DOI: 10.1016/j.jpeds.2006.02.036
Source: PubMed
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    ABSTRACT: ObjectiveTo determine the efficacy of a short course of antibiotics (<4 days) in comparison to a longer course (≥4 days) for the treatment of acute otitis media in children. Data sourcesElectronic databases, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences. Review MethodsRandomized controlled trials of the empiric treatment of acute otitis media comparing antibiotic regimens of <4 days versus ≥4 days in children between four weeks to eighteen years of age were included. The trials were grouped by pharmacokinetic behavior of short-course antibiotics into short-acting antibiotics, parenteral ceftriaxone, and long-acting azithromycin. ResultsWe reviewed 35 trials, which provided 38 analytic components. Overall, there was no evidence of an increased risk of treatment failure until one month with a short-course of antibiotics (RR=1.06, 95% CI 0.95 to 1.17, P=0.298). Use of short-acting oral antibiotic in short-course was associated with a significantly increased risk of treatment failure (RR=2.27, 95% CI: 1.04 to 4.99). There was a slightly increased risk of treatment failure with parenteral ceftriaxone (RR=1.13, 95% CI 0.99 to 1.30). The risk of adverse effects was significantly lower with short-course regimens (RR=0.58, 95% CI: 0.48 to 0.70). ConclusionThere is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media. Among the short-course regimens, azithromycin use was associated with a lower risk of treatment failure while short-acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure. Key WordsAcute otitis media-Antibiotics-Children-Management-Short-course therapy-Systematic review
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    ABSTRACT: To determine the efficacy of a short course of antibiotics (<4 days) in comparison to a longer course (>4 days) for the treatment of acute otitis media in children. Electronic databases, hand search of reviews, bibliographies of books, abstracts and proceedings of international conferences. Randomized controlled trials of the empiric treatment of acute otitis media comparing antibiotic regimens of <4 days versus > 4 days in children between four weeks to eighteen years of age were included. The trials were grouped by pharmacokinetic behavior of short-course antibiotics into short-acting antibiotics, parenteral ceftriaxone, and long-acting azithromycin. We reviewed 35 trials, which provided 38 analytic components. Overall, there was no evidence of an increased risk of treatment failure until one month with a short-course of antibiotics (RR=1.06, 95% CI 0.95 to 1.17, P=0.298). Use of short-acting oral antibiotic in short-course was associated with a significantly increased risk of treatment failure (RR=2.27, 95% CI: 1.04 to 4.99). There was a slightly increased risk of treatment failure with parenteral ceftriaxone (RR=1.13, 95% CI 0.99 to 1.30). The risk of adverse effects was significantly lower with short-course regimens (RR=0.58, 95% CI: 0.48 to 0.70). There is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media. Among the short course regimens, azithromycin use was associated with a lower risk of treatment failure while short acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure.
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