Efficacy of Amoxicillin with and without Decongestant-Antihistamine for Otitis Media with Effusion in Children

Abstract

In a randomized, double-blind, placebo-controlled trial involving 518 infants and children who had otitis media with effusion ("secretory" otitis media), we evaluated the efficacy of a two-week course of amoxicillin (40 mg per kilogram of body weight per day) with and without a four-week course of an oral decongestant-antihistamine combination. Among the 474 subjects who were evaluated at the four-week end point, the rate of resolution of middle-ear effusion was twice as high in those treated with amoxicillin, either with or without the decongestant-antihistamine, as in those who received placebo (P less than 0.001), but 69.8 percent of the amoxicillin-treated subjects still had effusion. Among both the amoxicillin-treated subjects and the placebo-treated subjects, resolution was more likely in those with initially unilateral effusion, in those who had had effusion for eight weeks or less, and in those without an upper respiratory tract infection at the four-week end point. Side effects were reported more often in subjects who received decongestant-antihistamine than in those who did not. Among the subjects without effusion at the four-week end point, recurrent effusion developed in approximately half those in both the amoxicillin and placebo groups during the subsequent three months. We conclude that in infants and children with otitis media with effusion, amoxicillin treatment increases to some extent the likelihood of resolution.

Antibiotics Are Not Effective for Otitis media with Effusion: Reanalysis of Meta-Analyses

“…We excluded Mandel et al [29] because it had several scientific lapses, including unexplained and undisclosed departures from the study protocol which inflated the antibiotic efficacy by some 53%. They did not use objective endpoint measures and did not correct for the unexplained distribution of poor prognostic factors unfavorable to the placebo control group.…”

“…They did not use objective endpoint measures and did not correct for the unexplained distribution of poor prognostic factors unfavorable to the placebo control group. Mandel et al [29] and the analysis of three other NIH-funded clinical trials of antibiotic efficacy in the treatment of otitis media were found to be 'less than objective' and biased in favor of antibiotic efficacy, as stated in a report (December 1990) of the Office of Scientific Integrity of the NIH [30]. We have earlier published [6] in JAMA a reanalysis of Mandel et al [29].…”

“…Mandel et al [29] and the analysis of three other NIH-funded clinical trials of antibiotic efficacy in the treatment of otitis media were found to be 'less than objective' and biased in favor of antibiotic efficacy, as stated in a report (December 1990) of the Office of Scientific Integrity of the NIH [30]. We have earlier published [6] in JAMA a reanalysis of Mandel et al [29]. Subsequently, an ad hoc committee of the AHCPR Clinical Guideline Panel performed a side-by-side comparison of Mandel et al [29] and Cantekin et al [6] and determined that the latter represented the unbiased interpretation.…”

“…2 Number of cured patients divided by total number of patients for the primary endpoint. 3 Reanalysis of Mandel et al [29], after correction for prognostic factors (uncorrected RD = 0.07; correction could be made for n = 416). 4 Problems in randomization and in analysis of data (see Cantekin [26] for critique).…”

Prevention of Severe and Recurrent Otitis media

“…Nasal and oral decongestants, administered either alone or in combination with an antihistamine, are currently among the most popular medications for treatment of AOM and OME. Unfortunately, decongestants and antihistamines were shown to be ineffective in two large-scaled clinical trials in infants and children with OME [18,19]. Antihistamines may be effective for those patients who have allergic rhinitis causing eustachian tube dysfunction.…”