Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial.

A total of 536 infants and children with acute otitis media were randomly assigned to one of six consistent year-long regimens involving the treatment of nonsevere episodes with either amoxicillin or placebo, and severe episodes with either amoxicillin, amoxicillin and myringotomy, or, in children aged 2 years or older, placebo and myringotomy. Nonsevere episodes had more favorable outcomes in subjects assigned to treatment with amoxicillin than with placebo, as measured by the proportions that resulted in initial treatment failure (3.9% vs 7.7%, P = .009) and the proportions in which middle-ear effusion was present at 2 and 6 weeks after onset (46.9% vs 62.5%, P less than .001; and 45.9% vs 51.5%, P = .09, respectively). In subjects whose entry episode was non-severe, those assigned to amoxicillin treatment had less average time with effusion during the succeeding year than those assigned to placebo treatment (36.0% vs 44.4%, P = .004), but recurrence rates of acute otitis media in the two groups were similar. In the 2-year-and-older age group, severe episodes resulted in more initial treatment failures in subjects assigned to receive myringotomy alone than in subjects assigned to receive amoxicillin with, or without, myringotomy (23.5% vs 3.1% vs 4.1%, P = .006). In the study population as a whole, severe episodes in subjects assigned to receive amoxicillin alone, and amoxicillin with myringotomy, had comparable outcomes. It is concluded that children with acute otitis media should routinely be treated with amoxicillin (or an equivalent antimicrobial drug). The data provide no support for the routine use of myringotomy either alone or adjunctively.

Amoxicillin-clavulanate potassium compared with cefaclor for acute otitis media in infants and children.

One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial.

To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.08 in the placebo group and 1.02 in the tympanostomy tube group (amoxicillin vs. placebo, P less than 0.001; tubes vs. placebo, P = 0.25). The average proportion of time with otitis media of any type was 10.0% in the amoxicillin group, 15.0% in the placebo group and 6.6% in the tympanostomy tube group (amoxicillin vs. placebo, P = 0.03; tubes vs. placebo, P less than 0.001). At the 2-year end point, the rate of attrition was 42.2% in the amoxicillin group, 45.5% in the placebo group and 26.7% in the tympanostomy tube group. Adverse drug reactions occurred in 7.0% of the amoxicillin group and persistent tympanic membrane perforations developed in 3.9% of the tympanostomy tube group. The observed degree of efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion must be viewed in light of the fact that study subjects proved not to have been at as high risk for acute otitis media as had been anticipated and in view of the differential attrition rates.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessment of otoscopists' accuracy regarding middle-ear effusion. Otoscopic validation.

Validation of otoscopic diagnostic accuracy is an important aspect of medical education and is necessary to substantiate clinical research observations. In addition, otoscopic accuracy is a prerequisite to optimal patient care. We describe an otoscopic validation program at the Children's Hospital of Pittsburgh (Pa) in which 27 physicians and three nurse practitioners participated from December 1980 to March 1990. The lowest acceptable limits for sensitivity and specificity regarding the diagnosis of middle-ear effusion were arbitrarily set at 80% and 70%, respectively. The 30 participating clinicians examined a total of 4147 ears. Mean sensitivity and mean specificity for the group as a whole were 87% and 74%, respectively. The chief benefit of the program was an improvement in diagnostic skills for some individuals. The chief limitation was the large amount of time required. We conclude that a formal validation program can document achievement of a reasonable standard of otoscopic diagnostic accuracy.

Diagnostic assessment of otitis media.

Accurate diagnosis of OM is important but often difficult. To enhance the likelihood of accurate diagnosis, pneumatic otoscopy is the preferred method of examination generally available to clinicians. Findings by pneumatic otoscopy should be coupled with the presence or absence of symptoms and signs to delineate a diagnosis of AOM or OME. Tympanometry can be a useful adjunct in the clinical assessment of middle ear effusion. Audiometry is particularly important for patients with recurrent or chronic middle ear disease.

Prevalence of bacterial respiratory pathogens in the nasopharynx in breast-fed versus formula-fed infants.

In several studies, breast-feeding has been associated with decreased frequency or duration of otitis media episodes. If a causal relationship exists, the mechanism of protection of breast-feeding has not been established. We hypothesized that infants who are breast-fed, compared with infants who are formula-fed, have a lower prevalence of nasopharyngeal colonization with the bacterial respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes) commonly isolated from the middle ear effusions of children with acute otitis media. In two private pediatric practices, we obtained specimens from the nasopharynx for culture from 211 infants at 1 month of age and from 173 of these infants at 2 months of age. A swab was left in place in the nasopharynx for 45 s and was then immediately transferred onto appropriate culture media. Exclusively breast-fed (n = 84) and exclusively formula-fed (n = 76) infants were similar regarding the number of persons in the household, the number of children in the household, the number of siblings in day care, and the proportion with a recent upper respiratory tract infection. The two groups did not differ significantly in the proportions found to have one or more respiratory pathogens at 1 month of age (10.7 versus 18.4%; P = 0.12) or 2 months of age (34.8 versus 35.1%; P = 0.57). We conclude that during the first 2 months after birth, the exclusive receipt of breast milk appears not to substantially influence the prevalence of nasopharyngeal colonization with common bacterial respiratory pathogens.

Sultamicillin (ampicillin-sulbactam) in the treatment of acute otitis media in children.

Sultamicillin, a dimer of ampicillin and a beta-lactamase-inhibiting agent, sulbactam, was given in oral form to 50 infants and children with acute otitis media. Tympanocentesis was performed on entry into the trial. Beta-lactamase-positive Haemophilus influenzae or Branhamella catarrhalis was isolated from 14 of 73 (19.2%) middle ear effusions in 9 children. Relief of symptoms (fever/otalgia) occurred in all children who completed therapy. However, in 8 children (16%), the antimicrobial agent was discontinued due to presumed adverse side effects (primarily gastrointestinal); vomiting which began prior to entry was noted in another subject who was withdrawn. An additional 14 children completed the course of treatment despite having diarrhea. Of the 41 children who completed drug therapy, 11 (26.8%) were effusion-free after 10 days, and 22 of 33 (66.7%) evaluable children were effusion-free after 6 weeks. Sultamicillin is a novel therapeutic approach to beta-lactamase-producing bacteria. In its oral form, however, diarrhea is a troublesome side effect.