Antibiotics for otitis media with effusion.

Otitis media with effusion (OME) is defined as asymptomatic middle-ear effusion, that is, without the signs and symptoms of acute otitis media (AOM), such as fever, otalgia, or otorrhea. OME can occur after an episode of AOM or may occur without any prior or concurrent symptoms and is often noted on a routine physical examination or screening. Because children with OME are usually not ill, there is a question of whether treatment is warranted for this condition. Also adding to the complexity of this problem is the high spontaneous cure rate of OME. This paper will review the many clinical trials of the efficacy of antimicrobial therapy for OME. We have grouped the studies into 4 major categories: antibiotic vs no treatment, antibiotic vs placebo, antibiotic vs antibiotic, and antibiotic prophylaxis. While study designs, definitions, and quality vary widely, these studies show a trend toward short-term efficacy of antimicrobial treatment, but long-term efficacy is doubtful. In this age of antimicrobial resistance, coupled with the high natural cure rate, routine antimicrobial treatment of OME is not warranted. It may be useful in selected patients, particularly those with chronic OME (3 months or longer of bilateral effusion or 6 months or longer of unilateral effusion) for whom surgery is being considered: a 1-time short course of antibiotic may allow cancellation or at least postponement of a surgical procedure, particularly in spring/summer when one would like to avoid placing tubes in the ears and placing the child at risk for otorrhea due to water exposure. Also, antimicrobial therapy may provide at least short-term relief for symptomatic children (hearing loss, developmental delay, etc.) for whom surgery must be postponed or is contraindicated.

Implications of the AHRQ evidence report on acute otitis media.

OBJECTIVE: To familiarize otolaryngologists with the Agency for Healthcare Research and Quality (AHRQ) Evidence Report on Acute Otitis Media (AOM) that reviews the natural history and role of antibiotics in management. The report, by the Southern California Evidence-Based Practice Center (SC-EPC), is the most recent of 15 literature syntheses published by the AHRQ. DATA SOURCES: MEDLINE (1966 to present), Cochrane Library, EMBASE, BIOSIS, HealthSTAR, and other computerized databases; manual reference search of proceedings, articles, reports, and guidelines. STUDY SELECTION: Randomized trials and cohort studies relevant to the natural history of AOM and the efficacy of antimicrobial therapy. AOM was defined by the 11-member technical expert panel (including 2 authors, RMR and MLC) as middle-ear effusion with the rapid onset of signs or symptoms of middle ear inflammation. DATA EXTRACTION: Two physician reviewers at the Southern California Evidence-Based Practice Center independently rated the articles and extracted data. DATA SYNTHESIS: Children receiving placebo or no antimicrobial had a pooled clinical success rate of 81% at 1 to 7 days (95% CI, 72% to 90%), with no increase in suppurative complications when followed closely. Amoxicillin or ampicillin increased the absolute success rate by 12.3% (95% CI, 2.8% to 21.8%) in 5 studies pooled using random effects meta-analysis. The antimicrobial benefit was robust to sensitivity analysis. In contrast, success rates were not influenced by the choice or duration of therapy. CONCLUSIONS: The AHRQ report emphasizes middle-ear effusion as a preeminent criteria for AOM diagnosis and provides extensive evidence tables on natural history and antimicrobial impact. About 8 children must receive antibiotics to avoid 1 clinical failure, but children younger than age 2 years or with severe symptoms may benefit more. The report is a starting point for organizations seeking to develop AOM guidelines, performance measures, and other quality improvement tools.

Efficacy of a stepwise protocol that includes intravenous antibiotic therapy for the management of chronic sinusitis in children and adolescents.

BACKGROUND: Recent concern regarding interference with facial skeletal growth and the risk of complications after endoscopic sinus surgery (ESS) has led to interest in exploring other treatment options for the management of chronic sinusitis in children. OBJECTIVE: To present the use of a stepwise protocol that includes intravenous (IV) antibiotic therapy as a therapeutic alternative to pediatric ESS. DESIGN: Retrospective analysis of pediatric patients with chronic sinusitis treated from January 1, 1993, to July 1, 1998, with a stepwise protocol that includes the use of IV antibiotics. SETTING: Academic tertiary care children's hospital. PATIENTS: Seventy patients, aged 10 months to 15 years, with the diagnosis of chronic sinusitis as defined by symptomatic disease for at least 12 weeks. All patients had persistent symptoms and radiographic evidence of sinus disease by computed tomographic scan after a minimum 3- to 4-week course of oral antibiotics. INTERVENTIONS: Patients were treated with maxillary sinus aspiration and irrigation with selective adenoidectomy, followed by a 1- to 4-week course of a culture-directed IV antibiotic. Most patients also underwent placement of a long-arm IV catheter. OUTCOME MEASURES: Medical charts were reviewed for clinical response to IV antibiotics, complications from IV antibiotic therapy, need for ESS, and recurrent episodes of sinusitis. RESULTS: Of the 70 patients studied, 62 (89%) had complete resolution of symptoms following IV therapy with selective adenoidectomy. Eight patients (11%) failed IV therapy and required ESS. Thirty-seven patients (53%) underwent concurrent adenoidectomy. Patients treated with concurrent adenoidectomy had equivocal response rates compared with patients treated with IV antibiotic therapy alone. Follow-up data were available for 52 patients (range, 6-62 months; mean, 25 months). All recurrent episodes resolved with oral antibiotic therapy. Complications from IV therapy included superficial thrombophlebitis in 6 patients (9%) and dislodgement of a catheter guidewire during placement in 1 patient (1%), requiring venotomy. Antibiotic-related complications also occurred in 3 patients (4%) and included serum sickness, pseudomembranous colitis, and drug fevers. CONCLUSION: A stepwise protocol that includes IV antibiotic therapy is a safe and efficacious mode of therapy for the management of chronic sinusitis in children and adolescents and may be a reasonable alternative to pediatric ESS.

The genetics of otitis media.

There is significant evidence from epidemiologic, anatomic, physiologic, and immunologic studies that susceptibility to recurrent episodes of acute otitis media (OM) and persistent OM with effusion is largely genetically determined. The genetics of OM are most likely complex, i.e., many genes are probably contributing to the overall phenotype. The knowledge of a hereditary component has important implications because closer surveillance of children at risk for OM could result in earlier detection and treatment. Further, once OM susceptibility genes have been identified it may be possible to develop molecular diagnostic assays that could enable the clinician to identify the child at high risk for OM and to develop more focused treatments in the future.

Impact of tympanostomy tubes on child quality of life.

BACKGROUND: The objective benefits of tympanostomy tubes for otitis media are well established, but the subjective impact of surgery on child quality of life (QOL) has not been systematically studied. OBJECTIVES: To determine the subjective impact of tympanostomy tubes on child QOL, and to compare the variability in QOL before surgery with that observed after surgery. DESIGN: Prospective, observational, before-and-after trial. SETTING: Fourteen referral-based pediatric otolaryngology practices in the United States. PATIENTS: Consecutive (64%) and convenience (36%) sample of 248 children (median age, 1.4 years) with otitis media scheduled for bilateral tympanostomy tube placement as an isolated surgical procedure. INTERVENTION: Tympanostomy tubes were inserted as part of routine clinical care. Validated measures of QOL (OM-6 survey), satisfaction with health care decision (Satisfaction With Decision Scale), and satisfaction with office visit; surveys were completed at baseline (visit 1), at surgery (visit 2), and after surgery (visit 3). MAIN OUTCOME MEASURES: Short-term changes in QOL before surgery (visit 1 to visit 2) and after surgery (visit 2 to visit 3). RESULTS: Changes in QOL before surgery were mostly trivial, and were smaller than changes observed after surgery (P<.001). Large, moderate, and small improvements in QOL occurred after surgery in 56%, 15%, and 8% of children, respectively. Physical symptoms, caregiver concerns, emotional distress, and hearing loss were most improved, but significant changes were also seen for activity limitations and speech impairment. Trivial changes occurred in 17% of children, and 4% had poorer QOL. Predictors of poorer QOL were otorrhea 3 or more days (10% of variance) and decreased satisfaction with surgical decision (3% of variance). Hearing status, child age, type of otitis media (recurrent vs chronic), and office visit satisfaction were unrelated to outcome. CONCLUSIONS: Tympanostomy tubes produce large short-term improvements in QOL for most children. The best outcomes occur when postoperative otorrhea is absent or minimal, and when parents are satisfied with their initial decision to have surgery. Further research is needed to document the long-term impact of tubes on child QOL.

Past history of otitis media and balance in four-year-old children.

OBJECTIVES/HYPOTHESIS: To obtain normative data for a population of children 4 years of age with respect to standard vestibular and balance test protocols and to determine, in the absence of concurrent middle ear effusion (MEE), the possible changes caused by a history of recurrent or persistent MEE. STUDY DESIGN: Comparative studies of the results of vestibular and balance tests in a cohort of young children with and without a history of MEE. METHODS: Seventy-one children, 4 years of age, with a well-documented history since early infancy regarding the presence or absence of MEE were evaluated using pneumatic otoscopy, tympanometry, audiometry, and vestibular and balance (rotational and moving platform posturography) tests. For the results of the vestibular and balance tests, comparisons were made between the group of 31 children (43.7%) without and the group of 40 children (56.3%) with a history of recurrent or persistent MEE, when a positive disease history was defined as at least a 10% cumulative percentage of time with MEE between early infancy and time of testing. RESULTS: When compared with children with a negative history of significant MEE, children with a positive history had a lower average gain to a rotational stimulus of 0.1 Hz, 150 degrees/s (0.57 vs. 0.44; P = .007). There were no significant differences between groups with respect to other measures. CONCLUSIONS: These results suggest that a history of recurrent or persistent MEE affects the vestibular and/or balance function of 4-year-old children when tested in the absence of a concurrent episode of MEE. The possible sequelae of the disease should be weighed in future considerations of early intervention for MEE.

Factors associated with tympanostomy tube insertion among preschool-aged children in the United States.

OBJECTIVES: Recurrent and persistent otitis media is often treated by tympanostomy tube insertion to ventilate the middle ear and restore hearing. This study examined the factors that predict which children are most likely to receive tympanostomy tubes through 3 years of age. METHODS: Multiple logistic regression was conducted on data from a nationally representative sample of children (N = 8285). RESULTS: By 3 years of age, 6.8% of US children had tubes inserted. Logistic regression indicated that after control for number of ear infections, children without any gaps in health insurance, who attended a day-care center, who were White, whose birth-weight was less than 1500 g, and who lived in the Midwest or South were significantly more likely to have tympanostomy tubes. CONCLUSIONS: These data suggest that differences exist as to who receives tubes. Of particular concern are differences by race/ethnicity and continuity of health insurance coverage. With expansions in health care coverage to larger proportions of uninsured children, it will be important to monitor these programs to ensure that all children who may need tympanostomy tubes have access to them.

Histopathological study on temporal bone and eustachian tube in trisomy 22.

Two temporal bone-eustachian tube (ET) specimens, one from a 34-gestational week-old male newborn and the other from a 3-month-old female infant, both with trisomy 22, were studied histopathologically. Both cases demonstrated severe inner-ear anomalies including hypoplastic cochlea, atrophy of the saccular macula, and dislocated endolymphatic sac and vestibular aqueduct. In addition, they had several anomalies in the ET including widely developed medial lamina of the ET cartilage, undeveloped lateral lamina of the ET cartilage, and absence of attachment of the tensor veli palatini muscle to the ET cartilage. We discuss the implications of the observed anomalies with regard to developmental and clinical issues.

The heritability of otitis media: a twin and triplet study.

CONTEXT: Anatomical, physiological, and epidemiological data indicate that there may be a significant genetic component to prolonged time with and recurrent episodes of otitis media in children. OBJECTIVE: To determine the genetic component of time with and episodes of middle ear effusion and acute otitis media (AOM) during the first 2 years of life. DESIGN: Prospective twin and triplet cohort study with enrollment from 1982 through 1995. SETTING: Otitis Media Research Center in the ear, nose, and throat clinic of Children's Hospital of Pittsburgh, Pittsburgh, Pa. PATIENTS: A total of 168 healthy same-sex twin and 7 triplet sets were recruited within the first 2 months of life; zygosity results were available for 140 sets; 138 (99%) of these were followed up for 1 year and 126 (90%) for 2 years. MAIN OUTCOME MEASURES: Proportion of time with middle ear effusion, episodes of middle ear effusion, and episodes of AOM by zygosity status. RESULTS: At the 2-year end point, the estimate of heritability of time with middle ear effusion was 0.73 (P<.001). The estimates of discordance for 3 or more episodes of middle ear effusion were 0.04 for monozygotic twins and 0.37 for dizygotic twins (P = .01). The estimate of discordance of an episode of AOM in monozygotic twins was 0.04 compared with 0.49 in dizygotic twins (P = .005). CONCLUSIONS: Our study suggests there is a strong genetic component to the amount of time with middle ear effusion and episodes of middle ear effusion and AOM in children.

What is wrong in chronic adenoiditis/tonsillitis anatomical considerations.

Waldeyer's ring is most prominent during childhood, when the size of the oro-nasopharyngeal space is not yet fully developed, but decreases spontaneously with age. In the child, enlarged tonsils and/or adenoids may cause Eustachian tube dysfunction/otitis media, rhinosinusitis, obstructive sleep apnea, voice changes, change in facial growth, swallowing problems and can affect overall quality of life. Consequently, tonsillectomy and/or adenoidectomy are among the most common surgical procedures in children. The size of the oro- and nasopharynx has been investigated in normal children with and without tonsil/adenoid hyperplasia, to assess whether or not it is the adenoid and tonsillar tissue that are enlarged and not the dimensions of the anatomic space that are reduced. Studies have supported that the nasopharyngeal space is not smaller in children with hyperplastic adenoids when compared to normal children. However, children with large obstructing tonsils have a smaller oropharyngeal diameter compared to children with small tonsils. Tonsil/adenoid hyperplasia appears to be due to an increase in the lymphoid elements. The size of the tonsil has been shown to be directly proportional to aerobic bacterial load and absolute number of B and T cells. Bacteria have been suggested in the etiology of the development of hyperplasia. Of interest is that of the different pathogens, Haemophilus influenzae in particular, has been associated with tonsil/adenoid hyperplasia. The distribution of dendritic cells, antigen presenting cells, is altered during disease, with fewer dendritic cells in the surface epithelium and more in the crypts and extrafollicular areas.

Oropharyngeal manifestations of lepidopterism.

OBJECTIVE: To describe previously unreported oropharyngeal manifestations and management of caterpillar ingestion. DESIGN: Retrospective case series. SETTING: Tertiary children's hospital. PATIENTS: A total of 733 cases of exposure to caterpillars from January 1, 1994, to November 1, 1997, were reviewed. Twenty-six patients had oropharyngeal exposure with 8 patients ingesting the caterpillar. Ages ranged from 7 months to 7 years with 14 boys and 12 girls. INTERVENTIONS: All patients had a thorough examination of the oropharynx for caterpillar spines. For children who ingested a caterpillar, direct laryngoscopy, bronchoscopy, and esophagoscopy with removal of caterpillar spines were performed. RESULTS: At the point of caterpillar contact, buried caterpillar spines with focal erythema were observed. The lips, tongue, and buccal mucosa were the most frequently involved areas. The esophagus was involved in 8 of the patients. No postoperative complications were noted. CONCLUSION: With individualized care and prompt removal of venomous caterpillar spines, complications are not likely to result from caterpillar ingestion.

Intratemporal complications of acute otitis media in infants and children.

We reviewed our experience with 100 children admitted to Children's Hospital of Pittsburgh between 1980 and 1995 with an intratemporal complication of acute otitis media. Seventy-two patients were treated for acute mastoiditis. Of these 72 children, 54 (75.0%) were treated conservatively with broad-spectrum intravenous antibiotics and myringotomy. Eighteen (25.0%) required mastoidectomy for treatment of a subperiosteal or Bezold's abscess or cholesteatoma, or because of poor response to conservative therapy. Twenty-two children presented with facial paralysis, complete in 5 (22.7%) and incomplete in 17 (77.3%). Eighteen (81.8%) were treated conservatively, but four required mastoid surgery. Nineteen patients had adequate follow-up; of these, 15 recovered normal facial function but 4 were left with partial paralysis. Three patients presented with serous labyrinthitis and recovered completely with conservative therapy. Of the two patients who presented with suppurative labyrinthitis, one was treated conservatively, but the other required tympanomastoidectomy with cochleotomy; both patients had permanent, profound sensorineural hearing loss in the affected ear. Four patients presented with acute petrositis, and in all four it resolved with mastoidectomy. In the antibiotic era, intratemporal complications of acute otitis media still occur in otherwise healthy children, often after inadequate treatment of acute otitis media.

Treatment of chronic suppurative otitis media with topical ciprofloxacin.

To date, only ofloxacin has been approved by the US Food and Drug Administration for treatment of ears with a nonintact tympanic membrane. The purpose of this study was to determine the safety and efficacy of topical ciprofloxacin hydrochloride in the treatment of experimental chronic suppurative otitis media caused by Pseudomonas aeruginosa infection in cynomolgus monkeys. Forty adult cynomolgus monkeys were divided into 4 equal groups, and their ears were challenged with P aeruginosa, drained for 3 weeks, then treated twice daily for 4 weeks with 1 of 4 randomly assigned agents: 1) ciprofloxacin, 2) saline, 3) Cortisporin, or 4) vehicle. The animals were followed up with auditory brain stem response testing, culture, otoscopy, and histopathology. Both ciprofloxacin and Cortisporin treatment resulted in a significantly more rapid rate of clearance of P aeruginosa as compared to treatment with saline (100% versus 20%). Eradication was not associated with resolution of otorrhea after a 4-week period of treatment. There were no significant changes in auditory brain stem response wave latencies for any of the treatment groups. Histopathologic data revealed that there was no statistically significant difference in the amount of outer hair cell loss for the ciprofloxacin group as compared to the control ear and other treatment groups. We conclude, therefore, that topical ciprofloxacin is not ototoxic and is effective in sterilizing the otorrhea, but does not promote resolution of the drainage, in this animal model.

Visual-induced postural sway in children with and without otitis media.

Children with otitis media with effusion (OME) have been shown to have a significantly higher velocity of sway than normal children. To further evaluate the effect of OME on balance, we studied visual dependency for balance by investigating the influence of optic flow on postural sway. The results of this preliminary study suggest that children with OME may be more visually dependent for balance than healthy age-matched controls. This was particularly evident for higher-frequency stimulus conditions (0.25 Hz) as opposed to lower-frequency stimulus conditions (0.10 Hz). These findings indicate that OME may affect vestibular function in children, thereby causing excessive reliance on other, nonvestibular sensory cues to maintain balance. Further studies are needed to define the role of vestibular function in the management of children with OME.

Efficacy of antimicrobial prophylaxis for recurrent middle ear effusion.

OBJECTIVES: This trial compared the efficacy of amoxicillin prophylaxis with that of placebo for the management of recurrent middle ear effusion (MEE) in children. METHODS: Children between 7 months and 12 years of age who were effusion-free at entry but had histories of chronic or recurrent MEE were randomly assigned to receive either amoxicillin (20 mg/kg once daily) or placebo for 1 year. They were examined monthly and when there were symptoms of ear, nose or throat disease. Acute otitis media (AOM) and new episodes of otitis media with effusion (OME) were treated with amoxicillin-clavulanate; tympanocentesis was performed when possible for episodes of AOM. Throat cultures were obtained at entry; 4, 8 and 12 months after entry; and with new episodes of AOM and OME. Tympanometry was performed at each visit and audiometry was performed at entry and 4, 8 and 12 months after entry. RESULTS: One hundred eleven children were entered in this study. The rates per person year of new episodes of disease in the amoxicillin and placebo groups, respectively, were: MEE, 1.81 vs. 3.18 (P < 0.001); AOM, 0.28 vs. 1.04 (P < 0.001); and OME, 1.53 vs. 2.15 (P = 0.016). Subjects in the amoxicillin group had less time with MEE than the placebo group (19.7 and 33.2%, respectively; P = 0.002). Middle ear and throat cultures did not reveal any increase in beta-lactamase-producing organisms or in Streptococcus pneumoniae attributable to daily use of amoxicillin. CONCLUSIONS: Amoxicillin prophylaxis lowered the rates of occurrence of MEE, AOM and OME and decreased the percentage of time with MEE. However, because of present day concerns regarding antibiotic resistance, management should be individualized.

Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children.

OBJECTIVES: This trial compared the efficacy of ceftibuten with that of amoxicillin in resolving otitis media with effusion. METHODS: Two hundred ten children with otitis media with effusion were randomly assigned to receive either ceftibuten (9 mg/kg/day in one daily dose) or amoxicillin (40 mg/kg/day divided into 3 daily doses) for 14 days. Outcome was assessed at 2 and 4 weeks in all subjects; those without middle ear effusion at the 4-week visit were examined at 8, 12 and 16 weeks. Middle ear status was determined by pneumatic otoscopy and by an algorithm combining pneumatic otoscopy with tympanometry. RESULTS: The percentages of subjects who were effusion-free in the ceftibuten and amoxicillin groups at 2 weeks by otoscopy were 29.8 and 27.2%, respectively (P = 0.59), and by the algorithm, 23.4 and 20.4%, respectively (P = 0.47). In children who were effusion-free at 2 weeks, recurrence of effusion by 16 weeks was noted in approximately 60% of the ceftibuten group and 67% of the amoxicillin group. No medication side effects were reported by 88% of subjects in the ceftibuten group and by 93% of subjects in the amoxicillin group. We found no significant differences between the ceftibuten and amoxicillin groups with respect to resolution of middle ear effusion, rate of recurrence or side effects. CONCLUSIONS: Amoxicillin remains the drug of first choice for treatment of otitis media with effusion when treatment is deemed advisable, but ceftibuten may be an alternative drug in selected situations.

Epiglottitis and Haemophilus influenzae immunization: the Pittsburgh experience--a five-year review.

OBJECTIVE: Current trends in the clinical presentation and management of children with epiglottitis at Children's Hospital of Pittsburgh were reviewed for the years 1988 to 1993. METHODOLOGY: The medical records of all patients diagnosed as having epiglottitis between July 1988 and June 1993 at the Children's Hospital of Pittsburgh were reviewed. An additional telephone survey was conducted among the primary care physicians of those patients to collect information regarding administration of Haemophilus influenzae type b (HIB) vaccines. RESULTS: During the study period 28 children (age range, 11 months to 11 years, 10 months) were admitted with the diagnosis of epiglottitis. Cases declined remarkably in 1991. Fever, sore throat, and stridor were the usual symptoms. HIB was the most common cause of epiglottitis accounting for 21 cases. Candida albicans was recovered from the surface culture of the epiglottis in two patients. At least 11 children experienced vaccine failure: nine with polysaccharide vaccine and two with the conjugate vaccine for HIB. CONCLUSION: Cases of epiglottitis have declined dramatically since licensure of HIB conjugate vaccines for use in early infancy. At least 52% of the reported cases represent vaccine failures with the purified polysaccharide vaccine.

Otitis media in a population of black American and white American infants, 0-2 years of age.

To determine the incidence of otitis media (OM) and the bacteriology of acute otitis media (AOM) in a clinic population of young children in Pittsburgh, 138 black infants and 60 white infants were followed from birth to 2 years of age, examined at monthly intervals and whenever an upper respiratory tract infection (URI) or OM intervened. By 24 months of age the cumulative incidence of episodes of AOM was 43% and 42%, and of episodes of middle-ear effusion (MEE) was 86% and 85% in black and white infants, respectively. The average rate of episodes of AOM was 0.41 and 0.39 and of episodes of MEE was 1.68 and 1.70 in black and white infants, respectively. Tympanocentesis was performed for episodes of AOM and the following organisms were isolated from black and white infants, respectively: Streptococcus pneumoniae 43% and 43% of episodes; Moraxella catarrhalis 24% and 24%; non-typable Haemophilus influenzae 18% and 24%; and Haemophilus influenzae type b 5% and 0%. In both black and white infants first born children had less ear disease. We found no difference in the incidence of otitis media during the first 2 years of life between black and white infants.

Effect of otitis media on the vestibular system in children.

Forty-one children with otitis media (OM) were evaluated by moving platform posturography (Equitest, NeuroCom) before and after insertion of tympanostomy tubes, and were compared to children with no ear disease (N = 50). Velocity of sway increased with increasing difficulty of test conditions (I-VI) for both groups of children (p < .001), and children less than 7 years of age had a higher velocity than children 7 years old or older (p < .001). Children with OM had a higher velocity than normal children (p < .05). For children tested less than 30 days after insertion of tympanostomy tubes, the velocity for condition VI was significantly lower than before insertion (p < .05). Also, that the 6 children who had fallen on all trials on condition V or VI were able to stand on these trials after insertion of tympanostomy tubes indicates an improvement. These findings indicate that episodes of OM may affect balance, leaving children more clumsy and accident-prone, and possibly impairing motor development.

Efficacy of 20- versus 10-day antimicrobial treatment for acute otitis media.

OBJECTIVE: The purpose of this trial was to determine whether 20 days of antimicrobial treatment is more efficacious than 10 days of treatment for acute otitis media (AOM) in clearing middle ear effusion and preventing recurrences of AOM, and whether changing to a beta-lactamase-stable antimicrobial agent after the initial 10-day treatment with amoxicillin for AOM is advantageous. METHODS: Children between 7 months and 12 years of age with AOM were randomly assigned to three treatment groups: (1) amoxicillin for days 1 through 10, then amoxicillin for days 11 through 20; (2) amoxicillin for days 1 through 10, then amoxicillin-clavulanate for days 11 through 20; and (3) amoxicillin for days 1 through 10, then a placebo for either amoxicillin or amoxicillin-clavulanate for days 11 through 20. Medication was dispensed in a double-blind manner. Children underwent tympanocentesis at entry and were re-examined on days 10, 20, 30, 60, and 90 after entry. RESULTS: Two hundred sixty-seven children entered the trial. At the 20-day visit, the percentages of children who were effusion free in the amoxicillin, amoxicillin-clavulanate, and placebo groups were 72.4%, 80.8%, and 52.5%, respectively. There was no statistically significant difference in the percentage of children who were effusion free between the amoxicillin and amoxicillin-clavulanate groups (95% confidence interval, -21.7, 4.9). Subsequent to the day 10 visit, the average proportions of time with middle ear effusion were not significantly different in the amoxicillin, amoxicillin-clavulanate, and placebo groups (0.29, 0.27, and 0.34, respectively), nor were there significant differences in the rates of recurrent episodes of AOM (0.56, 0.59, and 0.68, respectively). Regardless of treatment group, approximately 75% of children were effusion free at the time of their last visit. CONCLUSIONS: More children were effusion free by the day 20 visit if given antimicrobial treatment for 20 days rather than for 10 days, but this advantage was present for only a short time; by the end of the 90-day study period, the treatment groups were comparable with regard to effusion status. Recurrence of AOM during the study period was not prevented by the additional 10 days of treatment. Routine use of an additional 10-day course of antimicrobial treatment is therefore not recommended if a child is symptom free after the initial 10 days of treatment for AOM.