Persistent Acute Otitis Media Research Articles

Clinical decision making in paediatric otitis media: A pilot quality improvement study.

This study aimed to improve local management of paediatric otitis media using the 2022 American-Academy of Otolaryngology Head and Neck Surgery (AAO-HNS) Clinical Practice Guideline for Tympanostomy Tubes in Children. A SQUIRE 2.0 compliant quality improvement study was carried out within the outpatient department of our otolaryngology tertiary referral centre. Local outpatient management of paediatric otitis media was compared to the AAO-HNS guidelines, specifically focussing on the decision to offer tympanostomy tubes. Following initial audit of practice, an educational session was performed within the otolaryngology department and local practice was subsequently re-evaluated. Overall, 88 children were included (46 pre-intervention and 42 post-intervention) with a mean age of 7.6 years (range 1-12 years). Sixty-four (72.7%) children presented with suspected otitis media with effusion. The remainder presented with recurrent or persistent acute otitis media (24/88, 27.3%). Twenty-six children were offered tympanostomy tubes (29.5%). Initial evaluation of practice identified that the decision to offer tympanostomy tubes was guideline appropriate in 76.1% of children (35/46). This significantly improved following an educational session (40/42, 95.2%, p=0.02). The reasons for non-guideline compliance included: otitis media with effusion <3 months, no evidence of middle ear fluid and patients meeting criteria for tympanostomy tube insertion not being offered. A focussed educational intervention may improve local adherence to guidelines in the management of paediatric otitis media. Continued re-evaluation of local practice is essential in order to ensure children are managed in accordance with the guidelines.

Tympanostomy Tube Selection: A Review of the Evidence

ABSTRACT Tympanostomy tube (TT) insertion for ventilation of the middle ear is one of most commonly performed procedures in the United States. Indications for tube insertion include otitis media with effusion, recurrent acute otitis media, hearing loss caused by middle ear effusion and persistent acute otitis media. In general, TTs are divided into two categories, short-term tubes and long-term tubes. Depending on the indications for tube placement and surgeon experience with the TT, different tubes can be used. A myriad of tubes have been created since their first documented use in 1845 in attempts to provide better middle ear ventilation, improve ease of placement and prevent complications, such as post-tube otorrhea, persistent perforation and tube occlusion. In order for a tube to be effective, it should be biocompatible with the middle ear to minimize a foreign body reaction. Teflon and silicone remain two of the most commonly used materials in TTs. In addition, the tube design also plays a role for insertion and retention times of TTs. Lastly, TTs can also be coated with various substances, such as silver-oxide, phosphorylcholine and more recently, antibiotics and albumin, in order to prevent biofilm formation and decrease the rate of post-TT otorrhea. Persistent middle ear effusion affects many children each year and can impact their quality of life as well as hearing and language development. With nearly 1 out of every 15 children by the age of 3 years receiving TTs, it is imperative that the right tube be chosen to facilitate optimal ventilation of the middle ear while minimizing complications. How to cite this article Ho S, Kay DJ. Tympanostomy Tube Selection: A Review of the Evidence. Int J Head Neck Surg 2016;7(1):17-22.

Expression of Toll-like receptors on peripheral blood white cells in acute otitis media

ObjectiveFrom 10 to 15% of children suffer from recurrent acute otitis media (AOM). An association between polymorphism in TLRs and their co-receptor CD14 with otitis media proneness has been described in children. Moreover, the experiments on animal models have shown that TLRs and their signaling molecules are critical for timely resolution of bacterial otitis. AimThe aim of this study was to determine the expression of TLR1, TLR2 and TLR4 on lymphocytes, monocytes and granulocytes in peripheral blood in children with recurrent or persistent AOM. MethodsThe study was performed on a group of 25 children hospitalized for recurrent AOM, failures of previous treatments and/or acute mastoiditis. The results were compared to the control group of healthy children at the same age. The expression of TLRs on peripheral blood white cells was measured by flow cytometric analysis. The results were expressed as mean fluorescence intensity (MFI). The statistical analysis was performed using the Mann–Whitney U test. ResultsThe highest expression of TLR was found on monocytes, the lowest on lymphocytes in both groups of children (AOM and the control one). The expression of TLR1 was the lowest and expression of TLR4 was the highest on all examined cells. The expression of all examined TLRs on monocytes was significantly higher in the AOM group. ConclusionsPeripheral blood monocytes are characterized by increased expression of TLRs in the course of recurrent AOM.

What are the Most Responsible Pathogenic Bacteria in the Adenoid for Intractable Acute Otitis Media in Japanese Children?

Introduction: Although Streptococcus pneumoniae (SP), Haemophilus influenzae (HI), and Moraxella catarrhalis (MC) are major pathogenic bacteria of acute otitis media (AOM) in children, responsibility of their resistance to antimicrobial agents for intractable AOM has not been cleared. In this study, cultured bacteria from the adenoid of otitis-prone children were compared with those of children who had no apparent episodes of AOM to know the most responsible pathogens for intractable AOM. Methods: Sixty-eight children who had episodes of recurrent or persistent AOM were subjected to this study and 19 children without apparent episodes of AOM but with obstructive sleep apnea were taken as controls. Nasopharyngeal swab specimens were obtained from the adenoid transorally during the adenoidectomy, instead of conventional transnasal harvesting, to avoid contamination. Prevalence of SP, HI, and MC in each group was compared using the chi-squared or Fischer's exact test, and p-values <0.05 were considered significant. Results: SP was identified in 60.3% of otitis-prone children and in 52.6% of control children, and this difference indicated no statistically significance (p=0.54). HI was isolated from 77.9% of subjects and from 47.4% of controls, and the difference revealed significant (p=0.009). Above all, beta-lactamase negative HI (BLNAR) was caught in 39.7% of the study group, but in none of the control group (p=0.002). MC was identified in 32.4% and in 5.3%, individually, with significant difference (p=0.04). Conclusion: HI was more frequently isolated from otitis-prone children, and was considered to make AOM more intractable. The pathogenic role of MC for AOM may be evident.

Re-evaluation of CO 2 laser myringotomy for managing children with persistent acute otitis media

Background This study aimed to re-evaluate the utility of CO 2 laser myringotomy in children with persistent acute otitis media (PAOM). Methods From September 2002 to April 2008, 40 children with PAOM received CO 2 laser myringotomy. PAOM was defined as continuing symptoms and signs after systemic antibiotic treatment. Before laser myringotomy, the eardrums were checked under videotelescopy, pure tone audiometry or behavior audiometry and tympanometry. Middle ear effusions were collected using our own designed bottle culture device after laser myringotomy. The patients were followed up at outpatient clinics for 3 months. Cultured middle ear pathogens, healing time of the eardrums, hospital course (for admitted patients), and the development of middle ear effusions were recorded. Results Forty children with 53 ears with PAOM were enrolled. Eight patients (20%) had bilateral disease and underwent bilateral laser myringotomy. The overall culture rate was 28.3%, and Streptococcus pneumoniae was the most common pathogen. Eight patients (20%) were admitted for intravenous antibiotics. The average eardrum healing time was 22 days in those with positive cultures, and 16.4 days in those with negative cultures ( p = 0.125). All eardrums healed in 1 month. The resolution rate was 62.5% at 1 month. Patients with bilateral PAOM were prone to have positive middle ear culture (5/8) compared with those with unilateral PAOM (8/32) ( p = 0.086). Conclusion CO 2 laser myringotomy is an applicable means of treating PAOM. S pneumoniae is the most common pathogen in PAOM. CO 2 laser myringotomy allows for the drainage and culture sampling of middle ear effusion, relieving the need of taking prolonged medication.

WITHDRAWN: Decongestants and antihistamines for acute otitis media in children.

Acute otitis media (AOM) is a common and important source of morbidity in children, although the majority of cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit. To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, symptom resolution, medication side effects, and complications of AOM. In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2); MEDLINE (January 2004 to May 2007); and EMBASE (July 2003 to May 2007). Randomized controlled trials (RCTs) evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. The review authors independently evaluated studies for inclusion, performed validity assessments and completed data extraction. Dichotomous data were pooled to generate relative risks; homogeneity was assessed using approximate chi-square tests. No new studies were included following this updated search. Fifteen trials involving 2695 people were included. Only the combined decongestant-antihistamine group demonstrated statistically lower rates of persistent AOM at the two week period (fixed relative risk (RR) 0.76; 95% confidence interval (CI) 0.60 to 0.96; number needed to treat (NNT) 10). No benefit was found for early cure rates, symptom resolution, prevention of surgery or other complications. There was a five to eight -fold increased risk of side effects for those receiving an intervention, which reached statistical significance for all decongestant groupings. Validity sub analyses demonstrated that lower quality studies found benefit, while analysis of those studies with higher validity scores found no benefit of treatment. Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM. There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results. Thus, the routine use of antihistamines for treating AOM in children cannot be recommended.

Complicated otitis media and its implications

Complicated otitis media (OM) is a common paediatric problem and includes two major entities: persistent acute OM (AOM) and recurrent AOM (R-AOM). Double-tympanocentesis studies comparing the microbiology of initial and recurrent episodes of AOM have demonstrated that most recurrent episodes occurring within 1 month after antibiotic therapy are new infections, not true bacteriological relapses. These findings have highlighted the importance of bacteriological eradication in the prevention of subsequent R-AOM episodes. The seven-valent pneumococcal conjugate vaccine (PCV7) targets Streptococcus pneumoniae, one of the main AOM pathogens, and data on the impact of PCV7 on complications of AOM, such as mastoiditis, are presented.

A Randomized Comparative Study of Levofloxacin Versus Amoxicillin/Clavulanate for Treatment of Infants and Young Children With Recurrent or Persistent Acute Otitis Media

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections. In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM. A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent. Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

The Challenge of Recalcitrant Acute Otitis Media

Recalcitrant acute otitis media (AOM), including 2 well-defined and sometimes related entities (persistent AOM and recurrent AOM), is a common pediatric problem. Episodes of AOM in children with either persistent or recurrent AOM were shown to be associated with recovery of middle ear fluid bacterial pathogens (particularly Streptococcus pneumoniae) with higher resistance to antibiotics compared with children with AOM not recently treated with antibiotics. The relationships between nasopharyngeal carriage of Streptococcus pneumoniae and persistence of middle ear fluid pathogens despite clinical improvement or cure and subsequent recurrence are discussed in depth. The findings emphasize the importance of bacteriologic eradication in the prevention of recurrent AOM episodes.

Clinical Q&amp;A

The Clinical Knowledge Summaries guidelines (2007) on acute otitis media states, in its clinical scenario on persistent acute otitis media or treatment failure: ‘Consider sending a swab for culture and microbial sensitivity testing if there is perforation of the tympanic membrane that allows for a sample to be taken. This may be especially useful if first-line antibiotic treatment has failed.’ Regarding treatment of discharging otitis media, the GP Notebook (2007) states: ‘Swab should be sent for culture, and antibiotics commenced. Antibiotic therapy may be modified in light of the results of the bacteriology. There may be a requirement for regular aural toilet.’

Przyczyny niepowodzenia w leczeniu długo trwającego ostrego zapalenia ucha środkowego u dzieci

An increasing antibiotic resistance of pathogens is the main cause of failures during treatment of acute otitis media (AOM). Aim. A qualitative and quantitative bacteriological analysis of material isolated from the middle ear in children with AOM treated with antibiotic without improvement. This is a prospective study performed in Department of Otolaryngology in Warsaw between 2005 and 2007. An examined group consisted of 72 children aged from 6 months to 17 years, admitted to Department of Otolaryngology because of failure of antibiotic therapy of AOM, severe course of this disease and complications of AOM or persistent AOM. In all children were performed the myryngotomy and/or ventilatory tube insertion and/or mastoidectomy and the material from the middle ear was collected to bacteriological examinations. The positive cultures were obtained in 63.9% patients. Streptococcus pneumoniae (40.4%), Staphylococcus aureus (14%), Haemophilus influenzae (10.5%) and Pseudomonas aeruginosa (10.5%) were the most frequently found bacteria in the culture of middle ear. beta-lactamase producing bacteria were isolated in 12 children (21.1% of isolated bacteria). Staphylococcus aureus (7 children, 12.3% of positive cultures) was the bacteria most frequent producing beta-lactamase. The most of organisms were susceptibility to amoxicillin/clavulanate--56.1% of bacteria from the middle ear. The most of organisms presented resistance to penicillin--63.9% of bacteria from the middle ear. Microbiological identifications and antibiotic resistance determination of pathogens isolated from the middle ear in children with AOM not responding to empirical antibiotic treatment gives possibility of the choice of an effective antibiotic and its proper dosage. The pathogenic bacterial flora isolated from the middle ear in children with AOM shows evidence to accomplishing changes in the most frequent pathogens causing acute otitis media in children.

Levofloxacin is efficacious in the treatment of children with, or at high risk for, recurrent or persistent acute otitis media,

Levofloxacin is efficacious in the treatment of children with, or at high risk for, recurrent or persistent acute otitis media,

A Multicenter, Open Label, Double Tympanocentesis Study of High Dose Cefdinir in Children With Acute Otitis Media at High Risk of Persistent or Recurrent Infection

Given the relatively high prevalence of recurrent and persistent acute otitis media (AOM) and the prominent etiologic role of Streptococcus pneumoniae, especially penicillin-nonsusceptible strains in children with these conditions, new alternative treatments are desirable. Children 6 months-4 years of age with AOM considered to be at risk for recurrent or persistent infection received large dosage cefdinir 25 mg/kg oral suspension once daily for 10 days. Children were evaluated pretreatment (day 1), on therapy (days 4-6), end of therapy (days 12-14) and at follow-up (days 25-28). All children had tympanocentesis at enrollment. In culture-positive children, tympanocentesis was repeated after 3-5 days (days 4-6) unless evidence of absence of middle ear effusion was documented. Of 447 children enrolled, 230 were clinically and bacteriologically evaluable (74% 2 years old or younger; 57% treated for AOM in previous 3 months). Bacteriologic eradication, based on repeat tympanocentesis on days 4-6, was achieved in 74% (170 of 230) of children; 76% (201 of 266) of AOM pathogens were eradicated. Eradication of penicillin-susceptible, -intermediate and -resistant S. pneumoniae was 91% (50 of 55), 67% (18 of 27) and 43% (10 of 23), respectively (P < 0.001); eradication of H. influenzae was 72% (90 of 125). Overall clinical response at days 12-14 was 83% (76 and 82% for children with S. pneumoniae and Haemophilus influenzae, respectively). Sustained clinical response at days 25-28 was 85%. Clinical response was 83% for culture-positive children versus 96% for culture-negative children at baseline tympanocentesis (P < 0.001). In this study of AOM among children at risk for persistent or recurrent infection, large dose cefdinir resulted in an overall successful clinical response at end of treatment of 83%. This regimen was efficacious against penicillin-susceptible S. pneumoniae, but effectiveness was markedly decreased against nonsusceptible strains and was moderate for H. influenzae strains.

Current face of acute otitis media: Microbiology and prevalence resulting from widespread use of heptavalent pneumococcal conjugate vaccine

Background: Many causes can be proposed for achange in the microbiologic makeup of a specific disease state. However, when viewed through the scope of recent events, only one is likely to be the true cause of a change in the microbiology of acute otitis media (AOM): the release and widespread use of heptavalent pneumococcal conjugate vaccine (PCV-7). Objective: The aim of this report was to review themicrobiology and prevalence of AOM before and after the release and widespread use of PCV-7. Methods: For this brief review, we used a MEDLINEsearch to identify English-language literature related to the microbiology of AOM before and after the release of PCV-7 in 2000 in the United States (key terms: acute otitis media, AOM, Haemophilus influenzae, H influenzae, Streptococcus pneumoniae, and S pneumoniae; years: 1980–2005). Studies using tympanocentesis to identify the pathogen in recurrent or persistent AOM were examined; US studies reporting AOM microbiology before and after the release of PCV-7 in the same population were considered for the post-PCV-7 analysis. Results: Following the release of PCV-7, a decreasein the overall rates of AOM was noted. This decrease brings into question the resultant effect on the microbiology of AOM. Our literature search revealed 2 studies that examined the microbiology of AOM before and after the release of PCV-7 in the United States. These 2 studies, conducted in dispersed geographic regions (rural Kentucky and Rochester, New York), illustrated a change in the predominant causative pathogen in AOM, from S pneumoniae to H influenzae in the population of children 7 to 24 months of age with recurrent AOM. Given the time period of the change, these shifts could be related to the release and widespread use of PCV-7. Conclusions: Since the 1990s, the predominantcausative pathogen in recurrent AOM changed from S pneumoniae to H influenzae, possibly as a result of the release and widespread use of PCV 7. Although PCV-7 use was slowed from August 2001 to May 2003 and again from February to September 2004 by nationwide shortages, those shortages have now been resolved, and compliance with the full vaccine schedule is expected to increase.

Treating acute otitis media post-PCV-7: judicious antibiotic therapy.

Acute otitis media (AOM) is treated with antibiotics in the United States, but the changing distribution of bacterial pathogens that cause the disorder can present physicians with several challenges. Most physicians treat AOM empirically, and their treatment choice should target Streptococcus pneumonia, nontypeable Haemophilus influenzae, and Moraxella catarrhalis, as those bacteria are most often isolated in AOM. First-line treatment for new onset AOM remains amoxicillin (80-90 mg/kg/d, divided twice daily). For persistent or recurrent AOM, guidelines recommend high-dose amoxicillin-clavulanate, cefdinir, cefprozil, cefpodoxime, cefuroxime, or ceftriaxone. Improved diagnosis and optimizing the choice of therapy by considering in vitro and in vivo efficacy of the different antibiotics will improve patient outcomes. Improved patient outcomes will result in fewer AOM episodes, decreased antibiotic resistance, and reduced direct and indirect health care costs.

Decongestants and antihistamines for acute otitis media in children.

Acute otitis media (AOM) is a common and important source of morbidity in children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit. To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, symptom resolution, medication side effects, and complications of AOM. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2003); MEDLINE (January 1966 to December 2003), EMBASE (January 1990 to July 2003) and reference lists of articles for this updated review. We also contacted study authors and pharmaceutical companies. Randomized controlled trials evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. There were no quality or language restrictions. Investigators independently evaluated studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate relative risks; homogeneity was assessed using approximate chi-square tests. Fifteen trials involving 2695 people were included. Only the combined decongestant-antihistamine group demonstrated statistically lower rates of persistent AOM at the two week period (fixed relative risk (RR) 0.76; 95% confidence interval (CI) 0.60 to 0.96; number needed to treat (NNT) 10). No benefit was found for early cure rates, symptom resolution, prevention of surgery or other complications. There was a five to eight -fold increased risk of side effects for those receiving an intervention, which reached statistical significance for all decongestant groupings. Validity sub analyses demonstrated that lower quality studies found benefit, while analysis of those studies with higher validity scores found no benefit of treatment. Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM. There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results. Thus, the routine use of antihistamines for treating AOM in children cannot be recommended.

Management of recurrent and persistent acute otitis media: new options with familiar antibiotics.

Recurrent and persistent acute otitis media (AOM) is a common problem, affecting close to 20% of children in their first years of life. It presents a therapeutic challenge to physicians, particularly as beta-lactamase-producing Haemophilus influenzae, as well as penicillin- and, more recently, macrolide-resistant Streptococcus pneumoniae are often responsible for AOM in these patients. Intramuscular ceftriaxone (50 mg/kg, once daily for 3 days) has been shown to be effective in treating nonresponsive AOM, but there have been relatively few clinical trials exploring oral antibiotic regimens. Higher doses of commonly used antibiotics (amoxicillin-clavulanate ratio, 14:1 ratio and azithromycin 60 mg/kg divided into three equal once daily doses) have demonstrated high rates of clinical success. These studies will be discussed together with a review of the clinical and microbiologic characteristics of this disease. We will also address the impact that the pneumococcal conjugate vaccine may have on the microbiology of recurrent and persistent AOM.

Amoxicillin/clavulanate for infections in infants and children: past, present and future.

Chemical synthesis of the penicillin nucleus in the 1950s made introduction of a broad array of new and important antimicrobials, including ampicillin and amoxicillin, possible. Ampicillin was introduced in 1962 in oral and parenteral forms as the first of the semisynthetic penicillins to provide increased activity against Gram-negative bacteria. Amoxicillin replaced oral ampicillin beginning in 1974 because amoxicillin resulted in higher and more prolonged serum concentrations than did equivalent doses of ampicillin. Amoxicillin/clavulanate (Augmentin) was introduced in the United States in 1984 to enhance the activity of amoxicillin by addition of the beta-lactamase inhibitor, clavulanic acid. During the past 20 years, amoxicillin/clavulanate has proven effective for a variety of pediatric infectious diseases, particularly acute otitis media (AOM). In 2001, a new pediatric formulation, high dose amoxicillin/clavulanate (Augmentin ES-600) was approved for use in the United States. The high dose preparation addressed the needs of pediatricians by providing greater amounts of amoxicillin while maintaining the same daily dose of clavulanic acid as the regular strength formulation. Doubling the dose of amoxicillin for management of recurrent and persistent AOM was recommended in 1999 by the Centers for Disease Control and Prevention because of concern about the increased incidence of nonsusceptible strains of Streptococcus pneumoniae. The original formulation combined amoxicillin/clavulanate in a 4:1 ratio and was followed by a 7:1 ratio formulation. The high dose formulation (600 mg of amoxicillin per 5 ml) provides a 14:1 ratio of amoxicillin to clavulanate. Although management of AOM will likely undergo changes in the coming years, amoxicillin is expected to remain first line therapy for AOM. For children who fail initial therapy with amoxicillin, high dose amoxicillin/clavulanate, an oral cephalosporin or parenteral ceftriaxone is recommended.

Decongestants and antihistamines for acute otitis media in children.

Acute otitis media (AOM) is a common and important source of morbidity in children, although most cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit. To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, medication side effects, and complications of AOM. Comprehensive search of Cochrane's Controlled Trials Registry, Medline and Embase was conducted. Bibliographic review and requests for information from study authors and pharmaceutical companies supplemented this. Randomized controlled trials evaluating decongestant (DC) or antihistamine (AH) treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. There were no quality or language restrictions. Investigators independently evaluated studies for inclusion, performed validity assessments, and completed data extraction. Dichotomous data were pooled to generate relative risks and numbers needed to treat, and homogeneity was assessed using approximate chi-square tests. For the combined control groups, healing rates at 2 weeks were high, with rates of persistent AOM <23%. No additional benefit was demonstrated from intervention subgroupings DC, AH, or any medication (DC and/or AH). Only the combined treatment (DC + AH) group demonstrated statistically lower rates of persistent AOM at the 2-week period (RR 0.76, 95% CI, NNT 10.5, 95% CI). No benefit was found for other outcomes including early or late cure rates, symptom resolution, prevention of surgery or other complications. There was an increased risk of medication side effects for those receiving an intervention, which reached statistical significance for the "any medication" and decongestant groupings (NNH 16.6, 14.3 respectively, 95% CI ). Validity subanalyses demonstrated that lower quality studies found benefit, but analysis of those studies with higher validity scores found no benefit to treatment. Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant, antihistamine, or combined DC/AH treatment in children with AOM. The small statistical benefit found in the combination medication group is of small clinical significance and study design may be biasing the results.

Restricted use of antibiotic prophylaxis for recurrent acute otitis media in the era of penicillin non-susceptible Streptococcus pneumoniae

Objective/intervention: To compare the annual rates of acute otitis media (AOM) episodes, antibiotic days, and ventilating tube insertion during the first 3 years of life before and after a practice change to restrict use of antibiotic chemoprophylaxis for recurrent AOM. Methods setting: The sole pediatric private practice in a rural Kentucky community. Patients: Population-based sample of all children born consecutively in two different 13 month intervals. Cohort 1 ( n=251) was born before and Cohort 2 ( n=274) was born after restricted use of chemoprophylaxis and documented emergence of widespread penicillin non-susceptible Streptococcus pneumoniae (PNSP). Design: Retrospective case cohort comparison. Main outcome measures: Suppurative AOM diagnosed by validated experienced otoscopists using stringent tympanic membrane criteria. Results: Children were mostly white with the majority (50–65%) enrolled in daycare during each year. The first episode of AOM was experienced by 6 and 12 months of age in 64 and 86%, respectively. Rates of children with recurrent AOM in Cohorts 1 and 2 were 28 and 31% in Year 1, 17 and 23% in Year 2, and 7 and 10% in Year 3, respectively. Rates of new onset AOM and persistent AOM episodes were similar between cohorts in the first 2 years. Number of days of antibiotic prophylaxis were reduced from 11.2 to 3.4 days in Year 1, from 11.9 to 2.6 days in Year 2, and from 6.9 to 0.7 days in Year 3, respectively ( P<0.0001 for each year). Total antibiotic days for Years 1, 2 and 3 were reduced commensurately with prophylactic days from 61.7 to 55.5 days (nonsignificant), from 56.3 to 45.8 days ( P=0.047), and from 38.7 to 25.7 days ( P<0.0001), respectively. For each year a non-significant trend for increased ventilating tube placement from Cohort 1 to Cohort 2, respectively, was observed, 2 versus 2.2%, 4 versus 5.8%, and 0.8 versus 2.6%. Daycare attendance and white race were consistently significant risk factors for AOM and recurrent AOM. Conclusions: in the era of PNSP, restricted use of antibiotic chemoprophylaxis for recurrent AOM was not associated with significantly increased rates of new onset AOM episodes or tube placement in the first 24 months of life. Total antibiotic days were also significantly reduced in Cohort 2 during Years 2 and 3.