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Efficacy of antimicrobial prophylaxis for recurrent middle ear effusion
E M Mandel1, M L Casselbrant, H E Rockette
1Department of Otolaryngology, Children's Hospital of Pittsburgh, PA 15213-2583, USA. mandele@chplink.chp.edu
Insights
Amoxicillin prophylaxis significantly reduced the incidence of middle ear effusion (MEE), acute otitis media (AOM), and otitis media with effusion (OME) in children. Individualized management is recommended due to antibiotic resistance concerns.
Area of Science:
- Pediatric Otolaryngology
- Infectious Diseases
- Pharmacology
Background:
- Recurrent middle ear effusion (MEE) and acute otitis media (AOM) are common in children.
- Prophylactic antibiotic use is a potential strategy to reduce the incidence of these conditions.
- Understanding the efficacy and safety of prophylactic amoxicillin is crucial for clinical decision-making.
Purpose of the Study:
- To compare the effectiveness of amoxicillin prophylaxis versus placebo in managing recurrent middle ear effusion (MEE) in children.
- To evaluate the impact of amoxicillin on the rates of MEE, AOM, and otitis media with effusion (OME).
Main Methods:
- A randomized controlled trial involving children aged 7 months to 12 years with a history of recurrent MEE.
- Participants received daily amoxicillin (20 mg/kg) or placebo for one year, with monthly follow-ups and symptom-driven examinations.
- Audiometry and tympanometry were used to assess middle ear status, and cultures were obtained to monitor for resistant organisms.
Main Results:
- Amoxicillin prophylaxis significantly reduced the rates of MEE (1.81 vs. 3.18 per person-year, P < 0.001), AOM (0.28 vs. 1.04, P < 0.001), and OME (1.53 vs. 2.15, P = 0.016) compared to placebo.
- Children receiving amoxicillin experienced less time with MEE (19.7% vs. 33.2%, P = 0.002).
- No increase in beta-lactamase-producing organisms or Streptococcus pneumoniae was observed in the amoxicillin group.
Conclusions:
- Daily amoxicillin prophylaxis effectively lowers the incidence of MEE, AOM, and OME and reduces the duration of MEE in children.
- Despite the observed benefits, individualized treatment approaches are advised due to current concerns about antibiotic resistance.
- Amoxicillin prophylaxis demonstrates a favorable safety profile regarding the emergence of resistant pathogens in this study.
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.