Efficacy of antimicrobial prophylaxis for recurrent middle ear effusion.
OBJECTIVE
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.
Mandel
E M
EM
Department of Otolaryngology, Children's Hospital of Pittsburgh, PA 15213-2583, USA. mandele@chplink.chp.edu
Casselbrant
M L
ML
Rockette
H E
HE
Bluestone
C D
CD
Kurs-Lasky
M
M
D000158:Acoustic Impedance Tests; D000208:Acute Disease; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use*; D001299:Audiometry; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000188:drug therapy* / Q000517:prevention & control*; D010349:Patient Compliance; D010406:Penicillins / Q000008:administration & dosage / Q000627:therapeutic use*; D010614:Pharynx / Q000382:microbiology; D012008:Recurrence; D016896:Treatment Outcome
D010406:Penicillins; D000658:Amoxicillin