Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. 1986

C Gonzalez, and J E Arnold, and E A Woody, and J B Erhardt, and S R Pratt, and A Getts, and T J Kueser, and J W Kolmer, and M Sachs

Otitis media has long been recognized as one of the most common diseases of childhood. Several therapeutic modalities have been advocated for the prevention of recurrent episodes of acute otitis media (AOM). A blinded, prospective, randomized study was designed to determine the efficacy of tympanostomy tubes, antibiotic prophylaxis, and placebo. Children with recurrent AOM were entered in the study and followed for at least 6 months. A total of 65 children completed the protocol. Sixty-three of those were under the age of 4 years. Treatment failure was defined as two or more episodes of AOM or otorrhea in less than 3 months. Five of 22 children in the tympanostomy tube group failed, compared to 12 of 20 in the placebo group (p = .02). There were 8 or 21 treatment failures in the sulfisoxazole group. Children with otitis media with effusion (OME) at the time of their initial visit had significantly less middle ear disease when treated with tympanostomy tubes. Tympanostomy tube insertion for prophylaxis of recurrent acute otitis is supported by these findings. Improvement of recurrent AOM was observed in the sulfisoxazole group, but was not statistically significant.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D008297 Male Males
D008876 Middle Ear Ventilation Ventilation of the middle ear in the treatment of secretory (serous) OTITIS MEDIA, usually by placement of tubes or grommets which pierce the TYMPANIC MEMBRANE. Grommet Insertion,Tympanostomy Tube Insertion,Ventilation, Middle Ear,Myringostomy,Tympanostomy,Ear Ventilation, Middle,Ear Ventilations, Middle,Grommet Insertions,Insertion, Grommet,Insertion, Tympanostomy Tube,Insertions, Grommet,Insertions, Tympanostomy Tube,Middle Ear Ventilations,Myringostomies,Tube Insertion, Tympanostomy,Tube Insertions, Tympanostomy,Tympanostomies,Tympanostomy Tube Insertions,Ventilations, Middle Ear
D010033 Otitis Media Inflammation of the MIDDLE EAR including the AUDITORY OSSICLES and the EUSTACHIAN TUBE. Middle Ear Inflammation,Inflammation, Middle Ear
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D012008 Recurrence The return of a sign, symptom, or disease after a remission. Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females

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