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Antibiotic Treatment of Children With Secretory Otitis Media: Amoxicillin-Clavulanate Is Superior to Penicillin V in a Double-blind Randomized Study

Antibiotic Treatment of Children With Secretory Otitis Media: Amoxicillin-Clavulanate Is Superior... Abstract Objective: To compare the effect of 2 different antimicrobial agents in the treatment of secretory otitis media (SOM). Design: Prospective, double-blind, randomized study. Patients: From a pool of 1450 children (aged 1-10 years) with SOM, defined by tympanometry as having type B or C2 tympanograms, 429 with SOM of at least 3 months' duration were included in the trial. After exclusion of 69 patients, the remaining 360 were evenly distributed among 4 treatment groups: penicillin V (Primcillin) for 14 and 28 days, and amoxicillin and clavulanate potassium in combination (Spektramox) for 14 and 28 days. Criteria for improvement was a change in tympanometric findings to type C1 or type A. Results: The success rates were in favor of amoxicillin-clavulanate treatment for 28 days (P<.001) (rates for respective 14- and 28-day groups: penicillin V, 23% and 19%; amoxicillin-clavulanate, 31% and 44%). Antimicrobial therapy was more efficient (P<.001) in unilateral vs bilateral disease. Conclusion: Antibiotic treatment improves the middle ear status in patients with SOM, and amoxicillin-clavulanate provides superior improvement to penicillin V.Arch Otolaryngol Head Neck Surg. 1997;123:695-699 References 1. Bluestone CD. Otitis media in children: to treat or not to treat? N Engl J Med . 1982;306:1339-1404.Crossref 2. Cantekin El, Mandel EM, Bluestone, CD, et al. Lack of efficacy of a decongestantantihistamine combination for otitis media with effusion (secretory otitis media) in children . N Engl J Med . 1983;308:297-301.Crossref 3. Berman S. Otitis media in children . N Engl J Med . 1995;332:1560-1565.Crossref 4. Berman S. Management of acute and chronic otitis media in pediatric practice . Curr Opin Pediatr . 1995;7:513-522.Crossref 5. Rosenfeld RM. Nonsurgical management of secretory otitis media with effusion . J Laryngol Otol . 1995;109:811-816.Crossref 6. Thomsen J, Sederberg-Olsen J, Balle VH, Veilsgaard R, Stangerup SE, Bondesson G. Antibiotic treatment of children with secretory otitis media . Arch Otolaryngol Head Neck Surg . 1989;115:447-451.Crossref 7. Rosenfeld RM, Post JC. Meta-analysis of antibiotics for the treatment of otitis media with effusion . Otolaryngol Head Neck Surg . 1992;106:378-386. 8. Williams RL, Charmers TC, Stange KC, Charmers FT, Bowlin DO. Use of antibiotics in preventing acute otitis media and in treating otitis media with effusion . JAMA . 1993;270:1344-1351.Crossref 9. van Balen FAM, de Melker RA, Touw-Otten FWMM. Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice . Lancet . 1996;348:713-716.Crossref 10. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children: results of a double-blind, randomized trial . N Engl J Med . 1987;316: 432-437.Crossref 11. Cantekin El, McGuire TW, Griffith TL. Antimicrobial therapy for otitis media with effusion ('secretory' otitis media) . JAMA . 1991;266:3309-3317.Crossref 12. Tos M, Stangerup SE, Hvid G, et al. Epidemiology and natural history of secretory otitis media . In: Sadé J, ed. Proceedings of the International Conference on Acute and Secretory Otitis Media . Amsterdam, the Netherlands: Kugler Publications; 1986:95-106. 13. Stool SE, Berg AO, Berman S, et al. Otitis Media With Effusion in Young Children . Clinical Practice Guideline, Number 12. Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, Dept of Health and Human Services; (July) 1994. AHCPR publication 94-0622. 14. Paradise JL. Managing otitis media: a time for change . Pediatrics . 1995;96:712-715. 15. Rodriguez WJ, Schwartz RH, Thorne MM. Increasing incidence of penicillin- and ampicillin-resistant middle ear pathogens . Pediatr Infect Dis J . 1995;14:1075-1078.Crossref 16. Balle V, Sederberg-Olsen J, Thomsen J, Harzen S. Treatment of secretory otitis media with amoxicillin with clavulanate acid (Spektramox®) and penicillin-V (Primcillin®): bacteriological findings in nasopharynx before and after treatment. Int J Pediatr Otol. In press. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Otolaryngology - Head & Neck Surgery American Medical Association

Antibiotic Treatment of Children With Secretory Otitis Media: Amoxicillin-Clavulanate Is Superior to Penicillin V in a Double-blind Randomized Study

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Publisher
American Medical Association
Copyright
Copyright © 1997 American Medical Association. All Rights Reserved.
ISSN
0886-4470
eISSN
1538-361X
DOI
10.1001/archotol.1997.01900070039006
Publisher site
See Article on Publisher Site

Abstract

Abstract Objective: To compare the effect of 2 different antimicrobial agents in the treatment of secretory otitis media (SOM). Design: Prospective, double-blind, randomized study. Patients: From a pool of 1450 children (aged 1-10 years) with SOM, defined by tympanometry as having type B or C2 tympanograms, 429 with SOM of at least 3 months' duration were included in the trial. After exclusion of 69 patients, the remaining 360 were evenly distributed among 4 treatment groups: penicillin V (Primcillin) for 14 and 28 days, and amoxicillin and clavulanate potassium in combination (Spektramox) for 14 and 28 days. Criteria for improvement was a change in tympanometric findings to type C1 or type A. Results: The success rates were in favor of amoxicillin-clavulanate treatment for 28 days (P<.001) (rates for respective 14- and 28-day groups: penicillin V, 23% and 19%; amoxicillin-clavulanate, 31% and 44%). Antimicrobial therapy was more efficient (P<.001) in unilateral vs bilateral disease. Conclusion: Antibiotic treatment improves the middle ear status in patients with SOM, and amoxicillin-clavulanate provides superior improvement to penicillin V.Arch Otolaryngol Head Neck Surg. 1997;123:695-699 References 1. Bluestone CD. Otitis media in children: to treat or not to treat? N Engl J Med . 1982;306:1339-1404.Crossref 2. Cantekin El, Mandel EM, Bluestone, CD, et al. Lack of efficacy of a decongestantantihistamine combination for otitis media with effusion (secretory otitis media) in children . N Engl J Med . 1983;308:297-301.Crossref 3. Berman S. Otitis media in children . N Engl J Med . 1995;332:1560-1565.Crossref 4. Berman S. Management of acute and chronic otitis media in pediatric practice . Curr Opin Pediatr . 1995;7:513-522.Crossref 5. Rosenfeld RM. Nonsurgical management of secretory otitis media with effusion . J Laryngol Otol . 1995;109:811-816.Crossref 6. Thomsen J, Sederberg-Olsen J, Balle VH, Veilsgaard R, Stangerup SE, Bondesson G. Antibiotic treatment of children with secretory otitis media . Arch Otolaryngol Head Neck Surg . 1989;115:447-451.Crossref 7. Rosenfeld RM, Post JC. Meta-analysis of antibiotics for the treatment of otitis media with effusion . Otolaryngol Head Neck Surg . 1992;106:378-386. 8. Williams RL, Charmers TC, Stange KC, Charmers FT, Bowlin DO. Use of antibiotics in preventing acute otitis media and in treating otitis media with effusion . JAMA . 1993;270:1344-1351.Crossref 9. van Balen FAM, de Melker RA, Touw-Otten FWMM. Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice . Lancet . 1996;348:713-716.Crossref 10. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children: results of a double-blind, randomized trial . N Engl J Med . 1987;316: 432-437.Crossref 11. Cantekin El, McGuire TW, Griffith TL. Antimicrobial therapy for otitis media with effusion ('secretory' otitis media) . JAMA . 1991;266:3309-3317.Crossref 12. Tos M, Stangerup SE, Hvid G, et al. Epidemiology and natural history of secretory otitis media . In: Sadé J, ed. Proceedings of the International Conference on Acute and Secretory Otitis Media . Amsterdam, the Netherlands: Kugler Publications; 1986:95-106. 13. Stool SE, Berg AO, Berman S, et al. Otitis Media With Effusion in Young Children . Clinical Practice Guideline, Number 12. Rockville, Md: Agency for Health Care Policy and Research, Public Health Service, Dept of Health and Human Services; (July) 1994. AHCPR publication 94-0622. 14. Paradise JL. Managing otitis media: a time for change . Pediatrics . 1995;96:712-715. 15. Rodriguez WJ, Schwartz RH, Thorne MM. Increasing incidence of penicillin- and ampicillin-resistant middle ear pathogens . Pediatr Infect Dis J . 1995;14:1075-1078.Crossref 16. Balle V, Sederberg-Olsen J, Thomsen J, Harzen S. Treatment of secretory otitis media with amoxicillin with clavulanate acid (Spektramox®) and penicillin-V (Primcillin®): bacteriological findings in nasopharynx before and after treatment. Int J Pediatr Otol. In press.

Journal

Archives of Otolaryngology - Head & Neck SurgeryAmerican Medical Association

Published: Jul 1, 1997

References

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