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.
Archives of Otolaryngology - Head & Neck Surgery – American Medical Association
Published: Jul 1, 1997
It’s your single place to instantly
discover and read the research
that matters to you.
Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.
All for just $49/month
Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly
Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.
Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.
Read from thousands of the leading scholarly journals from SpringerNature, Wiley-Blackwell, Oxford University Press and more.
All the latest content is available, no embargo periods.
“Hi guys, I cannot tell you how much I love this resource. Incredible. I really believe you've hit the nail on the head with this site in regards to solving the research-purchase issue.”Daniel C.
“Whoa! It’s like Spotify but for academic articles.”@Phil_Robichaud
“I must say, @deepdyve is a fabulous solution to the independent researcher's problem of #access to #information.”@deepthiw
“My last article couldn't be possible without the platform @deepdyve that makes journal papers cheaper.”@JoseServera