Abstract
BACKGROUND: Appropriate use of antibiotics is one of the major issues in medicine today. In most countries, acute otitis media in children is treated with antibiotics; however, the efficacy of antibiotic use in every acute otitis media is a controversial issue. It may be worthwhile looking for special risk groups that benefit more from antibiotic treatment for acute otitis media. Children under two years of age with acute otitis media are at risk of poor outcome. AIM: To assess whether the current high prescription rates of antibiotics for acute otitis media in children under two years of age (being a risk group for poor outcome) are based on an established increased efficacy. METHOD: Systematic literature review and a quantitative analysis with an assessment of the methodological quality of published trials, comparing antibiotic treatment with non-antibiotic treatment in acute otitis media in children aged under two years. RESULTS: Six trials were included. Trials from before 1981 had a poor methodological quality. Four were suitable for the quantitative analysis. Only two of them were truly placebo-controlled. Of these two, one included only recurrent acute otitis media and the other included only non-severe episodes. With these restricted data, no statistically significant difference was found between antibiotic-treated children and controls under two years of age with acute otitis media, judged on the basis of clinical improvement within seven days (common odds ratio = 1.31; 95% CI = 0.83-2.08). CONCLUSION: The current high prescription rates of antibiotics among children under two years of age with acute otitis media are not sufficiently supported by evidence from published trials. New randomized placebo-controlled trials using reliable methodology are needed in this young age group.
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- Alho O. P., Lärä E., Oja H. What is the natural history of recurrent acute otitis media in infancy? J Fam Pract. 1996 Sep;43(3):258–264. [PubMed] [Google Scholar]
- Altman D. G. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996 Sep 7;313(7057):570–571. doi: 10.1136/bmj.313.7057.570. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Appelman C. L., Claessen J. Q., Touw-Otten F. W., Hordijk G. J., de Melker R. A. Co-amoxiclav in recurrent acute otitis media: placebo controlled study. BMJ. 1991 Dec 7;303(6815):1450–1452. doi: 10.1136/bmj.303.6815.1450. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bruijnzeels M. A., Foets M., van der Wouden J. C., van den Heuvel W. J., Prins A. Everyday symptoms in childhood: occurrence and general practitioner consultation rates. Br J Gen Pract. 1998 Jan;48(426):880–884. [PMC free article] [PubMed] [Google Scholar]
- Burke P., Bain J., Robinson D., Dunleavey J. Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ. 1991 Sep 7;303(6802):558–562. doi: 10.1136/bmj.303.6802.558. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Chalmers T. C., Smith H., Jr, Blackburn B., Silverman B., Schroeder B., Reitman D., Ambroz A. A method for assessing the quality of a randomized control trial. Control Clin Trials. 1981 May;2(1):31–49. doi: 10.1016/0197-2456(81)90056-8. [DOI] [PubMed] [Google Scholar]
- Claessen J. Q., Appelman C. L., Touw-Otten F. W., De Melker R. A., Hordijk G. J. A review of clinical trials regarding treatment of acute otitis media. Clin Otolaryngol Allied Sci. 1992 Jun;17(3):251–257. doi: 10.1111/j.1365-2273.1992.tb01838.x. [DOI] [PubMed] [Google Scholar]
- Del Mar C., Glasziou P., Hayem M. Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. BMJ. 1997 May 24;314(7093):1526–1529. doi: 10.1136/bmj.314.7093.1526. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Engelhard D., Cohen D., Strauss N., Sacks T. G., Jorczak-Sarni L., Shapiro M. Randomised study of myringotomy, amoxycillin/clavulanate, or both for acute otitis media in infants. Lancet. 1989 Jul 15;2(8655):141–143. doi: 10.1016/s0140-6736(89)90192-x. [DOI] [PubMed] [Google Scholar]
- Froom J., Culpepper L., Grob P., Bartelds A., Bowers P., Bridges-Webb C., Grava-Gubins I., Green L., Lion J., Somaini B. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ. 1990 Mar 3;300(6724):582–586. doi: 10.1136/bmj.300.6724.582. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Halsted C., Lepow M. L., Balassanian N., Emmerich J., Wolinsky E. Otitis media. Clinical observations, microbiology, and evaluation of therapy. Am J Dis Child. 1968 May;115(5):542–551. doi: 10.1001/archpedi.1968.02100010544003. [DOI] [PubMed] [Google Scholar]
- Hathaway T. J., Katz H. P., Dershewitz R. A., Marx T. J. Acute otitis media: who needs posttreatment follow-up? Pediatrics. 1994 Aug;94(2 Pt 1):143–147. [PubMed] [Google Scholar]
- Howie V. M., Ploussard J. H. Efficacy of fixed combination antibiotics versus separate components in otitis media. Effectiveness of erythromycin estrolate, triple sulfonamide, ampicillin, erythromycin estolate- triple sulfonamide, and placebo in 280 patients with acute otitis media under two and one-half years of age. Clin Pediatr (Phila) 1972 Apr;11(4):205–214. doi: 10.1177/000992287201100407. [DOI] [PubMed] [Google Scholar]
- Howie V. M., Ploussard J. H., Sloyer J. The "otitis-prone" condition. Am J Dis Child. 1975 Jun;129(6):676–678. doi: 10.1001/archpedi.1975.02120430016006. [DOI] [PubMed] [Google Scholar]
- Iino Y., Nakamura Y., Koizumi T., Toriyama M. Prognostic factors for persistent middle ear effusion after acute otitis media in children. Acta Otolaryngol. 1993 Nov;113(6):761–765. doi: 10.3109/00016489309135897. [DOI] [PubMed] [Google Scholar]
- Kaleida P. H., Casselbrant M. L., Rockette H. E., Paradise J. L., Bluestone C. D., Blatter M. M., Reisinger K. S., Wald E. R., Supance J. S. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics. 1991 Apr;87(4):466–474. [PubMed] [Google Scholar]
- Laupacis A., Sackett D. L., Roberts R. S. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988 Jun 30;318(26):1728–1733. doi: 10.1056/NEJM198806303182605. [DOI] [PubMed] [Google Scholar]
- Laxdal O. E., Merida J., Jones R. H. Treatment of acute otitis media: a controlled study of 142 children. Can Med Assoc J. 1970 Feb 14;102(3):263–268. [PMC free article] [PubMed] [Google Scholar]
- Lorentzen P., Haugsten P. Treatment of acute suppurative otitis media. J Laryngol Otol. 1977 Apr;91(4):331–340. doi: 10.1017/s0022215100083742. [DOI] [PubMed] [Google Scholar]
- Mandel E. M., Casselbrant M. L., Rockette H. E., Bluestone C. D., Kurs-Lasky M. Efficacy of 20- versus 10-day antimicrobial treatment for acute otitis media. Pediatrics. 1995 Jul;96(1 Pt 1):5–13. [PubMed] [Google Scholar]
- Mygind N., Meistrup-Larsen K. I., Thomsen J., Thomsen V. F., Josefsson K., Sørensen H. Penicillin in acute otitis media: a double-blind placebo-controlled trial. Clin Otolaryngol Allied Sci. 1981 Feb;6(1):5–13. doi: 10.1111/j.1365-2273.1981.tb01781.x. [DOI] [PubMed] [Google Scholar]
- Robins J., Greenland S., Breslow N. E. A general estimator for the variance of the Mantel-Haenszel odds ratio. Am J Epidemiol. 1986 Nov;124(5):719–723. doi: 10.1093/oxfordjournals.aje.a114447. [DOI] [PubMed] [Google Scholar]
- Rosenfeld R. M., Vertrees J. E., Carr J., Cipolle R. J., Uden D. L., Giebink G. S., Canafax D. M. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr. 1994 Mar;124(3):355–367. doi: 10.1016/s0022-3476(94)70356-6. [DOI] [PubMed] [Google Scholar]
- van Buchem F. L., Peeters M. F., van 't Hof M. A. Acute otitis media: a new treatment strategy. Br Med J (Clin Res Ed) 1985 Apr 6;290(6474):1033–1037. doi: 10.1136/bmj.290.6474.1033. [DOI] [PMC free article] [PubMed] [Google Scholar]
