PEDIATRICS Vol. 115 No. 4 April 2005, pp. 1087-1089 (doi:10.1542/peds.2004-2874)
COMMENTARY |
To Treat or Not to Treat
Department of Pediatrics
Children’s Hospital of Pittsburgh
University of Pittsburgh School of Medicine
Pittsburgh, PA 15213
Abbreviations: AOM, acute otitis media
Rosenfeld’s recent commentary "Otitis, Antibiotics, and the Greater Good"1 focuses on the importance of the paradigm shift that lies at the core of the new American Academy of Pediatrics clinical practice guideline2 for acute otitis media (AOM). This paradigm shift, referred to as the observation option, allows selected children to receive analgesics rather than antibiotics in the first few days after diagnosing AOM in the hope that their infection will resolve spontaneously. It is important to emphasize that this option is intended for a very limited set of children, including only those at least 2 years of age with either nonsevere symptoms or an uncertain diagnosis of AOM.2
Some of the current literature3 regarding the utility of antibiotic therapy in AOM, including Rosenfeld’s commentary,1 reflects an increasingly popular view that is largely based on the results of several recently published meta-analyses.4–6 These meta-analyses are reported to support the conclusion that antibiotics exert only a modest benefit compared with placebo for children with AOM and that there has been no demonstrable superiority of any antibiotic compared with amoxicillin in the treatment of this condition.7
To appreciate the conclusion of these meta-analyses, it is essential to review the individual studies that were included in them. In the design of clinical studies comparing 2 different antimicrobials or an antimicrobial to a placebo, it is essential to have a stringent definition for cases of AOM. AOM must be distinguished from otitis media with effusion, a considerably more common condition than AOM, in which the middle ear effusion is usually sterile and does not benefit from antibiotic therapy. The failure to make this distinction has led to substantial overuse of antimicrobials.
Although a discussion of criteria for the diagnosis of AOM evokes some controversy, most investigators agree that there are 2 essential findings: evidence of (1) middle ear effusion (demonstrated by an otoscopy that shows either opacification or an air-fluid level or absent mobility of the tympanic membrane as demonstrated by pneumatic otoscopy, tympanogram, or acoustic reflectometry) and (2) definite abnormalities of the tympanic membrane that indicate acute inflammation including either bulging or distinct fullness of the tympanic membrane (without bulging) with or without erythema.8 Middle ear effusion accompanied by constitutional signs of illness (fever, anorexia, nausea, irritability, and vomiting) is not sufficient for a diagnosis of AOM.
Rosenfeld’s confidence in the observation option is culled from a review of 9 randomized, controlled clinical trials performed between 1968 and 2000.9–17 The studies are described as high quality, albeit imperfect.1 Children <2 years of age were excluded from 3 of the 9 studies,12,13,15 and even when not excluded, in an additional 2 studies11,14 the mean age of study children was 4 years (indicating that only a minority of children were <2 years old, the age group that is most difficult to treat). Two investigations excluded children in whom antibiotics were thought to be indicated.15,17 Diagnoses of AOM were based on otoscopic plus clinical findings, and in some studies tympanometry was a confirmatory test. It is very important that we consider the basis for the otoscopic diagnosis of AOM that was used in these studies. Their definition of AOM was "bulging or opacification of the tympanic membrane—with or without erythema—accompanied by at least one of the following signs and symptoms: fever, otalgia, irritability, otorrhea, lethargy, anorexia, vomiting or diarrhea."4 However, although most studies had a requirement for both traditional acute symptoms of AOM (fever, otalgia, or irritability) and the presence of middle ear effusion (not a strong diagnosis without bulging of the tympanic membrane), 25% had even less specific and less stringent otoscopic criteria. It is likely that many of these children did not have AOM. Rosenfeld notes in a previous publication18 that children included in these studies were not a random sample of children with AOM but may represent a select group with less severe symptoms, children whose inclusion in these studies would raise no ethical problems because they were affected less severely. The exclusion of the sickest children, those most likely to benefit from antibiotics, biases the results of these studies in the direction of "no difference." Furthermore, in 5 of the 9 studies, the dose or selection of antimicrobial was inappropriate; in 2 studies penicillin V was compared with placebo,11,13 and in 3 studies fixed amounts of antibiotic resulted in insufficient doses in 20% to 100% of the children studied (5-9 mg/kg per dose rather than 15 mg/kg per dose).12,14,15 Accordingly, these studies, although perhaps the best available, are indeed very far from perfect and may not provide the most sound basis for our recommendations. Despite these considerable inadequacies, 6 of the studies still show a distinct advantage to the use of antibiotics in children with AOM.9–11,15–17 If cases were defined strictly, and antibiotics and antibiotic doses selected more carefully, the magnitude of the difference would surely be larger.
The objective of decreasing the overuse of antibiotics is sensible and desirable from every perspective imaginable, individually, societally, and for the health of the planet. As an infectious disease specialist, I am very committed to this goal. However, my recommendation to avoid the overuse of antibiotics would be to sharpen the otoscopic skills of primary care practitioners (family practitioners, pediatricians, nurse-practitioners) and trainees at all levels (students, residents, and fellows) to enable them to differentiate accurately between otitis media with effusion and AOM. Although the more common diagnosis of otitis media with effusion does not require the use of antibiotics, when a bona fide diagnosis of AOM is confirmed by the finding of middle ear effusion and bulging, regardless of the age of the patient or severity of the illness, antibiotics should be considered first-line therapy.
 |
FOOTNOTES |
|---|
Accepted Dec 30, 2004.
Address correspondence to Ellen R. Wald, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 3705 Fifth Ave, Pittsburgh, PA 15213. E-mail: ellen.wald{at}chp.edu
No conflict of interest declared.
|
REFERENCES |
|---|
 TOP REFERENCES |
|---|
- Rosenfeld RM. Otitis, antibiotics, and the greater good [commentary].
Pediatrics. 2004;114
:1333
–1335
[Free Full Text] - American Academy of Pediatrics, Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media.
Pediatrics. 2004;113
:1451
–1465
[Abstract/Free Full Text] - Hendley JO. Otitis media.
N Engl J Med. 2002;347
:1169
–1174
[Free Full Text] - Rosenfeld RM, Vertrees J, Carr J, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr. 1994;124 :355 –67[CrossRef][Web of Science][Medline]
- Takata GS, Chan LS, Shekelle P, Morton SC, Mason W, Marcy SM. Evidence assessment of management of acute otitis media: the role of antibiotics in treatment of uncomplicated acute otitis media.
Pediatrics. 2001;108
:239
–247
[Abstract/Free Full Text] - Glaszious PP, DelMar CB, Sanders SL, Hayem M. Antibiotics for acute otitis media in children. Cochrane Database Syst Rev. 2002;(3)
- Wald ER. Acute otitis media—more trouble with the evidence. Pediatr Infect Dis J. 2003;22 :103 –104[CrossRef][Web of Science][Medline]
- Hoberman A, Paradise JL. Acute otitis media: diagnosis and treatment in the year 2000. Pediatr Ann. 2000;29 :609 –620[Web of Science][Medline]
- Halsted C, Lepow ML, Balassanian N, Emmerich J, Wolinsky E. Otitis media: clinical observations, microbiology, and evaluation of therapy.
Am J Dis Child. 1968;115
:542
–551
[Abstract/Free Full Text] - Laxdal OE, Merida J, Jones RH. Treatment of acute otitis media: a controlled study of 142 children. Can Med Assoc J. 1970;102 :263 –268[Medline]
- Mygind N, Meistrup-Larsen KI, Thomsen J, Thomsen VF, Josefsson K, Sorensen H. Penicillin in acute otitis media: a double-blind, placebo-controlled trial. Clin Otolaryngol. 1981;6 :5 –13[Web of Science][Medline]
- van Buchem FL, Dunk JH, van’t Hof MA. Therapy of acute otitis media: myringotomy, antibiotics, or neither? A double-blind study in children. Lancet. 1981;2(8252) :883–887
- Thalin A, Densert O, Larsson A, Lyden E, Torvald R. Is penicillin necessary in the treatment of acute otitis media? In: Proceedings of the International Conference on Acute and Secretory Otitis Media, Part 1, Jerusalem, Israel, 17–22 November 1985. Amsterdam, Netherlands: Kugler Publications; 1986:441–446
- Appelman CL, Claessen JQ, Touw-Otten FW, Hordijk GJ, de Melker RA. Co-amoxiclav in recurrent acute otitis media: placebo controlled study. BMJ. 1991;303 :1450 –1452
- Burke P, Bain J, Robinson D, Dunloeavey J. Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ. 1991;303 :558 –562
- Kaleida PH, Casselbrant ML, Rockette HE, et al. Amoxicillin or myringotomy or both for acute otitis media; results of a randomized clinical trial.
Pediatrics. 1991;87
:466
–474
[Abstract/Free Full Text] - Damoiseaux RA, van Balen FA, Hoes AW, Verheij TJ, de Melker RA. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years.
BMJ. 2000;320
:350
–354
[Abstract/Free Full Text] - Rosenfeld RM, Bluestone CD, eds. Evidence-Based Otitis Media. 2nd Ed. Hamilton, ON, Canada: BC Decker Inc; 2003
PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
This article has been cited by other articles:
|
|
 |
|
  C. L. Collins, G. A. Smith, and R. D. Comstock Children Plus All Nonautomobile Motorized Vehicles (Not Just All-Terrain Vehicles) Equals Injuries Pediatrics, July 1, 2007; 120(1): 134 - 141. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. Renouf Review: children <2 years of age with bilateral acute otitis media and children with otorrhoea benefit most from antibiotics Evid. Based Nurs., April 1, 2007; 10(2): 45 - 45. [Full Text] [PDF]
|
|
|
|
 |
|
 S L Block Searching for the Holy Grail of acute otitis media. Arch. Dis. Child., December 1, 2006; 91(12): 959 - 961. [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
