FROM: J Am Board Fam Pract 2001; 14 (6): 474-476
By William F. Miser, MD, MA
Department of Family Medicine, The Ohio State University College of Medicine and Public Health, Columbus.
Acute otitis media (AOM) is a middle ear infection
with rapid onset of symptoms and an abnormal-appearing, immobile tympanic
membrane. Accounting for more than 20 million office visits a year in
the United States, AOM is one of the most common reasons a child sees
a family physician. [1-3] By their first birthday, nearly two
thirds of children will have at least one episode of AOM, and more than
90% will have one episode by age 2 years. [2,3] A diagnosis
of AOM is the most common reason children receive a prescription for antibiotics.
Nearly $5 billion is spent each year in the United States in managing
AOM [5,6]; this expenditure does not take into account the disruption
of child-care arrangements and work schedules. 
Despite the frequency and
enormous associated costs of AOM, recent evidence from the medical literature
has created controversy in nearly every aspect of its management. We,
as family physicians, overdiagnose AOM in the United States. [7,8]
A busy clinician examining a squirming, uncooperative toddler with an
ear canal occluded with cerumen often will err on the side of making a
diagnosis of AOM to please anxious parents. Diagnostic uncertainty by
primary care physicians is as high as 33% to 42%. [9,10]
Because symptoms and signs
(eg, fever, earache, tugging of the ear, irritability, etc) are nonspecific
and not always present, [3-11] an accurate diagnosis of AOM
requires a clear and well-illuminated view of the tympanic membrane. The
light of the otoscope should work well; bulbs for most otoscopes should
be changed every 2 years.  Pneumatic otoscopy and tympanometry
are tools useful in confirming middle ear effusion. A bulging or cloudy
tympanic membrane, with or without erythema, middle ear effusion, and
marked decrease or absence of tympanic membrane mobility, is nearly 100%
predictive of AOM.  Perforation of the tympanic membrane
with purulent drainage is also diagnostic of AOM.
Recent evidence has thrown
into question the use of antibiotics and the length of treatment, if prescribed.
The growing worldwide development of multidrug-resistant bacteria, the
uncertainty of diagnosis, and that up to one third of cases of AOM are
viral in origin  have made popular a wait-and-see approach
to the initial prescription of antibiotics, especially in many European
countries. In several randomized clinical trials, antibiotics provided
only a small benefit. [13-15] In a meta-analysis of more than
2000 children with AOM, ear pain resolved spontaneously without antibiotics
in two thirds by 24 hours and in 80% by day 7.  This study
estimated that 17 children would need to be given antibiotics to prevent
1 child from having some pain after 2 days, at the cost of a twofold increase
in adverse reactions, such as skin rash, vomiting, or diarrhea. Minimizing
the use of antibiotics in children with AOM does not increase the risks
of perforation of the tympanic membrane, hearing loss, contralateral or
recurrent AOM, or development of mastoiditis.  In summary,
the immediate prescription of antibiotics offers some benefits, but these
benefits are offset by the disadvantages of increased cost, drug resistance,
and adverse reactions. Watchful waiting is feasible and acceptable to
most parents, with a 76% reduction in the use of antibiotics. 
If antibiotics are used,
amoxicillin remains the drug of choice for most children. [16,17]
Although there are more than 1 dozen other clinically effective antibiotics
approved by the Food and Drug Administration for treating AOM, none of
these more expensive options has been shown to be more effective for empiric
therapy of uncomplicated AOM.  Because of recent in-vitro
evidence and some clinical experience of increasing penicillin-resistant
Streptococcus pneumoniae,  a working group of
the Centers for Disease Control advised doubling the amoxicillin dose
to 80-90 mg/kg/d.  For those children who show no improvement
with this increased dose in 3 to 5 days, alternatives such as amoxicillin-clavulanate
(Augmentin), cefuroxime axetil (Ceftin), or the more expensive but better
tolerated third-generation cephalosporins offer good alternative treatment
There is strong evidence
that 5 days of antibiotic therapy is as effective as the traditional 10-
to 14-day regimen for uncomplicated AOM in children. [21-23]
Although the 5-day regimen has a slightly higher risk of treatment failure
at a 1-month follow-up compared with the longer course, there appears
to be no difference in long-term (2 to 3 months) outcomes. 
Other controversies exist
as to the role of surgery (tympanostomy tubes, adenoidectomy, or tonsillectomy)
in the management of chronic effusion and frequent, recurrent episodes
of AOM. Clearly, more evidenced-based studies are needed.
In this issue of the JABFP,
we have yet another high-quality study from the International Primary
Care Network (IPCN) and the Ambulatory Sentinel Practice Network (ASPN),
which provides insight into the management of AOM.  From
an evidence-based medicine perspective, this group shows the benefit of
a large primary care practice-based research network in studying such
common primary care problems as AOM. These 131 family physicians, general
practitioners, and pediatricians enrolled 2,165 children with AOM, a feat
difficult to achieve in the traditional university medical center settings.
As outlined in their article,
our approach in North America to treating AOM is quite different from
that of colleagues worldwide. In the Netherlands, from which arise many
of the recent studies questioning the conventional management of AOM,
physicians treat AOM in children symptomatically with analgesics and antipyretics
and reserve antibiotics for those whose symptoms persist beyond 3 days.
The British physicians treat AOM in almost all children with antibiotics
for 5 to 7 days, whereas in North America our standard is to treat with
antibiotics for 10 days.
To eliminate the problems
of diagnostic uncertainty and overdiagnosis, physicians involved in this
study were well trained in doing an ear examination, performing pneumatic
otoscopy (except in the United Kingdom, where it is not routinely available),
and in interpreting tympanometry. The extensive history obtained from
parents showed that differences do exist in AOM risk factors among the
countries. At the same time it also confirmed what we already know - cigarette
smoking within the household, recent upper respiratory tract infections,
and attendance at a large day care center are associated with the occurrence
of AOM, whereas breast-feeding appears to be protective, particularly
in those aged 6 to 24 months.
The authors developed a
novel yet simple scale for assessing the severity of AOM. The use of this
severity scale suggested that parents in North America seek medical care
for their children much earlier than do those of their British and Dutch
counterparts. In the Netherlands, it usually takes more than just tugging
at the ears or fussiness for parents to bring their children to a primary
care physician. The cost for this delay, however, appears to be more tympanic
membrane perforations. It is unknown whether this delay results in future
worse outcomes, such as hearing or speech deficits or developmental problems,
but evidence thus far suggests that such outcomes do not occur.
It was encouraging to find
that most primary care physicians continue to use a first-line agent,
such as amoxicillin, in the initial treatment of AOM. Despite evidence
in the literature, however, physicians in North America tend to choose
the more costly second-line antibiotics, such as cephalosporins, for older
children and for those with perceived more severe disease.
This study rightly points
out that we need to be cautious when adopting treatment policies from
various countries that have different approaches to health care and different
risk factors. It also highlights the potential benefits of adopting the
wait-and-see approach, with its decrease in the use of antimicrobials
and a possible annual savings in the United States of $185 million. A
lot of prenatal care to the underserved can be provided with those savings.
Finally, this study is
just one step in evidence-based medicine. Applying this information in
clinical practice is equally important. Changing physician behaviors is
quite difficult, as highlighted in my own residency program. In the face
of mounting evidence 2 years ago that we overdiagnose AOM and should at
least consider shortening the course of antibiotics, if used, my residents
and colleagues continue to prescribe 10 days of antibiotics. When asked
why, the reply is, "Well, that's what they do in pediatrics." Obviously,
we have a long way to go before we fully adopt an evidence-based approach
Submitted 28 September 2001
Address reprint requests
to William F. Miser, MD, MA,
Department of Family Medicine, The
Ohio State University College of Medicine and Public Health, 2231 North
High St, Columbus, OH 43201.
Coyte PC, Croxford R, McIsaac W, Feldman W, Friedberg
J. The role of adjuvant adenoidectomy and tonsillectomy in the outcome
of the insertion of tympanostomy tubes. N Engl J Med 2001;344:1188-95.
Albrant D. APhA drug treatment protocols: management of
pediatric acute otitis media. J Am Pharm Assoc 2000;40:599-608.
McConaghy JR. The evaluation and treatment of children with
acute otitis media. J Fam Pract 2001;50:457-9, 463-5.
Finkelstein JA, Metlay JP, Davis RL, Rifas-Shiman SL, Dowell
SF, Platt R. Antimicrobial use in defined populations of infants and
young children. Arch Pediatr Adolesc Med 2000;154:395-400.
Gates GA. Cost-effectiveness considerations in otitis media
treatment. Otolaryngol Head Neck Surg 1996;114:525-30.
Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal
conjugate vaccine against acute otitis media. N Engl J Med
Berman S. Otitis media in children. N Engl J Med
Pichichero M. Acute otitis media: Part I. Improving
diagnostic accuracy. Am Fam Physician 2000;61:2051-6.
Froom J, Culpepper L, Grob P, et al. Diagnosis and antibiotic
treatment of acute otitis media: report from International Primary Care
Network. BMJ 1990;300:582-6.
Jensen P, Lous J. Criteria, performance and diagnostic
problems in diagnosing acute otitis media. Fam Pract 1999;16:262-8.
Heikkinen T, Ruuskanen O. Signs and symptoms predicting acute
otitis media. Arch Pediatr Adolesc Med 1995;149:26-9.
Heikkinen T, Thint M, Chonmaitree T. Prevalence of various
respiratory viruses in the middle ear during acute otitis media. N
Engl J Med 1999;340:260-4.
Del Mar C, Glasziou P, Hayem M. Are antibiotics indicated
as initial treatment for children with acute otitis media? A meta-analysis.
Glasziou P, Del Mar C, Sanders S. Antibiotics for acute otitis
media in children (Cochrane Review). The Cochrane Library, issue 3.
Oxford, England: Update Software, 2000.
Little P, Gould C, Williamson I, Moore M, Warner G, Dunleavey
J. Pragmatic randomized controlled trial of two prescribing strategies
for childhood acute otitis media. BMJ 2001;322:336-42.
Klein JO. Clinical implications of antibiotic resistance for
management of acute otitis media. Pediatr Infect Dis J 1998;17:1084-9.
Block SL. Strategies for dealing with amoxicillin failure
in acute otitis media. Arch Fam Med 1999;8:68-78.
Pichichero ME, Reiner SA, Brook I, et al. Controversies in the
medical management of persistent and recurrent acute otitis media.
Recommendations of a clinical advisory committee. Ann Otol Rhinol
Laryngol Suppl 2000;183:1-12.
Dowell SF, Butler JC, Giebink GS, et al. Acute otitis media:
management and surveillance in an era of pneumococcal resistancea
report from the Drug-resistant Streptococcus pneumoniae Therapeutic
Working Group. Pediatr Infect Dis J 1999;18:1-9.
Steele RW, Thomas MP, Begue RE. Compliance issues related to
the selection of antibiotic suspensions for children. Pediatr Infect
Dis J 2001;20:1-5.
Pichichero ME, Marsocci SM, Murphy ML, Hoeger W, Francis AB,
Green JL. A prospective observational study of 5-, 7-, and 10-day
antibiotic treatment for acute otitis media. Otolaryngol Head Neck Surg
Kozyrskyj AL, Hildes-Ripstein GE, Longstaffe SE, et al.
Treatment of acute otitis media with a shortened course of antibiotics:
a meta-analysis. JAMA 1998;279:1736-42.
Kozyrskyj AL, Hildes-Ripstein GE, Longstaffe SE, et al. Short
course antibiotics for acute otitis media. Cochrane Database Syst Rev
Froom J, Culpepper L, Green LA, et al. A cross-national study
of acute otitis media: risk factors, severity, and treatment at initial
visit. Report from the International Primary Care Network (IPCN) and
the Ambulatory Sentinel Practice Network (ASPN). J Am Board Fam
Return to the PEDIATRICS Section