There have been few true advances in the treatment of otitis media since Armstrong’s reintroduction of the tympanostomy tube in 1954.1 Management decisions have revolved around three primary options: not to treat, to use antibiotics, or to recommend tympanostomy tubes. Other modalities have been suggested, some shown to be of little benefit (decongestants, antihistamines),2 and others to have a limited degree of efficacy (Xylitol gum, Otovent balloons, steroids).3–7 However, with the millenium, there is the promise of new treatment options (laser myringotomy, vaccination), coexistent with the rapid proliferation of drug resistant Streptococcus pneumoniae.
Otitis media management has always been dogged by controversy. Any disorder in the United States alone that is estimated to cost $5 billion year,8 yet for which the benefits of intervention are often not evidence-based, is bound to generate controversy. It remains the commonest cause for visits to the doctor in the pediatric population (24.5 million visits/year in the United States), generating the largest number of antibiotic prescriptions (23.6 million).9
Otitis media research also has the potential to confuse and confound as much as it contributes to our knowledge. There are three main reasons for this. First, clinical research has to deal with so many coexistent factors (e.g., season, age, child care, upper respiratory tract infections [UTI]) that significance tends to be diluted, unless very large numbers are involved. Second, much research deals with surrogate outcomes (effusion resolution for example), while long-term true outcomes (e.g., IQ, employment status) are much harder to come by. Meta-analysis is particularly amiss when it comes to grouping subtly disparate studies. Finally, we are overwhelmed by definitions, and what seems very obvious is not always so. For example, Hayden10 illustrated this nicely when he surveyed 165 pediatricians, who had 147 different definitions for acute otitis media.
Background
References to the treatment of otitis media date back to Hippocrates. Myringotomy as a treatment was in vogue in the eighteenth and nineteenth centuries before its resurgence in the present day.11 The primary concern during the preantibiotic era was the potential for intracranial complications of acute otitis media.12 Historically, this was a significant cause of mortality; 70 years later, mortality from ear disease is so rare as to be occasionally—and regrettably—forgotten in the multitude of treatment paradigms available.
The current emphasis is more on otitis media with effusion (of the persistent or chronic variety) and on its long-term consequences. There is a general common sense consensus that long-term untreated otitis media with effusion is an undesirable state, but it has been remarkably hard for this to be proved conclusively. There is indirect evidence to back this view,13–16 as well as the usual contrary opinion.17 This is not an area suited to randomized double-blind controlled study, as nontreatment or placebo control cannot be justified in the management of long standing OME.
Acute Otitis Media
Acute otitis media (AOM) is a disorder that lacks a well-accepted universal definition. This problem significantly compromises the comparability of many studies. However, a purulent middle ear effusion with systemic signs of illness (e.g., pain, fever) is a useful yardstick. Systemic signs of illness, such as fever, with the presence of a middle ear effusion (which may be incidental), is not sufficient to necessarily warrant the diagnosis of AOM. Similarly, a not-infrequent incidental finding is of a cloudy or purulent effusion in an otherwise symptomless child—also not enough to warrant a label of AOM. AOM is not always an easy diagnosis to make (or refute!) which may partly explain why it is one of the most overdiagnosed conditions in pediatric practice.
AOM may be further subdivided into simple AOM, AOM with complications, resistant or prolonged AOM, recurrent AOM, or recurrent AOM with a background of otitis media with effusion (OME). It is prudent not to lump these many categories together when arguing the pros and cons of treating, or not treating, AOM. In this context, treatment implies antibiotics, though in a symptomatic child acetaminophen may be an equally and certainly more rapidly effective intervention.
Although rare, AOM does have serious complications, and otolaryngologists are more likely to have exposure to a few a year, as opposed to a few in a practicing lifetime. Untreated or partially treated AOM may result in facial nerve palsy, meningitis, mastoiditis, petrositis, labyrinthitis, sigmoid sinus thrombosis, and extradural, subdural, or cerebral abscesses. No one will argue the need to treat aggressively under these circumstances. The dilemma is that the incidence of these complications has plummeted, coincident—but surely not coincidental—with the onset of the antibiotics era. Currently, a body of opinion holds that we are over-using antibiotics and that we should not necessarily treat AOM. If so, are we on the threshold of returning to the era of the midnight cortical mastoid? Probably not. There is a body of mainly European literature on the nonantibiotic treatment of AOM.18–20 For the most part, complication risks are low and may often be intercepted. Similarly, the incidence of antibiotic use in AOM varies widely, from 98% in Australasia and the United States, to 31% in the Netherlands, with no discernable difference in the incidence of complications.21
There are two goals in treatment: the prevention of complications, and alleviation of symptoms. Symptomatically at 24 hours 60% of children are pain free whether on antibiotic or placebo, although antibiotics have a small symptomatic advantage at 1 week, and help prevent contralateral AOM.22 The high natural resolution rate of AOM is the primary argument for the nonantibiotic treatment of AOM. But as the complications may have profound consequences, who and when should we treat? There is no black-and-white answer to this but, in general, consensus opinion has it that a child who is symptomatic warrants antibiotic treatment. So when not to treat? It is reasonably common to observe a child who has been symptomatic but who arrives in your office totally asymptomatic despite a purulent effusion. It is implicit that the child should be closely monitored and timely intervention initiated if there is any deterioration.
The social setting of the child must also play a role in decision-making. An increasing number of families are now reliant on two working parents, often without an extended family for child care support. Day care for even the very young is now commonplace and is a significant risk factor for the onset of AOM,23 with a much higher incidence of resistant organisms than in the rest of the community. Most child care facilities will not tolerate a sick child, necessitating that a parent take time off from work. This problem increases the pressure to treat. Even a small advantage with antibiotics may be of significance to a working parent.
How long to treat? Recent articles suggest that 5 days of antibiotics is sufficient in the treatment of simple AOM in a child over 2 years, and that 10 days is prudent in a child under age 2.24 The minimum effective course is the aim both in terms of this environment of increasing antibiotic resistance, and because antibiotics treatment is not necessarily benign.9, 22
Recurrent AOM may be treated on an episode-to-episode basis, with the expectation that, as the eustachian tube matures, the tendency to AOM will steadily reduce. However, many cases warrant further intervention, whether by prophylactic antibiotics or by tympanostomy tubes. Both are designed to buy time while the eustachian tube matures. The use of prophylactic antibiotics, whether for AOM or any other condition, is a very contentious area especially when viewed in the light of increasing antibiotic resistance.25–27 A meta-analysis of nine papers by Williams et al.28 suggests a small benefit compared with placebo, particularly in children with multiple episodes of AOM. However, nine children needed treatment to benefit one. There is also evidence that if breakthrough AOM occurs while on prophylaxis, there is a much higher incidence of resistant organism recovery. Meanwhile, tympanostomy tubes usually require a general anesthetic and may be associated with discharging ears, or infrequently with a persistent perforation of the tympanic membrane. They are particularly appropriate in the very young, as recurrent AOM in children younger than 1 year of age significantly predisposes to ongoing AOM and OME problems for the next 6 or 7 years.29
The role of tympanocentesis remains an area of controversy. It is not a common procedure in the United States, unlike parts of Europe. The advantages of tympanocentesis are the confirmation of the diagnosis of otitis media and provision of a middle ear specimen to culture.30 It does not significantly aerate the middle ear, and in most circumstances, even with a myringotomy, the puncture site closes within hours to days. Opponents of the widespread use of tympanocentesis are concerned that there may be damage to other structures in the middle ear space (i.e., the ossicular chain, oval window, dehiscent jugular bulb, aberrant carotid artery). The reported incidence of such complications is very low, although there is potential for a reporting bias. It would seem reasonable that anyone who is suitably trained and who appreciates the anatomy could perform this procedure (which in some respects is comparable to a lumbar puncture). If the anatomy is unclear, the physician should know when to refer. When is tympanocentesis appropriate? In the research setting, in neonates, in the immunocompromised, when there is strong need for a microbiologic diagnosis and sensitivities, and in severe, persistent, or prolonged AOM.
Otitis Media with Effusion
Although, strictly speaking, AOM is a subset of OME, by implication OME describes a nonacutely infected middle ear effusion. Chronic OME is defined as an effusion persisting for more than 3 months’ duration, and is a rather limiting term—perhaps a better description is persistent OME. Synonyms include serous otitis, secretory otitis, glue ear, and middle ear catarrh. Unlike AOM, OME is probably underdiagnosed and may present a diagnostic challenge, especially if otoscopy alone is used. Pneumatic otoscopy, especially if complimented by tympanometry, is sensitive in experienced hands. The natural history of this disorder is for spontaneous resolution in the majority of cases—more than 80% resolution by 2 months.31