Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.

Current Medical Guidelines

In 2004, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) collaborated to issue evidence-based guidelines based on a review of the published evidence

Something was lost in the transmission: the guidelines have been over-simplified and misrepresented, so it’s useful to look at what they actually said. There were six parts:

1. Criteria were specified for accurate diagnosis.

• History of acute onset of signs and symptoms
• Presence of middle ear effusion (ear drum bulging, lack of mobility, air-fluid level)
• Signs and symptoms of middle ear inflammation: Either red ear drum or ear pain interfering with normal activity or sleep

They stressed that AOM must be distinguished from otitis media with effusion (OME). OME is more common, occurs with the common cold, can be a precursor or a consequence of AOM, and is not an indication for antibiotic treatment.

2. Pain should be treated regardless of whether antibiotics are used.

3A. Observation without antibiotics is an option for a child with uncomplicated AOM.

• Limited to otherwise healthy children and stratified by age
  • 6 mo to 2 years with non-severe illness and uncertain diagnosis
  • 2 and older without severe symptoms or with uncertain diagnosis.
  • All children under 6 mo should be treated.
• Parents must have ready means of communicating with clinician.
• A system must be in place to re-evaluate the child. Strategies include a parent-initiated visit and/or phone contact for worsening condition or no improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net antibiotic prescription to be filled if illness does not improve in 48 to 72 hours.

3B. Amoxicillin is the treatment of choice

4. Reassess in 48-72 hours.

• If AOM is confirmed in a patient being observed, start antibiotics.
• If patient is already on an antibiotic and symptoms persist, change it.

5. Encourage prevention

• Modify the modifiable risk factors: limit attendance at child care centers, breastfeed for 6 months, avoid supine bottle feeding and bottle propping, and avoid exposure to passive tobacco smoke.
• Influenza vaccine is 30% effective in reducing the incidence of AOM.
• Pneumococcal vaccine provides a 6% reduction.

6. No recommendations for CAM. They reviewed alternative medicine treatments and found no evidence to support them.

Alternative Medicine

Alternative medicine often misrepresents the facts: for instance, one homeopathic website says

Recent medical studies have shown that giving antibiotics does not effect [sic] the course of ear infections at all.

CAM offers a smorgasbord of options for treating ear infections, but none of them are supported by any credible scientific evidence. Here are a few examples:

• Jay Gordon, MD recommends herbal and homeopathic remedies.
• Joseph Mercola, DO warns that antibiotics are harmful, ineffective, and unnecessary. He recommends garlic ear drops, putting breast milk in the ear canal, and onion poultices.
• Natural News recommends chiropractic; essential oils; herbal remedies including Echinacea, goldenseal, olive leaf and St. John’s wort; and eliminating dairy.
• Andrew Weil, MD recommends cranial osteopathy and eliminating dairy products.
• Many chiropractors claim to treat ear infections with upper cervical adjustments to promote drainage of the ear and support immune function. Ear-related claims are particularly common in that profession because D.D. Palmer, founder of chiropractic, claimed to have been originally inspired by a case of curing deafness with a neck “adjustment.”
• An acupuncture website recommends needling TH 5, GB 41, GB 20, TH 17 and GB 2.
• A homeopathic website offers to treat the whole child instead of just treating ear infections. They consider the child’s personality, likes and dislikes, and other factors; then choose the right homeopathic remedy to strengthen the health of the child. They claim that their treatment will make everything in the patient’s life get better.

Difficulty of diagnosis

Parents suspect their child has an ear infection when they notice irritability, pulling at the ear, and fever. These symptoms may be due to other causes, some of them serious, so a diagnosis by a doctor is essential. Anyone who has attempted to examine the ears of a struggling 2-year-old realizes that diagnosis is not a straightforward, black-and-white procedure. Many clinicians are not skilled in pneumatic otoscopy and tympanometry and they may have to rely on the appearance of the tympanic membrane (TM) through a simple otoscope. The ear canal is narrow and the view often obstructed by wax. The TM can be red because the child is crying. It can be a difficult judgment call to say whether the TM is bulging or dull, especially when you can only see part of it. When a doctor sees a sick child with an unexplained fever, it is tempting to call it AOM and have an answer and an excuse to “do something” (give antibiotics) when the diagnosis is not really so clear.

New Studies

Critics have suggested that the studies the recommendations were based on had limitations such as biases in patient selection, varying diagnostic criteria, and suboptimal antibiotic regimens. Two new studies have re-assessed antibiotic treatment using strict diagnostic criteria and optimum antibiotic regimens.

On January 13, 2011 The New England Journal of Medicine published two very similar high-quality studies done in Pittsburgh and Finland. Neither was funded by Big Pharma or any other commercial entities. Both addressed acute otitis media in very young children (6-23 months and 6-35 months respectively). Both were randomized double-blind studies. Both used stringent diagnostic criteria, with examiners who were skilled otoscopists. Both used amoxicillin/clavulanate rather than amoxicillin alone, since the evidence now indicates it is the most effective treatment.

Both studies found that antibiotics were clearly superior to placebo. The Finnish study calculated an NNT of 3.8 (the number of children that must be treated for one to benefit). It found that the benefit was the same regardless of the severity of the illness. Diarrhea and diaper rash were more common in those getting antibiotics. One patient in the placebo group developed mastoiditis. No increase in colonization by antibiotic-resistant bacteria was found.

An accompanying editorial stresses that the key to the optimal management of acute otitis media remains the accuracy of the diagnosis.

Conclusion

It is now clear that young children with a certain diagnosis of AOM recover more quickly with antibiotic treatment. The benefits of antibiotic treatment must be balanced against the development of resistant strains and the recognized side effects of antibiotics. Watchful waiting is only appropriate for patients over 6 months old when the diagnosis is uncertain. The new studies suggest that severity of illness should not be a criterion for deciding which children to treat, but that the emphasis should be on accurate diagnosis. I’m guessing that these two new studies will lead to revised guidelines.