eMedicine Specialties > Otolaryngology and Facial Plastic Surgery > Middle Ear & Mastoid

Middle Ear, Otitis Media With Effusion: Treatment & Medication

Author: Richard D Thrasher III, MD, Private Practice, McKinney, Texas
Contributor Information and Disclosures

Updated: Oct 26, 2009

Treatment

Medical Care

A number of medical interventions have been suggested for the treatment of otitis media with effusion (OME), all with controversial but overall poor results. Historically, if MEE persists for 3 months, surgical intervention was indicated. This dogma has recently been revised and is discussed below.

• Modification of risk factors for OME: To the authors' knowledge, no randomized controlled trials have been performed to assess whether a modification of risk factors for OME decreases its prevalence. However, massive amounts of epidemiologic evidence suggest that modification of these risk factors is a reasonable primary care intervention. The following modifications may help:
  • Avoiding secondhand smoke
  • Breastfeeding whenever possible
  • Avoiding feeding, either by breast or bottle, while completely supine
  • Avoiding exposure to a large number of children, particularly in daycare centers
  • Avoiding exposure to children who are known to be affected
  • Avoiding known allergens
  • Kouwen and Dejonckere published a study in 2007 that demonstrated a 40% reduction in the prevalence of OME in children from the Netherlands who routinely (at least weekly) chew gum.⁴ Presumably, one hypothesis is that this is caused by the increased eustachian tube function secondary to palatal muscle action.
• Antimicrobial agents: Because OME demonstrates viable pathogenic bacteria, treatment with appropriate antibiotics is reasonable, albeit with evidence showing only short-term benefit.
  • Studies of erythromycin, sulfisoxazole, amoxicillin, amoxicillin-clavulanate, and trimethoprim-sulfamethoxazole have demonstrated clearance rates faster than those of a placebo, although the difference is barely statistically significant in most of these trials.
  • In 1992, a large meta-analysis of findings from 10 blinded randomized controlled trials involving 1041 children with OME revealed that resolution of MEE was significantly more likely in the patients treated with antimicrobials than in those treated with placebo or those receiving no treatment. The difference was noted at short-term (2- to 5-wk) follow-up. The findings of 2 other meta-analyses in 1993 and 1998 did not demonstrate a difference between antimicrobials and placebo with 6- to 11-week follow-up period.
  • When the OME becomes chronic (3 mo), the effectiveness of antimicrobials diminishes, although this finding is controversial.
  • Studies published between 2002 and 2004 and cited by the clinical practice guidelines for OME also demonstrate clearance of MEE with antibiotics; however, they also show rapid and frequent recurrence.
• Steroids
  • In 3 placebo-controlled randomized clinical trials, oral steroids alone did not improve OME clearance within 2 weeks of treatment. When oral steroids are combined with antibiotics, the rate of clearance of MEE does not improve compared with the rate with antibiotics alone. A couple of small studies of topical nasal steroid sprays (versus placebo) have demonstrated fewer effusions at 4 and 8 weeks, as well as improved middle ear pressure at 12 weeks. Empirical evidence indicates that these medications show promise. To the authors' knowledge, only one randomized study has been published comparing intranasal steroids (beclomethasone) and antibiotics to antibiotics alone. This study demonstrated no statistically significant difference between the 2 arms.
  • Williamson et al found that topical intranasal corticosteroids are very unlikely to be effective for treating otitis media with effusion.⁵ In a double-blind randomized placebo-controlled trial in 207 children aged 4-11 years with persistent bilateral otitis media with effusion, children received either mometasone, 50 mcg in each nostril, or placebo spray once daily for 3 months. Tympanometric clearance in one or both ears at 1, 3, and 9 months was 40.6%, 58.1%, and 55.6%, respectively, in the steroid group and 44.9%, 52.3%, and 65.3%, respectively, in the placebo group. Absolute risk reduction at 1 month was -4.3%; 95% confidence interval [CI], -18.05%-9.26%; odds ratio 0.84, 95% CI, 0.48-1.48).
• Antihistamines and decongestants: In the largest study to date, Cantekin and others randomly assigned 553 children with COME to receive an antihistamine/decongestant or placebo.⁶ The clearance rates of the effusion did not differ. That antihistamines increase the viscosity of secretions may account for this finding. The viscosity of COME is often substantial; thus, it is aptly termed glue ear in these cases. COME can also manifest as a serous effusion as well. However, nasal obstruction, rhinorrhea, and sinusitis often accompany otitis media, and antihistamines and decongestants may be considered for the relief of these associated symptoms. This is particularly true if the inciting cause is allergies. Antihistamines, as the name suggests, prevent the degranulation of mast cells and subsequent release of histamine, which can lead to mucosal engorgement with resultant increase in nasal obstruction and an increase in the production of mucus.
• Mucolytics: In 1993, a large randomized controlled study of 430 children revealed that clearance rates for OME did not significantly improve with mucolytics versus placebo. Findings of 2 smaller trials of other mucolytics confirmed this result.
• Autoinflation: Several investigators have reported mixed results when attempting to determine if autoinflation, compared with no intervention, improves effusion clearance rates. The ambiguity in the data may be a result of great variability in autoinflation methods and/or noncompliance in patients. In 1999, a meta-analysis of findings from 6 randomized controlled studies did reveal a benefit with the use of nasal balloons for autoinflation in children.

Summary of Medical Intervention

The American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on Otitis Media with Effusion published clinical guidelines in 2004 with the following verbatim nonsurgical recommendations for OME:

1. Document the laterality, duration of effusion, and presence and severity of associated symptoms at each assessment of the child with OME.
2. Distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME and more promptly evaluate hearing, speech, language, and need for intervention in children at risk.
3. Manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known), or from the date of diagnosis (if onset is unknown).
4. Hearing testing should be conducted when OME persists for 3 months or longer, or at any time that language delay, learning problems, or a significant hearing loss is suspected in a child with OME.
5. Children with persistent OME who are not at risk should be re-examined at 3-6 month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected.

Surgical Care

Surgery has become the most widely accepted therapeutic intervention for persistent otitis media with effusion (OME), and it is clearly effective. The interventions include myringotomy with or without tube insertion, adenoidectomy, or both. Tonsillectomy has been shown to be of little benefit as a primary treatment of OME.

The indications for surgical intervention remain controversial but have changed with the practice guidelines published in 2004. As with all surgery, the benefits of intervention must outweigh the risks.

Previously, surgical intervention was advocated if fluid persisted beyond 3 months. However, 2 well-conducted long-term studies showed that in the absence of a significant hearing loss, children who were only observed compared with those children who received pressure equalization (PE) tubes had no difference in quality of life or overall hearing, speech, and language abilities. Therefore, in the presence of hearing thresholds better than 20 dB, observation is an option. On the other hand, only 30% of patients who have OME after 3 months duration will clear that effusion over the next 12 months; therefore, ongoing monitoring of hearing levels is required.

According to clinical guidelines on OME, certain changes to the tympanic membrane may mandate PE tube insertion despite normal hearing. These conditions include posterosuperior retraction pockets, ossicular erosion, adhesive atelectasis, and retraction pockets that accumulate keratin debris. Ongoing surveillance is mandatory because the frequency of structural damage increases with effusion duration.

For patients with hearing loss and OME, a loss greater than or equal to 40 dB is felt to be an absolute indication for PE tube insertion. A loss in the range of 21-40 dB is a relative indication with a very low threshold for placement.

Moreover, the clinical guidelines suggest more aggressive therapy for children at risk for developmental delays, particularly in the areas of speech and language development. Children who may be at risk include any of the following:

• Children with permanent hearing loss independent of otitis media with effusion
• Those with suspected or diagnosed speech and language delay or disorder
• Those with autism spectrum disorder or other pervasive developmental disorders
• Children with syndromes (eg, Down syndrome) or craniofacial disorders that include cognitive, speech, and language delays
• Those who are blind or have uncorrectable visual impairment
• Children with cleft palate, with or without an associated syndrome
• Children with developmental delay

Again, most cases of OME resolve spontaneously, and such spontaneous resolution is more common in the spring and summer. Thus, a conservative approach is often warranted at these times of the year; whereas, in fall and winter, exacerbations are more common, and surgical intervention is likely to yield better control.

• Myringotomy and aspiration of effusion
• When performed alone without the placement of PE tubes, this procedure has proved disappointing in long-term follow-up in children. Gates and others have shown that when myringotomy is performed with PE tube placement, the following improved: hearing, duration of MEE, time to recurrence, and need for repeated procedures.
• Myringotomy and aspiration may be more a reasonable treatment in adults who can undergo the procedure in the office. The benefit is that immediate improvement in hearing and symptoms of aural fullness and pressure are possible. The drawback is that the incision usually heals within a week, whereas the underlying problem of eustachian tube dysfunction takes longer to resolve (6 wk on average); therefore, recurrences are common.
• Myringotomy and aspiration is useful to treat patients with moderate to severe hearing loss as they recover normal middle ear function. A 20-25 dB conductive hearing loss added to their underlying loss may render hearing aids or other coping devices or strategies inadequate.
• Myringotomy with pressure equalization tube (PET) insertion
• Introduced in 1954 by Armstrong, this intervention has become the criterion standard and most common therapy for COME. Improved hearing and decreased rates of AOM are absolute benefits of this procedure; these have been documented multiple times. Typically, the tubes self-extrude 9-12 months after placement.
• PETs are available in a variety of sizes, shapes, and materials. All are designed to permit ventilation of the middle ear and mastoid system. Prolonged aeration of the middle ear has been shown to reverse the mucosal hyperplasia and metaplasia that accompany OME.
• The overall complication rate after PET placement is about 11%. Persistent otorrhea is the most common complication, occurring in 15% of patients and persisting as long as 1 year in 5%. Second in frequency is tympanosclerosis, which is not likely to be clinically significant unless it is extensive. Persistent perforation is the third most common complication. Its exact frequency is unknown (estimates approximate 2%), but it increases markedly if PETs remain in place longer than 18 months. It is also known to increase with the placement of T-tubes that are designed to stay in the tympanic membrane longer than the typical grommet tube. They can stay in place for years and are more commonly used for the patient with recurrent or chronic OM that has failed to improve after the placement of grommet tubes. Other potential complications include granulation tissue formation, cholesteatoma, and sensorineural hearing loss.
• Clinical guidelines summarize a number of studies and state that tympanostomy tubes are recommended for initial surgery because randomized trials show a mean 62% relative decrease in effusion prevalence and an absolute decrease of 128 effusion days per child during the next year. Hearing levels improve by a mean of 6-12 dB while the tubes remain patent.
• Adenoidectomy
• Although adenoidectomy was once the principal treatment for OME, easy and low-risk PET placement is now favored.
• Three rationales exist for the removal of the adenoids in the treatment of OME.
• First is removal because of enlargement. This theory states that large adenoids occlude the nasopharynx and choanae and lead to excessive nasopharyngeal pressure during swallowing. This potentiates eustachian tube reflux. Multiple studies have revealed that the result of adenoidectomy, however, is independent of adenoid size. This finding suggests that processes other than simple adenoid mass are involved.
• The second rationale is the improvement of eustachian tube function. Improvement in the equilibration of positive middle ear pressure after adenoidectomy has been documented. In addition, extremely large adenoids may physically occlude the eustachian tube orifice, although Bluestone and others have shown that this is rare. The obstruction is nearly always functional.
• The third and most recent rationale for adenoidectomy is removal of a potential source of inflammation and infection at the eustachian tube orifice. When performed correctly, adenoidectomy can be used to create a smooth nasopharyngeal mucosa, which decreases the colonization of bacteria that can occur in the crypts of adenoid tissue.
• Whatever the rationale used, adenoidectomy alone was found to be nearly as effective as PET placement for treatment of OME. When adenoidectomy is performed with PET placement, the frequency of recurrent disease, disease-free interval, and duration of disease all improved, compared with the use of either procedure alone.
• Complications of adenoidectomy include bleeding (0.4%), velopalatal insufficiency (usually temporary), and a patulous eustachian tube. 

Summary of Surgical Intervention

Again, a verbatim summary of the recommendations of the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on Otitis Media with Effusion (2004) clinical guidelines are as follows:

• When a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure.
• Adenoidectomy should not be performed unless a distinct indication exists (eg, nasal obstruction, chronic adenoiditis).
• Repeat surgery consists of adenoidectomy plus myringotomy, with or without tube insertion.
• Tonsillectomy alone or myringotomy alone should not be used to treat OME.

Consultations

• An otolaryngologist should be consulted whenever the primary care physician is concerned about persistent conductive hearing loss in children, especially those with signs of language development delay.
• In addition, an otolaryngologist should be consulted if the disease is recurrent, if the appropriate medical therapies available to the primary care physician are exhausted, and/or if the criteria for surgical intervention have been met.
• An allergist, audiologist, and/or a speech therapist may be consulted, when appropriate.
• In select cases, an immunologist may be consulted for the workup for a possible immunocompromised state.

Diet

Breastfed babies have a lower risk of AOM and OME. Moreover, placing a child in the supine position while bottle feeding substantially increases the risk of OME, presumably because it contributes to eustachian tube reflux during swallowing.

Activity

During active OME, activity need not be limited. However, because of potential hearing loss, children may wish to sit closer to the teacher in their classrooms.

Medication

A consensus statement published in August of 2000 defined an appropriate logarithm for the medical treatment of AOM and RAOM.⁷ Antimicrobials are the only medications that have been shown to increase the rate of clearance of OME in randomized controlled trials. However, these benefits are temporary at best. The clinical guidelines from 2004 recommend avoiding the use of antibiotics, decongestants, oral steroids, and antihistamines for the treatment of OME due to evidence that cites their lack of effectiveness. The guidelines did not make a recommendation for or against the use of intranasal steroids, nor were any recommendations made for alternative medicine treatments.

Topical nasal steroids

Results of small trials have shown that nasal steroids speed the clearance of OME and prevent its recurrence. However, to the authors' knowledge, no large randomized trials have been performed to confirm this finding.

Fluticasone (Flonase)

Topical corticosteroid spray that has anti-inflammatory effects on the nasal mucosa and, presumably, on the nasopharynx, where the eustachian tube orifice is located.

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