SGEM#132: One Balloon for Otitis Media with Effusion

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Date: October 15th, 2015

Guest Skeptic: Dr. Richard Lubell is a community pediatrician in London, Ontario with over 30 years of experience. He is an associate professor in the Department of Pediatrics at Western University.

Case: A four-year-old boy presents to the emergency department after being picked up from school. The mother is worried he has another ear infection. This is because the teacher thought he was having trouble hearing in class. The child completed a course of antibiotics two months ago for acute otitis media. On examination the child looks well and has no fever. Otoscopic examination demonstrates some fluid behind the tympanic membrane.

Background: Otitis media with effusion or glue ear can be defined as a condition that that persists for more than six weeks. There were over two million cases diagnosed in the USA in 2004 with a cost of approximately four billion dollars.

Otitis media with effusion has been reported as the most common chronic condition of childhood and the most common reason for surgery in this age group. The reason we are so concerned about these effusion is hearing loss. Fluid in the middle early can cause a conductive hearing loss that if unrecognized and untreated can translate to broader developmental difficulties.

There are a number of ways to check for middle ear effusions all with various strengths and weaknesses:

Otoscopy: This allows you to look at the tympanic membrane and see if there is fluid but this does not tell you if the ear drum actually moves.
Pneumatic Otoscopy: This gives you a more dynamic assessment of the tympanic membrane (does it move in response to pressure changes).
Tympanometry: This give you objective/quantitative measure of the compliance of the tympanic membrane.
Pure Tone Audiometry: This can determine the degree and type of hearing loss. Depending on the results it can suggest a conductive hearing loss due to fluid in the middle ear.

Tympanometric evaluation to diagnose otitis media with effusion can give three main results:

Type A normal
Type B (flat) abnormal
Type C indicates negative pressure in middle ear and possibly an abnormality

Various treatments have been tried for treating otitis media with effusion:

Antibiotics – “our review do not support the routine use of antibiotics for children up to 18 years with otitis media with effusion”. Van Zon et al CDSR 2012
Antihistamines/Decongestants – “No statistical or clinical benefit was found for any of the interventions or outcomes studied. However, treated study subjects experienced 11% more side effects than untreated subjects (number needed to treat to harm = 9). Griffin and Flynn CDSR 2011
Oral or Topical Nasal Steroids –“there is no evidence of longer-term benefit and no evidence that they relieve symptoms of hearing loss. We found no evidence of benefit from treatment of OME with topical intranasal steroids, alone or in combination with an antibiotic, either at short or longer-term follow up.” Simpson et al CDSR 2011
Grommets (venting tubes) –“effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children” Browning et al CDSR 2010
Nasal Balloon Devices – “All of the studies were small, of limited treatment duration and had short follow-up. However, because of the low cost and absence of adverse effects it is reasonable to consider autoinflation whilst awaiting natural resolution of otitis media with effusion”. Perera et al CDSR 2013 This Cochrane review finished with a call for further research.

Clinical Question: Can a nasal balloon autoinflation device be a safe and effective treatment for children with otitis media with effusion?

Reference: Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. CMAJ Sept 2015

Population: Children age 4 to 11 years of age with recent history of ear symptoms and otitis media with effusion in one or both ears confirmed by tympanometry
- Exclusions: Already have acute otitis media; judged clinically to have high risk of recurrence (Down’s syndrome, Katagener’s, Primary Ciliary Dyskinesia, immunodeficiency states, etc); four year old children not attending school or unable to comply with the auto inflation device; recent or planned venting tube surgery; latex allergy; recent nose bleed)
Intervention: Autoinflation three times a day for one to three months
Comparison: Usual care
Outcome:
- Primary Outcome: Tympanometric resolution of effusion at one month
- Secondary Outcome:
  - Tympanometric resolution of effusion at three months
  - Study questionnaire at one and three months
  - Weekly diaries up to three months (record days with hearing loss, earache as well as recording periods of remission and recurrence
  - Tympanometric resolution in at least one affected ear per child at three months
  - Quality of life measured at three months using the OMQ-14, parents completed weekly diaries (hearing loss, earache, days off school, days requiring pain relief and sleep disturbances)
  - Hearing using the web Two Alternative Auditory Disability and Speech Reception Test (TADAST) speech recognition

Authors’ Conclusions: “Autoinflation in children aged 4–11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life.”

Quality Checklist for Randomized Clinical Trials:

The study population included or focused on those in the ED. No. Patients were identified through four possible routes. Once identified, the child had a screening appointment with a research nurse who performed an otoscopic exam and a tympanogram.
The patients were adequately randomized. Yes. 50:50 by a web based randomization method.
The randomization process was concealed. Yes
The patients were analyzed in the groups to which they were randomized. No. Their protocol was for an intention to treat (ITT) analysis but they did a modified ITT.
The study patients were recruited consecutively (i.e. no selection bias). No
The patients in both groups were similar with respect to prognostic factors. Unsure. There were some differences between groups: Specifically, the number of children who received antibiotics in the month prior to randomization.
All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No. This was an un-blinded study.
All groups were treated equally except for the intervention. Unsure. The autoinflation device was available over the counter. Parents/guardians were explicitly asked prior to randomization not to buy/use the device for three months. However, contamination bias could have occurred in the control arm. This was to be monitored in the study but we did not see if they discovered any contamination.
Follow-up was complete (i.e. at least 80% for both groups). Yes. They had 8% loss at one month and 12% loss at three months. Loss to follow up is an important concept and SketchyEBM has a great video explaining why.
All patient-important outcomes were considered. Unsure. Hearing was to be assessed as a secondary outcome using the web Two Alternative Auditory Disability and Speech Reception Test (TADAST). However, the TADAST data could not be found in the publication. In addition, pure tone audiometry was not performed to confirm any hearing loss.
The treatment effect was large enough and precise enough to be clinically significant. No.

Primary Outcome: Resolution at One Month – No Superiority

Key Results:

Primary Outcome: Resolution at One Month:
- 36% (standard) vs. 47% (intervention
- Adjusted Relative Risk (RR)=1.39 (95% CI 0.99-1.88)
- **RR=1.27 (95% CI 0.95-1.71)
Secondary Outcome: Resolution at Three Months:
- 38% (standard) vs. 50% (intervention)
- RR= 1.37 (95% CI 1.03-1.83)
- ** RR=1.22 (95% CI 0.92-1.63)
** Sensitivity Analysis: multiple imputation of all missing data using baseline variables
Harm to Autoinflation:
- Table #4 of the manuscript lists the adverse events by study group. They were fairly similar between standard care and autoinflation. However, there were more respiratory infections in the treatment group 15% vs. 10%. Most of these were mild afebrile rhinorrhea.
- There were also two children removed from the treatment group after randomization. One child was removed because of mild/early mastoiditis and the other due to otalgia. These two children had their data excluded from analysis as part of their “modified” intention to treat analysis.

Not Emergency Department Patients – This was a pragmatic primary care study. It is not known if the child recruited from the office setting would be different than the child brought into the emergency department.
Not Consecutive Patients –There could be selection bias. These were not patients consecutively recruited presenting to the office. Despite otitis media with effusion being the most common chronic condition of childhood, it would have taken many more sites or more time to recruit enough children with this condition.
Not Blinded – Lack of blinding is one of the big limitation of this study, especially when it comes to the subjective secondary outcome measures. They say that a placebo was not possible. Why not just have balloons that can be inflated with much less pressure? Why not have a sham device that would not impact the eustachian tube. This could have minimized the placebo effect and made the secondary results much stronger.
Modified Intention to Treat Analysis (ITT) – They performed a modified ITT (excluded children for whom no outcome measurements could be made). When they did the sensitivity analysis for missing data they got “similar” but smaller relative risk that were not statistically significant (crossed the line of no difference). They removed two children who had difficulty performing the technique. This should have been included in their analysis. They also removed two children in the treatment arm with adverse events (mastoiditis and otalgia)
Surrogate Marker –They used a surrogate marker of tympanometry rather than pure tone testing for hearing loss. This was because pure tone audiometry could not be done with adequate precision in a non-specialized setting. But hearing loss is a more patient oriented outcome than just having fluid in the middle ear. They had subjective hearing loss reported in their secondary analysis by parents/guardians. However, hearing loss was also to by determined by TADAST speech recognition but the results of these tests could be found in the published material.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: The conclusion at the end of the discussion state: “We have found use of autoinflation in young, school-aged children with otitis media with effusion to be feasible, safe and effective in clearing effusions, and in improving important ear symptoms, concerns and related quality of life over a 3-month watch-and-wait period. We do not think it was shown to be effective for the primary outcome, there were some concerning adverse events in the treatment group and it was underpowered to claim safety.

SGEM Bottom Line: Autoinflation devices to treat otitis media with effusion do not have enough good evidence to recommend their use at this time.

Case Resolution: Provide reassurance to the mother that her son’s effusion should resolve on its own without treatment. If it persists past a few months the child should be seen by her pediatrician/primary care physician.

Clinically Application: Will not change current management.

Dr. Richard Lubell

What Do I Tell My Patient? Your child has fluid in the middle ear. Unfortunately antibiotics, antihistamines, decongestants, and nasal steroids do not help clear this up quicker. Most children will get better without treatment and it can take a few months. If they get a fever, ear pain, or you are worried bring them back in and I will take a look. If the problem persists past a few months we will arrange pure tone audiometry testing to check on your son’s hearing.

Keener Kontest: Last weeks’ winner was not a pharmacist but an anesthesiologist from Germany. This is the second win for Dr. Ilja Osthoff. Ilia knew Lincomycin was originally isolated from Streptomyces lincolnesis, named such because it is a microbe found in soil near Lincoln, Nebraska. For the second win, Ilja will receive a double strength cool skeptical prize.

Listen to the podcast this weeks’ for the keener question. If you know the answer send an email to TheSGEM@gmail.com with keener in the subject line.