OME: Autoinflation study yields mixed reviews

A recent randomized, controlled trial showing the utility of balloon autoinflation for otitis media with effusion (OME) in general practice perhaps raises more questions than it answers, experts tell Contemporary Pediatrics.

Drawing from 43 family practices in the United Kingdom, researchers randomized 320 children to receive either usual care or usual care plus balloon autoinflation (Otovent, Abigo Medical, Askim, Sweden; various manufacturers) performed 3 times daily for 1 to 3 months. The device requires children to inflate a balloon through a nozzle inserted into 1 nostril, then the other.

To satisfy inclusion criteria, children aged 4 to 11 years had to have objective otoscopic and tympanometric confirmation of OME in 1 or both ears (ie, at least 1 flat or type B tympanogram) at the time of randomization. Children also had to have a history of hearing loss or other relevant ear-related problems in the previous 3 months. Investigators excluded children with signs of acute otitis media, such as fever, ear pain, or otoscopic features of acute inflammation.

Related: Acute otitis media update

At the 1-month follow-up, investigators advised children who still had a flat tympanogram in either ear to continue with autoinflation for another 2 months. At each follow-up visit, children treated with autoinflation were more likely to have achieved tympanometric resolution than those who did not: 1-month adjusted relative risk (RR), 1.36, 95% confidence interval (CI), 0.99 to 1.88; 3-month adjusted RR, 1.37, 95% CI, 1.03 to 1.83.¹ Analyses for individual ears, adjusted for subjects' interear correlation, showed that tympanometric resolution was significantly more likely with autoinflation at 1 month (adjusted RR, 1.38) and 3 months (adjusted RR, 1.41).

"Methodological issues"

The study has drawn criticism, however. Arlen D. Meyers, MD, MBA, says that the publication "adds some data, but because of methodological issues, we can't say whether autoinflation works or doesn't for OME." He is an emeritus professor of otolaryngology at the University of Colorado School of Medicine, Aurora, and editor-in-chief of the Medscape reference, Otolaryngology-Facial Plastic Surgery.

Likewise, a separate group including Fiona McClenaghan, MRCS, Matthew Rollin, FRCS, and Antony Narula, FRCS, wrote a letter to the editors of the Canadian Medical Association Journal, which published the autoinflation study. The letter highlights methodological missteps involving researchers' diagnosis of OME and the study's apparently high compliance rate.²

"Our main concern about this investigation was that the authors didn't diagnose OME," Rollin says. He is a consultant ears-nose-throat surgeon at Imperial College Healthcare in London. The cardinal symptom of OME is hearing loss, he says, "and the authors apparently didn't investigate, measure, or report this." The study protocol mentioned hearing tests, he says, but investigators chose tests that did not meet the International Organization for Standardization (ISO) quality standard. Using ISO-standard hearing tests would have allowed researchers to accurately gauge hearing loss severity and distinguish whether the loss stems from failure of sound transmission or inner-ear or nerve problems, he says.

"Without measuring a child's hearing loss, it is impossible to diagnose OME, because any hearing difficulty may be [due] to something else entirely. Even if a child has OME, its severity is graded on the basis of severity of hearing loss, and therefore a proper hearing test is necessary to decide whether intervention should be recommended or not," Rollin says.

NEXT: Further stumbling blocks?

Rather than testing children with parental reports of hearing loss, which have been shown to be poor reflectors of OME, he says, the authors "simply offered screening with tympanometry to all comers, then claimed to have diagnosed OME in some of them."

Diagnosing OME also requires expert examination of the eardrum, he says. In this regard, he and his co-authors write, "simple otoscopy . . . was performed by a practice-based nurse with unknown experience. Otoscopic findings consistent with OME are neither discussed nor defined."

For diagnosing OME, says Meyers, tympanometry is reliable but not 100% predictive. Accordingly, "We don't know, did the fluid clear at 1 month or 3?"

The study seemed to indicate that children who autoinflated had somewhat better reported quality of life than those who did not, notes Meyers. Specifically, Otitis Media Questionnaire (OMQ)-14 scores fell by 0.69 in the treatment group, versus 0.33 in the control group, at 3 months. Additionally, diaries kept by parents showed that children in the autoinflation cohort experienced fewer days with any OME-related symptom or problem than control-group children at 1 and 3 months.

More: Further support for nonsurgical OME intervention

"But the real issue, which was not addressed, is the impact of the intervention on patients' hearing loss. The study authors really didn't measure hearing-they measured it with tympanometry, which measures middle ear pressure, as an indicator or surrogate for OME. So it is possible that the kids felt better-they had less pressure or pain in their ears, but they still had hearing loss. So what have you accomplished? It doesn't matter if a kid has a hearing loss once for 2 weeks or 3 months. How recurrent OME and hearing loss contribute to possible speech and language delay or developmental delay is another whole topic. We're talking about an acute episode," Meyers says.

In a letter replying to the concerns of Rollin's group, study authors write that theirs was "not a population simply defined by tympanometry" because patients had OME symptoms-a median of 7 in the treatment group and 6 among controls.³

The study authors' letter continues, "Otoscopy was used primarily to exclude other ear pathology, since the specificity of otoscopy for OME is poor, (and) pneumatic otoscopy is not used reliably in primary care, and is also associated with concealment bias. Tympanometry was performed by trained nurses who used the modified Jerger criteria."⁴

Questioning compliance

Rollin and colleagues also question the designation "all or most of the time" used to record families' compliance with treatment. This ambiguity may explain the 1-month compliance rate of 89%, which, their letter says, "runs contrary to previously reported experience, including our own."^5,6

Meyers adds that 89% compliance is "just not believable." Investigators chose the 4-to-11-year-old age bracket because they considered this group likely to be capable of complying with autoinflation. However, Meyers says that if one told a 4-year-old to use the device 3 times daily for 3 months while one was at work and unable to supervise, it would not happen. "I'm not saying the authors are lying," but he questions the validity of the parents' reporting. Reported compliance at 3 months was 80%.

Study authors contend in their letter that Rollin and co-authors' references to experiences of poor compliance date back more than 20 years, "so either different explanations/techniques were used, or perhaps perceptions of parents and children have changed. Our simple, pragmatic approach was very acceptable in present-day primary care. If self-report overestimated compliance, we will have underestimated the benefit of autoinflation."³

Still, says Meyers, the balloon device is very technique dependent-its nozzle is designed for insertion while the user is drinking water. "When you swallow, it activates the muscles around the eustachian tube opening, that open the eustachian tube. That's why sometimes when you swallow, you feel your ears pop-air rushes into the middle ear to equalize the negative pressure." Based on the study, "I don't know whether there's a difference between the autoinsufflation of the eustachian tube passively, or with swallowing. They are different techniques. I don't know how technique-sensitive autoinsufflation needs to be for it to work, and in whom. All these are minor technical details," but they confound the study's conclusions.

Other confounding variables include eustachian tube structure and function, says Meyers. In study patients, "We must assume no craniofacial abnormalities that impact the eustachian tube." In 5% to 10% of children, he estimates, persistent malformation of the eustachian tubes prevents them from opening, and blowing into the autoinflation device will not help. Such abnormalities occur most frequently in children with cleft palate, cleft lip, or Down syndrome, all of whom have a higher incidence of OME, he says.

The study device is 1 of several ways to manage eustachian tube problems, Meyers adds. The Valsalva maneuver "pops" the ears as occurs during an airplane ride. The Politzer maneuver causes retrograde inflation of the middle ear by forcing air through the eustachian tube, somewhat like the balloon technique does. Eustachian tube catheters work somewhat similarly, he says, but this technique is no longer taught even in otolaryngology, much less primary care. These devices were more uncomfortable than the balloon method, and nearly impossible for young children to master, he explains. Because of the study's methodological issues, he says, he does not know if these catheters are better or worse than balloon autoinflation.

NEXT: Other thoughts

Meyers says, "The bottom line is, the article supports the use of autoinflation-I agree. I don't think it's harmful, and in most instances, it has a relatively small complication rate." One study patient withdrew because of mastoiditis that required hospitalization.

Next: Hearing loss and the pediatrician

The possible benefits in reducing symptoms and potentially hearing loss probably justify use of autoinflation, Meyers says, "although we can't say 100%. However, we take a lot of medications that aren't better than watchful waiting. So autoinflation is no different from many other things we do."

Disclosures: Dr. Meyers is president and CEO of the Society of Physician Entrepreneurs but reports no relevant conflicts of interest. Drs. Rollin, Narula, and McClenaghan report no relevant financial interests.

REFERENCES

1. Williamson I, Vennik J, Harnden A, et al. Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. CMAJ. 2015;187(13):961-969.

2. McClenaghan F, Rollin M, Narula A. Re: Effect of nasal balloon autoinflation in children with otitis media with effusion (OME) in primary care. http://www.cmaj.ca/content/early/2015/07/27/cmaj.141608/reply#cmaj_el_730715. Published August 21, 2015. Accessed December 15, 2015.

3. Williamson, I, Vennik J, Little P. Re: Effect of nasal balloon autoinflation in children with otitis media with effusion (OME) in primary care. http://www.cmaj.ca/content/early/2015/07/27/cmaj.141608/reply#cmaj_el_730715. Published September 15, 2015. Accessed December 15, 2015.

4. Jerger J. Clinical experience with impedance audiometry. Arch Otolaryngol. 1970;92(4):311-324.

5. Stangerup SE, Sederberg-Olsen J, Balle V. Autoinflation as a treatment of secretory otitis media. A randomized controlled study. Arch Otolaryngol Head Neck Surg. 1992;118(2):149-152.

6. Blanshard JD, Maw AR, Bawden R. Conservative treatment of otitis media with effusion by autoinflation of the middle ear. Clin Otolaryngol Allied Sci. 1993;18(3):188-192.

Mr Jesitus is a medical writer based in Colorado. He has nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.