Helping children with hearing loss from otitis media with effusion
Authors: Michael E Pichichero
Journal: The Lancet (2018)

Otitis media with effusion occurs during viral upper respiratory tract infections in around two-thirds of infants and young children because their Eustachian tube anatomy and function do not provide adequate ventilation and drainage of natural mucus production during a cold until the age of around 5 years. Children are also much more prone to develop a middle ear infection during an upper respiratory tract viral infection. Even with the introduction and widespread use of pneumococcal conjugate vaccines, acute otitis media following an upper respiratory tract viral infection remains common in childhood.1Kaur R Morris M Pichichero ME Epidemiology of acute otitis media in the post pneumococcal conjugate vaccine era.Pediatrics. 2017; 140: e20170181Crossref PubMed Scopus (132) Google Scholar Persistent otitis media with effusion following acute otitis media is caused by persistent inflammation in the middle ear and the Eustachian tube after infection has resolved. In the middle ear, bacterial biofilms occur that largely contribute to the persistent inflammation.2Hall-Stoodley L Hu FZ Stoodley P et al.Direct detection of bacterial biofilms on the middle-ear mucosa of children with chronic otitis media.JAMA. 2006; 296: 202-211Crossref PubMed Scopus (690) Google Scholar Bacterial biofilms in the middle ear persist best in microaerophilic or anaerobic conditions,3Osgood R Salamone F Diaz A Casey JR Pichichero ME Effect of pH and oxygen on biofilm formation in acute otitis media associated NTHi clinical isolates.Laryngoscope. 2015; 125: 2204-2208Crossref PubMed Scopus (13) Google Scholar so minor surgery to insert grommets through the tympanic membrane to provide aeration and fluid drainage is a common operation. An alternative to ventilation tube surgery for persistent otitis media with effusion has long been sought, with many failures noted such as the use of systemic and intranasal decongestants and antihistamines. Based on the pathophysiology of otitis media with effusion, a condition caused by low-grade inflammation, systemic steroids to open the Eustachian tube (as successfully used in the treatment of asthma) have been tried with varying success. Nick A Francis and colleagues4Francis NA Cannings-John R Waldron C-A et al.Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial.Lancet. 2018; 392: 557-568Summary Full Text Full Text PDF PubMed Scopus (19) Google Scholar report in The Lancet the results of a well designed, double-blind, placebo-controlled, randomised trial to assess whether oral steroids benefit children aged 2–8 years with prolonged otitis media with effusion by restoring hearing to normal levels. The trial appears to be the largest to date5Simpson S Lewis R van der Voort J Butler C Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children.Cochrane Database Syst Rev. 2011; 5 (CD001935.)Google Scholar with confirmed hearing loss at study entry; and included hearing, tympanometry, and quality-of-life assessments at follow-up. The short-term primary outcome was restoration of normal hearing 5 weeks after starting a 7-day oral steroid regimen. The investigators chose this timepoint because a short-term benefit (even if only temporary in some children) would be worthwhile from a relatively safe, cheap, and easy to implement intervention. They thought that demonstrable short-term improvement in hearing might be more important than longer-term outcomes as short-term improvement would be more likely to influence the decision to undergo surgery for insertion of ventilation tubes. The main finding was that a short course of oral steroids for otitis media with effusion was unlikely to be effective for most children aged 2–8 years, although steroid treatment was well tolerated. However, acceptable hearing was observed in 73 (40%) of 183 children in the oral steroid group and 59 (33%) of 180 in the placebo group (absolute difference 7% [95% CI −3 to 17] at 5 weeks, adjusted odds ratio 1·36 [95% CI 0·88 to 2·11]; p=0·16). The number needed to treat to benefit was 14·1; thus, one in 14 children benefited from oral steroids by achieving acceptable hearing. Similar estimates of effect for both longer-term follow-up points were calculated, suggesting that any treatment effect would be likely to occur early and be maintained for 12 months. Two key limitations should be noted. To be eligible for enrolment, the children had to be 2–8 years old (generally older than the age when otitis media with effusion predominates: age 6 months to 2 years). Therefore, all conclusions apply only to children aged 2–8 years. Also, all children had to have otitis media with effusion for at least 3 months, but in fact children had problems due to the current episode of otitis media with effusion for a remarkably long period: 131 (68%) of 193 children in the oral steroid group and 115 (61%) of 187 in the placebo group had otitis media with effusion for 12 months or longer. It is common knowledge that as otitis media with effusion persists, the viscosity of the fluid increases. Children who had otitis media with effusion for more than 12 months almost certainly had high viscosity fluid, so-called glue ear. Temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test of the efficacy of this treatment. These children had otitis media with effusion for far too long to anticipate more than marginal benefit, as observed. Therefore, all conclusions apply only to children with very long-standing otitis media with effusion (all of whom had the condition for more than 3 months, and two-thirds for 12 months or more). For most children, otitis media with effusion has a high rate of spontaneous resolution after acute otitis media. Previous studies have found that 1 month after diagnosis of acute otitis media, 50% of children have otitis media with effusion; at 2 months, 30% have the condition; and at 3 months, 10% have the condition.6NICESurgical management of otitis media with effusion in children. NICE Clinical Guideline. National Institute for Health and Clinical Excellence, London2008Google Scholar Therefore, most guidelines recommend watchful waiting (ie, no pharmacological or surgical treatment) for children who have had otitis media with effusion for less than 3 months.6NICESurgical management of otitis media with effusion in children. NICE Clinical Guideline. National Institute for Health and Clinical Excellence, London2008Google Scholar As such, this trial addressed the evidence gap for interventions to help children who have had otitis media with effusion for at least 3 months. The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion. Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion,4Francis NA Cannings-John R Waldron C-A et al.Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial.Lancet. 2018; 392: 557-568Summary Full Text Full Text PDF PubMed Scopus (19) Google Scholar the issue remains an open question for children who do not meet the enrolment criteria applied in the current trial. Apart from a clear answer about the effect of oral steroids in children aged 2–8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues' study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting. I declare no competing interests. Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trialOtitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2–8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence. Full-Text PDF Open Access