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. 1999 Aug 7;319(7206):383. doi: 10.1136/bmj.319.7206.383a

Autoinflation for treatment of glue ear

Autoinflation does not produce worthwhile benefit

Haytham Kubba 1
PMCID: PMC1127003  PMID: 10435975

Editor—A review of nasal balloons is welcome, given the high prevalence of glue ear (otitis media with effusion) and the devices’ simplicity.1 The authors conclude from three studies that the balloon may be of benefit. The two published studies to which they refer merit closer attention.2,3 The studies suggest short term benefit, but it is not sustained. No significant differences could be found in either study between treated and control groups in tympanometric resolution at two or three months’ follow up. Compliance was poor in over half the children and got worse with time. Any benefit is lost after treatment is stopped.

Reidpath et al have included the two-week outcomes in one trial2 and the 12-week outcomes in the two others (Blanshard et al3 and the unpublished data), even though benefit decreases significantly with time, biasing the results in favour of the treatment. The greater prevalence of type B tympanometry in one untreated group3 is an additional source of bias, as is the lack of blinding and adequate randomisation in any study. The result is the conclusion that the treatment is effective, with an odds ratio of 3.5. Meta-analysis of poor research gives poor answers.

Reducing all the information in a paper to a single odds ratio can be a powerful tool but also hides much of the available information. Meta-analysis is not the best way to analyse three small studies of variable methodology. The conclusion is the inevitable refrain that “more/bigger/better studies are needed.” In his commentary on the paper Haggard mentions the need to prioritise research endeavour to maximise payback.1 Surely it is wrong to recommend that large, expensive, time consuming studies be done on an issue for which the answer is already available. The nasal balloon produces no sustained benefit in glue ear, and after three months’ watchful waiting no large difference can be expected in the number of children requiring surgery. This is the real issue.

Haggard mentions that nasal balloons may have a place as a temporising measure. Is he suggesting that although the device produces no worthwhile benefit, we can use it as a placebo while nature takes its course? This would be deception of the worst kind, since the balloon is not available on prescription in the United Kingdom and must be paid for by parents. Glue ear is associated with social deprivation, and we must not ask our poorest patients to pay for a worthless device simply to keep them amused.

References

  • 1.Reidpath DD, Glasziou PP, Del Mar CD. Systemic review of autoinflation for treatment of glue ear [with commentary by M Haggard] BMJ. 1999;318:1177–1178. doi: 10.1136/bmj.318.7192.1177. . (1 May.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Stangerup SE, Sederberg-Olsen J, Balle V. Autoinflation as a treatment of secretory otitis media. Arch Otolaryngol Head Neck Surg. 1992;118:149–152. doi: 10.1001/archotol.1992.01880020041013. [DOI] [PubMed] [Google Scholar]
  • 3.Blanshard JD, Maw AR, Bawden R. Conservative treatment of otitis media with effusion by autoinflation of the middle ear. Clin Otol. 1993;18:188–192. doi: 10.1111/j.1365-2273.1993.tb00827.x. [DOI] [PubMed] [Google Scholar]
BMJ. 1999 Aug 7;319(7206):383.

Authors’ reply

Daniel D Reidpath 1,2, Paul P Glasziou 1,2, Chris Del Mar 1,2

Editor—The rapid responses to our review of trials of autoinflation for glue ear (http://www.bmj.com/cgi/content/full/318/7192/1177#responses) would suggest that we are damned if we do and damned if we don’t (recommend autoinflation). Of the five rapid responses, Kubba’s (printed here) suggests that autoinflation is worthless and would not support further trials; two (those from Willis and Tostevin) clearly support current use of autoinflation (“to discontinue the use of nasal balloons may deny a group of patients access to a non-invasive, non-surgical management option”); and two (those from Temmel and McKenzie) make useful suggestions about the trial’s design. Such equipoise is the ethical prerequisite for a randomised trial.

Kubba suggests that benefits may be only short term. Even if this proves to be so, it may be useful given the dynamic nature of middle ear effusions: in a monitoring study of the natural course of otitis media with effusion Hogan et al suggested a mean duration of unilateral effusion episodes of 5-6 weeks.1-1

We agree with Kubba that the quality of current trials is poor, but we interpret this to mean that better research rather than no research would be the best option. Paradise suggests that in the United States children younger than age 3 undergo an estimated 313 000 grommet operations a year, at a cost of about $750m (£500m).1-2 Given the current variation in the use of autoinflation, wouldn’t it be worthwhile investing a small portion of the millions spent on current treatment for properly testing simple interventions such as autoinflation? We believe that this makes good sense both clinically and economically.

References

  • 1-1.Hogan SC, Stratford KJ, Moore DR. Duration and recurrence of otitis media with effusion in children from birth to 3 years: prospective study using monthly otoscopy and tympanometry. BMJ. 1997;314:350. doi: 10.1136/bmj.314.7077.350. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 1-2.Paradise JL Otitis media and child development: should we worry? Pediatr Infect Dis J. 1998;17:1076–1083. doi: 10.1097/00006454-199811000-00038. ; discussion 1099-100. [DOI] [PubMed] [Google Scholar]

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