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BMJ Clin Evid. 2007; 2007: 0502.
Published online 2007 August 1.
PMCID: PMC2943809

Otitis media with effusion in children

Ian Williamson, MD, Senior Lecturer in Primary Medical Care

Abstract

Introduction

Up to 80% of children have been affected by otitis media with effusion (OME) by the age of 4 years, but prevalence declines beyond 6 years of age. Non-purulent middle-ear infections can occur in children or adults after upper respiratory tract infection or acute otitis media. Half or more of cases resolve within 3 months and 95% within a year, but complications such as tympanic membrane perforation, tympanosclerosis, otorrhoea, and cholesteatoma can occur.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent otitis media with effusion in children; and of pharmacological, mechanical, and surgical interventions to treat otitis media with effusion in children? We searched: Medline, Embase, The Cochrane Library and other important databases up to March 2006. (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 22 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: adenoidectomy, antibiotics, antihistamines, autoinflation, bottle feeding, decongestants, exposure to other children, intranasal corticosteroids, mucolytics, oral corticosteroids, passive smoking, ventilation tubes.

Key Points

Otitis media with effusion (OME, glue ear) usually presents with concerns about the child's behaviour, performance at school, or language development.

  • Children usually only have mild hearing impairment and few other symptoms.
  • Up to 80% of children have been affected by the age of 4 years, but prevalence declines beyond 6 years of age.
  • Non-purulent middle-ear infections can occur in children or adults after upper respiratory tract infection or acute otitis media.
  • Half or more of cases resolve within 3 months and 95% within a year, but complications such as tympanic membrane perforation, tympanosclerosis, otorrhoea and cholesteatoma can occur.

Risk of OME is increased with passive smoking, bottle feeding, low socioeconomic group, and exposure to many other children.

  • However, there is no evidence to show whether interventions to modify these risk factors reduce the risk of OME.

Autoinflation with purpose manufactured devices may improve effusions, but other non purpose manufactured devices have not been shown to be effective.

  • Purpose-manufactured nasal balloons may improve effusions over 2 weeks to 3 months, but long-term efficacy is unknown. Children may find autoinflation difficult.

Oral antibiotics, antihistamines plus oral decongestants, or mucolytics may be of no benefit in OME, and can cause adverse effects.

  • Antibiotics can cause adverse effects in up to a third of children with OME.
  • Antihistamines can cause behavioural changes, seizures, and blood pressure variability.

Oral corticosteroids are unlikely to improve symptoms in OME, and can cause growth retardation.

Ventilation tubes may improve short-term outcomes, but the clinical effect size is small. They may also increase the risk of tympanic membrane abnormalities.

  • Ventilation tubes improve hearing for the first 2 years, but have no longer-term benefit, and may not affect cognition or language development.
  • Adenoidectomy may improve hearing when performed with tympanostomy, but the clinical significance of the improvements are unclear.

About this condition

Definition

Otitis media with effusion (OME) or "glue ear", is serous or mucoid but not mucopurulent fluid in the middle ear. Children usually present with hearing impairment and speech problems. In contrast to those with acute otitis media (see review on acute otitis media), children with OME do not suffer from acute ear pain, fever, or malaise. Hearing impairment is usually mild and often identified when parents express concern regarding their child's behaviour, performance at school, or language development.

Incidence/ Prevalence

OME is commonly seen in paediatric practice, and accounts for 25-35% of all cases of otitis media. One study in the UK found that, at any time, 5% of children aged 5 years had persistent (at least 3 months) bilateral hearing impairment associated with OME. The prevalence declines considerably beyond 6 years of age. Studies in the USA and Europe have estimated that about 50-80% of children aged 4 years have been affected by OME at some time. One study in the USA estimated that, between the ages of 2 months and 2 years, 91.1% of young children will have one episode of middle ear effusion, and 52.2% will have bilateral involvement. OME is the most common reason for referral for surgery in children in the UK. The number of general practitioner consultations for OME increased from 15.2 per 1000 (2-10 year olds) per year to 16.7 per 1000 per year between 1991 and 2001. Middle-ear effusions also occur infrequently in adults after upper respiratory tract infection or after air travel, and may persist for weeks or months after an episode of acute otitis media.

Aetiology/ Risk factors

Contributory factors include upper respiratory tract infection and narrow upper respiratory airways. Case control studies have identified risk factors, including age 6 years or younger, day care centre attendance, large number of siblings, low socioeconomic group, frequent upper respiratory tract infection, bottle feeding, and household smoking. These factors may be associated with about twice the risk of developing OME.

Prognosis

Data from one prospective study of children aged 2-4 years showed that 50% of OME cases resolved within 3 months and 95% within a year. In 5% of preschool children, OME (identified by tympanometric screening) persisted for at least 1 year. One cohort study of 3-year-olds found that 65% of OME cases cleared spontaneously within 3 months. Most children aged 6 years or older will not have further problems. The disease is ultimately self-limiting in most cases. However, one large cohort study (534 children) found that middle-ear disease increased reported hearing difficulty at 5 years of age (OR 1.44, 95% CI 1.18 to 1.76) and was associated with delayed language development in children up to 10 years of age. Hearing impairment is the most common complication of OME. Most children with OME have fluctuating or persistent hearing deficits with mild to moderate degrees of hearing loss, averaging 27 decibels. The type of hearing impairment is usually conductive, but it may be sensorineural, or both. The sensorineural type is usually permanent. Tympanic membrane perforation, tympanosclerosis, otorrhoea, and cholesteatoma occur more frequently among children with OME than among those without OME.

Aims of intervention

To improve hearing and wellbeing; to avoid poor behavioural, speech, and educational development; to prevent recurrent earache and otitis media, with minimal adverse effects.

Outcomes

Symptom improvement : hearing impairment, assessed by audiometry or tympanometry (although the positive predictive value of these tests has been reported to be as low as 49%); resolution of effusion (both speed and completeness) assessed by otoscopy, tympanometry, or global clinical assessment. Developmental and behavioural tests: language and speech development. Adverse effects of treatment. Hearing losses as small as 15 decibels may have disabling consequences in children, and so changes of this magnitude are likely to be clinically significant. Patient-centred outcomes in children with OME (e.g. disability or quality of life) need further development and evaluation. Adequate follow-up for a single episode of OME is about 1-3 months, but relapses are common and so follow-up for quality of life outcomes should ideally be for at least 3 months.

Methods

BMJ Clinical Evidence search and appraisal March 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to March 2007, Embase 1980 to March 2007, and The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials 2007, Issue 1. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) — for Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA), Turning Research into Practice (TRIP), and National Institute for Health and Clinical Excellence (NICE). We also searched for retractions of studies included in the Review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using predetermined criteria to evaluate relevant studies.Study design criteria for evaluation for this review were: published systematic reviews and RCTs in any language, at least single blinded, and containing more than 20 individuals, of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded, unless blinding was impossible. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ).

Table
GRADE evaluation of interventions for OME in children

Glossary

Autoinflation
Autoinflation refers to any self-administered technique that opens up the Eustachian tube by increasing the intranasal pressure (e.g. use of a balloon and adaptor that can be blown up via the nostril).
High-quality evidence
Further research is very unlikely to change our confidence in the estimate of effect.
Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Ventilation tubes
A ventilation tube is a small prosthetic device (e.g. a grommet) that is inserted into the lower ear drum through a tympanostomy incision. The tube or grommet aerates the middle ear as long as it remains patent or functional.
Very low-quality evidence
Any estimate of effect is very uncertain.

Notes

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Notes

Acute otitis media

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2007; 2007: 0502.
Published online 2007 August 1.

Modifying risk factors

Summary

We found no clinically important results from RCTs about the effects of modifying risk factors such as passive smoking or bottle feeding, in preventing otitis media with effusion.

Benefits

We found no systematic review or RCTs of interventions aimed at modifying risk factors for OME (see comment below).

Harms

We found no RCTs.

Comment

Clinical guide:

There is good epidemiological evidence that the risk of otitis media with effusion is increased by passive smoking, bottle feeding, low socioeconomic group, and exposure to a large number of other children. Feasible preventive interventions may include strategies to reduce household smoking and encourage breastfeeding.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Antibiotics (oral)

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with placebo: Antibiotics may be no more effective than placebo at increasing the proportion of children with cure (not further defined) at 2-5 weeks ( low-quality evidence ). Compared with oral corticosteroids plus antibiotics: Antibiotics alone may be less effective than antibiotics plus oral corticosteroids at decreasing the proportion of children with persistance of effusion at 2 weeks, but we don't know about longer than 2 weeks (low-quality evidence). Compared with intranasal corticosteroids plus antibiotics: Antibiotics alone may be less effective than oral antibiotics plus intranasal corticosteroids at reducing effusion at 4–12 weeks in children aged 3-11 years ( very low-quality evidence ). NOTE Antibiotics are associated with adverse effects such as nausea, vomiting, and diarrhoea.

Benefits

Antibiotics versus placebo:

We found one systematic review (search date 1997, 8 RCTs, 1292 children with OME, age range not reported), which compared antibiotics versus placebo. It found no significant difference in cure rate over 2–5 weeks (cure rate: 179/813 [22%] with antibiotics v 85/479 [18%] with placebo; ARI of cure: +4.3%, 95% CI –0.1% to +8.6%).

Antibiotics plus oral corticosteroids versus antibiotics alone:

We found one systematic review (search date 2006, 5 RCTs, 418 children) comparing antibiotic (cefixime, amoxicillin, or sulphisoxazole) plus oral corticosteroids (betamethasone or prednisolone) versus antibiotic alone. Time to measurement of results varied from 1 week to 6 months. The review found that antibiotics plus oral corticosteroids significantly improved otitis media effusion resolution rate compared with antibiotic alone at 2 weeks (rate of persisting otitis media effusion: 112/214 [52%] with antibiotics plus oral corticosteroid v 153/204 [75%] with antibiotic alone; OR for non-clearance v antibiotic alone at 2 weeks 0.37, 95% CI 0.25 to 0.56). Longer-term effects were not sufficiently recorded for inclusion. The trials included in the review were small and showed significant heterogeneity (P < 0.01). Use of secondary care populations weakens the applicability of results to primary care.

Antibiotics plus intranasal corticosteroids versus placebo plus antibiotics:

See benefits of intranasal corticosteroids.

Harms

The systematic review gave no information on adverse effects. One earlier systematic review (search date 1992, 10 RCTs, 1041 children with OME, age range not reported) found that adverse events were frequent with antibiotics. For amoxicillin, diarrhoea was reported in 20–30% and rashes in 3–5% of children. For amoxicillin–clavulanic acid (co-amoxiclav), diarrhoea was reported in 9%, nausea and vomiting in 4%, and skin rashes and urticaria in 3% of children. However, the systematic review included RCTs that were heterogeneous in study design, and was criticised by the more recent systematic review for pooling data from studies with and without placebo controls, which introduced a significant bias toward antibiotic efficacy. For antibiotics overall, nausea and vomiting, diarrhoea, or both have been reported in 2–32% of children, and cutaneous reactions in less than 5%. Adherence to long courses of antibiotics is poor. Prescribing antibiotics for minor illness has been reported to encourage further consultations and increase antibiotic resistance.

Comment

None.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Oral corticosteroids

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with placebo: Oral corticosteroids may be more effective than placebo at increasing the proportion of children with clearance of effusion at 2 weeks, but we don't know about longer than 2 weeks ( low-quality evidence ). Oral corticosteroids plus oral antibiotics compared with oral antibiotics alone: Oral antibiotics plus oral corticosteroids may be more effective than oral antibiotics alone at decreasing the proportion of children with persistance of effusion at 2 weeks, but we don't know about longer than 2 weeks (low-quality evidence). NOTE Oral corticosteroids have been associated with growth retardation in children.

Benefits

We found one systematic review (search date 2006, 11 RCTs, 862 children in secondary care and selected [air force base] settings).

Oral corticosteroids versus placebo:

The systematic review identified three RCTs (108 children) comparing oral corticosteroids (either prednisolone or dexamethasone) versus placebo. Presence of effusion was assessed clinically by pneumatic otoscopy, tympanometry, and audiometry after 7–14 days of treatment. The review found that oral corticosteroids significantly improved otitis media effusion (OME) resolution rate compared with placebo at 2 weeks (rate of persisting OME: 42/56 [75%] oral corticosteroid v 49/52 [94%] with placebo; OR for clearance with oral corticosteroids v placebo 0.22, 95% CI 0.08 to 0.63). Longer-term effects were not sufficiently recorded for inclusion.

Oral corticosteroids plus antibiotic versus oral antibiotics alone:

See benefits of antibiotics.

Harms

The six RCTs in the review reporting on adverse events found no severe or lasting adverse effects of corticosteroids. The other RCTs mentioned that mild possible adverse effects of corticosteroids might include vomiting, diarrhoea, dermatitis, transient nasal stinging, and epistaxis. One systematic review in children with cystic fibrosis has found that long-term treatment with oral corticosteroids was associated with growth retardation compared with placebo.

Comment

None

Substantive changes

Corticosteroids (oral) Categorisation changed from Likely to be ineffective or harmful to Trade-off between benefits and harms

2007; 2007: 0502.
Published online 2007 August 1.

Intranasal corticosteroids

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with placebo: Intranasal dexamethasone may be no more effective than placebo at reducing effusion at 3 weeks (very low-quality evidence). Intranasal corticosteroids plus oral antibiotics compared with oral antibiotics alone: Intranasal corticosteroids plus oral antibiotics may be more effective than oral antibiotics alone reducing effusion at 4–12 weeks in children aged 3-11 years (very low-quality evidence).

Benefits

We found one systematic review (search date 2006, 11 RCTs, 862 children in secondary care and selected [air force base] settings).

Intranasal corticosteroids versus placebo:

The systematic review identified one RCT (45 children), which found no significant difference between intranasal dexamethasone and placebo in persistence of effusion at 3 weeks (OR 2.12, 95% CI 0.65 to 6.90).

Intranasal corticosteroids plus oral antibiotics versus placebo plus oral antibiotics:

The systematic review identified one RCT (59 children aged 3–11 years), which found that intranasal corticosteroids plus antibiotics significantly reduced effusions compared with placebo plus antibiotics at 4 weeks (P less than 0.05), 8 weeks (P less than 0.05), and 12 weeks (P less than 0.01).

Harms

See harms of oral corticosteroids.

Comment

None.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Antihistamines plus oral decongestants

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with placebo: Antihistamines plus oral decongestants are no more effective than placebo in clearing effusion at 4 weeks and 12 weeks ( high-quality evidence ). ADVERSE EFFECTS Compared with placebo: Antihistamines plus oral decongestants are associated with an increase in adverse effects compared with placebo at 4 weeks (high-quality evidence). NOTE Antihistamines are associated with hyperactivity, insomnia, drowsiness, behavioural change, blood pressure variability, and seizures. Decongestant nose drops given for 3 weeks or more can lead to iatrogenic rhinitis.

Benefits

We found two systematic reviews (search date 1992, 4 RCTs, 1202 infants and older children, age range not reported; search date 2006, 16 RCTs, 1737 people, predominantly children). Two RCTs were included in both reviews. The first review found no significant difference between 4 weeks of treatment with antihistamine plus oral decongestants and placebo in effusion clearance rate, as assessed by history, otoscopy, and tympanometry (mean difference –0.9%, 95% CI –3.6% to +5.4%). The RCTs in the review included clinically heterogeneous groups (e.g. infants and older children) and selected individuals from ambulatory care or waiting lists. However, the review suggested that the evidence could be generalised to a child of any age. The second review also found no significant difference in effusion clearance rate between antihistamine plus oral decongestant and placebo at 4 and 12 weeks (effusion persistence at 4 weeks: 4 RCTs, 901 people; 334/457 [73%] with antihistamines plus decongestant v 337/444 [76%] with placebo, RR 0.97, 95% CI 0.89 to 1.04; effusion persistence at 12 weeks: 3 RCTs, 158 people; 51/81 [63%] with antihistamine plus decongestant v 45/77 [58%] with placebo, RR 1.09, 95% CI 0.85 to 1.40).

Harms

Adverse effects of antihistamines include hyperactivity, insomnia, drowsiness, behavioural change, blood pressure variability, and seizures. One RCT in healthy volunteers found that decongestant nose drops given for 3 weeks or more led to iatrogenic rhinitis.The second review found a significant increase in adverse effects with antihistamines plus oral decongestant compared with placebo at 4 weeks (5 RCTs, 972 people; 90/487 [18%] with antihistamine plus decongestant v 35/485 [7%] with placebo, RR 2.54, 95% CI 1.76 to 3.67).

Comment

None.

Substantive changes

Antihistamines plus oral decongestants One systematic review added; benefits and harms data enhanced; categorisation unchanged (Likely to be ineffective or harmful).

2007; 2007: 0502.
Published online 2007 August 1.

Mucolytics

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with placebo or no active treatment: We don't know whether mucolytics, (bromhexine, carbocisteine, or carbocisteine lysine) are more effective than placebo or no treatment at increasing the proportion of children with complete resolution ( low-quality evidence ).

Benefits

Mucolytics versus placebo or no treatment:

We found one systematic review (search date 1993, 6 RCTs, 428 children aged 3–11 years and 2 adults) comparing 15–90 days' treatment with carbocisteine or carbocisteine lysine, or both, versus placebo or no treatment (control). The review found that mucolytics increased the proportion of children with complete resolution compared with control, but the difference was not significant (6 RCTs, 313 children; 80/161 [50%] with treatment v 54/152 [36%] with placebo; OR 2.25, 95% CI 0.97 to 5.22). The RCTs in the review were heterogeneous in their clinical outcomes and treatment duration. However, the RCTs combined in the meta-analysis were homogeneous regarding dosage and outcome. Three small additional RCTs (155 children and 195 ears) comparing another mucolytic (bromhexine) versus placebo found inconclusive results.

Harms

The review and additional RCTs gave no information on adverse effects.

Comment

None.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Autoinflation using purpose-manufactured devices

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with no treatment: Autoinflation with a purpose-manufactured device (Otovent device or ear-popper) may be more effective than no treatment at improving outcomes (measured by tympanogram, audiogram, or composite outcomes). However, results varied by the analysis undertaken and the specific outcome reported ( very low-quality evidence ).

Benefits

We found two systematic reviews (search date not reported, and search date 2006, ) comparing autoinflation versus no treatment. Both reviews included RCTs which used purpose-manufactured devices and also other non purpose-manufactured devices. We have only reported data on purpose-manufactured devices in this option. The reviews identified four RCTs between them, and two RCTs were common to both reviews. However, the reviews differed in the analysis they undertook and the outcomes they reported.

Autoinflation using purpose manufactured devices versus no treatment:

The first review included three RCTs which reported results by child or by ear. It found that purpose-manufactured nasal balloons significantly increased cure compared with no treatment (cured: 3 RCTs, AR 63/195 [32%] with autoinflation v 27/191 [14%] with control; OR 3.53, 95% CI 2.03 to 6.14; not clear what proportion of results relate to ears cured or children cured).Two RCTs included in the analysis measured outcomes using tympanograms, and one RCT reported "recovery" (not further defined). One RCT was unpublished, and children in this RCT also had myringotomy (further details not reported by the review). The review noted that methods varied between RCTs (for example, selection criteria [whether by tympanometry, audiometry, otoscopy], unilateral or bilateral disease, level of data analysis [by child or by ear]) and all were unblinded.The second review included the two published RCTs included in the first review (both using the Otovent device ) and one RCT subsequent to the first review (using the ear-popper). It did not seperately analyse purpose manufactured devices as a group versus no treatment. It analysed on the basis of intention-to-treat and calculated adjusted risk ratios of improvement, to correct for the fact that RCTs mainly reported ears as the analysis unit but had randomised by children. The review found that autoinflation using the Otovent device significantly improved tympanograms compared with no treatment at 1 month or less (1st RCT, 85 children aged 3-10 years, RR 2.42, 95% CI 1.24 to 4.70; 2nd RCT, 100 children aged 3-10 years, RR 4.29, 95% CI 2.24 to 8.22), but found no significant difference between groups at over 1 month (2 RCTs, 185 children aged 3-10 years, RR 1.89, 95% CI 0.77 to 4.67). One included RCT found no significant difference between autoinflation using the Otovent device and no treatment in improvement of pure tone audiogram (10 dB or greater improvement: 85 children, RR 1.37, 95% CI 0.63 to 2.94). The review found that, compared with no treatment, autoinflation using the ear-popper significantly improved a composite outcome (tympanogram or audiometry) at over 1 month and also significantly improved pure tone audiometry threashold (1 RCT, 94 children aged 4 to 11 years: improvement in composite outcome, RR 2.76, 95% CI 1.75 to 4.36; pure tone threashold improvement, mean difference 14.30, 95% CI 8.80 to 19.80). The review noted that follow up in the RCTs was short, and that none of the RCTs were of high quality.In one RCT using the Otovent device, 12% of children aged 3–10 years were unable to use the balloon.The adherence level in one RCT using the ear-popper (97.5% ) is not likely to be achieved in practice.

Harms

Autoinflation using purpose manufactured devices versus no treatment:

The first review did not report on adverse effects.The second review reported that none of the included RCTs found significant differences in adverse effects between autoinflation and no autoinflation (no further statistical details provided).

Comment

The studies conducted to date have had methodological problems (e.g. different devices, selection criteria, duration of treatment, outcome measures), and so the data are suggestive rather than conclusive.

Clinical guide:

Autoinflation may be used as a short-term measure — its long-term efficacy is unknown. Empirical use of autoinflation is reasonable, especially in older children, because it is associated with minimal adverse effects.

Substantive changes

Autoinflation using purpose manufactured devices One systematic review added; benefits and harms data enhanced, categorisation of 'autoinflation with purpose-manufactured devices' unchanged (Likely to be beneficial).

2007; 2007: 0502.
Published online 2007 August 1.

Autoinflation using non purpose-manufactured devices

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with no treatment: Autoinflation using non purpose-manufactured devices (a carnival blower or a modified anaesthetic mask) may be no more effective than no treatment at improving outcomes (measured by tympanogram or audiometry) at 3-6 weeks ( very low-quality evidence ).

Benefits

We found two systematic reviews (search date not reported, and search date 2006, ) comparing autoinflation versus no treatment. Both reviews included RCTs which used non-purpose manufactured devices and purpose-manufactured devices. We have only reported data on non purpose-manufactured devices in this option. The reviews identified three RCTs between them, and two RCTs were common to both reviews. However, the reviews differed in the analysis they undertook and the outcomes they reported.

Autoinflation non purpose manufactured devices versus no treatment:

The first review included 3 RCTs which reported results by child or by ear.It did not statistically analyse the autoinflation devices as a group versus no treatment. The review reported that one included RCT found no significant difference between a modified anaesthetic mask and no treatment in cure, and the remaining two RCTs found no significant difference between toy balloons (not further defined in the review) and no treatment in cure (absolute numbers of children in each RCT not reported, ORs for each RCT presented graphically, P values not reported).The RCT using a modified anaesthetic mask reported "absence of effusion" as an outcome (not further defined), and the remaining two RCTs had measured improvement in hearing (not further defined). The review noted that methods varied between RCTs (for example, selection criteria, unilateral or bilateral disease, level of data analysis [by child or by ear]), all were unblinded, and that one RCT did not provide direct data on the numbers who improved in treatment and control groups. The second review included two RCTs identified by the first review, and excluded the RCT using a modified anaesthetic mask due to weak methods (see comment below). The second review did not pool data for the two remaining RCTs. It performed a different analysis to the first review on the basis of intention-to-treat and by calculating an adjusted risk ratio, to correct for the fact that one of the RCTs had reported by ears but had randomised by children. It also found no significant difference between intervention and control in the two RCTs. The review reported that one RCT (40 children with unilateral or bilateral disease aged 3-10 years) found no significant difference between autoinflation using a carnival balloon and no treatment in tympanogram improvement or audiometry improvement at 3 weeks (tympanogram improvement, RR 0.27, 95% CI 0.07 to 1.05; 10 dB or greater improvement in audiogram, RR 0.36, 95% CI 0.09 to 1.46). It reported that both results favoured the no intervention group, but differences did not reach significance. The other RCT (85 children with bilateral disease, aged 3 to 12 years) found no significant difference with autoinflation using a carnival blower and no treatment in pure tone audiometry threashold at 6 weeks (mean difference +0.07, 95% CI -3.44 to +3.58).The review also reported that this RCT found no significant difference between groups in mean change in middle ear pressure (a tympanometry outcome) at 6 weeks (further numerical details and P value not reported). It reported that one of the RCTs (40 children) did not report a comparison of groups at baseline, follow up was short in both RCTs, and that neither RCT was deemed to be of high quality.

Harms

Autoinflation using non purpose manufactured devices versus no treatment:

The first review did not report on adverse effects associated with autoinflation.The second review reported that none of the included RCTs found significant differences in adverse effects between autoinflation and no autoinflation (no further statistical details provided).

Comment

The second review also found one further RCT but this was predominately in adults (age 16 - 75 years), so we have not reported it further here. The eustachian tubes can be inflated by several methods, including blowing up a balloon through a plastic tube inserted into the nostril. The studies conducted to date have had methodological problems (e.g. different devices, selection criteria, duration of treatment, outcome measures), and so the data are suggestive rather than conclusive.

Clinical guide:

See autoinflation with purpose manufactured nasal balloon.

Substantive changes

Autoinflation using non purpose-manufactured devices One systematic review added; benefits and harms data enhanced, categorisation of 'autoinflation using non purpose-manufactured devices' unchanged (Unknown effectiveness).

2007; 2007: 0502.
Published online 2007 August 1.

Adenoidectomy

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with no treatment: Adenoidectomy may be more effective than no treatment at reducing the median duration of otitis media with effusion at 5 years follow up, but we don't know whether adenoidectomy is more effective than no treatment in improving hearing at 6-12 months ( very low-quality evidence ). Ventilation tubes plus adenoidectomy compared with adenoidectomy alone: Adenoidectomy alone may be less effective than ventilation tube plus adenoidectomy at improving hearing at 1-12 months, but we don't know about at 2 and 5 years ( low-quality evidence ).

Benefits

Adenoidectomy versus no treatment:

We found one systematic review (search date 1992), which found three RCTs comparing adenoidectomy versus no treatment. One of the RCTs (79 ears) found that adenoidectomy significantly improved hearing compared with no treatment at up to 12 months (mean difference at 6 months 16.1 decibels [dB]; at 12 months 7.7 dB; 95% CIs displayed graphically). However, the other two RCTs included in the review found no significant difference between adenoidectomy and no treatment at up to 12 months (first RCT, 74 ears, mean difference at 6 months and 12 months 4.3 dB; second RCT, 72 ears, mean difference at 6 months 3.1 dB, at 12 months 2.8 dB; 95% CIs for all differences not significant [displayed graphically]). Five-year follow-up of the RCT that found benefit with adenoidectomy found that the median duration of otitis media with effusion was reduced from 7.8 years without treatment to 4 years with adenoidectomy alone (log-rank P = 0.001).

Ventilation tube plus adenoidectomy versus adenoidectomy alone:

See benefits of ventilation tubes plus adenoidectomy.

Harms

Adenoidectomy:

The reviews did not report on the harms of adenoidectomy.

Comment

The clinical significance of the hearing improvements seen in the reviews was variable. None of the RCTs described in either review was placebo controlled, although some RCTs were conducted in children who had received ventilation tubes in one ear only, and in these cases the operated and non-operated ears were compared with each other. The validity of this approach is uncertain, and the more recent studies have randomised children rather than ears.

Clinical guide:

Resolution after surgery takes longer in younger children and in those whose parents smoke, irrespective of treatment.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Ventilation tubes

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with no ventilation tube/watchful waiting: Unilateral ventilation tubes may be more effective than no ventilation tube at improving hearing at 2 years, but we don't know about at 5 years. Bilateral ventilation tubes may be more effective than no ventilation tubes at improving hearing at up to 6 months, and at reducing the proportion of time spent with effusion in the year after surgery ( very low-quality evidence ). Compared with adenoidectomy plus ventilation tubes: We don't know whether ventilation tube alone is more effective than ventilation tube plus adenoidectomy at improving hearing at 6-12 months ( low-quality evidence ). DEVELOPMENTAL AND BEHAVIOURAL TESTS Compared with no ventilation tube/watchful waiting: We don't know whether bilateral ventilation tubes are more effective than no ventilation tubes at improving language comprehension or expressive language at 6-9 months or cognition at up to 22 months (very low-quality evidence). ADVERSE EFFECTS Compared with no ventilation tube/watchful waiting: Ventilation tubes may be associated with an increased risk of tympanosclerosis at 1 year and tympanic membrane abnormalities at 3-4 years compared with no ventilation tube, but we don't know about retraction or atrophy, perforation, or otorrhoea at up to 1 year (low-quality evidence).

Benefits

Ventilation tubes versus no ventilation tube/watchful waiting:

We found one systematic review (search date 2003, 11 RCTs) comparing unilateral or bilateral ventilation tubes versus no ventilation tubes or watchful waiting (see comment below). It found that unilateral ventilation tubes significantly improved hearing compared with no ventilation tube at up to 2 years (see table 1 ). However, improvements decreased with time, and there was no significant difference between groups at 5 years. Randomisation in the unilateral ventilation tube trials was by ear; the ear that did not receive a ventilation tube received either no surgery or myringotomy alone (see comment below). The review found that bilateral ventilation tubes significantly improved hearing at up to 6 months compared with watchful waiting. The review found that bilateral ventilation tubes reduced the proportion of time spent with effusion in the year after surgery by 32% compared with watchful waiting. The review found no significant difference between bilateral ventilation tubes and watchful waiting in language comprehension or expressive language at 6–9 months, or cognition at up to 22 months. None of the children included in these analyses received adenoidectomy. Some of the meta-analyses in the review showed significant statistical heterogeneity, but this was unlikely to lead to mistaken reporting of benefit or lack thereof in most cases, because all of the RCTs tended to show the same trend in their results (i.e. either favouring treatment or control). Developmental outcomes used in the RCTs may have been relatively crude, and appropriate “softer” outcomes, along with speech-in-noise and binaural tests, have been recommended.

Table 1
Ventilation tubes versus no ventilation tube/watchful waiting (see text).

Ventilation tubes versus adenoidectomy plus ventilation tubes:

See benefits of ventilation tubes plus adenoidectomy

Harms

Ventilation tubes:

The most recent review (search date 2003) found that ventilation tubes significantly increased the risk of tympanosclerosis at 1 year and tympanic membrane abnormalities at 3–4 years compared with no ventilation tube (see table 1 ). Reviews have found that the rate of otorrhoea after swimming in children with ventilation tubes is low, particularly in non-divers, and protection to the ear confers no proven benefit.

Comment

Myringotomy is usually performed together with ventilation tube insertion but is not effective on its own. The clinical significance of the hearing improvements seen in the reviews was variable. None of the RCTs described in either review was placebo controlled, although some RCTs were conducted in children who had received ventilation tubes in one ear only, and in these cases the operated and non-operated ears were compared with each other. The validity of this approach is uncertain, and the more recent studies have randomised children rather than ears.

Clinical guide:

About half of children who have ventilation tubes inserted will have reinsertion within 5 years. Resolution after surgery takes longer in younger children and in those whose parents smoke, irrespective of treatment.

Substantive changes

No new evidence

2007; 2007: 0502.
Published online 2007 August 1.

Ventilation tubes plus adenoidectomy

Summary

SYMPTOM IMPROVEMENT (HEARING, EFFUSION, OR BOTH) Compared with no treatment: Ventilation tube plus adenoidectomy may be more effective than no treatment at improving hearing at 6 months, but we don't know about at 12 months ( low-quality evidence ). Compared with adenoidectomy alone: Ventilation tube plus adenoidectomy may be more effective than adenoidectomy alone at improving hearing at 1-12 months, but we don't know about at 2 and 5 years (low-quality evidence). Compared with ventilation tubes alone: We don't know whether ventilation tube plus adenoidectomy is more effective than ventilation tube alone at improving hearing at 6-12 months (low-quality evidence). NOTE Ventilation tubes may be associated with an increased risk of tympanosclerosis and tympanic membrane abnormalities.

Benefits

Ventilation tube plus adenoidectomy versus no treatment:

We found one systematic review (search date 1992, 3 RCTs, number of children not reported). It found that ventilation tube plus adenoidectomy significantly improved hearing at 6 months compared with no treatment (mean difference ranged from about 8 dB to about 20 dB; mean differences and 95% CIs for each RCT displayed graphically). At 12 months, although there was still a trend toward improved hearing in the combined treatment group, differences between groups had decreased, with only one of the three RCTs still finding significant benefit with ventilation tube plus adenoidectomy (mean difference ranged from about 2 dB to about 10 dB; mean differences and 95% CIs for each RCT displayed graphically).

Ventilation tube plus adenoidectomy versus adenoidectomy alone:

We found one systematic review (search date 2003, 8 RCTs). It found that ventilation tube plus adenoidectomy improved hearing compared with adenoidectomy alone at up to 12 months (improvement at 1–3 months: 5 RCTs, 472 ears; WMD 5.3 dB, 95% CI 3.5 dB to 7.1 dB; at 4–6 months: 6 RCTs, 558 ears; WMD 3.7 dB, 95% CI 2.0 dB to 5.3 dB; at 7–12 months: 7 RCTs, 751 ears; WMD 1.4 dB, 95% CI 0.1 dB to 2.8 dB). However, it found no significant difference between treatments at 2 and 5 years (2 years: 3 RCTs, 344 ears; WMD +1.0 dB, –1.0 dB to +3.0 dB; 5 years: 2 RCTs, 297 ears; WMD –0.88 dB, –4.4 dB to +2.6 dB).

Ventilation tube plus adenoidectomy versus ventilation tube alone:

We found one systematic review (search date 1992, 3 RCTs). The RCTs found no significant difference between ventilation tube plus adenoidectomy and ventilation tube alone at up to 12 months (first RCT, 74 ears; mean difference at 6 months: 2.1 dB; at 12 months: 2.4 dB; second RCT, 79 ears; mean difference at 6 months and at 12 months: 1.1 dB; third RCT, 72 ears; mean difference at 6 months: 2.6 dB; at 12 months: 1.7 dB; 95% CIs for all differences not significant [displayed graphically]).

Harms

Ventilation tubes:

See harms of ventilation tubes.

Comment

Myringotomy is usually performed together with ventilation tube insertion but is not effective on its own. The clinical significance of the hearing improvements seen in the reviews was variable. None of the RCTs described in either review was placebo controlled, although some RCTs were conducted in children who had received ventilation tubes in one ear only, and in these cases the operated and non-operated ears were compared with each other. The validity of this approach is uncertain, and the more recent studies have randomised children rather than ears. About half of children who have ventilation tubes inserted will have reinsertion within 5 years.

Clinical guide:

Resolution after surgery takes longer in younger children and in those whose parents smoke, irrespective of treatment.

Substantive changes

No new evidence


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