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.
We don't know whether intranasal corticosteroids are of benefit.
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
| Important outcomes | Symptom improvement (hearing, effusion, or both), developmental and behavioural tests, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of pharmacological, mechanical, and surgical interventions to treat otitis media with effusion in children? | |||||||||
| 8 (1292) | Symptom improvement | Antibiotics v placebo | 4 | -1 | 0 | -1 | 0 | Low | Quality point deducted for short follow up. Directness point deducted for unclear definition of outcome |
| 5 (418) | Symptom improvement | Antibiotics plus oral corticosteroids v antibiotics alone | 4 | –1 | –1 | –1 | +1 | Low | Quality point deducted for short follow-up. Consistency point deducted for heterogeneity between RCTs. Directness point deducted for uncertainty about generalisability of results. Effect size point added for odds ratio less than 0.5 |
| 3 (108) | Symptom improvement | Oral corticosteroids v placebo | 4 | –2 | 0 | –1 | +1 | Low | Quality point deducted for sparse data and short follow up. Directness point deducted for narrow population. Effect size point added for odds ratio less than 0.5 |
| 1 (45) | Symptom improvement | Intranasal corticosteroid v placebo | 4 | –2 | 0 | -2 | 0 | Very low | Quality points deducted for sparse data and short follow up. Directness points deducted for narrow population and small number of comparators |
| 1 (59) | Symptom improvement | Intranasal corticosteorids plus oral antibiotics v placebo plus oral antibiotics | 4 | -2 | 0 | -1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for narrow population |
| 18 (at least 1737 people) | Symptom improvement | Antihistamines plus oral decongestants v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 5 (972) | Adverse effects | Antihistamines plus oral decongestants v placebo | 4 | 0 | 0 | -1 | +1 | High | Directness point deducted for adverse effects not specified. Effect size point added for OR greater than 2 |
| 9 (583) | Symptom improvement | Mucolytics v placebo | 4 | -2 | 0 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results and unclear outcome measurement |
| 3 (at least 279) | Symptom improvement | Autoinflation using purpose-manufactured devices v no treatment | 4 | –3 | -1 | -2 | 0 | Very low | Quality points deducted for incomplete reporting of results, randomising by children but analysing by ear, and lack of blinding. Consistency point deducted for inconsistent results at different time points or by outcome. Directness points deducted for use of composite outcomes and inclusion of co-intervention (myringotomy) |
| 5 (at least 125) | Symptom improvement | Autoinflation using non purpose-manufactured devices v no treatment | 4 | –3 | 0 | -1 | 0 | Very low | Quality points deducted for inclusion of unpublished data, incomplete reporting of results, randomising by children but analysing by ear, and lack of blinding. Directness point deducted for unclear outcome |
| 3 (225 ears) | Symptom improvement | Adenoidectomy v no treatment | 4 | -2 | -1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and randomising by ears rather than children. Consistency point deducted for conflicting results |
| at least 5 (at least 574) | Symptom improvement | Ventilation tube v no ventilation tube/watchful waiting | 4 | -2 | -1 | 0 | 0 | Very low | Quality points deducted for randomising by ears, and inclusion of myringotomy in control group. Consistency point deducted for heterogeniety between RCTs |
| at least 3 (at least 559) | Developmental and behavioural tests | Ventilation tube v no ventilation tube/watchful waiting | 4 | -3 | -1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, inclusion of myringotomy in control group, and for unclear validty of outcomes used. Consistency point deducted for heterogeniety between RCTs |
| at least 4 (at least 610) | Adverse effects | Ventilation tube v no ventilation tube/watchful waiting | 4 | -1 | 0 | -1 | 0 | Low | Quality point deducted for inclusion of myringotomy in control group. Directness point deducted for unclear clinical relevance |
| 3 (not reported) | Symptom improvement | Ventilation tubes plus adenoidectomy v no treatment | 4 | –2 | 0 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results and incomplete reporting of included population |
| at least 7 (at least 751 ears) | Symptom improvement | Ventilation tubes plus adenoidectomy v adenoidectomy alone | 4 | -1 | –1 | 0 | 0 | Low | Quality point deducted for analysing by ears rather than children. Consistency point deducted for inconsistent results at different endpoints |
| 3 (225 ears) | Symptom improvement | Ventilation tubes plus adenoidectomy v ventilation tubes alone | 4 | –2 | 0 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results and for analysing by ears rather than children |
Type of evidence: 4 = RCT. Consistency: similarity of results across studies. Directness: generalisability of population or outcomes. Effect size: based on relative risk or odds ratio. OME, otitis media with effusion
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.
Acute otitis media
Disclaimer
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