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1General Practice de Hof van Blom, Hattem, The Netherlands
2Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
RD is the co-author of 4 systematic reviews referenced in this review. MMR was paid by GlaxoSmithKline for a presentation on the burden of otitis media at the ESPO in Budapest in 2008 and is co-author of 4 systematic reviews referenced in this review.
In the UK, about 30% of children under 3 years of age visit their GP each year with acute otitis media (AOM), and 97% of these receive antibiotics. In the US, AOM is the most common reason for outpatient antibiotic treatment. Without antibiotics, AOM resolves within 24 hours in about 60% of children, and within 3 days in about 80% of children.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for AOM in children; and what are the effects of interventions to prevent recurrence? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2010 (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 29 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: analgesics, antibiotics, delayed antibiotics, immediate antibiotics, long-term antibiotic prophylaxis, longer courses of antibiotics, myringotomy, pneumococcal vaccination, tympanostomy with ventilation tubes, xylitol syrup or gum, and influenza vaccination.
Key Points
AOM is characterised by sudden onset of earache with a cloudy or bulging erythematous eardrum caused by middle-ear infection.
Middle-ear effusion without signs of infection lasting >3 months suggests otitis media with effusion ('glue ear'), while chronic suppurative otitis media is characterised by continuing middle-ear inflammation and discharge through a perforated eardrum. These disorders are assessed in separate reviews in Clinical Evidence.
The most common pathogens in AOM in the US and UK are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
In the UK, about 30% of children under 3 years of age visit their GP each year with AOM, and 97% of these receive antibiotics. In the US, AOM is the most common reason for outpatient antibiotic treatment.
Without antibiotics, AOM resolves within 24 hours in about 60% of children, and within 3 days in about 80% of children.
Analgesics and topical anaesthetics may reduce earache.
Antibiotics seem to reduce pain at 2 to 7 days, but they increase the risks of vomiting, diarrhoea, and rashes compared with placebo.
Immediate antibiotic use seems most beneficial in children aged <2 years with bilateral AOM and in children with AOM presenting with otorrhoea.
We do not know whether any one antibiotic regimen should be used in preference to another, although amoxicillin may be more effective than macrolides, and it should be considered as first-line treatment.
Longer courses of antibiotics reduce short-term treatment failure but have no benefit in the longer term compared with shorter regimens.
Immediate use of antibiotics may provide short-term reduction in some symptoms of AOM, but it increases the risk of diarrhoea and rashes compared with delayed treatment.
Myringotomy seems less effective than antibiotics at reducing symptoms.
We found limited evidence of only a short-term benefit from tympanostomy with ventilation tubes, with possibly increased risks of tympanosclerosis.
Long-term antibiotic prophylaxis may reduce recurrence rates; however, the possibility of adverse effects and antibiotic resistance should be taken into account.
We do not know whether any one regimen should be used in preference to another to prevent recurrent attacks.
Vaccination with PCV in children aged 1 to 7 years does not reduce AOM recurrence.
Influenza vaccine in healthy children has no effect on incidence of AOM.
Xylitol given 5 times daily as prophylaxis has a small preventive effect on recurrent AOM, but the compliance issues in giving a medicine 5 times daily to such young children render it an unrealistic treatment option.
About this condition
Definition
Otitis media is an inflammation in the middle ear. Subcategories include acute otitis media (AOM), recurrent AOM, and chronic suppurative otitis media (CSOM). AOM is the presence of middle-ear effusion in conjunction with rapid onset of one or more signs or symptoms of inflammation of the middle ear. AOM presents with systemic and local signs, and it has a rapid onset. The diagnosis is made on the basis of signs and symptoms, principally earache in the presence of a cloudy or bulging eardrum (and immobility of the eardrum if pneumatic otoscopy is performed). Erythema is a moderately useful sign for helping to establish the diagnosis. If the eardrum has a normal colour, then risk of AOM is low. Uncomplicated AOM is limited to the middle-ear cleft. The persistence of an effusion beyond 3 months without signs of infection defines otitis media with effusion (also known as 'glue ear'; see review on otitis media with effusion), which can arise as a consequence of AOM, but can also occur independently. CSOM is characterised by continuing inflammation in the middle ear causing discharge (otorrhoea) through a perforated tympanic membrane (see review on CSOM). This review deals only with AOM in children.
Incidence/
Prevalence
AOM is common, and has a high morbidity and low mortality in otherwise healthy children. In the UK, about 30% of children under 3 years visit their general practitioner with AOM each year, and 97% receive antimicrobial treatment. By 3 months of age, 10% of children have had an episode of AOM. It is the most common reason for outpatient antimicrobial treatment in the US.
Aetiology/
Risk factors
The most common bacterial causes of AOM in the US and UK are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Similar pathogens are found in Colombia. There is some evidence that the predominant causative pathogen in recurrent AOM is changing from Streptococcus pneumoniae to Haemophilus influenzae after the release and widespread use of pneumococcal conjugate vaccine. The established modifiable risk factors for recurrent AOM are the use of pacifiers, and care in daycare centres. Probable risk factors are privation of mother's milk, presence of siblings, craniofacial abnormalities, passive smoking, and presence of adenoids.
Prognosis
Without antibiotic treatment, AOM symptoms improve in 24 hours in about 60% of children, and in about 80% of children the condition resolves in about 3 days. Suppurative complications occur in about 0.12% of children if antibiotics are withheld. Serious complications are rare in otherwise healthy children but include hearing loss, mastoiditis, meningitis, and recurrent attacks. The WHO estimates that, in developing countries, 51,000 children aged <5 years die from complications of otitis media each year.
Aims of
intervention
To reduce the severity and duration of pain and other symptoms; to prevent complications; to minimise adverse effects of treatment.
Outcomes
Symptoms of AOM (including pain [which can be assessed by surrogate measures such as parental observation of distress/crying and analgesic use], fever, middle-ear effusion, and otoscopic appearance); recurrence of infection, mastoiditis, and meningitis; complications of infection (including deafness), adverse effects of treatment.
Methods
Clinical Evidence search and appraisal September 2010. The following databases were used to identify studies for this systematic review: Medline 1966 to September 2010, Embase 1980 to September 2010, and The Cochrane Database of Systematic Reviews, August 2010 (online; 1966 to date of issue). This review was edited using The Cochrane Database of Systematic Reviews 2010, Issue 4. An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). 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 contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing >20 individuals of whom >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. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table.
GRADE Evaluation of interventions for AOM in children.
Important outcomes
Complications, Recurrence, Symptoms of AOM
Studies (Participants)
Outcome
Comparison
Type of evidence
Quality
Consistency
Directness
Effect size
GRADE
Comment
What are the effects of treatments for AOM in children?
2 (117)
Symptoms of AOM
Topical anaesthetic versus placebo
4
–1
0
–1
0
Low
Quality point deducted for sparse data. Directness point deducted for inclusion of studies that included oral analgesics
1 (219)
Symptoms of AOM
Oral analgesics versus placebo
4
–1
0
–1
0
Low
Quality point deducted for incomplete reporting of results. Directness point deducted for uncertain validity of outcome assessment
at least 19 (at least 3805)
Symptoms of AOM
Antibiotics versus placebo
4
0
–1
–1
0
Low
Consistency point deducted for conflicting results. Directness point deducted for range of interventions included
6 (2153)
Recurrence
Antibiotics versus placebo
4
0
0
0
0
High
1 (2287)
Complications
Antibiotics versus placebo
4
0
0
–1
0
Moderate
Directness point deducted for range of interventions included
at least 27 (at least 4580)
Symptoms of AOM
Different antibiotics versus each other
4
–2
0
–2
0
Very low
Quality points deducted for incomplete reporting of results and heterogeneity of outcome measures and controls. Directness points deducted for range of participants and interventions included
2 (498)
Symptoms of AOM
Immediate versus delayed antibiotic treatment
4
0
–1
0
0
Moderate
Consistency point deducted for conflicting results
27 (6727)
Symptoms of AOM
Longer versus shorter course of antibiotics
4
0
0
0
0
High
1 (171)
Symptoms of AOM
Myringotomy versus no myringotomy
4
–2
0
0
0
Low
Quality points deducted for sparse data and incomplete reporting of results
3 (821)
Symptoms of AOM
Myringotomy versus antibiotics
4
–1
–1
0
0
Low
Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results
What are the effects of interventions to prevent recurrence of AOM in children?
13 (at least 1358)
Recurrence
Antibiotic prophylaxis versus placebo
4
0
0
0
0
High
12 (46,457)
Recurrence
Pneumococcal vaccine versus placebo or control
4
–2
–1
0
0
Very low
Quality points deducted for incomplete reporting and for no intention-to-treat analyses in many RCTs. Consistency point deducted for conflicting results
3 (192)
Recurrence
Tympanostomy versus no surgery or myringotomy alone
4
–2
–1
0
0
Very low
Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for different results at different end points
1 (44)
Complications
Tympanostomy versus no surgery or myringotomy alone
4
–1
–1
0
0
Low
Quality point deducted for sparse data. Consistency point deducted for different results at different end points
6 (5253)
Recurrence
Influenza vaccine versus placebo
4
–1
0
0
0
Moderate
Quality point deducted for poor methodology (vaccination completed after the beginning of viral circulation in 1 large RCT)
4 (2411)
Recurrence
Xylitol versus placebo
4
0
–1
–1
0
Low
Consistency point deducted for conflicting results. Directness point deducted for range of interventions
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size.
Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]).
Consistency: based on similarity of results across studies.
Directness: based on generalisability of population or outcomes.
Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.
Glossary
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.
Mastoiditis
The presence of infection in the mastoid cavity.
Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Myringotomy
The surgical creation of a perforation in the tympanic membrane.
Very low-quality evidence
Any estimate of effect is very uncertain.
See chronic suppurative otitis media
See otitis media with effusion
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.
Contributor Information
Roger A J M Damoiseaux, General Practice de Hof van Blom, Hattem, The Netherlands.
Maroeska M Rovers, Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
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Analgesics and topical anaesthetics may reduce earache compared with placebo.
NOTE: A drug safety alert has been issued by the Food Drug Administration (FDA) on the risk of rare but serious skin reactions with paracetamol (acetaminophen).
Benefits and harms
Topical anaesthetic versus placebo:
We found one systematic review (search date 2009, 2 RCTs).
Symptoms of AOM
Compared with placebo Topical anaesthetic drops may be more effective at reducing earache 10 to 30 minutes after administration in children taking paracetamol (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Pain
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
25% reduction in ear ache
10 minutes
37/58 (64%) with topical anaesthetic drops 25/59 (42%) with placebo
RR 1.51
95% CI 1.06 to 2.15
P = 0.02
NNT 4
95% CI 3 to 27
Small effect size
topical anaesthetic drops
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
25% reduction in ear ache
20 minutes
46/58 (79%) with topical anaesthetic drops 35/59 (59%) with placebo
RR 1.34
95% CI 1.04 to 1.71
P = 0.02
NNT 5
95% CI 3 to 27
Small effect size
topical anaesthetic drops
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
25% reduction in ear ache
30 minutes
54/58 (93%) with topical anaesthetic drops 41/59 (69%) with placebo
RR 1.34
95% CI 1.12 to 1.61
P <0.002
NNT 5
95% CI 3 to 10
Small effect size
topical anaesthetic drops
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
50% reduction in ear ache
10 minutes
25/58 (43%) with topical anaesthetic drops 12/59 (20%) with placebo
RR 2.13
95% CI 1.19 to 3.80
P = 0.01
NNT 4
95% CI 3 to 16
Moderate effect size
topical anaesthetic drops
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
50% reduction in ear ache
20 minutes
34/58 (59%) with topical anaesthetic drops 28/59 (47%) with placebo
RR 1.24
95% CI 0.88 to 1.74
P = 0.22
Not significant
Systematic review
117 people aged 3 to 19 years 2 RCTs in this analysis
50% reduction in ear ache
30 minutes
49/58 (84%) with topical anaesthetic drops 35/59 (59%) with placebo
RR 1.43
95% CI 1.12 to 1.81
P = 0.003
NNT 4
95% CI 3 to 11
No data from the following reference on this outcome.
Complications
No data from the following reference on this outcome.
Adverse effects
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Adverse effects
Systematic review
63 people aged 3 to 19 years Data from 1 RCT
Adverse effects
with topical anaesthetic drops with placebo
One RCT in the review reported on adverse effects. The review reported that 3 people (treatment arm not specified) had mild dizziness that required no further treatment
All participants also received paracetamol. See further information on studies for full details of co-interventions
We found one RCT comparing the effects of treatment with ibuprofen or paracetamol three times daily versus placebo for 48 hours.
Symptoms of AOM
Compared with placebo Oral ibuprofen or paracetamol may be more effective at reducing pain after 48 hours in children taking antibiotics (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Pain
RCT
219 children, aged 1 to 6 years with otoscopically diagnosed AOM and receiving antibiotic treatment with cefaclor for 7 days
Incidence of ear ache
2 days
5/71 (7%) with ibuprofen 19/75 (25%) with placebo
P <0.01
Effect size not calculated
ibuprofen
RCT
219 children, aged 1 to 6 years with otoscopically diagnosed AOM and receiving antibiotic treatment with cefaclor for 7 days
Incidence of ear ache
2 days
7/73 (10%) with paracetamol 19/75 (25%) with placebo
The evidence from this RCT is limited because the assessment of the child's pain relief was based on parental observation using a scale of 0 or 1.
The review included studies in which participants were also given oral analgesics. It is therefore difficult to properly assess the real effects of the anaesthetic ear drops.
Drug safety alert
The FDA issued a drug safety alert on the risk of rare but serious skin reactions with paracetamol (acetaminophen) (August 2013).
August 2013, paracetamol (acetaminophen)
The Food and Drug Administration (FDA) has issued a drug safety alert on the risk of rare but serious skin reactions with paracetamol (acetaminophen). These skin reactions, known as Stevens–Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), can be fatal.(www.fda.gov/)
Comment
None.
Substantive changes
Analgesics for AOM in children One Cochrane systematic review updated. Categorisation unchanged (Likely to be beneficial).
Antibiotics may lead to more rapid reduction in symptoms of AOM, but they increase the risk of adverse effects.
Antibiotics seem to reduce pain at 2 to 7 days, but they increase the risks of vomiting, diarrhoea, and rashes compared with placebo.
Antibiotics seem most effective in children aged <2 years with bilateral AOM and in children with AOM presenting with otorrhoea.
Benefits and harms
Antibiotics versus placebo:
We found 4 systematic reviews (search dates 1997, 2008, and 2005
).
Symptoms of AOM
Compared with placebo Antibiotics may be more effective at reducing pain and other symptoms of AOM after 2 to 14 days (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
Systematic review
741 children aged <2 years 4 RCTs in this analysis
Symptomatic improvement
7 days
357/416 (86%) with antibiotics 277/325 (85%) with placebo alone or versus placebo plus myringotomy
OR 1.31 (weighted OR, Mantel–Haenszel)
95% CI 0.83 to 2.08
Not significant
Systematic review
2791 children aged 6 months to 15 years 9 RCTs in this analysis
Pain
2 to 7 days
228/1425 (16%) with erythromycin, penicillins, sulphonamides 303/1366 (22%) with placebo
ARR 6%
95% CI 4% to 9%
RR 0.72
95% CI 0.19 to 0.40
P <0.001
NNT 16
95% CI 11 to 25
Small effect size
antibiotics
Systematic review
1229 children aged 6 months to 15 years 4 RCTs in this analysis
Pain outcomes
24 hours
223/624 (36%) with antibiotics 241/605 (40%) with placebo
RR 0.90
95% CI 0.78 to 1.04
Not significant
Systematic review
273 children <2 years with bilateral AOM 6 RCTs in this analysis Subgroup analysis
Pain, fever, or both
3 to 7 days
42/140 (30%) with antibiotics 74/133 (55%) with placebo
RR 0.64
95% CI 0.62 to 0.80
The differences for children aged <2 years with unilateral AOM and in children >2 years with unilateral or bilateral AOM were not significant
Small effect size
antibiotics
Systematic review
116 children aged 6 months to 12 years presenting with otorrhoea 6 RCTs in this analysis Subgroup analysis
Pain, fever, or both
3 to 7 days
12/50 (24%) with antibiotics 39/66 (60%) with placebo
No data from the following reference on this outcome.
Complications
Compared with placebo Antibiotics seem no more effective at reducing the risk of abnormal tympanometry at 1 and 3 months in children with AOM (moderate-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Abnormal tympanometry
Systematic review
808 children aged 6 months to 10 years 3 RCTs in this analysis
Abnormal tympanometry
3 months
96/410 (23%) with antibiotics 96/460 (24%) with placebo
RR 0.97
95% CI 0.76 to 1.24
P = 0.81
Not significant
Systematic review
927 children aged 6 months to 12 years 4 RCTs in this analysis
Abnormal tympanometry
1 month
153/467 (33%) with antibiotics 168/460 (37%) with placebo
RR 0.89
95% CI 0.75 to 1.07
P = 0.21
Not significant
Systematic review
1328 children aged 6 months to 12 years 5 RCTs in this analysis
Abnormal tympanometry
1 month
47% with antibiotics 51% with placebo or no treatment Absolute numbers not reported
No data from the following reference on this outcome.
Further information on studies
Three RCTs based diagnosis of AOM on otoscopic appearance of the tympanic membrane and clinical signs of acute infection, and one RCT based diagnosis on otoscopy findings alone.
Comment
None.
Clinical guide:
The results of systematic reviews comparing antibiotics versus placebo may vary owing to differences in entry criteria and outcome measures. One quasi-randomised trial from Sweden conducted in 1954 comparing the effects of antibiotics versus placebo found no cases of mastoiditis in the penicillin-treated group, whereas 17% of the control group developed mastoiditis. Therefore, in populations in which the incidence of complicating mastoiditis is high, antibiotic treatment would be advised.
Substantive changes
Antibiotics versus placebo for AOM in children New evidence added.
Categorisation unchanged (Trade-off between benefits and harms).
We do not know whether any one antibiotic regimen should be used in preference to another, but amoxicillin may be more effective than macrolides, and it should be considered as first-line treatment.
NOTE Antibiotics increase the risk of vomiting, diarrhoea, and rashes compared with placebo, but rates may vary between different types of antibiotic.
Benefits and harms
Different antibiotics versus each other:
We found three systematic reviews (search dates 1992, 1999, and 2008).
Symptoms of AOM
Different antibiotics compared with each other Macrolide antibiotics may be less effective than amoxicillin or amoxicillin–clavulanic acid (co-amoxiclav) at reducing signs and symptoms of AOM after 7 to 14 days, while other antibiotics may be as effective as each other (very low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
Systematic review
4580 children aged 4 months to 18 years 27 RCTs in this analysis
Primary control defined as absence of any symptom or sign
7 to 14 days
with with Absolute numbers not reported
P values not reported
Reported as not significant for all comparisons
Not significant
Systematic review
491 children, aged 4 weeks to 18 years 3 RCTs in this analysis
Clinical failure rate
7 to 14 days
with penicillin with ampicillin or amoxicillin Absolute results not reported
Clinical failure rate difference: +4.5%
95% CI –1.8% to +10.7%
Not significant
Systematic review
185 children, aged 4 weeks to 18 years 4 RCTs in this analysis
Clinical failure rates
3 to 7 days
with cefaclor with ampicillin or amoxicillin Absolute numbers not reported
Clinical failure rate difference –5.4%
95% CI –15.2% to +4.4%
Not significant
Systematic review
2766 children aged 6 months to 15 years 10 RCTs in this analysis
Clinical failure
10 to 16 days
146/1371 (11%) with amoxicillin or amoxicillin–clavulanic acid 196/1395 (14%) with macrolide antibiotics
No data from the following reference on this outcome.
Further information on studies
Clinical failure was defined as the presence of pain, fever, middle-ear effusion, clinical signs of otitis media, or suppurative complications such as mastoiditis.
AOM was defined as bulging or opacification of the tympanic membrane with or without erythema, accompanied by at least one sign (fever, ear ache, irritability, otorrhoea, lethargy, anorexia, vomiting, diarrhoea, poor or absent mobility of the tympanic membrane). Treatment success was defined as absence of all presenting signs and symptoms of AOM at the evaluation point closest to 7 to 14 days after start of treatment.
Comment
Clinical guide:
Many RCTs have studied a variety of antibiotic regimens for the treatment of otitis media, but there is heterogeneity in participants, treatment regimens, controls, and outcome measures.
Substantive changes
Choice of antibiotic regimen New evidence added. Categorisation unchanged (Trade-off between benefits and harms).
Immediate use of antibiotics may provide short-term reduction for some symptoms of AOM, but it increases the risk of rashes and diarrhoea compared with delayed treatment.
Benefits and harms
Immediate versus delayed antibiotic treatment:
We found one systematic review (search date 2009). Owing to heterogeneity among studies, the review did not perform meta-analyses, so we report data from individual RCTs here.
Symptoms of AOM
Immediate antibiotics compared with delayed antibiotics Immediate antibiotics may be more effective at reducing pain and other symptoms of AOM at 3 days, but not after 7 days (moderate-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
Systematic review
212 children aged 6 months to 10 years Data from 1 RCT
Proportion of children with pain
3 days
28/111 (25%) with delayed antibiotics 15/101 (15%) with immediate antibiotics
OR 1.93
95% CI 0.96 to 3.88
Not significant
Systematic review
212 children aged 6 months to 10 years Data from 1 RCT
Proportion of children with pain
7 days
3/111 (3%) with delayed antibiotics 0/101 (0%) with immediate antibiotics
OR 6.55
95% CI 0.33 to 128.34
Not significant
Systematic review
285 children aged 6 months to 10 years Data from 1 RCT
Proportion of children with malaise
3 days
45/150 (30%) with delayed antibiotics 19/135 (14%) with immediate antibiotics
OR 2.62
95% CI 1.44 to 4.76
Moderate effect size
immediate antibiotics
Systematic review
213 children aged 6 months to 10 years Data from 1 RCT
Mean pain severity
3 days
2.56 with delayed antibiotics 1.81 with immediate antibiotics
Mean difference 0.75
95% CI 0.26 to 1.24
Effect size not calculated
immediate antibiotics
Systematic review
212 children aged 6 months to 10 years Data from 1 RCT
Mean pain severity
7 days
1.17 with delayed antibiotics 1.05 with immediate antibiotics
Mean difference +0.12
95% CI –0.04 to +0.28
Not significant
Systematic review
282 children aged 6 months to 12 years Data from 1 RCT
Mean number of spoons of paracetamol/day
2.28 with delayed antibiotics 1.69 with immediate antibiotics
Mean difference 0.59
95% CI 0.25 to 0.93
Effect size not calculated
immediate antibiotics
Systematic review
265 children aged 6 months to 12 years Data from 1 RCT
Fever
days 4 to 6
42/132 (32%) with delayed antibiotics 46/133 (35%) with immediate antibiotics
OR 0.88
95% CI 0.53 to 1.47
Not significant
Systematic review
265 children aged 6 months to 12 years Data from 1 RCT
Proportion of children with pain
days 4 to 6
85/132 (64%) with delayed antibiotics 89/133 (67%) with immediate antibiotics
OR 0.89
95% CI 0.54 to 1.48
Not significant
Systematic review
265 children aged 6 months to 12 years Data from 1 RCT
Use of paracetamol or ibuprofen
123/132 (93%) with delayed antibiotics 120/133 (90%) with immediate antibiotics
OR 1.48
95% CI 0.61 to 3.59
Not significant
Systematic review
265 children aged 6 months to 12 years Data from 1 RCT
Re-consultation rate
13/132 (10%) with delayed antibiotics 11/133 (8%) with immediate antibiotics
Prescribing delayed antibiotics, using a prescription to be filled later if symptoms do not improve, is a tool for the physician to reduce antibiotic use rather than a treatment option for AOM. If antibiotics have a small effect on the outcome of AOM, then this effect will clearly apply to immediate antibiotics. Because the evidence suggests that antibiotics should only be prescribed to certain subgroups of patients (children aged <2 years with bilateral AOM and children with AOM presenting with otorrhoea), physicians should discuss the wait-and-see policy with parents of children not in those subgroups. A delayed prescription should be provided with care, since oral antibiotics may not always be the best option in very young children with worsening symptoms. In these cases the physician and not the parents of the child should make the decision about whether to give antibiotics. In most developed countries, it is relatively easy for parents to re-consult a physician when symptoms either do not improve or get worse.
One study in the review showed no difference in re-consultation rate between the two groups. One study comparing delayed antibiotics versus no antibiotics showed no difference in the outcomes of pain and fever.
Substantive changes
Immediate or delayed antibiotics for AOM in children New evidence added. Categorisation unchanged (Trade-off between benefits and harms).
Longer courses of antibiotics reduce short-term treatment failure, but have no benefit over the longer term compared with shorter regimens.
Benefits and harms
Longer versus shorter course of antibiotics:
We found one systematic review (search date 2009).
Symptoms of AOM
Longer courses of antibiotics compared with shorter courses Longer (8–10 days) courses of antibiotics are more effective at reducing symptoms and preventing relapse or re-infection at 8 to 19 days compared with 7-day courses, but are no more effective than shorter courses after 20 to 30 days (high-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
Systematic review
5093 children aged between 4 weeks and 15 years 16 RCTs in this analysis
Treatment failure
1 month or less
486/2376 (20%) with short-course antibiotics (<7 days) 475/2717 (17%) with longer-course antibiotics (8–10 days)
OR 1.34
95% CI 1.15 to 1.55
P = 0.0001
Small effect size
longer-course antibiotics
Systematic review
3932 children aged between 4 weeks and 15 years 11 RCTs in this analysis
Treatment failure
8 to 19 days
340/1892 (18%) with short-course antibiotics (<7 days) 293/2040 (14%) with longer-course antibiotics (8–10 days)
OR 1.37
95% CI 1.15 to 1.64
P = 0.0004
Small effect size
longer-course antibiotics
Systematic review
2475 children aged between 4 weeks and 15 years 9 RCTs in this analysis
Treatment failure
20 to 30 days
238/1141 (21%) with short-course antibiotics (<7 days) 271/1335 (20%) with longer-course antibiotics (8–10 days)
OR 1.16
95% CI 0.94 to 1.42
Not significant
Systematic review
2068 children aged between 4 weeks and 15 years 7 RCTs in this analysis
Treatment failure
3 months or less
391/973 (40%) with short-course antibiotics (<7 days) 399/1095 (36%) with longer-course antibiotics (8–10 days)
OR 1.18
95% CI 0.98 to 1.41
Not significant
Systematic review
570 children aged between 4 weeks and 2 years 5 RCTs in this analysis
Treatment failure
1 month or less
99/296 (33%) with short-course antibiotics (<7 days) 85/274 (31%) with longer-course antibiotics (8–10 days)
OR 1.09
95% CI 0.76 to 1.57
Not significant
Systematic review
1064 children aged between 2 years and 15 years 6 RCTs in this analysis
Treatment failure
1 month or less
74/530 (14%) with short-course antibiotics (<7 days) 86/534 (16%) with longer-course antibiotics (8–10 days)
Treatment failure was defined as lack of clinical resolution, relapse, or recurrence of AOM during a 1-month period following the initiation of therapy. Clinical resolution was defined as improved or resolving signs or symptoms of AOM. Treatment failure at 3 months was defined as relapses and recurrences up to 3 months.
Comment
A subgroup analysis showed that children aged <2 years had no benefit from longer courses of antibiotics compared with shorter courses. In addition, they had a greater risk of treatment failure compared with older children irrespective of treatment duration.
Substantive changes
Longer versus shorter courses of antibiotics One Cochrane systematic review updated. Categorisation unchanged (Trade-off between benefits and harms).
Myringotomy seems less effective than antibiotics at reducing symptoms.
ADVERSE EFFECTS Myringotomy may be less likely than antibiotics to cause diarrhoea.
Benefits and harms
Myringotomy versus no myringotomy:
We found one RCT.
Symptoms of AOM
Compared with no myringotomy Myringotomy may be no more effective than no myringotomy at reducing the symptoms of AOM after 1 to 7 days (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
RCT 4-armed trial
171 children, aged 2 to 12 years with AOM
Pain
24 hours
26/36 (72.2%) with myringotomy only 29/40 (72.5%) with no treatment
P value not reported
Reported as not significant for myringotomy v no treatment
Not significant
RCT 4-armed trial
171 children, aged 2 to 12 years with AOM
Pain
7 days
31/35 (89%) with myringotomy only 34/38 (90%) with no treatment
P value not reported
Reported as not significant for myringotomy v no treatment
No data from the following reference on this outcome.
Complications
No data from the following reference on this outcome.
Adverse effects
No data from the following reference on this outcome.
Myringotomy versus antibiotics:
We found no systematic review but found three RCTs.
Symptoms of AOM
Compared with antibiotics Myringotomy may be less effective at reducing symptoms of AOM after 12 hours to 11 days (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Symptoms of AOM
RCT 3-armed trial
105 infants aged 3 months to 1 year with AOM
Persistent ear infection
9 to 11 days
21/30 (70%) with myringotomy plus placebo 2/30 (7%) with antibiotic (amoxicillin–clavulanic acid)
P <0.001
Effect size not calculated
antibiotic
RCT 3-armed trial
105 infants aged 3 months to 1 year with AOM
Persistent ear infection
3 to 6 days
28/35 (80%) with myringotomy plus placebo 11/35 (31%) with antibiotic (amoxicillin–clavulanic acid)
P <0.0001
Effect size not calculated
antibiotic
RCT 4-armed trial
171 children aged 2 to 12 years with AOM
No pain
24 hours
26/36 (72.2%) with myringotomy 34/47 (72.3%) with amoxicillin (250 mg three times daily for 7 days)
P value not reported
Reported as not significant for myringotomy v amoxicillin alone
Not significant
RCT 4-armed trial
171 children aged 2 to 12 years with AOM
No pain
7 days
31/35 (89%) with myringotomy 43/46 (93%) with amoxicillin (250 mg three times daily for 7 days)
P value not reported
Reported as not significant
Not significant
RCT 3-armed trial
83 episodes of AOM in children, aged 2 to 12 years with severe AOM or recurrent AOM
Initial treatment failure
12 hours
23% with myringotomy plus placebo 4% with amoxicillin (40 mg/kg/day in 3 divided doses for 14 days) Absolute numbers not reported
P = 0.006
Results include severe episodes of AOM in children aged 2 to 12 years only
No data from the following reference on this outcome.
Further information on studies
The RCT provided results in the form of children or as individual ears as the unit measured. Because randomisation was based on children, the figures reported here exclude those results based on individual ears.
AOM was defined as the presence of middle-ear effusion and bulging (with or without redness of the tympanic membrane) associated with recent irritability or fever. The RCT provided results in the form of children or as individual ears as the unit measured. Because randomisation was based on children, the figures reported here exclude those results based on individual ears.
AOM was diagnosed on the basis of fever, ear ache, or irritability with redness and/or bulging of the eardrum. An episode of AOM was classified as severe or non-severe according to the child's temperature and an ear ache score.
Long-term antibiotic prophylaxis may reduce recurrence rates; however, the possibility of adverse effects and antibiotic resistance should be taken into account.
We do not know whether any one regimen should be used in preference to another to prevent recurrent attacks.
Benefits and harms
Antibiotic prophylaxis versus placebo:
We found one systematic review (13 RCTs, search date 2006), which compared antibiotics versus placebo or no treatment for the prevention of AOM, AOM with perforation, or chronic suppurative otitis media.
Recurrence
Compared with placebo Prophylactic antibiotics are more effective at reducing the incidence of AOM compared with placebo or no treatment in children at risk of otitis media (high-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Recurrence
Systematic review
1358 children at increased risk of AOM 13 RCTs in this analysis
Proportion of children with AOM or chronic suppurative otitis media
253/748 (34%) with antibiotics 331/610 (54%) with placebo or no treatment
RR 0.62
95% CI 0.52 to 0.75
Small effect size
antibiotics
Systematic review
1112 children at increased risk of AOM 12 RCTs in this analysis
Number of episodes of otitis media
360 episodes with antibiotics 752 episodes with placebo or no treatment
Incidence rate ratio (IRR) 0.48
95% CI 0.37 to 0.62; see further information on studies for definition of IRR
Antibiotics prevented 1.5 episodes of AOM for every 12 months of treatment per child
The incidence rate ratio (IRR), also known as the rate ratio, is the incidence rate in the intervention group divided by the incidence rate in the placebo group.
Comment
Clinical guide:
We found insufficient evidence on which antibiotic to use and for how long, and on how many episodes of AOM to justify starting preventive treatment.
Substantive changes
Antibiotic prophylaxis for preventing recurrence of AOM in children One Cochrane systematic review updated. Categorisation unchanged (Trade-off between benefits and harms).
Vaccination in infancy with pneumococcal conjugate vaccine (PCV) has some effect on recurrent AOM.
Vaccination with PCV in children aged 1 to 7 years with recurrent AOM has no effect on recurrences.
The adverse effects associated with pneumococcal vaccination are unclear.
NOTE We found no clinically important results from RCTs about the effects of the 23-valent pneumococcal vaccine that is currently available.
Benefits and harms
Pneumococcal vaccine versus placebo or control:
We found one systematic review (search date 2007). The review included 7 RCTs on 7- to 11-valent pneumococcal conjugate vaccine (PCV) (with different carrier proteins). Owing to significant heterogeneity regarding study population, type of conjugate vaccine, and outcome measures, the review did not perform a meta-analysis. We therefore present results from individual RCTs.
Recurrence
Compared with placebo or control vaccine Pneumococcal conjugate vaccine (7- to 11-valent) may be more effective than placebo at reducing the incidence of AOM when administered during infancy, but may be no more effective when given to children aged 1 to 7 years with recurrent AOM (very low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Recurrence
Systematic review
37,868 children aged 2 months Data from 1 RCT
Episodes
per person-year
with vaccination with control vaccine Absolute results not reported
Relative risk reduction (RRR) 6%
95% CI 4% to 8%
Effect size not calculated
pneumococcal vaccine
Systematic review
1662 children aged 2 months Data from 1 RCT
Episodes
per person-year
1.16 with vaccination 1.24 with control vaccine
RRR +6%
95% CI –4% to +16%
Not significant
Systematic review
1666 children aged 2 months Data from 1 RCT
Episodes
per person-year
with vaccination with control vaccine Absolute results not reported
RRR –1%
95% CI –12% to +10%
Not significant
Systematic review
4968 children aged 6 weeks to 5 months Data from 1 RCT
Episodes
per person-year
0.08 with vaccination 0.13 with control vaccine
RRR 34%
95% CI 21% to 44%
Effect size not calculated
pneumococcal vaccine
Systematic review
264 children aged 12 months to 35 months Data from 1 RCT
Episodes
per person-year
0.66 with vaccination 0.79 with control vaccine
RRR +17%
95% CI –2% to +33%
Not significant
Systematic review
383 children aged 1 year to 7 years with recurrent AOM Data from 1 RCT
Episodes
per person-year
1.1 with vaccination 0.83 with control vaccine
RRR –29%
95% CI –62% to –2%
Effect size not calculated
control vaccine
Systematic review
74 children aged 1 year to 7 years with recurrent AOM Data from 1 RCT
Episodes
per person-year
0.78 with vaccination 0.67 with control vaccine
RRR –16%
95% CI –96% to +31%
Not significant
Systematic review
37,868 children aged 2 months Data from 1 RCT
Recurrent AOM
with vaccination with control vaccine Absolute results not reported
RRR 9%
95% CI 4% to 14%
Effect size not calculated
pneumococcal vaccine
Systematic review
1662 children aged 2 months Data from 1 RCT
Recurrent AOM
with vaccination with control vaccine Absolute results not reported
RRR +9%
95% CI –12% to +27%
Not significant
Systematic review
4968 children aged 6 weeks to 5 months Data from 1 RCT
Recurrent AOM
with vaccination with control vaccine Absolute results not reported
No data from the following reference on this outcome.
Complications
No data from the following reference on this outcome.
Adverse effects
No data from the following reference on this outcome.
Further information on studies
None.
Comment
Clinical guide:
Based on the current evidence, the review concluded that pneumococcal conjugate vaccine (PCV) is marginally beneficial in preventing AOM in infancy. The discrete reductions of 6% may, however, result in substantial reductions from a public health perspective. In most western countries, PCVs are implemented in national childhood vaccination programmes because of the effect on invasive pneumococcal infections. Administering PCVs in older children with a history of AOM has no effect on preventing further AOM episodes.
Substantive changes
Pneumococcal vaccine New evidence added. Categorisation changed from Unlikely to be beneficial to Likely to be beneficial.
Tympanostomy with ventilation tube insertion leads to short-term reduction in the number of episodes of AOM, but it increases the risk of complications.
We found limited evidence of only a short-term benefit from tympanostomy with ventilation tubes, with possibly increased risks of tympanosclerosis.
Tympanostomy plus drainage tubes may increase the risk of tympanosclerosis and hearing impairment.
Benefits and harms
Tympanostomy versus no surgery or myringotomy alone:
We found one systematic review (search date 2008) and one additional RCT.
Recurrence
Compared with no surgery or myringotomy alone Tympanostomy plus insertion of drainage tubes may be more effective at reducing the incidence of AOM after 6 months, but not after 18 months (very low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Recurrence
Systematic review
148 children aged <3 years 2 RCTs in this analysis
Proportion of children with at least 1 episode of AOM
6 months
40/85 (47%) with tympanostomy 51/63 (81%) with control
OR 0.18
95% CI 0.08 to 0.42
Large effect size
tympanostomy
RCT
44 children, aged 9 months to 7 years, with bilateral recurrent AOM of equal severity in each ear despite >3 months of antibiotic prophylaxis
Mean number of episodes of AOM
6 months
0.6% with tympanostomy tube insertion into a randomly selected ear 1.8% with contralateral ear receiving either no surgery or myringotomy alone Absolute numbers not reported
Difference in mean number of episodes: –1.2
95% CI –2.2 to –0.9
Effect size not calculated
tympanostomy
RCT
44 children, aged 9 months to 7 years, with bilateral recurrent AOM of equal severity in each ear despite >3 months of antibiotic prophylaxis
Mean number of episodes of AOM
18 months
0.8% with tympanostomy tube insertion into a randomly selected ear 0.8% with contralateral ear receiving either no surgery or myringotomy alone Absolute numbers not reported
Difference in mean number of episodes 0%
95% CI –0.3 to +0.3
Not significant
RCT
44 children, aged 9 months to 7 years, with bilateral recurrent AOM of equal severity in each ear despite >3 months of antibiotic prophylaxis
Recurrent ear infections
with tympanostomy tube insertion into a randomly selected ear with contralateral ear receiving either no surgery or myringotomy alone Absolute results not reported
P = 0.3
The RCT reported a non-significant trend towards more recurrent infections and worse hearing in ears that had received tympanostomy tubes, which became apparent after tube extrusion
Compared with no surgery or myringotomy alone Tympanostomy plus insertion of drainage tubes may increase the risk of tympanosclerosis in children with AOM (low-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Tympanosclerosis
RCT
44 children, aged 9 months to 7 years with bilateral recurrent AOM of equal severity in each ear despite >3 months of antibiotic prophylaxis
Tympanosclerosis
35/61 (57%) with tympanostomy tube 5/26 (19%) with myringotomy alone
P = 0.004
Effect size not calculated
myringotomy alone
RCT
44 children, aged 9 months to 7 years with bilateral recurrent AOM of equal severity in each ear despite >3 months of antibiotic prophylaxis
Tympanosclerosis
35/61 (57%) with tympanostomy tube 2/27 (7%) with no surgery
No data from the following reference on this outcome.
Symptoms of AOM
No data from the following reference on this outcome.
Adverse effects
No data from the following reference on this outcome.
Further information on studies
The review included only studies that randomised children and excluded the RCT that randomised ears.
Recurrent AOM was defined as the recurrent presence (>4 episodes) of ear ache with red and bulging tympanic membranes. Anatomical abnormalities (tympanosclerosis, atrophy, or retraction and chronic perforation), although not thought to be clinically significant, were more common in the ears receiving tympanostomy tubes. The RCT included some children with otitis media with effusion, although the results concerning benefits presented here refer only to those children in the study with recurrent AOM. It was not possible from the data available to differentiate the evidence on harms into children with recurrent AOM compared with otitis media with effusion. Medical treatment and antibiotic prophylaxis were allowed "whenever indicated". It was not possible from the data presented to tell whether the different groups differed in the amount of medical treatment and prophylactic antibiotics.
Comment
None.
Substantive changes
Tympanostomy (ventilation tubes) New evidence added. Categorisation unchanged (Likely to be ineffective or harmful).
Influenza vaccination in healthy children has no effect on the incidence of AOM.
Benefits and harms
Influenza vaccine versus placebo:
We found one systematic review (search date 2007, 6 RCTs).
Recurrence
Compared with placebo Influenza vaccine seems no more effective at preventing incidence of AOM in children aged 6 months to 7 years (moderate-quality evidence).
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Recurrence
Systematic review
5253 children aged 6 months to 7 years 6 RCTs in this analysis
Incidence of AOM
3 to 8 months
1249/3223 (39%) with influenza vaccination 832/2030 (41%) with placebo
Xylitol must be given as prophylaxis, not as treatment.
Xylitol chewing gum or syrup given 5 times daily has a small preventive effect on recurrence of AOM, but the compliance issues in giving a medicine to such young children 5 times daily render it an unrealistic treatment option.
Xylitol is not effective when given 3 times daily or only during an acute respiratory tract infection.
Benefits and harms
Xylitol versus placebo:
We found no systematic review, but found 4 RCTs.
Recurrence
Compared with placebo Xylitol given 5 times daily, but not 3 times daily, may be more effective at reducing recurrence of AOM in children aged up to 7 years. Xylitol may be no more effective at reducing AOM recurrence when given only during an acute respiratory tract infection (low-quality evidence). Note The issues of compliance in giving a medicine to such young children 5 times daily render xylitol an unrealistic treatment option.
Ref (type)
Population
Outcome, Interventions
Results and statistical analysis
Effect size
Favours
Recurrence of AOM
RCT
306 children with recurrent AOM, mean age 5 years
Children with at least one episode of AOM
2 months
19/157 (12%) with xylitol 31/149 (21%) with control (sucrose)
ARR 8.7%
95% CI 0.4% to 17.0%
P = 0.04
Effect size not calculated
xylitol chewing gum
RCT 5-armed trial
857 children with recurrent AOM
Incidence rate of AOM per person-years at risk
3 months
2.01 with xylitol syrup 3.03 with control syrup
Difference 1.02
95% CI 0.29 to 1.75
P = 0.006
Effect size not calculated
xylitol syrup
RCT 5-armed trial
857 children with recurrent AOM
Incidence rate of AOM per person-years at risk
3 months
1.04 with xylitol chewing gum 1.69 with control chewing gum
Difference 0.65
95% CI 0.14 to 1.16
P = 0.012
Effect size not calculated
xylitol chewing gum
RCT 5-armed trial
1277 children with recurrent AOM during an acute respiratory tract infection
Children with AOM
3 weeks
34/166 (20.5%) with xylitol syrup 32/157 (20.4%) with control syrup
ARR –0.1
95% CI –8.3 to +5.8
P = 0.72
Not significant
RCT 5-armed trial
1277 children with recurrent AOM during an acute respiratory tract infection
Children with AOM
3 weeks
31/220 (14%) with xylitol chewing gum 24/218 (11%) with control chewing gum
ARR –0.1
95% CI –9.4 to +3.2
P = 0.33
Not significant
RCT
663 children with recurrent AOM, mean age 4.1 years
Incidence rate of AOM per person-years at risk
3 months
2.09 with xylitol 1.83 with control
No data from the following reference on this outcome.
Complications
No data from the following reference on this outcome.
Adverse effects
No data from the following reference on this outcome.
Further information on studies
None.
Comment
Compliance is a potential problem with a medication that must be given 5 times a day to a young child. In addition, the preventing effect of xylitol is quite small — only one episode of AOM per year. For the time being, then, xylitol does not represent a realistic treatment option for AOM in children.
Substantive changes
Xylitol syrup or gum New option added. Categorised as Unlikely to be beneficial.
