Antibiotics for acute otitis media in children

Roderick P Venekamp; Sharon L Sanders; Paul P Glasziou; Chris B Del Mar; Maroeska M Rovers

doi:10.1002/14651858.CD000219.pub4

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Figure 1

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

L'Abbé plot of the rates of pain at 24 hours for the placebo (control) versus antibiotic (experimental) group.

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Figure 4

L'Abbé plot of the rates of pain at two to three days for the placebo (control) versus antibiotic (experimental) group.

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Figure 5

Funnel plot of comparison: 1 Antibiotic versus placebo, outcome: 1.1 Pain.

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Figure 6

Percentage with pain based on the subset of six studies included in the IPD meta‐analysis (Rovers 2006).

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Analysis 1.1

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.

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Analysis 1.2

Comparison 1 Antibiotics versus placebo, Outcome 2 Vomiting, diarrhoea or rash.

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Analysis 1.3

Comparison 1 Antibiotics versus placebo, Outcome 3 Abnormal tympanometry.

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Analysis 1.4

Comparison 1 Antibiotics versus placebo, Outcome 4 Tympanic membrane perforation.

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Analysis 1.5

Comparison 1 Antibiotics versus placebo, Outcome 5 Contralateral otitis (in unilateral cases).

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Analysis 1.6

Comparison 1 Antibiotics versus placebo, Outcome 6 Late AOM recurrences.

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Analysis 2.1

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain.

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Analysis 2.2

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 2 Vomiting, diarrhoea or rash.

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Analysis 2.3

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 Abnormal tympanometry at 4 weeks.

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Analysis 2.4

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Tympanic membrane perforation.

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Analysis 2.5

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 5 AOM recurrences.

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Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children

Antibiotics versus placebo for acute otitis media in children
Patient or population: children with acute otitis media Settings: primary care and secondary care Intervention: antibiotics versus placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Antibiotics versus placebo
Pain ‐ pain at 24 hours	Study population		RR 0.89 (0.78 to 1.01)	1394 (5 studies)¹	⊕⊕⊕⊕ high
	426 per 1000	379 per 1000 (332 to 431)
Pain ‐ pain at 2 to 3 days	Study population		RR 0.70 (0.57 to 0.86)	2320 (7 studies)	⊕⊕⊕⊕ high
	159 per 1000	111 per 1000 (90 to 137)
Pain ‐ pain at 4 to 7 days	Study population		RR 0.76 (0.63 to 0.91)	1347 (7 studies)¹	⊕⊕⊕⊕ high
	241 per 1000	183 per 1000 (152 to 220)
Pain ‐ pain at 10 to 12 days	Study population		RR 0.33 (0.17 to 0.66)	278 (1 study)	⊕⊕⊕⊝ moderate²
	216 per 1000	71 per 1000 (37 to 142)
Abnormal tympanometry ‐ 2 to 4 weeks	Study population		RR 0.82 (0.74 to 0.90)	2138 (7 studies)	⊕⊕⊕⊕ high
	481 per 1000	395 per 1000 (356 to 433)
Abnormal tympanometry ‐ 3 months	Study population		RR 0.97 (0.76 to 1.24)	809 (3 studies)	⊕⊕⊕⊕ high
	241 per 1000	234 per 1000 (183 to 299)
Vomiting, diarrhoea or rash	Study population		RR 1.38 (1.19 to 1.59)	2107 (8 studies)	⊕⊕⊕⊕ high
	196 per 1000	270 per 1000 (233 to 311)
The basis for the assumed risk* for ‘Study population’ was the average risk in the control groups (i.e. total number of participants with events divided by total number of participants included in the meta‐analysis). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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. Very low quality: We are very uncertain about the estimate.
¹The number of studies reported in the 'Summary of findings' table for the outcomes 'Pain at 24 hours' and 'Pain at 4 to 7 days' differ slightly from those reported in the Data Analysis Table 1 ‐ Antibiotics versus placebo (five versus six studies and seven versus eight studies, respectively). This is due to the van Buchem trial. This trial is included as one study in our review (and in the 'Summary of findings' table), but we included data from two different comparisons from this 2 x 2 factorial design trial in our analyses (van Buchem 1981a; van Buchem 1981b). ²We downgraded the evidence for pain at days 10 to 12 from high quality as this outcome was not specified a priori in this trial (secondary analysis).

Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children

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Comparison 1. Antibiotics versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	13		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Pain at 24 hours	6	1394	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.78, 1.01]
1.2 Pain at 2 to 3 days	7	2320	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.57, 0.86]
1.3 Pain at 4 to 7 days	8	1347	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.63, 0.91]
1.4 Pain at 10 to 12 days	1	278	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.17, 0.66]
2 Vomiting, diarrhoea or rash Show forest plot	8	2107	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.19, 1.59]

3 Abnormal tympanometry Show forest plot	8		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 2 to 4 weeks	7	2138	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.74, 0.90]
3.2 6 to 8 weeks	3	953	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.78, 1.00]
3.3 3 months	3	809	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.76, 1.24]
4 Tympanic membrane perforation Show forest plot	5	1075	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.18, 0.76]

5 Contralateral otitis (in unilateral cases) Show forest plot	4	906	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.25, 0.95]

6 Late AOM recurrences Show forest plot	6	2200	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.78, 1.10]

Comparison 1. Antibiotics versus placebo

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Comparison 2. Immediate antibiotics versus expectant observation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Pain at 3 to 7 days	4	959	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.50, 1.12]
1.2 Pain at 11 to 14 days	1	247	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.75, 1.10]
2 Vomiting, diarrhoea or rash Show forest plot	2	550	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [1.24, 2.36]

3 Abnormal tympanometry at 4 weeks Show forest plot	1	207	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.78, 1.35]

4 Tympanic membrane perforation Show forest plot	1	179	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

5 AOM recurrences Show forest plot	1	209	Risk Ratio (M‐H, Fixed, 95% CI)	1.41 [0.74, 2.69]

Comparison 2. Immediate antibiotics versus expectant observation

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