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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 1

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

'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 2

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

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

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 4

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

Funnel plot of comparison: 1 Antibiotic versus placebo, outcome: 1.1 Pain.
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Figure 5

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

Percentage with pain based on the subset of six studies included in the IPD meta‐analysis (Rovers 2006).
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Figure 6

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

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.
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Analysis 1.1

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.

Comparison 1 Antibiotics versus placebo, Outcome 2 Vomiting, diarrhoea or rash.
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Analysis 1.2

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

Comparison 1 Antibiotics versus placebo, Outcome 3 Abnormal tympanometry.
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Analysis 1.3

Comparison 1 Antibiotics versus placebo, Outcome 3 Abnormal tympanometry.

Comparison 1 Antibiotics versus placebo, Outcome 4 Tympanic membrane perforation.
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Analysis 1.4

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

Comparison 1 Antibiotics versus placebo, Outcome 5 Contralateral otitis (in unilateral cases).
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Analysis 1.5

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

Comparison 1 Antibiotics versus placebo, Outcome 6 Late AOM recurrences.
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Analysis 1.6

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

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain.
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Analysis 2.1

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

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 2 Vomiting, diarrhoea or rash.
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Analysis 2.2

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

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 Abnormal tympanometry at 4 weeks.
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Analysis 2.3

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

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Tympanic membrane perforation.
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Analysis 2.4

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

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 5 AOM recurrences.
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Analysis 2.5

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

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).

Figures and Tables -
Summary of findings for the main comparison. Antibiotics versus placebo for acute otitis media in children
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]

Figures and Tables -
Comparison 1. Antibiotics versus placebo
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]

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Comparison 2. Immediate antibiotics versus expectant observation