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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.

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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.

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L'Abbe plot of the rates of pain at two to three days for the placebo (control) versus antibiotic (experimental) group.
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Figure 3

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

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L'Abbe plot of the rates of pain at four to seven days for the placebo (control) versus antibiotic (experimental) group.
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Figure 4

L'Abbe plot of the rates of pain at four to seven days for the placebo (control) versus antibiotic (experimental) group.

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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.

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

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

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

Comparison 1 Antibiotics versus placebo, Outcome 1 Pain.

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Comparison 1 Antibiotics versus placebo, Outcome 2 Abnormal tympanometry.
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Analysis 1.2

Comparison 1 Antibiotics versus placebo, Outcome 2 Abnormal tympanometry.

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Comparison 1 Antibiotics versus placebo, Outcome 3 Tympanic membrane perforation.
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Analysis 1.3

Comparison 1 Antibiotics versus placebo, Outcome 3 Tympanic membrane perforation.

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Comparison 1 Antibiotics versus placebo, Outcome 4 Contralateral otitis (in unilateral cases).
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Analysis 1.4

Comparison 1 Antibiotics versus placebo, Outcome 4 Contralateral otitis (in unilateral cases).

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Comparison 1 Antibiotics versus placebo, Outcome 5 Late AOM recurrences.
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Analysis 1.5

Comparison 1 Antibiotics versus placebo, Outcome 5 Late AOM recurrences.

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Comparison 1 Antibiotics versus placebo, Outcome 6 Vomiting, diarrhoea or rash.
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Analysis 1.6

Comparison 1 Antibiotics versus placebo, Outcome 6 Vomiting, diarrhoea or rash.

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Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain at 3 to 7 days.
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Analysis 2.1

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 1 Pain at 3 to 7 days.

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Comparison 2 Immediate antibiotics versus expectant observation, Outcome 2 Tympanic membrane perforation.
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Analysis 2.2

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

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Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 AOM recurrences.
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Analysis 2.3

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 3 AOM recurrences.

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Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Vomiting, diarrhoea or rash.
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Analysis 2.4

Comparison 2 Immediate antibiotics versus expectant observation, Outcome 4 Vomiting, diarrhoea or rash.

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Antibiotic versus placebo for acute otitis media in children

Patient or population: children with acute otitis media

Setting: primary and secondary care

Intervention: antibiotic versus placebo

Outcomes

Illustrative comparative risks*

(95% CI)

Relative effect
(95% CI)

Absolute effect
(95% CI)

NNTB/NNTH
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

Control

Antibiotic versus placebo

Pain at 24 hours

Medium‐risk population

RR 0.89
(0.78 to 1.01)

RD ‐5%
(‐10% to 0%)

n/a

1394
(6)

⊕⊕⊕⊕
high

405 per 1000

360 per 1000
(316 to 409)

Pain at 2 to 3 days

Medium‐risk population

RR 0.70
(0.57 to 0.86)

RD ‐5%
(‐7% to ‐2%)

20

(14 to 50)

2320

(7)

⊕⊕⊕⊕
high

215 per 1000

151 per 1000

(123 to 185)

Pain at 4 to 7 days

Medium‐risk population

RR 0.79
(0.66 to 0.95)

RD ‐5%
(‐9% to ‐1%)

20

(11 to 100)

1263

(7)

⊕⊕⊕⊕
high

114 per 1000

90 per 1000

(75 to 108)

Abnormal tympanometry ‐ 4 to 6 weeks

Medium‐risk population

RR 0.92
(0.83 to 1.01)

RD ‐4%
(‐8% to 0%)

n/a

2144

(7)

⊕⊕⊕⊕
high

411 per 1000

378 per 1000

(341 to 415)

Abnormal tympanometry ‐ 3 months

Medium‐risk population

RR 0.97
(0.76 to 1.24)

RD ‐1%
(‐7% to 5%)

n/a

809
(3)

⊕⊕⊕⊕
high

234 per 1000

227 per 1000
(178 to 290)

Vomiting, diarrhoea or rash

Medium‐risk population

RR 1.34
(1.16 to 1.55)

RD 7%
(4% to 10%)

14

(10 to 25)

2023

(7)

⊕⊕⊕⊕
high

196 per 1000

263 per 1000

(227 to 304)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval (CI)) 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; RD: risk difference; NNTB: number needed to treat to benefit; NNTH: number needed to treat to harm.

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

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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

11

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

7

1263

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.66, 0.95]

2 Abnormal tympanometry Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 4 to 6 weeks

7

2114

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.83, 1.01]

2.2 3 months

3

809

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.76, 1.24]

3 Tympanic membrane perforation Show forest plot

4

991

Risk Ratio (M‐H, Fixed, 95% CI)

0.37 [0.18, 0.76]

4 Contralateral otitis (in unilateral cases) Show forest plot

4

906

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.25, 0.95]

5 Late AOM recurrences Show forest plot

6

2200

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.78, 1.10]

6 Vomiting, diarrhoea or rash Show forest plot

7

2023

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [1.16, 1.55]
Figuras y tablas -
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 at 3 to 7 days Show forest plot

4

959

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.50, 1.12]

2 Tympanic membrane perforation Show forest plot

1

179

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 AOM recurrences Show forest plot

1

209

Risk Ratio (M‐H, Fixed, 95% CI)

1.41 [0.74, 2.69]

4 Vomiting, diarrhoea or rash Show forest plot

2

550

Risk Ratio (M‐H, Fixed, 95% CI)

1.71 [1.24, 2.36]
Figuras y tablas -
Comparison 2. Immediate antibiotics versus expectant observation
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