Xylitol for preventing acute otitis media in children up to 12 years of age

Amir Azarpazhooh; Herenia P Lawrence; Prakeshkumar S Shah

doi:10.1002/14651858.CD007095.pub3

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

Forest plot of comparison: 1 Xylitol in any form (syrup, gum or lozenge) versus control in any form (gum, syrup), outcome: 1.1 Final diagnosis of at least one episode of AOM.

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Figure 4

Forest plot of comparison: 3 Xylitol syrup versus control for younger children unable to chew, outcome: 3.1 Final diagnosis of at least one episode of AOM.

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Figure 5

Forest plot of comparison: 4 Xylitol chewing gum/lozenges versus control chewing gum for older children able to chew, outcome: 4.1 Final diagnosis of at least one episode of AOM.

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Figure 6

Forest plot of comparison: 5 Xylitol chewing gum versus control chewing gum for older children able to chew, outcome: 5.1 Final diagnosis of at least one episode of AOM.

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Analysis 1.1

Comparison 1 Xylitol in any form (syrup, gum or lozenge) versus control in any form (gum, syrup), Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 2.1

Comparison 2 Adverse effect: xylitol versus control, Outcome 1 Gastrointestinal‐related adverse events.

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Analysis 2.2

Comparison 2 Adverse effect: xylitol versus control, Outcome 2 Rash.

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Analysis 3.1

Comparison 3 Antibiotic administration, Outcome 1 At least one exposure to antimicrobial drugs.

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Analysis 4.1

Comparison 4 Xylitol syrup versus control for younger children unable to chew, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 5.1

Comparison 5 Xylitol chewing gum/lozenges versus control chewing gum for older children able to chew, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 6.1

Comparison 6 Xylitol chewing gum versus control chewing gum for older children able to chew, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 7.1

Comparison 7 Xylitol lozenges versus control chewing gum for older children able to chew, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 8.1

Comparison 8 Comparison between active ingredients groups: xylitol chewing gum versus xylitol syrup, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 9.1

Comparison 9 Comparison between active ingredients groups: xylitol lozenges versus xylitol syrup, Outcome 1 Final diagnosis of at least one episode of AOM.

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Analysis 10.1

Comparison 10 Comparison between active ingredients groups: xylitol chewing gum versus xylitol lozenges, Outcome 1 Final diagnosis of at least one episode of AOM.

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Summary of findings for the main comparison. Xylitol versus control for prevention of AOM in healthy children

Xylitol versus control for prevention of AOM in healthy children
Patient or population: preventing acute otitis media in children up to 12 years of age Setting: daycare in Finland Intervention: xylitol in any form (syrup, gum or lozenge) Comparison: control in any form (gum, syrup)
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk with control in any form (gum, syrup)	Corresponding risk with xylitol in any form (syrup, gum or lozenge)
Final diagnosis of at least one episode of AOM	Study population		RR 0.75 (0.65 to 0.88)	1826 (3 RCTs)	⊕⊕⊕⊝ Moderate¹	RR 0.74 (0.54, 1.01) with random‐effects meta‐analysis
	299 per 1000	224 per 1000 (194 to 263)
	Moderate
	296 per 1000	222 per 1000 (192 to 261)
Gastrointestinal‐related adverse events	Study population		RR 1.43 (0.74 to 2.75)	1826 (3 RCTs)	⊕⊕⊕⊝ Moderate²	RR 1.41 (0.60, 3.33) with random‐effects meta‐analysis
	17 per 1000	24 per 1000 (13 to 47)
	Moderate
	15 per 1000	21 per 1000 (11 to 40)
Antibiotic administration	Study population		RR 0.64 (0.42 to 0.97)	306 (1 RCT)	⊕⊕⊕⊝ Moderate³
	289 per 1000	185 per 1000 (121 to 280)
	Moderate
	289 per 1000	185 per 1000 (121 to 280)
Hospitalisation ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Mortality ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Number of days missed at school or daycare ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Cost ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
CI: Confidence interval; RR: Risk ratio 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).
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ There is inconsistency in th findings of the first two studies as compared to the third study of the same group ² 95% CIs are wide and imprecise. Moreover, there are few events and the CI includes appreciable benefit and harm³ The evidence is based on 1 small trial of 306 patients

Summary of findings for the main comparison. Xylitol versus control for prevention of AOM in healthy children

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Summary of findings 2. Xylitol versus control for prevention of AOM in healthy children during a respiratory infection

Xylitol versus control for prevention of AOM in healthy children during a respiratory infection
Patient or population: preventing acute otitis media in children up to 12 years of age Setting: daycare in Finland Intervention: xylitol in any form (syrup, gum or lozenge) Comparison: control in any form (gum, syrup)
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with control in any form (gum, syrup)	Risk with xylitol in any form (syrup, gum or lozenge)
Final diagnosis of at least one episode of AOM	Study population		RR 1.13 (0.83 to 1.53)	1253 (1 RCT)	⊕⊕⊕⊝ Moderate¹
	115 per 1000	130 per 1000 (95 to 176)
	Moderate
	115 per 1000	130 per 1000 (95 to 176)
Gastrointestinal‐related adverse events	Study population		RR 2.82 (0.61 to 13.00)	1277 (1 RCT)	⊕⊕⊕⊝ Moderate¹
	4 per 1000	11 per 1000 (2 to 53)
	Moderate
	4 per 1000	12 per 1000 (3 to 53)
Antibiotic administration ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Hospitalisation ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Mortality ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Number of days missed at school or daycare ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Cost ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
CI: Confidence interval; RR: Risk ratio 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).
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ 95% CIs are wide and imprecise. The evidence is based on one trial. Moreover, there are few events and the CI includes appreciable benefit and harm

Summary of findings 2. Xylitol versus control for prevention of AOM in healthy children during a respiratory infection

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Summary of findings 3. Xylitol versus control for prevention of AOM in otitis‐prone children

Xylitol versus control for prevention of AOM in otitis‐prone children
Patient or population: preventing acute otitis media in children up to 12 years of age Setting: primary care in community Intervention: xylitol in any form (syrup, gum or lozenge) Comparison: control in any form (gum, syrup)
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with control in any form (gum, syrup)	Risk with xylitol in any form (syrup, gum or lozenge)
Final diagnosis of at least one episode of AOM	Study population		RR 0.90 (0.67 to 1.21)	326 (1 RCT)	⊕⊕⊝⊝ Low¹ ²
	367 per 1000	331 per 1000 (246 to 445)
	Moderate
	368 per 1000	331 per 1000 (246 to 445)
Gastrointestinal‐related adverse events	Study population		RR 1.04 (0.92 to 1.16)	326 (1 RCT)	⊕⊕⊕⊝ Moderate ¹ ³
	765 per 1000	796 per 1000 (704 to 887)
	Moderate
	765 per 1000	796 per 1000 (704 to 888)
Antibiotic administration	Study population		RR 0.90 (0.69 to 1.16)	326 (1 RCT)	⊕⊕⊕⊝ Moderate ¹ ³
	440 per 1000	396 per 1000 (303 to 510)
	Moderate
	440 per 1000	396 per 1000 (303 to 510)
Hospitalisation ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Mortality ‐ not reported	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Number of days missed at school or daycare ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
Cost ‐ not measured	See comment	See comment	Not estimable	(0 studies)	‐	Not reported in included studies
CI: Confidence interval; RR: Risk ratio 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).
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ High risk for attrition bias ² 95% CIs are wide and imprecise and includes appreciable benefit and harm ³ 95% CIs are wide and imprecise

Summary of findings 3. Xylitol versus control for prevention of AOM in otitis‐prone children

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Comparison 1. Xylitol in any form (syrup, gum or lozenge) versus control in any form (gum, syrup)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	5		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	3	1826	Risk Difference (M‐H, Fixed, 95% CI)	‐0.07 [‐0.12, ‐0.03]
1.2 Healthy children during respiratory infection	1	1253	Risk Difference (M‐H, Fixed, 95% CI)	0.01 [‐0.02, 0.05]
1.3 Otitis‐prone children	1	326	Risk Difference (M‐H, Fixed, 95% CI)	‐0.04 [‐0.14, 0.07]

Comparison 1. Xylitol in any form (syrup, gum or lozenge) versus control in any form (gum, syrup)

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Comparison 2. Adverse effect: xylitol versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Gastrointestinal‐related adverse events Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	3	1826	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.74, 2.75]
1.2 Healthy children during respiratory infection	1	1277	Risk Ratio (M‐H, Fixed, 95% CI)	2.82 [0.61, 13.00]
1.3 Otitis‐prone children	1	326	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.92, 1.16]
2 Rash Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Healthy children	1	663	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.20, 4.90]

Comparison 2. Adverse effect: xylitol versus control

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Comparison 3. Antibiotic administration

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 At least one exposure to antimicrobial drugs Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Healthy children	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Otitis‐prone children	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Antibiotic administration

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Comparison 4. Xylitol syrup versus control for younger children unable to chew

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	1	324	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.52, 0.95]
1.2 Healthy children during respiratory infection	1	418	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.70, 1.69]
1.3 Otitis‐prone children	1	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.67, 1.21]

Comparison 4. Xylitol syrup versus control for younger children unable to chew

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Comparison 5. Xylitol chewing gum/lozenges versus control chewing gum for older children able to chew

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	2	839	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.50, 0.87]
1.2 Healthy children during respiratory infection	1	835	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.86, 2.10]

Comparison 5. Xylitol chewing gum/lozenges versus control chewing gum for older children able to chew

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Comparison 6. Xylitol chewing gum versus control chewing gum for older children able to chew

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	2	663	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.42, 0.81]
1.2 Healthy children during respiratory infection	1	554	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.78, 2.14]
1.3 Otitis‐prone children	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. Xylitol chewing gum versus control chewing gum for older children able to chew

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Comparison 7. Xylitol lozenges versus control chewing gum for older children able to chew

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	1	354	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.56, 1.16]
1.2 Healthy children during respiratory infection	1	558	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.85, 2.29]

Comparison 7. Xylitol lozenges versus control chewing gum for older children able to chew

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Comparison 8. Comparison between active ingredients groups: xylitol chewing gum versus xylitol syrup

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	1	338	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.39, 0.89]
1.2 Healthy children during respiratory infection	1	484	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.43, 1.07]
1.3 Otitis‐prone children	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. Comparison between active ingredients groups: xylitol chewing gum versus xylitol syrup

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Comparison 9. Comparison between active ingredients groups: xylitol lozenges versus xylitol syrup

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	1	335	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.53, 1.11]
1.2 Healthy children during respiratory infection	1	488	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.47, 1.14]
1.3 Otitis‐prone children	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 9. Comparison between active ingredients groups: xylitol lozenges versus xylitol syrup

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Comparison 10. Comparison between active ingredients groups: xylitol chewing gum versus xylitol lozenges

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Final diagnosis of at least one episode of AOM Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healthy children	1	355	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.47, 1.13]
1.2 Healthy children during respiratory infection	1	558	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.59, 1.46]
1.3 Otitis‐prone children	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 10. Comparison between active ingredients groups: xylitol chewing gum versus xylitol lozenges

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