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Study flow diagram.
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Figure 1

Study flow diagram.

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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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Forest plot of comparison: 1 Regurgitation, posseting, or vomiting, outcome: 1.1 Number of episodes per day.Assumptions 1. There was insufficient information in Chao 2007 to report the change of baseline value, hence we used the endpoint data instead. Change from baseline value was used for the remaining five studies, where P value was used to determine the standard deviation for the change from baseline value.2. Frequency of regurgitation rather than vomiting was used for the Xinias 2005 study.3. In Miller 1999, median number of episodes of regurgitation was reported rather than the mean value. As the sample size was more than 25, it was assumed that median and mean were similar (Hozo 2005), and the standard deviation for the mean difference was obtained using the reported P value (Higgins 2011).4. We halved control groups for Hegar 2008 and Moya 1999, as these were three‐arm trials involving one control and two intervention arms.
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Figure 3

Forest plot of comparison: 1 Regurgitation, posseting, or vomiting, outcome: 1.1 Number of episodes per day.

Assumptions

1. There was insufficient information in Chao 2007 to report the change of baseline value, hence we used the endpoint data instead. Change from baseline value was used for the remaining five studies, where P value was used to determine the standard deviation for the change from baseline value.

2. Frequency of regurgitation rather than vomiting was used for the Xinias 2005 study.

3. In Miller 1999, median number of episodes of regurgitation was reported rather than the mean value. As the sample size was more than 25, it was assumed that median and mean were similar (Hozo 2005), and the standard deviation for the mean difference was obtained using the reported P value (Higgins 2011).

4. We halved control groups for Hegar 2008 and Moya 1999, as these were three‐arm trials involving one control and two intervention arms.

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Forest plot of comparison: 1 Regurgitation, posseting, or vomiting, outcome: 1.2 Proportion of asymptomatic infants.
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Figure 4

Forest plot of comparison: 1 Regurgitation, posseting, or vomiting, outcome: 1.2 Proportion of asymptomatic infants.

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Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.1 Reflux index (percentage of time pH < 4).
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Figure 5

Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.1 Reflux index (percentage of time pH < 4).

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Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.2 Number of reflux episodes lasting > 5 minutes.
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Figure 6

Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.2 Number of reflux episodes lasting > 5 minutes.

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Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.3 Duration of longest reflux episode (minutes).
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Figure 7

Forest plot of comparison: 2 Oesophageal pH probe study parameters, outcome: 2.3 Duration of longest reflux episode (minutes).

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Forest plot of comparison: 3 Sensitivity analysis, outcome: 3.1 Endpoint value ‐ number of episodes of regurgitation, posseting, or vomiting per day.
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Figure 8

Forest plot of comparison: 3 Sensitivity analysis, outcome: 3.1 Endpoint value ‐ number of episodes of regurgitation, posseting, or vomiting per day.

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Comparison 1 Regurgitation, posseting, or vomiting, Outcome 1 Number of episodes per day.
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Analysis 1.1

Comparison 1 Regurgitation, posseting, or vomiting, Outcome 1 Number of episodes per day.

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Comparison 1 Regurgitation, posseting, or vomiting, Outcome 2 Proportion of asymptomatic infants.
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Analysis 1.2

Comparison 1 Regurgitation, posseting, or vomiting, Outcome 2 Proportion of asymptomatic infants.

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Comparison 2 Oesophageal pH probe study parameters, Outcome 1 Reflux Index (percentage of time pH < 4).
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Analysis 2.1

Comparison 2 Oesophageal pH probe study parameters, Outcome 1 Reflux Index (percentage of time pH < 4).

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Comparison 2 Oesophageal pH probe study parameters, Outcome 2 Number of reflux episodes lasting > 5 minutes.
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Analysis 2.2

Comparison 2 Oesophageal pH probe study parameters, Outcome 2 Number of reflux episodes lasting > 5 minutes.

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Comparison 2 Oesophageal pH probe study parameters, Outcome 3 Duration of longest reflux episode (minutes).
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Analysis 2.3

Comparison 2 Oesophageal pH probe study parameters, Outcome 3 Duration of longest reflux episode (minutes).

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Comparison 3 Sensitivity analysis, Outcome 1 Endpoint value ‐ number of episodes of regurgitation, posseting, or vomiting per day.
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Analysis 3.1

Comparison 3 Sensitivity analysis, Outcome 1 Endpoint value ‐ number of episodes of regurgitation, posseting, or vomiting per day.

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Comparison 3 Sensitivity analysis, Outcome 2 Endpoint value ‐ reflux index (percentage of time pH < 4).
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Analysis 3.2

Comparison 3 Sensitivity analysis, Outcome 2 Endpoint value ‐ reflux index (percentage of time pH < 4).

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Comparison 3 Sensitivity analysis, Outcome 3 Endpoint value ‐ number of reflux episodes lasting > 5 minutes.
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Analysis 3.3

Comparison 3 Sensitivity analysis, Outcome 3 Endpoint value ‐ number of reflux episodes lasting > 5 minutes.

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Comparison 3 Sensitivity analysis, Outcome 4 Endpoint value ‐ duration of longest reflux episode (minutes).
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Analysis 3.4

Comparison 3 Sensitivity analysis, Outcome 4 Endpoint value ‐ duration of longest reflux episode (minutes).

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Summary of findings for the main comparison. Feed thickener compared to control for infants up to 6 months of age with gastro‐oesophageal reflux

Feed thickener compared to control for infants up to 6 months of age with gastro‐oesophageal reflux

Patient or population: Formula‐fed healthy term infants up to 6 months of age with gastro‐oesophageal reflux
Intervention: Feed thickener
Comparison: Control

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control

Risk with feed thickener

Number of episodes of regurgitation or vomiting per day
assessed with parental report of symptoms
Follow‐up: range 2 to 8 weeks

The mean number of episodes of regurgitation or vomiting per day was 3 episodes per day.

MD 1.97 episodes per day lower
(2.32 lower to 1.61 lower)

‐

442
(6 RCTs)

⊕⊕⊕⊝
MODERATE 1

Change from baseline value was used for 5 studies. Endpoint value was used for the remaining study due to insufficient data (Chao 2007).

Frequency of regurgitation value was used in preference to frequency of vomiting in 1 study (Xinias 2005).

Proportion of infants without regurgitation or vomiting at the end of intervention period (asymptomatic infants)
assessed with parental report of symptoms
Follow‐up: range 1 to 8 weeks

Study population

RR 2.50
(1.38 to 4.51)

186
(2 RCTs)

⊕⊕⊝⊝
LOW 2

128 per 1000

319 per 1000
(176 to 576)

Reflux index (percentage of time pH < 4) assessed with oesophageal pH probe study
Follow‐up: range 1 to 4 weeks

The mean reflux index was 12%.

MD 5.08% lower
(8.89 lower to 1.28 lower)

‐

116
(2 RCTs)

⊕⊕⊝⊝
LOW 3

Higher reflux index indicates higher percentage of total time that oesophageal pH is less than 4.

Number of reflux episodes lasting > 5 minutes assessed with oesophageal pH probe study
Follow‐up: range 1 to 4 weeks

The mean number of reflux episodes lasting > 5 minutes was 6 episodes.

MD 3.4 episodes lower
(5.44 lower to 1.36 lower)

‐

116
(2 RCTs)

⊕⊕⊝⊝
LOW 3

Duration of longest reflux episode
assessed with oesophageal pH probe study
Follow‐up: range 1 to 4 weeks

The mean duration of longest reflux episode was 20 minutes.

MD 12.41 minutes lower
(23.25 lower to 1.58 lower)

‐

116
(2 RCTs)

⊕⊕⊝⊝
LOW 3

Diarrhoea
assessed with parental report
Follow‐up: range 2 to 8 weeks

‐

‐

511
(6 RCTs)

⊕⊕⊝⊝
LOW 4

Insufficient data to perform analysis. No difference in diarrhoea incidence or stooling frequency in 4 studies. 17% of infants in the intervention group in Iacono 2002 and 10% of total infants in Hegar 2008 withdrew due to diarrhoea.

*The risk in the intervention group (and its 95% 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; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio

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 the effect.

1Downgraded one level for serious study limitation. There was unclear risk of bias for allocation concealment and high risk of bias for blinding, as frequency of regurgitation was dependent on parental report, who were likely to note the higher viscosity of the thickened formula.
2Downgraded two levels for: i) serious study limitations (unclear risk of bias for allocation concealment and high risk of bias for blinding, as frequency of regurgitation was dependent on parental report, who were likely to note the higher viscosity of the thickened formula) and ii) serious imprecision (analysis was derived from two studies which both contained incomplete reporting of all measurements but together could be combined).
3Downgraded by two levels for: i) serious study limitation (unclear/high risk of bias for randomisation and allocation concealment) and ii) serious imprecision (limited number of studies with small sample size and wide confidence interval).
4Downgraded by two levels for: i) serious study limitations (unclear risk of bias for allocation concealment and high risk of bias for blinding, as diarrhoea/side effect was dependent on parental report, who were likely to note the higher viscosity of the thickened formula) and ii) serious publication bias (none of the studies was designed to measure side effect/diarrhoea).

Figuras y tablas -
Summary of findings for the main comparison. Feed thickener compared to control for infants up to 6 months of age with gastro‐oesophageal reflux
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Comparison 1. Regurgitation, posseting, or vomiting

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of episodes per day Show forest plot

6

442

Mean Difference (IV, Fixed, 95% CI)

‐1.97 [‐2.32, ‐1.61]

1.1 Rice cereal

2

127

Mean Difference (IV, Fixed, 95% CI)

‐1.43 [‐3.36, 0.49]

1.2 Carob bean gum

2

39

Mean Difference (IV, Fixed, 95% CI)

‐1.47 [‐3.13, 0.19]

1.3 Cornstarch

3

188

Mean Difference (IV, Fixed, 95% CI)

‐1.98 [‐2.35, ‐1.61]

1.4 Alginate

1

88

Mean Difference (IV, Fixed, 95% CI)

‐3.5 [‐6.07, ‐0.93]

2 Proportion of asymptomatic infants Show forest plot

2

186

Risk Ratio (M‐H, Fixed, 95% CI)

2.50 [1.38, 4.51]

2.1 Carob bean gum

2

186

Risk Ratio (M‐H, Fixed, 95% CI)

2.50 [1.38, 4.51]
Figuras y tablas -
Comparison 1. Regurgitation, posseting, or vomiting
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Comparison 2. Oesophageal pH probe study parameters

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Reflux Index (percentage of time pH < 4) Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐5.08 [‐8.89, ‐1.28]

1.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

‐3.90 [‐9.36, 1.56]

1.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐6.20 [‐11.50, ‐0.90]

2 Number of reflux episodes lasting > 5 minutes Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐3.40 [‐5.44, ‐1.36]

2.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

‐3.4 [‐7.06, 0.26]

2.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐3.40 [‐5.85, ‐0.95]

3 Duration of longest reflux episode (minutes) Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐12.41 [‐23.25, ‐1.58]

3.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

‐1.80 [‐24.63, 21.03]

3.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐15.5 [‐27.81, ‐3.19]
Figuras y tablas -
Comparison 2. Oesophageal pH probe study parameters
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Comparison 3. Sensitivity analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Endpoint value ‐ number of episodes of regurgitation, posseting, or vomiting per day Show forest plot

5

345

Mean Difference (IV, Fixed, 95% CI)

‐1.91 [‐2.24, ‐1.58]

1.1 Rice cereal

1

30

Mean Difference (IV, Fixed, 95% CI)

‐1.20 [‐2.90, 0.50]

1.2 Carob bean gum

2

39

Mean Difference (IV, Fixed, 95% CI)

‐1.90 [‐3.25, ‐0.56]

1.3 Cornstarch

3

188

Mean Difference (IV, Fixed, 95% CI)

‐1.94 [‐2.29, ‐1.59]

1.4 Alginate

1

88

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.15, 1.15]

2 Endpoint value ‐ reflux index (percentage of time pH < 4) Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐4.01 [‐6.33, ‐1.68]

2.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

‐2.10 [‐6.87, 2.67]

2.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐4.60 [‐7.26, ‐1.94]

3 Endpoint value ‐ number of reflux episodes lasting > 5 minutes Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐2.24 [‐3.62, ‐0.85]

3.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

‐1.10 [‐4.30, 2.10]

3.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐2.50 [‐4.04, ‐0.96]

4 Endpoint value ‐ duration of longest reflux episode (minutes) Show forest plot

2

116

Mean Difference (IV, Fixed, 95% CI)

‐8.09 [‐11.93, ‐4.25]

4.1 Carob bean gum

1

20

Mean Difference (IV, Fixed, 95% CI)

1.20 [‐17.44, 19.84]

4.2 Cornstarch

1

96

Mean Difference (IV, Fixed, 95% CI)

‐8.5 [‐12.42, ‐4.58]
Figuras y tablas -
Comparison 3. Sensitivity analysis
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