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Cochrane Database of Systematic Reviews

Esmectita para la diarrea infecciosa aguda en niños

Información

DOI:
https://doi.org/10.1002/14651858.CD011526.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 25 abril 2018see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Enfermedades infecciosas

Clasificada:
  1. Actualizada

    All studies incorporated from most recent search

    All eligible published studies found in the last search (27 Jun, 2017) were included

    Evaluada: 2 April 2019

Copyright:
  1. Copyright © 2018 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
  2. This is an open access article under the terms of the Creative Commons Attribution‐Non‐Commercial Licence, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Autores

  • Giordano Pérez‐Gaxiola

    Correspondencia a: Evidence‐Based Medicine Department, Hospital Pediátrico de Sinaloa, Culiacán, Mexico

    [email protected]

  • Carlos A Cuello‐García

    Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada

  • Ivan D Florez

    Department of Pediatrics, University of Antioquia, Medellin, Colombia

  • Víctor M Pérez‐Pico

    Hospital Pediátrico de Sinaloa, Culiacán, Mexico

Contributions of authors

Giordano Pérez‐Gaxiola and Carlos Cuello‐García prepared the protocol and manuscript. Ivan D Florez checked the protocol and manuscript, and provided advice. Víctor Pérez‐Pico checked the protocol and provided advice as an infectious diseases specialist.

Sources of support

Internal sources

  • Liverpool School of Tropical Medicine, UK.

External sources

  • Department for International Development (DFID), UK.

    Grant: 5242

Declarations of interest

Giordano Pérez‐Gaxiola, Carlos A Cuello‐García, Ivan D Florez, Víctor M Pérez‐Pico: we certify that we have no affiliations with or involvement in any organization or entity with a direct financial interest in the subject matter of this Cochrane Review (for example, employment, consultancy, stock ownership, honoraria, or expert testimony).

Acknowledgements

The editorial base for the Cochrane Infectious Diseases Group is funded by UK aid from the UK Government for the benefit of low‐ and middle‐income countries (Grant: 5242).

Version history

Published

Title

Stage

Authors

Version

2018 Apr 25

Smectite for acute infectious diarrhoea in children

Review

Giordano Pérez‐Gaxiola, Carlos A Cuello‐García, Ivan D Florez, Víctor M Pérez‐Pico

https://doi.org/10.1002/14651858.CD011526.pub2

2015 Feb 10

Smectite for acute infectious diarrhoea in children

Protocol

Giordano Pérez‐Gaxiola, Carlos A Cuello‐García, Victor Pérez‐Pico

https://doi.org/10.1002/14651858.CD011526

Differences between protocol and review

We added Ivan D Florez as an author.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Child; Child, Preschool; Humans; Infant;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
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.
Figuras y tablas -
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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‘Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

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

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Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).
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Figure 4

Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).

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Funnel plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).
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Figure 5

Funnel plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).

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Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.2 Mean duration of diarrhoea, studies including only infants < 2 years.
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Figure 6

Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.2 Mean duration of diarrhoea, studies including only infants < 2 years.

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Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.3 Clinical resolution at day 3 after starting treatment.
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Figure 7

Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.3 Clinical resolution at day 3 after starting treatment.

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Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.1 Stool frequency, measured as number of depositions per day, on day 3 after starting treatment.
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Figure 8

Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.1 Stool frequency, measured as number of depositions per day, on day 3 after starting treatment.

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Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.2 Stool output, measured in g/kg at 72 hours.
Figuras y tablas -
Figure 9

Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.2 Stool output, measured in g/kg at 72 hours.

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Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.3 Need for hospitalization.
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Figure 10

Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.3 Need for hospitalization.

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Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.5 Constipation.
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Figure 11

Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.5 Constipation.

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Comparison 1 Diarrhoea primary outcomes, Outcome 1 Mean duration of diarrhoea.
Figuras y tablas -
Analysis 1.1

Comparison 1 Diarrhoea primary outcomes, Outcome 1 Mean duration of diarrhoea.

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Comparison 1 Diarrhoea primary outcomes, Outcome 2 Mean duration of diarrhoea, studies including only infants < 2 years.
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Analysis 1.2

Comparison 1 Diarrhoea primary outcomes, Outcome 2 Mean duration of diarrhoea, studies including only infants < 2 years.

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Comparison 1 Diarrhoea primary outcomes, Outcome 3 Clinical resolution at day 3 after starting treatment.
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Analysis 1.3

Comparison 1 Diarrhoea primary outcomes, Outcome 3 Clinical resolution at day 3 after starting treatment.

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Comparison 2 Diarrhoea secondary outcomes, Outcome 1 Stool frequency, measured as number of depositions per day, on day 3 after starting treatment.
Figuras y tablas -
Analysis 2.1

Comparison 2 Diarrhoea secondary outcomes, Outcome 1 Stool frequency, measured as number of depositions per day, on day 3 after starting treatment.

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Comparison 2 Diarrhoea secondary outcomes, Outcome 2 Stool output, measured in g or mL/kg per day.
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Analysis 2.2

Comparison 2 Diarrhoea secondary outcomes, Outcome 2 Stool output, measured in g or mL/kg per day.

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Comparison 2 Diarrhoea secondary outcomes, Outcome 3 Need for hospitalization.
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Analysis 2.3

Comparison 2 Diarrhoea secondary outcomes, Outcome 3 Need for hospitalization.

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Comparison 2 Diarrhoea secondary outcomes, Outcome 4 Need for intravenous access for rehydration.
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Analysis 2.4

Comparison 2 Diarrhoea secondary outcomes, Outcome 4 Need for intravenous access for rehydration.

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Comparison 2 Diarrhoea secondary outcomes, Outcome 5 Constipation.
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Analysis 2.5

Comparison 2 Diarrhoea secondary outcomes, Outcome 5 Constipation.

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Summary of findings for the main comparison. Smectite compared to control for acute infectious diarrhoea in children

Smectite compared to control for acute infectious diarrhoea in children

Patient or population: acute infectious diarrhoea in children
Setting: hospital and outpatients
Intervention: smectite
Comparison: control

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments (compared with control)

Risk with control

Risk with smectite

Duration of diarrhoea
assessed with: clinical and parental assessment, measured in total hours
Follow‐up: mean 1 week

The mean duration of diarrhoea ranged from 32.6 to 118.92 hours

MD 24.38 hours fewer
(30.91 fewer to 17.85 fewer)

‐

2209
(14 RCTs)

⊕⊕⊝⊝
LOW1,2

Smectite may reduce the duration of diarrhoea

Clinical resolution at day 3
assessed with: clinical assessment by parents and clinicians
Follow‐up: mean 3 days

Study population

RR 2.10
(1.30 to 3.39)

312
(5 RCTs)

⊕⊕⊝⊝
LOW3,4

Smectite may increase the resolution of diarrhoea by the third day

342 per 1000

718 per 1000
(445 to 1000)

Stool frequency assessed with: clinical assessment as number of depositions per day
Follow‐up: mean 1 week

The mean stool frequency was 0 depositions per day

MD 1.33 depositions per day fewer
(2.28 fewer to 0.38 fewer)

‐

954
(3 RCTs)

⊕⊝⊝⊝
VERY LOW5,6,7

We are uncertain whether or not smectite reduces stool frequency

Stool output assessed with: grams of stool output per kg of body weight in a 72‐hour period
Follow‐up: mean 1 week

The mean stool output ranged from 90.7 to 118.8 g/kg

MD 11.37 g/kg fewer
(21.94 fewer to 0.79 fewer)

‐

634
(3 RCTs)

⊕⊕⊝⊝
LOW7,8

Smectite may decrease stool output

Need for hospitalization
Follow‐up: mean 1 week

Study population

RR 0.93
(0.75 to 1.15)

885
(2 RCTs)

⊕⊕⊝⊝
LOW6,9

Smectite may make little or no difference in the need for hospitalization

85 per 1000

79 per 1000
(64 to 98)

Need for intravenous access for rehydration
Follow‐up: mean 1 week

Study population

RR 0.77
(0.54 to 1.11)

81
(1 RCT)

⊕⊕⊕⊝
MODERATE9

Smectite probably makes little or no difference in the need for intravenoous access

676 per 1000

520 per 1000
(365 to 750)

Adverse events – constipation
Follow‐up: mean 1 week

Study population

RR 4.71
(0.56 to 39.19)

128
(2 RCTs)

⊕⊕⊝⊝
LOW3,9

Smectite may make little or no difference in the appeareance of adverse events

0 per 1000

0 per 1000
(0 to 0)

Death

‐

‐

‐

‐

‐

There were no deaths in the included studies

Serious adverse events

‐

‐

‐

‐

‐

There were no serious side effects in the included studies

*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).

Abbreviations: CI: confidence interval; MD: mean difference; RCT: randomized controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Four trials are quasi‐randomized and without adequate blinding of participants.
2High heterogeneity (I2 = 96%) among studies that may be explained by differences in age and definition of resolution, although the effect in all studies points in the same direction.
3Three studies have high risk of selection bias, including one that is quasi‐randomized, and three did not perform adequate blinding of participants.
4High heterogeneity (I2 = 81%), although the effect in all studies points in the same direction.
5High heterogeneity (I2 = 97%), although all effects point in the same direction.
6Two of the three studies are classified as quasi‐randomized with inadequate blinding of participants.
7A wide CI that does not exclude the threshold of appreciable clinical benefit.
8One quasi‐randomized study was not pooled because the authors reported stool output as stool weight in total grams per day with an effect estimate favouring smectite (mean of 255.67 g in the smectite group versus 741.33 g in the control group) at day 3 of treatment.
9Wide CI that does not exclude an appreciable benefit or harm.

Figuras y tablas -
Summary of findings for the main comparison. Smectite compared to control for acute infectious diarrhoea in children
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Comparison 1. Diarrhoea primary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mean duration of diarrhoea Show forest plot

15

2209

Mean Difference (IV, Random, 95% CI)

‐24.38 [‐30.91, ‐17.85]

2 Mean duration of diarrhoea, studies including only infants < 2 years Show forest plot

6

441

Mean Difference (IV, Random, 95% CI)

‐24.11 [‐31.35, ‐16.87]

3 Clinical resolution at day 3 after starting treatment Show forest plot

5

312

Risk Ratio (M‐H, Random, 95% CI)

2.10 [1.30, 3.39]
Figuras y tablas -
Comparison 1. Diarrhoea primary outcomes
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Comparison 2. Diarrhoea secondary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Stool frequency, measured as number of depositions per day, on day 3 after starting treatment Show forest plot

3

954

Mean Difference (IV, Random, 95% CI)

‐1.33 [‐2.28, ‐0.38]

2 Stool output, measured in g or mL/kg per day Show forest plot

3

634

Mean Difference (IV, Random, 95% CI)

‐11.37 [‐21.94, ‐0.79]

3 Need for hospitalization Show forest plot

2

885

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.75, 1.15]

4 Need for intravenous access for rehydration Show forest plot

1

81

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.54, 1.11]

5 Constipation Show forest plot

2

128

Risk Ratio (M‐H, Random, 95% CI)

4.71 [0.56, 39.19]
Figuras y tablas -
Comparison 2. Diarrhoea secondary outcomes
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