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Meta-Analysis
. 2018 Apr 25;4(4):CD011526.
doi: 10.1002/14651858.CD011526.pub2.

Smectite for acute infectious diarrhoea in children

Giordano Pérez-Gaxiola  1 , Carlos A Cuello-García, Ivan D Florez, Víctor M Pérez-Pico
Affiliations
Meta-Analysis

Smectite for acute infectious diarrhoea in children

Giordano Pérez-Gaxiola et al. Cochrane Database Syst Rev. .

Abstract

Background: As mortality secondary to acute infectious diarrhoea has decreased worldwide, the focus shifts to adjuvant therapies to lessen the burden of disease. Smectite, a medicinal clay, could offer a complementary intervention to reduce the duration of diarrhoea.

Objectives: To assess the effects of smectite for treating acute infectious diarrhoea in children.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Pubmed), Embase (Ovid), LILACS, reference lists from studies and previous reviews, and conference abstracts, up to 27 June 2017.

Selection criteria: Randomized and quasi-randomized trials comparing smectite to a control group in children aged one month to 18 years old with acute infectious diarrhoea.

Data collection and analysis: Two review authors independently screened abstracts and the full texts for inclusion, extracted data, and assessed risk of bias. Our primary outcomes were duration of diarrhoea and clinical resolution at day 3. We summarized continuous outcomes using mean differences (MD) and dichotomous outcomes using risk ratios (RR), with 95% confidence intervals (CI). Where appropriate, we pooled data in meta-analyses and assessed heterogeneity. We explored publication bias using a funnel plot.

Main results: Eighteen trials with 2616 children met our inclusion criteria. Studies were conducted in both ambulatory and in-hospital settings, and in both high-income and low- or middle-income countries. Most studies included children with rotavirus infections, and half included breastfed children.Smectite may reduce the duration of diarrhoea by approximately a day (MD -24.38 hours, 95% CI -30.91 to -17.85; 14 studies; 2209 children; low-certainty evidence); may increase clinical resolution at day 3 (risk ratio (RR) 2.10, 95% CI 1.30 to 3.39; 5 trials; 312 children; low-certainty evidence); and may reduce stool output (MD -11.37, 95% CI -21.94 to -0.79; 3 studies; 634 children; low-certainty evidence).We are uncertain whether smectite reduces stool frequency, measured as depositions per day (MD -1.33, 95% CI -2.28 to -0.38; 3 studies; 954 children; very low-certainty evidence). There was no evidence of an effect on need for hospitalization (RR 0.93, 95% CI 0.75 to 1.15; 2 studies; 885 children; low-certainty evidence) and need for intravenous rehydration (RR 0.77, 95% CI 0.54 to 1.11; 1 study; 81 children; moderate-certainty evidence). The most frequently reported side effect was constipation, which did not differ between groups (RR 4.71, 95% CI 0.56 to 39.19; 2 studies; 128 children; low-certainty evidence). No deaths or serious adverse effects were reported.

Authors' conclusions: Based on low-certainty evidence, smectite used as an adjuvant to rehydration therapy may reduce the duration of diarrhoea in children with acute infectious diarrhoea by a day; may increase cure rate by day 3; and may reduce stool output, but has no effect on hospitalization rates or need for intravenous therapy.

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Conflict of interest statement

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).

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
‘Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 3
Figure 3
‘Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figure 4
Figure 4
Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).
Figure 5
Figure 5
Funnel plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.1 Mean duration of diarrhoea (hours).
Figure 6
Figure 6
Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.2 Mean duration of diarrhoea, studies including only infants < 2 years.
Figure 7
Figure 7
Forest plot of comparison: 1 Diarrhoea primary outcomes, outcome: 1.3 Clinical resolution at day 3 after starting treatment.
Figure 8
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.
Figure 9
Figure 9
Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.2 Stool output, measured in g/kg at 72 hours.
Figure 10
Figure 10
Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.3 Need for hospitalization.
Figure 11
Figure 11
Forest plot of comparison: 2 Diarrhoea secondary outcomes, outcome: 2.5 Constipation.
Analysis 1.1
Analysis 1.1
Comparison 1 Diarrhoea primary outcomes, Outcome 1 Mean duration of diarrhoea.
Analysis 1.2
Analysis 1.2
Comparison 1 Diarrhoea primary outcomes, Outcome 2 Mean duration of diarrhoea, studies including only infants < 2 years.
Analysis 1.3
Analysis 1.3
Comparison 1 Diarrhoea primary outcomes, Outcome 3 Clinical resolution at day 3 after starting treatment.
Analysis 2.1
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.
Analysis 2.2
Analysis 2.2
Comparison 2 Diarrhoea secondary outcomes, Outcome 2 Stool output, measured in g or mL/kg per day.
Analysis 2.3
Analysis 2.3
Comparison 2 Diarrhoea secondary outcomes, Outcome 3 Need for hospitalization.
Analysis 2.4
Analysis 2.4
Comparison 2 Diarrhoea secondary outcomes, Outcome 4 Need for intravenous access for rehydration.
Analysis 2.5
Analysis 2.5
Comparison 2 Diarrhoea secondary outcomes, Outcome 5 Constipation.
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Update of

References

References to studies included in this review

    1. Dupont C, Foo JL, Garnier P, Moore N, Mathiex‐Fortunet H, Salazar‐Lindo E, Peru and Malaysia Diosmectite Study Groups. Oral diosmectite reduces stool output and diarrhea duration in children with acute watery diarrhea. Clinical Gastroenterology and Hepatology 2009;7(4):456‐62. - PubMed
    1. Dupont C, Foo JL, Garnier P, Moore N, Mathiex‐Fortunet H, Salazar‐Lindo E, Peru and Malaysia Diosmectite Study Groups. Oral diosmectite reduces stool output and diarrhea duration in children with acute watery diarrhea. Clinical Gastroenterology and Hepatology 2009;7(4):456‐62. - PubMed
    1. Gilbert B, Liendhardt A, Palomera S, Barberis L, Borreda D. The efficacy of smectite in acute infantile diarrhea compared to a placebo and loperamide. Annales de Pediatrie 1991;38(9):633‐6. - PubMed
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    1. Lachaux A, Danzon A, Collet JP, Descos B, Hermier M. Acute infantile diarrhoea. Role of treatment with smectite as complement to rehydration. Randomised double‐blind study. International Review of Pediatrics 1986;163:29‐31.

References to studies excluded from this review

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    1. Dupont C, Moreno JL, Barau E, Bargaoui K, Thiane E, Plique O. Effect of diosmectite on intestinal permeability changes in acute diarrhea: a double‐blind placebo‐controlled trial. Journal of Pediatric Gastroenterology and Nutrition 1992;14(4):413‐9. - PubMed
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    1. Madkour AA. Placebo‐controlled, double‐blind clinical trial of smectite in acute pediatric diarrhea. Fortschritte der Medizin 1994;112(24):6p. - PubMed

Additional references

    1. Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea. Cochrane Database of Systematic Reviews 2010, Issue 12. [DOI: 10.1002/14651858.CD003048.pub3] - DOI - PMC - PubMed
    1. Das RR, Sankar J, Naik SS. Efficacy and safety of diosmectite in acute childhood diarrhoea: a meta‐analysis. Archives of Disease in Childhood 2015;100(7):704‐12. - PubMed
    1. Dupont C, Vernisse B. Anti‐diarrheal effects of diosmectite in the treatment of acute diarrhea in children: a review. Paediatric Drugs 2009;11(2):89‐99. [DOI: 10.2165/00148581-200911020-00001] - DOI - PMC - PubMed
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