Introduction <p>Acute diarrhea in children is a common condition. Standard treatment is oral rehydration, but antidiarrheal drugs are still widely used. However, their efficacy is debated: several trials and meta-analyses have yielded contradictory results with a low level of evidence. Consequently, an updated and rigorous analysis is warranted.</p> Objective <p>The aim of this study was to evaluate the efficacy of Racecadotril in acute diarrhea in children, through a systematic literature review and meta-analysis of randomized trials. We also introduce a new method for interpreting the available evidence : the REB method.</p> Method <p>A bibliographic search was conducted for articles published until October 2, 2023. The risk of bias was assessed using the RoB2 tool. The three endpoints were duration of diarrhea, stool production and length of hospitalization. The REB method was used to assess the overall level of evidence for efficacy. The REB method evaluates only low-risk-of-bias RCTs with confirmatory results to assess the solidity of evidence.</p> Results <p>Five trials were selected and included 904 patients. Only one trial was assessed as having a low risk of bias, precluding meta-analysis. This study was included in the REB analysis and showed neither statistically significant nor clinically significant effects. According to the REB method, the conclusion is an “absence of evidence” for efficacy of Racecadotril on all three endpoints.</p> Conclusion <p>This review found insufficient high-quality evidence to support the efficacy of Racecadotril in children with acute diarrhea.</p>

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Efficacy of Racecadotril in acute diarrhea in children: systematic review of double blind randomized clinical trials

  • Ivan Bittar,
  • Loris Guyenard,
  • Clara Blanchard,
  • Remy Boussageon

摘要

Introduction

Acute diarrhea in children is a common condition. Standard treatment is oral rehydration, but antidiarrheal drugs are still widely used. However, their efficacy is debated: several trials and meta-analyses have yielded contradictory results with a low level of evidence. Consequently, an updated and rigorous analysis is warranted.

Objective

The aim of this study was to evaluate the efficacy of Racecadotril in acute diarrhea in children, through a systematic literature review and meta-analysis of randomized trials. We also introduce a new method for interpreting the available evidence : the REB method.

Method

A bibliographic search was conducted for articles published until October 2, 2023. The risk of bias was assessed using the RoB2 tool. The three endpoints were duration of diarrhea, stool production and length of hospitalization. The REB method was used to assess the overall level of evidence for efficacy. The REB method evaluates only low-risk-of-bias RCTs with confirmatory results to assess the solidity of evidence.

Results

Five trials were selected and included 904 patients. Only one trial was assessed as having a low risk of bias, precluding meta-analysis. This study was included in the REB analysis and showed neither statistically significant nor clinically significant effects. According to the REB method, the conclusion is an “absence of evidence” for efficacy of Racecadotril on all three endpoints.

Conclusion

This review found insufficient high-quality evidence to support the efficacy of Racecadotril in children with acute diarrhea.