Racecadotril in the Management of Rotavirus and Non-rotavirus Diarrhea in Under-five Children: Two Randomized, Double-blind, Placebo-controlled Trials.
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Date
2016-07
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Abstract
Objective: To study the effect of racecadotril on reduction in the duration of acute rotavirus and non-rotavirus diarrhea.
Design: Two randomized double-blind placebo-controlled trials
Setting: Community-based trial in an urban area in Vellore, hospital-based trial at a secondary hospital in Vellore
Participants: 199 and 130 3-59 month old children in the community- and hospital-based trials, respectively.
Methods: Racecadotril (1.5 mg/kg/dose, thrice a day for three days) or placebo were given to manage acute diarrhea in both trials.
Main outcome measure: Median duration of diarrhea.
Results: Among 124 children completing the hospital trial, the median duration of diarrhea was 25 h in both arms (P=0.5); median total stool weight was 74 g/kg and 53.5 g/kg in racecadotril group and placebo group, respectively (P=0.4); and average fluid intake per day was 3.6 mL/kg/h and 3mL/kg/h in racecadotril and placebo arms, respectively (P=0.3). Among rotavirus-positive children, median duration of diarrhea was 26.9 h and 30.2 h in racecadotril and placebo arms, respectively (P=0.7). In the community, 196 completed the trial, the median duration of diarrhea was 2 days for both arms (P=0.8) and rotavirus positive children had similar outcomes with median diarrheal duration of 3 d in both arms (P=0.4).
Conclusion: Treatment with racecadotril did not reduce diarrheal duration, stool volume or the requirement for fluid replacement in children with acute gastroenteritis, both with and without rotavirus infection.
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Keywords
Antidiarrheal, Anti-secretory, Outcome, Treatment
Citation
Gagandeep Kang, Sowmyanarayanan V Thuppal, Rajan Srinivasan, Rajiv Sarkar, Beula Subashini, Srinivasan Venugopal, Kulandaipalayam Sindhu, Dhivya Anbu, Nathalie Parez, Lennart Svensson and Anuradha Bose. Racecadotril in the Management of Rotavirus and Non-rotavirus Diarrhea in Under-five Children: Two Randomized, Double-blind, Placebo-controlled Trials. Indian Pediatrics. 2016 Jul; 53(7): 595-600.