Abstract:Background: Racecadotril, an enkephalinase inhibitor with antisecretory action is a safe and effective treatment for acute diarrhea for children and adults. As an adjunct to oral rehydration therapy (ORT) in Indian children, its efficacy and safety data are scarce. Methods: A total of 117 children with acute watery diarrhea for not more than 7 days were randomized into two groups. Group A (control group) received ORT and zinc only while Group B (study group) received a combination of racecadotril (1.5 mg/kg q8… Show more
“…During study selection we encountered three non‐English articles and obtained help from the Cochrane Infectious Diseases Group (CIDG) with translating them into English (Calatayud 2009; Cojocaru 2002; García 2016). After selecting according to inclusion criteria, we included seven RCTs, involving 1140 participants (Cézard 2001; García 2016; Gharial 2017; [Kang 2016a; Kang 2016b]; Salazar‐Lindo 2000; Santos 2009; Sreenivas 2017). See Figure 1 for a flow diagram of the selection process.Figure 1Study flow diagram.…”
Section: Resultsmentioning
confidence: 99%
“…Two trials were conducted in India ([Kang 2016a; Kang 2016b]; Sreenivas 2017); the rest were conducted in France (Cézard 2001), Spain (Santos 2009), Peru (Salazar‐Lindo 2000), Kenya (Gharial 2017), and Ecuador (García 2016).…”
Section: Resultsmentioning
confidence: 99%
“…Gharial 2017 and [Kang 2016a; Kang 2016b] graded the severity of diarrhoea with the Vesikari score (Lewis 2011); and Gharial 2017 included participants with a score greater than 11 (severe) only. Two trials included outpatients only (García 2016; Santos 2009); while four included inpatients only (Cézard 2001; Gharial 2017; Salazar‐Lindo 2000; Sreenivas 2017). One trial included both inpatients and outpatients but reported their results separately (Kang 2016a; Kang 2016b).…”
Section: Resultsmentioning
confidence: 99%
“…One trial included both inpatients and outpatients but reported their results separately (Kang 2016a; Kang 2016b). Sreenivas 2017 included paediatric ward inpatients but children with severe diarrhoea were excluded.…”
Section: Resultsmentioning
confidence: 99%
“…Previous reviews did not include this outcome when evaluating the efficacy of racecadotril (Gordon 2016; Lehert 2011; Szajewska 2007). Although several systematic reviews have been conducted in order to assess the efficacy of racecadotril for children with acute diarrhoea, the benefit of using racecadotril is still controversial as newly published trials have inconsistent conclusions on its efficacy (García 2016; Gharial 2017; Kang 2016a; Kang 2016b; Sreenivas 2017). An updated systematic review that carefully assesses risk of bias of available trials and addresses outcomes both on symptomatic relief and success of rehydration was needed.…”
BackgroundAcute diarrhoea is a leading cause of death for children under five years of age. Most deaths are caused by excessive fluid and electrolyte losses. Racecadotril is an anti‐secretory drug that has been used for acute diarrhoea in children as an adjunct to oral rehydration therapy.ObjectivesTo assess the efficacy and safety of racecadotril for treating acute diarrhoea in children under five years of age.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library Issue 3, March 2019); MEDLINE; Embase; LILACS; ClinicalTrials.gov; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), up to 4 March 2019, for clinical trials regardless of publication language or status.Selection criteriaRandomized controlled trials (RCTs) that compared racecadotril to placebo or no intervention in addition to standard care (oral rehydration therapy) in children under five with acute diarrhoea. The primary outcomes were failure of oral rehydration, duration of diarrhoea, and number of stools. The secondary outcomes were stool output, length of the hospital stay, and adverse events.Data collection and analysisTwo review authors independently assessed trial eligibility, extracted the data and assessed risk of bias. We presented dichotomous data with risk ratios (RR) and continuous data with mean difference (MD) or standardized mean difference (SMD). Where appropriate, we combined trials with meta‐analysis and used a random‐effects model if there was significant heterogeneity (I² ≥ 50%). We assessed the certainty of the evidence using the GRADE approach.Main resultsSeven RCTs with a total of 1140 participants met the inclusion criteria. The trials were carried out on children aged three months to five years, in outpatient and inpatient facilities from France, Spain, Peru, India, Kenya, and Ecuador. The efficacy and safety of racecadotril were compared to placebo or no treatment. Racecadotril may reduce the risk of rehydration failure (RR 0.41, 95% CI 0.13 to 1.23; 2 RCTs, 192 participants; low‐certainty evidence). Data on duration of diarrhoea, number of stools in the first 48 hours are insufficient to reach a conclusion; stool output in the first 48 hours appears to be lower in the two trials measuring this, although the data is not combinable. Length of hospital stay was similar in two studies measuring this, and overall there was no evidence that racecadotril increased overall rate of adverse events (RR 0.90, 95% CI 0.66 to 1.22; 5 RCTs, 688 participants; low‐certainty evidence). Most adverse events in the racecadotril group were mild or moderate.Authors' conclusionsRacecadotril seems to be a safe drug but has little benefit in improving acute diarrhoea in children under five years of age. Current evidence does not support routine use of racecadotril in management of acute diarrhoea in children under five outside of the context of placebo controlled RCTs.
“…During study selection we encountered three non‐English articles and obtained help from the Cochrane Infectious Diseases Group (CIDG) with translating them into English (Calatayud 2009; Cojocaru 2002; García 2016). After selecting according to inclusion criteria, we included seven RCTs, involving 1140 participants (Cézard 2001; García 2016; Gharial 2017; [Kang 2016a; Kang 2016b]; Salazar‐Lindo 2000; Santos 2009; Sreenivas 2017). See Figure 1 for a flow diagram of the selection process.Figure 1Study flow diagram.…”
Section: Resultsmentioning
confidence: 99%
“…Two trials were conducted in India ([Kang 2016a; Kang 2016b]; Sreenivas 2017); the rest were conducted in France (Cézard 2001), Spain (Santos 2009), Peru (Salazar‐Lindo 2000), Kenya (Gharial 2017), and Ecuador (García 2016).…”
Section: Resultsmentioning
confidence: 99%
“…Gharial 2017 and [Kang 2016a; Kang 2016b] graded the severity of diarrhoea with the Vesikari score (Lewis 2011); and Gharial 2017 included participants with a score greater than 11 (severe) only. Two trials included outpatients only (García 2016; Santos 2009); while four included inpatients only (Cézard 2001; Gharial 2017; Salazar‐Lindo 2000; Sreenivas 2017). One trial included both inpatients and outpatients but reported their results separately (Kang 2016a; Kang 2016b).…”
Section: Resultsmentioning
confidence: 99%
“…One trial included both inpatients and outpatients but reported their results separately (Kang 2016a; Kang 2016b). Sreenivas 2017 included paediatric ward inpatients but children with severe diarrhoea were excluded.…”
Section: Resultsmentioning
confidence: 99%
“…Previous reviews did not include this outcome when evaluating the efficacy of racecadotril (Gordon 2016; Lehert 2011; Szajewska 2007). Although several systematic reviews have been conducted in order to assess the efficacy of racecadotril for children with acute diarrhoea, the benefit of using racecadotril is still controversial as newly published trials have inconsistent conclusions on its efficacy (García 2016; Gharial 2017; Kang 2016a; Kang 2016b; Sreenivas 2017). An updated systematic review that carefully assesses risk of bias of available trials and addresses outcomes both on symptomatic relief and success of rehydration was needed.…”
BackgroundAcute diarrhoea is a leading cause of death for children under five years of age. Most deaths are caused by excessive fluid and electrolyte losses. Racecadotril is an anti‐secretory drug that has been used for acute diarrhoea in children as an adjunct to oral rehydration therapy.ObjectivesTo assess the efficacy and safety of racecadotril for treating acute diarrhoea in children under five years of age.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library Issue 3, March 2019); MEDLINE; Embase; LILACS; ClinicalTrials.gov; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), up to 4 March 2019, for clinical trials regardless of publication language or status.Selection criteriaRandomized controlled trials (RCTs) that compared racecadotril to placebo or no intervention in addition to standard care (oral rehydration therapy) in children under five with acute diarrhoea. The primary outcomes were failure of oral rehydration, duration of diarrhoea, and number of stools. The secondary outcomes were stool output, length of the hospital stay, and adverse events.Data collection and analysisTwo review authors independently assessed trial eligibility, extracted the data and assessed risk of bias. We presented dichotomous data with risk ratios (RR) and continuous data with mean difference (MD) or standardized mean difference (SMD). Where appropriate, we combined trials with meta‐analysis and used a random‐effects model if there was significant heterogeneity (I² ≥ 50%). We assessed the certainty of the evidence using the GRADE approach.Main resultsSeven RCTs with a total of 1140 participants met the inclusion criteria. The trials were carried out on children aged three months to five years, in outpatient and inpatient facilities from France, Spain, Peru, India, Kenya, and Ecuador. The efficacy and safety of racecadotril were compared to placebo or no treatment. Racecadotril may reduce the risk of rehydration failure (RR 0.41, 95% CI 0.13 to 1.23; 2 RCTs, 192 participants; low‐certainty evidence). Data on duration of diarrhoea, number of stools in the first 48 hours are insufficient to reach a conclusion; stool output in the first 48 hours appears to be lower in the two trials measuring this, although the data is not combinable. Length of hospital stay was similar in two studies measuring this, and overall there was no evidence that racecadotril increased overall rate of adverse events (RR 0.90, 95% CI 0.66 to 1.22; 5 RCTs, 688 participants; low‐certainty evidence). Most adverse events in the racecadotril group were mild or moderate.Authors' conclusionsRacecadotril seems to be a safe drug but has little benefit in improving acute diarrhoea in children under five years of age. Current evidence does not support routine use of racecadotril in management of acute diarrhoea in children under five outside of the context of placebo controlled RCTs.
Objective: This study aimed to investigate the beneficial effect of racecadotril in children with acute diarrheal illness.
Methods: This randomized case-control study was conducted at Watim General Hospital over four months from April to July 2023. A total of 120 children aged 3 months to 12 years with acute diarrhoea were included and randomly allocated to two groups. Group A (n=60) received standard treatment with oral rehydration therapy, while Group B (n=60) received oral rehydration therapy, zinc, probiotics, and racecadotril. The primary outcome measured was the mean duration of illness, and the secondary outcome was the number of stools 48 hours after the start of treatment. Data were collected using a pre-designed proforma and analyzed using SPSS version 24.
Results: The study population had an average age of 50.35±41.52 months, with equal gender distribution. The mean duration of illness in Group A was 2.72±1.34 days, while in Group B, it was 2.70±1.29 days. There was no statistically significant difference in the mean duration of illness between the two groups (p=0.945).
Conclusion: This study did not demonstrate a significant reduction in the mean duration of illness for children with acute gastroenteritis using standard treatment with or without racecadotril. Further investigations and large-scale studies may be needed to establish the efficacy of racecadotril in the management of acute diarrhoea in children.
Keywords: Acute diarrhoea, ORS, Racecadotril.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
