OBJECTIVE: To compare the efficacy of therapy with racecadotril plus oral rehydration versus oral rehydration alone in children with gastroenteritis in an outpatient setting care. STUDY DESIGN: Prospective, randomized, open and parallel study performed in a Pediatric Emergency Service of a tertiary care hospital. The study included 189 patients, ages 3 to 36 months, with acute gastroenteritis: 94 were administered an oral rehydration solution (OR), 94 received oral rehydration solution plus racecadotril (OR + R). The principal variable studied was the number of bowel movements in 48 hours after initiating treatment. RESULTS: The groups were comparable clinically and epidemiologically at enrollment. No significant differences were found in the number of bowel movements between the 2 groups 48 hours after initiating treatment (4.1 +/- 2.7 bowel movements in the OR group vs 3.8 +/- 2.4 bowel movements in the OR + R group). No differences were found in the average duration of gastroenteritis (4.7 +/- 2.2 days in the OR group, 4.0 +/- 2.1 days in the OR + R group; P = .15). The incidence of adverse events was similar in both groups (19 patients [20.2%] in the OR group, 18 patients [19.1%] in the OR + R group). CONCLUSIONS: In our study group, the use of racecadotril did not improve the symptoms of diarrhea compared with standard rehydration therapy.
RCT Entities:
OBJECTIVE: To compare the efficacy of therapy with racecadotril plus oral rehydration versus oral rehydration alone in children with gastroenteritis in an outpatient setting care. STUDY DESIGN: Prospective, randomized, open and parallel study performed in a Pediatric Emergency Service of a tertiary care hospital. The study included 189 patients, ages 3 to 36 months, with acute gastroenteritis: 94 were administered an oral rehydration solution (OR), 94 received oral rehydration solution plus racecadotril (OR + R). The principal variable studied was the number of bowel movements in 48 hours after initiating treatment. RESULTS: The groups were comparable clinically and epidemiologically at enrollment. No significant differences were found in the number of bowel movements between the 2 groups 48 hours after initiating treatment (4.1 +/- 2.7 bowel movements in the OR group vs 3.8 +/- 2.4 bowel movements in the OR + R group). No differences were found in the average duration of gastroenteritis (4.7 +/- 2.2 days in the OR group, 4.0 +/- 2.1 days in the OR + R group; P = .15). The incidence of adverse events was similar in both groups (19 patients [20.2%] in the OR group, 18 patients [19.1%] in the OR + R group). CONCLUSIONS: In our study group, the use of racecadotril did not improve the symptoms of diarrhea compared with standard rehydration therapy.
Authors: Tammy Bui; Guohua Li; Inyoung Kim; Ke Wen; Erica L Twitchell; Shaoh Hualei; Ashwin K Ramesh; Mariah D Weiss; Xingdong Yang; Sherrie G Glark-Deener; Robert Km Choy; Lijuan Yuan Journal: Comp Med Date: 2017-03-01 Impact factor: 0.982
Authors: Varsha Singh; Jianbo Yang; Tiane-e Chen; Nicholas C Zachos; Olga Kovbasnjuk; Alan S Verkman; Mark Donowitz Journal: Clin Gastroenterol Hepatol Date: 2013-10-31 Impact factor: 11.382