Use of racecadotril as outpatient treatment for acute gastroenteritis: a prospective, randomized, parallel study.
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.


METHODS
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.
Santos
Mar
M
Department of Pediatrics, Hospital General Universitario Gregorio Marañón, Madrid, Spain. marimarsantos5@hotmail.com
Marañón
Rafael
R
Miguez
Concepión
C
Vázquez
Paula
P
Sánchez
Cesar
C
D000208:Acute Disease; D000553:Ambulatory Care; D000930:Antidiarrheals / Q000627:therapeutic use*; D003681:Dehydration / Q000209:etiology / Q000628:therapy; D003967:Diarrhea / Q000188:drug therapy; D004359:Drug Therapy, Combination; D004636:Emergency Service, Hospital; D005260:Female; D005759:Gastroenteritis / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D015532:Rehydration Solutions / Q000627:therapeutic use; D015244:Thiorphan / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000930:Antidiarrheals; D015532:Rehydration Solutions; C049331:racecadotril; D015244:Thiorphan