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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References
WHO. Diarrhoeal Disease Available from: http://www.who.int/mediacentre/factsheets/fs330/en/. Accessed Februry 27, 2015.
Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81:197–204.
Primi MP, Bueno L, Baumer P, Berard H, Lecomte JM. Racecadotril demonstrates intestinal antisecretory activity in vivo. Aliment Pharmacol Ther. 1999;13:3–7.
Hinterleitner TA, Petritsch W, Dimsity G, Berard H, Lecomte JM, Krejs GJ. Acetorphan prevents choleratoxin-induced water and electrolyte secretion in the human jejunum. Eur J Gastroenterol Hepatol. 1997;9:887–91.
Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. Racecadotril in the treatment of acute watery diarrhea in children. N Engl J Med. 2000;343:463–7.
Cézard JP, Duhamel JF, Meyer M, Pharaon I, Bellaiche M, Maurage C, et al. Efficacy and tolerability of racecadotril in acute diarrhea in children. Gastroenterology. 2001;120:799–805.
Cojocaru B, Bocquet N, Timsit S, Wille C, Boursiquot C, Marcombes F, et al. [Effect of racecadotril in the management of acute diarrhea in infants and children]. Arch Pediatrie Organe Off Sociéte Fr Pédiatrie. 2002;9:774–9.
Mehta S, Khandelwal PD, Jain VK, Sihag M. A comparative study of racecadotril and single dose octreotide as an anti-secretory agent in acute infective diarrhoea. J Assoc Physicians India. 2012;60:12–5.
Mar Santos RM. Use of racecadotril as outpatient treatment for acute gastroenteritis: A prospective, randomized, parallel study. J Pediatr. 2009;155:62–7.
Turck D, Berard H, Fretault N, Lecomte JM. Comparison of racecadotril and loperamide in children with acute diarrhoea. Aliment Pharmacol Ther. 1999;13:27–32.
Snyder JD, Merson MH. The magnitude of the global problem of acute diarrhoeal disease: a review of active surveillance data. Bull World Health Organ. 1982;60: 605–13.
World Health Organization, Department of Child and Adolescent Health and Development. The Treatment of Diarrhoea: A Manual for Physicians and Other Senior Health Workers. Geneva: Dept. of Child and Adolescent Health and Development, World Health Organization; 2005.
Sarkar R, Sivarathinaswamy P, Thangaraj B, Sindhu KNC, Ajjampur SSR, Muliyil J, et al. Burden of childhood diseases and malnutrition in a semi-urban slum in southern India. BMC Public Health. 2013;13:87.
Ruuska T, Vesikari T. A prospective study of acute diarrhoea in Finnish children from birth to 2 1/2 years of age. Acta Paediatr Scand. 1991;80:500–7.
World Health Organization, Department of Child and Adolescent Health and Development. Handbook IMCI Integrated Management of Childhood Illness. Geneva: World Health Organization, Dept. of Child and Adolescent Health and Development; 2005. Available from: http://site. ebrary.com/id/10137830. Accessed February 23, 2015.
Emparanza Knörr JI, Ozcoidi Erro I, Martínez Andueza MC, Callén Blecua MT, Alústiza Martínez E, Aseguinolaza Iparraguirre I. [Systematic review of the efficacy of Racecadotril in the treatment of acute diarrhoea]. An Pediatría Barc Spain. 2003. 2008;69:432–8.
Szajewska H, Ruszczyñski M, Chmielewska A, Wieczorek J. Systematic review: racecadotril in the treatment of acute diarrhoea in children. Aliment Pharmacol Ther. 2007;26:807–13.
Lehert P, Chéron G, Calatayud GA, Cézard J-P, Castrellón PG, Garcia J-MM, et al. Racecadotril for childhood gastroenteritis: An individual patient data meta-analysis. Dig Liver Dis. 2011;43:707–13.
Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, et al. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): A prospective, case-control study. Lancet. 2013;382:209–22.
Alam NH, Ashraf H, Khan WA, Karim MM, Fuchs GJ. Efficacy and tolerability of racecadotril in the treatment of cholera in adults: A double blind, randomised, controlled clinical trial. Gut. 2003;52:1419–23.
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Kang, G., Thuppal, S.V., Srinivasan, R. et al. Racecadotril in the management of rotavirus and non-rotavirus diarrhea in under-five children: Two randomized, double-blind, placebo-controlled trials. Indian Pediatr 53, 595–600 (2016). https://doi.org/10.1007/s13312-016-0894-0
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DOI: https://doi.org/10.1007/s13312-016-0894-0