medigraphic.com
ISSN 0016-3813 (Print)

2015, Number 3

<< Back Next >>

Gac Med Mex 2015; 151 (3)

Efficacy of racecadotril vs. smectite probiotics or zinc as an integral part of treatment of acute diarrhea in children under five years: A meta-analysis of multiple treatments

Gutiérrez-Castrellón P, Ortíz-Hernández AA, Llamosas-Gallardo B, Acosta-Bastidas MA, Jiménez-Gutiérrez C, Diaz-García L, Anzo-Osorio A, Estevez-Jiménez J, Jiménez-Escobar I, Vidal-Vázquez RP

Language: Spanish
References: 88
Page: 329-337
PDF size: 287.11 Kb.


ABSTRACT

Rationale: Despite major advances in treatment, acute diarrhea continues to be a public health problem in children under five years. There is no systematic approach to treatment and most evidence is assembled comparing active treatment vs. placebo. Objective: Systematic review of evidence on efficacy of adjuvants for treatment of acute diarrhea through a network meta-analysis. Methods: A systematic search of multiple databases searching clinical trials related to the use of racecadotril, smectite, Lactobacillus GG, Lactobacillus reuteri, Saccharomyces boulardii and zinc as adjuvants in acute diarrhea was done. The primary endpoint was duration of diarrhea. Information is displayed through network meta-analysis. The superiority of each coadjutant was analyzed by Sucra approach. Results: Network meta-analysis showed racecadotril was better when compared with placebo and other adjuvants. Sucra analysis showed racecadotril as the first option followed by smectite and Lactobacillus reuteri. Interpretation: Considering a strategic decision making approach, network meta-analysis allows us to establish the therapeutic superiority of racecadotril as an adjunct for the comprehensive management of acute diarrhea in children aged less than five years.


REFERENCES

  1. Payne DC, Vinje J, Szilagyi PG, et al. Norovirus and medically attended gastroenteritis in U.S. children. N Engl J Med. 2013;368(12):1121-30.

  2. Liu L, Johnson HL, Cousens S, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379(9832):2151-61.

  3. Freedman SB, Steiner MJ, Chan KJ. Oral ondansetron administration in emergency departments to children with gastroenteritis: an economic analysis. PLoS Med. 2010;7(10). pii: e1000350.

  4. Malek MA, Curns AT, Holman RC, et al. Diarrhea- and rotavirus-associated hospitalizations among children less than 5 years of age: United States, 1997 and 2000. Pediatrics. 2006;117(6):1887-92.

  5. Majowicz SE, McNab WB, Sockett P, et al. Burden and cost of gastroenteritis in a Canadian community. J Food Prot. 2006;69(3):651-9.

  6. Dennehy PH. Acute diarrheal disease in children: epidemiology, prevention, and treatment. Infect Dis Clin North Am. 2005;19(3):585.

  7. Powell EC, Hampers LC. Physician variation in test ordering in the management of gastroenteritis in children. Arch Pediatr Adolesc Med. 2003;157(10):978-83.

  8. Freedman SB, Gouin S, Bhatt M, et al. Prospective assessment of practice pattern variations in the treatment of pediatric gastroenteritis. Pediatrics. 2011;127(2):E287-95.

  9. Freedman SB, Sivabalasundaram V, Bohn V, Powell EC, Johnson DW, Boutis K. The treatment of pediatric gastroenteritis: a comparative analysis of pediatric emergency physicians’ practice patterns. Acad Emerg Med. 2011;18(1):38-45.

  10. Kinlin LM, Bahm A, Guttmann A, Freedman SB. Department resources and strategies employed in the treatment of pediatric gastroenteritis. Acad Emerg Med. 2013;20(4):361-6.

  11. Farthing M, Salam MA, Lindberg G, et al. Acute diarrhea in adults and children: a global perspective. J Clin Gastroenterol. 2013;47(1):12-20.

  12. Gonzales SC, Bada MC, Rojas GR, Bernaola AG, Chávez BC; Instituto Nacional de Salud del Niño. [Clinical practice guidelines on the diagnosis and treatment of infectious acute diarrhea in children Peru – 2011]. Rev Gastroenterol Peru. 2011;31(3):258-77.

  13. Salazar-Lindo E, Polanco Allué I, Gutiérrez-Castrellón P; Grupo Ibero- Latinoamericano sobre el Manejo de la Diarrea Aguda (GILA). Guía de práctica clínica ibero-latinoamericana sobre el manejo de la gastroenteritis aguda en menores de 5 años: tratamiento farmacológico. An Pediatr (Barc). 2014;80 Suppl 1:15-22.

  14. Gutiérrez Castrellón P, Polanco Allué I, Salazar Lindo E. ]An evidence based Iberic-Latin American guideline for acute gastroenteritis management in infants and prescholars]. An Pediatr (Barc). 2010;72(3):220. e1-220.e20.

  15. Pie´scik-Lech M, Shamir R, Guarino A, Szajewska H. Review article: the management of acute gastroenteritis in children. Aliment Pharmacol Ther. 2013;37(3):289-303.

  16. Guarino A, Albano F, Ashkenazi S, et al. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe. J Pediatr Gastroenterol Nutr. 2008;46 Suppl 2:S81-122.

  17. Wong SS1, Wilczynski NL, Haynes RB. Comparison of top performing search strategies for detecting clinically sound treatment studies and systematic reviews in MEDLINE and EMBASE. J Med Libr Assoc. 2006 Oct;94(4):451-5.

  18. Higgins JPT, Altman DG, Sterne JAC. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (eds). Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration, 2011. [Internet] Disponible en: http://www.cochrane-handbook. org.

  19. Purgato M, Barbui C, Cipriani A. Assessing risk of bias in randomized controlled trials. Epidemiol Psichiatr Soc. 2010;19(4):296-7.

  20. Scott, G (2001). Strategic Planning for High-Tech Product Development. Technology Analysis & Strategic Management, Vol. 13, No. 3.

  21. Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med. 2004;23(20):3105-24.

  22. Ades AE, Sculpher M, Sutton A, et al. Bayesian methods for evidence synthesis in cost-eff ectiveness analysis. Pharmacoeconomics. 2006;24(1):1-19.

  23. Salanti G, Higgins JP, Ades AE, Ioannidis JP. Evaluation of networks of randomized trials. Stat Methods Med Res. 2008;17(3):279-301.

  24. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011;64(2):163-71.

  25. Salanti G, Marinho V, Higgins JP. A case study of multiple-treatments meta-analysis demonstrates that covariates should be considered. J Clin Epidemiol. 2009;62(8):857-64.

  26. Dias S, Welton NJ, Caldwell DM, Ades AE. Checking consistency in mixed treatment comparison meta-analysis. Stat Med. 2010;29(7-8):932-44.

  27. Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. Racecadotril in the treatment of acute watery diarrhoea in children. N Engl J Med. 2000;343(7):463-7.

  28. Cezard JP, Duhamel JF, Meyer M, et al. Efficacy and tolerability of racecadotril in gastroenteritis in children. Gastroenterology. 2001;120(4): 799-805.

  29. Cojocaru B, Bocquet N, Timsit S, et al. Effet du racécadotril sur le recours aux soins dans le traitement des diarrhées aiguës du nourrisson et de l’enfant. Arch Pédiatr. 2002;9(8):774-9.

  30. Savitha MR. Racecadotrial – a novel drug for treatment of acute watery diarrhoea in Indian children. Karnataka Pedicon 2005-Conference Abstracts. Pediatric Oncall; 2006 [Internet] Consultado el 1 de enero de 2006. Disponible en: http://www.pediatriconcall.com/fordoctor/.

  31. Santos M, Marañón R, Miguez C, Vázquez P, Sánchez C. Use of racecadotril as outpatient treatment for acute gastroenteritis:a prospective, randomized, parallel study. J Paediatr. 2009;155(1):62-7.

  32. Alvarez Calatayud G, Pinel G, Taboada L, et al. Efectividad de racecadotrilo en el tratamiento de la gastroenteritis aguda. Acta Pediatr Esp. 2009;67:177-22.

  33. Gutiérrez-Castrellón P, Acosta-Bastidas M, Llamosas Gallardo B, et al. Ensayo clínico aleatorizado y análisis farmaco económico del impacto de racecadotrilo (Hidrasec®) como coadyuvante en el tratamiento de la gastroenteritis aguda sobre la reducción de los gastos hospitalarios relacionados en lactantes menores de 24 meses en México. Gac Med Mex. 2014 (in press).

  34. Melendez Garcia JM, Rodriguez JT. Racecadotril en el tratamiento de la diarrea aguda en niños. Rev Facultad Med (Guatemala). 2007;4:25-8.

  35. Vivatvakin B, Jongpipatvanich S, Harikul S, Eksaengri P, Lortholary O. Control study of oral rehydration solution (ORS)/ORS + dioctahedral smectite in hospitalized Thai infants with acute secretory diarrhea. Southeast Asian J Trop Med Public Health. 1992;23(3):414-9.

  36. Narkeviciute I, Rudzeviciene O, Leviniene G, Mociskiene K, Eidukevicius R. Management of Lithuanian children’s acute diarrhoea with Gastrolit solution and dioctahedral smectite. Eur J Gastroenterol Hepatol. 2002;14(4):419-24.

  37. Zong S, Chao YM, Qu Y, Liu L. Study on Smecta therapy for acute diarrhea in infants. J Tianjing Med Univ. 1997;3:60-3.

  38. Madkour AA, Madina EMH, El-Azzouni OEZ, Amer MA, El-Walili TMK, Abbass T. Smectite in acute diarrhoea in children: a double-blind placebo- controlled clinical trial. J Pediatr Gastroenterol Nutr. 1993;17(2): 176-81.

  39. Lachaux A, Danzon A, Collet JP, Descos B, Hermier M. Acute infantile diarrhoea. Role of treatment with smectite as complement to rehydration. Randomised double-blind study. Int Rev Pediatr. 1986;163:29-31.

  40. Guarino A, Bisceglia M, Castellucci G, et al. Italian Society of Pediatric Gastroenterology and Hepatology Study Group for Smectite in Acute Diarrhea. Smectite in the treatment of acute diarrhea: a nationwide randomized controlled study of the Italian Society of Pediatric Gastroenterology and Hepatology (SIGEP) in collaboration with primary care pediatricians. SIGEP Study Group for Smectite in Acute Diarrhea. J Pediatr Gastroenterol Nutr. 2001;32(1):71-5.

  41. Gilbert B, Lienhardt A, Palomera S, Barberis L, Borreda D. A study of the effectiveness of smectite versus placebo or loperamide in acute infantile diarrhoea. Ann Pediatr (Paris). 1991;38(9):633-6.

  42. Osman GAH, Mahomoud SAR, El-Shakankiry HM, Abulhana SM. An adsorbent! Role in the management of acute diarrea in infants and children. Ain Shams Med J. 1992;13:10, 11 and 12665-76.

  43. Lexomboon U, Harikul S, Lorthola O. Control randomized study of rehydration/ rehydration with dioctahedral smectite in ambulatory Thai infants with acute diarrhoea. Southeast Asian J Trop Med Public Health. 1994;25(1):157-62.

  44. DuPont C, Moreno JL, Barau E, Bargaoui K, Thiane E, Plique O. Effect of diosmectite on intestinal permeability changes in acute diarrhea: a doubleblind placebo-controlled trial. J Pediatr Gastroenterol Nutr. 1992;14(4):413-9.

  45. Mujawar QM, Naganoor R, Ali MD, Malagi N, Thobbi AN. Efficacy of dioctahedral smectite in acute watery diarrhea in indian children: a randomized clinical trial. J Trop Pediatr. 2012;58(1):63-7.

  46. Costa-Ribeiro H, Ribeiro TC, Mattos AP, et al. Limitations of probiotic therapy in acute, severe dehydrating diarrhea. J Pediatr Gastroenterol Nutr. 2003;36(1):112-5.

  47. Guandalini S, Pensabene L, Zikri MA, et al. Lactobacillus GG administered in oral rehydration solution to children with acute diarrhea: a multicenter European trial. J Pediatr Gastroenterol Nutr. 2000;30(1):54-60.

  48. Shornikova AV, Isolauri E, Burkanova L, Lukovnikova S, Vesikari T. A trial in the Karelian Republic of oral rehydration and Lactobacillus GG for treatment of acute diarrhea. Acta Paediatr. 1997;86(5):460-5.

  49. Jasinski C, Tanzi MN, Schelotto F, et al. Efficacy of Lactobacillus GG in oral rehydration solution. Pediátrica. 2002;22:231-43.

  50. Canani RB, Cirillo P, Terrin G, et al. Probiotics for treatment of acute diarrhea in children: randomised clinical trial of five different preparations. BMJ. 2007;335(7615):340.

  51. Ritchie BK, Brewster DR, Tran CD, Davidson GP, McNeil Y, Butler RN. Efficacy of Lactobacillus GG in aboriginal children with acute diarrheal disease: a randomised clinical trial. J Pediatr Gastroenterol Nutr. 2010;50(6):619-24.

  52. Isolauri E, Kaila M, Mykkänen H, Ling WH, Salminen S. Oral bacteriotherapy for viral gastroenteritis. Dig Dis Sci. 1994;39(12):2595-600.

  53. Basu S, Paul DK, Ganguly S, Chatterjee M, Chandra PK. Efficacy of high-dose Lactobacillus rhamnosus GG in controlling acute watery diarrhea in Indian children: a randomized controlled trial. J Clin Gastroenterol. 2009;43(3):208-13.

  54. Basu S, Chatterjee M, Ganguly S, Chandra PK. Efficacy of Lactobacillus rhamnosus GG in acute watery diarrea of Indian children: a randomized controlled trial. J Paediatr Child Health. 2007;43(12):837-42.

  55. Misra S, Sabui TK, Pal NK. A randomized controlled trial to evaluate the efficacy of Lactobacillus GG in infantile diarrhea. J Pediatr. 2009;155(1):129-32.

  56. Guarino A, Canani RB, Spagnuolo MI, Albano F, Di Benedetto L. Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea. J Pediatr Gastroenterol Nutr. 1997;25(5):516-9.

  57. Cetina-Sauri G, Busto GS. Therapeutic evaluation of Saccharomyces boulardii in children with acute diarrhea. Ann Ped. 1994;6:397-400.

  58. Hafeez A, Tariq P, Ali S, Kundi ZU, Khan A, Hassan M. The efficacy of Saccharomyces boulardii in the treatment of acute watery diarrhea in children: a multicentre randomized controlled trial. J Coll Physicians Surg Pak. 2002;12:432-4.

  59. Kurugol Z, Koturoglu G. Effects of Saccharomyces boulardii in children with acute diarrhoea. Acta Paediatr. 2005;94(1):44-7.

  60. Billoo AG, Memon MA, Khaskheli SA, et al. Role of a probiotic (Saccharomyces boulardii) in management and prevention of diarrhoea. World J Gastroenterol. 2006;12(28):4557-60.

  61. Ozkan TB, Sahin E, Erdemir G, Budak F. Effect of Saccharomyces boulardii in Children with Acute Gastroenteritis and Its relationship to the immune response. Journal of International Medical Research. 2007;35(2):201-12.

  62. Villarruel G, Rubio DM, Lopez F, et al. Saccharomyces boulardii in acute childhood diarrhoea: a randomized, placebo-controlled study. Acta Paediatr. 2007;96(4):538-41.

  63. Htwe K, Yee KS, Tin M, Vandenplas Y. Effect of Saccharomyces boulardii in the treatment of acute watery diarrhea in myanmar children: a randomized controlled study. Am J Trop Med Hyg. 2008;78(2):214-6.

  64. Grandy G, Medina M, Soria R, Terán CG, Araya M. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children. BMC Infectious Diseases. 2010;10:253.

  65. Corrêa NB, Penna FJ, Lima FM, Nicoli JR, Filho LA. Treatment of acute diarrhea with Saccharomyces boulardii in infants. J Pediatr Gastroenterol Nutr. 2011;53(5):497-501.

  66. Dalgic N, Sancar M, Bayraktar B, Pullu M, Hasim O. Probiotic, zinc and lactose-free formula in children with rotavirus diarrhea: Are they effective? Pediatrics International. 2011;53(5):677-82.

  67. Shornikova AV, Casas IA, Isolauri E, Mykkänen H, Vesikari T. Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children. J Pediatr Gastroenterol Nutr. 1997;24(4):399-40.

  68. Shornikova AV, Casas IA, Mykkänen H, Salo E, Vesikari T. Bacteriotherapy with Lactobacillus reuteri in rotavirus gastroenteritis. Pediatr Infect Dis J. 1997;16(12):1103-7.

  69. Rosenfeldt V, Michaelsen KF, Jakobsen M, et al. Effect of probiotic Lactobacillus strains in young children hospitalized with acute diarrhea. Pediatr Infect Dis J. 2002;21(5):411-6.

  70. Rosenfeldt V, Michaelsen KF, Jakobsen M, et al. Effect of probiotic Lactobacillus strains on acute diarrhea in a cohort of nonhospitalized children attending day-care centers. Pediatr Infect Dis J. 2002;21(5):417- 9.

  71. Francavilla R, Lionetti E, Castellaneta S, et al. Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acutediarrhoea-- a double-blind study. Aliment Pharmacol Ther. 2012;36(4):363-9.

  72. Brooks WA, Santosham M, Roy SK, et al. Efficacy of zinc in young infants with acute watery diarrhea. American Journal of Clinical Nutrition. 2005;82(3):605-10.

  73. Fischer Walker CL, Bhutta ZA, Bhandari N, et al. Zinc supplementation for the treatment of diarrhea in infants in Pakistan, India and Ethiopia. J Pediatr Gastroenterol Nutr. 2006;43(3):357-63.

  74. Dutta P, Mitra U, Datta A, et al. Impact of zinc supplementation in malnourished children with acute watery diarrhoea. J Trop Pediatr. 2000;46(5):259-63.

  75. Fajolu IB, Emokpae A, Oduwole AO, Silva BO, Abidoye RO, Renner JK. Zinc supplementation in children with acute diarrhoea. Nig Q J Hosp Med. 2008;18(2):101-3.

  76. Patel A, Dibley MJ, Mamtani M, Badhoniya N, Kulkarni H. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial. BMC Med. 2009;5(7):22.

  77. Sachdev HP, Mittal NK, Yadav HS. Oral zinc supplementation in persistent diarrhoea in infants. Ann Trop Paediatr. 1990;10(1):63-9.

  78. Pie´scik-Lech M, Shamir R, Guarino A, Szajewska H. Review article: the management of acute gastroenteritis in children. Aliment Pharmacol Ther. 2013;37(3):289-303.

  79. Guarino A, Dupont C, Gorelov AV, et al. The management of acute diarrhea in children in developed and developing areas: from evidence base to clinical practice. Expert Opin Pharmacother. 2012;13(1):17-26.

  80. World Health Organization. Diarrhoea. [Internet] Consultado el 7 de abril de 2013. Disponible en: http://www.who.int/topics/diarrhoea/en.

  81. National Collaborating Centre for Women’s and Children’s Health. Diarrhea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger Than 5 Years. Londres: RCOG Press; 2009. [Internet] Consultado el 31 de marzo de 2012. Disponible en: http://www.nice.org.uk/nicemedia/pdf/CG84FullGuideline.pdf.

  82. Chow CM, Leung AK, Hon KL. Acute gastroenteritis: from guidelines to real life. Clin Exp Gastroenterol. 2010;3:97-112.

  83. Murphy C, Hahn S, Volmink J. Reduced osmolarity oral rehydration solution for treating cholera. Cochrane Database Syst Rev. 2004;4:CD003754.

  84. Rautenberg TA, Zerwes U, Foerster D, Aultman R. Evaluating the cost utility of racecadotril for the treatment of acute watery diarrhea in children: the RAWD model. Clinicoecon Outcomes Res. 2012;4:109-16.

  85. Szajewska H, Dziechciarz P, Mrukowicz J. Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children. Aliment Pharmacol Ther. 2006;23(2):217-27.

  86. Szajewska H, Skorka A, Ruszczynski M, Gieruszczak-Białek D. Meta- analysis: Lactobacillus GG for treating acute gastroenteritis in children – updated analysis of randomised controlled trials. Aliment Pharmacol Ther. 2013;38(5):467-76.

  87. Szajewska H, Skórka A, Dylag M. Meta-analysis: Saccharomyces boulardii for treating acute diarrhoea in children. Aliment Pharmacol Ther. 2007;25(3):257-64.

  88. Lazzerini M, Ronfani L. Oral zinc for treating diarrhoea in children. Cochrane Database Syst Rev. 2013;1:CD005436.




2020     |     www.medigraphic.com