Efficacy of dioctahedral smectite in infants with acute diarrhea: a double blind randomized controlled trial

• Main Authors: A. A. Made Widiasa, Soetjiningsih Soetjiningsih, Putu Gede Karyana
• Format: Article
• Language: English
• Published: Indonesian Pediatric Society Publishing House 2009-03-01
• Series: Paediatrica Indonesiana
• Subjects: acute diarrhea; dioctahedral smectite; diarrhea duration
• Online Access: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/455
• ISSN: 0030-9311; 2338-476X

Background  Acute  diarrhea  is  a sudden diarrhea which lasts less than  seven days  on  babies and children.  The  standard  treatment by  WHO  in managing acute diarrhea  is  still  not  satisfactory for parents whose infants and children suffering from the disease. Dioctahedral  smectite  is  expected  to  decrease  the  volume, frequency, and duration  of  diarrhea. Objective  To  assess the clinical effects  of  dioctahedral smectite in infants with acute diarrhea. Methods  A double-blind, randomized clinical controlled trial was performed on six to  12  months-old infants who were hospitalized in Sanglah Hospital, Denpasar due to acute diarrhea .The subjects were divided into two groups.  The  treatment  group was given standard  management  with  adjuvant  dioctahedral  smectite while  and  control group was given standard management with placebo. Results  From  68  infants enrolled in this study, the  mean  duration of  diarrhea was significantly shorter in treatment group compared to placebo group  [39.03  hours (SD  2.03)  vs  70.58  hours (SD 3.78),  mean  difference  31.6 (95%  CI  22.90  to  40.19), P=0.001]. The  RRR was  50%,  and  ARR  was  29%.  Kaplan-Meier survival analysis showed  that  duration  of  acute diarrhea was shorter in treatment  group  [36  hours (SD  1.7)  versus 72 hours (SD  4.18), mean difference  36.0 (95%  CI  21.81  to  50.19),  log rank test, P<0.0001].  In multivariate Cox regression analysis, it was found that  dioctahedral smectite influenced the duration  of  diarrhea in infants with acute diarrhea  [OR  4.403 (95%  CI  2.39  to  8.12), P<O.OOOl]. Conclusion  Dioctahedral smectite  can  shorten the duration  of acute diarrhea.