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

Abstract

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.

Keywords

• acute diarrhea
• dioctahedral smectite
• diarrhea duration