THE EFFECTIVENESS OF DIOSMECTITE IN HOSPITALIZED CHILDREN WITH ACUTE WATERY DIARRHEA AND DEHYDRATION

Aim: To determine the effect of diosmectite on the reduction of diarrhea duration compared to placebo.

Method and Material: This randomized, open-label clinical study was conducted at Pediatric Unit-I of Sir Ganga Ram Hospital Lahore for one-year duration from December 2019 to December 2020. Children 6-24 months of age taken with acute watery diarrhea ≤ 72 hours but ≥ 24 hours and with some dehydration / severe dehydration. Patients were assigned either group A (Diosmectite group) or group B (placebo group) by lottery method. After initial rehydration, Diosmectite at a dose of 1 gram in children under 12 months of age and 1.5 grams in children aged 12-24 months three times a day after dilution in water or other semi-solid food together with zinc sulphate was orally administered 5 days to group A, while group B was given a placebo (oral zinc sulfate). All study participants were followed from initiation of therapy to normalization, defined as passing the first pre-diarrheal stool (hours) and for a maximum of six days after starting therapy in the absence of a pre-diarrheal stool.

Results: There were 103 children in each group who were initially recruited into the study. 99 (96.12%) children in the diosmectite group and 97 (94.17%) children in the placebo group completed the study. Both groups had similar characteristics. There were 6 of 99 cases in the diosmectite group and 7 of 97 cases in the placebo group in which no pre-diarrheal stool was expelled at the end of six days after initiation of treatment (p-value 0.782). The time required to pass the first pre-diarrheal stool (hours) for the remaining 93 diosmectites was 58.935 ± 30.482, while the transit time for the first pre-diarrheal stool (hours) for the remaining 90 placebo patients was 76.511 ± 35.323 (p-value 0.0004). This showed that the drug was moderately effective compared to the placebo.

Conclusion: Smectite may be a useful additive to rehydration therapy in the treatment of acute watery diarrhea in children, but cost-effective research is needed before its routine use is recommended.

Key words: randomized clinical trial with acute diarrhea, drug efficacy.