Loperamide in acute diarrhoea in childhood: results of a double blind placebo controlled multicentre clinical trial.

A total of 315 young children with acute diarrhea were included in a double blind hospital based multicenter study of loperamide at 2 dose levels (0.8 mg and 0.4 mg/kg/24 hours) given with standard oral rehydration therapy vs. placebo plus oral rehydration therapy. The overall recovery rate was slowest in the placebo group and fastest in the group given loperamide 0.8 mg. Comparisons between weights on admission and weights by day 3 showed a larger proportion of children in the loperamide groups gained weight than in the placebo group. No serious side effects of loperamide were observed but the drug was withdrawn in 1 infant because of mild abdominal distention. Results indicate that loperamide in the doses used is safe and may in selected cases be a useful adjunct to oral rehydration therapy in the management of acute diarrhea in well-nourished children. (authors modified)