Effect and safety of Xiao Er Fu Xie Tie in acute diarrhea:a multicenter randomized controlled clinical trial in children / 临床儿科杂志

ABSTRACT

Objectives To evaluate the effect and safety of Xiao Er Fu Xie Tie in children with acute diarrhea. Methods A multicenter, randomized, open-label, active-controlled clinical trial was carried out in three hospitals from March 2011 to December 2012. Children with acute diarrhea were enrolled and divided randomly into two groups, the observation group (treated with Xiao Er Fu Xie Tie) and the control group (treated with smectite powder). Boths groups received oral rehydration salts treatment. Symptoms and signs were recorded before and after therapy. The therapeutic effect was evaluated at 3 and 5 days after therapy. All of the adverse drug reactions were recorded during the study. Results In 197 children who completed the study, 100 children received Xiao Er Fu Xie Tie and 97 received smectite powder. Both groups were similar in age and gender distribution, weight, duration and frequency of diarrhea, times of vomiting, degree of dehydration and so on (P>0.05). After therapy, effective rates of the observation group at 3 days (97%) and 5 days (100%) were similar to those of control group (P>0.05). The effective rate for relieving vomiting in the observation group was higher than that in control group (P<0.05). No obvious adverse drug reactions were found during the study. Conclusions Xiao Er Fu Xie Tie has the same effect as smectite powder for treatment of acute diarrhea in children and is more effective in vomiting. Furthermore, no obvious adverse drug re-actions were found.