Efficacy Of Chinese Herbal Medicine Xiaojidaozhi Decoction In The Treatment Of Childhood Functional Constipation: A Double Blind,Randomized And Placebo-controlled Trial

Background: Functional constipation(FC)is a common clinical symptom.Despite the lack of conclusive evidence,Chinese medicine(CHM)has some advantages in treating the clinical efficacy of functional constipation in children and has become a popular alternative treatment.The purpose of this study was to evaluate the effectiveness of the treatment of functional constipation in children through rigorous design studies.Methods: A randomized,controlled,double-blind study was conducted to compare the efficacy and safety of Xiaojidaozhi Decoction in patients with functional constipation(Rome IV standard).200 children with constipation who met the inclusion criteria were selected.All patients were 4-14 years old children with functional constipation who met the inclusion criteria in the constipation clinic of Shengjing Hospital Affiliated to China Medical University from June 2018 to August 2018.All participants received a 2-week test,8-week treatment and 12-week follow-up.The main outcome was complete spontaneous bowel movement(CSBM)during treatment and at 12 weeks of follow-up.Secondary outcome measures included Individual symptom assessment(ISA),safety and adverse effects(AEs)during follow-up.Results: In the trail,200 subjects were randomly divided into two groups(100 in each group).During the 8-week treatment period,the average weekly CSBM of CHM group increased from 1.60±0.573 to 5.10±1.456,and the placebo group's average weekly CSBM increased from 1.41±0.688 to 2.85±1.407.At the end of 12-week follow-up,the average weekly CSBM in CHM group decreased to 3.86±1.570 and 2.04±0.977 in placebo group.After 12 weeks of treatment,the recurrence rate of constipation in the treatment group was significantly lower than that in the control group,that is,the recurrence rate in the treatment group was 19.05%,and that in the placebo group was 62.5%(P < 0.05).Compared to the placebo group,patients in the CHM group showed an advantage in increasing CSBM,relieving the severity of constipation and relieving stress,and effectively reduced the recurrence rate without serious adverse reaction reports.Conclusions: Xiaojidaozhi Decoction has good clinical efficacy in treating constipation in children,and no obvious adverse reactions have been found.It also delays the recurrence of constipation in children,which is worthy of clinical application.