OBJECTIVES: Management of constipation is still challenging in childhood. The pharmacological effect of XiaojiDaozhi Decoction, a prescription of Chinese Herbal Medicine (CHM), has been well described for the treatment of food and Qi stagnation which account for childhood constipation. However, the efficacy and safety of XiaojiDaozhi Decoction in childhood constipation remains unclear. METHODS: A randomized, double-blind, and placebo-controlled trial was conducted to evaluate the efficacy and safety of XiaojiDaozhi Decoction in childhood constipation. Two hundred children were recruited and randomly allocated to the CHM or placebo group to receive their respective interventions. The duration of treatment was 8 weeks, with a 12-week follow-up. Main outcome measures were complete spontaneous bowel movements and satisfaction with bowel function. Safety and adverse effects were evaluated by blood laboratory measurements. RESULTS: At the end of follow-up, the response rates of CHM and placebo were 62% and 31%, respectively (χ 2 = 19.315, P < 0.01). At the end of treatment, recurrence was found in 7 cases (10.14%) in CHM and 11 cases (26.19%) in placebo (χ 2 = 4.947, P < 0.05). In the main outcome measures, 56 patients (56%) in the CHM group and 25 patients (25%) in the placebo group were satisfied with their bowel movements (χ 2 = 19.940, P < 0.05). Increased complete spontaneous bowel movements ≥3 per week from baseline were found in 40 patients (40%) who received CHM and 19 patients (19%) who received placebo (χ 2 = 10.602, P < 0.05). No serious adverse effects were found in any of the recruited cases. DISCUSSION: CHM XiaojiDaozhi Decoction is a safe and effective method for the treatment of childhood constipation.

INTRODUCTION: The management of childhood constipation is challenging. Pelvic floor dysfunction (PFD) is one of the most common causes of childhood constipation. Percutaneous tibial nerve stimulation (PTNS) with pelvic floor exercises (PFE) has achieved a satisfactory outcome in the elderly individuals and women with PFD. The efficacy of PTNS with PFE in childhood constipation has not been established. METHODS:A randomized, double-blind, controlled trial with 84 children who met the inclusion criteria was conducted.All participants were randomly assigned to PTNS with PFE or sham PTNS with PFE groups and received their individual intervention for 4 weeks with a 12-week follow-up evaluation. The spontaneous bowel movements (SBM) ‡3 per week were the main outcomes, and the risk ratio (RR) with 95% confidence interval (CI) were calculated. High-resolution anorectal manometry and surface electromyography were used for the assessment of pelvic floor function, and the adverse effects were assessed based on symptoms.