A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation

Lei Qiao, Luo-Jia Wang, Yang Wang, Ying Chen, Hai-Lan Zhang, Shu-Cheng Zhang, Lei Qiao, Luo-Jia Wang, Yang Wang, Ying Chen, Hai-Lan Zhang, Shu-Cheng Zhang

Abstract

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 (χ2 = 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 (χ2 = 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 (χ2 = 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 (χ2 = 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.

Trial registration: ClinicalTrials.gov NCT00318607 NCT03186079.

Conflict of interest statement

Guarantor of the article: Shu-Cheng Zhang, MD.

Specific author contributions: S.C.Z. and L.Q. conceptualized and designed the study and reviewed and revised the manuscript. L.J.W., H.L.Z., Y.W., and Y.C. collected the data. L.J.W. performed the initial analyses and drafted the initial manuscript. L.Q. supervised data collection and critically reviewed the manuscript for important intellectual content. The study was sponsored by Shengjing Hospital.

Financial support: This study was supported by the National Natural Science Foundation of China (No. 81570465, 30700917) and the General Funding Project from Department of Education of Liaoning Province (No. JC2019014).

Potential competing interests: None to report.

Data sharing statement: All data collected for the study, including individual participant data and a data dictionary defining each field in the set, will be made available to others.

Clinical trial registration: https://clinicaltrials.gov/ (NCT 03186079). Efficacy of Chinese Herbal Medicine in the Treatment of Childhood Constipation: A Randomized, Double Blind and Placebo-Controlled Trial.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.

Figures

Figure 1.
Figure 1.
The consort flow diagram. CHM, Chinese Herbal Medicine.

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