A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children
Joint Authors
Zhong, Cheng-liang
Hu, Siyuan
Cai, Qiu-han
Ma, Rong
Li, Xin-min
Xiang, Xi-xiong
Ding, Ying
He, Ping
Han, Xin-min
Chang, Ke
Zhang, Wei
Xue, Zheng
Wang, Xue-feng
Yang, Na
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-04-05
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
Objective.
To confirm the effect and safety of Xiao’er Biantong (XEBT) granules for treating chronic constipation in children.
Methods.
This randomized, double-blind, multicenter study enrolled 480 children with age of 1–14 years who had FC.
All of them were randomly assigned to receive either XEBT granules or its placebo in the ratio of 3 : 1.
The primary efficacy outcome was the frequency of spontaneous bowel movements (SBM) for 14 days, and secondary outcomes were effectual time, score of main symptoms, effect of constipation, disappearance rate of accompanying symptoms, and recurrence rate.
We also observed the adverse event (AE) and adverse drug reaction (ADR) to evaluate safety.
Results.
The sociodemographic characteristics and efficiency data were comparable in the two groups at baseline.
The mean values of SBM for 14 days were 8.89 and 5.63 in the XEBT group and the placebo group, respectively, and there were 86.87% and 30.91% subjects in two groups up to SBM ≥ 3/week, respectively.
There were significant differences between the two groups.
The effects in the XEBT group on median effectual time of defecation, main symptom score, disappearance rate of symptoms, and the differences were significant.
The conclusions based on full analysis set (FAS) and per protocol set (PPS) were consistent.
Nine AEs were reported, of which 7 were in the XEBT group (2.02%) while 2 were in the placebo group (1.77%).
There were no significant differences in the occurrence rate of AE and ADR between the two groups.
Conclusions.
Xiao’er Biantong granules have superior efficacy compared to the placebo for the treatment of functional constipation in children and are well tolerated.
American Psychological Association (APA)
Cai, Qiu-han& Ma, Rong& Hu, Siyuan& Li, Xin-min& Xiang, Xi-xiong& Ding, Ying…[et al.]. 2018. A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children. Evidence-Based Complementary and Alternative Medicine،Vol. 2018, no. 2018, pp.1-7.
https://search.emarefa.net/detail/BIM-1155352
Modern Language Association (MLA)
Cai, Qiu-han…[et al.]. A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children. Evidence-Based Complementary and Alternative Medicine No. 2018 (2018), pp.1-7.
https://search.emarefa.net/detail/BIM-1155352
American Medical Association (AMA)
Cai, Qiu-han& Ma, Rong& Hu, Siyuan& Li, Xin-min& Xiang, Xi-xiong& Ding, Ying…[et al.]. A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children. Evidence-Based Complementary and Alternative Medicine. 2018. Vol. 2018, no. 2018, pp.1-7.
https://search.emarefa.net/detail/BIM-1155352
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1155352