TY - JOUR
T1 - Whether Syndrome Differentiation Affects Treatment Result
T2 - Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial
AU - Cheng, Chung Wah
AU - Zhang, Li
AU - Zhao, Chen
AU - Zhong, Linda LD
AU - Shi, Li Jie
AU - Dai, Liang
AU - Zheng, Rui
AU - Chen, Jing
AU - Li, Ge
AU - Zhai, Jing Bo
AU - Kun, Wai
AU - Lu, Ai Ping
AU - Shang, Hong Cai
AU - Bian, Zhao Xiang
N1 - Funding Information:
Supported by the National Natural Science Foundation of China (No. NSFC-81173363)
Publisher copyright:
Copyright © 2018, The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature
PY - 2019/3
Y1 - 2019/3
N2 - Background: Syndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs).Objectives: To determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (麻子仁丸, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study.Methods: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events.Discussion: This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)]
AB - Background: Syndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs).Objectives: To determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (麻子仁丸, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study.Methods: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events.Discussion: This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)]
KW - Chinese herbal medicine
KW - functional constipation
KW - MaZiRenWan
KW - randomized controlled trial
KW - syndrome di f ferent iat ion
UR - http://www.scopus.com/inward/record.url?scp=85051666907&partnerID=8YFLogxK
U2 - 10.1007/s11655-018-2848-y
DO - 10.1007/s11655-018-2848-y
M3 - Journal article
C2 - 30109589
AN - SCOPUS:85051666907
SN - 1672-0415
VL - 25
SP - 175
EP - 181
JO - Chinese Journal of Integrative Medicine
JF - Chinese Journal of Integrative Medicine
IS - 3
ER -