Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial
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Original Article|Updated:2021-08-27
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Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial
Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial
Chinese Journal of Integrative Medicine2019年25卷第3期 页码:175-181
Affiliations:
1.Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
2.Department of Clinical Pharmacology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300250), China
3.Department of Gastroenterology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300193), China
4.Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin (300193), China
5.Department of Health Care, Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300193), China
6.School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin (300193), China
7.Research Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin (300193), China
8.Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing (100700), China
Author bio:
Correspondence to: Prof. BIAN Zhao-xiang, Tel: 852-34112905, Fax: 852-34112929, E-mail: bzxiang@hkbu.edu.hk
Funds:
the National Natural Science Foundation of China(NSFC-81173363)
Chung-wah CHENG, Li ZHANG, Chen ZHAO, 等. Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2019,25(3):175-181.
Chung-wah CHENG, Li ZHANG, Chen ZHAO, et al. Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2019,25(3):175-181.
Chung-wah CHENG, Li ZHANG, Chen ZHAO, 等. Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2019,25(3):175-181. DOI: 10.1007/s11655-018-2848-y.
Chung-wah CHENG, Li ZHANG, Chen ZHAO, et al. Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2019,25(3):175-181. DOI: 10.1007/s11655-018-2848-y.
Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial
摘要
Abstract
Background:
2
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).
Objective:
2
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:
2
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:
2
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)]
关键词
Keywords
functional constipationChinese herbal medicinesyndrome di f ferent iat ionMaZiRenWanrandomized controlled trial
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