Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan () for Functional Constipation in A Randomized Controlled Trial.
10.1007/s11655-018-2848-y
- Author:
Chung-Wah CHENG
1
;
Li ZHANG
2
;
Chen ZHAO
1
;
Linda Ld ZHONG
1
;
Li-Jie SHI
3
;
Liang DAI
1
;
Rui ZHENG
4
;
Jing CHEN
5
;
Ge LI
6
;
Jing-Bo ZHAI
7
;
Wai KUN
1
;
Ai-Ping LU
1
;
Hong-Cai SHANG
8
;
Zhao-Xiang BIAN
9
Author Information
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.
9. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. bzxiang@hkbu.edu.hk.
- Publication Type:Journal Article
- Keywords:
Chinese herbal medicine;
MaZiRenWan;
functional constipation;
randomized controlled trial;
syndrome di f ferent iat ion
- MeSH:
Constipation;
diagnosis;
drug therapy;
Double-Blind Method;
Drugs, Chinese Herbal;
therapeutic use;
Humans;
Medicine, Chinese Traditional;
Outcome Assessment (Health Care);
Prospective Studies;
Randomized Controlled Trials as Topic
- From:
Chinese journal of integrative medicine
2019;25(3):175-181
- CountryChina
- Language:English
-
Abstract:
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 (, 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)].
