Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial

Chung wah Cheng, Li Zhang, Chen Zhao, Lidan ZHONG, Li jie Shi, Liang Dai, Rui Zheng, Jing Chen, Ge Li, Jing bo Zhai, Wai Kun, Aiping LYU, Hong cai Shang, Zhaoxiang BIAN*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

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 (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)].

Original languageEnglish
Pages (from-to)175-181
Number of pages7
JournalChinese Journal of Integrative Medicine
Volume25
Issue number3
DOIs
Publication statusPublished - 1 Mar 2019

Scopus Subject Areas

  • Complementary and alternative medicine
  • Pharmacology (medical)

User-Defined Keywords

  • Chinese herbal medicine
  • functional constipation
  • MaZiRenWan
  • randomized controlled trial
  • syndrome di f ferent iat ion

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