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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

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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)]

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Authors and Affiliations

  1. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China

    Chung-wah Cheng, Chen Zhao, Linda LD Zhong, Liang Dai, Wai Kun, Ai-ping Lu & Zhao-xiang Bian

  2. Department of Clinical Pharmacology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China

    Li Zhang

  3. Department of Gastroenterology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Li-jie Shi

  4. Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Rui Zheng

  5. Department of Health Care, Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Jing Chen

  6. School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Ge Li

  7. Research Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China

    Jing-bo Zhai

  8. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China

    Hong-cai Shang

Authors
  1. Chung-wah Cheng
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  2. Li Zhang
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  3. Chen Zhao
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  11. Wai Kun
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  13. Hong-cai Shang
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  14. Zhao-xiang Bian
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Corresponding author

Correspondence to Zhao-xiang Bian.

Additional information

Supported by the National Natural Science Foundation of China (No. NSFC-81173363)

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Cheng, Cw., Zhang, L., Zhao, C. et al. Whether Syndrome Differentiation Affects Treatment Result: Study Protocol of MaZiRenWan (麻子仁丸) for Functional Constipation in A Randomized Controlled Trial. Chin. J. Integr. Med. 25, 175–181 (2019). https://doi.org/10.1007/s11655-018-2848-y

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  • DOI: https://doi.org/10.1007/s11655-018-2848-y

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