Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine

Ji-qian Fang; Feng-bin Liu; Zheng-kun Hou

doi:10.1007/s11655-010-0534-9

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Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine

Updated：2021-08-27

- Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine
- Chinese Journal of Integrative Medicine Vol. 16, Issue 5, Pages: 394-398(2010)
- Affiliations：
  
  1. Department of Medical Statistics, School of Public Health, Sun Yat-sen University,Guangzhou,China
  2. Gastroenterology Department, the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,Guangzhou,China
  3. Postgraduate Department, Guangzhou University of Traditional Chinese Medicine,Guangzhou,China
- Author bio：
- Funds：
- DOI：10.1007/s11655-010-0534-9
  CLC：
- Published：2010，
  
  Published Online：25 September 2010，
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Fang, Jq., Liu, Fb. & Hou, Zk. Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine., Chin. J. Integr. Med. 16, 394–398 (2010). https://doi.org/10.1007/s11655-010-0534-9

Ji-qian Fang, Feng-bin Liu, Zheng-kun Hou. Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine. [J]. Chinese Journal of Integrative Medicine 16(5):394-398(2010)
Fang, Jq., Liu, Fb. & Hou, Zk. Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine., Chin. J. Integr. Med. 16, 394–398 (2010). https://doi.org/10.1007/s11655-010-0534-9 DOI：

Ji-qian Fang, Feng-bin Liu, Zheng-kun Hou. Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine. [J]. Chinese Journal of Integrative Medicine 16(5):394-398(2010) DOI： 10.1007/s11655-010-0534-9.

摘要

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine

which serve the same medical aim but are based on substantially different theoretical systems

was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial (PSD-RCT)

participants were recruited following identical inclusion and exclusion criteria and were randomly allocated into two groups to receive treatment using the respective approaches of Chinese medicine and Western medicine. The Chinese medicine group was divided into subgroups according to the theory of Chinese medicine and the Western medicine group was also divided into subgroups according to the theory of Western medicine. The treatment for each subgroup was well defined in the protocol

including major formulae and principles for individualized modifications. The primary outcome measure was ascertained to be directly related to the patients’ status but independent from both theories of Chinese medicine and Western medicine

while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then

taking functional dyspepsia as an example

the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine

and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine

and the comparison among subgroups can provide valuable clues for further studies.

Abstract

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine

which serve the same medical aim but are based on substantially different theoretical systems

was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial (PSD-RCT)

while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then

taking functional dyspepsia as an example

the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine

and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine

and the comparison among subgroups can provide valuable clues for further studies.

关键词

Chinese MedicineWestern Medicineparallel subgroup designrandomized controlled trialsyndrome differentiation and treatmentindividualized treatmentfunctional dyspepsia

Keywords

Chinese MedicineWestern Medicineparallel subgroup designrandomized controlled trialsyndrome differentiation and treatmentindividualized treatmentfunctional dyspepsia

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