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

OriginalPaper | Updated：2021-08-27

- Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine
- Parallel subgroup design of a randomized controlled clinical trial—comparing the approaches of Chinese medicine and Western medicine
- 中国结合医学杂志（英文版） 2010年16卷第5期页码：394-398
- 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
  中图分类号：
- 纸质出版日期：2010，
  
  网络出版日期：2010-9-25，
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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, 2010,16(5):394-398.
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, 2010,16(5):394-398. 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

references

Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, et al. Functional gastroduodenal disorders. Gastroenterology 2006;130(5):1466–1479.

The Digestion Branch of Chinese Association of the Integration of Traditional and Western Medicine. Guidance for diagnosis and treatment of functional gastrointestinal disorders with integration of traditional and Western Medicine (draft). Chin J Integr Tradit West Med (Chin) 2005;25:559–561.

Zhang LX, Bai YP, Song PH, You LP, Yang DQ. Effect of Chinese herbal medicine combined with acitretin capsule in treating psoriasis of blood-heat syndrome type. Chin J Integr Med 2009;15(2):141–144.

He QY, Wang J, Zhang YL, Tang YL, Chu FY, Xiong XJ. Effect of Yiqi Yangyin Decoction on the quality of life of patients with unstable angina pectoris. Chin J Integr Med 2010;16(1):13–18.

Wang L, Zhang ZZ, Tu XH, Zou ZD, Liu JH, Wang Y. Safety and efficacy of Qingre Buyi Decoction in the treatment of acute radiation proctitis: a prospective, randomized and controlled trial. Chin J Integr Med 2009;15(4):272–278.

Fu WB, Liang ZH, Zhu XP, Yu P, Zhang JF. Analysis on the effect of acupuncture in treating cervical spondylosis with different syndrome types. Chin J Integr Med 2009;15(6):426–430.

Shi HF, Xu B, Guo XC, Qiu XW, Zhang YP, Ding XJ. Effect of Gan-Pi regulatory needling in treating chloasma. Chin J Integr Med 2010;16(1):66–70.

Li L, Zhang XJ, Lan Y, Xu L, Zhang XZ, Wang HH. Treatment of non-alcoholic fatty liver disease by Qianggan Capsule. Chin J Integr Med 2010;16(1):23–27.

Zhou N, Bai YP, Man XH, Zhang YB, Kong YH, Ju H, et al. Effect of new Pulian Ointment in treating psoriasis of bloodheat syndrome: a randomized controlled trial. Chin J Integr Med 2009;15(6):409–414.

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