Tian Yuan-xiang

China Academy of Chinese Medical Sciences

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Weiliang Weng

Xiyuan Hospital

Jianxin Zhao

Jiangnan University

Yan‐Ming Xie

Chinese Academy of Medical Sciences & Peking Union Medical College

Fang Lü

Zhejiang University of Science and Technology

Hongling Xiao

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Man-xiang HU

Tang Hospital

Jianwen Guo

Guangzhou University of Chinese Medicine

Yang Mu-xiang

Hebei Medical University

Wei-ran CHEN

Hebei Medical University

Xu Zhai

Chinese Academy of Medical Sciences & Peking Union Medical College

Cooperative Institutions

Chinese Academy of Medical Sciences & Peking Union Medical College

China Academy of Chinese Medical Sciences

Hebei Medical University

Beijing University of Chinese Medicine

Peking University

Shanxi Medical University

Chinese Academy of Sciences

Xiyuan Hospital

Sichuan University

Sun Yat-sen University

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Research On Pharmacology of JKD

Zhongguo zhongyi jichu yixue zazhi (1998)

Yang Mu-xiang Tian Yuan-xiang Jin Guochun Gong Zhenling Gang Cao

Clinical Pharmacology

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Statistical analysis plans optimization of TCM clinical research

Zhonghua zhongyiyao zazhi (2010)

Tian Yuan-xiang

Statistical analysis plan (SAP) is an important guidance document in clinical research which is intended to be a comprehensive and detailed description of the methods and presentation of data analyses proposed for a clinical research. The analysis plan will be completed after finalising the protocol and should be finalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and figures to be presented in the statistical report. Any changes between the methods in the protocol and analysis plan will be explained in the analysis plan. In order to improve the quality of TCM clinical research, it is need to optimize the SAP. Considerations in optimizing the SAP include: determine the analysis sets and analysis variables, select analysis methods and statistical software.

Statistical Analysis

Presentation (obstetrics)

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Effect of electroacupuncture on brain-derived neurotrophic factor mRNA expression in mouse hippocampus following cerebral ischemia-reperfusion injury

Deleted Journal (2013)

Jianxin Zhao XU Huazhou Tian Yuan-xiang Man-xiang HU Hongling Xiao

This work aims to observe the effects of electroacupuncture on brain-derived neurotrophic factor (BDNF) mRNA expression in mouse hippocampus following cerebral ischemia-reperfusion injury. The models of mouse cerebral ischemia-reperfusion injury were established. A total of 96 healthy mice were randomly assigned into 4 groups, namely, the sham surgery, model, model + electroacupuncture, and mode + hydergine groups. Mice in the model + electroacupuncture group were treated through electroacupuncture at the Shenshu (BL 23), Geshu (BL 17), and Baihui (GV 20) acupoints. Mice in the model + hydergine group were intragastrically administered with hydergine (0.77 mg/kg−1 · day−1). The levels of BDNF mRNA expressions in the hippocampus were analyzed through a semi-quantitative reverse transcription-polymerase chain reaction assay on days 1 and 7 after the surgeries. BDNF mRNA expressions in the mouse hippocampus of the model group on days 1 and 7 after the surgery were higher than those of the sham surgery group (both P<0.01). On days 1 and 7 of the electroacupuncture treatment, BDNF mRNA expression in the mouse hippocampus of the model + electroacupuncture group was significantly elevated compared with the model group (both P< 0.01) or the model + hydergine group (both P< 0.01). On days 1 and 7 of the hydergine treatment, BDNF mRNA expression in the mouse hippocampus of the model + hydergine group tended to increase compared with the model group; however, statistical significance was not achieved (both P> 0.05). Electroacupuncture treatment enhances endogenous BDNF expression, which may improve the survival environment for intracerebral neurons and inhibit the apoptosis of hippocampal cells.

10.1016/s0254-6272(13)60135-1

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Optimization of design types in TCM clinical research.

Zhonghua zhongyiyao zazhi (2010)

Tian Yuan-xiang Weiliang Weng Fang Lü

TCM clinical research covers different design types on basis of objective of the study. For exploratory research of TCM, cross-sectional study and descriptive research (e.g. case report and case analysis) is suitable. For hypothesis-testing research, RCT design is commonly adopted. RCT is most commonly used in activity or prevention therapy research, when using randomized cross-over design, the influence of sequence effects should be considered, and double-blind method is the best choice. Cohort study includes various intervention measures, as it doesn’t involve randomized allocation and blinding. Case-control study is widely applicable, but it may bring about bias. Cross-sectional study is much used in syndrome investigation of TCM clinical research. Descriptive research is available for summarization of TCM clinical experience and TCM exploratory research. Third party-central randomization system is recommended, as the randomization is not easy to be damaged. Randomization concealment should also be attached importance to. When blinding is impossible, blindness testing could reduce measurement bias, positive control should be supported high-level evidence. Placebo application could improve the level of evidence-based medicine.

Blinding

Research Design

Clinical study design

Clinical Research

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Efficacy and safety of electroacupuncture in treatment of lumbar disc herniation: a protocol for a cohort study.

PubMed (2019)

Yaru Liu Jianxin Zhao Tian Yuan-xiang

Dry Needling

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Optimization of diagnosis standard in traditional Chinese medicine clinical research.

Zhonghua zhongyiyao zazhi (2010)

Tian Yuan-xiang Weiliang Weng Rui Li

The principle of TCM diagnosis standard is communicational convenience, and the international universal standard recommended by WHO should also be paid attention to. When there’s no corresponding standard, inferior standard is available, but self made standard is generally not accepted. It’s suggested to apply the same standard for one program. The standards include international standard, regional standard, domestic standard, industrial standard, provincial standard and enterprise standard, the hierarchies and levels of these standards reduce successively. It’s thought that medical standard consists of international standard (issued by WHO or set by international academic conference), domestic standard (set by government authorities, national academic organization and conference), diagnosis standard set by provincial academic organization and textbook standard by universities and colleges. A lot of literature network database, as well as ICD-10, therapy guide, professional periodicals, professional society website, and books could be used for searching. TCM clinical trials also cover syndrome diagnosis standard. The conclusion standard and exclusion standard setting and influence of improper standard setting is also discussed in this article.

International standard

Standard of care

National standard

Gold standard (test)

Professional Standards

Quality standard

Standard system

Standard operating procedure

Standard of review

Standard English

Double standard

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Ethical issues and optimization of TCM clinical research design

Zhonghua zhongyiyao zazhi (2010)

Tian Yuan-xiang

TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.

Research Ethics

Clinical Research

Bioethics

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Effects of Electroacupuncture on Hippocampal and Cortical Apoptosis in A Mouse Model of Cerebral Ischemia-reperfusion Injury

Deleted Journal (2011)

Jianxin Zhao Tian Yuan-xiang Hongling Xiao Man-xiang HU Wei-ran CHEN

To observe the effects of electroacupuncture on hippocampal and cortical apoptosis in a mouse model of cerebral ischemia-reperfusion injury. Mouse models established by repeated cerebral ischemia-reperfusion, followed by electroacupuncture at Shenshu, Geshu, and Baihui points. The control group mice were intragastrically administered Hydergine. On day 1 and 7 post-treatment, hippocampal and cortical apoptosis was detected by terminal-deoxynucleotidyl transferase mediated dUTP nick-end labeling (TUNEL), and apoptosis images in the hippocampal CA1 zone and cortical area were analyzed. In the model group, apoptotic cells were detected one day after treatment and some cellular fibers were disarrayed. By day 7 post-treatment, there was an increase in the number of apoptotic cells in the hippocampal CA1 region. In addition, there were apoptotic cells in the cortical area, the cortical layers were thinner with localized neuronal loss and sieve-like lymphocyte infiltration, as well as glial cell proliferation and visible infarct lesions. However, in the Hydergine and electroacupuncture groups, there was a small number of apoptotic cells. At 7 days post-treatment in the model group, field number, numerical density on area, and surface density were increased. However, in the Hydergine and electroacupuncture groups these parameters were decreased (P<0.01), with a significant difference between the two treatment groups (P<0.01). Electroacupuncture treatment inhibited apoptosis and provided neuroprotection.

Terminal deoxynucleotidyl transferase

10.1016/s0254-6272(12)60017-x

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Effect of electropuncture on expressions of c-fos in hippocampus neurons of mice with vascular dementia

Zhonghua xingwei yixue yu naokexue zazhi (2006)

Tian Yuan-xiang

Objective To explore the effect of electropuncture on apoptosis and expressions of c-fos in hippocampus neurons of mice with vascular dementia(VD). Methods The VD model of mice was established by repeated cerebral ischemia- reperfusion,and were acupuncted the acupuncture points of shenshu,geshu,and baihui.The mice of control group were administered intragastrically with hydergine.With method of flow cytometry,to detect the apoptosis rate and expressions of c-fos in hippocampus neurons of mice on the first and seventh day after treatment. Results The apoptosis rate of hippocampus cells in model group on the first and seventh day after operation was higher than that in sham group (respectively 6.86±1.10, 13.49±1.72, 3.59±0.70), P 0.01. Compared with the sham group, the expressions of c-fos in hippocampus neurons started to increase on the first day(respectively 1.00±0.25, 1.08±0.33,P0.05), and increased notablely on the seventh day(2.65±0.29),P 0.01.Compared with model group , Electropuncture could up -regulate the expressions of c-fos(2.26±0.31,3.76±0.41, P0.01), lower the apoptosis rate of hippocampus cells of mice(3.68±1.48,6.36±1.52, P 0.01). Conclusion The treatment with electropuncture could inhibit apoptosis,protect neurons,which possibely is one of mechanism on improving intelligence of VD mice.

Vascular dementia

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Necessity, principle and procedures of clinical trials optimization in TCM.

Zhonghua zhongyiyao zazhi (2010)

Weiliang Weng Tian Yuan-xiang Rui Li

Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.

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