On Dermatomes, Meridians and Points: Results of a Quasiexperimental Study

Background Traditional Chinese medicine (TCM) meridians and points run vertically, reflecting their function in the Zhang-Fu system (meridian pattern). However, the trunk's spinal nerves show a traverse orientation, or a ‘horizontal pattern’. Objective The aim of the present work was to evaluate, via a cognitive quasiexperiment, whether the clinical indications of the points on the trunk are associated with their meridian function or with their innervation and visceral–somatic connection. Methods The points in each dermatome of the trunk were considered crosswise, regardless of their meridians. The clinical indications for each point were differentiated into two mutually exclusive categories: (a) vertical distribution effect (VDE) or ‘meridian pattern’, when indications were quite different regarding the indications for the other points on the dermatome; and (b) transverse distribution effects (TDE) or ‘horizontal pattern’, represented by mainly local or segmental indications except for Shu-Mu points. After observing that the proportions between both categories often exceeded 60% in pilot samples, 60% was adopted as the reference value. Results A total of 22 dermatomes accommodated 148 points with 809 indications, of which 189 indications (23.4%) exhibited VDE features, whereas 620 (76.6%) exhibited TDE features. Conclusions A TDE/VDE ratio of 3 : 1 implies that the clinical indications for the points of any dermatome on the torso are similar, regardless of their meridians, and suggests that most of the indications for trunk points involve a ‘horizontal pattern’ due to their neurobiological nature. These findings may help in understanding acupuncture's neurobiology and clarify some confusing results of clinical research, for example, excluding sham acupuncture as an inert intervention for future clinical trials.

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Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine

Journal of Chinese Integrative Medicine ◽

10.3736/jcim20060101 ◽

2006 ◽

Vol 4 (1) ◽

pp. 1-6 ◽

Cited By ~ 6

Author(s):

Jian-Ping Liu

Keyword(s):

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Quality Assessment ◽

Evidence Based Medicine ◽

Methodological Quality ◽

Evidence Based ◽

Based Medicine

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Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽

10.1186/s13063-021-05113-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Zhuoran Kuang ◽

◽

Xiaoyan Li ◽

Jianxiong Cai ◽

Yaolong Chen ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Secondary Outcome ◽

Specific Information ◽

Clinical Trial Registry ◽

Data Set ◽

Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

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Bilateral Integrative Medicine, Obviously

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nel027 ◽

2006 ◽

Vol 3 (2) ◽

pp. 279-282 ◽

Cited By ~ 4

Author(s):

Steven H. Stumpf ◽

Simon J. Shapiro

Keyword(s):

Medical Education ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Integrative Medicine ◽

The Other ◽

Educational Model ◽

Profound Impact ◽

Integrative Education ◽

Education Model ◽

New Generation

Unstated and unacknowledged bias has a profound impact on the nature and implementation of integrative education models. Integrative education is the process of training conventional biomedical and traditional Chinese medicine practitioners in each tradition such that patient care may be effectively coordinated. A bilateral education model ensures that students in each tradition are cross-taught by experts from the ‘other’ tradition, imparting knowledge and values in unison. Acculturation is foundational to bilateral integrative medical education and practice. Principles are discussed for an open-minded bilateral educational model that can result in a new generation of integrative medicine teachers.

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Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032256 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032256 ◽

Cited By ~ 3

Author(s):

Ruijin Qiu ◽

Changming Zhong ◽

Songjie Han ◽

Tianmai He ◽

Ya Huang ◽

...

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set ◽

Semistructured Interviews

IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at:http://www.comet-initiative.org/studies/details/1243).

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The Reporting Quality Assessment of Complex Interventions’ Articles in Traditional Chinese Medicine

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/250690 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8

Author(s):

Meng Wu ◽

Jingqing Hu ◽

Biaoyan Liu

Keyword(s):

Quality Control ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Complex Interventions ◽

Reporting Quality ◽

Chinese Journal ◽

Inform Consent ◽

Ethical Approval ◽

Selection Of

Objective.To realize the current situation and problems of complex interventions’ clinical trials.Methods.Searching at Chinese Journal Integrated Traditional and Western Medicine and Journal of Traditional Chinese Medicine from 2007 to 2012 by hand, we identified complex interventions’ articles, and then we used the proposed criteria of complex interventions and CONSORT FOR TCM to evaluate.Results.All data is presented as counts with percentages and details in tables.Conclusion.Our evaluation presented that complex interventions have many defects: the selection of the intervention’s components lacks rationale, complex interventions were short of fundamental researches, components’ interactions were ambiguous, and the advantages of complex interventions were not mentioned. Furthermore, explanation of sample size, blind, quality control, ethical approval, and inform consent were neglected in different degrees.

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Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽

10.1136/bmjopen-2018-025218 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025218 ◽

Cited By ~ 2

Author(s):

Xuan Zhang ◽

Ran Tian ◽

Zhen Yang ◽

Chen Zhao ◽

Liang Yao ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Reporting Quality ◽

Reporting Rate ◽

Trial Registration ◽

Clinical Trial Registration ◽

Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

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Arsenic Bioaccessibility of Realgar Influenced by the Other Traditional Chinese Medicines in Niuhuang Jiedu Tablet and the Roles of Gut Microbiota

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/8496817 ◽

2019 ◽

Vol 2019 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Wenfeng Xu ◽

Shuo Xu ◽

Shanshan Zhang ◽

Xuejun Wu ◽

Pengfei Jin

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Gut Microbiota ◽

Incubation Medium ◽

Toxic Elements ◽

The Other ◽

Traditional Chinese Medicines ◽

Chinese Medicines ◽

Scutellariae Radix

Niuhuang Jiedu tablet (NJT), a realgar (As2S2) containing Traditional Chinese Medicine (TCM), is a well-known formula. The safety of NJT is of growing concern since arsenic (As) is considered as one of the most toxic elements. NJT was demonstrated to be safer than realgar by our previous experiments and some other studies. The toxicity of realgar has been shown to be related to the amount of soluble or bioaccessible arsenic. In this study, the influences of the other TCMs in NJT on the bioaccessibility of arsenic from realgar, and the roles of gut microbiota during this process were investigated in vitro. Results showed that Dahuang (Rhei Radix et Rhizoma), Huangqin (Scutellariae Radix), Jiegeng (Platycodonis Radix), and Gancao (Glycyrrhizae Radix et Rhizoma) could significantly reduce the bioaccessibility of arsenic from realgar in artificial gastrointestinal fluids. Gut microbiota played an important role in decreasing the bioaccessibility of realgar because it was demonstrated to be able to absorb the soluble arsenic from realgar in the incubation medium. Dahuang, Huangqin, and Jiegeng could modulate the gut microbiota to enhance its arsenic absorption activity.

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Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/256782 ◽

2013 ◽

Vol 2013 ◽

pp. 1-11 ◽

Cited By ~ 5

Author(s):

Mengzhu Xue ◽

Shoude Zhang ◽

Chaoqian Cai ◽

Xiaojuan Yu ◽

Lei Shan ◽

...

Keyword(s):

Clinical Trials ◽

Natural Products ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Drug Safety ◽

Large Scale ◽

Drug Candidate ◽

Topology Analysis ◽

Drug Safety Surveillance ◽

Approved Drugs

As the major issue to limit the use of drugs, drug safety leads to the attrition or failure in clinical trials of drugs. Therefore, it would be more efficient to minimize therapeutic risks if it could be predicted before large-scale clinical trials. Here, we integrated a network topology analysis with cheminformatics measurements on drug information from the DrugBank database to detect the discrepancies between approved drugs and withdrawn drugs and give drug safety indications. Thus, 47 approved drugs were unfolded with higher similarity measurements to withdrawn ones by the same target and confirmed to be already withdrawn or discontinued in certain countries or regions in subsequent investigations. Accordingly, with the 2D chemical fingerprint similarity calculation as a medium, the method was applied to predict pharmacovigilance for natural products from an in-house traditional Chinese medicine (TCM) database. Among them, Silibinin was highlighted for the high similarity to the withdrawn drug Plicamycin although it was regarded as a promising drug candidate with a lower toxicity in existing reports. In summary, the network approach integrated with cheminformatics could provide drug safety indications effectively, especially for compounds with unknown targets or mechanisms like natural products. It would be helpful for drug safety surveillance in all phases of drug development.

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Efficacy of Shitei-To, a Traditional Chinese Medicine Formulation, Against Convulsions in Mice

The American Journal of Chinese Medicine ◽

10.1142/s0192415x99000136 ◽

1999 ◽

Vol 27 (01) ◽

pp. 107-115 ◽

Cited By ~ 11

Author(s):

Eiko Minamil ◽

Hiroki Shibata ◽

Yoshiki Nunoura ◽

Masahiro Nomoto ◽

Takeo Fukuda

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

The Other ◽

Repeated Treatment ◽

Maximal Electroshock ◽

Chemical Agents ◽

Clonic Convulsions ◽

Traditional Chinese Medicine Formulation ◽

Electroshock Seizures ◽

Anticonvulsant Effects

The anticonvulsant effects of Shitei- To and its components on maximal electroshock seizures and chemical convulsions were examined. Shitei-To significantly prolonged the latency to bicuculline (2.0 mg/kg, s.c.)-induced clonic convulsions. Repeated treatment with Shitei-To also significantly prolonged the latency to strychnine (1.5 mg/kg, i.p.)- and pentylenetetrazol (90 mg/kg, i.p.)-induced clonic convulsions. On the other hand, Shitei-To had no effect on maximal electroshock seizures. Of the components of Shitei-To, Shitei had almost the same effect as Shitei-To against the clonic convulsions induced by the three chemical agents tested. These findings suggest that Shitei-To has anticonvulsant effects.

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