Clinical Trials Of Traditional Chinese Medicine Research Articles

Anti-aging mechanism and effect of treatment with raw and wine-steamed Polygonatum sibiricum on D-galactose-induced aging in mice by inhibiting oxidative stress and modulating gut microbiota.

Polygonatum sibiricum (PS) is a traditional Chinese medicine (TCM) first recorded in Mingyi Bielu. The book documents that PS can nourish five internal organs, be taken for a long time, relax the body and prolong lifespan. Presently, PS is widely used in TCM to prevent premature graying of hair. Based on TCM theory and clinical trials, the wine steaming processed product from PS provides a better effect. However, no published study has elucidated the anti-aging mechanism. The study aim was to investigate the anti-aging mechanism of PS and its wine steaming processed product in mice, specifically focusing on the effect of D-galactose (D-gal) surrounding the intestinal flora and the Kelch-like ECH-associated protein 1-nuclear factor erythroid 2-related factor 2-antioxidant response elements (Keap1/Nrf2/ARE) pathway. The chemical components in Raw PS (RPS) and Wine-steamed PS (WPS) were identified by ultra-performance liquid chromatography-hybrid quadrupole-Orbitrap high-resolution mass spectrometry (UPLC-Q-Orbitrap HRMS). An aging model using Kunming mice was established through intraperitoneally injected D-gal. Concentrations of RPS and WPS at 5, 10, or 15g/kg/day levels were administered intragastrically, respectively. The body weight, liver and spleen indexes, superoxide dismutase (SOD), glutathione peroxidase (GSH-PX), and malondialdehyde (MDA) activities in serum and brain tissue were recorded. Hematoxylin and eosin (HE) stained brain tissue was histopathologically examined. The expressions of Keap1, Nrf2 and heme oxygenase 1 (HO-1) in the brain tissue at the mRNA and protein levels were respectively detected by reverse transcription-polymerase chain reaction (RT-PCR) and western blot (WB). Moreover, an Illumina Hiseq platform was used for 16S ribosomal RNA (16S rRNA) high-throughput sequencing to evaluate the proportions of intestinal flora in aging mice. The proportions of saccharides, flavonoids, and triterpene acids were different between RPS and WPS. In the aging model mice, WPS outperformed RPS in improving body weight and mental state by increasing the spleen index, SOD and GSH-PX activities, decreasing the liver index and MDA activities, and restoring the histopathological morphology in D-gal-induced aging mice. At the mRNA levels, RPS and WPS significantly reduced the expression of Keap1 and increased the expressions of Nrf2 and HO-1. The trend in protein expressions was similar to that of the mRNA results, and WPS had a stronger effect than RPS. Fecal microbiota analysis showed that RPS and WPS restored intestinal microbiota proportions to normal levels. The results demonstrated that PS and its WPS had a positive effect in relieving oxidative stress in aging mice. WPS outperformed RPS, which might be related to the activation of the Keap1/Nrf2/ARE pathway and regulation of intestinal flora.

Exploration on Standardization of Clinical Research Data in a Clinical Trial Institute of Traditional Chinese Medicine

Traditional Chinese Medicine(TCM) products and practices are widely used worldwide with increasing popularity. The number of TCM clinical trials has increased significantly in the past two decades. There is an urgent need to standardize TCM data and terminology for use in clinical studies. It will ensure data quality, improve the efficiency and expedite scientific communications in TCM. This paper illustrates our exploration processes in the application and development of the data standards in TCM clinical trials. We hope these explorations will help TCM data exchange, sharing, and aggregation which will ultimately accelerate the launch of TCM products and bring benefits to people.

Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials.Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528–536.

Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture

There are inconsistencies in treatment outcomes, measurement instruments, and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF), resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges, international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However, it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently, there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research, nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps, our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments, initially derived from a thorough literature review and expert consensus, which will then undergo further refinement and updates based on real-world clinical experiences, incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM, and provide high-quality evidence for clinical practice.

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study.

Among the common malignant tumors in men worldwide, the incidence of prostate cancer ranks second to lung cancer. This disease will bring an economic burden to patients and their families and can reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine (TCM) combined with standard treatment regimens. However, the currently published clinical trials exhibit inconsistent and irregular reporting of outcome measures. The objective of this paper is to emphasize the need for a core outcome set (COS) to facilitate future prostate cancer research, aiming to improve the quality of trials and generate high-quality evidence. This mixed methods project has three phases, as follows: (1) a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions involving TCM for the treatment of prostate cancer as well as a qualitative component using interviews to obtain the views of patients with prostate cancer, their families, and their caregivers who have a history of TCM treatment; (2) a Delphi survey among stakeholders to prioritize the core outcomes-Participants will include traditional Chinese and Western medicine clinicians in prostate cancer-related directions, nurses, and methodology experts who will participate in 2 rounds of the Delphi method expert consultation to score each outcome in the list of outcome indicators; and (3) a face-to-face consensus meeting to discuss and agree on the final COS for the application of TCM in the treatment of prostate cancer. The protocol has been registered in PROSPERO (CRD42022356184) before the start of the review process, and we will initiate the review on August 1, 2023; results should be expected by September 1, 2023. The Delphi survey among stakeholders is expected to start in October 2023. The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of TCM will provide a significant first step to assist Chinese doctors, researchers, and policy makers. PROSPERO CRD42022356184; https://tinyurl.com/ysakz74r. PRR1-10.2196/46794.

Traditional Chinese Medicine and COVID-19: Experiences, Lessons, and Suggestions

Traditional Chinese Medicine and COVID-19: Experiences, Lessons, and Suggestions

Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol

BackgroundIntracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary ICH. A lot of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating HICH have been carried out. However, these RCTs have a lot of problems, such as heterogeneous outcomes, non-uniform point of measurement. These lead to systematic review/meta-analysis only can include a small number of studies. And outcome measures did not take the wishes of patients and other stakeholders into account. The aim of this study is to establish the core outcome set (COS) for future TCM clinical trials of HICH.Methods and analysisFirst, we will develop a long list of general outcomes by making systematic literature review and semi-structured interviews. Then healthcare professionals and patients with HICH will be invited to participate in two rounds of the Delphi survey to determine the importance of the outcome. Finally, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes.ResultsWe aim to develop a COS that includes TCM core syndrome for HICH to determine what outcomes should be reported and when and how to measure them.ConclusionBy doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.Ethics and disseminationThe entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.Trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1475. Registered on December 2019.

Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol.

IntroductionStroke, an acute cerebrovascular disease, is mainly caused by the sudden rupture or occlusion of blood vessels, and is subdivided into ischemic stroke and hemorrhagic stroke. It has become the second leading cause of death worldwide. In Chinese clinical practice, traditional Chinese medicine (TCM)/Integrative Medicine has been widely used for the treatment of stroke. Numerous randomized controlled trials (RCTs) of TCM/Integrative Medicine for stroke have been conducted to improve the efficacy and safety outcomes. However, their conclusions should be treated with caution because of the methodological quality defects in the clinical research. Pervasive inconsistencies are present in the outcomes collected and reported across these studies, which may lead to the pooling of discrepant data and preclude meta-analysis. The issue could be addressed by developing a core outcome set (COS).AimThe aim of this study is to develop a COS in the clinical trials of TCM/Integrative Medicine in the treatment of stroke.Method and AnalysisA steering group will be set up to organize and guide the development of the COS. The study contains three phases: (I) development of an initial outcome list covering all relevant outcomes, via two steps: (i) systematic reviews of outcomes for clinical trials of TCM/ Integrative Medicine for stroke; (ii) semi-structured interviews with patients suffering from stroke; (II) conduction of three round of Delphi surveys with different stakeholder groups to prioritize important outcomes; (III) integration of outcomes into a core outcome set by a consensus meeting.Ethics and DisseminationThis study has been granted by the Ethics Committee of Tianjin University of Traditional Chinese Medicine (TJUTCM-EC20210003). When the COS is completed, we will publish it in an appropriate journal to promote further widespread use.RegistrationThis study has been registered at the Core Outcome Measures in Effectiveness Trials initiative, COMET database (Registration #1678).

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Abstract Objective: This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine (TCM) for patients with stable angina pectoris, and to provide baseline data for the development of core outcome sets (COSs) for relevant clinical trials. Methods: Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris. Outcome measures of each trial were extracted. Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM. Results: 94 randomized trials (with 9,111 participants) involving 79 different outcomes were identified. The mean number of outcomes was 5 (1–21 per trial). The 5 most commonly reported outcomes were efficacy rate of electrocardiogram, efficacy rate of angina pectoris, efficacy rate of TCM syndrome, fasting lipid indices, and withdrawal rate of nitroglycerin. Several challenges were identified: (1) significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome; (2) transformation of continuous data into categorical data and presented as such in >90% of trials; (3) few trials on the outcomes associated with the advantages and characteristics of TCM; and (4) selective reporting of outcomes. Conclusions: The outcomes used are excessively heterogenous, and the choice of some outcomes (timing and techniques) for measurement is confusing or inappropriate. Hence, developing and implementing a COS is necessary for greater consistency.

A precision‐preferred comprehensive information extraction system for clinical articles in traditional Chinese Medicine

This study established a precision-preferred system specially designed for the data extraction of traditional Chinese medicine (TCM) articles, providing foundational data for subsequent clinical article analysis and synthesis of TCM clinical evidence. Information extraction is commonly used in many fields to identify relevant concepts and the relationship between pairs of concepts from the vast information sources. Previous studies that performed information extraction primarily focused on scattering targeted fields to achieve a balance between precision and recall. Therefore, this study aims to create a comprehensive information extraction system for TCM articles. This system will extract all relevant information from research articles on a broad research field, including the 11 diseases that can be efficiently treated with TCM, with high precision and efficient measurement to address bias in every study. It covers the most essential information related to patients, interventions, comparisons, outcomes, and study design (PICOS) principles in TCM clinical trials. This system covers 34 target fields on 14 topics. Impediments such as the various typesetting of TCM clinical articles were managed by a hybrid of machine vision and optical character recognition. Thus, TCM researchers can be spared of laborious, unscalable, and inefficient manual extraction processes. Our system could also enhance TCM researcher awareness of frequently missing information or TCM clinical trial design methods that could introduce bias, by analyzing the overall information integrity of TCM clinical articles, which is beneficial for future research designs.

Core outcome set for stable angina pectoris in traditional Chinese medicine (COS-SAP-TCM)

Abstract Objective: This study aimed to develop a core outcome set (COS) for use in future studies of stable angina pectoris (SAP) in traditional Chinese medicine (TCM). Methods: Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes. Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings. Following the final consensus meeting, a final COS was generated. Results: An initial set of 324 outcomes was identified. A preliminary list of 65 outcomes was employed in the Delphi study. In total, 223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round: 87 completed round 1 and 47 completed round 2. Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains: frequency of angina attack, duration of angina attack, Seattle angina questionnaire, total exercise duration in the exercise treadmill test, cardiovascular events, and QT interval on electrocardiography. Conclusions: The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP. The employment of this COS may reduce heterogeneity across trials and facilitate evidence-based decision-making for stakeholders.

Quality evaluation of clinical trial literatures on the COVID-19 treatment with traditional Chinese medicine (TCM)

Objective To evaluate the quality of the clinical trial literatures published on the treatment of COVID-19 with find out the shortcomings and put forward corresponding suggestions, in order to promote TCM against COVID-19. Methods COVID-19, New Coronavirus Pneumonia, TCM, Medicine, Clinical Trial, Lianhua Qingwen, Huoxiang Zhengqi, Jinhua Qinggan, and other keywords were used to search relevant literatures in CNKI and PubMed database. Among the all the screened relevant literatures on the treatment of COVID-19 with the literature quality was assessed according to evaluation criteria of clinical trial literatures. Results A total of 463 papers related to the treatment of COVID-19 with TCM were obtained. 440 papers on theoretical research on the network pharmacology mechanism of Chinese medicine treatment of COVID-19 were excluded. Among the 23 articles included in the quality analysis, there are 3 randomized controlled studies, 1 multi-center prospective randomized controlled trial, 2 disease case report trials, and 5 uncontrolled single arm studies, 5 controlled trials and 7 retrospective studies. In the period of more than half a year, although many clinical trial documents of TCM for the treatment of COVID-19 have been published, the clinical trial design reflected in most TCM clinical trials were not standardized. There are problems in randomness and rationality, such as no control group, no randomization design, only case studies, no blinding method in controlling bias, and insufficient objectivity in the evaluation criteria of efficacy. All of these need to be improved. Conclusion The treatment of new coronavirus pneumonia with TCM still requires more and standardized clinical trial verifications and publications to generate strong evidence-based results, such as adding control groups, increasing sample size, and using blinding methods to increase the credibility of clinical trials.

Clinical trials for Traditional Chinese Medicine against coronavirus disease 2019 (COVID-19): Interpretation based on bibliometric analysis

<p indent="0mm">The coronavirus disease 2019 (COVID-19) has been spreading worldwide, posing a significant threat to human health. Currently, vaccines are available, but there is still no reliable cure for this disease. Traditional Chinese Medicine (TCM) has played an important role in addressing this epidemic, and several clinical studies have emerged regarding treatments for COVID-19 by TCM; status of those treatments, and patterns regarding these are worth summarizing and interpreting systematically. A comprehensive search of clinical trials was performed in various platforms, including PubMed, Embase, Web of Science, medRxiv, China National Knowledge Infrastructure, WanFang Data, and SinoMed, from January 1, 2020 to March 1, 2021. Analyzed information included language, received date, quantity, citations, affiliation, number of authors, research type (randomized controlled trial or non-randomized controlled trial), trial registry information, disease severity, sample size, specific interventions, outcomes, and adverse reactions, among others. Based on the aforementioned information, a quantitative and qualitative literature analysis was done. A total of 47 articles were retrieved, most of which were published in Chinese (42 articles, 89.36%). Based on the results of the number of trial registrations (12 articles), the number of citations (the maximum for a single article was 62), and the modified Chalmers scale (total: 100 points, average: 61.40 points), the overall study quality still needs improvement. Most patients presented with the mild and common type of COVID-19 and were recruited in Hubei Province, while researchers from these studies were from all over the country (135 institutions). TCM interventions included 66 different formulas and 134 herbs, of which Armeniacae semen amarum (Kuxingren), Agastache rugosa (Huoxiang), Ephedra sinica stapf (Mahuang), Gypsum fibrosum (Shigao), Glycyrrhizae radix et rhizome (Gancao), and Gtractylodes rhizoma (Cangzhu) appeared at high frequencies. Highlighted outcomes from these studies included the following: Clinical symptoms (fever, cough, fatigue, etc.), progression rate from normal stage to heavy stage, laboratory indices including leukocyte and lymphocyte counts, and c-reactive protein levels, imaging diversity of lung computed tomography (CT), and recorded adverse reactions. With a certain number of published clinical trials, the landscape of TCM clinical trials for COVID-19 was established. Most studies have a relatively low quality and impact, and standardized implementation of evidence-based research in TCM was lacking. The mainstay TCM treatment for COVID-19 involved clearing heat, releasing the exterior, and resolving its dampness. Additionally, the Maxing Shigan Decoction was one of the most common classical prescriptions for COVID-19, and the “three drugs and three perceptions” were also widely used. Some symptoms, laboratory indicators, and imaging diversity of lung CT were found to have significantly improved after taking these decoctions. Overall, TCM is safe, and no serious adverse reactions have been reported. Through multiple mechanisms, TCM has shown great clinical effects, but its underlying mechanisms and patterns should be further explored. It is of great practical significance to enhance the level of clinical and evidence-based research for TCM application in the prevention and treatment of acute and emergent infectious diseases. Furthermore, such research will help strengthen clinical expertise in this field and further standardize the implementation of evidence-based TCM medical research.

A Series of N-of-1 Trials for Traditional Chinese Medicine Using a Bayesian Method: Study Rationale and Protocol.

Background. Our previous studies showed that N-of-1 trials could reflect the individualized characteristics of traditional Chinese medicine (TCM) syndrome differentiation with good feasibility, but the sensitivity was low. Therefore, this study will use hierarchical Bayesian statistical method to improve the sensitivity and applicability of N-of-1 trials of TCM. Methods/Design. This is a randomized, double-blind, placebo-controlled, three-pair crossover trial for a single subject, including 4–8 weeks of run-in period and 24 weeks of formal trial. In this study, we will recruit a total of 30 participants who are in the stable stage of bronchiectasis. The trial will be divided into three pairs (cycles), and one cycle contains two observation periods. The medications will be taken for three weeks and stopped for one week in the last week of each observation period. The order of syndrome differentiation decoction and placebo will be randomly determined. Patient self-reported symptom score (on a 7-point Likert scale) is the primary outcome. Discussion. Some confounding variables (such as TCM syndrome type and potential carryover effect of TCM) will be introduced into hierarchical Bayesian statistical method to improve the sensitivity and applicability of N-of-1 trials of TCM, and the use of prior available information (e.g., “borrowing from strength” of previous trial results) within the analysis may improve the sensitivity of the results of a series of N-of-1 trials, from both the individual and population level to study the efficacy of TCM syndrome differentiation. It is the exploration of improving the objective evaluation method of the clinical efficacy of TCM and may provide reference value for clinical trials of TCM in other chronic diseases. This trial is registered with ClinicalTrials.gov (ID: NCT04601792).

Treatment of Chronic Pulmonary Heart Disease with Traditional Chinese Medicine: A Protocol for the Development of a Core Outcome Set (COS-TCM-CPHD).

Background Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. These can be evaluated by the measurement and analysis of related outcomes. Because of selective reporting bias and the heterogeneity of study outcomes, it is not possible to combine similar studies in a meta-analysis. Consequently, not only does the low quality of original studies fails to support evidence-based decision-making, but also the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required. Methods The development is conducted in five steps: (1) a library of outcomes through systematic review, the retrieval of libraries from two clinical trials registries, and semistructured interviews is established; (2) following data extraction and analysis of the library of outcomes, each outcome can be classified into seven outcome domains, including TCM disease, symptoms/signs, physical and chemical testing, quality of life, long-term prognosis, economic evaluation, and adverse events to form a preliminary list of outcomes; (3) stakeholder groups for participation are selected; (4) stakeholder groups are invited to participate in two rounds of Delphi surveys to score outcomes and provide additional outcomes; (5) a consensus meeting is organized to produce the final COS-TCM-CPHD. Discussion. The protocol is consistent with the guidelines defined by the Core Outcome Set-STAndardised Protocol (COS-STAP) statement and formulated with reference to Core Outcome Set-STAndards for development (COS-STAD). The COS-TCM-CPHD will improve the consistency of study reports and reduce publication bias, thereby improving the quality of TCM clinical trials and decision-making for evidence-based medicine. The study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677).

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

ObjectiveTo assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.MethodWe 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.ResultsA 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).ConclusionOverall, 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.

Understanding Traditional Chinese Medicine Therapeutics: An Overview of the Basics and Clinical Applications.

Traditional Chinese medicine (TCM) is a systematic healthcare system developed from clinical experience based on a scientific model of regulation. TCM relies on unique theories and practices to treat diseases and enhance health. These practices include Chinese herbal medicine and dietetics, acupuncture and moxibustion, and other non-medication therapies such as Chinese bodywork or manual therapy, known as “Tuina”, and traditional biofeedback exercises, known as “Qigong” and “Taijiquan”. The integration of TCM in Western health systems and research requires a rational communicable theory, scientific proof of efficacy and safety, and quality control measures. Understanding the structural concepts of the TCM language makes possible the parallelism to Western physiology, and the inherent rational use of the reflex therapeutic systems, anti-inflammatory mechanisms and mental training involved, for example, in acupuncture and “Qigong”. The results of TCM clinical trials and fundamental research on its nature and mechanisms have encouraged the development and application of well-designed research strategies such as double blinding in acupucture to overcome limitations and resistances in integrating these practices into the existing biomedical paradigms of the West. This review aims to overview some TCM theoretical concepts and the evidence-based clinical application of TCM’s leading practices to create an easy-to-consult and condensed source of information, available for the healthcare community, facilitating the understanding and communication between conventional health professionals and TCM practitioners and acupuncturists.

Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine.

BackgroundDevelopment of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials.MethodsA preliminary list of outcomes was developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses, and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Then different stakeholders participated in a consensus meeting by video conference to vote.ResultsNinety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS included clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), and symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instruments/definitions were also recommended.ConclusionThough there are some limitations for the research, such as insufficient patients and the public involvement, and the unbalanced stakeholders' region, the COS for COVID-19 may improve consistency of outcome reporting in clinical trials. It also should be updated with research progression.

Radix Stephaniae Tetrandrine: An Emerging Role for Management of Breast Cancer.

Radix Stephaniae Tetrandrine (RST), known as FangJi (Pinyin name) in Chinese, is the dried root of Stephania tetrandra S.Moore, and has been prescribed in combination with other herbs to treat cardiovascular diseases and breast cancer in traditional Chinese medicine (TCM) clinical trials. The aim of the review is to provide a comprehensive evaluation about the application of RST in breast cancer management in TCM clinical trials, its ingredients, and its action on preventing the development of breast cancer in vitro and in vivo studies. Literature sources used were Pubmed, CNKI.net, Cqvip.com, and the Web of Science. For the inquiry, keywords such as Fangji, breast cancer, clinical trials, Radix Stephaniae Tetrandrine, tetrandrine, and fangchinoline were used in various combinations. About 150 research papers and reviews were consulted. In TCM, RST exhibited the anti-tumor ability through its action on the bladder and lungs through dispersing phlegm and blood stasis. 10 clinical trials were identified which used RST in combination with other herbs to treat breast cancer. On average, the trials were characterized by high efficacy (>85%) and low toxicity. However, most of the clinical trials are characterized as small patient samples, poor design, and different combinations of herbs in prescriptions. To date, more and more compounds have been isolated from this plant. RST exhibited anti-tumor activities by targeting reversing multidrug resistance, inhibiting cell proliferation, inducing apoptosis, preventing tumor angiogenesis, anti-oxidation, anti-inflammation, and enhancing the sensitization and attenuating the toxicity of radiotherapy. The successful applications of RST in TCM clinical trials and preclinical experiments to beating breast cancer will provide potent lead compounds in the identification of novel anti-cancer drugs, which further contributes to the scientific exploration of functions of RST in TCM.

The global registry of COVID-19 clinical trials: indicating the design of traditional Chinese medicine clinical trials

The global registry of COVID-19 clinical trials: indicating the design of traditional Chinese medicine clinical trials