Search

In recent years, the number of clinical practice guidelines for the integration of traditional Chinese medicine (TCM) and western medicine(WM) has been increasing year by year. However, there are obvious problems of "knot without compatibility". The recommendations of TCM and WM are mostly independent, inconsistent with the actual clinical diagnoses and treatment processes, and lacking in important information. All the above issues are unable to bring the role of the cooperation between TCM and WM in improving clinical practice. In order to achieve the organic integration of Chinese and western medicine, the research team has carried out methodological research in response to the above-mentioned problems. In November 2023, China Association for Standardization released the Specifications for Developing Clinical Practice Guidelines for Organic Integration of Traditional Chinese and Western Medicine at the 6th-8th Academic Annual Meeting of the Clinical Research Branch of China Information Association of Traditional Chinese Medicine. Therefore, this paper interprets the formulation process, scope of application and main content of the specification, with the aim of improving the overall quality of related research and promoting the collaborative development of the integration of TCM and WM. more...

In the era of evidence-based medicine, it is necessary to explore the unique advantages of traditional Chinese medicine (TCM) based on standardized technical methods and operating procedures in order to achieve the modernization and internationalization of TCM and benefit all humanity. The proposal of a three-pronged evidence system combining TCM theory, human experience and experimental evidence marks an important progress in the thinking method of the TCM evaluation system. The multi-evidence body integrated through appropriate methods provides a strong support for the clinical guideline recommendations and evidence-based health decision-making in TCM. Based on the current methodological progress of international evidence synthesis and grading, this paper proposes a novel approach for integrating multi-evidence in TCM: the MERGE framework. The aim is to establish a solid foundation for the development of this methodology and provide guidance for the advancement of evidence-based medicine framework in TCM. more...

Clinical practice guidelines are an important basis for clinical decision-making, but there are still many factors that prevent physicians from following the guidelines. One of the problems, the limited external validity of the guidelines, ultimately prevents the guidelines from providing an adequate basis for clinical decision-making, thus forming the gap between the guidelines and clinical decisions. Real-world research can enhance the external validity of the guidelines, provide a basis for clinical decision-making, and offer localized evidence for the guidelines, evidence of cost-effectiveness and other evidence for the guidelines. It can also monitor the implementation of the guidelines and help to make up for the lack of evidence in the formulation of traditional guidelines. Therefore, high-quality real-world studies and real-world evidence may be considered in the guideline development process to facilitate guideline optimization and serve as an aid to guideline quality improvement. more...

Although the incidence of rare diseases is extremely low, 6% to 8% of the global population are affected by more than 7000 rare diseases. Rare diseases guidelines are playing an increasingly important role as guiding documents in improving the health outcomes of patients with rare diseases. Therefore, we aim to systematically elaborate on the status quo, challenges and opportunities of rare disease guidelines at home and abroad, and put forward thoughts and suggestions on promoting the development of rare diseases guidelines in the future. more...

As an important guidance of medical practice, clinical practice guideline of integrative Chinese medicine (ICM-CPG) plays an extremely important role in showing the respective advantages of Chinese and Western medicine and in promoting the integrated Chinese and Western medicine. However, the research status on ICM-CPG is faced with the problem of emphasizing development but neglecting implementation. The establishment of ICM-CPG implementation model based on the theoretical framework of implementation science is conducive to promoting the implementation of ICM-CPG and advancing the integration and development of Chinese and Western medicine. In this paper, by sorting out and analyzing the knowledge to action (KTA) framework, we discuss the implementation framework development of ICM-CPG in order to provide reference for future research. more...

More and more scholars have paid attention to traditional Chinese medicine since the concept of translational medicine was introduced into this field. Most scholars believe that it is of great benefit to the inheritance and development of traditional Chinese medicine by the integration of translational medicine concepts and traditional Chinese medicine research. By reviewing the connotation and development of translational medicine, this paper explained the similarities between translational medicine and the basic theories of traditional Chinese medicine, and further described the content and practice of translational research on traditional Chinese medicine. It points out that the research foundation of traditional Chinese medicine was weak, the evidence was scattered, and the overall evaluation of efficacy needed to be strengthened. Finally, the viewpoints and strategies of strengthening the transformation research of TCM were put forward, such as strengthening the integration of resources, focusing on the areas of advantage and improving the overall evaluation, so as to provide new ideas for the future research of TCM transformation. more...

Traditional Chinese medicine (TCM) is the treasure of Chinese civilization. Its advantage lies in clinical practice. It takes the concept of holism and treatment based on syndrome differentiation as the guiding ideology, emphasizes the people-oriented concept, and has the dual attributes of science and humanity. The clinical efficacy reflects the vitality of TCM. In recent years, the researchers focus on the TCM clinical regnant diseases and therapies, master the evidence-based medicine method, establish new methods and technologies for clinical efficacy evaluation in line with the characteristics of TCM, integrate with the international clinical research mode so as to gain consensus and recognition.Using the ideas and methods of translational medicine, starting from the needs and efficacy, to build a clinical and basic transformation platform, improve the quality of clinical services, and promote the development of new drugs and new technologies. In general, the development of TCM clinical research should adhere to the principles of Chinese Learning, carry forward original thinking, be fully inclusive and equitable, learn mutually, collaborate with each other, and cooperate in multi-disciplinarity, so as to welcome a new era of high concepts, big data, integration of information and intelligence under the background of big science and health, grasp the hard-won development trend of TCM from integration of TCM and western medicine to placing equal emphasis on TCM and western medicine, and realize the inheritance and innovation of TCM led by us. more...

Objective To evaluate the efficacy and safety of yinqiao qingre tablet in treating common cold with wind-heat type.Methods The randomized, double-blind, placebo, parallel control research were applied to this study. The eligible subjects were divided into a experimental group, a positive control group and a placebo control group. The test drug was yinqiao qingre tablet, positive control drug was yinqiao jiedu tablet, and simulation drugs were yinqiao qingre simulation tablet and yinqiao jiedu simulation tablet. The experimental group was given yinqiao qingre tablet and yinqiao jiedu simulation tablet, the positive control group was given yinqiao qingre simulation tablet and yinqiao jiedu tablet, and the placebo control group was given yinqiao qingre simulation tablet and yinqiao jiedu simulation tablet.The course of treatment for each group was 3 days. Before and after treatment, the disappearance rate of major symptoms, individual symptom scores, efficacy of TCM syndrome, change of temperature, used of antipyretic analgesics and safety were evaluated. Results The disappearance rate of major symptoms was 62.12% in experimental group, was the highest among three groups(P more...

The significance of the existence of clinical practice guidelines lies in their implementation, however, there are still many problems in the implementation of guidelines and bottlenecks in the translation of clinical evidence. The introduction of knowledge graph technology provides a solid foundation for guideline intel-ligence and a good tool for solving guideline implementation problems. The combined Traditional Chinese Medi-cine (TCM)/ Integrated Traditional Chinese and Western Medicine (IM) reflect the characteristics of the healthcare system in China. Using the current status of TCM/IM diagnosis and treatment of cardiovascular diseases and the current problems in the application of TCM/IM guidelines for cardiovascular diseases, this study defined the objectives of constructing a knowledge graph for TCM/IM clinical guidelines for cardiovascular diseases, and accordingly designed a knowledge graph framework for TCM/IM clinical guidelines that is con-sistent with professional knowledge and practical application. We analyzed the scope of the guidelines, ar-ranged their content and summarized their knowledge structure. We then established concept structure tables and entity semantic relationship tables. The design of the knowledge graph framework for TCM/IM guidelines proposed in this paper provides a basis for the digitization and communication of guidelines, and is conducive to promoting their implementation and dissemination. more...

OBJECTIVE: To evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC). METHODS: Nine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 1980-5/2010), China Biomedicine Database disc (CBMdisc, 1980-5/2010), VIP (a full text issues database of China, 1989-5/2010) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 14 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). RESULTS: In regard to the items in the CONSORT statement, 13(92.86%) RCTs described baseline demographic and clinical characteristics in each group. 7 (50.0%) mentioned the method of generating the random sequence, only 2 (14.3%) RCTs had adequate allocation concealment. No RCTs used blinding. RCTs reported the sample size calculation. In regard to the items in STRICTA, 10 (71.43%) mentioned the depths of insertion, 6 (42.86%) reported acupuncture response, 11 (78.57%) mentioned the technique of acupuncture, 12 (85.71%) recorded the time, and only 3 (21.43%) RCTs reported the numbers of needles inserted. No RCTs reported the background of the acupuncture practitioners and professional title of practitioners. CONCLUSION: The reporting quality of RCTs of acupuncture for mild cognitive impairment was moderate to low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture in future. more...

Abstract Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register ChiCTR-TRC-00000401 more...

Abstract Background Experts in Traditional Chinese Medicine (TCM) have studied the TCM subject of the pathogenesis of heart failure (HF) for several decades. As a result, the general idea is ben deficiency and biao excess. However, the clinical evaluation system which combined the TCM and western medicine in HF has not been developed yet. The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods. Methods Nine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome. Discussion By putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index system which built in the study will be helpful for the clinical effect expression of HF by integrated medicine in future. Trial Registration ChiCTR-TRC-00000059 more...

Background: Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of thrombosis. However, bleeding-related complications during antithrombotic therapy remain a major barrier to effective treatment and can often lead to adverse outcomes. This meta-analysis aimed to determine the efficacy and safety of bivalirudin and heparin in patients with ACS after PCI. Methods: Randomized controlled trials (RCTs) on the efficacy and safety of bivalirudin versus heparin in patients with ACS after PCI were identified from the PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang, and VIP database until August 2024. The outcomes included all-cause mortality, major adverse cardiovascular events (MACEs), incidence of recurrent myocardial infarction, stent thrombosis, short-term bleeding, revascularization, and retransfusion. Meta-analysis was performed using RevMan 5.3 and Stata 12.0 softwares. The included studies were assessed for risk of bias using the Cochrane risk-of-bias assessment tool. Results: A total of 70,199 patients from 27 randomized controlled trials (RCTs) were analyzed in this review. There were no significant differences between the bivalirudin and heparin groups in terms of all-cause mortality, major adverse cardiovascular events (MACEs), recurrent myocardial infarction, stent thrombosis within 30 days, or subacute stent thrombosis. Specifically, the incidence of short-term bleeding (P = 0.001) and retransfusion (P = 0.001) was significantly lower in the bivalirudin group compared to the heparin group. Conversely, the incidence of acute stent thrombosis (P < 0.0001) and revascularization (P = 0.009) was significantly higher in the bivalirudin group. Conclusions: Compared with heparin, bivalirudin has definite anticoagulant effect in patients with acute myocardial infarction after PCI, and the risk of bleeding and the incidence of retransfusion were lower in the bivalirudin group. This review helps doctors in PCI management choose bivalirudin or heparin more precisely based on patients' conditions for better treatment and fewer adverse events. [ABSTRACT FROM AUTHOR] more...

Large language models (LLMs) have the potential to enhance evidence synthesis efficiency and accuracy. This study assessed LLM-only and LLM-assisted methods in data extraction and risk of bias assessment for 107 trials on complementary medicine. Moonshot-v1-128k and Claude-3.5-sonnet achieved high accuracy (≥95%), with LLM-assisted methods performing better (≥97%). LLM-assisted methods significantly reduced processing time (14.7 and 5.9 min vs. 86.9 and 10.4 min for conventional methods). These findings highlight LLMs' potential when integrated with human expertise. [ABSTRACT FROM AUTHOR] more...

Background: Lumbar spinal stenosis (LSS) is a common cause of low back pain, especially in the elderly, and accurate diagnosis is critical for effective treatment. However, manual diagnosis using MRI images is time consuming and subjective, leading to a need for automated methods. Objective: This study aims to develop a convolutional neural network (CNN)-based deep learning model integrated with multiple attention mechanisms to improve the accuracy and robustness of LSS classification via MRI images. Methods: The proposed model is trained on a standardized MRI dataset sourced from multiple institutions, encompassing various lumbar degenerative conditions. During preprocessing, techniques such as image normalization and data augmentation are employed to enhance the model's performance. The network incorporates a Multi-Headed Self-Attention Module, a Slot Attention Module, and a Channel and Spatial Attention Module, each contributing to better feature extraction and classification. Results: The model achieved 95.2% classification accuracy, 94.7% precision, 94.3% recall, and 94.5% F1 score on the validation set. Ablation experiments confirmed the significant impact of the attention mechanisms in improving the model's classification capabilities. Conclusion: The integration of multiple attention mechanisms enhances the model's ability to accurately classify LSS in MRI images, demonstrating its potential as a tool for automated diagnosis. This study paves the way for future research in applying attention mechanisms to the automated diagnosis of lumbar spinal stenosis and other complex spinal conditions. [ABSTRACT FROM AUTHOR] more...