Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Scientism and humanism are two main views on the development of medicine, which run through both theory and practice. Under the guidance of the modern medical concept of " bio-psycho-social”, the views of scientism and humanism on medicine have reached an unprecedented level of development and integration, which jointly determine the connotations and demands of current medicine. As one of the current mainstream medical models, evidence-based medicine (EBM) has played an important role in the management of current medical theories and practices. Meanwhile, EBM has also encompassed views of scientism and humanism in its own development and has successfully shaped the knowledge and methodological system. EBM will continue to gain insight into the characteristics of views of scientism and humanism in the future of medicine to improve itself and should pay more attention to the development of humanism view. As an important branch discipline of EBM, evidence-based Chinese medicine may become a model of the perfect combination of scientism view and humanism view.
Objective To assess the effect of integrated traditional Chinese medicine with western medicine (ICWM) in the treatment of SARS. Methods We searched MEDLINE, EMBASE, and Chinese BioMed Database ( CBM ) , and the Intemet performed handsearching in Chinese journals and reference lists. We included randomised controlled trials and prospective controlled studies of integrated Chinese medicine with western medicine versus western medicine alone in people with SARS. Three independent reviewers collected details of study population, interventions, and outcomes using a data extraction form. We conducted meta-analysis for similar data of studies.Results Nine studies (n =812) were included, all with the possibility of containing serious bias. ICWM in the treatment of SARS was associated with the following reductions: case fatality [ OR 0.32, 95% CI (0.14,0.71 ) ] , fever clearance time [ WMD -1.17, 95% CI ( -1.83, -0.50 ) , symptom remission time [ WMD-1.47, 95% CI ( - 1.96, - 0. 98) ] and the number of inflammation absorption cases [ MD 1.63, 95% CI(0.95, 2.80 ) ], having no significant difference in symptom scores of convalescents [ WMD -1.25, 95% CI ( -2.71, 0.21 ) ], cumulative dose of corticosteroids [ WMD - 236.96, 95% CI ( - 490.64, 16.73) ] and inflammation absorption mean time [ WMD 0.63, 95% CI ( - 1.33, 2.59) ] .Conclusions Due to the methodological limitations of the studies, the effect of ICWM for SARS is unclear. The apparent improvements in cases fatality, fever clearance time, syndromes remission time and numbers of inflammation absorption cases warrant further evaluation with high quality and large scale trials to be expected.
As an interdisciplinary subject of medicine and artificial intelligence, intelligent diagnosis and treatment has received extensive attention in both academia and industry. Traditional Chinese medicine (TCM) is characterized by individual syndrome differentiation as well as personalized treatment with personality analysis, which makes the common law mining technology of big data and artificial intelligence appear distortion in TCM diagnosis and treatment study. This article put forward an intelligent diagnosis model of TCM, as well as its construction method. It could not only obtain personal diagnosis varying individually through active learning, but also integrate multiple machine learning models for training, so as to form a more accurate model of learning TCM. Firstly, we used big data extraction technique from different case sources to form a structured TCM database under a unified view. Then, taken a pediatric common disease pneumonia with dyspnea and cough as an example, the experimental analysis on large-scale data verified that the TCM intelligent diagnosis model based on active learning is more accurate than the pre-existing machine learning methods, which may provide a new effective machine learning model for studying TCM diagnosis and treatment.
Integrated traditional Chinese and Western medicine has been used to treat acute pancreatitis (AP) for more than 50 years. It has become a dominant and specialized disease treated by integrated traditional Chinese and Western medicine. After many years of clinical practice, a relatively mature and complete treatment system has been formed. Therefore, it was proposed by the Chinese Society of Integrated Traditional Chinese and Western Medicine, the Chinese Medical Association, and the Chinese Association of Traditional Chinese Medicine to update and formulate the “Guidelines for the Diagnosis and Treatment of Acute Pancreatitis with Integrated Traditional Chinese and Western Medicine” (2021) group standards in 2022, and “Integrated Traditional Chinese and Western Medicine Practice Guidelines for Diagnosis and Treatment of Acute Pancreatitis” finally published. The guideline condenses 25 kinds of important clinical issues, which guide to explain the diagnosis and treatment of AP in detail, focusing on the integration of traditional Chinese medicine and Western medicine in the management of AP, such as staging and syndrome differentiation, early fluid therapy, pain management, and organ function support in early stage. The advantages and the timing of early intervention of traditional Chinese medicine in AP are emphasized. This guideline also proposes suggestions on nutritional support, management of causes, treatment of late local complications and infections, as well as prevention of recurrence and follow-up strategies for long-term complications. This paper provides an interpretation of this guideline.
Objective?To investigate the relationship between syndromes of traditional Chinese medicine (TCM) and lung function in patients with chronic obstructive pulmonary disease (COPD) at stable phase. MethodsBased on diagnostic criterion of TCM, five groups of symptoms of TCM about stable COPD were established including lung Qi deficiency, lung and spleen Qi deficiency, lung and kidney Qi deficiency, lung Spleen Kidney Qi deficiency, and deficiency of both Qi and Yin. A total of 300 cases which were up to the standard were differentiated into 5 groups by the symptoms. Some basic details and lung function of the patients were recorded, and then statistical analysis was performed to analyze the differences of lung function among groups. ResultsForced expiratory volume in the first second in descending order was lung Qi deficiency group, lung and spleen Qi deficiency group, lung and kidney Qi deficiency group, and lung spleen kidney Qi deficiency group (P<0.05). ConclusionThese findings suggest that with the progressing of COPD, the symptom type of TCM for COPD patients at stable phase may vary from lung Qi deficiency to lung and spleen Qi deficiency, or to lung and kidney Qi deficiency, and even lung, spleen and kidney Qi deficiency. Lung function tests help reveal substance and pathogenesis of TCM syndromes of patients with stable COPD, and provide evidence for the clinical syndrome.
Objective To analyze the differences in distribution of traditional Chinese medicine (TCM) syndrome elements and salivary microbiota between the individuals with pulmonary nodules and those without, and to explore the potential correlation between the distribution of TCM syndrome elements and salivary microbiota in patients with pulmonary nodules. Methods We retrospectively recruited 173 patients with pulmonary nodules (PN) and 40 healthy controls (HC). The four diagnostic information was collected from all participants, and syndrome differentiation method was used to analyze the distribution of TCM syndrome elements in both groups. Saliva samples were obtained from the subjects for 16S rRNA high-throughput sequencing to obtain differential microbiota and to explore the correlation between TCM syndrome elements and salivary microbiota in the evolution of the pulmonary nodule disease. Results The study found that in the PN group, the primary TCM syndrome elements related to disease location were the lung and liver, and the primary TCM syndrome elements related to disease nature were yin deficiency and phlegm. In the HC group, the primary TCM syndrome elements related to disease location were the lung and spleen, and the primary TCM syndrome elements related to disease nature were dampness and qi deficiency. There were differences between the two groups in the distribution of TCM syndrome elements related to disease location (lung, liver, kidney, exterior, heart) and disease nature (yin deficiency, phlegm, qi stagnation, qi deficiency, dampness, blood deficiency, heat, blood stasis) (P<0.05). The species abundance of the salivary microbiota was higher in the PN group than that in the HC group (P<0.05), and there was significant difference in community composition between the two groups (P<0.05). Correlation analysis using multiple methods, including Mantel test network heatmap analysis and Spearman correlation analysis and so on, the results showed that in the PN group, Prevotella and Porphyromonas were positively correlated with disease location in the lung, and Porphyromonas and Granulicatella were positively correlated with disease nature in yin deficiency (P<0.05). ConclusionThe study concludes that there are notable differences in the distribution of TCM syndrome elements and the species abundance and composition of salivary microbiota between the patients with pulmonary nodules and the healthy individuals. The distinct external syndrome manifestations in patients with pulmonary nodules, compared to healthy individuals, may be a cascade event triggered by changes in the salivary microbiota. The dual correlation of Porphyromonas with both disease location and nature suggests that changes in its abundance may serve as an objective indicator for the improvement of symptoms in patients with yin deficiency-type pulmonary nodules.
This paper introduces the application and funding of evidence-based research projects on traditional Chinese medicine (TCM) of the National Natural Science Foundation of China (NSFC) in 2019 in terms of clinical research and methodology research, summarizes the primary problems existing in evidence-based research on TCM, discusses the quality of evidence-based research on TCM in clinical research, highlights the characteristics of TCM and reveals the evidence-based methodology on TCM.
ObjectiveTo assess the efficacy and safety of Tiao-She nursing of traditional Chinese medicine (TCM) for mild cognitive disorder (MCD), and to provide theoretical basis for developing evidence-based guideline of Tiao-She nursing of TCM. MethodsWe searched PubMed, Web of Science, The Cochrane Library, EMbase, MEDLINE, Springerlink, CBM, CNKI, VIP and WanFang Data for systematic reviews/meta-analyses (SRs/MAs), as well as randomized controlled trials (RCTs), up to December 2014. Two reviewers screened literature according to the inclusion and exclusion criteria and extracted data. Methodological quality and evidence quality of included SRs/MAs were assessed using AMSTAR scale and GRADE tool, respectively. Methodological quality of included RCTs was assessed using risk of bias assessment tool of the Cochrane Handbook 5.1.0. ResultsNine RCTs were identified, but no SRs/MAs was retrieved. Interventions for MCD included acupoint massage, moxibustion, auricular-plaster therapy, qigong, Tai chi, calligraphy, and food therapy of ginseng. All included RCTs showed that Tiao-She nursing of TCM was effective on cognitive ability and psychosocial function. ConclusionTiao-She nursing of TCM might be effective and safe, and the methods are variable. Due to the limitation of the quality of included RCTs, the efficacy and safety of Tiao-She nursing of TCM for MCD are still needed to be verified by high quality studies.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.