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.
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.
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.
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.
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.
Objective To assess the clinical efficacy of stroke unit (SU) of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke. Methods Randomized or quasi-randomized controlled trials (RCTs or q-RCTs) were identified from CBM (1978-2009), CNKI (1994-2009), VIP (1989-2009), PubMed (1966-2009), MEDLINE (1978-2009), Scifinder (1998-2009), and The Cochrane Library (Issue 6, 2009), and relevant journals from Liaoning University of Traditional Chinese Medicine were also hand searched. Data were extracted and evaluated by two reviewers independently with a designed extraction form. RevMan5.0.23 software was used for data analyses. Results A total of 12 RCTs and q-RCTs involving 2 316 patients were included. Meta-analyses showed that, stroke unit of integrated traditional Chinese medicine and western medicine was superior to general medicine treatment (Plt;0.05) in case fatality rate one month after stroke (RR= 0.34, 95%CI 0.22 to 0.54), discharge NIHSS score (WMD= –1.01, 95%CI –1.52 to –0.51) and discharge OHS score (WMD= –0.48, 95%CI –0.78 to –0.18); and it was superior to SU of western medicine (Plt;0.05) in NIHSS score one week after stroke (WMD= –2.38, 95%CI –4.08 to –0.68), NIHSS score one month after stroke (WMD= –1.52, 95%CI –2.32 to –0.73) NIHSS score three months after stroke (WMD= –1.77, 95%CI –2.59 to –0.95), difference value of NIHSS score of hospital admission and discharge (WMD= –1.94, 95%CI –2.54 to –1.34), OHS score one month after stroke (WMD= –0.56, 95%CI –0.95 to –0.17) and OHS score three months after stroke (WMD= –1.05, 95%CI –1.44 to –0.66). Conclusion The current limited evidence shows that there is a significant difference between stroke unit of integrated traditional Chinese medicine and western medicine and general medicine treatment. Although there is no significant difference compared with SU of western medicine, it is superior in improving the functional impairment of nerve as well as disability of injury. More large-scale RCTs with high quality are required to verify the effect of stroke unit of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke.
Objective To investigate the effectiveness of teaching morning handover in clinical teaching of traditional Chinese medicine (TCM) in general hospitals. Methods A retrospective study was conducted at the Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University from April 2023 to March 2024, involving a total of 220 participants including interns, postgraduates/standardized training students, and residents/refresher students. The control group consisted of trainees who studied from April to September 2023, while the observation group included those who studied from October 2023 to March 2024. Teaching morning handover was added to the clinical morning report for the observation group, while the control group only conducted the conventional clinical morning report. Due to the differences in basic knowledge and clinical positioning, trainees except interns were classified as clinical residents. A questionnaire survey including satisfaction of teaching content, teaching methods, teaching ability and teaching management and graduation assessment including total score, theoretical assessment score, clinical process score and participation in teaching activities were compared between the two groups. Results Compared with those of the interns (n=57) and clinical residents (n=49) in the control group respectively, there was no statistically significant difference in satisfaction of teaching content, teaching methods or teaching ability of the interns (n=78) and clinical residents (n=36) in the observation group (P>0.05); however, teaching management satisfaction was significantly improved (interns P=0.002, clinical residents P=0.022). Both the interns and clinical residents in the observation group had a significantly higher total score as well as theoretical assessment score and increased participation in teaching activities (P values for interns were <0.001, 0.001, and <0.001, respectively, and for clinical residents were <0.001, 0.013, and <0.001, respectively). However, there was no significant difference observed between groups regarding clinical process score (P>0.05). Conclusion Teaching morning handover is helpful in improving the quality of TCM teaching in general hospitals and is an effective model for clinical teaching of TCM.
Objective To discuss the rules of using traditional Chinese medicine (TCM) to treat systemic lupus erythematosus (SLE) and Sjögren syndrome (SS). Methods The TCM prescriptions for patients with SLE or SS treated at the Department of Rheumatology of Longhua Hospital, Shanghai University of Traditional Chinese Medicine between January 2013 and July 2021 were collected. The prescriptions collected were broken down and analyzed for frequencies of the efficacies, properties, flavors and meridian tropisms of drugs in the prescriptions. The correlation and clustering analysis was performed in VOSviewer software. Results The medication information of 3689 cases of inpatients was included, from which 69167 pieces of data of using TCM prescriptions were extracted. The top 20 high-frequency drugs for treating SLE patients were mainly drugs for promoting blood circulation and removing blood stasis, qi-tonifying drugs, and drugs for heat clearing and detoxicating, which were mostly sweet, bitter or acrid in flavor, cold, warm or neutral in properties, and of the spleen, liver or stomach meridian. The drugs could be seperated into 3 clusters, the blue cluster mainly included qi-tonifying drugs, blood-tonifying drugs, and drugs for promoting blood circulation and removing blood stasis; the green cluster mainly included drugs for heat clearing and drugs for promoting blood circulation and removing blood stasis; and the red cluster mainly consisted of drugs for promoting blood circulation and removing blood stasis, drugs for inducing diuresis and alleviating edema, drugs for dispelling wind-heat, and digestant drugs. The top 20 high-frequency drugs for treating SS patients were mainly drugs for promoting blood circulation and removing blood stasis, qi-tonifying drugs, and drugs for inducing diuresis and alleviating edema, which were mostly sweet, bitter or acrid in flavor, slightly cold, cold or warm in properties, and of the spleen, stomach or liver meridian. The drugs could be seperated into 2 clusters, the green cluster mainly consisted of yin-tonifying drugs, drugs for promoting blood circulation and removing blood stasis, and drugs for heat clearing; the red cluster mainly included qi-tonifying drugs, drugs for promoting blood circulation and removing blood stasis, and drugs for inducing diuresis and alleviating edema. Conclusions The medication for SLE is in line with the treatment principle of “supplementing qi and nourishing yin, detoxicating and removing stasis”; the medication for SS, on the other hand, agrees with the basic rule of “nourishing yin and clearing away heat, promoting body fluid to moisten dryness”. Both are based on the approach of strengthening the body resistance, which is in line with the diagnostic and treatment ideas of rheumatology department and may offer the ideas of TCM syndrome differentiation for clinical use of drugs and thereby guiding the current clinical practice.
Acute pancreatitis (AP) is a common clinical emergency of the abdomen with increasing incidence and lack of effective treatment. Traditional Chinese medicine, as a treasure of the Chinese people, has been used in the treatment of AP for decades with favorable therapeutic effects. Currently, clinical trials and experimental studies have shown that traditional Chinese medicine has the effects of inhibiting pancreatic enzyme activity, anti-inflammation, promoting gastrointestinal dynamics, as well as delaying the progress of AP, improving clinical symptoms, reducing related complications, and reducing the mortality rate. Therefore, traditional Chinese medicine has considerable clinic value in treating AP. Based on the related research progress and clinical practice of our team, the authors summarized the targets and mechanism of traditional Chinese medicine in treating AP.
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.