Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
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.
ObjectiveTo evaluate the efficacy of western conventional treatment based on traditional Chinese medicine retention enema on patients with hepatic encephalopathy. MethodsSuch databases as the Cochrane Library, PubMed, EMbase, VIP, CNKI, CBM and WanFang Database were searched from the inception to November 2013 to collect randomized controlled trials (RCTs) about Western conventional treatment based on traditional Chinese medicine retention enema to treat hepatic encephalopathy, and the references of the included literature were also retrieved. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and evaluated and cross-checked the methodological quality. Then meta-analysis was conducted using RevMan 5.1 software. ResultsA total of 26 RCTs involving 1 691 patients were included. The subgroup analyses based on the length of intervention time showed that when the course of treatment intervention was less than one, the overall effective rate of the Chinese herbal retention enema group was higher than that of the control group, with a significant difference[RR=1.34, 95%CI (1.25, 1.44), P<0.000 01]; after more than one course of treatment intervention, the overall effective rate of the Chinese herbal retention enema group was higher than that of the control group, with a significant difference[RR=1.34, 95%CI (1.21, 1.48), P<0.000 01]. ConclusionOn the basis of available evidence, the western medicine treatment based on traditional Chinese medicine retention enema for hepatic encephalopathy has a certain effect. However, the heterogeneity among the included studies is large. It is necessary to design multicenter, strictly randomized and double-blind test controlled trials with large samples to validate these conclusions and to further confirm the clinical curative effect.
The method of evaluating clinical efficacy of traditional Chinese medicine is one of the hotspots in the field of traditional Chinese medicine in recent years. How to dynamically evaluate individual efficacy is one of the key scientific problems to explain the clinical efficacy of traditional Chinese medicine. At present, there are no recognized methods of evaluating individual efficacy of traditional Chinese medicine. In this study, we provided a method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials after analyzing the current status of researches on methods of evaluating individual efficacy of traditional Chinese medicine. This method has the advantages of both N-of-1 trials and Bayesian multilevel models. It is feasible to evaluate individual efficacy of traditional Chinese medicine from the perspective of the design and analysis method. This study can provide an important basis for enriching and improving the methodology of evaluating individual efficacy of traditional Chinese medicine.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treatingchronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs included the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integrated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported.Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTsof high quality and large scale are required.
We described our understanding of EBM, the ‘three principles＇ and ‘five steps＇ to practice it. EBM is an embodiment of human moral rule and axiom in clinical medicine; it is an advanced clinical model and medical practical methodology; it results from a basis of developed and perfected clinical research methodology, best evidence database, information technology. We also discussed the relationship between EBM and traditional Chinese medicine （TCM） modernization. The definition of modernization of TCM was suggested as scientifical standardization and internationalization. TCM theory in fact is not a basic but a clinical practice theory. EBM model should become the standard model of TCM practice to accelarate the standardization of TCM diagnostic technique and therapy. The key is not try to explain TCM theories with modern medical theroies, but work out common effectiveness evaluation criteria. Only when the effectiveness is intemationally acknowledged, can TCM be internationalized.