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 compare the effectiveness of dressing by a combination of traditional Chinese medicine (TCM)-Western medicine (WM) after TCM bath and by the silver sulfadiazine cream (SD-Ag) in treating residual deep burn wound. Methods A total of 128 cases of residual deep burn wound between July 2003 and December 2009 were randomly divided into the TCM-WM treatment group (70 cases) and the WM control group (58 cases). In the treatment group, there were 45 males and 25 females with an average age of 38.6 years (range, 18-60 years), including 34 cases of flame burns, 28 cases of molten steel burns, and 8 cases of chemical burns with an average burn area of 57.6% total body surface area (TBSA) and an average residual wound of 7.4% TBSA. In the control group, there were 50 males and 8 females with an average of 37.9 years (range, 20-59 years), including 26 cases of flame burns, 12 cases of hot water burns, 16 cases of molten steel burns, and 4 cases of chemical burns with an average burn area of 56.5% TBSA and an average residual wound of 6.9%TBSA. There was no significant difference in general data between 2 groups (P gt; 0.05), so the cl inical data of 2 groups had comparabil ity. In the treatment group, the patients had a bath with TCM, and then the wounds were treated with dressing change of combined TCM-WM. In the control group, the wounds were treated with SD-Ag after cleaning the wounds with chlorhexidine solution. The pain, wound heal ing time, and the rate of scar formation were observed in 2 groups after treatment. Results According to wound pain classification after medication, the results were excellent in 23 cases, good in 30 cases, fair in 17 cases in the treatment group; were excellent in 17 cases, good in 20 cases, fair in 13 cases, poor in 5 cases, and fairly poor in 3 cases in the control group. The wound heal ing time of the treatment group (13.45 ± 4.74) days was significantly shorter than that of the control group [(23.87 ± 14.45) days, P lt; 0.05)]. After 2 weeks of treatment, scar occurred in 15 patients (21.4%) of the treatment group and 35 patients (60.3%) of the control group, showing significant difference (P lt; 0.05). Conclusion Based on TCM bath, a combination of TCM-WM for the residual burn wounds is obviously superior to SD-Ag. It has the advantages of rapid heal ing, l ight pain, no obvious scar, and short hospital ization time.
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.
Objective To evaluate the radiographic and postoperative function of computer navigation versus traditional methods for total knee arthroplasty through meta-analysis. Methods we searched the specialized trials registered in Cochrane muscle group, The Cochrane Library (CCTR), MEDLINE (1966 to 2009), EMbase (1980 to 2009), PubMed (1966 to 2009), NRR (http://www.update-software.com/National/), CCT (http://www.controlled-trials.com), and CBMdisc (1979 to July 2009), and we manually searched some Chinese orthoopaedics journals. Data were extracted and evaluated by two reviewers independently. Randomized controlled trials of computer navigation and traditional methods for total knee arthroplasty were included. The quality of the included trials was critically assessed. RevMan 4.2.8 software was used for data analysis. Results Eighteen RCTs of computer navigation and traditional methods for total knee arthroplasty were included. A total of 2 349 patients met the inclusion criteria for the review. The results showed that, computer navigation versus traditional methods for the total knee arthroplasty: a) about radiography: there was difference in the precise measurement of lower limbs mechanical axis (WMD= – 0.56, 95%CI – 0.74 to – 0.38, Plt;0.00001), but no obvious difference in measurement of the femoral frontal axis (WMD= – 0.29, 95%CI – 0.58 to 0.00, P=0.05), sagittal axis (WMD= – 1.64, 95%CI – 3.49 to 0.21, P=0.08) and angle of rotation (WMD= – 0.11, 95%CI – 0.87 to 0.66, P=0.79). Obvious difference was not found in the tibial frontal axis (WMD= – 0.31, 95%CI – 0.69 to 0.06, P=0.10), but found in the tibial sagittal axis (WMD= – 0.69, 95%CI – 1.10 to – 0.28, P=0.001). No difference was found in the tibiafemoral angle (WMD= 0.03, 95%CI – 0.78 to 0.84, P=0.95), patella tilt angle (WMD= – 1.45, 95%CI – 3.12 to 0.22, P=0.09) and patella angle of rotation (WMD= – 0.34, 95%CI – 0.71 to 0.02, P=0.06); b) there was obvious difference in operating time (WMD= 13.31, 95%CI 10.00 to 16.63, Plt;0.000 01), but no obvious difference in the complications (RR= 1.65, 95%CI 0.87 to 3.13, P=0.13) and the hemorrhage volume (WMD= – 74.81, 95%CI – 184.71 to 35.09, P=0.18); and c) about the evaluation of postoperative function: the follow-up in all studies was more than 6 months; there was no obvious difference in joint motion (WMD= – 2.17, 95%CI – 5.66 to 1.33, P=0.22), KSS scores (WMD= 6.28, 95%CI – 3.69 to 16.25, P=0.22), and OXFORD scores (WMD= – 0.31, 95%CI – 2.05 to 1.43, P=0.72). Conclusions Compared with traditional methods, computer navigation using for the total knee arthroplasty: a) is much accurate in measurement of the lower limbs mechanical axis and tibial sagittal axis, but is not superior in measurement of the femoral frontal axis, femoral sagittal axis, femoral angle of rotation, tibial frontal axis, tibiafemoral angle, patella tilt angle, and patella angle of rotation; b) may spend a longer operating time if not performed by proficient for it is a kind of new technique realm, but is similar in decreasing complications and hemorrhage volume; and c) is not obvious different in function evaluation after over 6 months follow-up which has to be further studied.
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.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.