In recent years, clinical research in traditional Chinese medicine (TCM) has witnessed vigorous development, with increasingly close integration with clinical epidemiological methodologies. However, certain controversies persist, such as the difficulty in aligning epidemiology’s population-based perspective with TCM’s principle of syndrome differentiation and treatment and the characteristics of individualized diagnosis and treatment. This paper reviews the development and current status of TCM clinical research, integrating the practice rules of TCM, and analyzes the manifestations and applicability of the basic characteristics of epidemiology in TCM clinical research. The study shows that epidemiological concepts and characteristics are fully compatible with the practical features of TCM clinical practice and its research needs. Moreover, epidemiological techniques can effectively uncover and elucidate the scientific basis of TCM clinical practice. Building on these analyses, we propose future directions for TCM clinical research, aiming to promote the integration of epidemiology and TCM clinical research and advance TCM clinical research to a higher level.
There is huge clinical value in real world data from traditional Chinese medicine (TCM), but the real world study of TCM faces many challenges, because of its diverse data types, different standards, and serious data island phenomenon. Data governance is the key to transforming real world data into real world evidence. As the last step of data governance, data transformation has not been standardized. The key technologies and methods of data transformation, including data classification, natural language processing, standardization, data system construction, and derivative variables, will be discussed in this article based on the characteristics of real world data of TCM and the current development status of data transformation technology. At the same time, the suggestions of safety control and quality control of data transformation are put forward, and the data transformation system of real world study of TCM is preliminarily constructed, combined with the characteristics of TCM data. It is hoped that this paper can provide references for future real world studies of TCM.
A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
Evidence-based research is the essential method for the modernization of traditional medicine. China and Japan have made great progress in traditional Chinese medicine and Japanese Kampo medicine after years of evidence-based research, but there are also shortcomings. This paper compares the current situation of evidence-based research in traditional medicine from the aspects of the system of clinical evidence production and evaluation, standardization of clinical research report, standardization of traditional medicine in China and Japan, evaluation of the totality of clinical evidence via systematic review, application of clinical evidence via clinical practice guideline and development of research methodology. The purpose of this paper is to seek mutually complementary fields, and to provide enlightenment for future Chinese medicine and Japanese Kampo medicine evidence-based cooperation research.
Objective To explore the correlation between traditional Chinese medicine (TCM) blood stasis pattern of coronary heart disease (CHD) and coronary angiography result, so as to screen dangerous patterns and provide evidence for the objectification of TCM pattern differentiation. Methods Literature on correlation between blood stasis pattern and coronary angiography results from January 1992 to May 2012 were searched in the following databases: China Academic Journal Network Publishing Database (CAJD), Chinese Biomedical Literature Database (CBM), China Doctor Dissertation Full-text Database (CDFD), Chinese Selected Master’s Theses Full-Text Databases (CMFD), PubMed and MEDLINE. According to the inclusion and exclusion criteria, literature screening, data extraction and methodological quality assessment of the included studies were conducted. Then meta-analysis was performed using RevMan 5.1 software. Results A total of 28 studies involving 4 901 patients were included. The results of meta-analysis showed that, there is a significant significance between blood stasis pattern and the following coronary angiography result, namely, number of culprit vessels (OR=1.38, 95%CI 1.08 to 1.77, Plt;0.05), severity of stenosis (OR=1.79, 95%CI 1.04 to 3.08, Plt;0.05), and Gensini score (OR=7.74, 95%CI 3.99 to 11.49, Plt;0.05). Conclusion Compared with other TCM patterns, CHD with blood stasis pattern easily tends to present multi-vessels lesions, more than 75% stenosis and higher Gensini score, indicating the condition of CHD with blood stasis pattern is more severe than with other patterns. Due to the discrepancy of pattern differentiation and the limited quality of original studies, this conclusion is insufficient to be fully applied into clinical practice, and more large scale and high quality clinical trials are required.
ObjectiveTo systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. ResultsA total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. ConclusionTDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.
Objective To assess the quality of reporting of randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) in China from 1999 to 2004 by CONSORT statement and Jadad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine,ect using stratified sampling from about 100 journals of TCM in mainland China, and all issues of selected journals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs . A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials (CONSORT) checklist and Jadad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 (n=746), 0.82±0.63 (n=941), 0.90±0.61 (n=1 243), 1.03±0.60 (n=1 325), 1.12±0.58 (n=1 533) and 1.20±0.62 (n=1 634) respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 (standard deviation=5.78) of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation (1.1%), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random allocation sequence (0.0%) , analysis of intention to treat (0.0%), were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.
ObjectivesTo systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. MethodsCFDA, CNKI, VIP, WanFang Data, Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. ResultsA total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection (2.54%). The related factors of ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days, indication, dose and distribution of the tube. ConclusionsThe safety of traditional Chinese medicine injection is generally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic, and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
Objective To investigate inpatient disease constitution in Traditional Chinese Medicine (TCM) Hospital of Xinjiang Uygur Autonomous Region from 2008 to 2010, in order to provide baseline data for medicine allocation of hospitals in western China and development of TCM hospitals. Methods A questionnaire combined with a subject interview was carried out, and the case records of inpatients from 2008 to 2010 were collected. The diseases in discharge records were classified according to International Classification of Diseases (ICD-10) based on the first diagnosis. Data including general information of the inpatients, discharge diagnosis etc. were rearranged and analyzed by Excel software. Results a) The top four systematic diseases seen commonly from 2008 to 2010 were as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases were hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. Respiratory system diseases ranked the third in 2009 and 2010 from the fourth in 2008, and circulatory system diseases had ranked the first during the past three years; b) The following diseases as hypertension, bronchial emphysema and other chronic obstructive pulmonary diseases, diabetes, fractures, airway (bronchus, lung) cancer, and viral hepatitis were commonly seen in males rather than in females. By contrast, intervertebral disc disease, gallstone disease and cholecystitis, and anemia were commonly seen in females; and c) Hypertension was commonly seen in the aged above 60 years old; intervertebral disc disease mainly focused on the patients at the age of 15 to 59; and bronchial emphysema and other chronic obstructive pulmonary diseases, airway (bronchus, lung) cancer involved in the patients who were mostly over 60 years old. Conclusion a) The top four systematic diseases seen commonly from 2008to 2010 are as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases are hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. So these diseases should be taken into well consideration when making development plans by hospital and complementing essential drugs list by local development; b) Chronic diseases become the main disease for troubling Xinjiang population; and c) Male and female are susceptible to different diseases which should be rationally avoided in order to prevent the induced occurrence.
