ABSTRACT
Determining effective traditional Chinese medicine (TCM) treatments for specific disease conditions or particular patient groups is a difficult issue that necessitates investigation because of the complicated personalized manifestations in real-world patients and the individualized combination therapies prescribed in clinical settings. In this study, a multistage analysis method that integrates propensity case matching, complex network analysis, and herb set enrichment analysis was proposed to identify effective herb prescriptions for particular diseases (e.g., insomnia). First, propensity case matching was applied to match clinical cases. Then, core network extraction and herb set enrichment were combined to detect core effective herb prescriptions. Effectiveness-based mutual information was used to detect strong herb-symptom relationships. This method was applied on a TCM clinical data set with 955 patients collected from well-designed observational studies. Results revealed that groups of herb prescriptions with higher effectiveness rates (76.9% vs. 42.8% for matched samples; 94.2% vs. 84.9% for all samples) compared with the original prescriptions were found. Particular patient groups with symptom manifestations were also identified to help investigate the indications of the effective herb prescriptions.
Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Child , Female , Humans , Male , Middle Aged , Young Adult , Case-Control Studies , China , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Propensity Score , Sleep Initiation and Maintenance Disorders , Drug TherapyABSTRACT
Syndromes of coronary heart disease with angina pectoris were analyzed to provide guidance for clinical practice and to improve accuracy of traditional Chinese medicine (TCM) diagnoses and efficacy of TCM treatment. A total of 860 cases with coronary heart disease with angina pectoris were selected from TCM Clinical Research Information Sharing System for TCM clinics and research. Syndromes were automatically extracted with the cluster method and were analyzed to provide objective evidence for clinical studies. Final syndrome classifications were recognized and confirmed by clinical experts. Popular syndromes included Qi and blood deficiency, blood stasis and obstruction collaterals, liver depression and spleen deficiency, and Qi stagnation and blood stasis. Syndromes Qi and blood deficiency and blood stasis and obstruction collaterals accounted for 28.61% of total syndromes, whereas liver depression and spleen deficiency and Qi stagnation and blood stasis accounted for 26.44%. The main syndrome elements comprised Qi deficiency, blood deficiency, blood stasis, and Qi stagnation.
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Angina Pectoris , Diagnosis , Therapeutics , Cluster Analysis , Coronary Disease , Diagnosis , Therapeutics , Diagnosis, Differential , Hemostasis , Medicine, Chinese Traditional , SyndromeABSTRACT
Premature ovarian insufficiency (POI) is characterized by amenorrhea before age 40 with raised FSH level and decreased E2 level. POI, as a main reason for infertility, poses great threat on patients. physical and psychological health.By reviewing clinical trials of acupuncture in treating premature ovarian insufficiency, this study focuses on the significance and feasibility of patient registry about acupuncture therapy for premature ovarian insufficiency. Patient registry can be used in collecting real-world evidence and exploring effective intervention to improve pregnancy rate
ABSTRACT
With the increasing popularity of acupuncture therapy in the world, the safety of acupuncture has attracted more attention. The objective and impartial assessment of the safety of acupuncture becomes very important. The "adverse events of acupuncture" and "adverse reactions of acupuncture" are the common concepts in the research of acupuncture safety. In the paper, on the basis of the conceptual characteristics of "adverse events" and "adverse reactions" and in combination with the particular characteristics of acupuncture itself, the connation and features of the concepts of the "adverse events of acupuncture" and "adverse reactions of acupuncture" are analyzed. The interaction and differences are summarized. Both "adverse events of acupuncture" and "adverse reactions of acupuncture" are in the category of adverse medical events. The "adverse events of acupuncture" includes the damages induced by acupuncture therapy and also those without relationship with acupuncture therapy. The "adverse reactions of acupuncture" refers to the adverse outcomes induced by acupuncture therapy specially. It has the definite relationship with acupuncture therapy. Hence, the application of "adverse reactions of acupuncture" is more objective and accurate in the assessment of acupuncture safety.
ABSTRACT
As the new development of scientometrics and informetrics, knowledge graph has infiltrated into the financial, industrial and medical fields, and become a hot issue in the real world research. In this article, the concept and features of knowledge graph, construction and the existing softwares, the application status and development prospect in the TCM field were reviewed, which may provide references for research on the knowledge graph in the TCM field.
ABSTRACT
Objective To evaluate the effects of low blood sugar production index (LGI) combined with low blood sugar production burden (LGL) dietary intervention on blood glucose, oxidative stress and anthropometric indicators in type 2 diabetes mellitus. Methods A total of 150 cases of type 2 diabetes were randomly divided into two groups,maintain the original treatment plan of two groups,75 patients in the control group were given traditional food interchange method for dietary intervention;the experimental group of 75 patients, provide food education based on LGI+LGI food exchange method , the time period of 3 months. Fasting blood glucose (FPG)、2h postprandial blood glucose (2hPG), Glycated hemoglobin (HbAlc), Superoxide dismutase (SOD), Malondialdehyde (MDA), Vitamin C, Vitamin E, Body Mass Index (BMI), Waist circumference (WC) Upper arm muscle circumference (AMC), Triceps skin fold thickness (TSF) were observed before and after the intervention. Results There were no significant differences in blood glucose, oxidative stress and anthropometry between the two groups (P>0.05). After intervention, in the control group: FPG, 2hPG, HbAlc, SOD, MDA, Vitamin C, Vitamin E, BMI, WC, AMC, TSF were (10.27 ± 2.67) mmol/L, (11.51 ± 2.54) mmol/L, (8.78 ± 1.95)%, (322.73 ± 51.97) kU/L, (5.80 ± 1.76)μmol/L, (40.78±4.86)μmol/L, (19.33±4.79)μmol/L, (23.94±3.18) kg/m2, (89.57±10.23) cm, (24.10± 3.01) cm, (18.38 ± 3.79)mm respectively. In the experimental group: they were (8.76 ± 2.77) mmol/L, (10.63 ± 1.76) mmol/L, (7.96 ± 1.86)%, (357.29 ± 60.04) kU/L, (5.26 ± 1.33)μmol/L, (44.01 ± 7.06)μmol/L, (21.58 ± 5.25) μmol/L, (22.93 ± 2.75) kg/m2, (86.05 ± 10.79) cm, (22.75 ± 2.86) cm, (16.98 ± 4.48) mm respectively. There was significant difference between the two groups after intervention (t=2.049-3.769, all P < 0.05). In the experimental group, the improvement of blood sugar, oxidative stress and anthropometry was better than that of the control group (P < 0.05). Conclusions LGI combined with LGL diet intervention is better than the traditional method of food interchange, the blood glucose, oxidative stress and anthropometric indicators have improved, which can improve treatment efficacy in type 2 diabetes and easy for home self-management.
ABSTRACT
Acupuncture-moxibustion has been used in more than 180 countries,but high quality evidences for its efficacy and safety are still insufficient,which is a key issue limiting the development of acupuncture-moxibustion.Combined with characteristics of acupuncture-moxibustion discipline,this study was aimed to use international patient registry to collect real world clinical data and design meaningful clinical outcome in order to exploit the efficacy and safety of acupuncture-moxibustion and to provide important basis and supplement for confirmatory research.This paper summarized key technologies of international patient registry study for acupuncture-moxibustion based on real world to guide the design,implementation and evaluation.
ABSTRACT
This paper systematically summarized the core problems in the field of medical and health services and did the root analysis.It is concluded that the current domestic and international related medical service modes deviated from the essence of health services and led to difficulties in the idea and method,bringing people to new problems and new crises.KY3H health care service model,set innovative ideas,innovative technical methods,innovative products,innovative processes,standards and standards into one,by providing a full range and the whole cycle of people-oriented,self-help,"diagnosis and treatment of security" integration of health careservice,improve people's health status,fundamentally change the traditional passive "seeking medical treatment" service mode,to active "seeking one's own" health service mode,so as to achieve "health status continues to rise,the medical costs continue to decline,"which is the social development aims.The paper systematically analyzes the idea,operational logic,goal,mode structure,characteristics of the model,and its significance to individuals,industries,society,countries and even the international community in order to make a positive contribution to the healthy development strategy in China and provide a Chinese case for global Health.
ABSTRACT
This study was aimed to assess scales with the unidimensional item response models (UIRM) and classical test theory.The reliability and validity of 841 sub-health status samples were analyzed by CTT.Surveying evaluation from the project perspective was also conducted.The results showed that Cronbach'so coefficients in five areas were all larger than 0.6 with relatively high consistency.The scale structures of five areas were relatively good and the CFI was 0.96.When discriminations of all items were larger than 0.3,the sensitivity of item for its area was high.When the scale test information was 33.8,the accuracy of sub-health status was relatively high.However,there were still some items should be further revised.It was concluded that UIRM can be used to evaluate the psychological measurement performance in the project.It is a supplement to the evaluation result of classical test theory.The reliability and validity of sub-health status scale are relatively high.After IRT correction,it can be used for human-computer interaction techniques “preventive treatment” dynamic monitoring.
ABSTRACT
As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.
ABSTRACT
Acupuncture is developing rapidly in the world, and more attention is paid on acupuncture in various countries. Because of the cultural differences, there are different views on acupuncture between China and the west, which has brought influence and challenge to the development of acupuncture in the world. Acupuncture-related research is becoming increasingly extensive and complex, but the definition of acupuncture is lack of unified standards. The definition of acupuncture is in urgent need. Based on the analysis of acupuncture definition in the 201 international organizations of 48 countries on five continents and legislation of representative countries, this paper summarized the development status of acupuncture in foreign countries, and put forward that the definition of acupuncture should adopt the model of small connotation and large extension, integrate discipline superiority, expand the scope of acupuncture, and focus on the overall situation.
ABSTRACT
This article summarized and analyzed problems about clinical evaluation of new traditional Chinese medicine, including the staging and dynamics in clinical research stage, indexes of therapeutic evaluation, and post-marketing revaluation. It also proposed that the research and development of new traditional Chinese medicine should attach importance to clinical efficacy and conduct clinical evaluation reasonably. The article provides references for research and development of new traditional Chinese medicine.
ABSTRACT
Based on a retrospective study design, this article was aimed to discuss the transformation path and method of hospital medical records information into analyzable data, in order to solve the problem of text-based information digitalization, and improve the credibility of statistical results. The hospital medical records information of traditional Chinese medicine (TCM) treatment for infantile cerebral palsy was taken as example. After the identification of research purpose, the study contained 8 steps, which were index identification, index definition, coding and assignment, database design, data entry, quality control, and database locking. The database contained research-related indicators was received. The results showed that a set of path and method based on indicator extraction and conversion of hospital medical records information into data. It was concluded that in the retrospective study design, the conversion of text information into analyzable data was the key step. Extraction and digitalization of indicators should be based on the research plan. Key elements such as the crowd, treatment plan, evaluation indicator, should be paid attention to for the systematic analysis, in order to ensure the system integrity of research indicators.
ABSTRACT
This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
ABSTRACT
Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.
ABSTRACT
This study was aimed to compare the criteria on quality of questionnaire development and psychometric property evaluation. The references listed in the ISOQOL and consequent included criteria were searched. Two reviewers independently screened papers to include articles with inclusion criteria as follows: fully evaluating the questionnaire development and/or psychometric property; published or unpublished, but not book. Two reviewers independently extracted the information which contained criteria name, types of questionnaire assessed, criteria purpose, research methods, content, evaluation method and etc. Qualitative analysis was conducted to synthesize common characteristics of criteria, and to compare what each criterion emphasized on. The results showed that 9 included criteria sharing the same purpose which evaluated the questionnaire development process and/or psychometric properties of the health related quality of life questionnaire or patient reported outcome. Experts consensus based on previous studies were the criteria development methods. The standard content included conceptual framework, targeted population, content validity, internal consistency, test-retest reliability, structure validity and responsiveness with interpretability. Assessment scoring system used in the criteria was categorized as 2- or 4-point Likert scales. Or document of evaluation evidence was required to be provided. It was concluded that nine criteria can be used to develop new questionnaires, evaluate existed/new questionnaires, or choose the right questionnaires for clinic, based on the following elements such as their research purpose, trials types, questionnaire types or questionnaire administrations.
ABSTRACT
Objective To analyze the relationship between fasting plasma glucose (FPG) level and complexity of coronary artery lesions in patients with coronary stenosis by angiography. Methods The data of clinic and coronary angiogram (CAG) were retrospectively collected in 929 patients with established coronary stenosis by coronary angiography at Peking University Third Hospital from January 2009 to January 2011. The patients were grouped according to SYNTAX score, and the relationship between FPG level and SYNTAX score were analyzed using bivariate, Multivariate stepwise regression and logistic regression analysis. Results ①929 patients were devided into three groups:47 cases into low risk group (score<22), 189 into moderate risk group (score≥22 and<33) and 639 into high risk group (score≥33). Intergroup analysis showed that age (P=0.000), FPG level [5.20 (4.70,6.30) mmol/L, 5.70 (4.90,7.15) mmol/L, 5.80 (5.30,7.60) mmol/L, P=0.000], proportions of FPG abnormality [283 (40.8%), 100(52.9%), 28(59.6%), P=0.001] and patients with diabetes history (P=0.003) were increased along with SYNTAX score elevated.②Correlation analysis showed correlativity (r=0.167, P=0.000) between SYNTAX score and FPG. In non-diabetes history subgroup, correlation between SYNTAX score and FPG remained signiifcant (r=0.149, P=0.000). However, in diabetes history subgroup, the correlation was not significant. ③ Multivariate stepwise regression analysis showed an independent correlation between FPG and SYNTAX score (β=0.452, P=0.002). In non-diabetes history subgroup, the correlation remained significant (β=1.039, P=0.000).④ When moderate-high risk group serve as dependent variable, and age, gender, CAD risk factors and FPG serve as independent variables, logistic regression analysis screened out two variables:age (whole group:OR 1.033, 95%CI 1.017 ~ 1.049, P=0.000;non-diabetes history subgroup:OR 1.039, 95%CI 1.020 ~ 1.059, P=0.000) and FPG (whole group: OR 1.114, 95% CI 1.038 ~ 1.195, P=0.003; non-diabetes history subgroup:OR 1.299, 95%CI 1.088 ~ 1.387, P=0.001). Conclusions FPG is likely to relfect complexity of coronary artery lesions and predict SYNTAX score in patients with coronary stenosis, especially in patients without diabetes history.
ABSTRACT
The sub-health status is closely related to the functions and activities of heart in traditional Chinese medicine (TCM). The sub-health is commonly presented with a series of heart system symptoms such as palpitation, chest distress, shortness of breath, fatigue, fidgets and insomnia. It may also be accompanied with arrhythmia or blood pressure value between normal and high level. This heart system sub-health status can be transformed into re-lated heart system diseases with high possibility. This article made a review from aspects of theoretical literature, an-imal experiment, curative effect observation and clinical evaluation on the research progress of heart system sub-health status.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the statement on randomized controlled trials on Wenxin granule for treatment of atrial fibrillation and to judge whether those trials could offer high quality evidence or not, thus improve design level and quality.</p><p><b>METHOD</b>RCTs were searched from home and abroad about atrial fibrillation treated with Wenxin granule, which reported before October, 2010. Jadad scale and CONSORT statement were used.</p><p><b>RESULT</b>There were 66 RCTs retrieved that met inclusion criteria. Using Jadad rating scale, only 2 literatures gain score 4 and 1 literature gains score 3, 54 literatures gain score 2, 7 literatures gain score 1, 2 literatures gain score 0. Only 2 literatures described random number table as the method of grouping. None of the RCTs was reported the allocation concealment. Only 1 literature was used blinding. Fifty-nine literatures were mentioned the lost to follow-up conditions. According to the CONSORT standards, only six literatures (9.1%) mentioned the method of generating the random sequence. Four literatures (6.1%) were quasi-random. Nineteen literatures (28.8%) had inclusion criteria. Six literatures (9.1%) had the follow-up record. Fifty one literatures (77.3%) described the adverse events. None had the estimation of the sample size, intention-to-treat analysis and stratified analysis. None had the ethical approval or informed consent.</p><p><b>CONCLUSION</b>The quality of clinical trials of Wenxin granule in treating atrial fibrillation needs to be improved.</p>
Subject(s)
Humans , Atrial Fibrillation , Drug Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Randomized Controlled Trials as TopicABSTRACT
Chronic lung diseases, including bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, allergic rhinitis and repeated respiratory tract infection (RRTL) in infants, exacerbate frequently in winter because of respiratory viral infections and low temperature. Summer acupoint application therapy (SAAT) is thought to be effective in reducing exacerbation frequency of chronic lung diseases in winter. It is a kind of therapy using a herbal mixture for external application on special acupoints during summer. The herbal mixture basically contains Semen Sinapis Albae, Herba Asari, Radix Euphorbiae Kansui and Rhizoma Corydalis. The acupoints include Feishu (BL13), Dazhui (GV14) and Danzhong (CV17). Through a large-scale multicenter trial based on three years of clinical observation, and retrospective and prospective analyses, this study aims to explore the efficacy of SAAT.