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.
Traditional Chinese Medicine (TCM) standardization is an important carrier for TCM inheriting and innovating. As an important content of TCM standardization system, TCM clinical practice guidelines' designation and revision play an important role for medical staff to regulate medical behavior, and improve the quality of health services. This paper expounds the significance and function of the TCM guidelines, analyzes the present situation, opportunities and challenges, and puts forward the strategies and suggestions to promote the development of evidence-based TCM guidelines.
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.
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.
Objective To analyze the heterogeneity of systematic reviews (SRs)/Meta-analysis on traditional Chinese medicine (TCM), and explore strategies for addressing heterogeneity correctly during the process of conducting TCM related to systematic reviews (SRs). Methods Both electronic and hand searches were used to identify TCM SRs in CBM, CNKI, VIP database, and Chinese Journal of Evidence-Based Medicine. Two researchers performed data extracting and heterogeneity evaluation independently. Results A total of 115 TCM SRs were included, involving 17 types of diseases, among which the cardiovascular and cerebrovascular diseases were the most addressed (n=36, 31.30%). There were 35.65% (n=41) of SRs which integrated two or more types of studies; interventions of the included studies were inconsistent in 53.91% (n=62) of TCM SRs; control groups of the included studies were completely different in 60 (52.17%) SRs; and 8.7% (n=10) of SRs failed to investigate heterogeneity in the process of synthesis analysis. Conclusion The heterogeneity is common in TCM related to SRs, and the most addressed is clinical heterogeneity. Addressing heterogeneity incorrectly would downgrade the quality of TCM related to SRs.
The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
Objectives To discuss the methodology of evaluation of traditional Chinese medicine (TCM) placebo simulation effects and the problems of blind implementation and so as to improve the quality of double-blind clinical trials of TCM. Methods Focusing on case of placebo preparation of TCM investigational new drug, simulation effects of the placebo were evaluated in terms of shape, color, taste and smell. The possibility of placebo be a drug and the similarity between placebo and drug were tested. Results There was no significant difference between placebo and investigational new drug to be judged as a drug (P>0.05). As for the similarity between placebo and drug, there was no significantly difference of the shape (P>0.05), for which the similarity was 100%. The color, taste and smell were significant different between placebo and drug (P<0.05), for which the similarity were 50%, 10% and 15% respectively. Conclusions It is very difficult to simulate TCM based on its certain color, taste or smell. Therefore, the subjects and the investigators’ compliance should be kept to avoid breaking the blind intentionally in the process of the trial and the influence of unblinding should be estimated at the end of the trial.
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.
Objective To explore the recognition capabilities of electronic nose combined with machine learning in identifying the breath odor map of benign and malignant pulmonary nodules and Traditional Chinese Medicine (TCM) syndrome elements. MethodsThe study design was a single-center observational study. General data and four diagnostic information were collected from 108 patients with pulmonary nodules admitted to the Department of Cardiothoracic Surgery of Hospital of Chengdu University of TCM from April 2023 to March 2024. The patients' TCM disease location and nature distribution characteristics were analyzed using the syndrome differentiation method. The Cyranose 320 electronic nose was used to collect the odor profiles of oral exhalation, and five machine learning algorithms including random forest (RF), K-nearest neighbor (KNN), logistic regression (LR), support vector machine (SVM), and eXtreme gradient boosting (XGBoost) were employed to identify the exhaled breath profiles of benign and malignant pulmonary nodules and different TCM syndromes. Results(1) The common disease locations in pulmonary nodules were ranked in descending order as liver, lung, and kidney; the common disease natures were ranked in descending order as Yin deficiency, phlegm, dampness, Qi stagnation, and blood deficiency. (2) The electronic nose combined with the RF algorithm had the best efficacy in identifying the exhaled breath profiles of benign and malignant pulmonary nodules, with an AUC of 0.91, accuracy of 86.36%, specificity of 75.00%, and sensitivity of 92.85%. (3) The electronic nose combined with RF, LR, or XGBoost algorithms could effectively identify the different TCM disease locations and natures of pulmonary nodules, with classification accuracy, specificity, and sensitivity generally exceeding 80.00%.ConclusionElectronic nose combined with machine learning not only has the potential capabilities to differentiate the benign and malignant pulmonary nodules, but also provides new technologies and methods for the objective diagnosis of TCM syndromes in pulmonary nodules.
Big data technology is an inevitable result of the information age, which not only promotes the development of biomedical science, but also opens up new paths for the development of traditional Chinese medicine (TCM). This paper introduced the application status of big data technology in the field of TCM in recent years, and put forward some thinkings and prospects so as to provide new insights and methods for the future development direction of TCM.