Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
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.
Inconsistency, impracticability and non-standardization of the selection, measurement and reporting of outcomes are three primary existing issues in clinical trials. These problems pose a threat to huge research waste when the results of similar studies are not able to be combined or compared. The key for resolution will be to standardize outcomes in traditional Chinese medicine (TCM) clinical trials and to establish a core outcome set (COS), which is a set of outcomes to be reported as a minimum in all TCM clinical trials of similar healthcare system and syndromes. The first step in the development of COS is to collect all existing outcomes, that is, to build a pool of outcomes for clinical trials of TCM. A pool of outcome is the basis of developing COS, which is important to follow strict and scientific methodology. This paper aims to construct an outcome pool from published literature, clinical trial registration protocols, and clinicians, and patients questionnaires were used to form a list of outcomes. In addition, the influencing factors of constructing an outcome pool and considerations for each problem are summarized in order to provide guidance and reference for the development of COS in clinical trials for TCM.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Research on the Chinese medicine standardized calendar is not only required for the development of evidence-based pharmacy, but it is also needed in order to adapt to, and promote, clinical rational use of Chinese medicine. The experience of the clinical calendar is summarized in this article. This may provide some significant clues and basis for the design and conduct of research when constructing a Chinese medicine standardized calendar.
ObjectiveTo systematically review the efficacy of Chinese medicine for endometrial hypoplasia.
MethodsDatabases such as PubMed, EMbase, MEDLINE (Ovid), The Cochrane Library (Issue 8, 2014), CNKI, VIP and WanFang Data were searched for randomized controlled trials (RCTs) and quasi-RCTs concerning the efficacy of Chinese medicine for endometrial hypoplasia up to August 2014. According to the inclusion and exclusion criteria, two reviewers screened literature, extracted data, and assessed methodological quality of included studies. Then meta-analysis was performed using RevMan 5.3 software.
ResultsA total of 5 RCTs and 6 quasi-RCTs involving 914 patients were included. The results of meta-analysis showed that Chinese medicine group was superior to control group in endometrial thickness (MD=0.86, 95%CI 0.35 to 1.37, P=0.000 01), clinical pregnancy rates (RR=2.62, 95%CI 2.02 to 3.38, P<0.000 01), endometrial morphous (RR=1.23, 95%CI 1.06 to 1.42, P=0.005), PI of uterine artery blood flow (MD=-0.54, 95%CI -0.80 to -0.28, P<0.000 1), RI of uterine artery blood flow (MD=-0.12, 95%CI -0.17 to -0.08, P<0.000 1), and estradiol level (MD=96.03, 95%CI 44.32 to 144.74, P=0.003); However, the two groups were alike in progesterone level without significant difference (MD=2.00, 95%CI -0.64 to 4.65, P=0.14).
ConclusionCurrent evidence indicated that, Chinese medicine is beneficial for endometrial hypoplasia. Due to limited quantity and quality of the included studies, the above conclusion still needs to be verified by conducting more high quality studies.
Objective To investigate the effectiveness of teaching morning handover in clinical teaching of traditional Chinese medicine (TCM) in general hospitals. Methods A retrospective study was conducted at the Institute of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University from April 2023 to March 2024, involving a total of 220 participants including interns, postgraduates/standardized training students, and residents/refresher students. The control group consisted of trainees who studied from April to September 2023, while the observation group included those who studied from October 2023 to March 2024. Teaching morning handover was added to the clinical morning report for the observation group, while the control group only conducted the conventional clinical morning report. Due to the differences in basic knowledge and clinical positioning, trainees except interns were classified as clinical residents. A questionnaire survey including satisfaction of teaching content, teaching methods, teaching ability and teaching management and graduation assessment including total score, theoretical assessment score, clinical process score and participation in teaching activities were compared between the two groups. Results Compared with those of the interns (n=57) and clinical residents (n=49) in the control group respectively, there was no statistically significant difference in satisfaction of teaching content, teaching methods or teaching ability of the interns (n=78) and clinical residents (n=36) in the observation group (P>0.05); however, teaching management satisfaction was significantly improved (interns P=0.002, clinical residents P=0.022). Both the interns and clinical residents in the observation group had a significantly higher total score as well as theoretical assessment score and increased participation in teaching activities (P values for interns were <0.001, 0.001, and <0.001, respectively, and for clinical residents were <0.001, 0.013, and <0.001, respectively). However, there was no significant difference observed between groups regarding clinical process score (P>0.05). Conclusion Teaching morning handover is helpful in improving the quality of TCM teaching in general hospitals and is an effective model for clinical teaching of TCM.
Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
The traditional Chinese medicine has played an important role in the prevention and control of coronavirus disease 2019 (COVID-19). Based on the role of traditional Chinese medicine in dealing with the previous epidemics and COVID-19, this paper analyzes the problems and challenges of current situation, and focuses on improving traditional Chinese medicine scientific identification, strengthening the construction of traditional Chinese medicine system, and increasing the intensity of Chinese and Western medicine and so on. In order to improve the cooperation mechanism of Chinese and Western medicine for epidemic prevention and control, and give full play to the role of traditional Chinese medicine in the construction of national public health emergency system, this paper also gives ten corresponding suggestions.
