Objective To assess the quality of randomised controlled trials on traditional Chinese medicine (TCM) for coronary heart disease (CHD) angina published from 1977 to 2002. Method We did electronic search in Medline, Embase and hand searched 83 journals of traditional Chinese medicine (the earliest published in 1977 and the latest in June 2002). We assessed the quality of obstained studies. Results Four hundred and forty articles met the criteria,of which 33 (7.5%) described randomization. None of them mentioned allocation concealment; 94.77% (417 studies) mentioned diagnosis criteria; only one mentioned the calculation basement of sample size; 84.09% (370 studies) mentioned comparability of baseline. Fifty three studies (12.05%) noted double-blind; 28 studies used single blind. Twenty-five studies used double-blind. Drop-outs were described in 7 cases without intention-to-treat (ITT); 159 studies applied statistical methods properly, while 4 did not. Ten studies never mentioned statistical methods; 73.18％ (322 studies) used forms to express their results. Conclusions Till now, the quantity and quality of RCTs of traditional Chinese medicine for coronary heart disease angina were inadequate. Some well designed scientific methods were not adequately applied.
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.
ObjectiveTo investigate the chronic insomnia incidence and traditional Chinese medical (TCM) constitution of students in Southern Medical University, in order to discover the correlation between chronic insomnia and TCM constitution.
MethodsA survey by means of the TCM Constitution Scales, the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and the Deep Sleep Scale (DSS) in 110 participants studying in Southern Medical University between September 2009 and July 2014 was conducted. We analyzed the characteristics of chronic insomnia in subjects of qi-deficiency type and gentleness type.
ResultsA total of 115 questionnaires were sent out, and 110 were recovered with a recovery rate of 95.65%. All the 110 questionnaires were useful and the effective rate was 100%. There were 34 cases of gentleness type and 44 cases of qi-deficiency type in the 110 participants. It was found that qideficiency type got significantly different scores for all the three types of scales, compared with gentleness type (P＜ 0.01) . Meanwhile, qi-deficiency type showed significant differences in terms of sleep quality, sleep time, sleep disorder and daytime dysfunction from gentleness type (P＜ 0.05) . We also found that the incidences of shallow sleep and insomnia for qi-deficiency type were higher than those for gentleness type (P=0.002, 0006) , respectively. Finally, it was detected that the level of insomnia for qi-deficiency type was higher than that for gentheness type (P＜ 0.01) . Conclusions This study has revealed that there is a statistically significant association between qi-deficiency type and chronic insomnia. It is suggested that further research should be conducted for cure of chronic insomnia from the perspective of changing TCM constitution.
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.
ObjectivesTo systematically review the current status of cognitive impairment of the elderly in China.MethodsCNKI, VIP, CBM, WanFang Data, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect studies on the current status of cognitive impairment of the elderly in China from January 1st, 2000 to March 12th, 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed by using Stata 14.1 software.ResultsA total of 126 studies involving 187 115 elderly were included. The results of meta-analysis showed that the cognitive impairment rate of the elderly in China was 22.0% (95%CI 20.4% to 23.6%). Subgroup analysis showed that the cognitive impairment rate was higher in females, seniors, low education level, residing in rural area, engaging in manual labor, no spouse, living alone, monthly income less than 1 000 yuan, and suffering from chronic diseases.ConclusionsCurrent evidence shows that the cognitive impairment rate of the elderly in China is 22%, which is relatively high in females, seniors, low education level, residing in rural area, engaging in manual labor, no spouse, living alone, low-income, and suffering from chronic diseases.
