The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
ObjectivesTo investigate the citation status of systematic reviews (SRs)/meta-analyses in clinical practice guidelines and consensuses of traditional Chinese medicine (TCM).MethodsWe electronically searched PubMed, CBM, WanFang Data and CNKI databases to collect TCM guidelines and consensus from January 1st, 2009 to December 31st, 2018. Two reviewers independently screened literature and extracted data. Citation analysis method was used to analyze the citation status of SRs/meta-analysis in TCM guidelines and consensuses.ResultsA total of 142 TCM guidelines and consensuses were included, of which 39 (26.5%) failed to provide relevant citations. Of the 103 (72.5%) TCM guidelines and consensuses providing citations, 48 (34.3%) cited SRs/meta-analyses, and 43 cited outdated SRs/ meta-analyses. Four TCM guidelines and consensuses cited Cochrane reviews. In terms of citations, the average citations of guidelines and consensuses were 35.1 and 42.2, respectively; and the average SRs/meta-analyses citations of guidelines and consensuses were 3.8 and 5.5, respectively.ConclusionsTCM guidelines and consensuses citation report rates and the proportion of citation SRs/meta-analyses still require increase. TCM guidelines developers should strengthen the role and significance of SRs, especially Cochrane reviews, in supporting recommendations.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
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.
ObjectiveTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) about traditional Chinese medicine for essential hypertension. MethodsWe comprehensively searched PubMed, EMbase, The Cochrane library (Issue 4, 2014), CBM, CNKI and WanFang Data to collect SRs of traditional Chinese medicine for essential hypertension from the establishment time of databases to April 30th, 2014. The AMSTAR tool was applied for methodological quality assessment of included studies, and the GRADE system was applied for evidence quality assessment of included outcomes of SRs. ResultsA total of 12 SRs involving 31 outcomes were included, of which 11 SRs focused on the comparison of therapeutic effects between traditional Chinese medicine combined with western medicine and western medicine alone. Nine SRs adopted Jadad tool to assess methodological quality of included original studies. The results of assessment using AMSTAR showed that, among 11 items, there were the most problems concerning Item 1 "Was an 'a prior' design provided?" (none of the 12 SRs provided it); followed by Item 11 "Were potential conflict of interest included?" (nine SRs didn't described it), and Item 6 "Were the characteristics of included studies provided" (six SRs didn't provided it). The results of grading showed that, 29 outcomes were graded as "low" or "very low" quality. The main factors contributed to downgrading evidence quality were limitations (31 outcomes), followed by imprecision (12 outcomes), and inconsistency (13 outcomes). ConclusionCurrently, the methodological quality of SRs about traditional Chinese medicine for essential hypertension was poor on the whole, with low quality of evidence as well as lack of enough attention to the end outcomes of patients with essential hypertension. Thus, physicians should apply the evidence to make decision about traditional Chinese medicine for essential hypertension with caution in clinical practice.
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 evaluate quality and current status of traditional Chinese medicine (TCM) guidelines and consensus, and to promote the improvements in the quality of guidelines and consensus. Methods A systematic collection of TCM guidelines and consensus published in medical journals in 2022 was conducted. We used scientific, transparent, and applicable ranking tools (STAR) for evaluation, analyzed the scoring rates (%), and assessed the quality level and influencing factors of guidelines and consensus through methods such as comparison and stratification. Results A total of 130 TCM guidelines and consensus were included. Guideline areas with higher scores included recommendations (65.3%), evidence (55.9%), and guideline development groups (54.2%). In the case of consensus, higher scores were observed in recommendations (38.7%), guideline development groups (37.0%), and funding (30.0%). The total score rate of TCM guidelines exceeded that of national guidelines, while the consensus rate was lower. Stratified analysis revealed statistical differences in guideline score rates among journals and issuing institutions, as well as significant differences in consensus score rates among journals, formulation institutions, subjects, and funding categories. Conclusion The quantity and quality of TCM guidelines and consensus are on a positive trajectory, with higher quality levels in guidelines than in consensus. The overall quality of TCM guidelines surpasses that of national guidelines, particularly emphasizing the scientificity of guideline formulation. However, the overall quality of consensus remains lower than that of the national consensus. Factors such as journals, formulation institutions, subjects, and funding categories are identified as potential influences on the quality of TCM guidelines and consensus.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
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.