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.
Acute pancreatitis (AP) is a common clinical emergency of the abdomen with increasing incidence and lack of effective treatment. Traditional Chinese medicine, as a treasure of the Chinese people, has been used in the treatment of AP for decades with favorable therapeutic effects. Currently, clinical trials and experimental studies have shown that traditional Chinese medicine has the effects of inhibiting pancreatic enzyme activity, anti-inflammation, promoting gastrointestinal dynamics, as well as delaying the progress of AP, improving clinical symptoms, reducing related complications, and reducing the mortality rate. Therefore, traditional Chinese medicine has considerable clinic value in treating AP. Based on the related research progress and clinical practice of our team, the authors summarized the targets and mechanism of traditional Chinese medicine in treating AP.
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.
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.
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.
Currently, there is a lack of clarity and standardization regarding the implementation details of interventions in traditional Chinese medicine clinical practice guidelines (CPGs). This in methodological guidance for standardizing the implementation prescription adversely impacts the quality of implementation and hinders the clinical application rate of recommendations. Through in-depth analysis of implementation prescription of evidence-based CPGs in traditional Chinese medicine, we identified the challenges associated with standardization. In response, we propose enhancing the technical specifications of implementation prescriptions, advocating for improved formulation processes, diverse reporting approaches, and standardizedological guidelines. These recommendations aim to serve as a methodological reference and guidance for clinical practice guideline developers.
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.
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.
ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.