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.
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 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.
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 systematically review the clinical effect and safety of traditional Chinese medicine (TCM) in the treatment of cough variant asthma (CVA). MethodsWe searched MEDLINE (Ovid), PubMed, EMbase, The Cochrane Library, VIP, WanFang Data, CNKI and CBM databases to collect randomized controlled trials (RCTs) about TCM for CVA from inception to May 2014. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed by RevMan 5.2 software. ResultsA total of 17 RCTs were included. The results of qualitative analysis showed that:in improving cough symptom, three of four RCTs showed that TCM was superior to western medicine alone. In improving airway hyper responsiveness and overall treatment effect, the difference between TCM and western medicine alone remained uncertain. No serious adverse reactions related to TCM was reported in 17 RCTs. ConclusionBased on the current evidence, some trials suggest the TCM is superior to western medicine alone in improving cough symptom, however in the improvement of airway hyper responsiveness and overall efficacy, the difference between TCM and western medicine alone remains uncertain. Due to the variety of TCM and western medicine as well as limited methodological quality and different intervention of the included studies, more high-quality RCTs with large scale are needed to verify the above conclusion.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treating Chronic Rhinosinusitis (CRS) after Functional Endoscopic Sinus Surgery (FESS). Methods The following databases and periodicals such as PubMed (Jan. 1980 to Jan. 2009), MEDLINE (1980 to 2009), EBSCOhost (Jan. 1975 to Jan. 2009), CALIS (1984 to 2009), CNKI (1979 to 2007), VIP (1989 to 2009), CBM (1978 to 2009); Chinese Journal of Otorhinolaryngology Head and Neck Surgery (1990 to 2008), Journal of Clinical Otorhinolaryngology Head and Neck Surgery (1988 to 2008), Otorhinolaryngology Head and Neck Surgery (1990 to 2008), and Chinese Journal of Otorhinolaryngology of Integrated Traditional and Western Medicine (1996 to 2008) were searched by computer and handwork for randomized controlled trials (RCTs) about TCM to treat CRS after ESS. The trial screening, quality assessment, and the data extraction of the included trials were conducted before performing statistical analyses by using RevMan 4.2.10 software. Results A total of 32 RCTs in three sub-groups in Chinese literatures were identified with meta-analyses in comparisons of the cure rate (OR=1.99, 95%CI 1.78 to 2.23), total effective rate (OR=2.66, 95%CI 2.20 to 3.22), degree I postoperative improvement rate (OR=2.22, 95%CI 1.60 to 3.06), total postoperative improvement rate (OR=8.77, 95%CI 1.09 to 70.64), postoperative clean time (OR=2.54, 95%CI 1.70 to 3.79), postoperative epithelization time (OR= –29.46, 95%CI –37.73 to –21.18), and mucociliary transport rate (OR=1.14, 95%CI 0.22 to 2.06). A total of 4 RCTs were meta-analyzed to evaluate the safety in comparisons of gastrointestinal reaction (OR=0.25, 95%CI 0.00 to 33.78) and local reaction (OR=0.03, 95%CI 0.01 to 0.12). Conclusion The current evidence shows TCM in treating CRS after ESS tends to improve the clinical efficacy and reduce the cure time without obvious adverse reaction. Due to the low methodological quality of included trials, more RCTs with high quality and large scale are required.
Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM) paste in treating chronic obstructive pulmonary disease (COPD) in stable stage. Methods We electronically searched databases including PubMed, EMbase, The Cochrane Library (Issue 12, 2016), VIP, WanFang Data, CNKI and CBM to collect randomized controlled trials (RCTs) regarding TCM paste in combination with conventional Western therapy versus Western therapy alone in treating stable COPD from inception to December 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. The meta-analysis was conducted by RevMan 5.3 software. Results A total of 9 RCTs involving 605 Chinese patients were included. The results of meta-analysis showed that: when compared with conventional Western medicine alone, TCM paste combined with the conventional Western medicine significantly improved clinical effective rate (RR=1.20, 95% CI 1.10 to 1.31,P<0.000 1), decreased SGRQ score (MD=–4.53, 95% CI –5.41 to –3.65,P<0.000 01) and CAT score (MD=–2.45, 95% CI –3.38 to –1.51,P<0.000 01), increased FEV1% (MD=3.80, 95% CI 0.40 to 7.20,P=0.03), and reduced the frequency of acute exacerbation (P<0.05). No serious adverse reaction occurred in both groups. Conclusion The current evidence shows that combination of TCM paste and conventional Western medicine may improve clinical effective rate, quality of life, increase FEV1%, and reduce the frequency of acute exacerbation in patients with stable COPD. Due to the limited quality and quantity of included studies, the above results are needed to verify by more studies.
Objective To assess the benefits and harms of traditional Chinese medicine in the treatment of postmenopausal osteoporosis. Methods We electronically searched MEDLINE (1966-2003), EMBASE (1974-2003), Controlled Trials Register and The National Research Register, The Cochrane Library Issue 4, 2003, CBM disc, VIP, CNKI, and CMCC. We also handsearched some related journals. The search was conducted in Nov., 2003. The quality of included randomized controlled trials was evaluated and meta-analysis was conducted by RevMan 4.2.2. Results We identified 33 studies including 2 337 patients and 27 traditional Chinese medicines. Some traditional Chinese medicines alone or integrated Chinese and Western medicine may be effective for improving patients’ bone mineral density, serum oestradiol and serum calcium. For example, Compared with placebo, Bushen Yigu soft extraction with WMD 0.76, 95% confidence interval 0.65 to 0.87, Bushen Qianggu capsule with WMD 39.94, 95% confidence interval 35.12 to 44.76 were effective for improving the level of serum oestradiol.There were no confirmed results of the other traditional Chinese medicines because of the small number of studies or inconsistent conclusions among studies. We didn’t find obvious side effects. Conclusions Some traditional Chinese medicines may be effective for treating postmenopausal osteoporosis. Due to the limited evidence identified, we can not draw a firm conclusion. More randomised controlled trials of high quality are needed for ber evidence.
Objective To investigate the pollution status of ultrasonic atomization fumigation and washing machine of traditional Chinese medicine and the effect of precision disinfection intervention, and to provide scientific basis for strengthening the cleaning and disinfection work of ultrasonic atomization fumigation and washing machine of traditional Chinese medicine. Methods From January to February 2024, samples were collected from the surface of seven ultrasonic atomization fumigation and washing machines of traditional Chinese medicine that could be used normally in the Department of Traditional Chinese Proctology of the First People’s Hospital of Longquanyi District, Chengdu. Samples were collected from four points, namely the nozzle, the front edge of the hip bath cover, the rear edge of the hip bath cover, and the outer edge of the hip bath cover, and at four times, namely before use, after use, after pre-intervention routine disinfection, and after post-intervention precision disinfection (including training of personnel, solidification of disinfection process, and improvement of disinfection supplies), to compare the pollution status and disinfection effect of the object surface at different points and sampling times, and analyze the microbial detection. Results In terms of different times, the qualified rate of specimens was 28.6% before use, which decreased to 14.3% after use; the qualified rate of specimens was 39.3% after pre-intervention routine disinfection, which increased to 92.9% after post-intervention precision disinfection, with a statistically significant difference (χ2=17.923, P<0.001). A total of 158 strains of bacteria were detected from unqualified specimens, including 121 strains of Gram-positive bacteria (accounting for 76.58%) and 37 strains of Gram-negative bacteria (accounting for 23.42%). The detected bacteria were mainly common environmental bacteria. The top three were Kocuria rhizophila, Dermacoccus nishinomurai, and Microbacterium aureum. The main pathogenic bacteria of common nosocomial infections were Staphylococcus epidermidis and Escherichia coli, and no multi-drug resistant strains were detected. Conclusion Targeted cleaning and disinfection measures should be taken to ensure the disinfection effect and reduce the risk of nosocomial infection for special medical instruments such as ultrasonic atomization fumigation and washing machine of traditional Chinese medicine.