Objective To review the current status of evidence-base medicine (EBM) research on traditional medicine in Japan. Methods Serial reports of EBM special committee of Japan Society for Oriental Medicine (JSOM) were reviewed. Results EBM special committee of JSOM was established earlier and carried out systematic reviews of Kampo treatment throughout Japan. The quality of preparations was standardized and reliable. Evidence Reports of Kampo Treatment 2009 (EKAT 2009) may be a promising promotion for Kampo treatment in Japan. Conclusion For the promotion and development of evidence-based Chinese medicine in China, we need to learn from EBM research projects of JSOM. Based on the current status of EBM research in China, special efforts should be made in validity of research data and scientific analysis and reports of non-randomized trials. According to the characteristics of traditional Chinese medicine, EBM research should be systematically carried out from simple to complex.
ObjectivesTo systematically review the efficacy and safety of ultrasound-guided percutaneous microwave ablation versus traditional open surgical operation in the treatment of benign thyroid nodules.MethodsPubMed, The Cochrane Library, EMbase, CBM, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on ultrasound-guided percutaneous microwave ablation versus traditional open surgery for benign thyroid nodules from inception to June 30th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was then performed by RevMan 5.3 software.ResultsA total of 38 RCTs involving 4 078 patients were included. The results of meta-analysis showed that: ultrasound-guided percutaneous microwave ablation might be more effective than traditional open surgery for the treatment of benign thyroid nodules (RR=1.09, 95% CI 1.00 to 1.19, P=0.04), and compared with traditional open surgery, ultrasound-guided percutaneous microwave ablation reduced the rate of postoperative complication (RR=0.26, 95%CI 0.21 to 0.31, P<0.000 01), shortened postoperative hospital stay (MD=–3.60, 95%CI –4.04 to –3.15, P<0.000 01) and the time consumed in operation (MD=–48.79, 95%CI –54.16 to –43.41, P<0.000 01), and reduced operative blood loss (MD=–22.02, 95%CI–23.87 to –20.17, P<0.000 01). Meanwhile, microwave ablation reduced the elevated levels of serum IL-6 content (MD=–10.34, 95%CI –10.70 to –9.97, P<0.000 01), serum CRP content (MD=–9.70, 95%CI –10.95 to –8.44, P<0.000 01) and serum TNF-α content (MD=–7.94, 95%CI –9.00 to –6.88, P<0.000 01).ConclusionsCurrent evidence shows that ultrasound-guided percutaneous microwave ablation may improve clinical efficacy and can reduce postoperative complications, bleeding volume, operation time, hospitalization days and postoperative inflammatory reaction. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectiveTo systematically review the application status of Delphi method in clinical research of traditional Chinese medicine (TCM).MethodsPubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect original research and methodological research on Delphi method in TCM from inception to August 30th, 2020. Two reviewers independently screened literature, extracted data, and then, descriptive analysis was performed by using qualitative methods.ResultsA total of 612 articles involving 573 original studies and 39 methodological studies were included, which involved 167 types of diseases. The primary research purposes were disease diagnosis and treatment, syndrome research, scale development, evaluation research, index research, clinical investigation, methodology research, and other 8 categories. 487 papers reported the implementation process and results of Delphi method in varying degrees.ConclusionsDelphi method is widely used in clinical research of TCM, however, there are deficiencies in the specific implementation process.
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.
ObjectiveTo explore the clinical effect of keeping the pancreatic capsule in radical gastrectomy for early stage of gastric cancer. MethodsTwo hundreds and seven patients with early stage of gastric cancer who were treated in our hospital from Jan 2011 to December 2011 were enrolled prospectively, and were divided into experimental group (n=95) and control group (n=112). Patients in experimental group kept the pancreatic capsule in radical gastrec-tomy, but patients in control group didn't keep the pancreatic capsule. Comparison of the clinical effect between the 2 groups was performed. ResultsThe blood loss[(134.1±5.3) mL vs. (150.3±3.7) mL] and operation time[(76.4±5.7) min vs. (87.5±9.1) min]of experimental group were all lower or shorter than those of control group (P<0.05), but there were no significant difference between the 2 groups in incidence of total complication[7.37% (7/95) vs. 10.71% (12/112)], stomal leak[3.16% (3/95) vs. 4.46% (5/112)], and anastomotic stenosis[4.21% (4/95) vs. 6.25% (7/112)], P>0.05. All of the 207 patients were followed-up for 1-36 months, with the median time of 17.5 months. During the follow-up period, in experimental group, there were 30 patients suffered from recurrence, 23 patients suffered from metastasis, and 44 patients died, and the 1-and 3-year survival rates was 84.21% (80/95) and 53.68% (51/95) respectively, 1- and 3-year disease free survival rates was 80.00% (76/95) and 48.42% (46/95) respectively; in control group, there were 37 patients suffered from recurrence, 23 patients suffered from metastasis, and 49 patients died, and the 1-and 3-year survival rates was 85.71% (96/112) and 56.25% (63/112) respectively, 1-and 3-year disease free survival rates was 81.25% (91/112) and 49.11% (55/112) respectively. There were no significant difference in the 1-and 3-year survival rate, 1-and 3-year disease free survival rate (P>0.05). In addition, there were no significant difference in the survival and disease free survival situation (P>0.05). ConclusionsSurvival and disease free survival situation of keeping the pancreatic capsule in radical gastrectomy is similar with traditionally radical gastrectomy, but surgery of keeping the pancreatic capsule in radical gastrectomy has the advantages of less bleeding and shorter operation time, which is worthy of further study.
There is huge clinical value in real world data from traditional Chinese medicine (TCM), but the real world study of TCM faces many challenges, because of its diverse data types, different standards, and serious data island phenomenon. Data governance is the key to transforming real world data into real world evidence. As the last step of data governance, data transformation has not been standardized. The key technologies and methods of data transformation, including data classification, natural language processing, standardization, data system construction, and derivative variables, will be discussed in this article based on the characteristics of real world data of TCM and the current development status of data transformation technology. At the same time, the suggestions of safety control and quality control of data transformation are put forward, and the data transformation system of real world study of TCM is preliminarily constructed, combined with the characteristics of TCM data. It is hoped that this paper can provide references for future real world studies of TCM.
Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.
Objective To compare the efficacy of one kind of modified De Vega technique and traditional De Vega technique. Methods From January 2002 to August 2005, 70 patients were treated with tricuspid valve plasty. These patients were divided into modified De Vega annuloplasty group and traditional De Vega annuloplasty group randomly before operation. The tricuspid regurgitation （TR） were functional and secondary in all patients. The grade of TR and New York Heart Association（NYHA） functional class of two groups were analyzed by Ridit analysis. The changes of right ventricular end-diastolic dimension of two groups were analyzed by paired-sample t test. Results There was no statistically difference between two groups about preoperative characteristics. The follow-up time of modified De Vega annuloplasty group was 12.91±8.84 months and that of traditional De Vega annuloplasty group was 13.61±11.21 months. There was no significant difference between two groups. The outcome of follow-up was satisfactory. In modified De Vega annuloplasty group, there were 12 patient with no TR, 17 patient with mild TR, and 6 patients with moderate TR. There was no patient with severe TR. In traditional De Vega annuloplasty group, 7 patients were observed with no TR, 19 patients mild TR, 7 patients moderate TR and 2 patients severe TR. In modified De Vega annuloplasty group, 32 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and only 1 patient in NYHA class Ⅲ. As for traditional De Vega annuloplasty group, 31 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and 2 patients in NYHA class Ⅲ. The Ridit analysis showed that there was no significant difference about NYHA class between two groups. However, the difference of TR between two groups was statistically significant （P〈0.05）. The outcome of modified De Vega annuloplasty was superior to that of traditional De Vega technique. Paired-sample t test demonstrated that the modified De Vega annuloplasty could reduce the right ventricular end-diastolic dimension significantly （P〈0.05）. However, the right ventricular end-diastolic dimension of traditional De Vega annuloplasty groups did not change significantly （P 〉 0.05）. Conclusion The efficacy of modified tricuspid De Vega technique is superior to that of traditional De Vega technique in patients with secondary TR.
Objective To assess the effects and possible adverse reactions of traditional Chinese medicine (TCM) in treating arteriosclerosis obliterans. Methods Materials were collected with both electronic retrieval including EMbase (1978 to October 2009), OVID-MEDLINE (1950 to October 2009), Cochrane Controlled Trials Register (Issue 3, 2009), Current Controlled Trials, The National Research Register, CBM (1983 to September 2009), CNKI (1995 to September 2009), Wanfang Data (1994 to 2009), and VIP Data (1989 to 2009), and manual retrieval of related journals. All the retrievals were published before November 10, 2009 without limitation of languages. The quality of included studies was evaluated, and meta-analysis was conducted with RevMan 5.0.2 software. Results A total of 10 included studies were all randomized controlled trials, including 837 patients, and the sample size of each study was from 36 to 260 cases. Because both Chinese medicines and control drugs used in studies were different from each other, the effect size of each study can only be singley described and newly calculated. Most included studies showed that, the effects of TCM on cure rate, total effective rate and decrease of TC and TG were similar to that of aspirin, acipimox, prostaglandin E1; a few studies showed the effect of TCM was much better; one study on side effect showed that, TCM was less than western medicine. Conclusion The evidences of TCM effects in treating arteriosclerosis obliterans is quite limited, which has to be strengthened by more studies of high quality.
Integrated traditional Chinese and Western medicine has been used to treat acute pancreatitis (AP) for more than 50 years. It has become a dominant and specialized disease treated by integrated traditional Chinese and Western medicine. After many years of clinical practice, a relatively mature and complete treatment system has been formed. Therefore, it was proposed by the Chinese Society of Integrated Traditional Chinese and Western Medicine, the Chinese Medical Association, and the Chinese Association of Traditional Chinese Medicine to update and formulate the “Guidelines for the Diagnosis and Treatment of Acute Pancreatitis with Integrated Traditional Chinese and Western Medicine” (2021) group standards in 2022, and “Integrated Traditional Chinese and Western Medicine Practice Guidelines for Diagnosis and Treatment of Acute Pancreatitis” finally published. The guideline condenses 25 kinds of important clinical issues, which guide to explain the diagnosis and treatment of AP in detail, focusing on the integration of traditional Chinese medicine and Western medicine in the management of AP, such as staging and syndrome differentiation, early fluid therapy, pain management, and organ function support in early stage. The advantages and the timing of early intervention of traditional Chinese medicine in AP are emphasized. This guideline also proposes suggestions on nutritional support, management of causes, treatment of late local complications and infections, as well as prevention of recurrence and follow-up strategies for long-term complications. This paper provides an interpretation of this guideline.