Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
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.
ObjectiveTo systematically review the efficacy of Chinese medicine injection (CMI) for treating heart failure (HF).MethodsCNKI, WanFang Data, VIP, The Cochrane Library, PubMed, and EMbase databases were electronically searched from inception to January 2021 to identify randomized controlled trials (RCTs) on CMI for treating HF. Two reviewers independently screened literature, extracted data, and evaluated the risk of bias of included studies. Network meta-analysis was then performed by RevMan 5.2 software and Stata 16.0 software.ResultsA total of 47 studies were included involving 4 902 patients and 5 types of CMIs, including Shenmai, Shenfu, Yiqi Fumai (lyophilized), Shengmai, and Danhong injections. The results of network meta-analysis showed that the efficacy of combined CMIs was superior to conventional Western medicine alone. For the main efficacy, Shenmai, Shengmai, and Shenfu injections had significant advantages in improving the total clinical effectiveness. Shengmai, Shenmai, and Yiqi Fumai (lyophilized) injections were significantly more effective for reducing NT pro-BNP levels than other injections. Shenfu and Shengmai injections were significantly more effective for reducing BNP levels than other injections. Shenmai, Danhong and Shengmai injections were significantly more effective for improving the left ventricular ejection fraction than the other injections. These CMIs showed similar advantages for secondary efficacy indicators as for main efficacy indicators.ConclusionsThe combined 5 types of CMIs for treating HF can improve the clinical efficacy when compared with conventional Western medicine treatment. Shenmai injection, Yiqi Fumai injection (lyophilized), and Shengmai injection, which is part of Sheng Mai San, have clear advantages in terms of the overall curative effect or on individual indices.
Objective To explore the research trends of traditional Chinese exercise in the rehabilitation of chronic obstructive pulmonary disease (COPD). Methods The Web of Science core collection database was searched to collect literature on traditional Chinese exercise for COPD rehabilitation published from 2004 to 2023. VOSviewer was used for bibliometric analysis of publication year, author, publication institution and country, citation and co-citation information. Results A total of 125 publications were included. No relevant publication was published from 2004 to 2008. Since 2009, the overall number of publications had shown a fluctuating upward trend, with no publications in 2012. From 2019 to 2023, the number of publications on related topics remained at a high level. Reached maximum publication volume in 2020. The annual citation frequency also showed a fluctuating increase, reaching its peak in 2022. Based on comprehensive analysis, Peter M. Wayne and Wu Weibing were the authors with high productivity, high citation, and frequent collaborations. The country with the highest number of publications was China, and the highest institution was Shanghai University of Sport. Initially, the keywords focused on rehabilitation, exercise testing, aerobic exercise, resistance exercise, and respiratory muscle strength. As the times progressed, the focus shifted to lung function, exercise tolerance, and mental health. The current trends included self-management and telemedicine. Conclusions Traditional Chinese exercises have been widely applied in the clinical practice of COPD rehabilitation, showing an upward trend. Facilitating patient self-management and establishing the role and significance of traditional Chinese exercises in remote healthcare for COPD patients may be the focus of future research.
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
ObjectiveTo systematically review vitamin D nutritional status among children and adolescents in China.MethodsCNKI, CBM, WanFang Data, VIP and PubMed databases were electronically searched to collect cross-sectional studies on vitamin D nutritional status among children and adolescents in China from inception to September, 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata 11.0 software.ResultsA total of 23 cross-sectional studies involving 38 047 total sample size were included.The results of meta-analysis showed that the combined vitamin D deficiency rate was 27.9% (95%CI 21.9% to 33.8%), and the inadequate rate was 31.6% (95%CI 25.7% to 37.6%).Subgroup analysis showed that vitamin D deficiency rate of females was higher than that of males (25.3% vs. 22.5%). The vitamin D deficiency rate of children aged 10 to 18 was higher than those aged 6 to 9 (44.9% vs. 32.9%). The vitamin D deficiency rate of children in the north was higher than that in south (36.1% vs. 14.8%). The vitamin D deficiency rate from 2015 to 2018 was higher than that from 2011 to 2014 (34.9% vs. 17.6%). In addition, the vitamin D deficiency rate ofurban children was higher than that of rural children (29.9% vs. 24.9%).ConclusionsThe incidence of vitamin D deficiency among children and adolescents is high in China. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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.
ObjectiveTo observe the clinical effect of combined traditional Chinese and Western medicine in the treatment of knee osteoarthritis (KOA). MethodsA total of 180 KOA patients treated between January 2012 and June 2015 were randomly assigned to 3 groups: Chinese medicine group (group A, n=60) with acupuncture and irradiation therapy of specific electromagnetic wave therapeutic apparatus , western medicine group (group B, n=60) with oral glucosamine hydrochloride tablets and knee joint cavity injection of sodium hyaluronate, and integrated traditional Chinese and Western medicine group (group C, n=60) with treatments combining those in both group A and B. The treatment course was 6 weeks. The Western Ontario & McMaster University (WOMAC) osteoarthritis index score and total effective rate were evaluated before treatment and 2 weeks after treatment, end of treatment and 5 months after treatment. ResultsAfter treatment, the average improvement of WOMAC scores in the three groups was significantly different (P ＜ 0.05) . The total effective rate was 78.33% in group A, 83.33% in group B, and 91.67% in group C. The difference of total effective rate between group C and A, and between group C and B was statistically significant (P＜0.05) ; and it was also statistically significant between group A and B (P ＜ 0.05) . There were two cases of adverse reactions in group A, two in group B, and two in group C, and the reactions were all relatively mild without any serious adverse events. ConclusionsChinese medicine and western medicine are both effective and safe for the treatment of KOA. When they are combined, the effect is further enhanced with no increase of adverse reactions.
OBJECTIVE: In the guinea pig-to-rat cardiac xenotransplantation model, the effect of complement depletion by using Chinese Cobra Venom Factor(CVF) on hyperacute rejection was evaluated. METHODS: Cardiac xenograft from guinea pig was transplanted into the abdomen of rat after the recipient being given i.p. a dose of CVF 0.20 microgram/g. the recipients were divided into group A (control group), group B (only given CVF), group C (CVF + Cytoxan + Splenectomy), group D (Cytoxan + Splenectomy) Cytoxan was injected into the abdominal cavity with a dose of 60 mg/Kg. The survival time of xenograft was measured and histologic observation was carried out after the cardiac arrest. RESULTS: The survival time of xenograft ranged from 15 to 3,120 minutes. There were significant difference among group A compared with group B and C (P lt; 0.01), and no difference between group A and group D, as well as group B and C (P gt; 0.05). There were significant difference between group B and D, as well as group C and D(P lt; 0.01). The histologic observation proved that the hyperacute rejection in group A and D was milder than group B and C. CONCLUSION: The study reveals that CVF can prolong the xenograft time by depleting complement activities and restricting hyperacute rejection in this model. Further basic and clinical study of effect of CVF in xenograft transplantation is worthwhile.