Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018) / 中国结合医学杂志

Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.

Systematic Reviews/Meta-Analyses of Integrative Medicine in Chinese Need Regulation and Monitoring Urgently and Some Suggestions for Its Solutions / 中国结合医学杂志

With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges / 中国结合医学杂志

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

Evidence-based Chinese medicine：theory and practice / 中国中药杂志

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine.

Effectiveness of moxibustion for exercise-induced fatigue--a systematic review for randomized controlled trials / 中国结合医学杂志

<p><b>OBJECTIVE</b>To review and assess the effect of single moxibustion for exercise-induced fatigue: (EIF).</p><p><b>METHODS</b>Computer-search for 8 medical databases and 5 clinical trail registries were conducted for: randomized controlled trials (RCTs), added with hand-search for 10 Chinese acupuncture-moxibustion journals and additional references. Data from included RCTs were pooled by RevMan5.1. Methodology quality of RCTs was judged by Cochrane Collaboration assessment tool while quality of primary outcomes was evaluated by GRADE3.2.</p><p><b>RESULTS</b>Five RCTs were finally included, all reported in small sample size with high risk of: bias. Comparisons on single moxibustion and rest relief (without treatment) were studied. Six outcomes were reported, all favored moxibustion to rest relief for EIF. Primary outcomes showed as rating of perceived exertion (RPE) with mean difference (MD)=-0.49, 95% confidence interval (CI) [-0.80, -0.19], 800-m race performance with MD=-2.21, 95% CI [-3.57, -0.85], and Harvard Step Index (HSI) with MD=14.75, 95% CI [8.35, 21.15]. Moreover, all primary outcomes as RPE, 800-m race performance and HSI were rated low quality.</p><p><b>CONCLUSIONS</b>Single moxibustion might be considered effective for EIF. However, due to small samples of included RCTs, high risk of bias among studies and poor quality of primary outcomes and subjects restricted to Chinese athletes only, these results present limitation, and should be taken with caution for practice. More large-size studies with rigorous design are warranted to further test effectiveness of moxibustion for EIF.</p>

How to connect the gap between clinical trials and clinical practice / 中国结合医学杂志

Clinical research methods have been rapidly developing, and the design of clinical trials including traditional Chinese medicine is advancing. To a certain extent, all of these ensure that the results of clinical research are objective and scientific, but whether these results and the resulting guidelines or consensus have much practical significance on clinical practice is still controversial. The authors engage in both clinical practice and clinical research; they strongly feel that it is necessary to discuss the relationship between clinical trials and clinical practice. This essay discusses this relationship in four parts.

Thinking and methods in practical assessment of TCM clinical therapeutic effect / 中国中西医结合杂志

Although traditional Chinese medicine (TCM) shows its effectiveness undoubtedly in clinical practice, the deficiency in objective assessment methods is yet a bottleneck which has restricted its development of modernization and internationalization. On the basis of clinical experiences, the authors discussed the title cutting from current situation and tendency, and expanded gradually. It is concluded that by aiming directly at problems and referring to the principle and methods of evidence-based medicine (EBM), using rationally the design in clinical practice and combined with individualization and standardization should be a feasible way for TCM clinical therapeutic effect assessment.

Influence of anoxia/reoxygenation on immunofunction of endothelial cells and effect of intervention with yisheng injection on it / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the influence of ischemia/reperfusion (anoxia/reoxygenation) on immunofunction of endothelial cells (ECs) and effect of intervention with Yisheng injection (YSI, a pure natural medicine) on it.</p><p><b>METHODS</b>Model of ECs induced by anoxia/reoxygenation was established to mimic ECs ischemia/reperfusion injury in vivo with human umbilical vein endothelial cell line ECV304. Then YSI was used to intervene the anoxia/reoxygenation process. Nuclear transcriptional factor-kappa B (NF-kappa B) was exhibited by fluorescent staining, HLA-ABC, HLA-DR, CD86 and CD54 were detected by flow cytometry. Mixed endothelial cell-lymphocyte reaction (MELR) was conducted to examine the proliferation of lymphocyte, production of IL-2 and percentage of apoptotic lymphocyte.</p><p><b>RESULTS</b>Anoxia/reoxygenation made the ECV304 cell became round, shrunk and abscised, with increased plasma NF-kappa B, and changed from positive cytoplasm to positive nucleus. HLA-ABC, HLA-DR and CD86 on surface of cells increased but CD54 showed unchanged. MELR showed the incorporation of 3H-TdR and production of IL-2 increased significantly and the percentage of apoptotic lymphocyte decreased. After YSI intervention, the ECV304 cell shaped recovered, NF-kappa B expression didn't down-regulated, but the percentage of positive cells decreased, changed to positive dominant. Besides, reversal changes were shown in other parameters.</p><p><b>CONCLUSION</b>Anoxia/reoxygenation influences some important immune related molecules in ECV304 cells, YSI could antagonizing these influences to maintain the immune function of endothelial cells in a relative normal manner.</p>

An appraisal of immunonutrition for clinical nutritional support with a systematic review of English and Chinese documents / 中国医学科学院学报

<p><b>OBJECTIVE</b>To evaluate the efficacy, safty and economical values of immunonutrition for clinical nutritional support.</p><p><b>METHODS</b>The following electronic databases were searched: Chinese Biomedicine database (CBM), MEDLINE, EMBASE, Cochrane Library and SCI. Data were extracted by two reviewers. RevMan 4.1 was applied for statistical analysis.</p><p><b>RESULTS</b>Seventeen randomised trials comparing the use of immunonutrition which comprises nucleotides, omega-3 fatty acids and arginine with standard enteral nutrition in surgical, trauma/burn and critical illness patients. Combined analysis indicated that the use of immunonutrition decreased infectious events (pooled OR was 0.51, 95%CI [0.38, 0.67], P = 0.00001), length of hospitalization, and the cost. In sensitivity analysis for mortality, we found an increased tendency in immunonutrition (pooled OR was 1.94, 95%CI [1.05, 3.57], P = 0.03). Further sub-group analysis indicated that the effects of immunonutrition were various in different patient types.</p><p><b>CONCLUSIONS</b>Immunonutrition is associated with decreasing of infectious rates, length of hospitalization and cost in selective operation patients. But current evidence can't affirm the role of immunonutrition on critical illness patients. Further studies are urgently needed to clarify the reliability of immunonutrition in this group.</p>