Scientism and humanism are two main views on the development of medicine, which run through both theory and practice. Under the guidance of the modern medical concept of " bio-psycho-social”, the views of scientism and humanism on medicine have reached an unprecedented level of development and integration, which jointly determine the connotations and demands of current medicine. As one of the current mainstream medical models, evidence-based medicine (EBM) has played an important role in the management of current medical theories and practices. Meanwhile, EBM has also encompassed views of scientism and humanism in its own development and has successfully shaped the knowledge and methodological system. EBM will continue to gain insight into the characteristics of views of scientism and humanism in the future of medicine to improve itself and should pay more attention to the development of humanism view. As an important branch discipline of EBM, evidence-based Chinese medicine may become a model of the perfect combination of scientism view and humanism view.
Evidence-based medicine (EBM) provides a reliable evidence decision-making model for the medical field. The concepts and methods of EBM are gradually extended to other disciplines. At present, the paradigm of evidence-based science (EBS) is formally proposed, which is not only based on a methodological cooperation between different disciplines, but also a deeper potential driving force in optimizing the operation process of knowledge. The advantages of EBS helps promote its extension to other disciplines through standardization concepts and systematic methods, through which the common theories and supporting organization of EBS are formed. Under the guideline of EBS, the evidence-based concepts and methods will play a supportive role in scientific development.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
ObjectiveTo systematically review the interventional effects of Simiao Yong'an decoction on atherosclerosis animal models.MethodsDatabase including CNKI, WanFang Data, VIP, PubMed, The Cochrane Library, and Web of Science were searched to collect animal experiments on atherosclerosis model intervention by Simiao Yong’an decoction from inception to October 2020. Two reviewers independently screened the literature, extracted data, and used the SYRCLE animal experiment bias risk assessment tool to evaluate risk bias of included studies, and then used RevMan 5.4.1 software for meta-analysis.ResultsA total of 14 animal experiments were included. The results of meta-analysis showed that compared with the blank model group, the Simiao Yong’an decoction group could reduce the aortic plaque area (SMD=−2.04, 95%CI −3.35 to −0.74), the ratio of aortic plaque to lumen area (SMD=−1.72, 95%CI −2.48 to −0.97), total cholesterol level (SMD=−0.97, 95 %CI −1.72 to −0.22), triglyceride level (SMD=−1.21, 95%CI −1.82 to −0.60), low-density lipoprotein cholesterol level (SMD=−1.82, 95%CI −3.12 to −1.53), tumor necrosis factor-α level (SMD=−3.36, 95%CI −4.21 to −2.52), monocyte chemotactic factor-1 level (SMD=−2.98, 95%CI −4.60 to −1.35) and C-reactive protein level (SMD=−0.60, 95%CI −1.08 to −0.11); however, in the high-density lipoprotein cholesterol level (SMD=0.66, 95%CI −0.10 to 1.42) and the level of interleukin 1 (SMD=−1.41, 95%CI −4.11 to 1.30), the differences were not statistically significant.ConclusionsThe existing evidence shows that the intervention of Simiao Yong’an decoction in the atherosclerosis model can reduce the aortic plaque area and the ratio of the aortic plaque to the lumen area, reduce total cholesterol, triglycerides, and low-density lipoprotein cholesterol levels, and reduce tumor necrosis factor-α, monocyte chemotactic factor-1, and C-reactive protein levels. Due to limited quality of included studies, more high quality studies are required to verify the above conclusions.
Evidence-based Chinese medicine is a relatively new discipline which applies the concepts and methods of evidence-based medicine (EBM) to the clinical research and practice of Chinese medicine. It is not only a branch of EBM but also a natural product of the development of Chinese medicine. This paper introduces the theoretical concepts of evidence-based Chinese medicine and reviews the process of its development. It then elucidates the main characteristics of evidence-based Chinese medicine, emphasizes its holistic approach, prescription-syndrome relationship, and its human-centered approach. Research contents and status quo are also summarized to point out the challenges of the production and application of evidence. Finally, we innovatively indicate further research directions on combining individual-based research with population-based research and developing narrative EBM.
Reporting standard system of clinical research of traditional Chinese medicine (TCM) is composed of ten reporting standards in the areas of the design and preparation of TCM clinical researches, researches of different types, randomized controlled trials of various interventions, systematic reviews of the trials and the translation of research evidence, which were developed by different research groups. This article systematically analyzed the current reporting standards of clinical research of TCM. Achievements and problems were found in the review so as to provide insights for the ongoing reporting standards and to assist the construction of the reporting standard system so as to improve the reporting quality of clinical researches of TCM.
ObjectivesTo conduct an overview of systematic reviews (SRs) on Tuina from 2013 to 2017, and to explore recent research improvements on Tuina.MethodsPubMed, Web of Science, The Cochrane Library, SpringerLink e-book database, CNKI, VIP, WanFang Data and CBM databases were searched to collect SRs including randomized controlled clinical trials on Tuina from January 1st, 2013 to December 31st, 2017. Two reviewers independently screened literature, extracted data, and used AMSTAR 2 tool and PRISMA statement to assess methodology quality and reporting quality of included studies, respectively. The R 3.4.3 software was used to analyze data.ResultsA total of 8 SRs studies were included in the overview. The studied diseases involved radiculopathy cervical spondylotic, myelopathy cervical spondylotic, constipation, child anorexia, child diarrhea and external humeral epicondylitis. The results of above SRs showed that massage might be superior to other interventions in clinical efficacy, curative effects or total effective rate. However, due to the low quality of included studies of SRs, further evidence from high-quality clinical studies is required to verify above conclusions. For the results of AMSTAR 2 assessment, all 8 SRs were rated as very low quality. The quantity of items accomplished for each SR ranged from 7 to 13, 2 SRs had low methodological quality (percentage of accomplishment or partial accomplishment <50.0%) and 6 SRs with high methodological quality (percentage of accomplishment or partial accomplishment ≥50.0%). All 8 SRs did not report item 2 "Whether to declare research methods", item 10 "Whether reports have included funding sources for each study" and item 11 "Whether reports used the correct statistical method". The results of PRISMA assessment showed that all SR had good quality of reporting. The accomplished items number of each SR ranged from 22 to 26. However, there were defects in item 5(0), item 16(25.0%) and item 23(25.0%). All SRs did not report item 5 "Whether to declare research program".ConclusionsThis study finds that Tuina has supportive evidence-based medical evidence for treating anorexia, cervical spondylosis and other diseases, however, the SRs of Tuina are yet needed to be improved in terms of standardized degree. Therefore, establishing a reporting consolidated standard for evidence-based medicine on Tuina in order to improve the quality of clinical studies so as to provide clinicians with high-quality evidence is the focus of our further research.
背景 单病例随机对照试验是评价中医药干预措施有效性和安全性较为理想和适宜的方法之一。目前已有一定数量的中医药单病例随机对照试验发表。然而，由于缺乏相应的报告规范，这些试验的报告质量普遍较差。鉴于中医药临床研究的独特性，工作组制定了单病例随机对照试验报告标准（CONSORT extension for reporting N-of-1 trials，CENT 2015）的中医药扩展版（中医药 CENT），以帮助研究者报告中医药单病例试验。 方法 我们在提高健康研究质量和透明度协作网（Enhancing the QUAlity and Transparency Of health Research，EQUATOR）上注册了中医药 CENT。中医药单病例随机对照试验报告规范的制定是一个综合过程，包括收集初始报告条目，与 17 名专家小组成员进行两轮科学的德尔菲共识调查，修订和形成最终报告清单。 结果 清单共包括 6 个领域的 25 项条目，其中的 8 项对 CENT 2015 清单条目进行了扩展和详细说明。中医药 CENT 清单充分考虑了中医药的诊疗特点，并详细阐释了中医药单病例随机对照试验中辨证的概念和不同的中医药干预措施。 结论 中医药 CENT 是中医临床研究的一个实用工具，可用于评价中医药单病例对照试验报告的完整性，并可指导中医药单病例对照试验的设计、实施和报告，期望此报告规范可切实提高中医药单病例试验的全面性和透明度。