The issue of waste in medical research has been widely concerned in recent years. Research waste is also significant in the field of traditional Chinese medicine (TCM). This study summarized the causes of research waste in TCM and provided suggestions to researchers and administrators for reducing research waste and promoting rational use of medical research resources.
With the advancement of modern research in traditional Chinese medicine (TCM), evidence regarding the clinical efficacy and mechanisms of action of TCM has rapidly accumulated. However, due to a lack of methodological safeguards, the disconnection between clinical and basic research in TCM has become increasingly prominent, making it difficult to form an evidence chain that supports the scientific value of TCM in a manner that is "clear and understandable". Therefore, it is necessary to develop methods for the translation and integration of clinical and basic research evidence oriented towards clinical value, to form a reliable evidence chain that can further discover patterns, confirm efficacy, and highlight advantages. This article discusses the construction and evaluation methods of the evidence chain for the efficacy of TCM, aiming to provide theoretical and methodological references for related work.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
背景
核心指標集（Core Outcome Set，COS）的應用是為確保研究人員測量并報告那些與其研究最可能相關的結局指標。目前，已開展數百個 COS 研究，但還沒有對這些研究進行正式的質量評價。核心指標集研制標準（Core Outcome Set-STAndards for Development，COS-STAD）項目目的是制定國際工作組公認的 COS 研究最低設計標準，而對于 COS 研究的最終報告還有其他具體指南：COS-STAR（Core Outcome Set-STAndards for Reporting，COS-STAR）。
方法與結果
一個由經驗豐富的 COS 研制者、方法學家、期刊編輯、COS 潛在使用者（臨床試驗員、系統評價員和臨床指南制定者）及患者代表組成的國際組織制定了 COS-STAD 推薦，用以幫助改善 COS 的研制質量，并為判斷已經形成的 COS 所采用的方法是否恰當提供評估支撐。通過公開的專家問卷調查產生了一份初始條目清單，并經兩輪德爾菲（Delphi）問卷調查優化，共有近 250 名來自關鍵利益相關方的代表參加。參與者使用一個 1～9 分的量表為每個條目的重要性打分。某個條目可以進入到最低標準集合的共識原則是，每個相關方的投票參與者中至少有 70%對該條目打分為 7～9 分。德爾菲調查之后，還要與代表多個相關方的研究管理組進行共識討論。COS-STAD 包含 11 條最低標準，是所有 COS 研究項目的最低設計建議規范。本推薦重點包括 3 個關鍵領域：范圍、相關方和共識過程。
結論
COS-STAD 項目確立了 11 條最低標準，供 COS 研制者設計研究項目和 COS 使用者判斷已形成的 COS 研究方法學是否應用合理。
To describe the construction and application of clinical evidence database of traditional Chinese medicine (TCM-CED) so as to provide evidence for TCM research. The construction process primarily includes: expert team building, TCM-CED function module design, evidence collection and quality control. The applications of TCM-CED primarily include the following aspects: automatic generation of systematic review/meta-analysis in TCM, automatic generation of evidence reports on dominant diseases of TCM, automatic generation of evidence index of Chinese patent medicine, optimizing the selection of outcomes in TCM research, tracking methodological and reporting quality of TCM research, and promoting international dissemination of TCM evidence. With the rapid development of information technology and artificial intelligence, TCM-CED will be combined with artificial intelligence to achieve the construction of all-dimensional TCM evidence chain and the automation of the whole process.
To ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.
Objectives
To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor.
Methods
CNKI, WanFang Data, PubMed, EMbase, SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using ReMan 5.3 software.
Resluts
A total of 15 RCTs were included. The results of meta-analysis showed that: compared with the chemotherapy alone, Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate (RR=1.26, 95%CI 1.07 to 1.49, P<0.000 01), the clinical efficacy of TCM syndrome (RR=1.71, 95%CI 1.50 to 1.96,P<0.000 01), and the quality of life scores of patients (RR=1.44, 95%CI 1.13 to 1.82,P=0.003). The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions.
Conclusions
Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract, clinical efficacy of TCM syndrome, the quality of life, and improving immune function. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectiveTo analysis the regularity of prescriptions of Chinese Medicine for syndrome of intense fire and heat (syndrome of Shi-Re-Huo-Du), and to provide evidences for the clinical treatment.MethodsCNKI, Sinomed, WanFang Data, VIP and Chinese medical databases were electronically searched to collect literatures about traditional Chinese Medicine for syndrome of Shi-Re-Huo-Du from inception to October, 2018. Two reviewers independently screened literature and extracted data. Then BICOMS 2 software was used to generate the co-occurrence matrix, NetDraw software was used to draw network maps.ResultsA total of 381 literatures involving 335 patients were included. There were 716 prescriptions of Shi-Re-Huo-Du (390 Chinese medicinal herbs), in which the frequently used herb included radix glycyrrhizae (346), Scutellariae Radix (255), Fructus Gardeniae (241), Rehmanniae Radix (239), Moutan Cortex (218), etc. The classification was performed according to traditional efficacy, Qing-re herbs (73), Bu-xu herbs (47), and Hua-tan-zhi-ke-ping-chuan herbs (39), accounted for 40.77% of the total herbs. The results of the analysis showed that the top herbs in Degree and Betweenness were consistent with high-frequency herbs. Among them, Rehmanniae Radix, Fructus Gardeniae, Scutellariae Radix, Moutan Cortex are the most important traditional Chinese herbs. High-frequency herbs are mainly based on Qing-re herbs, and the highest frequency of the herbs combination is Scutellariae Radix-Fructus Gardeniae.ConclusionAlthough there are kinds of herbs for syndrome of Shi-Re-Huo-Du, the commonly used herbs are relatively concentrated, and there is obvious interaction between high-frequency herbs, which is in line with the principle of compatibility of Chinese medicine. The high-frequency Chinese herbs and herb pairs were main components of the Chinese patent medicines and classic prescription. It reflected the rule of medicine used and essence in the treatment of syndrome of Shi-Re-Huo-Du.
The systematic review/meta-analysis database of traditional Chinese medicine (SMD-TCM) was focused on incubation and application of the secondary research achievement. At present, the establishment of front and back websites, evidence input and evaluation have been completed. In the near future, the automation of overview and the visual presentation of evidence information will be realized, which provides the technical support for integration, analysis and application of evidence in the secondary research of TCM. This paper introduces the construction of SMD-TCM database which includes: requirements of construction, design principles, working process, evidence processing, ensuring quality of data input, data analysis and application, etc.
