Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.
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.