[Status of outcome indicators of randomized controlled trial of traditional Chinese medicine in treatment of non-severe community-acquired pneumonia].

To analyze the outcome indicators of randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of non-severe community-acquired pneumonia(NSCAP), and to provide a basis for the design of NSCAP clinical trials and the construction of core outcome set. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science were systematically searched from establishment to August 31, 2023. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Qualitative analysis was used to describe the outcome indicators of the included studies. A total of 42 903 articles were preliminarily obtained, and 47 articles were finally included(4 articles in English and 43 articles in Chinese core). Seventy-nine outcome indicators were extracted, with 434 times. They were mainly divided into 9 categories: physical and chemical indicators(23 kinds, 96 times) [including inflammatory indicators(16 kinds, 78 times), arterial blood gas analysis(4 kinds, 8 times), and immune indicators(3 kinds, 10 times)], symptoms and signs(7 kinds, 86 times), clinical efficacy time(15 kinds, 83 times), clinical efficacy rate(12 kinds, 69 times), safety events(3 kinds, 50 times), TCM syndrome efficacy(4 kinds, 26 times), rating scales(13 kinds, 22 times), economic indicators(1 kind, 1 time), and other indicators(1 kind, 1 time). Numerous issues with the selection of outcome indicators of RCT in TCM treatment of NSCAP existed. These issues primarily showed up as unclear distinctions between primary and secondary outcome indicators, non-standard end point selection and TCM syndrome efficacy indicator evaluation criteria, and insufficiently used quality of life scales and health economics indicators. It is suggested to refer to the establishment method of the international core outcome set, improve the standardized TCM clinical efficacy evaluation system for NSCAP under the doctor-patient co-construction mode, and improve the quality of clinical trial.