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| Outcome measures analysis of randomized controlled trials on traditional Chinese medicine for gouty arthritis |
| Hits 519 Download times 376 Received:April 29, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.08.11 |
| Key Words
gouty arthritis;traditional Chinese medicine;randomized controlled trial;outcome measures;core outcome set |
| Author Name | Affiliation | E-mail | | ZHANG Wen | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | LIU Hanchi | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | SUN Tianhao | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | SHAN Xinjue | Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China
China Academy of Chinese Medical Science Guang'anmen Hospital, Beijing 100053, China | | | WU Shentao | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | shtaowu@163.com |
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| Abstract
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| [Objective] This study evaluates the current status of outcome indicators in randomized controlled trial（RCT） for traditional Chinese medicine treatment of gouty arthritis（GA） and provides reference for clinical research and the construction of a core outcome set reference and support. [Methods] Eight databases were comprehensively searched，including four Chinese-language databases（CNKI，VIP，Wanfang Data，SinoMed） and four English databases（Cochrane Library，EMbase，PubMed，Web of Science） up to July 16，2024.Relevant RCTs were screened according to the inclusion and exclusion criteria，and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool. [Results] Seventy-seven RCTs were finally included，with sample sizes ranging from 40 to 474 cases. There were 123 types of outcome indicators，with a total frequency of 668 times，including 320 for laboratory tests（46.51%），202 for symptoms/signs（30.24%），96 for safety events（14.37%），25 for traditional Chinese medicine symptoms/syndromes（3.74%），12 for long-term prognosis（1.80%），10 for others（1.50%），and 3 for quality of life（0.45%），but economic evaluation indicators were lacking.[Conclusion] The current clinical research on outcome indicators had a variety of problems，such as imperfect trial design，unclearly defined primary outcome indicators，has a wide variety of outcome indicators but lack of systematicity，lack of attention to a number of key indicators，and failure to standardize the traditional Chinese medicine-specific indicators. It is recommended to enhance the scientific nature of research，integrate the unique efficacy of traditional Chinese medicine with clinical research needs，and establish a set of key indicator systems that align with the characteristics of traditional Chinese medicine. |
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