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| Literature study on outcome indicators of clinical trials of traditional Chinese medicine in the treatment of rheumatoid arthritis |
| Hits 264 Download times 195 Received:December 11, 2023 |
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| DOI
10.11656/j.issn.1672-1519.2024.06.11 |
| Key Words
traditional Chinese medicine;rheumatoid arthritis;outcome measure;core outcome set |
| Author Name | Affiliation | E-mail | | SONG Mengge | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | JIANG Quan | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | doctorjq@126.com | | HAN Man | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | YAO Chuanhui | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | ZHANG Fuyuan | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | ZHAO Xueqi | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | GONG Xun | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | | | XIA Congmin | Department of Rheumatism, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China | |
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| Abstract
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| [Objective] To systematically analyze outcome measures in clinical trials of rheumatoid arthritis with intervention of traditional Chinese medicine（TCM），and to establish the basis for core outcome set（COS） of clinical trials of rheumatoid arthritis. [Methods] CNKI， WANFANG DATA，SinoMed，VIP，PubMed，Cochrane library and EMbase databases were searched by computer，and the clinical trials of TCM for the treatment of rheumatoid arthritis were comprehensively collected. The retrieval time was set in 2020. Literature screened and data extraction were conducted independently by 2 researchers according to inclusion and exclusion criteria. [Results] The 69 studies were included，involving 56 randomized controlled trials（RCT），3 non-RCTs，9 case-control studies and 1 before-after study，with a total of 4 077 patients and 37（class） outcome indicators. The number of outcome indicators in one of included RCTs varied from 3 to 29 with the average of 11. After frequency analysis，the top 10 rate of outcome indicators were erythrocyte sedimentation rate（ESR，73.91%），C-reactive protein（CRP，71.01%），effective rate（71.01%），rheumatoid factor（RF，66.67%），adverse effects（60.87%），Disease Activity Score 28（DAS28，46.38%），visual analogue scale（VAS，40.58%），tender joint count（TJC，40.58%），morning stiffness duration（MSD，40.58%），swollen joint count（SJC，39.13%）. Classified by the functional properties of the indicators，the setting rate of the indicator domains of the included studies were，in descending order，physical and chemical tests evaluation（92.75%），overall disease evaluation（91.30%），symptoms/signs evaluation（73.91%），safety events evaluation（60.87%），TCM disease evidence evaluation（34.78%），quality of life evaluation（4.35%），and no economics and long-term prognostic evaluation were involved. [Conclusion] There were some common problems about outcome indicators of clinical trials，such as heterogeneity，non-standardization and lack of TCM characteristics，long-term prognosis and economic evaluation. Therefore，it is urgent to establish COS-TCM characteristic indicator of rheumatoid arthritis. |
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