TY - JOUR
T1 - China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN)
T2 - Rationale, design, and baseline characteristics of the first 11,764 enrollees
AU - Gong, Xun
AU - Liu, Wei-xiang
AU - Li, Da
AU - Peng, Qiu-wei
AU - Xia, Cong-min
AU - Chang, Tian
AU - Guan, Jin-zhi
AU - Song, Meng-ge
AU - Zhang, Fu-yuan
AU - Tang, Xiao-po
AU - Liu, Ying
AU - Liu, Jian
AU - Peng, Jiang-yun
AU - He, Dong-yi
AU - Huang, Qing-chun
AU - Gao, Ming-li
AU - Yu, Jian-ping
AU - Liu, Wei
AU - Zhang, Jian-yong
AU - Zhu, Yue-lan
AU - Hou, Xiu-juan
AU - Wang, Hai-dong
AU - Fang, Yong-fei
AU - Wang, Yue
AU - Su, Yin
AU - Tian, Xin-ping
AU - Su, Xiao
AU - Meng, Qing-liang
AU - Wen, Shu-yun
AU - Wang, Bei
AU - Li, Ze-guang
AU - Liu, Ju
AU - Jiang, Hong
AU - Hu, Yan
AU - Li, Hui-Ling
AU - Wei, Shu-Feng
AU - Zhu, Wan-Hua
AU - Lyu, Ai-ping
AU - Zhang, Chi
AU - Jiang, Quan
N1 - Publisher Copyright:
© 2022
PY - 2022/9
Y1 - 2022/9
N2 - Background: Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA. Purpose: The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data. Study design: The CERTAIN is a prospective, multicenter, observational disease registry. Methods: Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol. Results: In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline characteristics of the first 11,764 enrollees. Conclusions: The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. Registration: The study was registered at ClinicalTrials.gov (NCT05219214).
AB - Background: Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA. Purpose: The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data. Study design: The CERTAIN is a prospective, multicenter, observational disease registry. Methods: Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol. Results: In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline characteristics of the first 11,764 enrollees. Conclusions: The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. Registration: The study was registered at ClinicalTrials.gov (NCT05219214).
KW - Rheumatoid arthritis
KW - Registry
KW - Chinese medicine
KW - Real-world data
UR - http://www.scopus.com/inward/record.url?scp=85133703552&partnerID=8YFLogxK
U2 - 10.1016/j.phymed.2022.154236
DO - 10.1016/j.phymed.2022.154236
M3 - Journal article
C2 - 35797864
AN - SCOPUS:85133703552
SN - 0944-7113
VL - 104
JO - Phytomedicine
JF - Phytomedicine
M1 - 154236
ER -
