Xun Gong1, Wei-Xiang Liu1, Da Li1, Qiu-Wei Peng1, Cong-Min Xia1, Tian Chang1, Jin-Zhi Guan1, Meng-Ge Song1, Fu-Yuan Zhang1, Xiao-Po Tang1, Ying Liu2, Jian Liu3, Jiang-Yun Peng4, Dong-Yi He5, Qing-Chun Huang6, Ming-Li Gao7, Jian-Ping Yu8, Wei Liu9, Jian-Yong Zhang10, Yue-Lan Zhu11, Xiu-Juan Hou11, Hai-Dong Wang12, Yong-Fei Fang13, Yue Wang14, Yin Su15, Xin-Ping Tian16, Xiao Su17, Qing-Liang Meng18, Shu-Yun Wen19, Bei Wang20, Ze-Guang Li21, Ju Liu22, Hong Jiang23, Yan Hu24, Hui-Ling Li25, Shu-Feng Wei26, Wan-Hua Zhu27, Ai-Ping Lyu28, Chi Zhang29, Quan Jiang30. 1. Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China. 2. The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, China. 3. The First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui, China. 4. Yunnan Probincial of Traditional Chinese Medicine, Yunnan, China. 5. Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China. 6. Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, China. 7. The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China. 8. The Affiliated Hospital of Jiangxi University of Chinese Medicine, Jiangxi, China. 9. The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China. 10. Shenzhen Traditional Chinese Medicine Hospital, Guangdong, China. 11. Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China. 12. Gansu Provincial Hospital of Traditional Chinese Medicine, Gansu, China. 13. Affiliated Hospital of the Third Military Medical University of the Chinese People's Liberation Army, Chongqing, China. 14. Jiangsu Provincial Hospital of Traditional Chinese Medicine, Jiangsu, China. 15. Peking University People's Hospital, Beijing, China. 16. Peking Union Medical College Hospital, Beijing, China. 17. Shanghai Traditional Chinese Medicine Hospital, Shanghai, China. 18. Henan Provincial Hospital of Traditional Chinese Medicine, Henan, China. 19. Dezhou People's Hospital, Shandong, China. 20. Beijing Hospital Of Traditional Chinese Medicine, Beijing, China. 21. First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Heilongjiang, China. 22. Jiujiang NO.1 People's Hospital, Jiangxi, China. 23. The Ninth People's Hospital of Chongqing, Chongqing, China. 24. Shangrao People's Hospital, Jiangxi, China. 25. Hubei Provincial Hospital of Traditional Chinese Medicine, Hubei, China. 26. Fangshan Hospital Beijing University of Traditional Chinese Medicine, Beijing, China. 27. Nantong Liangchun Hospital of Traditional Chinese Medicine, Jiangsu, China. 28. School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China. 29. Dongzhimen Hospital Beijing University of Chinese Medicine, Beijing, China. Electronic address: sage618@126.com. 30. Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China. Electronic address: jiang.quan@hotmail.com.
Abstract
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).
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).