China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees

Xun Gong, Wei-xiang Liu, Da Li, Qiu-wei Peng, Cong-min Xia, Tian Chang, Jin-zhi Guan, Meng-ge Song, Fu-yuan Zhang, Xiao-po Tang, Ying Liu, Jian Liu, Jiang-yun Peng, Dong-yi He, Qing-chun Huang, Ming-li Gao, Jian-ping Yu, Wei Liu, Jian-yong Zhang, Yue-lan ZhuXiu-juan Hou, Hai-dong Wang, Yong-fei Fang, Yue Wang, Yin Su, Xin-ping Tian, Xiao Su, Qing-liang Meng, Shu-yun Wen, Bei Wang, Ze-guang Li, Ju Liu, Hong Jiang, Yan Hu, Hui-Ling Li, Shu-Feng Wei, Wan-Hua Zhu, Ai-ping Lyu, Chi Zhang*, Quan Jiang

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

1 Citation (Scopus)

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).

Original languageEnglish
Article number154236
Number of pages7
JournalPhytomedicine
Volume104
Early online date14 Jun 2022
DOIs
Publication statusPublished - Sept 2022

Scopus Subject Areas

  • Molecular Medicine
  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery
  • Complementary and alternative medicine

User-Defined Keywords

  • Rheumatoid arthritis
  • Registry
  • Chinese medicine
  • Real-world data

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