The Effectiveness and Safety of Yi Shen Juan Bi Pill on Rheumatoid Arthritis: a Protocol for Systematic Review and/or Meta-Analysis.

Importance: The Yi Shen Juan Bi (YSJB) pill has been used to treat rheumatoid arthritis (RA), with several studies reporting its anti-inflammatory effects and ability to prevent bone destruction. However, the lack of evidence regarding the effectiveness and toxicity of individual components of YSJB limits its widespread use.

Objective: This protocol outlines a systematic review and/or meta-analysis to evaluate the effectiveness and safety of YSJB.

Data resources: We will search worldwide electronic databases, including MEDLINE, Cochrane Library, China National Knowledge Infrastructure, Wanfang, CiNii, J-STAGE, KoreaMed, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, Korea Institute of Science and Technology Information, and Oriental Medicine Advanced Searching Integrated System. In addition, we will conduct manual searches, and, if necessary, contact authors directly. The search will cover publications until June 2024.

Study selection: We will select randomized controlled trials (RCTs) that compare the use of YSJB for the treatment of RA against other treatments.

Study extraction and synthesis: Data from the selected RCTs will be extracted, including sample size, patient characteristics, intervention details, and outcome measures. We will perform a meta-analysis using Review Manager software.

Main outcome(s) and measure(s): The primary outcome measures will include disease activity scores such as effective rate, swollen joint count, tender joint count, and morning stiffness. Secondary outcome measures will include blood test results and adverse events.

Results: The results will reveal the effectiveness and safety of YSJB for the treatment of RA.

Conclusions: and Relevance: The findings will provide an evidence-based review of the use of YSJB for RA.S.