The effectiveness and safety of Wu tou decoction on rheumatoid arthritis: A protocol for systematic review and/or meta-analysis.

Background: Rheumatoid arthritis (RA) is one of the common inflammatory diseases with arthritis due to a malfunction of the immune system. The treatments for RA include surgery, physiotherapy, occupational therapies, and medication. The representative treatment is medication and its usage has improved through several guidelines. However, it has some limitations and occurs adverse effects. Meanwhile, traditional Chinese medicine treatments have been used for RA treatment and Wu tou decoction (WTD) is one of them. Regardless of recent studies about WTD's efficacy on RA, there has been no systematic review on this issue. Therefore, this review will focus on the effectiveness and safety of WTD on RA.

Methods: The search for randomized controlled trial about WTD on RA will be performed using multiple electronic databases, manual searches, and the author's e-mail if necessary. According to predefined criteria, randomized controlled trials will be selected and summarization will be performed by the data on study participants, result measurements, interventions, adverse events, and risk of bias. Disease activity score including effective rate, swollen joint count, tender joint count, morning stiffness will be primary outcome measures while blood test about RA including erythrocyte sedimentation rate, C-reactive protein, rheumatoid factors, and adverse events will be secondary outcome measures. We will perform meta-analysis by using Review Manager software, assess the risk of bias by Cochrane Collaboration "risk of bias" tool, and determine the quality of evidence by Grades of Recommendation, Assessment, Development, and Evaluation.

Results: This study we will investigate the clinical evidence of the effectiveness and safety of WTD on RA.

Conclusion: For the RA patients and clinicians, our study will be informative. It can be also a great help for the researchers and policy makers who concentrates on conservative management for RA.

Trial Registration Number: INPLASY; INPLASY202220099.