May Traditional Chinese Medicine Reduce the Risk of Developing Rheumatoid Arthritis? An One-armed Prospective Study

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BackgroundRheumatoid arthritis (RA) is a worldwide public health problem. Intervention and prevention before the onset of rheumatic diseases is a new direction in current research. ObjectiveThe aim of this study was to evaluate the potential and feasibility of traditional Chinese medicine (TCM) in the prevention of RA. MethodsThis was a single-armed prospective clinical trial. All participants were recruited from a single center in Guangdong, China. Adults who were tested positive for anti-cyclic citrullinated peptide antibody (anti-CCP) and/or rheumatoid factor (RF), had no synovitis and never been treated with disease-modifying anti-rheumatic drugs (DMARDs), were enrolled to take the Huayu-Qiangshen-Tongbi (HQT) decoction orally twice daily, 200 mL each time for 24 weeks. Primary outcome was the proportion of patients who met 2010 ACR(American College of Rheumatology)/EULAR(European League Against Rheumatism) classification criteria of RA during observation. Secondary outcomes included levels of anti-CCP, RF, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), assessment of signs and symptoms, and radiographic progression by magnetic resonance imaging (MRI). Results19 individuals were enrolled in the study, 4 of which withdrew because of the epidemic of COVID-19. During the observation period, 3 individuals (20%) developed RA and they had longer morning stiffness (P = 0.009) and more obvious synovial enhancement in MRI (P = 0.041) at baseline when compared with those who did not develop RA. After 24 weeks of intervention, there were improvements in 28-swollen joint count (SJC28) (P = 0.046), Visual Analog Scale (VAS) (P = 0.019), Patient's Global Assessment (PtGA) (P = 0.019) and Physician's Global Assessment (PGA) (P = 0.031), but no statistical significance was observed in the levels of anti-CCP, RF, ESR, CRP, morning stiffness, 28-tender joint count (TJC28), Health Assessment Questionnaire (HAQ) and magnetic resonance imaging (MRI) analysis (P > 0.05). ConclusionThe HQT formula is safe and could improve joint symptoms and signs in these at-risk individuals, but it remains to be investigated in futher study to see if it might potentially reduce the risk of developing RA. Besides, for individuals at high risk to develop RA, morning stiffness and synovial enhancement in MRI might be predictive factors and warning signs.