Objective To investigate the efficacy of Qizhu Bishi Granules combined with methotrexate in the treatment of patients with rheumatoid arthritis (RA).

Methods A total of 140 RA patients in the Shijiazhuang City Third Hospital from January to May 2023 were selected as research objects and randomly divided into a treatment group and a control group, with 70 cases in eachgroup. The control group was treated with methotrexate, while the treatment group was treated with Qizhu Bishi Granules combined with methotrexate, and the treatment duration was 3 months for both groups. The total effective rate, score of traditional Chinese medicine (TCM) syndromes, the number of swollen joints, the number of tender joints, the Visual Analogue Scale (VAS) score for pain, the Disease Activity Score in 28 Joints (DAS28), interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α), erythrocyte sedimentation rate (ESR), high-sensitivity C reactive protein (hs-CRP), rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibody (anti-CCP antibody) levels before treatment and at 1 month and 3 months after treatment as well as therapeutic safety were compared between the two groups.

Results The total effective rate in the treatment group was 97.14%, which was significantly higher than 87.14% in the control group (P < 0.05). After 1 month and 3 months of treatment, the scores of TCM syndromes, the number of swollen joints, the number of tender joints, the VAS score, DAS28, IL-1, TNF-α, ESR, hs-CRP, RF and anti-CCP antibody levels in the treatment group were significantly lower than those in the control group (P < 0.05). No adverse reactions occurred in both group.

Conclusion Qizhu Bishi Granules combined with methotrexate in treating RA can effectively alleviate clinical symptoms, improve TCM syndromes, reduce inflammatory responses, decrease disease activity, and the therapeutic efficacy is reliable and safe.