Qushi Juanbi Granules Combined with Shenling Baizhu Powder in Rheumatoid Arthritis Patients with Low Disease Activity and Pi Deficiency and Dampness Pattern: A Randomized, Double-Blind, Controlled Trial.

objectiveTo evaluate the efficacy and safety of Qushi Juanbi Granules (QSJB) combined with Shenling Baizhu Powder (SLBZ) for treating rheumatoid arthritis (RA) patients with low disease activity (LDA) and Pi (Spleen) deficiency and dampness dampness pattern.

methodsThis is a single-centre, randomized, double-blind, placebo-controlled clinical trial executed from November 29, 2022 to August 15, 2024. Participants were randomly assigned to the QSJB (with placebo) group or the QSJB+SLBZ group at a ratio of 1:1 using block randomization method. QSJB, SLBZ and placebo were given twice per day for 12 weeks. The primary outcome was the Disease Activity Score-28 with C-reactive protein (DAS28-CRP), assessed both as the between-group difference in DAS28-CRP values and the proportion of patients achieving remission (DAS28-CRP<2.6). The secondary outcomes included the 28-tender joint count (TJC28), 28-swollen joint count (SJC28), morning stiffness time, resting pain, Health Assessment Questionnaire (HAQ) score, Physician's Global Assessment of Disease Activity (PhGADA) score, Patient's Global Assessment of Disease Activity (PtGADA) score, rheumatoid factor (RF), anti-cyclic citrullinated peptide antibody (anti-CCP), erythrocyte sedimentation rate (ESR) and CRP. Safety was monitored during the trial.

resultsIn total, 60 participants were enrolled, 7 dropped out. Fifty-three patients completed the study, with 30 cases in the QSJB+SLBZ group and 23 cases in the QSJB group. Between-group comparisons of DAS28-CRP value at weeks 4 and 12 were not significant (P=0.702, P=0.520). For remission, the week-12 remission rate was numerically higher in the QSJB+SLBZ group than in the QSJB group, without statistical significance (P=0.745). In the QSJB group, both DAS28-CRP and TJC28 were improved after 12 weeks of treatment (P=0.024, P=0.014, respectively), but RF level was elevated at weeks 4 and 12 (both P=0.021). In the QSJB+SLBZ group, DAS28-CRP, TJC28 and SJC28 were improved after 4 weeks (P=0.002, P=0.029 and P=0.001, respectively), TJC28 and SJC28 also improved after 12 weeks (P=0.018, P=0.004, respectively). However, there was no significant difference in DAS28-CRP, anti-CCP, RF, ESR, CRP, TJC28, PhGADA, PtGADA, HAQ, morning stiffness time or resting pain between the two groups (P>0.05). No significant differences were noted between groups in overall adverse events (AEs) and AE-related discontinuation rates (all P>0.05).

conclusionsQSJB alone achieved beneficial clinical responses with acceptable tolerability in treating RA patients with LDA and dampness pattern, while QSJB+SLBZ relieved joint pain faster and thus could be a better alternative option. (Trial registration No. ChiCTR2100053894).