Efficacy of Qingrehuoxue granule for bone protection in patients with active rheumatoid arthritis in China: The PRE-ERODE randomized controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Qingrehuoxue (QRHX) granules, composed of 12 Chinese herbs, have been used for over 40 years to treat rheumatoid arthritis (RA) in China and show potential in protecting bone health. However, high-quality evidence on their effects is limited.

AIM OF THE STUDY: To assess the effects of QRHX granules on bone marrow edema (BME) in active RA patients.

MATERIALS AND

METHODS

This multicenter, randomized, double-blind, placebo-controlled trial enrolled RA patients from 13 hospitals in China. Participants were randomly assigned in a 1:1 ratio to receive either QRHX granules (10 g, twice daily) plus methotrexate (MTX) or a placebo plus MTX for 24 weeks. The primary outcome was the change in MRI-assessed BME score at week 24. Secondary outcomes included changes in bone erosion scores, Disease Activity Score in 28 joints, and safety outcomes.

RESULTS

A total of 204 patients (mean age, 48.77 years; SD, 11.96) were randomized to either the QRHX or placebo group. At week 24, the QRHX group showed a significantly greater reduction in BME scores compared to the placebo group (adjusted between-group difference, -2.50; 95 % CI, -4.76 to -0.25; P = 0.030). QRHX also significantly reduced bone erosion progression (adjusted between-group difference, -2.90; 95 % CI, -5.49 to -0.31; P = 0.030). Adverse events were rare and similar across both groups, with no deaths or life-threatening events.

CONCLUSION

QRHX granules, combined with MTX, significantly reduced MRI-detected BME and slowed bone erosion in active RA, suggesting potential as a complementary treatment for bone protection in RA.