OBJECTIVETo investigate the effects of Qingre Huoxue Decoction , clearing heat and promoting blood flow; QRHXD), on the radiographic progression in patients with rheumatoid arthritis (RA) by X-ray imaging.

METHODSEighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate (MTX) group, with 43 cases in each group. After one-year of treatment, 21 cases in each group (42 in total) were evaluated. Radiographs of hands were obtained at the baseline and after 12 months of treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to the Sharp/Van der Heijde methods.

RESULTSHigh intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months in either group; and the differences between the two groups were not significant (P>0.05). The mean of the changing score in the QRHXD group was 3.5 ± 4.1, and 2.4 ± 3.5 in the QRHXD+MTX group, while the baseline radiographic score of patients in the QRHXD group was relatively higher (18.9 ± 19.1 vs. 14.0 ± 14.0). The mean rates of the changing scores of the two groups were similar (0.24 ± 0.28 vs. 0.25 ± 0.44, P=0.40). The severity of progression in the two groups was also similar (P=0.46), 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group, 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group.

CONCLUSIONRadiographic progression of RA patients in both groups is similar, indicating that the QRHXD Decoction has a potential role in preventing bone destruction.