OBJECTIVETo observe the clinical efficacy and safety of Simiao Xiaobi Decoction (SXD) in treating active rheumatoid arthritis (RA) of humid pyretic toxic Bi-Zheng (HPTB) syndrome type.

METHODSOne hundred and twenty RA patients were randomly assigned to 2 groups, 60 in the treatment group receiving SXD, and 60 in the control group receiving methotrexate, all were treated for 12 weeks. Clinical efficacy in patients was evaluated, referring to the criteria recommended by European League Against Rheumatoism (EULAR), in terms of effective rate, main symptoms, signs, scoring on symptom/sign by Chinese medicine scale and DAS28, physical and chemical indices, long-term outcome of patients and the average therapeutic effect initiating time. Meantime, the adverse reaction was recorded.

RESULTSThe study was completed in 103 patients, 52 in the treated group and 51 in the control group. According to a per-protocol analysis, the effective rate was better in the treatment group than in the control group with marked difference in terms of Chinese and Western medicine respectively (92.3% vs 70.6% and 86.5% vs 62.7%, P<0.05). Superiorities in the treatment group were also seen in the improvements of main symptoms and signs, symptom/sign scores, DAS28 scores, and long-term outcome. Moreover, the average therapeutic effect initiating time was shorter (5.31 +/- 0.36 weeks vs 8.28 +/- 0.45 weeks), while the incidence of adverse reaction was less in the treatment group than in the control group (6.7% vs 43.3%, P<0.05).

CONCLUSIONSXD can improve the joint symptoms and general condition of RA patients of HPTB type with shorter initiating time and less adverse reaction.