OBJECTIVETo observe the clinical effects of Biqi Capsule (BQC) combined with methotrexate (MTX) for treatment of rheumatoid arthritis (RA), and to study an effective protocol of RA treated by integrative medicine.

METHODSOne hundred and thirty-eight patients with RA were randomly assigned to Group I (44 cases, treated by BQC), Group II (46 cases, treated by MTX), and Group III (48 cases, treated by BQC combined with MTX). The therapeutic course for each group was 12 weeks. The degree of joint pain, the tender joint number, the tender joint index, the swollen joint number, the swollen joint index, the two-hand grip, the morning stiffness time, and related laboratory indices were observed in each group before and after treatment. The adverse reactions were recorded.

RESULTSCompared with before treatment, there was statistical difference in the degree of joint pain, the tender joint number, the tender joint index, the swollen joint number, the swollen joint index, the two-hand grip, the morning stiffness time, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and rheumatoid factor (RF) in the 3 groups (P < 0.05, P < 0.01). Besides, better results were obtained in Group III (P < 0.01). As for the inter-group therapeutic efficacy, better results were obtained in Group III (P < 0.01). The gastrointestinal discomfort was the only adverse reaction in the 3 groups. No treatment was given due to its milder symptoms without any effects on the treatment.

CONCLUSIONSBQC showed favorable effects on treating RA with no obvious adverse reaction. BQC combined with MTX showed better clinical efficacy than use of BQC or MTX alone. It could reduce the adverse reactions of MTX. BQC combined with MTX could reduce the toxic reactions and enhance the therapeutic effects, indicating it was an effective treatment program for RA.