OBJECTIVETo study the clinical efficacy of Suogudan Granule (SGDG) in the treatment of rheumatoid arthritis (RA).

METHODSNinety patients with RA were randomly divided into the treated group and the control group. The treated group was administered orally with SGDG 6 g each time, thrice a day, while the control group with the combined therapy of Fenbid Capsules 0.3 g each time, twice a day and Tripterygium tablet 20 mg each time, thrice a day. The treatment course for both groups was 6 weeks. The changes of clinical symptoms and signs, and laboratory indices such as erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), antistreptolysin O (ASO), routine examination of blood and urine, liver and kidney function, etc. before and after treatment were observed.

RESULTS(1) The total effective rate in the treated group (88.0%) was obviously higher than that in the control group (67.5%) with significant difference (P < 0.05). (2) The improvement in arthralgia, joint swelling, time of morning stiffness, 15-meter walking, analgesia initiation and persistence in the treated group was better than that in the control group (P < 0.05, P < 0.01), but there was no obvious difference in improvement of joint tenderness, range of joint motion, grip strength, and initiating detumescence time (P > 0.05). (3) The improvement in ESR and RF in the treated group was better than that in the control group with significant difference (P < 0.05). The negative-conversion rate of ASO in the treated group was also higher than that in the control group (P < 0.01). (4) No evident abnormality in blood, urine, liver or kidney function was found in either group.

CONCLUSIONSGDG is effective and safe for the treatment of RA.