Objective To observe the clinical efficacy and safety of Jiawei Shaogan Fuzi（SGFZ） Decoction（加味芍甘附子汤） in treating rheumatoid arthritis（RA） with cold-damp obstruction syndrome. Methods Sixty RA patients were randomly divided into treatment group and control group

with 30 patients in each group. The control group was treated with methotrexate（MTX） or/anduse leflunomide（LEF）

and the treatment group was given SGFZ Decoction on the basis of control group

once a day. Both groups were treated for 12 weeks. Chinese medicine syndrome scores

DAS28 score

control rate of ACR（20/50/70）

time of morning stiffness

swollen joint count

painful joint count

VAS scores

musculoskeletal ultrasound evaluation of 2 to 5 metacarpophalangeal joints（MCPJ）

the number of affected 2 to 5 proximal interphalangeal joint（PIPJ）

and MCPJ hypertrophic synovium grading were recorded. The clinical efficacy and safety were evaluated. Results After treatment

the scores of Chinese medicine syndromes and symptoms of morning stiffness

joint swelling

joint pain

joint tenderness

joint cold

aversion to cold

soreness and weakness of waist and knees

cold in extremities of treatment group were lower than those in the the control group（P < 0. 05）. The total effective rate of Chinese medicine syndrome in the treatment group was 96. 67%

which was higher than 66. 67% in the control group（P < 0. 01）. Compared with before treatment

the time of morning stiffness

joint pain and swelling count

VAS score of two groups were decreased（P < 0. 05）. After treatment

the total effective rate of DAS28 in the treatment group was 90. 00%

which was higher than 66. 67% of control group（P < 0. 05）. There was not statistically significant difference in control rate of ACR20/50/70 of two groups after treatment（P > 0. 05）. After treatment

the number of affected MCPJ of two groups was decreased（P < 0. 05）

and MCPJ hypertrophic synovium grading was decreased（P < 0. 05）. There was no significant difference in the number of affected MCPJ

PIPJ of two groups after treatment（P > 0. 05）. Conclusion Jiawei Shaogan Fuzi Decoction combined with western medicine is better than simple conventional western medicine in improving the symptoms and signs of RA patients with cold-damp obstruction syndrome simple

with better safety.