Objective: To explore the clinical efficacy of Bixietang in treatment of rheumatoid arthritis (RA) cold-dampness syndrome and investigate its effects on levels of erythrocyte sedimentation rate (ESR)

blood uric acid (UA)

C-reactive protein (CRP) and superoxide dismutase (SOD). Method: A total of 114 eligible patients were randomly divided into control group and observation group

57 cases in each group. Methotrexate tablets were given in both groups (10 mg/time

1 time/week). Based on this

control group also received paeonia capsule (0.6 g/time

2 times/d); and the observation group received Bixietang (1 dose/d). The treatment course was 3 months in both groups. The disease activity scores 28-joint counts (DAS28)

the oswestry disability index (ODI)

the health assessment questionnaire (HAQ) and the traditional Chinese medicine (TCM) differentiation RA cold-dampness syndrome (TCM symptom) scores were applied to estimate the efficacy. The changes in ESR

UA

CRP and SOD were detected in two groups

and the efficacy and incidence of adverse reactions were compared between two groups. Result: The 3 cases were withdrawn in control group

and 6 cases were withdrawn in observation group. The total effective rate was 94.1% in observation group

better than 79.6% in control group (P<0.05). After treatment

the improvement in scores of DAS28

ODI

HAQ

and TCM symptom was more obvious in observation group (P<0.05); improvement in ESR

UA

CRP and SOD was also more significant in observation group (P<0.05). The incidence of adverse events (gastrointestinal reactions

liver damage

oral ulcers

dermatitis

herpes simplex

and white blood cell decline) in observation group (7.8%) was lower than that (20.4%) in control group (P<0.05). Conclusion: Bixietang combined with western medicine in the treatment of RA cold-dampness syndrome was effectiveness to improve the clinical symptoms of RA

ESR

UA

CRP and SOD and decrease the adverse events.