Objective To observe the clinical effect and safety of Pingle Jingu Tongxiao Plaster（平乐筋骨痛消膏） external application combined with Western medicine oral administration for treating patients with rheumatoid arthritis of damp-heat obstruction syndrome. Methods A total of 150 patients with rheumatoid arthritis were randomly divided into a treatment group and a control group with 75 in each group. Patients in control group were treated with oral methotrexate tablets 10 mg each time

once a week and celecoxib capsules 0.2 g each time

twice daily

while patients in the treatment group were additionally treated by Pingle Jingu Tongxiao Plaster for external application on hand joints（10 h each time

plaster change daily）. Both groups were treated for 12 weeks. The clinical effective rate

changes in joint symptoms

pain severity

erythrocyte sedimentation rate（ESR） and C-reactive protein（CRP） were observed before and after treatment. Results The number of patients who had reached the American College of Rheumatology 20% improvement criteria（ACR20）

50% improvement criteria（ACR50）

and 70% improvement criteria（ACR70） in the treatment group were 66

49 and 25 respectively

while those of control group were 55

25 and 13 respectively. The difference in ACR20

ACR50

ACR70 were significantly different between two groups（P<0.05）. The disease activity score in 28 joints（DAS28）

total joint symptom score

visual analogue score（VAS）

ESR

and CRP level after treatment were significantly lower than before treatment in both groups（P<0.05）; and after treatment

the above indexes in treatment group were significantly lower than in the control group（P<0.05）. There was no significant difference in rate of adverse reactions between the two groups（P>0.05）. Conclusion Pingle Jingu Tongxiao Plaster combined with oral Western medicine was more effective than oral Western medicine alone in improving clinical symptoms as well as decreasing inflammatory indicators when treating rheumatoid arthritis of damp-heat obstruction syndrome

and there was no obvious adverse events.