Modified Guizhi Shaoyao Zhimu Decoction In The Treatment Of Rheumatoid Arthritis Due To Phlegm And Blood Stasis

Objective: To evaluate the efficacy and safety of modified Guizhi Shaoyao Zhimu Decoction in the treatment of rheumatoid arthritis(RA)by comparing the efficacy of the experimental group(modified Guizhi Shaoyao Zhimu Decoction combined with leflunomide and methylprednisolone tablets)and the control group(leflunomide combined with methylprednisolone tablets).Methods: The type of study was a randomized controlled trial.The study included 80 patients with RA of phlegm and blood stasis type who were treated in the outpatient department of Rheumatism K,Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from December 2016 to November 2018.According to the random number table method,the patients were randomly divided into the control group and the experimental group according to the ratio of 1:1.There were 40 cases in the control group(leflunomide +methylprednisolone tablet)and 40 cases in the experimental group(leflunomide +methylprednisolone tablet + modified Guizhi Shaoyao Zhimu Decoction).Both groups have a treatment cycle of 8 weeks.The clinical symptoms,signs,laboratory indicators,safety indicators and adverse reactions of patients before and after treatment were observed and recorded.Finally,DAS28 score and the efficacy of TCM syndromes and signs were used as evaluation criteria.Result: 1.Evaluation of disease efficacy(DAS28 score): In the experimental group,one person fell off and 39 people finished the experiment.Among them,11 cases were markedly effective,21 cases were effective and 7 cases were ineffective.So,the total effective rate of the experimental group was 82.05%.In the control group,two people fell off and 38 people finished the experiment,of which 8 cases were markedly effective,22 cases were effective and 8 cases were ineffective.So,the total effective rate of the control group was 78.95%.There was no significant difference in the total effective rate between the two groups(P >0.05).2.Evaluating the curative effect of TCM syndromes: the total effective rate of theexperimental group was 84.6%,and that of the control group was 60.5%.The total effective rate of the experimental group was higher than that of the control group,and there were significant difference between the two groups.(P < 0.01).Eight observation indexes: morning stiffness time,joint tenderness,joint swelling,limb numbness,chillness,aggravation of cloudy and rainy days,fatigue and weakness,and heavy limbs.After treatment,the experimental group was better than the control group(P < 0.01 or P < 0.05).3.Evaluation of other observation indicators: After treatment,the Health Assessment Questionnaire(HAQ)of the experimental group was better than that of the control group significantly(P < 0.05).There was no significant difference in Erythrocyte sedimentation rate(ESR)and C-reactive protei(CRP)between the two groups(P > 0.05).4.Safety evaluation: There were no abnormalities in blood routine,liver and kidney function and other safety indicators in the two groups during the treatment period.There were 5 cases with mild adverse reactions and no need to stop medication.Conclusion: Modified Guizhi Shaoyao Zhimu Decoction combined with western medicine can effectively treat RA of phlegm and blood stasis type.It is superior to western medicine in improving TCM syndromes,signs and quality of life,and has low side effects and high safety.