A 12-Week Clinical Trial Of Traditional Chinese Medicine Jia-Wei-Qing-Luo-Yin Granules In Managing Active Rheumatoid Arthritis:Efficacy Observation

OBJECTIVE To observe and evaluate of clinical efficacy of a 12-week clinic trial of JiaWei-Qing-Luo-Yin(JWQLY)Granules management in patients with active rheumatoid arthritis(RA).METHODS Clinical Research: Patients with rheumatoid arthritis who meet the criteria for inclusion were recruited and treated with JWQLYgranules for 12 weeks and 41 of 43 completed the main study.Patients were followed up for 4 times: before treatment(0 weeks),at 4th week,8th week and 12 th week.The data of demographic information were recorded,including age,sex,dust exposure,exercise,BMI;disease related information,including the course of disease,age and season of onset,previous treatment,tongue coating,pulse,TCM physique.Main indexes observed before and after treatment included tenderness joint count(TJC),swollen joint count(SJC),disease activity score(DAS28-ESR,CRP),TCM symptom scores,visual analogue score(VAS),health assessment questionnaire(HAQ).Secondary indicators including rythrocyte sedimentation rate(ESR),rheumatoid factors(RF),c-reactive protein(CRP),anticitrullinated protein antibody(Anti-CCP,ACPA),Self-rating scale of anxiety and depression(SDS,SAS),Pittsburg Sleep Quality Index(PSQI),blood glucose(GLU)and blood lipid related indexes,joint ultrasound test results;serological indicators included IL-17 a,IL-35,VEGF,D-Dimer,Fibrinogen(Fb);Safety indicators included electrocardiogram(ECG),blood routine,urine routine,liver function,kidney function.The efficacy evaluation was assessed by both ACR20/50/70 improvement standard and TCM effect evaluation standard.RESULTS Clinical study: 1)The symptoms of RA patients including TJC,SJC,VAS were alleviated significantly;HAQ scale suggested that joint function of patients has been improved.2)Anxiety and depression had been relieved,and overall sleep quality has improved.3)DAS28-CRP and DAS28-ESR indicated that the patient’s disease activity decreased.There were 53% and 57% of the patients rated as low activity or complete remission,the number of patients with high activity decreased 22.5%;4)after treatment,IL-17 A decreased while IL-35 increased.This indicated that a possible mechanisms JWQLY on inflammation might be increasing IL-35 to promote Treg cell hyperplasia,while reducing the production of IL-17 a.5)The D-Dimer is significantly reduced,but serum fibrinogen has no significant change.6)At 4th week,the disease activity may fluctuate,however,it would be gradually controlled.7)JWQLY had no adverse effect on the blood routine,liver and kidney function of RA patients during 12-week treatment.CONCLUSION JWQLY granules is effective and safe in 12-week clinic trail of treating active RA,which not only had good effect in relieving joint symptoms and improving joint function,but also can play a crucial role by controlling inflammation,regulating immunity,inhibiting angiogenesis and reducing coagulation.At the same time,it took a period to show effects of JWQLY.Through the comparison with QLY treatment,it has been proved by this trial that the efficiency of the treatment,the degree of improvement and the safety of the disease have been improved after the addition of certain herbs.