Treatment Of Rheumatoid Arthritis By Huayu Qiangshen Tongbi Recipe Combined Methotrexate

Objective:Advantage in treating RA with traditional Chinese medicine is obvious.Based on our previous studies,we desined a randomized controlled trial for further evaluating the clinical efficacy,safety,and the potential of bone protection of Huayu Qiangshen Tongbi Recipe combined with Methotrexate?MTX?in the treatment of active patients with Rheumatoid Arthritis?RA?.Methods:It was a single center,open,randomized controlled,prospective trial.Sixty RA patients who met the inclusion criteria were randomly divided into two groups:The patients in the experimental group were given methotrexate?MTX?combined with Huayu Qiangshen Tongbi Recipe and the control group were given MTX combined with Leflunomide?LEF?for 24 weeks,and 52 weeks of follow-up.In this research,ACR remission rates were used as the main efficacy indicators,while CRP,CDAI,SDAI,DAS28,HAQ,bone mineral density measurement,ect.as the secondary efficacy indicators,blood routine,liver and kidney function,electrocardiogram,etc.as safety indicators,so as to evaluate the clinical efficacy of Qiang Tong Tong Bi Fang combined with MTX in the treatment of RA,observe its safety,and explore its bone protection.Results:A total of 60 patients were enrolled in this study,30 patients in the experimental group and 30 in the control group.The main efficacy and secondary efficacy indicators were compared between the two groups as follows:The main efficacy indicators:1.ACR20:The remission rates of the experimental group at 4 weeks,12 weeks,and 24 weeks were 39.3%,67.9%,and 82.1%,respectively.The remission rates at the 4th,12th,and 24th weeks in the control group were 28.6%,60.7%,and82.1%.There was no statistical difference between both of groups?P=0.40,0.58,1?.2.ACR50:The remission rate at the 4th,12th,and 24th weeks in the experimental group was 28.6%,42.9%,and 71.4%,respectively.The remission rates at the 4th,12th,and 24th weeks in the control group were 17.9%,50.0%,and 71.4%.There was no statistical difference between both of groups?P=0.34,0.59,1?.3.ACR70:The remission rates of the experimental group at 4,12,and 24 weeks were 3.6%,25.0%,and 46.4%,respectively.The remission rates at 4 weeks,12 weeks,and 24 weeks in the control group were 0%,28.6%,and 50.0%.There was no statistical difference between both of groups at each time?P=1,0.76,0.79?.Secondary efficacy indicators:1.Laboratory indicators:?1?CRP:Both groups improved at the 4^th week,the 12^th week and 24^th week after treatment,and there was a significant statistical difference between before and after treatment?P<0.05?.There was no significant difference between both groups in each observation point?P>0.05?.?2?RF:In the experimental group,it improved at the 4^th week and the 12^th week after treatment,the difference was statistically significant?P<0.05?,but indicator of RF at the 12^th week and 24^th week was higher than that before treatment,difference was no statistical significant at the 24^thh week?P>0.05?.The RF improved at the 12^th week and the 24^th week after treatment compared with before in the control group,difference was statistically significant?P<0.05?,but there was no significant difference at the 4^th week?P>0.05?.There was no significant difference between groups in each observation point?P>0.05?.?3?Anti Cycliccitrullinated peptide?CCP?antibody:The ratio of anti-CCP antibody in experimental group and control group changed a bit after treatment,but there was no statistical difference between both of groups?P>0.05?.2.Non-laboratory indicators:?1?Clinical symptoms:The tender joint counts were improved at the 12^th week and the 24^th week but not the 4^thh week,which in the experimental group after treatment,and difference was statistically significant?P<0.05?.It improved at the 4^th week,the 12^th week,and the 24^thh week after treatment in the control group.The difference was statistically significant?P<0.05?.There was no significant difference between both of groups in each observation point?P>0.05?.In terms of the swollen joint counts,Both groups improved at the 4^th week,the 12^th week and24^th week after treatment,and there was a significant statistical difference between before and after treatment?P<0.05?.There was no significant difference between groups at the 12^th week and 24^th week?P>0.05?,but except the4^th week?P<0.05?.Other indictors such as the patient global assessment,physician global assessment,patient pain assessment,and the morning stiffness time,there was a statistical difference between the baseline and after treatment in two groups?P<0.05?.There was no significant difference between both of groups in each observation point?P>0.05?.The comprehensive efficacy indicators:In DAS28,CDAI,and SDAI,there was a statistical difference between the baseline and after treatment in this two groups?P<0.01?.There was no significant difference between both of groups in each observation point?P>0.05?.?3?Radiographic indicators:On X-rays of hands and the dual-energy X-ray bone density screening,there was no statistical difference in the groups between baseline and after treatment point?P>0.05?.However,three patients in the experimental group had a clear improvement in bone mineral density after 24weeks of treatment.?4?HAQ:There was a significant statistical difference between before and after treatment?P<0.01?.There was no significant difference between both of groups in each observation point?P>0.05?.Safety evaluation:During the observation period,there were 5 adverse reactions in the experimental group while 21 in the control group.There was a significant statistical difference between both of groups?P<0.05?.Conclusion:The combination of Huayu Qiangshen Tongbi Recipe and MTX could effectively improve the clinical symptoms and relieve the disease activity of RA patients,and also safer than the control group.It suggests that Huayu Qiangshen Tongbi Recipe combined with MTX is an alternative therapeutic regimen for the treatments of RA,and it may have the potential of bone protection.