Clinical Trial Of Traditional Chinese Medicine Fumigation As Adjuvant Therapy Of Active Rheumatoid Arthritis

Objective: To evaluate and compare the clinical efficacy and safety of the combination therapy of DMARDs(disease modifying antirheumatic drugs)and non-steroidal anti-inflammatory drug(NSAID)together with Traditional Chinese Medicine(TCM)fumigation,and the combination therapy of only DMARDs and NSAID in the treatment of active rheumatoid arthritis(RA),so as to provide objective and accurate clinical evidence for TCM fumigation used in the treatment for RA.Method: This study was a randomized,controlled and prospective clinical trial.112 cases of active RA admitted from Jan 2014 to June 2015 in the Second Hospital of Dalian Medical University were randomized and divided into 2 groups of the experimental group(n=57)and the control group(n=55).All the patients of both groups were treated with traditional DMARDs(single drug therapy or combined therapy of Methotrexate,Leflunomide,Iguratimod,Kunxian Capsules and Tripterygium wilfordii)and NSAID(single drug therapy of Loxoprofen,Celecoxib and Meloxicam)while patients of the experimental group received TCM fumigation treatment on the affected joint(s)for 4 weeks,30-40 min/ day.Patients of both groups were followed up in Week 0,4,8,12 and 24,and the clinical efficacy and adverse effects were recorded and evaluated.The efficacy assessment indexes were ACR20,ACR50 and ACR70 of American College of Rheumatology ACR,as well as DAS28(Disease activity scores in 28 joints)-erythrocyte sedimentation rate(ESR),number of swollen joints,number of joint tenderness,length of morning stiffness,doctor's visual analogue scale(VAS)of overall conditions,patient's VAS of pain,Health assessment questionnaire(HAQ)and C-reactive protein(CRP).Results: 1)In week 4 of the treatment,the experimental group achieved higher improvement rates of ACR20,ACR50,ACR70 and higher rate of DAS28 remission,but the differences were not of statistical significance.The number of joint tenderness,length of morning stiffness,doctor's VAS of overall conditions and patient's VAS of pain were all decreased compared with the baseline,and the differences between the groups were both statistically significant.The number of swollen joints and the results of ESR,CRP,DAS28-ESR and HAQ were all lowered than the baseline,but the differences were not significant between two groups.2)In week 8,12,24,the results of improvement rates of ACR20,ACR50,ACR70 and DAS28 remission rate were not significant between two groups.And the number of swollen joints,number of joint tenderness,length of morning stiffness,doctor's VAS of overall conditions,patient's VAS of pain and HAQ were all lower than the base line,the differences of statistical significance were not between the two groups.3)All above efficacy and adverse effects' differences were significant within groups in the end of the.4)Clinical Trial.The differences of the results of rheumatoid factor(RF)and anti-cyclic citrullinated peptide antibody were not statistically significant in week 4,12 or 24.Drug safety evaluation: there were no adverse events of the patients in both groups during the clinical trial.Conclusion: The combination therapy of DMARDs and NSAID together with TCM fumigation,and the combination therapy of only DMARDs and NSAID in the treatment of active rheumatoid arthritis are both effective.TCM fumigation can reduce the symptoms such as joint tenderness and morning stiffness,reduce pains and improve patient's VAS results.The clinical efficacy of TCM fumigation to shorten the time to achieve ACR20,ACR50 and ACR70 improvements as well as the reduction of RA activity is not evident,while it can still be used as the adjuvant therapy of rheumatoid arthritis with clinical safety for long-term application.