Efficacy And Safety Evaluation On Moderate Rheumatoid Arthritis With Cold And Dampness Syndromes Treated By Gufuwenjingtongbi Decoction

Objective:With a purpose of critically evaluate the curative effect of Guifuwenjingtongbi Decoction in the treatment of Moderate Rheumatoid Arthritis (RA) with Cold and Dampness Syndromes, TCM symptom complex score and EULAR DAS28 efficacy criteria were adopted simultaneously in this study. Additionally, the safety of this treatment was also examined through safety indicators, such as liver and kidney function, thus to provide a valuable clinical evidence to support an integrated treatment on moderate RA with Cold and Dampness Syndromes, namely, combining TCM with western medicine therapy.Method:With a non-blind, positive drug, random, and parallel-group study method, a total number of 48 cases of RA patients that met inclusion criteria were randomly but evenly divided into two groups:the control group and the observation group. And these two groups, consisting of 24 cases each, were observed synchronously throughout the whole research project.The control group was treated methotrexate (MTX) 10mg qw, and celecoxib capsules (Celecoxib) 200mg qd, while observation group, on the basis of the same regular treatment of control group, were additionally serviced with Guifuwenjingtongbi Decoction 150ml Bid.Treatment for each group lasted 12 weeks, and clinical symptoms of patients from each group were recorded before and after the treatment, same as the laboratory parameters, including RF, anti-CCP, ESR, CRP, and clinical efficacy such as TCM symptom complex score and DAS28 (ESR) standards. In addition, safety of the treatment and decoction were guaranteed via recording safety indicators, such as blood routine, urine routine, fecal routine, liver function, kidney function, and ECGResults:1. Observations on 45 out of the total 48 patients with RA were finally completed in this study (dropout rate= 6.25%), including 23 cases from observation group and 22 cases from the control group.2. The in-group comparison of 48 patients’ number of joint count (SJC), tender joint count (TJC), morning stiffness, pain VAS scores, TCM symptom complex score, DAS28 score, ESR, CRP reveals there is a statistically significant difference before and after treatment (P<0.05), while the differences between the recorded RF and anti-CCP are not statistically significant(P> 0.05).3. After the 12-week treatment, there is no significant difference observed between observation group and control group in terms of SJC, or TJC, neither did morning stiffness, pain VAS score, ESR, CRP, or DAS28 score.4. In terms of the TCM symptom complex score improvement, observation group is significantly better than control group (P<0.05). More specifically, observation group’s more improvement of night pain, joint cold and fear bad cold, when compared with control group, is statistically significant (P<0.05). Similarly, in the aspects of limbs not being warm and malaise and fatigue performance, there is also a dramatically difference between two groups, which is also statistically significant (P<0.01).5. Comparing the DAS28 score of the two groups, there are 17 of 23 cases in observation group recorded as remarkable effective with 2 other cases effective. Therefore, the total effective rate is 82.61%. On the other hand,15 of 22 cases in control group were revealed as remarkable effective, with 3 other cases effective. As a consequence, the total effective percentage of control group is 81.82%.Although there is no statistically difference (P>0.05), the TCM symptom complex score of observation group is obviously better than the control group. For instance, the total effective rate of observation group is 91.30%, with 17 out of 23 cases’obvious effectiveness and other 4 cases’ effectiveness. At the same time, the total effective rate of control group is only 86.36%, with 9 out of 22 cases’remarkable effectiveness and 10 other cases’effectiveness. And this difference is proved to be statistically significant (P<0.05).6. There is no significant difference between control group and observation groups in terms of the incidence of adverse drug reactions (P>0.05). Conclusion:Very similar to simply using western medicine, Guifuwenjingtongbi Decoction, when combined with methotrexate and celecoxib, works effectively in the treatment of moderate rheumatoid arthritis with Cold and Dampness Syndromes, for both of the therapies in this study were able to reduce patients’ ESR, CRP levels obviously, improve clinical symptoms and TCM symptom complex score, while reduce DAS28 score.However, it is also revealed that the combination therapy performs significantly better in improving TCM symptom complex score than western medicine. And the combination of TCM and western medicine does not increase the incidence of adverse drug reactions. As a consequence, safe and effective is using Gufuwenjingtongbi Decoction to treat Moderate Rheumatoid Arthritis with cold and dampness syndromes.