| Background and Purpose:Rheumatoid arthritis (RA) which can result in vasculitis, peripheral nerve inflammation, interstitial pneumonia, ophthalmitis and other complications is a symmetry, invasive, systemic autoimmune diseases. Western medicine has made great progress in this field over the past decades and a variety of biological agents combined MTX or other DMARDs have achieved better outcomes.However many adverse reactions may turn up and lots of patients have to bear the high economic cost resulted from drugs. Donglegao(external drug made of Chinese herb medicine) is invented for RA in the1980s by professor FangDingya, who is the former president of Xiyuan Hospital Academy of Chinese Medical Sciences and the first director of RA department in that hospital. The medicine has effects in clearing heat detoxicating, promoting blood circulation and stopping pain. Since Donglegao could have efficacy, supported by cohort study, in RA treatment, a well-designed large-scale research is needed to supply the high-level evidence. Before that a pilot study must conduct. This pilot study aims to test the drug’s clinical efficacy by objective evaluation and observe and evaluate the adverse reactions,if have.Method:In this double-blinded parallel controlled clinical trail,120patients,from Wangjing Hospital and Jinzhong Hospital,who are in the active stage of RA were divided randomly into two groups each of which has60cases. The intervention is sticking Donglegao on one suffered joint one piece per day. The patients in control group were received placebo which are same in appearance and smell as Donglegao.The placebo were applied on the joint one piece per day. Before and after treatment,we observed and tested joint pain, swelling, fever, morning stiffness, activities,redness,grip strength and15m walk time, liver and kidney function, blood, urine routine and other safety indicators were also observed.Results:1The baseline comparison:the age, gender, disease duration, joint symptoms total score,VAS, ESR,CRP were statistically not significant differences (P>0.05) between two group.2Clinical evaluation:2.1Total efficiency: Statistics on FAS:The total efficiency in the treatment group is60.4%, while that in the control group is20.0%. The treatment group is significantly better than the control group (P<0.01).Statistics on PPS:The total efficiency of the treatment group is61.8%, while that in the control group is21.1%. The treatment group is significantly better than the control group (P<0.01), two data sets show the same results.2.2The comparison of primary outcomes (Joint total symptom score, VAS) before and after treatment:2.2.1Comparison of the total score of joint symptoms between two groups decrease (P <0.01) before interventions. In the1th and2th visit, the treatment group is significantly better than the control group (P<0.01).2.2.2Pain, Swelling, febrile, tenderness score of two groups have decreased after interventions (P<0.01). Pain score in the treatment group is significantly better than the control group in the lth and2th visit(P<0.01). Swelling score in the treatment group is significantly better than the control group in the2th visit(P<0.01). Febrile score in the treatment group is better than the control group in the1th visit(P <0.01),and significantly better than the control group in the2th visit(P<0.01). Tenderness score in the treatment group is better than the control group in the2th visit(P<0.05).2.2.3VAS score of two groups decrease after interventions (P<0.01). VAS score in the treatment group is significantly better than the control group in the1th and2th visit, (P<0.01).2.3Secondary outcomes:Grip strength in two groups is better than before (P<0.05).There is no significant difference in the lth and2th visit (P>0.05).15meters walking time in the treatment group have shortened after interventions in the lth visit (P<0.05), and have shortened significantly after interventions in the2th visit (P<0.01).The treatment group better than the control group in the2th visit(P<0.05).3. Laboratory indicators:ESR in the treatment group have significantly decreased in1th visit(P<0.01),but there are no significant difference between the two groups.There are no significant difference between the before and after treatment in CRP.Security:One cases had rash in treatment group. The case withdrew, the rash disappeared without any intervention three days after the withdrawal. Three cases in control group had rash,and one patient of them exit the test. Rash was disappeared after two days. The rash of other two cases of patients disappears without exit the test.The adverse events have no significant difference between the two groups. Since the abnormal values of liver function, kidney function, blood, urine are not related to any treatments the Donglegao is safe.Conclusion:The study enrolled patients of active RA. Compared with placebo Donglegao is a better anti-inflammatory analgesic and the main symptoms improved significantly. Moreover no obvious adverse advents are seen in the study. We can say that Donglegao is a safe, effective and inexpensive drug for RA. Now a further research is needed to popularize the protocol in clinical practice. But we must know that the external medicine can not stop the step of RA, the systematic oral medications for RA are necessary. |
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