Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial

OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.

Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan(CV 12) on body temperature in healthy participants:a cross-over single-blind randomized study

OBJECTIVE:To evaluate the efficacy,safety,satisfaction,discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa.METHODS:This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan(CV 12) is a cross-over single-blinded,randomized clinical trial.A total of 40 healthy subjects(24 males and 16females) participated in this study.Two subjects dropped out of the trial.Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design.After treatment,the patients underwent a 30 minute waiting period,and then the temperatures at Tanzhong(CV 17),Zhongwan(CV 12) and Guanyuan(CV 4) were measured using digital infrared thermal imaging.RESULTS:After the use of Artemisia vulgaris moxa,the patients' body temperatures were slightly lowered at Tanzhong(CV 17),Zhongwan(CV 12)and Guanyuan(CV 4),but the changes were not statistically significant.After the use of charcoal moxa,the patients' body temperatures were somewhat increased at Zhongwan(CV 12) and Guanyuan(CV 4),but the changes were not statistically significant.After Artemisia vulgaris moxa use,the body temperature difference between Zhongwan(CV 12) and Guanyuan(CV 4)was significantly increased.After charcoal moxa use,the body temperature difference between Tanzhong(CV 17) and Zhongwan(CV 12) was significantly decreased in males and in the whole group.This change was caused by the difference in the moxibustion type and by gender differences.CONCLUSION:This pilot study found that moxibustion did not raise the body temperature,but temperature differences between acupoints were affected.Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.