Treatment of Psoriasis Vulgaris with Medicated Thread Moxibustion of Zhuang Medicine:A Multicenter Randomized,Parallel Controlled Trial

Objective:To explore the efficacy and safety of Zhuang medicine medicated thread moxibustion(ZMTM)on psoriasis vulgaris.Methods:A multicenter,randomized,parallel controlled clinical trial was designed.A total of 241 outpatients with psoriasis vulgaris were randomly divided into a control group(120 cases)and a treatment group(121 cases)using a central block randomization from June 2015 to May 2018.The control group was treated with Western medicines alone including pidotimod dispersible tablets,vitamin B compound tablets,and compound cod liver oil-zinc oxide ointment.The treatment group was treated with ZMTM every 2 days combined with Western medicines.The two groups received continuous intervention for 30 days.The primary outcome was Psoriasis Area and Severity Index(PASI),and the secondary outcomes included Itch Rating Scale,Dermatology Quality of Life Index(DLQI),Hamilton Anxiety Rating Scale(HAMA),as well as PASI response rate.Meanwhile,adverse events were evaluated during the whole clinical trial.Follow-up was carried out 30 days after treatment.Results:There were 5 cases of shedding in this trial.In intention-to-treat analysis,236 cases were included and each group contained 118 cases.On the 30th and 60th days,PASI scores of patients in each group were significantly lower than that at baseline(P<0.01)and the PASI score reduction of the treatment group was greater than that of the control group(P<0.01).Itch Rating Scale,DLQI,and HAMA scale were decreased in both groups after treatment,and the treatment group showed a better therapeutic effect(P<0.01).The response rates of PASI 50 and 75 were significantly higher than those in the control group[81.4%(96/118),43.2%(51/118)vs.41.5%(49/118),11.0%(13/118),respectively,P<0.05].During follow-up,the improvements in scores of PASI,Itch Rating Scale,DLQI,and HAMA of the treatment group were significantly greater than those of the control group(P<0.01).The response rates of PASI 50 and 75 in the treatment group were significantly higher than those in the control group,respectively(both P<0.05).No obvious adverse reaction was found in either group.Conclusion:ZMTM combined with Western medicines showed a better therapeutic effect in the treatment of psoriasis vulgaris without obvious adverse reaction.(Trial Registration No.ChiCTR-IOR-16008159)

Multicenter randomly controlled trial on acupoint injection therapy with Chinese herbal medicines for oculomotor paralysis

Objective To evaluate the clinical effect of acupoint injection therapy for paralysis of oculomotor nerve with Chinese herbal medicines. Methods A total number of 456 patients from 3 centers with paralysis of oculomotor nerve were randomly divided into an acupoint injection group and a control group with 228 cases each. Patients in the acupoint injection group were treated with injection of Chinese herbal medicines to Jingming （晴明 BL 1）, Yangbai （阳白GB 14}, Sibai （四白 ST 24 Tongziliao （瞳子髎 GB I） on the affected side, and Ganshu （肝俞 BL 18） on both sides, Compound Angelica Injection was the main drug, and the corresponding acupoints and other injection drugs were also used according to differentiation of syndrome. Patients in the control group were treated with common western medicine. The treatment was given once a day, 10 times constituted one course with 3 days of interval. After 3 courses, the effect was assessed. TCM syndrome score, eyeball movement degree, the sizes of oculi rimae and pupil of the two groups were recorded before and after treatment. Results The effective rate of acupoint injection group was 91.7% （209/228）, and that of the control group was 73.6% （168/228）. There was statistical significance in comparing the difference between the two groups （P〈0.05）. TCM syndrome scores of the two groups after the treatment became less obviously than those before the treatment （P〈0.01, P〈0.05）, the score of acupoint injection group was more reduced than that of the control group （P〈0.05）. Eyeball movement degree and oculi rimae were enlarged and the pupil reduced in the affected eye in both groups after the treatment Call P〈0.05）. The musculus rectus medialis for the eyeball movement in the acupoint injection group was more improved than that of the control group, and the oculi rimae was bigger in the acupoint injection group than that in the control group （both P〈0.05）. Conclusion Acupoint injection therapy with Chinese herbal medicines has assured effect on the treatment of oculomotor paralysis.

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.