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 o...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)展开更多
基金Supported by the Scientific Research Special Fund of Traditional Chinese Medicine Industry(No.201507006)。
文摘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)
