摘要
Objective: To observe the clinical effectiveness and safety of fire-needle therapy,an external approach of Chinese medicine in treating plaque psoriasis.Methods: This study was a two-parallel-arm randomized controlled trial.A total of 151 participants with plaque psoriasis were randomly assigned to the ?re-needle therapy group(treatment group,76 cases) or the control group(75 cases) at a 1:1 allocation ratio using SAS software.All participants received Oral Huoxue Jiedu Decoction(活血解毒汤,HXJDD) and applied externally vaseline cream twice a day.Participants in the treatment group received ?re-needle therapy once weekly for 4 weeks plus HXJDD and vaseline cream applied the same as the control group.The primary outcome measure was Psoriasis Area and Severity Index(PASI) score,and the secondary outcomes were Dermatology Life Quality Index(DLQL),and Hamilton Anxiety Rating Scale(HAMA),as well as Chinese medicine(CM) syndrome score and photos of target lesions.The indices were evaluated before and after treatment.Results: Sixty-eight patients in each group completed the study.The treatment group has not yet achieved signi?cant improvement in PASI score(P>0.05)compared to the control group.However,signi?cant differences were found between the two groups in relieving CM syndrome(P<0.05) and improving quality of life(P<0.05).Conclusions: Fire-needle appears to be safe and may have bene?t for psoriasis,the short-term treatment and small sample size limit the conclusions of this study.Further rigorous randomized controlled trials with longer treatment are recommended.
Objective: To observe the clinical effectiveness and safety of fire-needle therapy,an external approach of Chinese medicine in treating plaque psoriasis.Methods: This study was a two-parallel-arm randomized controlled trial.A total of 151 participants with plaque psoriasis were randomly assigned to the ?re-needle therapy group(treatment group,76 cases) or the control group(75 cases) at a 1:1 allocation ratio using SAS software.All participants received Oral Huoxue Jiedu Decoction(活血解毒汤,HXJDD) and applied externally vaseline cream twice a day.Participants in the treatment group received ?re-needle therapy once weekly for 4 weeks plus HXJDD and vaseline cream applied the same as the control group.The primary outcome measure was Psoriasis Area and Severity Index(PASI) score,and the secondary outcomes were Dermatology Life Quality Index(DLQL),and Hamilton Anxiety Rating Scale(HAMA),as well as Chinese medicine(CM) syndrome score and photos of target lesions.The indices were evaluated before and after treatment.Results: Sixty-eight patients in each group completed the study.The treatment group has not yet achieved signi?cant improvement in PASI score(P>0.05)compared to the control group.However,signi?cant differences were found between the two groups in relieving CM syndrome(P<0.05) and improving quality of life(P<0.05).Conclusions: Fire-needle appears to be safe and may have bene?t for psoriasis,the short-term treatment and small sample size limit the conclusions of this study.Further rigorous randomized controlled trials with longer treatment are recommended.
基金
the External Treatment Technology Project,Chinese Medicine Science in Beijing,Undertaken by the Beijing Administration of Traditional Chinese Medicine(No.WZF 2012-97)