Effect of governor vessel moxibustion (GVM) therapy with mild to moderate psoriasis: A randomized clinical trial.

BACKGROUND: It was hypothesized that governor vessel moxibustion (GVM) therapy may improve the course of mild to moderate psoriasis (PS) in patients. METHODS: A randomized, controlled clinical trial lasting 40 days was conducted at the Shaanxi Provincial Hospital of Chinese Medicine. Investigators were blinded to patient groupings. Individuals with mild to moderate PS ranging in age from 18 to 70 years were enrolled. GVM therapy was administered one every 10 days for 40 days with 1.5 hours on the governor meridian in the GVM therapy group. The PS area and severity index (PASI) and dermatological life quality index (DLQI) scores were monitored before and after treatment. RESULTS: There was a significant reduction in the mean PASI score in the GVM therapy group of 0.76 points (2.37 [2.61]; SE, 0.39) after 40 days of treatment compared with the control group (3.12 [2.12], SE, 0.32) (P < .01). There were also significantly greater changes in the DLQI scores of the GVM therapy group (4.23 [2.25]; SE, 0.34) compared with those in the control group (8.91 [3.85]; SE, 0.59) (P < .001). CONCLUSION: GVM therapy effectively reduced both PASI and DLQI scores in patients with mild to moderate PS.

Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial.

BACKGROUND: Fire needle therapy is a characteristic treatment in traditional Chinese medicine (TCM). An increasing number of studies have indicated that fire needle treatment for psoriasis provides satisfactory results with few side effects and a low recurrence rate. We herein describe the protocol for a multicenter, randomized, single-blind, placebo-controlled trial that will provide high-quality evidence on the efficacy and safety of fire needle therapy for plaque psoriasis. METHODS: Ninety-two patients with blood stasis syndrome (BSS) of plaque psoriasis will be enrolled and randomly assigned to receive fire needle therapy (intervention group) or fire needle control therapy (control group) once a week for 4 weeks. The Psoriasis Area and Severity Index (PASI) score will serve as the major efficacy index, while the body surface area (BSA), Physician Global Assessment (PGA) score, Dermatology Life Quality Index (DLQI) score, patient-reported quality of life (PRQoL), visual analog scale (VAS) score for itching, TCM symptom score, and relapse rate will be assessed as secondary outcomes. The PASI score, BSA, PGA score, and VAS score for itching will be evaluated at baseline and during the 4-week treatment and follow-up periods. DLQI score, PRQoL, and TCM symptom score will be assessed at baseline and during the treatment period. Recurrence will be evaluated during the follow-up period. Safety assessments include vital sign monitoring, routine blood tests, blood biochemistry, routine urine tests, pregnancy tests, physical examinations, and adverse-event recording. SAS software will be used for data analysis. The data network platform will be designed by the data management center of Nanjing Ningqi Medical Technology Co., Ltd. DISCUSSION: It is believed that fire needle therapy can activate the meridians, promote blood circulation, and regulate skin immunity. BSS of plaque psoriasis is related to not only immune dysfunction but also poor or stagnant blood flow. We anticipate that the results of the trial described in this protocol will provide strong evidence for the safety and efficacy of fire needle therapy for BSS of plaque psoriasis. TRIAL REGISTRATION: Clinicaltrials.gov NCT03953885 . Registered on May 15, 2019. Name: Fire Needle Therapy on Plaque Psoriasis with Blood Stasis Syndrome.

Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial.

BACKGROUND: Psoriasis is a common chronic inflammatory skin disease with high recurrence rates and increasing incidence. Patients require long-term medication to reduce symptoms and prevent disease progression. Therefore, the development of treatments with high efficiency and low rate of adverse events is of utmost importance. Traditional Chinese medicine (TCM) plays an outstanding role in reducing disease symptoms and improving quality of life. The aim of this trial is to clarify the treatment efficacy, safety, and control of disease recurrence in patients with psoriasis with blood-stasis syndrome treated with Taodan granules (TDKL). METHODS: This trial is a five-center, randomized, double-blind, placebo-controlled study planned to transpire between September 1, 2019, and December 31, 2021. A sample size of 216 participants (108 per group) with mild-to-moderate psoriasis will be randomly assigned to receive TDKL or placebo twice per day, 7 days per week, for 8 weeks. The study duration will be 17 weeks, including a 1-week screening period, 8 weeks of intervention, and another 8 weeks of follow-up. The primary outcomes are improvement in the Psoriasis Area and Severity Index score and recurrence rate after 8 weeks of treatment. Secondary outcomes include body surface area affected and the scores for the Physician Global Assessment, Dermatology Life Quality Index, pain-related quality of life, pain on the visual analogue scale, and TCM syndromes. The number, nature, and severity of adverse events will be carefully recorded. DISCUSSION: The study results will help clarify the safety and efficacy of TDKL as treatment for psoriasis with respect to both disease regression and recurrence rate. We expect that this study will provide high-quality evidence with important public health implications that may alter the approach to psoriasis management in China. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (ID: NCT03942198).

[Meta-analysis of traditional Chinese medicine Jianpi therapy in treatment of atopic dermatitis].

To evaluate the clinical efficacy of traditional Chinese medicine Jianpi therapy in the treatment of atopic dermatitis. CNKI, Wanfang knowledge service platform, VIP journal database, Chinese biomedical literature database (CBM), PubMed, the Cochrane Library and EMbase database from inception to December 2017 were searched for the randomized controlled trials (RCTs) on traditional Chinese medicine Jianpi therapy in the treatment of atopic dermatitis. Literature selection and information extraction was completed and screened by two independent reviewers, and then the Cochrane recommended bias risk assessment method was used to evaluate the bias risk, and Review Manager 5.3 was used for the data analysis. Totally 37 clinical RCTs were included in this study, involving 2 973 patients. Analysis results showed that as compared with the western medicine, traditional Chinese medicine Jianpi therapy had higher clinical effective rate, with statistically significant difference (OR=4.05,95%CI[3.27, 5.03],P<0.000 01); the improvement of score was more evident, including SCORAD score (WMD=-9.82,95%CI[-13.31,-6.33],P<0.000 01), EASI score (WMD=-2.80,95%CI[-3.54,-2.07],P<0.000 01), and itching VAS score (WMD=-0.79, 95%CI[-1.10,-0.47],P<0.000 01)；the improvement of serum biochemical levels was more evident,including interferon-γ (IFN-γ) (WMD=1.75,95%CI[1.14,2.35],P<0.000 01), interleukin-4 (IL-4) (WMD=-3.15,95%CI[-4.16,-2.15],P<0.000 01), and Eosinophil direct count (EOS) (WMD=-0.11,95%CI[-0.20,-0.02], P=0.02)；recurrence rate was significantly reduced (OR=0.36,95%CI[0.21,0.60],P<0.000 1); and trial-related adverse events were reported in 11 RCTs. Studies have shown that traditional Chinese medicine Jianpi therapy had significantly higher clinical efficacy than western medicine in the treatment of atopic dermatitis. However, due to the publication bias and low quality bias of included RCTs in this study, more multicenter, high quality, large-sample, randomized double-blind controlled trials are needed to further demonstrate the conclusion.