Liangxue Jiedu Runzhi ointment in the treatment of mild and moderate psoriasis with blood-heat syndrome: A double-blind randomized controlled trial.

INTRODUCTION: Psoriasis is a kind of chronic inflammatory skin disease characterized by erythema, skin hyperplasia, scales and keratinocyte hyperproliferation. Psoriasis Vulgaris, the most common kind of psoriasis, severely deteriorates the life quality of patients. Traditional Chinese Medicine (TCM) is a good choice for the treatment of psoriasis, which has been proved to be safe and effective, and may reduce the recurrence rate. In clinical practice, Liangxue Jiedu Runzhi (LJR) ointment can effectively treat mild and moderate psoriasis with blood-heat syndrome, but there is a lack of evidence-based medical evidence. This trial aims to evaluate the efficacy and safety of LJR ointment for the treatment of mild and moderate psoriasis with blood-heat syndrome. METHODS: A multicenter, randomized, double-blind, placebo-controlled, and self-controlled clinical trial was carried out according to this paper. The symmetrical rashes of each subject were regarded as the target lesions and were randomly divided into a treatment group (LJR ointment group) and a control group (placebo group). The LJR ointment or placebo ointment were externally administered on bilateral symmetric rashes, twice a day for eight weeks. The follow-up examination was made for subjects every two weeks. The primary research finding was conveyed by Psoriasis Area and Severity Index (PASI) in 8 weeks. The secondary research finding includes adverse events. RESULTS: 46 subjects undergo this research project. The difference between PASI scores of the target lesions in the treatment group and control group is statistically significant were in 8 weeks (P < .001). The percentage of PASI 75 in treatment group and control group were 48% and 15% in week 8, respectively (x2 = 11.33, P < .05). No severe adverse events were reported. CONCLUSIONS: LJR ointment was proved to have efficacy in the treatment of mild and moderate psoriasis with the blood-heat syndrome.

Effectiveness of flesh-moistening paste in psoriasis vulgaris patients with symptom pattern of blood stasis: a randomized and parallel-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine (TCM). METHODS: Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris, diagnosed via TCM as blood stasis pattern, were selected as the targeted skin lesions. A randomized, double-blind, parallel-controlled, multicenter controlled trial was conducted. The targeted skin lesions were categorized into either the treatment or control group. The treatment group used the flesh-moistening paste; the control group used a placebo. Both the paste and the placebo were topically applied twice daily for eight weeks. The patients were examined biweekly to evaluate the effects. The two groups were compared in terms of the psoriasis area and severity index (PASI) of the targeted skin lesions, which is scored according to erythema, desquamation, infiltration, area, pruritus, and improvement of skin barrier function. Adverse events were recorded during the study period. SPSS 21.0 was used to analyze the data. RESULTS: Fifty-six patients were enrolled between February 2016 and October 2017. Two were complicated by cardio-cerebrovascular disease and were excluded; thus, 54 outpatients were finally enrolled in the study. Four dropped out during the study period: three failed to complete their follow-up visits for unknown reasons, and one exited due to an adverse event. The final trial comprised 50 of the 56 originally selected patients, with a 92.6% completion rate. After 8 weeks of treatment, the targeted skin lesion scores differed significantly (P < 0.05). The PASI scores of the targeted skin lesions differed significantly beginning at week 6 (P < 0.05). The treatment group presented better results than those of the control group. Only one patient had an adverse reaction associated with the treatment. Improvements in skin barrier function differed significantly (P < 0.05). CONCLUSION: The flesh-moistening paste demonstrated a reliable curative effect and safety for treating psoriasis vulgaris in patients with blood stasis patterns. The topical paste improved the barrier function of the skin lesions.

Traditional Chinese medicine for psoriasis vulgaris: A Protocol of a prospective, multicenter cohort study.

INTRODUCTION: The incidence of psoriasis vulgaris is increasing worldwide. Chronic recurrence of the disease, as well as accompanying cardiovascular disease, metabolic syndrome, and depression has affected the physical and mental health of these patients. Psoriasis vulgaris is a difficult and major disease in the dermatology field. Short-term curative effects using conventional therapy for psoriasis vulgaris has made major strides. However, traditional Chinese medicine (TCM) treatment has long-term curative advantages for psoriasis vulgaris but lacks the scientific and clinical evidence for its use. This study intends to demonstrate and provide scientific and clinical evidence for the use of TCM to delay the recurrence of psoriasis vulgaris. METHODS AND ANALYSIS: This will be a prospective, multicenter cohort study. We intend to recruit 1521 psoriasis vulgaris patients from 14 hospitals in Beijing, Tianjin, and Hebei. Treatment will be based on the diagnosis specifications and clinical practice guidelines of TCM and conventional therapy. During inclusion and the subsequent follow-up period, doctors through electronic case reports will collect different therapeutic TCM regimens and conventional therapy that were administered. Information on life condition, skin lesions at each visit, World Health Organization Quality of Life Instruments, Zung Self-rating Anxiety Scale, Zung Self-assessment of Depression, laboratory examinations, incidence of new rash and recurrence during the remission and recurrence stages will be recorded. ETHICS AND DISSEMINATION: The clinical trial protocol for this study was approved by the ethics committee of the Beijing hospital of TCM affiliated to capital medical university (Ethics number: 2019BL02-010-02). We will publish and present our results at national and international conferences and in peer-reviewed journals specialized in dermatology. TRIAL REGISTRATION: This protocol has been registered in clinicaltrials. gov (ChiCTR1900021629).

Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial.

BACKGROUND: Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis being the primary manifestation during the remission stage. Patients often have a slow course and long history of the disease. The refractory type of psoriasis is a stubborn rash that does not subside easily. We designed this randomized controlled trial to compare the effectiveness and relapse rates of plaque psoriasis in patients treated with either acupuncture, moxibustion or calcipotriol ointment. The ultimate aim of the study is to select an effective traditional Chinese medicine therapy for patients with plaque psoriasis. METHODS: The study will be a multicenter, prospective, randomized controlled trial that compares the effectiveness of fire needle therapy, moxibustion and calcipotriol ointment. In total, 160 patients with plaque psoriasis who meet the inclusion criteria will be recruited from three hospitals in Beijing and then randomly assigned to receive either fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment (group B). All participants will receive an 8-week treatment and will then be followed up for another 24 weeks, with time points at weeks 12 and 24 after treatment completion. The primary outcomes to be measured are relapse rates and psoriasis area and severity index score of the target lesions. In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured. Adverse events will be recorded for safety assessment. DISCUSSION: The aim of this study is to determine whether fire needle therapy or moxibustion could improve the clinical effectiveness for psoriasis lesions and reduce the relapse rate. Once completed, it will provide information regarding therapeutic evaluation on fire needle therapy or moxibustion for plaque psoriasis, which will assist clinicians in selecting the most effective treatment options for patients. TRIAL REGISTRATION: International Clinical Trials Registry Platform (ICTRP), ChiCTR1800019588. Registered on 19 November 2018.

Effect of Traditional Chinese Medicine plus narrow-band medium-wave ultraviolet B radiation on moderate-to-severe psoriasis vulgaris in a case series.

OBJECTIVE: To investigate the efficacy and safety of Traditional Chinese Medicine (TCM) therapy combined with ultraviolet B light therapy in the treatment of moderate-to-severe psoriasis. METHODS: Patients with moderate-to-severe psoriasis (skin lesion area > 10% of the body surface area) for 2 consecutive years were treated with TCM (oral and external use of herbal medicines, acupuncture, and herbal bathing) and narrow-band medium-wave ultraviolet B light treatment for 12 weeks. The treatment effect was evaluated based on the Psoriasis Area Severity Index (PASI), the achievement of a 50% reduction in the PASI (PASI50), the achievement of a 75% reduction in the PASI (PASI75), pruritus score, Dermatology Life Quality Index, and safety. RESULTS: A total of 95 outpatients were enrolled, and 92 subjects (96.8%) completed the 12-week treatment course. At baseline, the average proportion of the body surface area covered by skin lesions was 12.4%, and the average PASI was 17.7. All patients had previously been treated with conventional medicine (89.1% of patients received ultraviolet light treatment, 50.0% received glucocorticoids, and 21.7% received acitretin). After the 12-week treatment course, 22 patients (23.9%) achieved PASI75, and 43 (46.7%) achieved PASI50. The post-treatment pruritus score and Dermatology Life Quality Index of all treated patients were significantly lower than the respective baseline values (P < 0.0001). No adverse effects were detected by the monitoring of blood, urine, stools, liver and kidney function, and echocardiography. CONCLUSION: Comprehensive therapy comprising TCM therapy combined with ultraviolet B light therapy achieved good outcomes for patients with moderate-to-severe psoriasis.