Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7.
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.
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.
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.
Clinicaltrials.gov NCT03953885 . Registered on May 15, 2019. Name: Fire Needle Therapy on Plaque Psoriasis with Blood Stasis Syndrome.
火针疗法是中医的一种特色疗法。越来越多的研究表明，火针治疗银屑病疗效满意，副作用少，复发率低。本研究旨在描述一项多中心、随机、单盲、安慰剂对照试验的方案，旨在为火针治疗斑块状银屑病的疗效和安全性提供高质量的证据。
将招募 92 例血瘀证斑块状银屑病患者，随机分为火针治疗组（干预组）和火针对照组（对照组），每周治疗 1 次，共 4 周。银屑病面积和严重程度指数（PASI）评分作为主要疗效指标，同时评估体表面积（BSA）、医生总体评估（PGA）评分、皮肤病生活质量指数（DLQI）评分、患者报告的生活质量（PRQoL）、瘙痒视觉模拟量表（VAS）评分、中医证候评分和复发率。在基线、治疗 4 周及随访期间评估 PASI 评分、BSA、PGA 评分和瘙痒 VAS 评分。在基线和治疗期间评估 DLQI 评分、PRQoL 和中医证候评分。在随访期间评估复发情况。安全性评估包括生命体征监测、常规血液检查、血液生化、常规尿液检查、妊娠检查、体格检查和不良事件记录。采用 SAS 软件进行数据分析。数据网络平台由南京宁岐医疗科技有限公司数据管理中心设计。
火针疗法可以激活经络，促进血液循环，调节皮肤免疫。斑块状银屑病的血瘀证不仅与免疫功能障碍有关，还与血流不畅有关。我们预计，本方案中描述的试验结果将为火针治疗血瘀证斑块状银屑病的安全性和有效性提供有力证据。
Clinicaltrials.gov NCT03953885。注册于 2019 年 5 月 15 日。名称：火针治疗血瘀证斑块状银屑病。
