Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
Department of Dermatology, Shaanxi Traditional Chinese Medicine Hospital, Shaanxi, 710003, China.
Trials. 2020 Feb 26;21(1):229. doi: 10.1186/s13063-020-4155-0.
It is difficult to achieve a balance among safety, efficacy, and cost for the clinical treatment of plaque psoriasis. The current treatment of psoriasis often involves comprehensive therapy such as topical plasters, internal medicine, and phototherapy, which are expensive, and some of the drugs have serious side effects. Moving cupping is a type of cupping that has been used clinically for thousands of years in China. It has the advantage of being inexpensive and easy to perform. Therefore, it is widely used in public hospitals in China for psoriasis treatment. However, a comprehensive evaluation of the current clinical evidence of its efficacy is lacking. In this study, we aimed to evaluate the efficacy and safety of moving cupping to treat plaque psoriasis.
A multicenter, two-arm parallel group, single-blind, randomized, controlled trial will be conducted at six hospitals in China between August 1, 2019 and December 31, 2021. A total of 122 adult patients (aged 18-65 years) who meet the inclusion criteria are being recruited. Participants will receive either basic treatment combined with moving cupping therapy or basic treatment combined with moving cupping placebo. The treatment cycle will be 4 weeks, and the efficacy of treatment will be assessed weekly by the Psoriasis Area and Severity Index during the treatment period and follow-up visits at weeks 6 and 8. The body surface area, physician's global assessment, Dermatology Life Quality Index, patient-reported quality of life, visual analog scale, Traditional Chinese Medication syndrome scoring scale, combined medication, and adverse events will also be recorded and compared to the relative baseline values.
The findings of this trial may lead to better decisions regarding the treatment of plaque psoriasis. If the trial outcomes are considered favorable, this ancient Chinese medical therapy may be worthy of widespread use because of its convenience and low cost.
This study was registered on May 15,2019 at ClinicalTrials.gov with the identifier number NCT03952676.
斑块型银屑病的临床治疗，在安全性、疗效和费用方面很难达到平衡。目前银屑病的治疗常涉及外用药膏、内用药物和光疗等综合疗法，费用昂贵，部分药物有严重的副作用。走罐是我国临床应用几千年的一种拔罐方法，具有经济、操作简单的优点，因此在中国公立医院中广泛用于治疗银屑病。然而，目前缺乏对其疗效的综合评估。本研究旨在评价走罐治疗斑块型银屑病的疗效和安全性。
本研究为多中心、两臂平行组、单盲、随机、对照临床试验，将于 2019 年 8 月 1 日至 2021 年 12 月 31 日在中国的六家医院进行。共招募 122 名符合纳入标准的成年患者（年龄 18-65 岁）。参与者将接受基础治疗联合走罐治疗或基础治疗联合走罐安慰剂治疗。治疗周期为 4 周，在治疗期间和随访期间的第 6 周和第 8 周，通过银屑病面积和严重程度指数每周评估治疗效果。还将记录和比较患者的体表面积、医生整体评估、皮肤病生活质量指数、患者报告的生活质量、视觉模拟评分、中药证候评分量表、联合用药和不良反应与相对基线值。
该试验的结果可能会影响斑块型银屑病的治疗决策。如果试验结果被认为是有利的，这种古老的中国医疗疗法可能因其方便和低成本而值得广泛应用。
本研究于 2019 年 5 月 15 日在 ClinicalTrials.gov 上注册，注册号为 NCT03952676。
