Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine
Xiaoying Sun,
Xiaoyong Zhou,
Yuegang Wei,
Wenxin Yang,
Ning Huang,
Yangfeng Ding,
Rongyi Hu,
Shun Guo,
Chunyan Yang,
Huilan Weng,
Ying Zhang,
Xi Chen,
Xiaojie Ding,
Liu Liu,
Qingfeng Yin,
Ruiping Wang,
Xin Li,
Bin Li
Affiliations
Xiaoying Sun
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Xiaoyong Zhou
Department of Dermatology, Wuhan No. 1 Hospital
Yuegang Wei
Department of Dermatology, Affiliated Hospital of Nanjing University of Chinese Medicine
Wenxin Yang
Department of Dermatology, Traditional Chinese Medicine Hospital of Southwest Medical University
Ning Huang
Department of Dermatology, The Second Affiliated Hospital of Fujian Traditional Chinese Medical University
Yangfeng Ding
Department of Dermatology, Shanghai Dermatology Hospital
Rongyi Hu
Department of Dermatology, Wuhan No. 1 Hospital
Shun Guo
Department of Dermatology, Affiliated Hospital of Nanjing University of Chinese Medicine
Chunyan Yang
Department of Dermatology, Traditional Chinese Medicine Hospital of Southwest Medical University
Huilan Weng
Department of Dermatology, The Second Affiliated Hospital of Fujian Traditional Chinese Medical University
Ying Zhang
Department of Dermatology, Shanghai Dermatology Hospital
Xi Chen
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Xiaojie Ding
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Liu Liu
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Qingfeng Yin
Jiangsu Famous Medical Technology Co. Ltd., Nanjing University of Traditional Chinese Medicine
Ruiping Wang
Office of Clinical Medical Research Center, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Xin Li
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Bin Li
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Abstract Background Plaque psoriasis is a refractory inflammatory skin disease. The common therapies used to treat plaque psoriasis in traditional Chinese medicine (TCM) and western medicine (WM) have distinct characteristics and advantages. Although a combination of TCM and WM therapies, adjusted to the clinical situation, is widely used, there are no systematic studies on the hierarchical selection of this treatment combination based on the severity of skin lesions. We therefore designed a randomized clinical trial to focus on the sequence of internal and external treatments of TCM in patients with mild-to-moderate plaque psoriasis and to optimize the integration of Chinese and western medicine for the treatment of patients with severe plaque psoriasis, thereby achieving high-level clinical evidence and establish treatment norms for the integrated use of Chinese and western medicines. Methods In this proposed multicenter, single-blinded, randomized controlled trial, 108 patients with mild-to-moderate plaque psoriasis will be randomly assigned to two groups in a 1:1 ratio to receive either internal or external TCM treatment, and 270 patients with severe plaque psoriasis will be randomly assigned to three groups in a 1:1:1 ratio to receive treatment with TCM or WM, or TCM + WM. All enrolled patients will receive 8 weeks of treatment. Follow-up assessments will be done 8 weeks after the treatment. The primary outcome of this study is the evaluation of efficacy and relapse rate, based on the Psoriasis Area and Severity Index, and the secondary outcome measures include determination of the affected body surface area, physician’s global assessment, pruritus scores (determined using a visual analog scale), TCM symptom score, Dermatology Life Quality Index, patient-reported quality of life score and incidence of serious adverse events. Discussion This study will provide high-level clinical evidence for internal and external TCM treatment optimization and will contribute to establishing norms for the integration of Chinese and western Medicines. Trial registration ClinicalTrials.gov, NCT03941431 . Registered on 8 May 2019.
