A Randomized Controlled Trial for the Optimal Implementation of Psoriasis Treatment by Integrating Chinese and Western Medicine

Yuanting Yu,1,2,&ast; Xiaoying Sun,1,2,&ast; Rongyi Hu,3,&ast; Ping Xia,3 Yuegang Wei,4 Wenxin Yang,5 Ning Huang,6 Yangfeng Ding,7 Shun Guo,4 Chunyan Yang,5 Huilan Weng,6 Ying Zhang,7 Xiaojie Ding,1,2 Qinsi Huang,3 Xiaoyong Zhou,3 Xin Li,1,2 Bin Li1,2,7 1Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, People’s Republic of China; 2Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, 200437, People’s Republic of China; 3Department of Dermatology, Wuhan No. 1 hospital, Wuhan, 430022, People’s Republic of China; 4Department of Dermatology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 5Department of Dermatology, Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, 646000, People’s Republic of China; 6Department of Dermatology, second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, 350001, People’s Republic of China; 7Department of Dermatology, Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, 200443, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Xin Li, Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200437, People’s Republic of China, Email [email protected] Xiaoyong Zhou, Department of Dermatology, Wuhan No. 1 Hospital, 215 Zhongshan Avenue, Qiaokou District, Wuhan, 430022, People’s Republic of China, Email [email protected]: Psoriasis is a refractory inflammatory disease affecting people worldwide. Currently, the prevalent guideline-recommended regimen is based on psoriasis severity; however, no corresponding studies have been conducted on the hierarchical selection of integrated Chinese and Western medicine treatments.Objective: To explore the optimal implementation of psoriasis treatment by integrating Chinese and Western medicine.Methods: We conducted a 16-week multicenter single-blind randomized controlled trial in China between December 2019 and July 2022. Patients with mild-to-moderate psoriasis (n=107) were randomized to receive oral Jueyin granules (JYG) or moving cupping treatment for 4 weeks, and then transferred to combine the internal or external TCM treatment for another 4 weeks base on the Psoriasis Area and Severity Index (PASI) score. Patients with severe psoriasis (n=193) were randomized to receive treatment with JYG and moving cupping (Group C), narrow-band ultraviolet B (Group D), or JYG, moving cupping and narrow-band ultraviolet B (Group E). Corresponding placebo therapies are applied to ensure single blind implementation. The primary outcome was the effective rate at week 8 and the incidence of relapse at week 16.Results: The mild-to-moderate psoriasis group showed no differences in the efficacy or relapse resulting from the sequence of internal or external TCM treatment. However, both groups showed significant improvements in PASI score at week 8 compared to baseline (P < 0.001). The severe psoriasis group showed no significant difference in effective rates. While, more participants of Group E achieved PASI 75 (26.79%, P=0.02) at week 8, and Group D had a higher relapse rate at week 16 (21.57%, P=0.03).Conclusion: Patients with mild-to-moderate psoriasis whether start with internal or external TCM treatment would be viable alternative. Integrated Chinese and Western medicine treatment favors patients with severe psoriasis in the improvement of skin lesions and reduction of recurrence.Clinicaltrials.gov Listing: NCT03941431. Keywords: plaque psoriasis, integrated Chinese and Western medicine, hierarchical therapy, Jueyin granules, moving cupping therapy, NB-UVB