Abstract
BACKGROUND: 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. CLINICALTRIALSGOV LISTING: NCT03941431.