A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris by auricular therapy combined with optimized Yinxieling Formula (银屑灵优化方)

Abstract

To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula on psoriasis vulgaris. A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted. The patients were randomized to a treatment group (43 cases treated by auricular therapy combined with optimized Yinxieling Formula) and a control group (41 cases treated by optimized Yinxieling Formula alone) according to a random number generated by SPSS 17.0 software. The treatment duration for both groups was 8 weeks. The therapeutic effect was comprehensively measured by the primary outcome measure [Psoriasis Area and Severity Index (PASI) reduction rate] and the secondary outcome measure [PASI, Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS)]. The outcomes of both groups were obtained and compared before and after the intervention. The PASI reduction rate in the treatment group was 74.4% (32/43), which was higher than that in the control group (36.6%, 15/41, P<0.01). The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group P<0.01). With stratified analysis, there were significant differences between the PASI scores in the following subgroups: age 18-30, baseline PASI>10 and stable stage (P<0.05). DLQI decreased in both groups on some categories after treatment, but there were no significant differences between the two groups in SDS, SAS and VAS (P >0.05). No obvious adverse reactions were found in either group. The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.