The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, Australia.
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.
PLoS One. 2024 Mar 21;19(3):e0297834. doi: 10.1371/journal.pone.0297834. eCollection 2024.
Psoriasis vulgaris is a chronic dermatological disease with a high global prevalence. It significantly reduces patients' quality of life and is associated with a substantial economic burden. Conventional therapies for mild-to-moderate psoriasis are often associated with insufficient long-term symptomatic relief and side effects. Chinese herbal medicine (CHM) is commonly used for psoriasis management. A CHM formula, namely Fu zheng he fu zhi yang (FZHFZY), has shown promising treatment effects in clinical practice when used as a bath therapy. However, its efficacy and safety has not been evaluated by a rigorous randomized controlled trial (RCT). Therefore, we designed a double-blinded pilot RCT embedded with a qualitative study on CHM formula FZHFZY plus topical urea for mild-to-moderate psoriasis vulgaris to advance the evidence development and practice of CHM external application for psoriasis. This will be a mixed-method design consisting of a pilot RCT and a qualitative study. The pilot RCT is a two-arm, parallel, placebo-controlled, double-blinded trial. Sixty eligible participants will be randomized at a 1:1 ratio to receive eight weeks' treatment of either FZHFZY plus 10% urea cream, or placebo plus 10% urea cream, with 12-week follow-up visits after the treatment phase. The CHM or placebo will be administered externally as a bath therapy. Outcome measures include trial feasibility, efficacy and safety. The primary efficacy outcome will be Psoriasis Area Severity Index (PASI). Secondary efficacy outcomes include Physician Global Assessment, PASI-75, PASI-50, Body Surface Area, Dermatology Life Quality Index, Skindex-16, itch visual analogue scale and relapse. The qualitative study will be conducted to collect participants' feedback on CHM external application and their experience with the pilot RCT. This study will advance the evidence-based clinical practice of using CHM for psoriasis vulgaris and then to support translation of findings into clinical practice in the future. Trial registration number: ChiCTR2200064092.
寻常型银屑病是一种具有较高全球患病率的慢性皮肤病。它显著降低了患者的生活质量，并与巨大的经济负担有关。轻度至中度银屑病的传统疗法通常与长期症状缓解不足和副作用有关。中药（CHM）常用于治疗银屑病。一种 CHM 配方，即扶正和扶正（FZHFZY），在临床实践中作为浴疗显示出有希望的治疗效果。然而，其疗效和安全性尚未通过严格的随机对照试验（RCT）进行评估。因此，我们设计了一项双盲试点 RCT，并嵌入了一项关于 CHM 配方 FZHFZY 加外用尿素治疗轻度至中度寻常型银屑病的定性研究，以推进 CHM 外用治疗银屑病的证据开发和实践。这将是一项混合方法设计，包括试点 RCT 和定性研究。试点 RCT 是一项两臂、平行、安慰剂对照、双盲试验。将有 60 名符合条件的参与者以 1:1 的比例随机分为两组，分别接受 FZHFZY 加 10%尿素乳膏或安慰剂加 10%尿素乳膏治疗 8 周，并在治疗阶段后进行 12 周的随访。CHM 或安慰剂将作为浴疗进行外用。结局指标包括试验可行性、疗效和安全性。主要疗效结局将是银屑病面积严重程度指数（PASI）。次要疗效结局包括医生总体评估、PASI-75、PASI-50、体表面积、皮肤病生活质量指数、Skindex-16、瘙痒视觉模拟量表和复发。定性研究将收集参与者对 CHM 外用的反馈意见以及他们对试点 RCT 的体验。这项研究将推进使用 CHM 治疗寻常型银屑病的循证临床实践，然后为未来将研究结果转化为临床实践提供支持。试验注册号：ChiCTR2200064092。
