China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.
The Dermatological Institute of Victoria, South Yarra, Victoria, Australia.
Clin Transl Med. 2021 Jan;11(1):e286. doi: 10.1002/ctm2.286.
Mild-moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non-steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI-CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double-blinded, placebo-controlled randomized controlled trial (RCT) evaluating the effects of PSORI-CM01 when added to topical calcipotriol cream.
People with moderate psoriasis vulgaris were randomized to receive oral PSORI-CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants' satisfaction and willingness to repeat were also assessed.
The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow-up. Participants' baseline basic characteristics were comparable. No between-group statistical significance was found on pre-defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI-CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported.
The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add-on effects of oral CHM PSORI-CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full-scale RCT.
轻度至中度寻常型银屑病是一种常见的皮肤科自身免疫性疾病，常规治疗选择有限。需要安全有效的辅助治疗方法来辅助外用非甾体类抗银屑病治疗。口服中药（CHM）配方 PSORI-CM01 已被证明具有潜在的抗银屑病药理活性。本文报告了一项试点研究，该研究设计为一项双盲、安慰剂对照随机对照试验（RCT），评估 PSORI-CM01 联合外用钙泊三醇乳膏的疗效。
将中度寻常型银屑病患者随机分为口服 PSORI-CM01 组或安慰剂组，联合钙泊三醇乳膏治疗 12 周。主要临床终点为第 12 周和第 24 周时银屑病面积严重指数（PASI）评分的变化。次要临床终点包括 PASI75、PASI50、复发率、体表面积变化、皮肤病生活质量指数和 Skindex29，以及不良反应（AE）。还评估了参与者的满意度和重复治疗意愿。
该试点研究在澳大利亚和中国进行，共 29 名参与者随机分组，26 名参与者完成了治疗和随访。参与者的基线基本特征相当。虽然联合 PSORI-CM01 治疗组似乎有治疗效果的趋势，但在预先定义的临床终点测量上，两组之间没有统计学意义。两组的 AE 频率和严重程度相似，无严重 AE 报告。
该研究的设计和持续时间似乎可行。需要进行适当的、有足够效力的 RCT，并对方法进行轻微调整，以揭示口服 CHM PSORI-CM01 的附加治疗效果。该试点研究的经验和结果将有助于完善未来研究的目标和设计，并为全面 RCT 的样本量计算提供帮助。
