title: Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial.
abstract: BACKGROUND
  To provide evidence that the Chinese herbal medicine (CHM) PSORI-CM01 combined with Western medicine reduces the relapse rate of psoriasis vulgaris (PV), we plan to conduct a large-scale randomized control trial (RCT). In order to improve and perfect the RCT, this pilot study was designed to determine the feasibility and the potential of a modified protocol for the full-scale RCT.
  
  
  METHODS
  Eligible patients with psoriasis vulgaris (PV) were enrolled into a randomized comparison in which all subjects received topical sequential therapy and PSORI-CM01 or placebo for 12 weeks. The primary outcome measure was the relapse rate. Treatment response was computed from Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Dermatology Life Quality Index (DLQI). The secondary outcome measures included time to relapse, time to onset, rebound rate, PASI score, pruritus scores on the Visual Analog Scale (VAS), BSA, DLQI and SF-36 (short form health survey), and incidence of serious adverse events (SAEs).
  
  
  RESULTS
  Six of 7 (86 %) subjects reached the PASI-50 in the CHM group compared with nine of 10 (90 %) in the placebo group during the treatment period. Among the subjects who reached PASI-50, one out of six subjects (17 %) relapsed in the CHM group during the treatment period compared with six out of nine patients in the placebo group (67 %). No subjects met the rebound criteria. Changes to baseline in the PASI scores were not significantly different between the two groups (t = 1.764, P = 0.098).
  
  
  CONCLUSIONS
  Oral PSORI-CM01 combined with topical sequential treatment showed a smaller recurrence rate (P = 0.118) than placebo combined with the same topical therapy for moderate-to-severe PV in this pilot study.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry ( http://www.chictr.org.cn/searchproj.aspx ) ChiCTR-TRC-13003233 ; date of registration: 15 April 2013.
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China.
authors.forename: Dan-Ni
authors.initials: DN
authors.lastname: Yao
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China. luchuanjian888@vip.sina.com.|Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China. luchuanjian888@vip.sina.com.|Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, 510120, China. luchuanjian888@vip.sina.com.
authors.forename: Chuan-Jian
authors.initials: CJ
authors.lastname: Lu
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.|National Centre for Design Measurement and Evaluation of Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
authors.forename: Ze-Huai
authors.initials: ZH
authors.lastname: Wen
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China.
authors.forename: Yu-Hong
authors.initials: YH
authors.lastname: Yan
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Mei-Ling
authors.initials: ML
authors.lastname: Xuan
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Li
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Geng
authors.initials: G
authors.lastname: Li
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Ze-Hui
authors.initials: ZH
authors.lastname: He
authors.affiliation: Team of standardization of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Xiu-Li
authors.initials: XL
authors.lastname: Xie
authors.affiliation: Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China.
authors.forename: Jing-Wen
authors.initials: JW
authors.lastname: Deng
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Xin-Feng
authors.initials: XF
authors.lastname: Guo
authors.affiliation: Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
authors.forename: Ai-Hua
authors.initials: AH
authors.lastname: Ou
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012008:Recurrence; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; C000601118:PSORI-CM01; C517164:betamethasone dipropionate, calcipotriol drug combination; D001623:Betamethasone; D002117:Calcitriol
keywords: Chinese herbal medicine; PSORI-CM01; Psoriasis vulgaris; pilot randomized controlled trial; topical sequential treatment