PMID- 33549019
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20220531
IS  - 2224-5839 (Electronic)
IS  - 2224-5820 (Linking)
VI  - 10
IP  - 2
DP  - 2021 Feb
TI  - Comparison of PSORI-CM01 granules and Yinxieling tablets for patients with 
      chronic plaque psoriasis: a pilot study for a randomized, double-blinded, 
      double-dummy, multicentre trial.
PG  - 2036-2047
LID - 10.21037/apm-20-2575 [doi]
AB  - BACKGROUND: To compare the efficacy and safety of PSORI-CM01 granules with 
      Yinxieling tablets in patients with chronic plaque psoriasis (CPP), we plan to 
      conduct a multicentre, randomized, double-blinded, double-dummy, controlled 
      trial. This pilot study was conducted to determine the feasibility and the 
      potential of the protocol for the full-scale randomized controlled trial (RCT). 
      METHODS: This pilot study was conducted in three centers, and compared PSORI-CM01 
      granules with Yinxieling tablets in patients with CPP during a 12-week treatment 
      and 3-month follow-up period. The primary efficacy endpoint was the decrease of 
      the psoriasis area severity index (PASI) at week 12. The secondary outcome 
      measures included reduction rates of PASI, pruritus scores on the Visual Analogue 
      Scale (VAS), body surface area (BSA), and the Dermatology Life Quality Index 
      (DLQI). Safety was assessed via the incidence of adverse events (AEs) in each 
      treatment group. RESULTS: A total of 211 patients were screened, and 63 subjects 
      who met the inclusion criteria were randomised to PSORI-CM01 granule group (N=31) 
      or Yinxieling tablets group (N=32) while 39 subjects finished the study. The 
      primary outcome measure showed a mean decrease of PASI of 2.03 in the PSORICM01 
      group compared to 0.89 in the Yinxieling group at week 12. Except for the VAS 
      score (t=-2.261, P=0.027), the secondary outcomes showed no significant 
      improvement from baseline in both groups at week 12. No safety or tolerability 
      concerns related to the drugs were observed in either group. CONCLUSIONS: This 
      pilot study showed that the RCT is feasible for randomization, patient 
      recruitment, and assessment. Major strategies are necessary to reduce the patient 
      dropout rate before conducting the full RCT. In this pilot study, the PSORI-CM01 
      granule exhibited greater potential for development compared to its original 
      formula (Yinxieling tablets) for the treatment of CPP.
FAU - Yao, Dan-Ni
AU  - Yao DN
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, 
      Guangzhou, China.
FAU - Lu, Chuan-Jian
AU  - Lu CJ
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, 
      Guangzhou, China; Guangdong Provincial Key Laboratory of Clinical Research on 
      Traditional Chinese Medicine Syndrome, Guangzhou, China; State Key Laboratory of 
      Dampness Syndrome of Chinese Medicine; Guangdong-Hong Kong-Macau Joint Lab on 
      Chinese Medicine and Immune Disease Research. lcj@gzucm.edu.cn.
FAU - Wen, Ze-Huai
AU  - Wen ZH
AD  - Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of 
      Chinese Medicine, Guangzhou, China; National Centre for Design Measurement and 
      Evaluation of Clinical Research, Guangzhou University of Chinese Medicine, 
      Guangzhou, China.
FAU - Yan, Yu-Hong
AU  - Yan YH
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, 
      Guangzhou, China.
FAU - Lu, Li-Ming
AU  - Lu LM
AD  - Clinical Research and Data Center, South China Research Center for Acupuncture 
      and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou 
      University of Chinese Medicine, Guangzhou, China.
FAU - Wu, Hui-Mei
AU  - Wu HM
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China.
FAU - He, Zi-Yang
AU  - He ZY
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China.
FAU - Deng, Hao
AU  - Deng H
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, 
      Guangzhou, China.
FAU - Deng, Jing-Wen
AU  - Deng JW
AD  - Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 
      Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, 
      Guangzhou, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210203
PL  - China
TA  - Ann Palliat Med
JT  - Annals of palliative medicine
JID - 101585484
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (PSORI-CM01)
RN  - 0 (Tablets)
SB  - IM
MH  - Double-Blind Method
MH  - *Drugs, Chinese Herbal
MH  - Humans
MH  - Pilot Projects
MH  - *Psoriasis/drug therapy
MH  - Severity of Illness Index
MH  - Tablets
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese herbal medicine;
OT  - PSORI-CM01 granule
OT  - Psoriasis vulgaris
OT  - Yinxieling tablet
OT  - randomized double-blinded, double-dummy, controlled trial
EDAT- 2021/02/08 06:00
MHDA- 2021/05/15 06:00
CRDT- 2021/02/07 20:25
PHST- 2020/10/26 00:00 [received]
PHST- 2021/01/21 00:00 [accepted]
PHST- 2021/02/08 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2021/02/07 20:25 [entrez]
AID - apm-20-2575 [pii]
AID - 10.21037/apm-20-2575 [doi]
PST - ppublish
SO  - Ann Palliat Med. 2021 Feb;10(2):2036-2047. doi: 10.21037/apm-20-2575. Epub 2021 
      Feb 3.