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.
机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China大德路总院皮肤科大德路总院皮肤科广东省中医院[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China广东省中医院[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China[4]State Key Laboratory of Dampness Syndrome of Chinese Medicine[5]Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou China[6]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China广东省中医院[7]National Centre for Design Measurement and Evaluation of Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou, China[8]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
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).
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.
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.
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.
基金:
This research was supported by the Guangdong
Financial Industry Technology Research Development
Fund (No. 2011(285)05) and the Traditional Chinese
Medicine Bureau Foundation of Guangdong Province (No.
20183005).
第一作者机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China
通讯作者:
通讯机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China[4]State Key Laboratory of Dampness Syndrome of Chinese Medicine[5]Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou China[*1]Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Yuexiu District, Guangzhou 510120, China.
推荐引用方式(GB/T 7714):
Dan-Ni Yao,Chuan-Jian Lu,Ze-Huai Wen,et al.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.[J].ANNALS OF PALLIATIVE MEDICINE.2021,10(2):2036-2047.doi:10.21037/apm-20-2575.
APA:
Dan-Ni Yao,Chuan-Jian Lu,Ze-Huai Wen,Yu-Hong Yan,Li-Ming Lu...&Jing-Wen Deng.(2021).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..ANNALS OF PALLIATIVE MEDICINE,10,(2)
MLA:
Dan-Ni Yao,et al."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.".ANNALS OF PALLIATIVE MEDICINE 10..2(2021):2036-2047