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
机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou 510120, 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 510120, China.广东省中医院[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China[4]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China广东省中医院[5]National Centre for Design Measurement and Evaluation of Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China深圳市中医院深圳医学信息中心[6]Team of standardization of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.广东省中医院
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). Conclusion: 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.
基金:
National Key Technology R&D Program for the 12th Five-year Plan of Ministry of Science and Technology, China [2013BAI02B03]; Guangdong Financial Industry Technology Research Development Fund [2011(285)05]
第一作者机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou 510120, China
通讯作者:
通讯机构:[1]Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou 510120, China[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510120, China.[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China
推荐引用方式(GB/T 7714):
Yao Dan-Ni,Lu Chuan-Jian,Wen Ze-Huai,et al.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[J].TRIALS.2016,17:doi:10.1186/s13063-016-1272-x.
APA:
Yao, Dan-Ni,Lu, Chuan-Jian,Wen, Ze-Huai,Yan, Yu-Hong,Xuan, Mei-Ling...&Ou, Ai-Hua.(2016).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.TRIALS,17,
MLA:
Yao, Dan-Ni,et al."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".TRIALS 17.(2016)