Abstract
BackgroundTo 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.MethodsEligible 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).ResultsSix 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).ConclusionOral 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.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx) ChiCTR-TRC-13003233; date of registration: 15 April 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1272-x) contains supplementary material, which is available to authorized users.
Highlights
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)
The primary outcome measure was the incidence of relapse during the study. Design and eligibility This pilot study was designed as a randomized, doubleblind, placebo-controlled trial to evaluate the efficacy of oral PSORI-CM01 plus topical sequential treatment compared with placebo plus topical sequential treatment for moderate-to-severe PV
Patients In this pilot study, 77 patients were recruited for 2 months, and 18 (8 in CHM group vs 10 in placebo group) of them were enrolled from the outpatient department at Guangdong Provincial Hospital of Chinese Medicine (GPHCM)
Summary
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). Psoriasis is a chronic skin disease characterized by disfiguring scaling and erythematous plaques that may be painful or often severely pruritic and may cause many quality of life (QOL) issues [1]. A quarter of those affected have moderate-to-severe disease for which treatment options include topical treatment, systemic treatment, or phototherapy. Due to its chronic nature, frequent relapses, and high impact on QOL, patients often require long-term treatment. Most of the therapies are associated with side effects and not appropriate for long-term use. The goal of treating psoriasis is to maintain the success of the treatment as far as possible with fewer side effects
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
