Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

Abstract

BackgroundPsoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients.Methods/DesignUsing an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles.DiscussionTo address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects.Trial registrationChinese Clinical Trial Registry (http://cwww.chictr.org): ChiCTR-TRC-13003233, registered 26 May 2013.

Traditional Chinese medicine for psoriasis vulgaris

“…The sample size of this study was calculated based on the recurrence rates which is the primary outcome. According to the previous study, taking methotrexate as an example, the recurrence rate of conventional therapies is 73.7%, [ 5 ] The recurrence rate of integrated Chinese Medicine is 28.6%, [ 20 ] We suppose the recurrence rate of TCM group was 20%. Using non-equality test design by the PASS software, we set the α=0.05 and the power 1-β=0.8, the ratio of cases among each group is 1:1:1, the number of cases calculated is 390 in each group.…”

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

“…For the large-scale study, we calculated sample size based on White’s study [ 9 ] in the protocol [ 10 ]. Sample size calculations are not a prerequisite for pilot studies [ 15 ].…”

“…We designed a run-in period before enrollment and used urea ointment and cetirizine hydrochloride as rescue medicine when skin itchiness affected the patients’ QOL during the whole study. The modified protocol was registered in April 2013 ( ChiCTR-TRC-13003233 ) and published in July 2014 [ 10 ] .…”

Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial

“…The study will investigate Chinese herbal medicine YXBCM01 combined with conventional therapy (calcipotriol) for psoriasis vulgaris in an Australian population with PASI severity ≥7 and ≤12. The study was developed in collaboration with a Chinese study also currently investigating YXBCM01 but combined with a different conventional therapy (calcipotriol betamethasone), for relapse rate in a Chinese population with psoriasis vulgaris of greater severity [ 30 ]. The Australian study is designed as a double-blind, randomized placebo controlled trial to determine the feasibility of the trial protocol, prior to undergoing a full scale trial.…”