The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.
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.
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.
Background Seborrheic dermatitis (SD) is a common, chronic, inflammatory skin disorder, yet few studies have reported its clinical characteristics, or addressed its effect on quality of life (QoL). This study assesses the clinical characteristics and QoL of SD patients in China. It also identifies the clinical, demographic and environmental factors that may influence QoL. Methods Three hundred twelve SD outpatients from 9 hospitals completed a survey. QoL was measured with the dermatology-specific instrument Skindex-29. We collected social demographic characteristics and disease severity, and conducted logistic regression to determine the factors associated with QoL impairment. Results 67.3% of the patients were females. The mean Skindex-29 overall score was 33.97 (SD = 20.55). The breakdown was 40.79 (SD = 24.24) for emotions, 32.83 (SD = 19.84) for symptoms and 28.3 (SD = 23.24) for functioning. 48.1% had severe emotional problems. Logistic regression analysis showed that BMI less than 25 (OR = 0.223; 95% CI: 0.072–0.692; P = 0.009), skin disease-related hospitalization (OR = 6.882; 95% CI:1.767–26.795; P = 0.005), environmental PM 10 levels above 120 μg/m3 (OR = 3.386; 95% CI: 1.253–9.15; P = 0.016) and severe disease conditions (OR = 4.438; 95% CI:1.26–15.626; P = 0.02) were risk factors for severe emotional impairment. Moreover, skin disease-related hospitalization (OR = 6.057; 95% CI:1.351–27.149; P = 0.019), environmental PM 10 levels between 70 and 120 μg/m3 (OR = 6.317; 94% CI: 1.704–23.42; P = 0.006), moderate (OR = 2.388; 95% CI: 1.272–4.487; P = 0.007) and severe disease conditions (OR = 5.732; 95% CI: 1.838–17.88; P = 0.003) were each risk factors for overall severe impairment. Conclusion In China, nearly half of SD patients had severely emotional problems. Disease severity, BMI, dermatologic hospitalization, and ambient PM 10 levels are each risk factors for QoL impairment in SD patients. These implications are alarming, and warrant public health attention in SD disease management.
BackgroundHyperlipidemia, defined as elevated lipid levels, is the primary and major risk factor for atherosclerotic cardiovascular disease. Several studies have evaluated the effects of Chinese medicine (CM) on hyperlipidemia. However, due to the varied designs and methods of these studies, data synthesis has been difficult, restricting the practical value of the findings. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for CM clinical trials for hyperlipidemia (COS-CM-Hyperlipidemia).MethodsThe development of COS-CM-Hyperlipidemia will include four stages: (1) a systematic review to identify potential important outcomes—a study advisory group, composed of core stakeholders of hyperlipidemia, will be set up afterwards to evaluate the identified outcomes and a candidate outcome set will be developed accordingly; (2) a panel of experts will be invited to conduct a three-round Delphi survey, so that the experts’ opinions on the importance of outcomes for treating hyperlipidemia with CM will be collected; (3) a consensus meeting with clinicians, patients, and other key stakeholders will be conducted to finalize the items and definitions; and (4) COS-CM-Hyperlipidemia will be promoted and updated.DiscussionThe development of this COS will improve the design and operation of CM trials on hyperlipidemia, keeping them in compliance with international standards, as well as the comparability and utility of their results.Trial registrationThe Core Outcome Measures in Effectiveness Trials Initiative (COMET): http://www.comet-initiative.org/studies/details/983. Registered on 25 April 2017.
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