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.

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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn/searchproj.aspx ) ChiCTR-TRC-13003233 ; date of registration: 15 April 2013.

[The development of quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer and item screening].

OBJECTIVE: To develop quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer (QLQ-CMPPCC), thus comprehensively and objectively evaluating the clinical efficacy of Chinese medicine and pharmacy in treating postoperative patients with colorectal cancer (CC). METHODS: The theoretical structure model of the questionnaire was addressed in combined with basic theories of Chinese medicine according to the principle of WHO quality of life (QOL). The primary questionnaire was developed using methods of structuralization policy making after we extensively retrieve various universal and specific questionnaires for CC cancer patients at home and abroad. The 205 CC patients were tested by questionnaire. The items were screened using experts grading method, item selection analysis, dispersion trends of standard deviation, t-test, correlation coefficient method, factor analysis,and Cronbach's alpha. RESULTS: The QLQ-CMPPCC was developed containing four domains of physical, psychological, independence, and social functions, involving 20 aspects and 54 items. Of them, non-fistula patients answered 43 items and fistula patients answered 46 items. One item covered the general QOL evaluation. CONCLUSIONS: QLQ-CMPPCC showed Chinese medical features. It comprehensively reflected the connotation of QOL for postoperative CC patients. It could be taken as a tool for evaluating Chinese medical efficacy for postoperative CC patients.

A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris by auricular therapy combined with optimized Yinxieling Formula.

OBJECTIVE: To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula on psoriasis vulgaris. METHODS: A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted. The patients were randomized to a treatment group (43 cases treated by auricular therapy combined with optimized Yinxieling Formula) and a control group (41 cases treated by optimized Yinxieling Formula alone) according to a random number generated by SPSS 17.0 software. The treatment duration for both groups was 8 weeks. The therapeutic effect was comprehensively measured by the primary outcome measure [Psoriasis Area and Severity Index (PASI) reduction rate] and the secondary outcome measure [PASI, Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS)]. The outcomes of both groups were obtained and compared before and after the intervention. RESULTS: The PASI reduction rate in the treatment group was 74.4% (32/43), which was higher than that in the control group (36.6%, 15/41, P<0.01). The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group P<0.01). With stratified analysis, there were significant differences between the PASI scores in the following subgroups: age 18-30, baseline PASI>10 and stable stage (P<0.05). DLQI decreased in both groups on some categories after treatment, but there were no significant differences between the two groups in SDS, SAS and VAS (P >0.05). No obvious adverse reactions were found in either group. CONCLUSION: The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.