Abstract
Background: Eczema is the most common allergic skin disorder in the world. The treatment of eczema with western medicine generally involves antihistamines, antibiotics, glucocorticoids, and immunomodulatory preparations, which are limited by common relapse events following drug withdrawal. Many traditional Chinese medicines have demonstrated significant effects on eczema; however, high-quality clinical studies are lacking.Objectives: We performed a multi-center, randomized, double-blind, clinical trial to evaluate the efficacy and safety of a Chinese herbal medicine, Qinzhuliangxue (QZLX) granules, and its effect on recurrence of eczema.Methods: A total of 342 patients with eczema who met the inclusion criteria were recruited and randomly divided into a traditional Chinese medicine (TCM) treatment group, a Western medicine (WM) treatment group, and a TCM plus WM treatment group, according to random numbers generated using the central stratified zone group random method. The Eczema Area and Severity Index (EASI) score and the level of pruritus were set as the primary outcome measures, and the Dermatology Quality of Life Index (DLQI) score served as the secondary outcome measure. In this study, a two-sided p-value less than 0.05 was considered statistically significant. Results: The median EASI score and the pruritus level at baseline were not statistically significant. However, as the treatment period progressed, the EASI score (including the total score and scores for the head, upper limb, trunk, and lower limb) and pruritus level decreased significantly in all three treatment groups. Repeated measures Analysis of Variance (ANOVA) demonstrated that the DLQI scores in the TCM, WM, and TCM+WM groups decreased significantly over time. Limitations: Basic experiments need to be increased.Conclusions: The Chinese herbal medicine QZLX granules significantly improved the EASI score and decreased the pruritus level in eczema patients, with good safety and no obvious adverse reactions.Trial RegistrationThe protocol for this study was registered with the Clinical Trials database (NCT02517957). Registered 1 May 2015, Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research - Full Text View - ClinicalTrials.gov
Therapeutic effects oflow-frequency phonophoresis with a Chinese herbal medicine versus sodium diclofenac for treatment of knee osteoarthritis: a double-blind, randomized, placebo-controlled clinical trial
