The Efficacy and Safety of a Fixed Combination of Chinese Herbal Medicine in Chronic Urticaria: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Abstract
Background: Chronic urticaria is a bothersome skin disease, and Chinese herbal medicine (CHM) is commonly used as adjuvant therapy. This study aimed to evaluate the effectiveness and safety of the mixture of two CHM formula, Xiao-Feng-San (XFS) and Qing-Shang-Fang-Feng-Tang (QSFFT), in treating urticaria through a randomized, double-blind, placebo-controlled clinical trial. Methods: 78 participants entered the screening phase between November 2012 and August 2015. Participants were randomly and equally allocated in either CHM group (2 gm XFS and 2 gm QSFFT four times a day and 5 mg levocetirizine once daily for 28 days followed by 5 mg levocetirizine once daily alone for 28 days) or control group (placebo and 5 mg levocetirizine daily followed by 5 mg levocetirizine once daily for 28 days alone). Symptom improvement was set as the primary outcome, and the influence on sleep quality and changes in serum markers were used as secondary outcomes. Per protocol design was applied to the final analysis. Results: A total of 56 participants entered the final analysis stage. Participants in the CHM group had more prominent symptom relief on day 56 (the weekly urticaria activity score, UAS7, as 9.9 ± 9.2 vs. 15.6 ± 10.8, p = 0.038). In the CHM group, participants' symptom severity reduced progressively (trend analysis, p < 0.001) while the decreasing trend was less favored in the control group (trend analysis, p = 0.056). The life quality improved gradually in both groups, while the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 78 participants or records.
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