Original Research ARTICLE
The Efficacy and Safety of a Fixed Combination of Chinese Herbal Medicine in Chronic Urticaria: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
- 1Chang Gung University, Taiwan
- 2Chang Gung Immunology Consortium, Linkou Chang Gung Memorial Hospital, Taiwan
- 3Taoyuan Chang Gung Memorial Hospital, Taiwan
- 4Chang Gung University of Science and Technology, Taiwan
- 5Royal Blackburn Hospital, United Kingdom
- 6Matsumoto Dental University, Japan
- 7Chung Shan Medical University, Taiwan
- 8Linkou Chang Gung Memorial Hospital, Taiwan
Background: Chronic urticaria is a bothersome skin disease, and Chinese herbal medicine (CHM) is commonly used as adjuvant therapy. This study aimed at evaluating the effectiveness and safety of CHM 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 (Xiao-Feng-San 2 gm and Qing-Shang-Fang-Feng-Tang 2 gm, 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 versus 15.6±10.8, p-value=0.038). In the CHM group, participants’ symptom severity reduced progressively (trend analysis, p-value < 0.001) while the decreasing trend was less favored in the control group (trend analysis, p-value=0.056). The life quality improved gradually in both groups, while the differences between CHM and control groups were statistically insignificant. For urticaria-related cytokines, interferon-γ seemed to decrease positively in the CHM group (about 30.8% reduction from baseline, trend analysis p-value: 0.013). For safety issue, the CHM prescription was well tolerated with no noticeable long-term side effects when compared to the control group. At 6-month follow-up of symptom changes after the end of the trial, the CHM group participants reported positive results in no recurrence or ≥50% improvement (36.3% in CHM group versus 20% in Control group, p-value 0.103).
Conclusions: CHM adjuvant treatment tends to be feasible and tolerable management for urticaria in addition to standard therapy. However, larger study population with longer follow-up duration may be still needed.
Keywords: chronic urticaria, Chinese herbal medicine (CHM), clinical trial, double-blind, Placebo-control, Randomization
Received: 11 Aug 2018;
Accepted: 30 Nov 2018.
Edited by:Aiping Lu, Hong Kong Baptist University, Hong Kong
Reviewed by:Anthony Booker, University of Westminster, United Kingdom
Meaghan Coyle, School of Health and Biomedical Sciences, RMIT University, Australia
Copyright: © 2018 YANG, Lin, Lin, Chen, Hu, Yang, Yang, Yang and Fang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Prof. SIEN-HUNG YANG, Chang Gung University, Guishan, Taiwan, firstname.lastname@example.org