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Chinese herbal formula Huoxiang Zhengqi Qral liquid for atopic dermatitis: The CHARM randomized controlled trial
Meiling Xuan1, Xiaohui Guo2, Geng Li1
1Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China; State Key Laboratory of Dampness Syndrome of Chinese Medicine, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China.
Background:
There is an unmet treatment need and a lack of efficacy evidence for Huoxiang Zhengqi (HXZQ) oral liquid for atopic dermatitis (AD).
Objectives:
To assess the therapeutic efficacy and safety profile of HXZQ therapy in adult Chinese patients with AD or eczema.
Methods:
In the CHARM study (a multi-center, double-blind, randomized controlled trial), randomized participants with mild AD or eczema received HXZQ or a placebo for 4 weeks randomly. The primary outcome was the change in the Eczema Area and Severity Index (EASI) scores from baseline to the end of treatment. Several secondary outcomes were also measured.
Results:
In total, 218 participants were enrolled who received either HXZQ (n = 110) or a placebo (n = 108). The adjusted difference in the change in the EASI score from baseline to Week 4 between the two groups was -0.44 (95 % confidence interval [CI]:0.83, -0.04; p = 0.033) in the intention-to-treat analysis. At Week 8, 70 participants (66 %) in the HXZQ group had a 50 % or greater reduction from baseline in the EASI score, as compared with 53 participants (50.5 %) in the placebo group (p = 0.022).
Limitations:
Only mild AD or eczema participants were observed; due to the limited 4-week treatment timeframe, HXZQ oral liquid's long-term clinical benefits could not be fully determined.
Conclusions:
In participants with mild AD/eczema, treatment with HXZQ oral liquid resulted in greater EASI reduction than treatment with placebo at Week 4, and had more benefits in skin clearance benefits over 8 weeks.
