Efficacy of herbal medicine Xiao-Feng-San combined with auricular acupuncture for atopic dermatitis: A randomized controlled trial.

Background: Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a considerable burden. Xiao-Feng-San (XFS) has been widely used in traditional medicine for the wind-dampness-heat pattern. Auricular acupuncture (AA) may relieve AD symptoms, but its added benefit with XFS is unclear. Methods: In this randomized, sham-controlled clinical trial, 156 adults with non-severe AD and wind-dampness-heat pattern, all of whom were prescribed XFS decoction, were additionally assigned to receive either AA (XFS plus AA group, n=78) or sham AA (XFS plus Sham AA group, n=78) for four weeks. The primary outcome was the change in the SCORAD index from baseline to week 4. Secondary outcomes included fexofenadine use, Dermatology Life Quality Index (DLQI), serum total IgE, and adverse events. Results: Compared with the XFS plus sham AA, the XFS plus AA group showed a significantly greater reduction in SCORAD at week 4 (mean difference [MD] -9.1; Conclusions: Adding AA to XFS enhanced clinical outcomes and quality of life in patients with non-severe AD, with a favorable safety profile. These findings support AA as a promising adjunctive therapy in integrative approaches for AD. Further studies should validate these results across broader populations, with post-intervention follow-up, and diverse traditional medicine regimens. Trial registration information: ClinicalTrials.gov (NCT06492902).