Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense pruritus, eczematous lesions, and impaired quality of life. Xiao-Feng-San (XFS), a traditional Chinese herbal formula, has been used as a complementary therapy for AD; however, its clinical efficacy and safety remain uncertain. This study aimed to systematically review and meta-analyze the efficacy and safety of XFS in patients with atopic dermatitis. This systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. PubMed, Scopus, Embase, Cochrane Library, and Web of Science were searched from inception. Randomized controlled trials comparing XFS with placebo or sham treatment in patients with AD were included. Continuous outcomes were pooled as mean differences (MDs), and dichotomous outcomes as risk ratios (RRs), each with 95% confidence intervals (CIs), using random-effects models. Three randomized controlled trials involving 245 participants were included. Follow-up ranged from 4 to 8 weeks. Meta-analysis demonstrated a statistically significant improvement in dermatology-specific quality of life at 4 weeks in patients treated with XFS compared with control (MD −1.97, 95% CI −3.51 to −0.44). Findings for pruritus and disease severity were inconsistent across studies. Immunologic markers, including serum total IgE, did not differ significantly between groups. Xiao-Feng-San might provide modest short-term improvement in quality of life in patients with atopic derma titis. However, evidence remains limited by small sample sizes, short follow-up duration, and methodological concerns. Larger, well-designed randomized trials are required to establish its clinical efficacy and safety.
Key words: Atopic dermatitis, Xiao-Feng-San, sopoongsan, traditional chinese medicine, herbal medicine, meta-analysis, randomized controlled trials
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