Acupuncture for chronic urticaria: a systematic review and meta-analysis with trial sequential analysis

Background and purpose: Chronic urticaria (CU) manifests as recurrent skin wheals and itching, considerably impacting patient quality of life. This study aimed to evaluate the efficacy and safety of acupuncture treatment for CU using meta-analysis and trial sequential analysis (TSA), providing a basis for clinical decision-making. Methods: A systematic search was performed across six English databases, four Chinese databases, and additional resources up to 30 September 2025. Randomized controlled trials comparing acupuncture with Western medicine (WM), sham acupuncture (SA), and waitlist control (WC) were included. The revised Cochrane Collaboration Risk of Bias tool was used to assess methodological quality. Review Manager (version 5.4) and STATA (version 17) were used for statistical analysis and complex modeling, respectively. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used to evaluate the evidence level, and TSA was used to estimate the required sample size and evaluate the stability of the study conclusions. Subgroup analyses were performed based on acupuncture methods and control methods. Results: The analysis included 18 studies involving 1,829 patients. Acupuncture demonstrated a significant advantage over SA and WC in reducing the Weekly Urticaria Activity Score (UAS7), while no significant difference was observed compared to WM. For secondary outcomes, acupuncture demonstrated a significant advantage over WM, SA, and WC in terms of the Dermatology Life Quality Index (DLQI). TSA's findings indicated that the evidence of reducing UAS7 and DLQI scores with acupuncture for patients with urticaria was conclusive. Meanwhile, the difference between acupuncture and WM regarding serum IgE levels was statistically non-significant. TSA showed that the evidence of improving IgE levels is inconclusive. The incidence of adverse effects associated with acupuncture treatment, including ecchymosis and pain, was higher than that in SA and WC. Conclusion: Acupuncture is a potential therapeutic intervention for CU, capable of reducing the frequency of urticarial episodes and significantly improving patient symptoms and quality of life. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier: CRD42023480490.