Acupoint Plaster Application Combined with Omalizumab for Severe Allergic Asthma: A Randomized Controlled Trial

Some patients with severe allergic asthma remain poorly controlled despite guideline‑recommended therapy. This prospective randomized controlled trial evaluated whether adding acupoint plaster therapy to omalizumab provides additional benefits in asthma control, inflammatory biomarkers, immune function, and pulmonary function. Fifty‑six adults with severe allergic asthma were randomized 1:1 to receive either omalizumab plus acupoint plaster (experimental group) or omalizumab alone (control group), with 28 patients per group. Outcomes were assessed at 8 and 16 weeks, including co‑primary endpoints (asthma control test (ACT) score and traditional Chinese medicine (TCM) symptom score) and secondary endpoints (rescue medication use, mini asthma quality of life questionnaire (mini‑AQLQ), peripheral blood eosinophils, fractional exhaled nitric oxide (FeNO), T‑cell subsets, and pulmonary function). Analyses were performed on an ITT basis using multiple imputation. At both time points, the experimental group showed greater improvements in co‑primary endpoints than the control group. At 16 weeks, the experimental group also demonstrated greater improvements in eosinophils, FeNO, percentage of CD4⁺ T lymphocytes (CD4⁺%), percentage of CD8⁺T lymphocytes (CD8⁺%), CD4⁺/CD8⁺ ratio. No significant differences were observed in pulmonary function parameters. Two participants (7.7%) in the experimental group experienced mild local skin reactions, with no serious adverse events reported. This exploratory study suggests that adding acupoint plaster to omalizumab may confer additional clinical, inflammatory, and immunological benefits in severe allergic asthma, with a favorable safety profile. However, these findings warrant confirmation in larger, blinded, multi‑center studies with extended follow‑up.