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Research Article
* These authors contributed equally
This randomized controlled trial indicated that adding acupoint plaster application to omalizumab may improve symptom control, inflammatory profiles, and immune status in severe allergic asthma, but did not significantly affect conventional pulmonary function.
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.
Bronchial asthma is a chronic airway inflammatory disorder characterized by variable respiratory symptoms and fluctuating airflow limitation1. Allergic asthma remains the predominant phenotype and accounts for a substantial share of severe disease worldwide2. Despite receiving guideline-recommended treatment with inhaled corticosteroids/ long‑acting beta₂-agonists (ICS/LABA) therapy, an estimated 5–10% of patients progress to severe asthma with persistent symptoms, impaired lung function, and recurrent exacerbations3. The disease burden has continued to grow in China, where aller....
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Ethics statement
The study protocol was approved by the Ethics Committee of Chengdu Hospital of Integrated Traditional Chinese and Western Medicine (Approval No. 2024KT019). The trial was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. All the materials used in this study are listed in the Table of Materials.
Study design and participants
This was a prospective, randomized, open-label, parallel-group, single-center trial conducted between June 2024 and December 2024....
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Participant flow and follow-up
A total of 64 patients were screened; 56 met eligibility criteria and were randomized in a 1:1 ratio, with 28 participants assigned to each group. During follow-up, two participants in the treatment group discontinued the intervention after week 8 for personal reasons. Therefore, 54 participants completed the 16-week follow-up (26 in the treatment group and 28 in the control group). All randomized participants were included in the ITT analysis. T.......
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This randomized controlled trial evaluated whether acupoint plaster application could provide additional benefit when added to omalizumab in adults with severe allergic asthma. The main findings were that the combination therapy was associated with greater improvement in asthma control, TCM symptom burden, rescue medication use, eosinophilic inflammatory indices, and peripheral T-cell immune profiles than omalizumab alone. In contrast, conventional spirometric parameters showed significant improvement over time in both g.......
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All authors declare no financial or non-financial conflicts of interest related to this work. No author has any financial involvement with any organization or entity discussed in this manuscript.
AUTHORS’ CONTRIBUTION:
YaoXuan Tan and Yi Yang contributed equally as co-first authors. The study was conceptualized and designed by Hui Wang, Yu Zhang, and ZhenXing Mao. Funding for the research was acquired by Hui Wang. Participant recruitment and eligibility screening were conducted by Ya Li, Min Tao, GuoJiao Kou, and Yu Zhang. Omalizumab administration was carried out by Yu Zhang and ZhenXing Mao. Acupoint plaster preparation and application were performed by YaoXuan Tan and Yi Yang. Data collection was undertaken by YaoXuan Tan, Yi Yang, Min Tao, and GuoJiao Kou. Statistical analysis was conducted by YaoXuan Tan, Yi Yang, and Hui Wang. The initial manuscript was drafted by YaoXuan Tan and Yi Yang. Manuscript revision and supervision were provided by Hui Wang, Yu Zhang, and ZhenXing Mao. All authors have reviewed and approved the final version of the manuscript.
This research was supported by the Science and Technology Research Special Project of the Sichuan Provincial Administration of Traditional Chinese Medicine (Grant No. 2024MS143). The funder had no role in study design, data collection, analysis, interpretation, or manuscript preparation.
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| Name | Company | Catalog Number | Comments |
|---|---|---|---|
| 75% medical alcohol | Shandong Lierkang Medical Technology Co., Ltd. | 1202050004 | 100 mL/bottle |
| Acupoint Patches | Sichuan Sanhe Medical Materials | WZ102000982 | Disposable, 60 mm x 70 mm |
| Bai Jie Zi | Sichuan Jingxin Traditional Chinese Medicine Decoction Pieces Co., Ltd. | CHUAN20160145 | stir-frying, 500 g/bag |
| BD Multitest 6-Color TBNK Kit | BD Biosciences | 662967 | BD Multitest 6-Color TBNK |
| Dilution solution for blood cell analysis | Mindray | DWX-50101 | Used for diluting samples for complete blood count (CBC) testing |
| DuraClone IM T Cell Subsets Tube | Beckman Coulter | B53328 | 10-color/10 types of monoclonal antibody premixed tubes |
| FeNO Analyzer | Sunvou Medical Electronics Co.,Ltd | Sunvou-CA2122 | For exhaled nitric oxide test |
| Flow cytometry | BD Biosciences | FACSCelesta | Flow Cytometry Analysis Platform |
| Fully Automated Blood Analyzer | Mindray | BC7500CST | Five-part blood cell analyzer |
| Fully Automatic Biochemical Analyzer | Roche | Cobas 8000 | Suitable for comprehensive biochemical tests including liver function and renal function assays |
| Gan Sui | Beijing Qijing Yinpian Co., Ltd. | PC81627 | root, 500 g/bag |
| ginger | Ito-Yokado Supermarket | N/A | For preparing ginger juice |
| Hemolysin for blood cell analysis | Mindray | M-68FD | For lyzing red blood cells and releasing white blood cells |
| Liver function biochemical quality control reagents | Zhongsheng Beikong | Biochemical composite quality control samples | For liver function testing |
| Omalizumab | Novartis | SJ20170042 | Anti-IgE monoclonal antibody |
| Renal function biochemical quality control reagents | Zhongsheng Beikong | Biochemical composite quality control samples | For renal function Tests |
| Spirometer | Yeager | Master screen | For lung function test |
| SPSS Statistics | IBM | Version 25.0 | Statistical software |
| Staining solution for blood cell analysis | Mindray | WNR-800A | For leukocyte classification staining |
| Xi Xin | Sichuan Guoqiang Traditional Chinese Medicine Decoction Pieces Co., Ltd. | YJY002439729 | root and rhizome, 500 g/bag |
| Yan Hu Suo | Sichuan Guoqiang Traditional Chinese Medicine Decoction Pieces Co., Ltd. | YJY002439815 | tuber, 500 g/bag |
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