Acupuncture for Persistent Asthma: Protocol for a Randomized, Sham-Controlled Trial with Neuroimaging

Although acupuncture has shown therapeutic potential for asthma, its clinical application is limited by insufficient high-quality evidence and an incomplete understanding of its neurophysiological mechanisms. This study aims to evaluate the efficacy and safety of acupuncture in patients with persistent asthma and to further investigate its central mechanisms.

This randomized, sham-controlled neuroimaging trial will enroll 72 patients with mild-to-moderate persistent asthma. Participants will be randomly assigned in a 1:1 ratio to receive either genuine or sham acupuncture. The intervention comprises 12 sessions over 4 weeks. The primary outcome is the change in the Asthma Control Test score from baseline to week 4. Secondary outcomes encompass scores from the Asthma Quality of Life Questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, Montreal Cognitive Assessment, along with forced expiratory volume in 1 second and fractional exhaled nitric oxide levels. Cerebral changes will be assessed via magnetic resonance imaging conducted before and after the treatment course. Statistical analyses will adhere to the intention-to-treat principle and will employ analysis of covariance and linear mixed-effects models. Furthermore, correlation and mediation analyses will be performed to investigate the relationships between clinical improvements and neuroimaging data, thereby exploring potential neurobiological mechanisms of acupuncture.

This randomized controlled trial aims to evaluate the clinical efficacy and central neural mechanisms of acupuncture in patients with persistent asthma. The findings are expected to provide evidence supporting its therapeutic role. By elucidating the underlying neuroregulatory mechanisms, this study may contribute to a more mechanism-informed and optimized application of acupuncture in asthma management.

This trial is registered on the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/) on April 2025 (ITMCTR2025000737).