Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial

Abstract

BackgroundPrevious studies suggested that acupuncture was a promising adjunct treatment for asthma. However, the underlying mechanism of acupuncture for asthma remains unclear. The present trial aimed to explore whether and how specific meridian acupuncture works in quality of life and symptomatic improvement by modulating brain function in asthma patients.Methods: A randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 48 patients with mild to moderate, persistent asthma will be recruited randomly allocated to two acupuncture groups: acupuncturing at Lung Meridian and acupuncturing at Heart Meridian. The treatment period will last for 4 weeks. The Asthma quality of life questionnaire (AQLQ) is the primary outcome. Asthma control test (ACT), the rate of Peak expiratory flow (PEFR), Forced expiratory volume in 1 second (FEV1), Montreal cognitive assessment (MoCA), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) will also assess the clinical efficacy of different interventions. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral activity changes in each group. The clinical data and fMRI data will be analyzed, respectively. Pearson correlation analysis will be used to assess the association between the changes of cerebral activity features and the improvement of clinical outcomes in each group.Discussion: The present study has been established on the “meridians-viscera relationship” theory of traditional Chinese medicine and modern central mechanism of acupuncture. The results of this trial would be useful to identify the efficiency of the specific meridian acupuncture for asthma. The investigation of its central mechanism would further expand our knowledge of the acupuncture for asthma. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027478. Registered on 15 November 2019.