Clinical observation and mechanism of acupuncture on amnestic mild cognitive impairment based on the gut-brain axis: study protocol for a randomized controlled trial

Qiongnan Bao; Yiwei Liu; Xinyue Zhang; Yaqin Li; Ziqi Wang; Fang Ye; Xia He; Manze Xia; Zhenghong Chen; Jin Yao; Wanqi Zhong; Kexin Wu; Ziwen Wang; Mingsheng Sun; Jiao Chen; Xiaojuan Hong; Ling Zhao; Zihan Yin; Fanrong Liang

doi:10.3389/fmed.2023.1198579

Clinical observation and mechanism of acupuncture on amnestic mild cognitive impairment based on the gut-brain axis: study protocol for a randomized controlled trial

Front Med (Lausanne). 2023 Jun 21:10:1198579. doi: 10.3389/fmed.2023.1198579. eCollection 2023.

Authors

Qiongnan Bao^{1

2}, Yiwei Liu³, Xinyue Zhang^{1

2}, Yaqin Li¹, Ziqi Wang⁴, Fang Ye⁵, Xia He⁶, Manze Xia^{1

2}, Zhenghong Chen^{1

2}, Jin Yao^{1

2}, Wanqi Zhong^{1

2}, Kexin Wu^{1

2}, Ziwen Wang^{1

2}, Mingsheng Sun^{1

2}, Jiao Chen^{1

2}, Xiaojuan Hong^{1

2}, Ling Zhao^{1

2}, Zihan Yin^{1

2}, Fanrong Liang^{1

2}

Affiliations

¹ School of Acu-Mox and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
² Sichuan Provincial Acupuncture Clinical Medicine Research Center, Chengdu, China.
³ The West China Hospital, Chengdu, China.
⁴ The Fourth People's Hospital of Chengdu, Chengdu, China.
⁵ The Sichuan Province People's Hospital, Chengdu, China.
⁶ The Rehabilitation Hospital of Sichuan Province, Chengdu, China.

Abstract

Background: Amnestic mild cognitive impairment (aMCI) is a pre-dementia condition associated with declined cognitive function dominated by memory impairment. The occurrence of aMCI is associated with the gut-brain axis. Previous studies have shown cognitive improvements in MCI after acupuncture treatment. This study evaluates whether acupuncture can produce a therapeutic effect in patients with aMCI by modulating the gut-brain axis.

Methods and design: This is a prospective, parallel, multicenter randomized controlled trial. A total of 40 patients with aMCI will be randomly assigned to an acupuncture group (AG) or a waiting-list group (WG), participants in both groups will receive health education on improving cognitive function at each visit, and acupuncture will be conducted twice a week for 12 weeks in the AG. Another 20 matched healthy volunteers will be enrolled as normal control. The primary outcome will be the change in Alzheimer's Disease Assessment Scale-cognitive scale score before and after treatment. Additionally, functional magnetic resonance imaging data, faeces, and blood will be collected from each participant to characterize the brain function, gut microbiota, and inflammatory cytokines, respectively. The differences between patients with aMCI and healthy participants, and the changes in the AG and WG groups before and after treatment will be observed. Ultimately, the correlation among brain function, gut microbiota, inflammatory cytokines, and clinical efficacy evaluation in patients with aMCI will be analyzed.

Discussion: This study will identify the efficacy and provide preliminary data on the possible mechanism of acupuncture in treating aMCI. Furthermore, it will also identify biomarkers of the gut microbiota, inflammatory cytokines, and brain function correlated with therapeutic effects. The results of this study will be published in peer-reviewed journals.

Clinical trial registration: http://www.chictr.org.cn, identifier ChiCTR2200062084.

Keywords: acupuncture; amnestic mild cognitive impairment; gut-brain axis; protocol; randomized controlled trial.