Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 25, 2025
Date Accepted: Jul 31, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Changes in gut microbiome following acupuncture and moxibustion in patients with Parkinson’s disease: A study protocol of a single-group, prospective, observational study
ABSTRACT
Background:
Parkinson’s disease (PD), a prevalent neurodegenerative disorder characterized by motor and non-motor symptoms, is becoming increasingly prevalent worldwide. Conventional treatment for PD involves dopamine therapy, including levodopa; however, this treatment is ineffective for non-motor symptoms and may cause adverse effects. The gut-brain axis has been hypothesized to promote PD, and regulation of gut microbiome, which modulates the gut-brain axis, is emerging as a treatment target. Acupuncture and moxibustion exert therapeutic effects on PD and modulate the gut microbial composition.
Objective:
We present a protocol for analyzing the effects of acupuncture and moxibustion on gut microbiome and exploring its association with symptoms in patients with PD.
Methods:
This single-group, prospective, observational study will recruit 60 patients with idiopathic PD and 20 healthy participants. Baseline gut microbiome patterns and motor and non-motor symptoms of both groups will be compared. Patients with PD will be treated with acupuncture, moxibustion, and intradermal acupuncture twice a week for 12 weeks (24 sessions total). Motor and non-motor symptoms and gut microbiome changes in patients with PD will be compared before starting treatment (Day 0), during treatment (6 weeks), at the end of treatment (12 weeks), and 2 months after the end of treatment (20 weeks). The correlation between motor and non-motor symptoms of PD changed by acupuncture and moxibustion treatment and changes in gut microbiome will be analyzed. Healthy participants will be assessed for motor and non-motor symptoms of PD and gut microbiome after screening.
Results:
The study was funded by the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT, Republic of Korea and recruitment for the study started on October 21, 2021. As of February 19, 2025, recruitment and observation ended and data analysis is being conducted.
Conclusions:
This is the first clinical study to assess the effects of acupuncture and moxibustion on gut microbiome and explore its association with symptoms in patients with PD. The results will provide clinical evidence to explain the microbiome-gut-brain axis mechanism of acupuncture and moxibustion for PD and suggest the possibility of acupuncture as an alternative therapy for PD. Clinical Trial: This study was registered with the Clinical Research Information Service (CRIS, KCT0006669, 2021-10-15).
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.