Effects of acupuncture on Parkinson's disease-related constipation and roles of gut microbial ecology: study protocol for a randomized controlled clinical trial

Abstract

Background: Motor disturbances and non-motor manifestations, notably constipation, stand as primary factors influencing the quality of life in individuals with Parkinson's disease (PD). Recent microbiological research increasingly links PD with the gastrointestinal environment, highlighting the crucial role of gut microbiota. Clinical studies suggest acupuncture may alleviate motor impairments and associated non-motor issues, like constipation, in PD patients. However, limited research on underlying mechanisms necessitates further evidence-based investigation for comprehensive validation. This study aims to investigate whether acupuncture improves the clinical symptoms of patients with Parkinson's disease-related constipation (PDC) by modulating the balance of intestinal microecology. Methods: This single-blind randomized controlled clinical trial enrolls 84 patients with PDC, randomly allocated in a 1:1:1 ratio to real acupuncture group (RA), sham acupuncture group (SA), and waitlist control group (WG). Treatments will span four weeks, with primary outcomes measured through changes in the Unified Parkinson’s Disease Rating Scale (UPDRS). Secondary outcomes include the Stool diary, the Non-Motor Symptoms Scale (NMSS), 30-meter walking test, fecal 16S rDNA gene sequencing, serum Lipopolysaccharide (LPS) and Lipopolysaccharide-binding protein (LBP) levels. The adherence and adverse events will also be recorded. Participants will be followed until week 16, and statistical analyses will encompass all allocated individuals. Discussion: The outcomes of this study are anticipated to substantiate the efficacy and underlying mechanisms of acupuncture as a complementary treatment for PDC. The study holds the potential to furnish robust clinical evidence, thereby contributing to the establishment of novel guidelines for the treatment of PDC. Trial registration: The Research Ethical Committee at the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine authorized this trial. The trial is registered with the Chinese Clinical Trials Registry (ChiCTR) under registration number ChiCTR2400082060, registered on March 20, 2024. (https://www.chictr.org.cn/showproj.html?proj=200177)