Role of Prucalopride in the Treatment of Chronic Constipation in Parkinson’s Disease: A Randomized Controlled Trial

Abstract

BACKGROUND: – Constipation, a prevalent nonmotor symptom in Parkinson’s disease (PD), adversely impacts patients’ quality of life. Prucalopride, a selective 5-HT4 receptor agonist, has shown efficacy as a treatment for functional constipation, but its role in PD-related constipation remains underexplored.OBJECTIVE: – To assess the efficacy, safety, and quality-of-life impact of prucalopride in PD patients with chronic constipation.METHODS: – In this double-blind randomized controlled trial, PD patients with chronic constipation received prucalopride (2 mg) or placebo once daily for 8 weeks. The primary outcome was the change in the number of spontaneous bowel movements (SBMs) per week from baseline to week 8. Secondary outcomes included stool consistency, straining, and changes in Patient Assessment of Constipation-Symptoms and Patient Assessment of Constipation-Quality of Life scores. Parkinsonian motor severity was assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS).RESULTS: – Fifty-seven patients were included (prucalopride = 30, placebo = 27). At week 8, the change in the number of weekly SBMs was significantly larger in the prucalopride group (3.2 ± 2.8) than in the placebo group (1.6 ± 1.9; P = 0.02). Longitudinal analysis confirmed a significantly higher SBM frequency in the prucalopride group throughout the 8-week period (P = 0.015). Secondary outcomes showed trends toward improvement, but no statistically significant differences. No serious adverse events were reported, and UPDRS scores remained unchanged.CONCLUSION: – Prucalopride was safe, well-tolerated, and more effective than placebo in increasing bowel movement frequency in PD patients with chronic constipation, supporting its potential as a therapeutic option in this population.