Colon to Rectum
Aliment Pharmacol Ther. 2024;60(7):855-862
Clinical trial: Effects of treatment with a vibrating capsule in patients with severe chronic constipation
Background: There is little information on the effectiveness of therapies for severe chronic constipation. In a phase 3 trial, the authors previously demonstrated that a vibrating capsule was significantly more efficacious than a placebo in chronic constipation.
Aim: To examine the effects of a vibrating capsule and placebo on symptoms and health-related quality of life (HRQoL) in patients with severe chronic constipation.
Methods: The authors performed a post hoc analysis of phase 3, multicentre, randomised, double-blind, and placebo-controlled 8-week clinical trial of a vibrating capsule to specifically assess outcomes among subjects who reported 0 complete spontaneous bowel movements (CSBMs) during the 2-week baseline period. They assessed effects of treatment on bowel symptoms, patient satisfaction, and HRQoL. CSBM responders were defined as subjects with increases of ≥ 1 or ≥ 2 or ≥ 3 weekly CSBMs (CSBM1 or CSBM2, CSBM3, respectively) over baseline for ≥ 6 out of 8 weeks of treatment.
Results: The severe chronic constipation subgroup comprised 175 (56%) of the 312 subjects. Significantly more subjects with severe chronic constipation who received the vibrating capsule than those who received the placebo were CSBM1 (44.9% vs. 20.9%, p = 0.007), CSBM2 (29.2% vs. 11.6%, p = 0.004), and CSBM3 (19.10% vs. 6.98%, p = 0.017) responders. Straining effort, stool consistency, patient satisfaction, and HRQoL significantly improved in the severe chronic constipation subgroup. A mild vibrating sensation was reported in 10%.
Conclusion: The vibrating capsule significantly improved constipation-related symptoms and health-related quality of life in patients with severe constipation, affirming its efficacy and safety across the spectrum of chronic constipation.
DOI: 10.1111/apt.18198