Colon to Rectum
Randomized placebo-controlled phase 3 trial of vibrating capsule for chronic constipation
Background and aims: Despite therapeutic advances, effective treatments for chronic constipation remain an unmet need. The vibrating capsule is a non-pharmacologic, orally ingested, programmable capsule that vibrates intraluminally to induce bowel movements. The authors aimed to determine the efficacy and safety of the vibrating capsule in patients with chronic constipation.
Methods: They conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic constipation, who were randomized to re-ceive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks. The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM1 responder) or 2 or more CSBMs per week (CSBM2) from baseline during at least 6 of the 8 weeks. Safety analyses were performed.
Results: Among 904 patients screened, 312 were enrolled. A greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared with placebo (39.3% vs. 22.1%, p = 0.001 for CSBM1; 22.7% vs. 11.4%, p = 0.008 for CSBM2). Significantly greater improvements were seen with the vibrating capsule for the secondary end points of straining, stool consistency, and quality-of-life measures compared with placebo. Adverse events were mild, gastrointestinal in nature, and similar between groups, except that a mild vibrating sensation was reported by 11% of patients in the vibrating capsule group, but none withdrew from the trial.
Conclusions: In patients with chronic constipation, the vibrating capsule was superior to placebo in improving bowel symptoms and quality of life. The vibrating capsule was safe and well tolerated.