Introduction: Approximately 50 million Americans report constipation, of whom 28% have moderately severe illness (Am J Gastro 2020;115:895-905). The effectiveness of current therapies for severe chronic idiopathic constipation (CIC) is unknown. In a recent Phase III trial, a vibrating capsule (VC) proved superior to placebo in improving bowel and abdominal symptoms in patients with CIC. Aim: To determine the efficacy and safety of VC in patients with severe CIC.
Methods: We performed a post-hoc analysis of CIC patients (Rome III) who were enrolled in an 8-week phase 3, multicenter, double-blind trial, and randomly received one VC (Vibrant, Yokneam, Israel) or placebo orally for 5 days/week. Severe CIC was defined as patients who reported 0 complete spontaneous bowel movements (CSBM) during a 2-week baseline period on a daily electronic stool diary. Patients with history of dysphagia or bowel obstruction were excluded. Primary outcome measures were percentage of subjects with an increase of one (CSBM1), two (CSBM2), or three (CSBM3) CSBM/week, during at least 6 of 8 treatment weeks compared to baseline. Secondary outcomes and safety were also assessed.
Results: 312 CIC patients were enrolled of whom 56% (VC n=89, placebo n=86) had severe CIC. There were significantly greater CSBM1 (p=0.0007), CSBM2 (p=0.0040), and CSBM3 (p=0.0176), responders in the VC group compared to placebo (Fig). The straining effort (p=0.0027) and stool consistency (p=< .0001) also improved significantly in the VC group compared to placebo. Also, QOL significantly improved in the VC group (p=< .0001) compared to placebo. The treatment was generally safe, without severe adverse events or diarrhea. The most common AEs in the group were a sensation of mild vibration (11.2%) and abdominal discomfort (2.25%), table 1.
Discussion: In individuals with severe CIC, VC significantly improved bowel and abdominal symptoms and QOL compared to placebo. The VC was safe and well tolerated. Vibrating Capsule is a first in class, novel, non-pharmacological treatment that is efficacious and safe in patients with severe chronic constipation.
