Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation

Satish S C Rao, Anthony Lembo, William D Chey, Keith Friedenberg, Eamonn M M Quigley, Satish S C Rao, Anthony Lembo, William D Chey, Keith Friedenberg, Eamonn M M Quigley

Abstract

Background: Constipated patients remain dissatisfied with current treatments suggesting a need for alternative therapies.

Aim: Evaluate the mechanistic effects of oral vibrating capsule in chronic idiopathic constipation (CIC) by examining the temporal relationships between the onset of vibrations, complete spontaneous bowel movements (CSBM), and circadian rhythm.

Methods: In post hoc analyses of two double-blind studies, CIC patients (Rome III) were randomized to receive 5 active or sham capsules/week for 8 weeks. The capsules were programmed for single vibration (study 1) or two vibration sessions with two modes, 8 hours apart (study 2). Daily electronic diaries assessed stool habit and percentage of CSBMs associated with vibrations. Responders were patients with ≥ 1 CSBM per week over baseline.

Results: 250 patients were enrolled (active = 133, sham = 117). During and within 3 hours of vibration, there were significantly more % CSBMs in the active vs. sham group (50% vs. 42%; P = .0018). In study 2, there were two CSBM peaks associated with vibration sessions. Significantly more % CSBMs occurred in active mode 1 (21.5%) vs. sham (11.5%); (P = .0357). Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75). Device was well-tolerated barring mild vibration sensation.

Conclusions: Vibrating capsule may increase CSBMs possibly by enhancing the physiologic effects of waking and meals, and augmenting circadian rhythm, although responder rate was not different from sham. Two vibration sessions were associated with more CSBMs.

Trial registration: ClinicalTrials.gov NCT03031301 NCT03879239.

Keywords: Vibrating capsule; circadian rhythm; constipation; motility.

Conflict of interest statement

Writing Assistance: Medical writing support for this manuscript was provided by Shiri Diskin, PhD (Bioforum, Israel) and paid for by Vibrant Ltd.

SR, AL, and EMMQ: Serve on the advisory board of Vibrant capsule technology and have received honoraria and research grant support for performing clinical studies.

© 2020 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Studies 1 and 2—scheme and consort flow diagrams
Figure 2
Figure 2
Correlations between the timing of vibration and the percentage of complete spontaneous bowel movements (CSBMs). Time 0 on the X‐axis is the time of ingestion of the capsules; black lines in both graphs denote the period of active vibration, one session in (A) study 1 and 2 sessions in (B) study 2
Figure 3
Figure 3
Frequency of complete spontaneous bowel movements (CSBMs) following the last administration of capsules. Time 0 on the X‐axis is the time of ingestion of the capsules; black horizontal line in the graph denotes the period of active vibration of the last capsule

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