Fact checked byHeather Biele

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November 18, 2022
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Vibrating capsule safe, well tolerated, easy to use in chronic idiopathic constipation

Fact checked byHeather Biele
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CHARLOTTE, N.C. — An orally ingested vibrating capsule was found to be safe, well tolerated and easy to use for the treatment of chronic idiopathic constipation, according to data presented at the ACG Annual Scientific Meeting.

Perspective from Christine Y. Lee, MD

“The study represents the safety and harms data that was collected during a phase 3 randomized, controlled trial comparing the vibrating capsule to a sham capsule in patients with chronic idiopathic constipation,” William D. Chey, MD, H. Marvin Pollard Professor of Gastroenterology and professor of nutrition sciences and chief of gastroenterology and hepatology at Michigan Medicine, told Healio.

“The [vibrating capsule] is both safe and effective in patients with chronic idiopathic constipation. It offers a novel, nonmedication means by which to treat patients with CIC.” William D. Chey, MD

The secondary outcome analysis examined data from a prospective, randomized, multicenter, double-blind, placebo-controlled study in patients with chronic idiopathic constipation (CIC) who received the vibrating capsule Vibrant (Vibrant Gastro) in one of two stimulation modes or placebo capsule once daily, 5 days a week for 8 weeks. Participants were taught how to activate the vibrating capsule system by using a mobile app, and a questionnaire evaluated the system’s ease of use.

Whereas the previous study found the orally ingested nonpharmacologic vibrating capsule significantly improved key constipation symptoms in patients with CIC, the current study evaluated the vibrating capsule’s safety, tolerability and ease of use.

“The main finding was that adverse events were very evenly matched between the vibrating capsule and the sham capsule except for an increase in sensing a feeling of vibration in the [vibrating capsule] group,” Chey said.

According to the poster, there were 79 adverse events reported that were possibly related to the study treatment, including 44 in the first vibrating capsule group, nine in the second vibrating capsule group and 26 in the placebo group. There were no serious adverse events or treatment-related diarrhea reported in the vibrating capsule groups, and two serious adverse events reported in the placebo group were determined to not be related to the study treatment. None of the 11% of patients in the vibrating capsule groups that reported a vibrating sensation withdrew from treatment.

Regarding ease of use, most patients found it easy to connect the base unit to Wi-Fi (94%), set up the base unit (97%) and activate the capsules (82%), according to the poster. After several months of treatment, 85% reported the system would be easy to use when commercialized.

“The [vibrating capsule] is both safe and effective in patients with chronic idiopathic constipation,” Chey told Healio. “It offers a novel, nonmedication means by which to treat patients with CIC.”

Although Chey told Healio he was unsure whether further safety studies were warranted, he did suggest it would be interesting to study the vibrating capsule’s efficacy in special populations prone to constipation, including those with neuromuscular disease, spinal cord injuries or scleroderma.