Vibrating capsule safe, well tolerated, easy to use in chronic idiopathic constipation
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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.
“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](/~/media/slack-news/gastroenterology/misc/infographics/2022/1122/hgi1022chey_acg_graphic_01.jpg?w=800)
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.
Perspective
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Christine Y. Lee, MD
Chronic idiopathic constipation (CIC) afflicts millions of people in the United States. Health care professionals’ mainstay recommendations generally involve use of laxatives in various forms (prescription and over-the-counter medications, herbals, etc.) to help mitigate CIC. Unfortunately, these options have a plethora of side effects that include nausea, gas, bloating, diarrhea, fecal urgency, abdominal pains and allergic reactions among many others. Frequently patients report being unsatisfied with their treatment options.
The orally ingested, nonpharmacologic vibrating capsule utilizes a biomechanical approach. The disposable capsule is programmed to vibrate several hours after being swallowed (to allow the pill to arrive to the lower GI tract) at a rate that mimics the pace of the intestine’s natural motions. The goal of the vibrating capsule is to stimulate further contractions by the intestines to move stool along. It is an intraluminal therapy that appears to be safe and well tolerated in patients with CIC.
It remains to be determined whether it is equally safe and well tolerated in patients with irritable bowel syndrome, neuromuscular disease, autoimmune disease or gastroparesis or in patients with a history of partial bowel resection, hernia or adhesions.
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Chey WD, et al. Safety and tolerability of vibrating capsule in patients with chronic idiopathic constipation (CIC). Presented at: ACG Annual Scientific Meeting; Oct. 12-16, 2022; Charlotte, N.C. (hybrid meeting).
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