A vibrating capsule that stimulates bowel movements, Vibrant, shows promise in alleviating chronic constipation. Here's all that you need to know before using it.
About 35 million Americans experience chronic idiopathic constipation (CIC), a long-lasting condition characterized by difficult, infrequent, or incomplete bowel movements.
The treatment for CIC generally involves over-the-counter laxatives and more powerful prescription medications, along with lifestyle changes like increased water and fiber intake.
The newer approaches to treat chronic constipation include Vibrant, a vibrating capsule that stimulates bowel motility, which received the Food and Drug Administration's (FDA) marketing authorization in 2022.
A recent study published in Neurogastroenterology & Motility provides a more detailed look into Vibrant's safety profile.
The study included data from six trials involving 800 individuals with CIC who took either the Vibrant capsule or a similarly looking placebo pill.
The most common adverse gastrointestinal events observed in the trials were bloating and abdominal pain, each affecting 2.9% of the participants, nausea, observed in 2.3% of individuals, and diarrhea which affected 1.9%. However, the researchers categorized most of them as unrelated to treatment.
The overwhelming majority of patients (83%) found the system convenient, with an overall treatment satisfaction rate of 71%.
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The Vibrant system is a non-pharmacological approach to treating chronic idiopathic constipation.
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Swallowed at night, the capsule travels to the colon, where it starts vibrating to stimulate bowel movements.
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In a trial, 71% of the participants found the system satisfactory, and no major adverse effects were observed.
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Experts say more studies are needed to compare the Vibrant capsule to common prescription medications.
How does the Vibrant capsule work?
The capsule, about the size of a multivitamin, must be activated before swallowing using an activation pod that comes with the Vibrant kit.
Once activated, the capsule should be swallowed with a glass of water at night. It takes between 10 and 16 hours before the medication reaches the colon, where it starts vibrating to increase motility.
Presenting the findings in the news briefing, Bryan Curtin, MD, director of Neurogastroenterology and Motility at the Mercy Medical Center, said that the vibrant capsule vibrates with the intensity of a cell phone. However, only 11.7% of participants reported a sensation of vibration.
Eventually, the capsule is removed from the colon with bowel movements. It is one-time use only and can be safely flushed in the toilet without causing plumbing issues, according to Curtin.
The recommended dose of Vibrant is five capsules per week – such dosage was tested in clinical trials.
The Vibrant toolkit includes an activation pod, USB cable, AC/DC USB adapter, and two blister packs with 10 Vibrant capsules.
How effective is the Vibrant pill?
A pivotal study testing the medication's effectiveness included 300 adults with CIC who were given either Vibrant or a placebo consisting of a biodegradable soft gel capsule for eight weeks, five times per week.
Among those using Vibrant, 40.51% had at least one additional complete spontaneous bowel movement per week, compared to 22.92% in the placebo group.
About one in four (23.42%) participants in the Vibrant group had at least two additional complete bowel movements per week, compared to 11.81% in the placebo group.
Who shouldn't use Vibrant?
While the capsule is considered generally safe, it cannot be prescribed for individuals with the following conditions:
- History of complicated/obstructive diverticular disease
- History of intestinal or colonic obstruction or suspected intestinal obstruction
- Current significant gastroparesis (delayed gastric emptying)
- History of significant gastrointestinal disorders, such as inflammatory bowel disease, gastrointestinal malignancy, anal fissures, and fistulas
- History of Zenker's diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis
The pill shouldn't be used by individuals who need to undergo MRIs on a regular basis.
Curtis says the medications should be discontinued two weeks before an MRI scan, and their removal must be confirmed by an X-ray scan.
Individuals who swallowed the capsule shouldn't be close to any powerful electromagnetic fields, according to the drug label.
However, users of the Vibrant pill didn't have issues with TSA X-ray machines at the airport, Curtis said in a press briefing.
Vibrant may not be a great fit for individuals who have difficulty swallowing large pills. This is a relatively common phenomenon, as up to 40% of Americans report trouble with swallowing pills, especially older adults.
The Vibrant capsule isn't specifically tailored to treat irritable bowel syndrome (IBS), a condition affecting 5-10% of the population that commonly causes constipation.
Curtis says some patients have achieved improvements in abdominal pain and bloating while on the capsule; however, other prescription medications may work better for IBS treatment.
How much does the Vibrant pill cost?
Vibrant is available prescription-only. Therefore, you will need your doctor's approval to use the medication.
A monthly supply of Vibrant costs $89 without insurance. The out-of-pocket price for those with insurance may depend on the plan.
What do experts say?
Pratima Dibba, MD, a board-certified gastroenterologist with Medical Offices of Manhattan, says there is not enough data to conclude whether or not the Vibrant capsule is superior to common prescription medications for constipation.
Current data suggests that the vibrating capsule is superior to patients treated with placebo, but there are no head-to-head trials comparing the capsule specifically to common prescription medications for constipation.
Pratima Dibba, MD
The Vibrant is currently not included in the American Gastroenterological Association's recommendations for pharmacological management of CIC.
Philip Schoenfeld, MD, MSEd, MSc, editor-in-chief of the American College of Gastroenterology journal, called the initial trial testing the Vibrant capsule 'very well-designed' and said some patients may benefit from combination therapy that includes Vibrant and other CIC medications.
Individuals who are already taking the vibrating pill can improve its efficacy with regular physical activity and adequate fiber and water intake, Dibba says.
Adults need 14 g of fiber per 1,900 kcal consumed. In a standard 2,000 kcal diet, that would be 28 g of fiber per day. Some of the best sources of fiber are legumes, vegetables, fruits, whole grains, and nuts.
Takeaway
While the Vibrant capsule may be a good choice for those who have tried many other medications for chronic idiopathic constipation and didn't achieve relief, more long-term studies are needed to understand its effectiveness. However, the vibrating pill is not safe to use in individuals with conditions like IBD and anal fissures.
7 resources
- FDA. De Novo classification request for Vibrant system.
- The American Journal of Managed Care. Update on the management of chronic idiopathic constipation.
- Neurogastroenterology & Motility. The vibrating capsule: Safety and tolerability in patients with chronic idiopathic constipation.
- Vibrant. Instructions for use Vibrant system.
- Harvard Medical School. When pills pose problems.
- The American Gastroenterological Association. Pharmacological management of chronic idiopathic constipation.
- The American College of Gastroenterology. Vibrating capsules for chronic constipation: The new non-pharmacologic approach.
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