Last August, the U.S. Food and Drug Administration approved a new, if somewhat unorthodox, treatment for chronic idiopathic constipation: a vibrating pill called Vibrant that just recently became available by prescription. It offers another treatment option for people unable to find relief with laxative therapy, but it’s so new that, as the company’s website acknowledges, physicians may not even be aware of its existence yet.
Many people experience periodic constipation, which can be caused by changes in diet, inadequate hydration, not getting enough fiber or exercise, or a range of medications. But chronic idiopathic constipation—defined as three or fewer bowel movements per week, usually with hard stools that may be difficult to pass—stems from no apparent cause.
The two-part Vibrant system consists of single-use capsules made of medical-grade material and a pod that activates them. The activated pill is swallowed with a glass of water, usually around bedtime. Once it reaches the colon (large intestine), the pill vibrates on and off during two two-hour sessions, several hours apart. These vibrations are intended to stimulate peristalsis—the waves of involuntary constriction and relaxation that push stomach contents through the digestive system. Having done its job, the pill is excreted with a bowel movement.
In a phase 3 randomized controlled trial that compared Vibrant to a placebo in 349 adults with chronic constipation, those in the vibrating pill group experienced a significant increase in the number of complete spontaneous bowel movements by week three, peaking in week six of the eight-week trial and continuing through the trial’s duration. Overall, nearly 40 percent increased the number of bowel movements by at least one a week over baseline; more than 20 percent increased their bowel movements by two or more per week.
The treatment group also reported greater improvements in stool consistency, straining, and quality of life compared to the placebo group. While adverse gastrointestinal side effects (nausea and vomiting) were reported by 6.5 percent of those assigned Vibrant (and 9.4 percent of those in the placebo group), only two people experienced diarrhea, and none reported serious adverse events.
But there are caveats
The FDA’s approval would suggest Vibrant is safe enough to be prescribed to people who haven’t been able to relieve their constipation through more traditional means, and it may appeal to those who don’t want to use drugs to manage their constipation, or who are bothered by the diarrhea that can be a side effect of laxative treatment.
But the phase 3 trial upon which the FDA based its approval—though it tested the safety and efficacy of the pill in a larger number of people than earlier studies—was still relatively short; there are no data on long-term use. There are also a number of potential side effects and a fairly long list of contraindications, including for people who have complicated or obstructive diverticular disease, a history of intestinal obstructions, gastroparesis (delayed gastric emptying), inflammatory bowel disease, colon cancer, Zenker’s diverticulum or other large diverticulum, and pregnancy.
“I do think Vibrant holds promise,” says Steven Jacobsohn, M.D., a clinical professor emeritus of gastroenterology at UC San Francisco and a member of our editorial board, “but I would only consider using this at present in patients who are really miserable from constipation or who have failed or had complications from drug interventions. Longer-term data and corroborating studies are needed before I’d recommend it for wider use.” Dr. Jacobsohn further advises that since Vibrant has to be prescribed by a doctor, “a discussion with a gastroenterologist would be useful in deciding if it is appropriate to use.”
Bear in mind also that Vibrant is not yet widely available, and the cost is pretty steep—$69 to $89 a month out of pocket.
