A new chronic constipation treatment became available for doctors to prescribe last week. In contrast to other approved remedies, the new treatment—a capsule called Vibrant—does not contain or release any medication.

Instead, and as its name implies, it works by vibrating through a person’s gastrointestinal system. The vibrations assist in muscle and nerve contractions which stimulate the colon and help push digested food down and out of a person’s system.

The capsule is not a cure for chronic constipation, but may increase weekly bowel movements along with other remedies. To what extent Vibrant can improve regularity, and for how long improvements last after taking a monthly prescription, is currently unknown. Physicians may need to evaluate how to maximize effectiveness over time. 

 

A novel treatment?

 

While this may seem like a novel approach for treating constipation, Rudolph Bedford, MD, gastroenterologist at Providence Saint John’s Health Center in Santa Monica, Ca, reminds physicians that capsules have a long history of use in the GI world. 

“A vibrating pill to try to reset the peristaltic waves is not something unusual or out of the ordinary,” Bedford says. “It makes sense that you can reset the peristaltic mechanisms to get things moving as another way of dealing with constipation, quite frankly, without side effects from medication.”

According to Vibrant Gastro, the manufacturer, the capsule is made out of the same medical-grade material that is used for gastroenterologist pill cameras that survey the GI tract.

 

Access and affordability

 

Regardless of effectiveness, access and affordability may depend on insurance coverage—or lack thereof.

“We don’t know how much it costs yet, or whether or not it's covered by insurance,” says Rudolph Bedford, MD, gastroenterologist at Providence Saint John’s Health Center in Santa Monica, Ca.

The insurance coverage will be the barrier [and] if this is something to be taken every day, it's going to be a very expensive prescription.

It’s not covered by insurance, currently, although Vibrant Gastro plans to offer insured patients a discount coupon to help with costs, and are working with providers to obtain coverage, Cathy Collis, chief commercial officer for Vibrant Gastro said in a press release. The coupon will cap monthly out-of-pocket costs at $69.

 

A safer alternative to medicinal treatments?

 

A clinical trial (which served as the basis for the pill’s Food and Drug Administration (FDA) approval this August) found Vibrant to be successful in increasing numbers of weekly bowel movements with few side effects.

The study evaluated 349 people in a small, blind, clinical trial. Of the total, 200 participants took Vibrant once a day for eight weeks, while 149 people took a lookalike pill following the same regime. All were diagnosed with chronic constipation. In the results, about 40% of people taking Vibrant had an increase in weekly bowel movements (with at least one extra movement), compared to about 23% of the placebo group. 

Notably, researchers found the pill less likely to cause diarrhea than constipation relief medicines. Out of the 200 participants who took the pill, only two reported diarrhea, according to the press release.

Medicinal treatments for constipation are more likely to cause diarrhea because they release fluid in the small intestine and intervene with the digestive process, Eamonn Quigley, chief of gastroenterology at Houston Methodist Hospital, said in a press release.

“It’s essentially stimulating the nerve endings in the colonic wall,” says Bedford. “There should not be any real side effects from that except for maybe feeling the capsule vibrating from time to time.”

Most study participants could not feel the vibrations, but some did, according to the press release.

 

Not a laxative?

 

Vibrant doesn’t work like a typical laxative, which stimulates bowel movement through medicine. and might not be considered a laxative, either. But this may depend on individual labeling.

“There are some laxatives that stimulate the bowel wall to move and squeeze, but this is a different technology,” Bedford says. “It is something to wake up the colonic nerves and muscles to get things moving through. In my mind I have a hard time thinking of this as a traditional laxative.”

 

Variables with vibration

 

Vibrant’s new approval (and so-far small clinical trial) serve as a launching pad for more clinical discoveries on how to maximize the capsule’s safety and effectiveness going forward. It leaves room for physicians to assess the pills effectiveness on a patient-by-patient basis, too.

“I see this is something that somebody would take for a period of time and hopefully, getting the so-called biological clock back in order,” Bedford says. “We'll see where we go after that.”