vibrating pill
(CNN) --
People struggling with chronic constipation have a new drug-free option to help get things back on track.
It is the first capsule of its kind that is the size of a regular pill, but instead of releasing the medication after swallowing, it vibrates to stimulate the colon.
The capsules, called Vibrant, were approved by the US Food and Drug Administration (FDA) in August, but are only available for prescription by doctors this week.
Doctors consider a person to be constipated when they have fewer than three bowel movements in a week.
Between 10% and 20% of Americans live with persistent constipation that has no discernible cause, according to a recent survey.
They tend to have hard, dry stools that can cause pain and swelling.
Vibrant Pill.
The idea behind the treatment is that a single vibrating tablet is taken every day at bedtime.
The pill then travels the same route as food, through the stomach and small intestine, finally reaching the large intestine about 14 hours later.
So, he gets to work.
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The pills stimulate specialized nerve cells in the intestine called mechanosensory cells.
These help trigger peristalsis, the rippling muscle contractions that help squeeze food through the intestine.
“There are little vibrations for three seconds on, three seconds off,” said Cathy Collis, commercial director of Vibrant Gastro, which is based in Israel but has offices in the US.
Before use, each pill is activated in a small capsule that ignites it.
After you swallow it, it is active for about two hours, goes silent for about six hours, and then becomes active again for another two hours.
Finally, after it has done its job, the person's body expels it and it is disposed of.
The capsules are not a cure.
They are designed to be taken daily, in the same way that other treatments are taken.
According to the company, the capsules are made from a medical-grade material that is also used for the pill chambers gastroenterologists have used for the past 15 years.
To get FDA approval, Vibrant had to prove that there were no toxic materials in the pills and that they could withstand, for example, the force of a bite if someone accidentally bit into them.
The company also had to prove that the capsules did not pose certain risks such as causing infection, irritating tissue, interfering with other electronic devices, getting stuck, or not working at all.
Like contact lenses and syringes, they are considered Class 2 medical devices by the FDA, meaning they carry an intermediate risk of harm to the wearer.
Once the pills reach the wastewater, they are sieved and taken to a landfill as non-compostable material.
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fewer side effects
In a small clinical trial, 349 people with chronic constipation were divided into two groups: 200 who took the vibrating capsules every day for eight weeks and 149 swallowed a similar non-vibrating pill.
People who took the Vibrant pills reported that they were able to go to the bathroom more often and empty their bowels more completely compared to those who did not receive the active capsules.
About 40% of the group that took the Vibrant pills reported having at least one extra bowel movement a week, compared with about 23% of the placebo group.
They also reported softer stools and less bloating.
The percentage of patients who reported two or more additional bowel movements each week was 23% in the Vibrant pill group and about 12% in the placebo group.
Most people said they didn't feel the pills vibrate, although some did.
“A minority might feel it,” said Dr. Eamonn Quigley, chief of Gastroenterology at Houston Methodist Hospital.
Quigley helped test the capsules, but he has no financial interest in the company.
“None of them felt that he was uncomfortable.
And no one stopped taking it because of that."
He says he can't directly compare the effectiveness of Vibrant capsules with other types of remedies because they weren't tested head-to-head in the study.
But he says the degree of relief with the Vibrant capsules appears to be similar to the effects of other prescription constipation medications in his clinical trials.
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People who took the Vibrant capsules did not report any serious adverse events, such as intestinal obstructions.
More gastrointestinal side effects were reported in the placebo group than in the Vibrant group: 9.4% vs. 6.5%, respectively.
Two people who took the Vibrant capsules reported diarrhea, but it is not common.
“One of the important side effects that you don't have is diarrhea, as many of the prescription drugs can cause it,” Quigley said.
This is because most prescription constipation medications work in the small intestine, where it releases more fluid and secretions to digest food.
Dr. Satish Rao, distinguished chair of Gastroenterology at Augusta University School of Medicine, says there's no question that prescription constipation medications work, but they target a different area than the vibrating pill .
“If you just think about it from a mechanistic perspective, they are working a little bit away from where the problem is, even though they are fixing it,” said Rao, who also helped test the capsules.
Instead, the Vibrant capsules work on the colon, which is the source of the problem, he says.
Stimulate the intestine without drugs
The vibrating capsules are programmed to work in a specific way and are FDA-cleared only to treat chronic constipation in adults who have not received help or cannot tolerate the side effects of prescription or over-the-counter medications.
People who have trouble swallowing or who have stomach paralysis, called gastroparesis, shouldn't take Vibrant pills, Collis said.
They are also not a good idea for people who have a history of intestinal obstructions.
But Rao believes that with further study and tweaking, experts could reprogram the pills to work earlier, perhaps in the stomach, which could help people with gastroparesis.
He thinks it is also possible in the future that capsule programming will be customized to better address the needs of individual patients.
Vibrant is currently not covered by health insurance, Collis says.
For those who have health insurance, the company offers a coupon to limit out-of-pocket costs to $69 per month.
They are not a cure;
people need to take them consistently to see relief.
“We are working right now with insurance companies to get coverage on commercial plans,” he said.
"But until we get that coverage, our goal and commitment is to make sure it's accessible and affordable for patients."
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