Last week there was a bit of potentially exciting news for the millions of Americans with chronic functional constipation who don’t tolerate, or perhaps would simply like to avoid, medication side effects. A vibrating pill, made from the same material as the pill cameras (capsule endoscopy) used to capture images of areas of the intestines that are difficult to reach using standard endoscopy, is now officially available by prescription after having been cleared by the FDA last August. But does it really work? And is it even safe?
Chronic constipation is an extremely common problem that affects people of all ages, and is particularly common in young children. I covered this issue in kids a few years ago. In the adult population for which this new drug-free medical device is cleared, chronic constipation is a daily concern for millions (10-20%) of Americans, most of which have functional, also known as idiopathic, constipation. This is diagnosed when constipation occurs but no anatomic or physiologic cause can be identified. In functional constipation, there are many potential contributing factors such as diet, poor hydration, stress, and a sedentary lifestyle.
Constipation is typically treated with lifestyle modifications and laxatives, of which there are many different types. Some work by simply softening or lubricating the stool for easier passage through the intestines. Others act as a stimulant that causes the intestines to contract and push stool on its way. These can cause nausea and uncomfortable cramping, but they can all potentially result in diarrhea. There are prescription treatments, but these have typically been prescribed for irritable bowel syndrome rather than functional constipation.
The new vibrating pills are claimed to work through a similar mechanism as stimulant laxatives. Instead of triggering contractions (peristalsis) through chemical irritation, however, they work by stimulating specialized sensory cells in the lining of the intestine mechanically. So there is at least the plausible possibility that these pills could also cause cramping, nausea, and diarrhea.
But do they really work?
New reports, along with a press release from the company that developed the device, are touting a study that involved 349 people, 200 of which took the vibrating pill 5 days a week for 8 weeks. The remaining 149 study subjects took a placebo pill that did not vibrate. The study wasn’t published, instead being presented at a conference, but I was eventually able to track down the study design, which was randomized and blinded, although it is unclear how well blinding held considering that some subjects reported being able to feel the vibrations.
The study found that 39% of patients taking the vibrating pill had one or more additional “complete spontaneous bowel movement” per week compared to their individual baseline, which was 17% more than in the placebo group. 23% of subjects in the treatment group reported two or more additional satisfying poops per week, compared to half that in the placebo group. These results, along with reported improvements in stool consistency, amount of straining, and overall quality of life were statistically significant and there were no severe adverse events or worrisome diarrhea or nausea in the treatment group.
So it appears that the pill could be a safe and helpful intervention for many, but won’t work for a decent percentage of people. And unfortunately, because I don’t have access to a published and peer reviewed paper, I can’t speak to how well the study was controlled and blinded. If blinding broke down, there could have been some inspired changes in lifestyle that resulted in improvement in constipation rather than the treatment.
Also, the study did not compare the vibrating pill to other treatment options, so we don’t know how they stack up. I doubt that these pills work better than other options, however. But I can believe that they result in fewer side effects. I don’t think patient non-adherence to constipation treatment because of side effects is a common concern though.
One concern with the vibrating pills, however, is expense. They are not currently covered by insurance, and the company making them claims that they will offer a coupon to cap the monthly out-of-pocket cost at $69 per month for patients who have health insurance. That isn’t terrible as far as pharmaceutical interventions go, but it works out to several dollars per extra poop. You can easily find a month supply of name brand Miralax, an effective and gentle stool softener in common use for chronic constipation in pediatric and adult patients, for less than a third of that amount.
Conclusion: Vibrating pills are likely not a game changer for chronic constipation
Meh. I’m not saying that these devices are useless. They will likely help some people who are dealing with chronic constipation and are sensitive to the nausea and cramping sometimes caused by standard drug treatments. But it doesn’t look like this will be some kind of revolution in management.
*The very first SBM reference to a CAKE song: Clever and Funny or Not Worth the Effort?