The physicians may now prescribe the newly Food and Drug Administration (FDA)-approved, first-of-its-kind vibrating pill to ease the symptoms of chronic constipation, as published in ‘Health’ earlier this month. This vibrating therapy was given thumbs-up by the FDA in August 2022 in patients who do not get relief from the use of laxatives for constipation.

Chronic constipation is depicted by hard, infrequent, or incomplete bowel movements without any fundamental physiological causes or evidence of disease. Simple dietary modifications, such as the intake of more fiber, or the use of laxatives are effective therapies for easing constipation.

Drug-free relief from constipation…

But this vibrating pill is not the same, the drug-free capsule offers mechanical stimulation to the large intestine from the inside which kindles the specialized nerve cells in the gut (mechanosensory neurons) to prompt peristalsis (muscle contractions to move the food through the digestive tract).

The idea of a vibrating pill for constipation treatment may seem futuristic. However, the FDA-approved medication has been demonstrated to significantly relieve the symptoms of those who suffer from chronic constipation.

Pill’s vibrations might aid to “wake up” the body’s digestive system…

This drug-free therapy supports colonic motility by adding some mechanical assistance to the biological clock of the body.

How and when to take the vibrating pill?

These capsules are to be taken orally and prior to sleep for 5 nights in a week (7-day suggested routine: 3 days on, 1 no-pill day, 2 days on, 1 no-pill day).

These pills must be actuated prior to use with a pod that comes with them. Thereafter, it needs to be instantly gulped with a glass of water. After swallowing, the capsule is actuated which stays in the body for 2 hours; turn off for 6 hours following that, and then initiate again for the next 2 hours.

Therefore, colonic motility is improved by leveraging the body’s biological clock due to the pre-programmed timing of the mechanical stimulation. When the capsule is in activation mode, it constantly vibrates in the human body. There are small vibrations for 3 seconds on, and 3 seconds off.  The movement of the capsule in the body can be tracked via a smartphone app.

 

Safety and Effectiveness…

As per a phase 3 clinical trial comprising 312 patients with chronic idiopathic constipation, this vibrating pill was found to be safe and effective. About 40% of patients had one additional bowel movement after using this drug-free capsule than 23% of patients in the placebo group. About 23% of individuals had 2 additional bowel movements per week with a vibrating pill, in comparison with almost half of the patients (12%) on a placebo.

The capsules were better tolerated to some extent with lesser cases of pain in the abdomen, abdominal distension, and overall gastrointestinal complaints than the placebo. The patients who took these capsules experienced slightly higher rates of vomiting, nausea, and diarrhea. But, these were not recurrent. Very less patients were able to feel the vibrations and were quite at ease through the course of the therapy.

This drug-free therapy is categorized by the FDA as a Class II medical device, meaning the capsules have a moderate risk and need distinctive controls to warrant their safe use. These capsules are composed of a medical-grade material that is also utilized for pill cameras that gastroenterologists utilize under certain clinical settings.

These pills have been confirmed to be safe and can endure a bite if someone unintentionally bit them. Also, no side effects like infections or irritation have been reported, and they don’t affect electronic devices, get trapped, or be ineffective. 

This therapy is not a cure…

As per Rudolph Bedford, MD, a gastroenterologist at Providence Saint John’s Health Center, if you had chronic constipation before you started taking it, you may still be constipated after. But it’s not going to aggravate the problem or make the large intestine lazy.

This pill is contraindicated in people with:

• Past history of complicated or obstructive diverticular illness
• Past history of colonic or intestinal obstruction, or doubted intestinal obstruction
• Clinical evidence of recent and noteworthy gastroparesis
• History of noteworthy gastrointestinal illness (inflammatory bowel disease [IBD], gastrointestinal cancer, untreated/active celiac illness, and/or anal fissures or ulcers and fistulas)
• History of Zenker’s diverticulum (pharyngeal pouch), swallowing difficulty, oesophagal stricture, eosinophilic esophagitis, or cardiospasm

It is also contraindicated in females who are pregnant or lactating. Presently, this pill is costlier compared to other over-the-counter drugs but, the organization is working to make it affordable for everyone. “We intent and commit to make sure that this remarkable therapy is inexpensive with unrestricted access to patients”, mentioned Ben Feldman, chief marketing officer of this FDA-approved therapy.