Bowel Cleansers

Psychological therapies, such as CBT, are recommended as a treatment for IBS; however, 60% of gastroenterologists in the United States do not have access to a psychologist who specializes in treatment approaches that focus on the link between gastrointestinal disorders and the brain. Use of digitally delivered gut-directed CBT may provide a potential solution to this clinical practice problem, if found similarly effective in terms of results.

Researchers conducted a real-world user data study from August 2021 and April 2023 to determine whether the digital mobile app, Mahana, could provide effective CBT to successfully manage IBS symptoms.

The researchers analyzed the data obtained from 699 individuals with IBS (median age, 41 years) who used the Mahana app. Approximately 195 of the 699 individuals completed 5 or more sessions/week, and 101 of these 195 individuals went on to finish the full 10 sessions/week. The remaining 504 people were nonadherent to the digital program.

The primary outcome measurement involved a calculation of the change in IBS symptom severity, which was determined using the IBS Symptom Severity Scale (IBS-SSS). Any decrease of 50 points or more was considered clinically significant. IBS-SSS was measured at baseline and repeated at weeks 5 and 10. App users also completed the Perceived Stress Scale (PSS) at baseline, week 5, and week 10.

The median IBS-SSS score of 279 at baseline indicated overall moderate severity of IBS symptoms among study participants. Irrespective of IBS subtype and other confounding factors, higher IBS-SSS scores at baseline were associated with greater response to the digital CBT program (odds ratio [OR], 1.07; 95% CI, 1.03-1.10).

At baseline, 43% of individuals with IBS self-reported anxiety and depression. Anxiety and depression (OR, 1.43; 95% CI, 1.01-2.03) as well as older age (OR, 1.12; 95% CI, 1.02-1.24) were both independently associated with adherence to the digitally delivered CBT program.

Overall IBS-SSS scores decreased by 81.5 points (P <.001) between baseline and week 5 and by 112.5 points (P <.001) between baseline and week 10. Severity of abdominal distention decreased by 9.6 points by week 5 (P <.001) and 13.4 points by week 10 (P <.001). Abdominal pain severity decreased by 11.3 points by week 5 (P <.001) and maintained a 10-point decrease at week 10 (P <.001). At both week 5 and week 10, individuals with IBS reported one less day of pain due to IBS symptoms compared with baseline (both P <.001).

“Digital health applications have the potential to democratize specialty services such as CBT and allow integrated care to scale for patients with IBS,” study authors concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

HealthDay News — A new treatment for chronic constipation may bring relief without having to use drugs. It is a vibrating pill called Vibrant that stimulates the colon as it passes through the body. Although the pill was approved by the US Food and Drug Administration last August, doctors can start prescribing Vibrant this week.

“We are working right now with insurance companies to obtain coverage in commercial plans,” Cathy Collis, chief commercial officer for Vibrant Gastro Inc., told CNN. “But until we get that coverage, our goal and commitment is to make sure that this is accessible and affordable to patients.”

The company had to show the pills contained no toxic materials, could withstand an accidental bite, and did not carry risk for infections, becoming stuck, irritating tissues, or interfering with other medical devices, CNN reported.

A person prescribed the pill would take it at bedtime daily. The pill would then travel through the stomach and small intestine before reaching the large intestine about 14 hours later and stimulating nerve cells. In doing this, it causes muscle contractions that move food out. The pill then leaves the body with the feces. The pills are made of medical-grade material similar to what gastroenterologists use for pill cameras, CNN reported.

Vibrant is intended for the 10 to 20% of people who live with chronic constipation, having fewer than 3 bowel movements each week for unknown reasons and typically experiencing hard, painful stools.

To study the pill, 200 people with chronic constipation took Vibrant for 8 weeks, while another 149 took a placebo. In the group that took the actual Vibrant pills, 40% had at least one additional bowel movement each week, softer stools, and less bloating. About 23% had 2 or more additional bowel movements weekly. The placebo group also reported more bowel movements, with about 23% experiencing at least one more and 12% at least 2 or more additional bowel movements. Side effects appeared to be minimal and reported by more of those in the placebo group than in the vibrating pill group. The pill does not cause diarrhea, which is not true of most prescription laxatives.

The pills are authorized to treat adults who have not been helped by other constipation medication or cannot tolerate it. They are not meant for people who have trouble swallowing, have paralysis of the stomach, or have a history of bowel obstructions, CNN reported.

While Vibrant is not covered by insurance, the company is capping out-of-pocket costs at $69 by offering a coupon.

CNN Article

Family Dollar has initiated a recall of several over-the-counter (OTC) products and medical devices that were stored outside of labeled temperature requirements. These products were shipped to stores between June 1, 2023 and September 21, 2023 and were sold through October 4, 2023.

The recall includes cough and cold products, pain relievers, and medications to relieve constipation and diarrhea, among others. The full list of affected products can be found here. The items were sold in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.

At this time, there have been no reports of adverse events associated with the recalled products. According to the Company, the recall is being conducted out of an abundance of caution. 

Individuals with questions related to this recall can contact Family Dollar customer service at 844-636-7687. Adverse events and quality issues should be reported to the Food and Drug Administration’s MedWatch program.