February 28, 2023 – Several digital tools – available as smartphone apps or web-based platforms – could help patients with irritable bowel syndrome (IBS), in keeping with a new study published in American Journal of Gastroenterology.
These tools, often called “Digital Therapeutics” (DTx), usually are not yet widely used but are expected to achieve popularity over the following decade.
“Digital therapeutics make a lot of sense and solve many access problems,” says co-author William Chey, MD, chief of gastroenterology at Michigan Medicine.
Irritable bowel syndrome, which causes recurrent abdominal pain and irregular bowel movements, often affects quality of life. The simplest treatments are a mixture of medicines, dietary changes and behavioral interventions tailored to the person patient, say Chey and colleagues.
In this context, cognitive behavioural therapy (CBT) and gut-focused hypnotherapy (GDH) have been shown to be effective in changing behaviours and thought patterns. However, many patients with IBS shouldn’t have access to gut-specific CBT or GDH services.
DTx could change this, but doctors are rigorously evaluating the tools to make sure that they’re effective for patients.
“Their promises could easily exceed their content,” says Chey. “We need to hold the companies that make digital therapeutics accountable to properly demonstrate the benefits of the products so that patients and doctors don't chase the latest shiny object.”
Chey and colleagues wrote concerning the current generation of DTx that supply behavioral interventions in a digital format. They covered several specific services, including the studies conducted, pricing, and other vital information.
Mahana Irritable Bowel Syndromemanufactured by Mahana Therapeutics, is an FDA-approved, prescription cognitive behavioral therapy program for adults with irritable bowel syndrome with a maximum out-of-pocket cost of $90. The product includes 10 sessions over 12 weeks.
Mahana IBS is obtainable as a mobile app or web-based platform and has been validated in a randomized comparative effectiveness trial on a bunch of 558 patients divided into three groups receiving web-based cognitive behavioral therapy, telephone-based cognitive behavioral therapy, or usual care. Before treatment, the typical IBS symptom severity rating (IBS-SSS) for all the group was 265.
After 12 weeks, the control group had a mean reduction of 52.9 points, the phone group had a discount of 133.3 points, and the web-based group had a discount of 101.2 points. Compared to the control group, the typical Work and Social Adjustment Scale decreased by an additional 3.5 points in the phone group and by 3 points within the web-based group.
Zemedymade by Bold Health, is a mobile app that gives virtual cognitive behavioral therapy to patients with irritable bowel syndrome through a chatbot. It costs $19.49 per 30 days or $154.99 per 12 months. The app will not be FDA approved and doesn’t require a prescription.
The program includes six weekly psychoeducational modules with details about IBS and cognitive behavioral therapy, followed by cognitive behavioral therapy training modules. Users can chat with an automatic system that gives computer-generated responses for support, and a “flare module” supports patients when symptoms worsen.
Zemedy was evaluated in a randomized, controlled crossover trial with 62 people in an energetic treatment group and 59 people in a waitlist control group. The app improved several parameters, including quality of life related to irritable bowel syndrome, gastrointestinal symptoms, visceral tenderness, and depression. A bigger clinical trial to validate the outcomes is currently underway.
Controllermanufactured by metaMe Health, is an FDA-approved, prescription GDH program for the treatment of abdominal pain related to IBS, with a maximum out-of-pocket cost of $75. The protocols were developed by GI behavioral health researchers on the University of North Carolina at Chapel Hill. The program is obtainable on a web-based platform or mobile app and includes seven 30-minute sessions over 12 weeks.
Regulora was studied in a randomized comparative effectiveness trial of 362 patients using this system or one other muscle rest app. Although there was no significant difference between the apps based on the study's primary goal—a 30% or greater reduction in abdominal pain—some relief did occur. In the GDH group, 31% of individuals reported a 30% or greater reduction in abdominal pain and 45% experienced a 30% or greater improvement within the proportion of stools with normal consistency. The full results of the study have yet to be formally peer-reviewed and published in a scientific journal.
nervemade by Mindset Health, is a GDH program delivered via mobile app or web browser and costs $79.99 for 3 months. It will not be FDA approved and doesn’t require a prescription. The protocols were developed in collaboration with researchers at Monash University in Australia. The program includes every day sessions over 6 weeks that include psychoeducational readings and respiratory techniques.
Nerva was studied in an observational study of 190 patients who accomplished all 42 sessions, often inside 2 months. About 64% responded to this system and reported relief of symptoms. Study participants also reported improvement of their abdominal pain, bloating, dissatisfaction with stool consistency, flatulence, and nausea. The results were reported as an abstract, and full results from a proper randomized controlled trial usually are not yet available.
Although DTx tools are still within the early stages of development and validation, they’ve the potential to assist patients, especially those that shouldn’t have access to a physician who can address their needs.
“Digital transplants are the only truly scalable interventions that are accessible and affordable,” says Dr. Melissa Hunt, associate director of clinical training in psychology on the University of Pennsylvania.
Hunt, who was not involved on this report, has studied DTx options for patients with IBS, including Zemedy's randomized controlled trial. Her research suggests that about 50% of IBS patients may benefit from self-help DTx.
“Most IBS patients believe that dietary changes (such as highly restrictive diets) are the only solution. In fact, cognitive behavioral therapy and GDH are much more effective at restoring quality of life,” she says. “If you address the underlying miscommunication between the gut and the brain, you can usually eat pretty much anything you want. The biggest obstacles to finding good behavioral therapy are cost and the lack of available, competent therapists. DTx can help bridge that gap.”