Treating Chronic Gastrointestinal Symptoms with Digital Therapeutics
Chronic disorders of the intestinal tract, such as inflammatory bowel diseases (IBD) and irritable bowel syndrome (IBS) are common, affect both children and adults, greatly impact patients’ quality of life and contribute significantly to the economic healthcare burden. About 1.6 million Americans suffer from IBD and the prevalence of these disorders has increased by 200,000 since 2011. Ten to fifteen percent of the US population meet the symptom criteria for IBS. Despite their different disease mechanisms, scientific and clinical evidence point towards alterations in the bidirectional interactions between the brain and the gut, and the important role of the brain in influencing symptom severity.1, 2 The great majority of patients are treated symptomatically with medications which do not always provide satisfactory symptom relief or are limited by side effects.
It has been more than 7 years since our group published the results from a small clinical trial on the effectiveness of a psychoeducational treatment program for IBS patients which showed significant clinical benefits.3 A plan to move this treatment program to an online format did not materialize as not enough patients regularly used the internet at the time. A recent large clinical trial from Dr. Jeffrey Lackner’s group at the University of Buffalo show a persistent clinical benefit of a patient-centered cognitive behavior therapy (CBT) approach in IBS patients.4 And our two groups showed in a recent study that CBT not only improves symptoms in IBS, but that this clinical benefit is associated by changes in the brain and the gut microbiome, a finding that qualifies CBT as a biological therapy.5
Even though CBT has been shown to be one of the most effective treatments for IBS patients, the widespread application of CBT in gastrointestinal (GI) disorders is greatly limited by two major factors. Even though it is not a new treatment, there are still a very limited number of CBT therapists with expertise in GI disorders, in particular in non-metropolitan areas. The other issue is that when you do find someone, the duration and cost of traditional face to face CBT has prevented this therapy from being adopted widely.
Welcome to 2020 and the age of digital therapeutics. Digital therapeutics or prescription digital therapeutics (PDTs) are clinically validated software treatments prescribed by a doctor and have the potential to greatly improve life outcomes for millions of people. They offer substantial benefits for patients, providers and payers.
Mahana Therapeutics is one of the leading players in this new world of PDTs. They have a strong commitment to developing evidence-based CBT PDTs for patients with IBS and IBD. With the acceleration of telemedicine approaches, in part pushed by COVID-19, I believe digital therapeutics are here to stay and will play a growing role as an adjuvant treatment modality in chronic GI disorders. Mahana’s treatment program called Parallel is based on a successful clinical trial performed by King’s College, London.6
*DISCLAIMER: Emeran Mayer is on the scientific advisory board of Mahana Therapeutics.
- Mayer EA. Et al. Towards a systems view of IBS. Nat Rev Gastroenterol Hepatol 2015; 12:592-605
- Bonaz BL and Bernstein CN. Brain gut interactions in Inflammatory Bowel Diseases. Gastroenterology 2012;144:36-49.
- Labus JS, et al. Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. Aliment Pharmacol Ther 2013;37:304–315.
- Lackner JM et al. Improvement in Gastrointestinal symptoms after cognitive behavioral therapy for refractory irritable bowel syndrome. Gastroenterology 2018; 155:47-57.
- Jacobs JP, et al. Intestinal microbiota predict response to cognitive behavioral therapy for irritable bowel syndrome. Gastroenterology 2018;6:S181
- Everitt HA, Landau S, O’Reilly G, et al. Cognitive behavioural therapy for irritable bowel syndrome: 24-month follow-up of participants in the ACTIB randomised trial. Lancet Gastroenterol Hepatol 2019;4(11):863-872. doi:10.1016/S2468-1253(19)30243-2