Reimagining GI Care: Digital Therapeutics for Managing IBS and IBD Symptoms

Dr. Buch:
This is GI Insights on ReachMD. I’m Dr. Peter Buch, and today I’m joined by Dr. Iris Wang to discuss how digital therapeutics can help us manage irritable bowel syndrome and inflammatory bowel disease. Dr. Wang is an Associate Professor of Medicine and the Associate Program Director of the Gastroenterology Fellowship at the Mayo Clinic in Rochester, Minnesota.

Dr. Wang, welcome to the program.

Dr. Wang:
Thank you so much, Dr. Buch. It’s really an honor to be here. Thank you for having me.

Dr. Buch:
Looking forward to our discussions. To start us off, Dr. Wang, can you give us a quick overview of what digital therapeutics are and how we can apply them in clinical practice?

Dr. Wang:
So I’m going to answer the question in two ways. A digital therapeutic, to me, is a pill, and instead of taking a traditional pill, it’s a pill that’s delivered via your smartphone, so it’s a digital application that is meant to treat a disease. But really, when we use this term “digital therapeutic,” we can really look at it in a very broad spectrum of things, starting from things like digital tools to actual hybrid digital telehealth platforms. So I’m going to give you a couple of examples of those, starting with more of a tool and less of a therapeutic. Those are things like symptom trackers, where patients can go in and input what they ate, what their bowel movements look like, and try to kind of correlate what they ate, what their daily activity was with a GI symptom, and how their bowel movements are. More commonly known apps in that category are things like My Fitness Pal, where they’re really just food-based trackers that may give you some guidance on what you’re eating.

The next level of app in my mind are these education-only apps where, similar to something like My Fitness Pal, the patient is going to get a little bit of education on what they’re tracking and how that’s working. An example of that in GI is Monash University’s FODMAP app, where patients can go in and look at a food like an avocado, and the app is going to tell them is this a high FODMAP food or a low FODMAP food, and help them to understand more about their diet.

The next level up is more standard education protocols, and here we’re really getting into that therapeutic category. And even the Monash University app is a little bit more therapeutic because it’s really trying to deliver a low FODMAP diet to the patient via an app. Some of the more standard education protocols deliver gut symptom-directed CBT, or cognitive behavioral therapy, through this app. A couple of the platforms did that, and one of them was the Mahana Therapeutic platform where there wasn’t anything particularly different about this app for each individual patient, so it was like a cookie cutter, standardized CBT, but it worked because it was able to deliver the CBT education to your patient.

The next level up then uses kind of AI-driven algorithms that can use patient input information to then customize the content that a patient experiences to better deliver therapy.

And then that last level up is not just written content that is already available via an app, but takes that education and adds a layer of providers that are now using the app platform to deliver care. So that upper level is probably the most common app that we see for a number of reasons.

Dr. Buch:
So if we zero in on irritable bowel syndrome, or IBS, when and how can we integrate digital therapeutics into patient care?

Dr. Wang:
So the reason why I wanted to break the apps down like that is because then, depending on your patient, you could integrate an app into the care of your IBS patient depending on what they need. If all they need is to try to understand, “Okay, what am I eating that’s triggering my symptoms?” then you want to go with the symptom tracker, and that’s something that you can build into your therapeutic relationship. On the other hand, if you’re finding that your patients need more—they need someone to help them either deliver a brain-gut behavioral therapy like CBT or like gut-directed hypnotherapy but you can’t find a provider—then one of these digital therapeutics that’s going to deliver that in an app-based platform might be reasonable for your patient. And we can get into who’s reasonable for that app-based care and who’s not. And then for patients who need more hand-holding and more management of chronic pain, then there are companies available now, like Lin Health and Able Health, who are able to take your patient and provide multidisciplinary care in this app-based platform so that it can really address the chronicity and burden of their symptoms. They have pain coaches, they have psychologists, and they have dieticians that are on board, depending on which app platform you’re choosing. So it can be at any stage of the patient’s IBS journey.

Dr. Buch:
Dr. Wang, if we choose one of those more sophisticated kinds of programs, what would that cost the patient?

Dr. Wang:
That’s a really, really great question and super important to ask upfront. It depends a lot on the insurance. And we have had a huge change in the IBS digital therapeutic world because a couple of the primary apps that first went out for FDA approval for their product and really established themselves as a digital therapeutic unfortunately are now out of business, and the reason for that is because of insurance coverage. Because they couldn’t get payers to sign on board, they weren’t able to recoup those costs, and so the reason why a lot of these new companies are integrating providers into their app platforms is because they are better reimbursed. So Lin Health and Able Health both have insurance companies on board and they have payer coverage, so depending on the patient’s insurance, it could be completely covered. Or if they’re not completely covered, they can be something in the order of 200 to 300 dollars a month, which is going to be prohibitive for certain patients, but overall going to be more accessible or equally accessible to seeking psychologic support in a traditional provider platform.

Dr. Buch:
Do we have any data on the available digital options and how they compare in terms of evidence, usability, and patient outcomes?

Dr. Wang:
We had a lot of data for things like the two apps that I previously mentioned, Regulora and Mahana. Regulora was a prescription-only digital app for gut-directed hypnotherapy. And there’s a lot of data that’s worked its way to show that hypnosis as a therapeutic tool for disorders of gut-brain interaction can be delivered both in person and virtually, and then studies that show that a cookie cutter standardized protocol is quite effective for gut-driven symptoms. Similarly, Mahana Therapeutic was a digital CBT platform, and they had evidence as well showing that their CBT platform was equivalent to office-based CBT and also quite effective for patient symptoms.

Now, unfortunately, both of them are bankrupt, but Nerva, which is currently an app-based digital hypnotherapy platform, is still available, and their data that recently was published does show that the digital hypnotherapy is quite effective in controlling IBS symptoms. They are not prescription based. They are subscription based, and so they are direct to consumer, and they have not gone through the FDA approval process, but they are also one of the few available options currently on the market.

Dr. Buch:
Thank you. What should we know about the limitations of these digital tools?

Dr. Wang:
They’re remote, right? Unless we are talking about that upper tier where there is a provider, even those you cannot lay hands on a patient, and it’s very important not to directly send your patients to these apps without a reasonably thorough evaluation, right? They should be seen by GI. They should be thought about to actually have a diagnosis of IBS causing their symptoms, right? I see a number of patients who have abdominal wall pain as the reason for their chronic abdominal pain. Those aren’t going to get better with an app-based platform no matter how good those app-based platforms are because it’s not IBS, and so it’s still really important for us to critically think about these patients instead of just prescribing them an app. It’s a similar message to prescribing them a drug.

Often these are standardized, and so they’re not having nuanced care. So in our patients who have high psychological comorbidity, we do want to think about whether they would benefit from a psychology evaluation by a provider either before they are referred to an app or to work directly in a more personalized fashion. And then access, right? Some of these are not covered. Some of these, it really depends on the patient’s payer. So understanding where you’re referring the patients and whether this is something that they will have to pay out of pocket for, like Nerva, or whether this is something like Lin Health, which will take some insurance and so they’ll screen the patients for their coverage—Able Health as well— it’s going to be important to have that conversation with patients up front.

Dr. Buch:
Thank you so much. For those just tuning in, you’re listening to GI Insights on ReachMD. I’m Dr. Peter Buch, and I’m speaking with Dr. Iris Wang about digital therapeutics in gastroenterology.

So, Dr. Wang, let’s now move on to inflammatory bowel disease, or IBD. What kinds of digital therapeutics are available for patients with IBD, and how do they compare?

Dr. Wang:
So it’s actually very similar to the world of IBS, where it’s a similar class of therapeutics that are available, and a couple of companies are undergoing trials to see whether providing multidisciplinary therapy in an app-based platform, such as CBT, behavior intervention, or acceptance commitment therapy—which is a new therapeutic technique that is becoming better and better studied in the IBD world—whether delivering these in a digital platform can be helpful.

Nori Health is a company that is currently undergoing a clinical trial. They’re based out of the Netherlands. Able Health is a company that provides that multidisciplinary therapy, including dietitians and psychology support, and they were actually developed first in the IBD world, and now they have expanded the other way into the IBS world. There are other therapeutics that are available for IBD patients but only through payer platforms.

So Trellus Health is another company that is available for IBD patients specifically, and this was developed by one of our GI psychologists, Dr. Laurie Keefer from Mount Sinai, because this is the area that she has a lot of expertise in. But their participation goes through the actual healthcare providers and organizations, so the organization actually has to sign up and not the patients themselves, but they did show that participants who went through this had reduction in healthcare utilization compared to those who just had an NP support.

Dr. Buch:
So Dr. Wang, when we’re talking about this, are there any challenges or limitations that come up when using these tools for patients with IBD?

Dr. Wang:
For IBS patients who have been proven not to have inflammation, it is okay to use a therapeutic that is brain-gut derived in order to help with flares. But for an IBD patient, when they flare, it is very important for us to understand whether this is a flare of symptoms or a flare of inflammation. And so not forgetting about those validated biomarkers like a fecal calprotectin or endoscopy when needed to work up these patients appropriately before they are then given these digital tools in order to augment their IBD care, right? These are meant to help maintain remission. They are not meant to replace a biologic or a steroid, and that’s a really important caveat for IBD patients.

Dr. Buch:
Absolutely. In the last few moments of our conversation, Dr. Wang, do you have any additional thoughts you’d like to share with our audience?

Dr. Wang:
Brain-gut behavioral therapies are really important, and these digital therapeutics really allow us better access to bring up behavioral therapies for patients who can use standardized protocols, but there are a lot of patients who have high psychiatric comorbidities—those with high degrees of anxiety, depression, or other psychiatric issues— who will not be the right patient to just give a script to or have them follow an app, and so those patients need to be referred to our partners in GI psychology or overall psychology so that they can get the nuanced care that they need.

On the flipside, patients should not equate failure of a digital therapeutic with failure of BGBT, right? Just because the app didn’t work doesn’t mean that a provider won’t work. Maybe they need more. Maybe they didn’t get the right app, and so have patients try it, but if it didn’t work, that doesn’t mean CBT is not going to work for this patient. So they can try other resources or a provider. These are just tools. It’s like another pill that we have in our toolbox, and it should be looked at that way.

Dr. Buch:
I want to ask you, do you have any studies that you’re doing at the Mayo?

Dr. Wang:
We have a couple of clinical trials enrolling, actually, one for functional dyspepsia, patients who have epigastric pain, postprandial distress syndrome, and we also have another trial for bloating and/or upper GI symptoms, where patients will be getting actually a body surface gastric mapping test and then gut-directed hypnotherapy to both try to prognosticate them and then try to treat them.

Dr. Buch:
Dr. Wang, how can they reach you?

Dr. Wang:
They could e-mail me. My e-mail address is wang.xiao@mayo.edu.

Dr. Buch:
Thank you. As those insights bring us to the end of the program, I want to thank my guest, Dr. Iris Wang, for joining me to talk about digital therapeutic options for IBS and IBD. Dr. Wang, thanks so very much for this wonderfully informative session.

Dr. Wang:
Thank you so much again for having me.

Dr. Buch:
For ReachMD, I’m Dr. Peter Buch. To access this and other episodes in this series, visit GI Insights on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening, and looking forward to learning with you again very soon.