VIDEO AND TRANSCRIPT AVAILABLE: Vibrating Capsule to Treat Constipation – Virtual Press Briefing | Newswise
What: THE VIBRATING CAPSULE- Safety and Tolerability in Patients With Chronic Idiopathic Constipation
Who: Dr. Bryan Curtin – Director of Neurogastroenterology and Motility, The Institute for Digestive Health and Liver Disease, Mercy Medical Center
PIO Contact: Dan Collins, Senior Director of Media Relations – [email protected]
When: May 21 at 12:30 PM ET
Where: Newswise Live Zoom Room (address will be included in follow-up email)
Transcript:
Thom Canalichio (TC):
Hello and welcome everyone to this Newswise Live virtual press briefing. I’m here with Dr. Bryan Curtin from Mercy Medical Center to talk about recent trials confirming the safety and efficacy of a vibrating capsule to treat constipation. So Dr. Curtin, just to ask you, first off, if you tell us your name and position, and everything there at Mercy Medical and what your job is, and then we’ll get into the vibrating capsule.
Dr. Bryan Curtin (BC):
Absolutely. So my full name, Dr. Bryan Curtin, I’m the director of Neurogastroenterology and Motility at Mercy Medical Center. And so, you know, I see patients, you know, typically referred for refractory issues with constipation, with bloating, nausea, vomiting, like any sort of, like dysfunction of the gut itself that’s not easily solved with like kind of an endoscopy or colonoscopy if there’s a functional problem with it, with the GI tract. I’m usually the person that most gastroenterologists will go to in order to try to answer those questions.
TC:
So you’ve specialized in this area, so specifically, you obviously must be very knowledgeable about it. It’s sometimes an awkward conversation for some folks, but it’s something that everyone deals with. So it’s really interesting to see a new approach to treating constipation. So tell us, how does this distinguish, what distinguishes, specifically, this vibrating capsule type of treatment from other ways of treating constipation? What’s the real defining factor?
BC:
Yeah, and that’s a good question. So I mean, I think that you know, one of the challenges with the treatment of constipation has been that most of the mechanisms of action that we’ve had for the treatment of constipation usually revolves around trying to essentially flood the colon with water, and that includes kind of our over the counter agents that things like MiraLAX, polyethylene glycol, magnesium-based products, or when you go up to your prescription strength medication. So that’d be things like Linzess, Amitiza, and Trulance, there’s a newer one called Ibsrela. All of these, through various different kinds of mechanisms, are trying to essentially put more water content into the colon. And even kind of our basic strategies, like, you know, drinking more water or eating more fiber in your diet are around that as well. And the problem with those mechanisms is that it’s very easy, especially with the prescription strength medicines, to overshoot the mark, and so a lot of patients will get significant diarrhea with these treatments. And so having different options and having different mechanisms of action out there is incredibly important. And so that’s a good segue into the vibrating capsule itself. So this is a physical capsule. And so I have sort of an example of this right here. So this is a physical capsule. It’s not a pill that dissolves and gets absorbed pharmacologically. It is a physical capsule that you swallow at night, and then the next day it’s going to make its way into the colon, and then at the appropriate time it’s going to start vibrating. It vibrates with the intensity of about like a cell phone, essentially, and it’s going to stimulate the colon from within, and it seems to stimulate peristalsis, and it seems to stimulate sort of, you know, motility within the colon. And so what we’ve seen in the studies that have been released so far, and the initial trial that led to the FDA approval of this device was it came out in 2022 and that showed that it increased, improved complete, spontaneous bowel movements more than two per week in a chronic idiopathic constipation population. And so this new paper that I put out mostly talks about the safety, and it’s a post hoc analysis of basically looking at all the trials that kind of led up to that sort of landmark trial. Because one of obviously the impediments is sort of prescribing something like this, is that it’s a new technology. We don’t have a whole lot of mechanical pills out there that treat various conditions, and so constipation, a lot of times, is in the domain of, you know, a lot of times the primary care doctor or the general gastroenterologist, you shouldn’t have to necessarily go to sort of like a super sub-specialist in motility to get a treatment like this. And so it’s important to kind of put more data and be transparent about the safety of these kind of devices, in order to make sure that you know, not only patients are comfortable with it, but also that you know people are ever going to be prescribing these devices for the treatment of constipation, are comfortable with it as well. Comfortable with it as well.
TC:
We have a question from Alice in the chat, how big is that capsule and is it uncomfortable? It looks like the size of a large vitamin. How are patients handling the process of swallowing that and the sensation it provides?
BC:
Yeah. I mean, I don’t think I don’t know if I have the dimensions right in front of me, but I’m kind of holding it up, sort of like right in front of my face. Right here, so you can see, so I would say it’s basically the size of a large multivitamin. And, you know, it’s funny, you should ask that I actually had a patient this morning who, you know, when we talked about the vibrant and sort of the mechanism behind it, they did say that, you know, you know, looking at that pill, I’m a little bit worried about that, and that is a drawback on that it is a larger pill. And so, you know, some patients will have issues with swallowing large pills. And so it’s not going to be a perfect treatment for those kinds of patients, specifically. But you know, in general, most people are able to swallow the pill without any major problems. You know, obviously, as a motility specialist, I will see people. It’s very rare that they have just kind of one problem, you know, constipation. A lot of times they’ll have more diffuse issues. They might have constipation, they might have swallowing problems, and we have nausea, vomiting, gastroparesis. And so from my practice, it’s very common to sort of have people with multiple issues or other types of sensitivities to medications or foods or things like that. And so, you know, even in my practice, I find that in general, the vibrating capsule is generally pretty well tolerated. And having this, I mean, this is kind of the capsule that we show people in the clinic, because, you know, if they feel like they’re gonna have a problem with swallowing it, like we know that right away, without, kind of like having them go through the process of getting it approved or getting it written, and then and discovery at home, so we always kind of walk them through that process and the clinic right here.
TC:
Question about, sort of the cost is, is part of, you know, reason, my reason for asking these are maybe meant to be disposable. I can imagine anyone’s retrieving them. So how does that work? Cost wise, and the patient gets a pack of several of these in order to take them over the course of some time. Tell us a little bit more about that.
BC:
Yeah, very good question. So first of all, let me just say that there’s, there’s no retrieval of the capsules. Yeah, that would, I don’t think that that would be a very sustainable model, for sure, these are, they’re environmentally safe as part of the FDA approval is that they can be just flushed in the toilet, and they’re not going to cause any, like, kind of plumbing issues. They’re not going to come apart like in the human body or something like that. So they’re very safe from that standpoint. And that’s part of why releasing the data from 800 patients was important, because we didn’t have anybody who had any kind of capsule retention. We didn’t have any, like, you know, capsule failures in terms of the capsule, like breaking apart, you know, so that that’s important information to kind of put out there in terms of the actual logistics of taking it. So, in general, it’s meant to be taken on the label for the FDA approval is you take it five days a week, and so there’s actual an app on your phone that people will download commonly, in order to try and basically, kind of keep track of that. And what happens is that, you know, in general, how it works is that, so there’s an activation pod, and so that’s what I’m holding right here. And what happens is, at night, you’ll take the capsule and you’ll put it inside the activation pod. And then I don’t have this plugged in right now, just for demonstration purposes, but basically it activates the capsule directly. Then you swallow it at night. Now it takes some time for the capsule to get into the colon. So it takes around 10 to 16 hours or so for the capsule to make its way into the colon, and then once it’s in the colon, the very next day, around early afternoon, like one or 2pm depending on what time you took the capsule, that’s when it’s going to engage as a vibrating protocol. And some people will feel that. Most people will not. Based on the data that we presented, a little over 10% of people actually will feel the vibration, although most people, in my experience, and also within the clinical trial there, there wasn’t really a whole lot of people that were bothered by that, necessarily. But then you do that on a regular basis, five times a week, and the clinical trials went on typically for around eight weeks, and so that was long enough to sort of demonstrate efficacy at that point in time.
TC:
So that pod is what starts the clock of the timer.
BC:
Exactly. Yeah, it’s, it’s essential, because otherwise the capsules by themselves wouldn’t know necessarily when to activate they have. They have to be activated by the pod. And I think the other question you mentioned was, like, what do they come in? So this is, like an example of, like a blister pack. So it’ll come in a blister pack that looks just like any other medication, except, you know, each of these pods, you know, each of these will contain sort of a vibrant and so there’s five, five capsules per week, and that’s how it’s distributed.
TC:
Mechanically, this is, I assume, using something similar to what makes your phone vibrate when it rings. Is that right?
BC:
Exactly, yes, these capsules, they’re produced in Israel. And so I actually was able to see the factories a few years ago before they got FDA approval. And so yes, the technology in terms of the battery is very similar to what causes a phone to vibrate.
TC:
And another question from Alice in the chat is, are there any contraindications, like a particular GI disorder that this would not be appropriate for?
BC:
Yes, it is a very important question, and I definitely don’t use this blanket with every constipation patient. So a couple of key things. Number one is that this has really been approved for chronic idiopathic constipation, and so you got to sort of juxtapose that with irritable bowel syndrome, with constipation. Irritable bowel syndrome like you know, the main sort of difference between those two is the presence of abdominal pain and abdominal pain and bloating. And while I have seen some improvements in abdominal pain and bloating with use of the capsule, if your main goal is to treat abdominal pain and bloating and treat IBS, there are other prescriptive strength medicines for that that are probably a better fit for those particular conditions. So this is mainly for chronic idiopathic constipation is not really for the upper symptoms, specifically other contraindications. So obviously, like, this is a mechanical pill. So if there’s any concerns about any sort of, like small bowel pathology, like strictures, if anyone’s had any kind of an anatomy altering surgery. So I don’t use this. Anybody with any kind of, like bariatric surgeries, like a gastric bypass. I don’t use this. Anybody who has a history of bowel obstructions, or, you know, I typically don’t use it in patients who have any kind of upper motility problems. So, you know, I mentioned that, you know, part of the mechanism of action relies on the capsule getting to the colon the appropriate amount of time. Well, if I have somebody with gastroparesis and their emptying is significantly delayed, then the capsule might sit on the stomach for the entire time. And so I don’t use it in people with proximal motility issues as well. Another important consideration is that these are not MRI safe. And so one of the questions that I ask if I’m determining whether or not I’m going to use the vibrating capsules as a treatment option is, do you need to get MRIs on a regular basis? Do you anticipate getting an MRI in the next six months? Because if the answer is yes, and this is not something that is safe to go through an MRI machine, in terms of, like an abdominal MRI. If somebody needs to get an MRI while they’re on the medication, generally, what happens is that we stop the medication for like one or two weeks ahead of time, and then we will get an x-ray to make sure that the capsules have passed. And then in a couple of situations, we’ve had to give somebody, like a bowel prep in order to kind of flush out the capsules. But I mean that if somebody needs to get regular MRIs. It’s probably not the best treatment modality for them specifically. But those are the big things, like mechanical obstructions need for the frequent MRIs proximal motility issues. And I wouldn’t use this in somebody who has any kind of active like Crohn’s or inflammatory bowel disease as well, just because of the potential for strictures and things like that. But those are the big contraindications. So this is generally the sweet spot for this medication, in my opinion, is somebody who has kind of failed over the counter medications, and the label, you know, requires a failure of at least one month of an over the counter option like Miralax, but who maybe the other prescription strength medications like Linzess or Ibsrela really kind of blows our doors off and gives them diarrhea. That’s like a really good sort of sweet spot for this particular therapy.
TC:
Alice in the chat also asked specifically if diverticulitis was approved or a complication for this?
BC:
So that’s a very good question. You know, there haven’t, you know, obviously, almost everybody over the age of 60 is going to have some form of like, diverticulitis. You know, as the colon gets older, there’s, you know, it’s very common when we do, you know, screening colonoscopies, or surveillance colonoscopies, that will see diverticulosis. And we’ve never had any kind of problems, at least documented in the literature, like, the capsules getting stuck in the diverticula specifically. I mean, I would say that if somebody is having recurring issues with diverticulitis, I probably would not necessarily think about the vibrating capsules as my first treatment option. But there hasn’t been any evidence to suggest that, like, increases the incidence of diverticulitis or anything like that. That’s a very good question,
TC:
And you mentioned this, but just to confirm this does show up on X-ray in case it needs to be scanned, to confirm that it has passed or not in any situation,
BC:
Yes, absolutely shows up in x-ray clear as day. In fact, one of the the challenges, and one of the reasons that I’m trying to get more more literature and more more publications out there about this particular technology, is because, you know, it’s very common that when I put somebody on the vibrating capsule, sometimes, like, you know, they get an x-ray for another reason. Like, maybe they went for pneumonia, and then the radiologist sees these capsules in the colon, and they’re like, oh my gosh, what are these, you know, like, and they don’t know exactly what they are, you know. And you know, they’re not necessarily showing up on MRI checklist. Like, if you get an MRI like, you get an MRI, like, you know, they’ll check for, like, stimulators or other sort of things that you know, to make sure that they don’t put it through. And so, because this is such a new technology, like, you know, radiologists are not as familiar with them, the MRIs are not familiar with them. And so putting more data out there about the safety and efficacy of this is very important to get people more comfortable and familiar with this. But yeah, they show up clear as day on the X-ray, specifically. And, you know, I don’t necessarily recommend, like, monitoring with X-rays, like, while you’re on the therapy, because it’s normal, especially when you’re constipated. Like, some capsules might sit in there for a while. Like, you might have a cluster of, you know, three to five capsules sitting in there through the week, but they eventually will come out. And there was no incidents in any of these trials where, like, you know, somebody had like, 20 capsules inside them, or something like that. In general, they were, they were coming out at a regular basis.
TC:
Great, great. Adding that to the MRI checklist, the technician asking you, did you remove all your piercings, and did you happen to take a vibrating capsule for constipation that needs to be part of the safety checklist. Another question in the chat from Margaret, is this appropriate for use in Parkinson’s related constipation?
BC:
Yeah. I mean, there haven’t been any specific studies looking at, like, the vibrant capsule and Parkinson’s. Mean, it’s a great idea for, like, another trial specifically. But, I mean, I would say that this, I would, I would have this in the toolbox depending on the severity of the Parkinson’s. One of the things we talked about earlier was the swallowing issues, and that’s very common in Parkinson’s, where people will actually have difficulty with swallowing. So if somebody comes into my clinic and they’re having constipation problems and they’re already having difficulty with swallowing, I don’t think I’m going to have them take this just because of the size of the pill. But I think if this is relatively early at Parkinson’s, and they’re having constipation when they’re presenting symptoms with no swallowing impairment that I would feel comfortable trying, as long as they don’t have any other contraindications. But there’s no specific data on Parkinson’s specifically, but I think that that’s a good idea for sort of a future direction.
TC:
Another question from the chat, Les from Media Post beyond the clinical trial, how many people have you treated with this? And what are the commercialization plans?
BC:
So, very good question. So personally, I probably prescribed vibrant a little over 150 times. And we actually have a database where we kind of keep track of people like that. And so I’ve got a fair amount of experience in terms of prescribing therapy, and in terms of, you know, in addition to looking at the safety paper here, you know, I’ve never had any like, catastrophic complications, like somebody had me go for surgery or something like that, with regards to using the vibrating capsule. Again, I mentioned a couple of times, you know, some snafus with the MRI like people forgetting and then it not being in the MRI checklist. Again, nobody had any major complications from that. But, you know, that’s one of those things that, you know, we’re trying to get the word out there to, you know, try to prevent those kinds of things from happening. And then, as I mentioned, like, you know, sometimes if you get X-rays, incidentally, you’ll find that there’s some capsules in there. And that’s not necessarily a problem specifically, but, you know, just like any other therapy, there are some, you know, patients that respond really, really well to it, and there are some patients that, you know, need some other types of therapy. That’s always going to be the case, I think, with constipation specifically, you know, commercialization a little bit beyond, sort of my scope, specifically as I’m not as involved. I’m not really involved with the business aspect of the company. I serve on an advisory board and to get medical advice, but I’m not really involved in the business aspect of the company specifically so. But I’m not entirely sure what their plans are with regards to the commercialization. I probably defer that to the company themselves.
TC:
Will this go off? Will this set off the X-rays at TSA going through airport security?
BC:
So the answer to that question is no, and they’ve actually done it. They had the company actually had people take the capsules through that and they had no problems with actually passing through the security checkpoints. So it does not appear to set off the security checkpoint. So I think that if you had somebody who is particularly constant, particularly constipated, who maybe had multiple pills there, it’s possible, but at least so far, the evidence will suggest that it does not set off those, those monitors, those x-rays.
TC:
And what if any information can you share about the cost and insurance coverage of this treatment?
BC:
Gotcha. So that’s a good question. I know that they mentioned that before. So, you know, obviously it’s in a little bit of a weird space therapeutically, because, you know, especially when you talk about things like, you know, Medicare, Medicaid, you know, it’s not like a traditional pharmacologic drug, but it’s also not entirely, sort of on the device side of things. And there’s also two parts of it, right? I mentioned that there’s kind of like, there’s the activation pod, and then there’s the capsules themselves, and so, you know, right now, especially because of the novelty of the product, it sort of fits in kind of a weird space. A lot of the commercial insurances will have some partial coverage of this, especially since the label from the FDA says, All you have to do in order to qualify for this is to fail an over-the-counter treatment for one month. And that’s not really hard to achieve, especially in treating constipation. Whereas, you know, some of the other prescription strike medications, you need to fail, except, like you know, in order to get approved for something like Motegrity, a lot of times you need to fail like three other prescription strike medicines to get there. The cost without any kind of insurance coverage is also very, quite reasonable right now. It’s about $90 a month if you pay for it entirely out of pocket, which compared to some of these other medications, which can cost upwards of like $2,000 a month if you pay for them completely by themselves, is fairly reasonable. And so a lot of patients are getting insurance coverage for them, but some of the patients that I’m prescribing them are also paying them out of pocket with that cost.
TC:
Is this most likely to be a long term treatment that patients experiencing this kind of constipation would need to continue to use regularly, or is this something that is part of a more big picture plan that is trying to resolve the constipation from happening in the first place? Where is that kind of falling with the types of patients that you’re talking about? I assume that this may be many people that this is a chronic issue, they may be taking these on a regular basis, kind of permanently. Is that a good assumption?
BC:
Yeah. I mean, that’s, it’s a very good question, and something that we really struggle with, with constipation, because, you know, constipation is one of those conditions where it’s really difficult to completely resolve it. You know, unless you find something like somebody has pelvic floor dysfunction, you send them through appropriate therapy. Appropriate therapy, it’s or you find some sort of other like medication or secondary cause, like for some does, like chronic idiopathic constipation, tends to be a chronic condition that is not something that we can necessarily cure, and usually we’re looking in order to try to manage it. And so to that end, you know, whenever, and this goes for, really, any treatment with with for constipation, whether you’re talking about the over the counter agents, when you’re talking about the prescription strength, like secretagogues, retainagogues, like Linzess and Ibsrela, or when you’re talking about the vibrating capsule, there is a possibility this could end up being a long term therapy. Now, one of the, I would say, criticisms of the trial so far the environment, is that they’ve all been relatively short term. They’ve been, like, eight weeks long. In fact, the landmark trial that came out in 2022 that showed efficacy and led to the FDA approval was only eight weeks long. And so what we need to have is more like a kind of long term data looking at efficacy. And my hope, and obviously I don’t have any data to sort of support this assertion, but my hope is that, you know, it seems to be like, you know, there’s lots of other similar therapies in medicine where, kind of stimulating parts of the body. Maybe you, you know, re-grow some of those nerves, or, sort of like, re-attune some of that motility. And it’s possible that if somebody’s on the vibrating capsule for like, six months or a year, and then maybe they can get off of it, and then there will be some sort of residual effect from that stimulation. Again, I don’t have any there’s no data that have been done about that specifically. But for something, for a therapy and a mechanism like that, that would be like, kind of the hope for the future. Of the hope for the future is that maybe this could be used as sort of a, you know, sort of a medium term therapy that could potentially have long term results. But as of right now, based on the data that we have, there certainly remains the possibility that this is going to be a long term condition, that they might need to be on it for a long term period of time.
TC:
And how many patients are typically dealing with this type of constipation? What are the numbers on that?
BC:
Oh, I mean, you know, constipation, just like, from a national level. I mean, like, easily, 10s of millions, like, more than more than 30 million people, you know, and obviously, you know, depending on the Census you look at it, plus, you know, a lot of patients are going to be classified, you know, between chronic idiopathic constipation versus irritable bowel syndrome with constipation. So both of these are huge populations, but this is a massive problem, 10s of million people in the United States alone, hundreds of millions of people across the world, constipation. And again, this can range from like, sort of like, you know, very, you know, situationally, travel related constipation or medication related constipation, to sort of debilitating, like, you know, people need to get surgery. People need to use, like, irrigation devices, you know, or secondary conditions like Parkinson’s. So there’s a wide range. There’s a huge amount of patients that deal with this, and there’s a very wide range of severity of constipation. So this, in particular, I’d say, is sort of right in the middle where this is somebody who’s constipation is, you know, affecting their quality of life to the point that you want to put them on a prescription strength medication. But probably not the best treatment for somebody who’s like, you know, at the extreme end of the spectrum is tearing down a potential like colectomy or some sort of major treatment for like, severe neurogenic bowel.
TC:
What types of capsules are available that patients could go out and ask their doctor about today?
BC:
So right now, the only vibrant is the only one that’s FDA approved, and so that’s that’s important. There are other pieces of technology that are in development out there. There is a product called vibrabot, which is mentioned in the paper. That is a Chinese development but it is not the data on it is not as robust as what we have on the vibrant capsule. And so it’s not FDA approved, and so it’s not something that’s typically being prescribed, especially in this country. There are some external stimulators. They’ve done some studies on basically, kind of like wearing, like belts or things like that that can actually stimulate the colon, kind of like through the skin from the outside. And again, the data on that has not been as great either, to sort of recommend those types of treatments. So in terms of the capsule itself, this is the only type of this is the only capsule that’s FDA approved and has this level of evidence and data that supports its use.
TC:
What next research do you have in mind for this to continue to prove its effectiveness?
BC:
Yeah, I mean, I think that you know, after looking at the safety because right now, I think the safety data is so important to make both patients as well as people who are prescribing the medication, you know, comfortable with it. Because obviously prescribing like a device and taking kind of a physical capsule, like it is, it’s new. It’s not something that is typically available. You know, I think most people are familiar with technologies like a pill camera, where you swallow a camera in order to take pictures of your small bowel, but that’s a one time thing, whereas this is kind of a continuous, sort of taking of a physical capsule. So safety data is incredibly important from that standpoint. So in terms of looking at future looking at future options, I think some of the questions alluded to that earlier, I think looking at it in specific patient populations, you know, specifically to see if there’s if the stimulation component can help somebody who’s, for example, Parkinson’s disease, looking at that sort of targeted patient population, looking at populations of, you know, like one of the very challenging patient populations, or patients with sort of spinal cord injuries or other neurogenic injuries, like, you know, in these patients, you know, a lot of times they can’t take traditional options because, you know, they’re paralyzed or they have impaired mobility, and so giving them, like, a really powerful laxative, it makes them, you know, kind of go to the bathroom on themselves. And that’s not really what you’re aiming for. And because this doesn’t cause diarrhea to nearly the same extent, this could be a really good option in those kind of patients as well. I think further studies are needed for that. And then I mentioned earlier, you know, to the longevity of the treatment. You know, is there some benefit of being on it for six months and then stopping it? Could there be some long term benefit of, you know, just getting the stimulation for a period of time? And is there some long carryover for that? I mean, that would be a real game changer if that was the case.
TC:
It seems that with certain patients just getting relief from the issue itself, might allow them to make other lifestyle and health changes that could lead to better overall gastrointestinal health. Is that part of the process that you’re envisioning with that?
BC:
Yeah, absolutely. I mean, obviously, you know, that’s part of the reason why I go into motility. You know, a lot of times when patients are referred to patients are referred to me, you know, in medicine, we’re pretty good at ruling out the big, bad, life threatening things, in general, for the most part. You know, we can detect cancers. You know, we can detect Crohn’s disease and inflammatory bowel disease. And a lot of times, you know, by the time they get to me, like somebody’s having severe, ongoing constipation. And we know it’s not like cancer or something that’s threatening the traditional sense, but you know, these patients are really suffering. You know, a lot of times, you know these patients, you know they aren’t going to they aren’t able to go, like, restaurants. They aren’t able to go on. I see a lot of retirees that aren’t able to go on, like trips or cruises or things like that they had planned and saved up their whole lives for because of their, you know, constipation issues. And I think that kind of gets short shrift. People don’t realize. Kind of how much people suffer. And I think in the very beginning, you mentioned that this isn’t something that people talk about, right, you know. And I think an old joke goes that, you know, people, when they’re having like, a heart problem, they’ll tell you all about, like, their cardiologist, and then they fix their heart, or if they’re having an orthopedic issue, oh, you know, my shoulder is acting up, and this guy fixed it. But nobody’s going to talk at a party about, you know, oh, yeah, I was having some pooping problems, and then this guy fixed this problem. So people suffer in silence. There’s a lot of stigma associated with it, and it can be a tremendous impact to quality of life. And so having another option to sort of try to help people’s quality of life is tremendously important.
TC:
That’s a great perspective. Doc. A question from the chat again is, what is the success rate? Does it ever not work?
BC:
Yeah. I mean, I think, you know, if you look at, you know, constipation, IBS and those kind of trials in general, you know, efficacy, you know, especially when you’re looking at placebo controlled trials. And the landmark trial that came out in 2022 was a placebo controlled trial. They actually gave them capsules that just didn’t go off. And so that this was basically a, you know, a better placebo controlled trial than most people can. Most people can can go through with of course, it’s not going to work some of the time, your efficacy for most of these medications, like in the clinical trial setting, is going to be probably around 50% or so for most treatments with constipation, and that’s because of the multifactorial nature of IBS and constipation in general. And so there’s always going to be people that it’s not going to work for. And sometimes part of the process is kind of going through various different options and finding the right correct treatment. But because, you know, there’s all sorts of things that contribute to gut motility, like, there’s, you know, the microbiome, there’s, you know, food intolerances, there’s immune system dysfunction, there’s neurologic dysfunction, gut brain access, the muscles, gut motility, and it’s going to be a different distribution every single patient. There’s never going to be a treatment for constipation or IBS that’s just going to work for 100% of people, that’s never going to that’s never going to be in existence. And so that’s why it’s important to develop several different mechanisms, so that you know if one mechanism doesn’t work for somebody, you have another one to go to. And having more options is very important in these conditions.
TC:
Speaking of those options, this is obviously something that people might need when it comes to chronic issues. They’ve tried everything. They’ve tried and failed, taking things that are causing diarrhea, other issues. Tell us, if you can just in a few bullet points, what are some of the other approaches that you’re recommending to people alongside of these things, diet, probiotics, what else? Give us a quick tutorial on the overall.
BC:
Sure, yeah. I mean, I can give you kind of a very quick sort of bullet points of, kind of my approach to somebody with refractory constipation. I mean, obviously you mentioned some of the more basics, like you always want to go over, kind of the basics of you know, water intake, the main, the main physiologic purpose of the colon is to resorb water from the stool. So the more dehydrated you are, the more water has to resorb, the harder that stool gets. So adequate hydration, very, very important, fiber intake. The data has been very clear about fiber intake for a long time. You generally want to aim for 20 to 30 grams of fiber per day in terms of intake. And most people are not gonna be able to get there by accident. So fiber intake is very important. Exercise and moving around, the more you move, the more your gut will move. And so exercise, getting up, moving around, even walking, helps a lot with that. So that’s kind of your basic sort of lifestyle modifications. You mentioned probiotics. There’s not really a whole lot of data that supports the use of probiotics in the treatment of constipation, so it’s not something that I typically recommend. Then you go to your over the counter agents, which typically get classified into your osmotic laxatives. So that’s like your MiraLAX, which possibly draw water into the colon. You have your stimulant laxatives, like Senna and Dulcolax, which are good rescue agents, but have some abuse potential. And also, you don’t generally want to have people using those every day, because sometimes they can contribute to abdominal pain as well. Then you jump into your prescription strength medications, where that’s where vibrant is, and that’s where you have your secretagogue. So that’s like Linzess, Amitiza, and Trulance. Those are all within one drug class. There’s a newer agent called Ibsrela (Tenapanor), generic, which blocks sodium reuptake channels inside the lumen of the colon. And so that’s a different mechanism of action, but it’s more for an IBS treatment. There’s another neurologic agent called Procaliprid or Motegrity which affects serotonergic receptors inside the colon and that can actually improve high amplitude contractions and then there’s some off-label therapies after that, you know, things like Pritostigmine which is a cholinergic activator. Some people use Colchicine which is a rheumatologic agent and so that’s kind of a real like kind of overview of the treatment of constipation and then obviously for me as a motility specialist, I’m looking for other secondary causes. I mentioned pelvic floor dysfunction, people have dysenergic defecation which is problems where they can’t coordinate their bowels or they can’t sense the stool coming in and if you have a problem like that, then a medication isn’t really going to be the answer. Giving you a medication for a Dyssynergia or coordination problem is kind of like giving somebody medication to get better at basketball. It’s really not going to work and you need to send them to appropriate biofeedback nurse or pelvic floor therapist for that and then sometimes breath tests can be helpful to look for like Methanogen Overgrowth or SIBO which can be a contributing factor too and treating that can sometimes help people with constipation. So that’s a real distilling motility for constipation down into a few minutes.That’s sort of a good overview right there.
TC:
Well now having this as part of your whole toolkit for helping patients with this kind of constipation, what are your hopes for people to understand about GI health and awareness about this as an option? What would you like people to know?
BC:
I think from a patient standpoint, I think I would like them to know that we have more options than we used to. I actually, interestingly enough, I saw a patient recently who basically had been having some GI functional problems 35 years ago, went to a bunch of doctors, went through this big medical odyssey for five years and then essentially gave up and now is finally coming back 35 years later to see what else is new and I think that some people kind of lose hope. They try some over-the-counter agents and I think a lot of doctors, constipation isn’t something that I think a lot of people sort of specialize in or sort of focus in even among gastroenterologists and so just knowing that there’s more options out there and that in general while we don’t have the ability to kind of cure constipation and at least at this current capability, we do have a lot of options for treatment, different mechanisms of action and so most of the time I’m able to get people to the point where their quality of life is better and that has value. Even if it’s like 50 percent better, 70 percent better, that has tremendous value for somebody and so I think the biggest thing to know is just there’s more options than there ever were before and talking to your primary care doctor or gastroenterologist is very important to kind of know what those options are and get started on them.
TC:
One more question from the chat. Like the ingestible camera that you mentioned that people might know about as an alternative for colonoscopy kind of situation, is there any potential for a device like this to not only do the vibrating to treat constipation but also to potentially be gathering data on the person’s GI health?
BC:
Yeah, I mean there are several technologies like that that are in development and obviously they’re a little bit different in terms of how they’re made. You know the measurement device like where you have a camera, there’s more technology that has to be in that so the capsule is like a little bit bigger. There’s another capsule that’s in development right now, I do not believe it is FDA approved yet, called the Atmo capsule which is going to be detecting various like gas levels within the GI tract to basically measure transit. There used to be a product called SmartPill which was able to kind of detect pH within the GI system to sort of approximate transit in the stomach, the small bowel and the colon. So yeah, there are pieces of technology out there that are able to do this, there’s some present, there’s some on the way. So absolutely using capsule technology and you know there are some people that think that because right now we have to do endoscopy colonoscopy, I mean having like a little like almost drivable drone with like a little capsule that could be drawn as like a camera that could be controlled by a doctor is something else that’s also in development as well. So I think in the future there are lots more capsules and these kind of technologies.
TC:
Very interesting. Thank you so much for taking the time to share about this Dr. Curtin. Members of the media, if you have questions and would like to follow up, I sent in the chat, Dan at Mercy Medical Center’s email address and we will share the recording and the transcript of this briefing here with you later. Dr. Curtin, thanks and best of luck with all of this and for those of you out there with GI questions, talk to your doctors, you don’t have to suffer in silence, there are new therapies available that may be right for you. So I hope the media is able to get the word out about that for people dealing with this kind of condition. Thanks again Dr. Curtin. To everyone, thank you for joining. Namaste and good luck.
