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IBS-C Patient POV
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Patient POV: Incorporating Shared Decision Making in IBS-C Management
Module 1: Introduction and Diagnosis
Brian Lacy, MD, PhD, FACG: Welcome. My name is Brian Lacy. I'm a Professor of
Medicine at Mayo Clinic. Today's discussion is that of Patient Point of View:
Incorporating Shared Decision Making in IBS with Constipation Management. And this is
jointly sponsored by the American Gastroenterological Association and CME Spark. And
I am absolutely delighted to have Regina Ciavarella joining us today. Do you want to
say hello, Regina?
Regina Ciavarella: Thank you, Dr. Lacy. Yes, my name is Regina Ciavarella. I'm a patient
advocate.
Dr. Lacy: Wonderful. So that's going to provide a great perspective for our discussion
today. Our disclosures are noted here and the objectives for our presentation are listed
here. And in brief, we want to discuss the diverse pathophysiologic mechanisms of IBS
with constipation. We'll discuss efficacy and safety data and we're going to discuss
strategies to optimize patient-provider communication regarding IBS with constipation.
Let's begin briefly with an overview and remember that IBS—irritable bowel syndrome—
is a disorder of gut-brain interaction, abbreviated as DGBI. And these DGBIs were
formerly called functional bowel disorders. These arise due to dysfunction in the brain-
gut axis illustrated here on the right side of the screen, and this is a bidirectional
pathway from the brain to the gut and from the gut to the brain. The underlying
pathophysiology of DGBI is that of a perceptive abnormality, and really the
predominant symptom is that of abdominal pain. I like this slide a lot illustrating how
external events: stress, emotion, anxiety, can affect the brain, which can affect the gut.
Of course, changes in the gut, which could include changes in the gut microbiome,
can then affect the brain.
Now how common are these DGBIs, formerly called functional bowel disorders? I like
this slide because it illustrates how very common these disorders are. On the very inner
ring are located countries. So this is a survey study of 33 countries involving more than
80,000 patients. On the second inner ring this lists the prevalence of IBS. So if we use the
U.S. as an example, the prevalence of IBS in the U.S. is over 5%. But if we look at any
disorder of gut-brain interaction, we recognize that the prevalence in the United States
is over 40% and that's quite common throughout the world.
I already briefly mentioned the epidemiology of IBS. We know that the worldwide
prevalence is about 4.1 to 4.6% using the Rome IV criteria. Those are a bit more strict
than the Rome III criteria where the worldwide prevalence was about 10%. As
mentioned, the prevalence of IBS in the United States is over 5% and in many clinic
populations it's about 10%. So that means about 1 in 10 patients in a GI clinic likely
comes in with symptoms of IBS. This is a disorder more frequently identified in women
and in younger patients than older patients. That being said, I refer to this as an equal
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opportunity offender. Regardless of race, ethnicity, religion, or socioeconomic status,
IBS affects all of these patients.
Now how impactful is IBS? We can think about the impact on patients, and we can
think about the impact of IBS in terms of the healthcare system. But this slide really
illustrates how impactful IBS is in terms of patients. If we think about just a single question
of “how bothersome is this to you?” And we think about patients with IBS and
constipation shown in blue, 53% said this was extremely bothersome and 36% said it was
somewhat bothersome. So that's 89% of patients think that their IBS symptoms of
constipation are either extremely or somewhat bothersome.
On the right-hand side of this slide, this is a very interesting study by Sarah Ballou coming
from Boston. They asked, "What would you give up to be symptom-free of your IBS-C
symptoms for one month? What would you give up?" 62% said they'd give up all
alcohol. 58% said they'd give up all caffeine, that morning coffee or afternoon coffee
as well. 42% said they'd abstain from sex for a month if they could be symptom-free and
a quarter said they'd give up their cell phone service.
The economic burden is huge for patients with IBS with constipation. If we compare
patients with IBS and constipation to age- and gender-matched controls, costs are
nearly double. In addition, we recognize that these patients are more frequently seen in
the office. They're more frequently going to the emergency room, and they're using
more medicines and are even hospitalized for their IBS with constipation symptoms. So a
huge impact to patients and a huge impact to the healthcare system.
Let's now shift to our patient, Regina. Could you chime in and discuss your journey?
Regina: Yes. I have had IBS-C for most of my life. I have been having chronic
constipation since I was a young child. I have been to many primary care physicians,
and they've all told me basically, "Drink more water, take over-the-counters, enemas,
eat more fiber, eat less fiber, try more greens, drink this laxative tea." I mean you've
name it, I've done it. My flares are basically 15 to 16 days without going to the
bathroom, which makes me not be able to eat or swallow anything. Also makes a lot of
nausea and the vomiting.
I have gone to the doctor, I have been told, I've had colonoscopies, a couple of
colonoscopies. I have been told that I have, obviously, constipation. I've had kinky
intestines. It wasn't until my second one that I went back that I was severely impacted
and she told me that I definitely have the IBS-C, which to be honest, I was very glad
that my colonoscopy came out normal but even more ecstatic when I found out that
there is actually a name to what I have that I have been suffering for all of these years.
I have had tests done to see how the muscles in my colon, my rectum work. Yeah, I
have tried it all. I have been on different medications. Some of them have worked,
some of them have not worked at all. Some have worked for a little while. Ones that did
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work were such horrific diarrhea that I really just could not live my life without... I had to
stay in this house.
I was also told to take magnesium, but the amount of magnesium that I have to take is
enough probably to really affect me and make me very, very sick, so I was told to stop
taking that. So basically, I was told that my brain just does not tell my gut. They're not on
the same wavelength and they're not sending the right messages.
Dr. Lacy: Wonderful, Regina, that's helpful. I want to point out two really important
pieces of information. One is, it sounds like you were reassured when you received
good news with the colonoscopy, but more importantly, it sounds like one of the best
pieces of news you got was that somebody finally gave you your diagnosis. Is that true?
Regina: That's true. I was very relieved that there was actually a name to what was
happening to me.
Dr. Lacy: Wonderful. You could imagine that as a patient struggling with these
symptoms and trying so many medications and getting conflicting advice, if you don't
have a name for what you have, that could be very frustrating, couldn't it?
Regina: It's horrible. It's absolutely frustrating, and just knowing that there is no, you feel
like there's no help, you feel alone and it really does cause depression, you don't know
what to do anymore.
Dr. Lacy: Great. So important points, and we're going to come back to that because I
think you're going to highlight some of the great points that in terms of communication
and how maybe healthcare providers can communicate better and what points they
should communicate to their patients regarding the diagnosis of IBS with constipation.
So, thank you.
Let's think about the pathophysiology of IBS. Certainly, when I see a patient with IBS in
clinic, I'd like to briefly go through this because I think it points out how complex this
diagnosis and disease state can be, but it also explains to the patient maybe why it
developed. And we know that in about 25 to 30% of patients there may be a genetic
predisposition to develop IBS, not a guarantee, but a predisposition. Then we know that
there may be environmental factors, and we know that in some households, different
factors may play a role in developing IBS and patients as young children or adolescents
may even be rewarded for having symptoms of pain or bloating or constipation.
We know that there may be what I call insults to the GI tract, and we know that for
many patients it's not a single insult, but it's a case of food poisoning. It's some prior
infection, it's a history of abuse and that can be emotional, physical, sexual, financial
abuse. That can all lead to these pathophysiologic events of abnormal central
processing of sensations. Remember, IBS is a disorder of visceral hypersensitivity. Patients
sense things differently in their GI tract.
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Dr. Lacy: We know that there may be changes in the motor function of the GI tract as
well. There may be changes in the gut microbiome and changes in intestinal
permeability, and all of that can lead to these symptoms, which of course can be
exacerbated by food. We know that 60 to 80% of patients report a worsening of
symptoms with different types of food. Of course, with ongoing psychological distress, it
can exacerbate symptoms leading to a visit with a primary care provider or a
gastrointestinal specialist.
So how do we make the diagnosis of IBS with constipation? And here's our first polling
question. I'll just leave this on the screen and now let's review the answer. And the
correct answer is C. A colonoscopy is not required to make the diagnosis of IBS in all
patients and is not recommended by the American College of Gastroenterology
guidelines.
How do you make a positive diagnosis of IBS? I think there are five key features. One is
to take that great clinical history. Remember William Osler told you that 95% of the time,
patients will give you the correct diagnosis by taking that careful history, including
looking for allergies and adverse drug reactions. And as an example, for many of our
providers listening in today, when you see a patient who has 10 or 15 different drug
allergies or side effects, typically that's not a true allergic reaction. It just shows that they
are sensitive to medications as well. Make sure you take that great surgical history, ask
about diet, ask about ongoing psychological distress, and ask about those alarm or
warning signs, which I'm going to come back to.
Don't forget a careful physical examination reassures the patient. For some of your
patients who maybe you've seen for a while, remember new things develop, new
organic processes develop, and that exam can identify an organic process and
distinguish it from a disorder of gut-brain interaction. Of course, as Regina highlighted,
sometimes patients with IBS and constipation may have an overlapping pelvic floor
disorder and that can be identified with a digital rectal exam.
We don't have a great biomarker for IBS, but using the Rome IV criteria with a good
history and limited laboratory test is probably the best biomarker that we have. As
we've mentioned to some degree with a test question, a colonoscopy is not required in
all patients.
What about those alarm features? We ask about unintentional weight loss more than
10% in the last three months. We ask about blood in the stools not caused by
hemorrhoid or a known anal fissure. We think about fever and anemia or symptoms that
awaken the patient at night and obviously that physical examination looking for a
mass, ascites or lymphadenopathy. And we ask about a family history of colorectal
cancer, polyposis syndromes, celiac disease or inflammatory bowel disease. Of course,
if the answer is yes to any of these, it may change your test strategy.
The Rome IV criteria, I'm sure all of us are quite comfortable with this. We think about
recurrent abdominal pain at least one day per week on average in the last three
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months. Remember, abdominal pain does not have to be present every day, just one
day per week on average associated with either defecation or associated with a
change in stool frequency or change in stool form. Like all other Rome criteria, we want
symptoms to be active in the last three months and symptoms should have started
approximately six months ago. It's the chronicity that's so important for the diagnosis of
IBS.
I'd like to show this slide because remember that these disorders of IBS and chronic
constipation or functional constipation exist on a spectrum. As Regina highlighted
earlier, she had symptoms of chronic constipation dating way back, and that might
involve Bristol stool form type 1 or 2 shown on the left. But as you start increasing your
level of pain shown on the X-axis, that's where you would be confidently diagnosed
with IBS and constipation. Similarly, although not a topic for discussion today, if you
have loose watery bowel movements but no abdominal pain, so Bristol stool form 6 or 7,
you'd be diagnosed correctly with functional diarrhea, but as you have more
abdominal pain, then you'll be confidently diagnosed and correctly diagnosed with IBS
and diarrhea. Bloating and distension is quite common in patients with IBS, especially IBS
with constipation affecting 60 to 70%, but it's not part of the Rome criteria because it's
so nonspecific.
I mentioned limited diagnostic tests and what we recommend both from the Rome
committee and from the ACG guidelines is in the appropriate patient remember what I
call "The 4 C's." It's an easy way to remember. If not recently performed, a CBC, a CRP,
C-reactive protein for patients with IBS and possible diarrhea symptoms, get a fecal
calprotectin, and celiac serologies. But remember, if somebody just had recent
laboratory tests and they're normal, you probably don't need to do all these laboratory
tests. As I've already stated, there's no role for a colonoscopy in all your patients. Reflect
back on some of the patients you've seen with IBS in their 20s or 30s. Almost all the time
colonoscopies are normal. As Regina pointed out, fortunately she had two separate
colonoscopies, and both were normal. A great take home message is at that first visit,
make a confident diagnosis of IBS, the history, the background, the exam, the Rome IV
criteria and limited diagnostic testing, and then start to initiate treatment right away.
That will instill confidence in your patient.
When we think about this positive diagnostic approach, it's really important because
this improves communication between patients and providers. During this visit, we want
to educate our patient. We want to reassure them, we want to start treatment as soon
as we can, and we don't need to wait until all testing is completed. Remember too,
that tests can be expensive, and tests carry some risks, so we really don't want to do
unnecessary testing in all these patients.
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Module 2: Treatment
Dr. Lacy: All right, so how can we treat IBS with constipation? Let's do this second poll
question, and I'll leave this on the screen for a second for you to read. And the correct
answer is D, tenapanor improves symptoms of IBS with constipation by decreasing
absorption of sodium from the small intestine and colon.
Let's think about IBS-C treatment options. I want to think about it in three different ways.
One, let's discuss agents with limited utility that we probably just shouldn't be using. Let's
think about over-the-counter agents, because Regina pointed out that she'd used a
variety of different medications, sometimes getting conflicting advice, and let's look at
prescription medications and their mechanisms of action and review efficacy and
safety.
This is from the ACG guideline published in 2021, therapies with limited utility.
Loperamide for IBS with diarrhea has very low quality of evidence. Polyethylene glycol
shown here is safe and it's very effective for patients with chronic constipation. But
remember, the primary symptom for patients with IBS is abdominal pain. The secondary
most common symptom is bloating and polyethylene glycol does nothing for either of
those two symptoms. There's very little data for prebiotics and synbiotics, I don't
recommend it. There are now 53 published studies in IBS looking at probiotics, and these
are marginally better than placebo, so I do not routinely recommend them. And
antispasmodics may help intermittent abdominal pain but are not good for chronic
pain, and we know with the Rome criteria, pain is a chronic condition in patients with
IBS and chronic constipation.
What about OTC agents? I'm going to come back to fiber in a second, but there is
some good data for fiber. Laxatives may help occasional constipation, but generally
do not improve abdominal pain or bloating. Again, cardinal symptoms of IBS
constipation, Docusate or Colase is not very effective at all, and actually in one study
compared to placebo, it was no better than placebo and I do not recommend it.
Fiber for IBS. We have 15 randomized controlled studies involving nearly a thousand
patients and consistently fiber is better than placebo. It's not a miracle drug, but it's
certainly better and there's a strong recommendation with a moderate quality of
evidence. But it's important to point out that this should be soluble fiber such as psyllium,
not insoluble, and bran does not help and it makes things worse, so do not recommend
bran.
Now let's look at FDA-approved treatments for IBS with constipation. We're fortunate
that we have five FDA-approved medications. I'm going to go through this in three
separate ways so you'll see a little bit of repetition here. We have lubiprostone, a
chloride type two channel activator. Note that is technically only approved for women
and not men with IBS and constipation; although it did work in men, it's not approved
for men.
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We have two GC-C agonists, guanylate cyclase-C agonists, linaclotide and
plecanatide. We have a sodium hydrogen isoform exchanger inhibitor, Tenapanor, and
we have tegaserod. I'm not going to mention tegaserod much more, although it is FDA
approved and does help patients, it is no longer commercially available. It's not a
safety issue, it's a commercial availability issue, so we really won't focus on that right
now.
How do these agents work? If we think about tenapanor, kind of the new kid on the
block, this is a sodium hydrogen exchanger isoform three inhibitor, and it creates an ion
gradient that promotes water and sodium secretion into the intestinal lumen that
stimulates peristalsis, and it also improves visceral pain. Lubiprostone, as I mentioned, is
a type-two chloride channel activator and also creates an ion gradient through
secretion of chloride, again, increasing intestinal movement and improving visceral
pain. And the two GC-C agonists, linaclotide and plecanatide, act on the GC-C,
guanylate cyclase receptor. And again, this stimulates fluid movement through the GI
tract and improves visceral pain.
Using the mechanism of action, we can categorize three of these agents as
secretagogues: lubiprostone, linaclotide and plecanatide, because they all increase
fluid secretion into the GI tract, thus increasing intestinal motility. Then I want to focus on
the new kid in the block, tenapanor, this sodium hydrogen isoform exchanger type-
three because it does work differently working on the sodium hydrogen isoform
exchanger. This is important to point out because for patients who may have tried other
agents such as lubiprostone, linaclotide or plecanatide and may not have had
improvement in their symptoms, we now have a new medication with a new
mechanism of action.
Now, does this medication, tenapanor work? Well, looking at data from a 26-week trial
involving 620 patients, we find that tenapanor, shown here in black, at 50 milligrams
twice daily compared to placebo, had a significant improvement in the overall
treatment response during this trial period, and that means an improvement in both
abdominal pain and an improvement in constipation symptoms measured by one
complete spontaneous bowel movement per week more compared to baseline. If we
look at abdominal pain as a single indicator, patients treated with tenapanor, shown in
black, were more likely to have an improvement in their chronic abdominal pain
symptoms compared to the patients treated with placebo, shown in white. And
similarly, if we look at constipation symptoms using complete spontaneous bowel
movement as the indicator, once again, patients treated with tenapanor were more
likely to respond than patients treated with placebo.
In terms of side effects, diarrhea was a common side effect, and we expect that of
agents used to stimulate the GI tract. This is no surprise. As Regina highlighted earlier,
she had had side effects of diarrhea with several different medications. One way for
healthcare providers to explain that to patients is one, explain early on when you start
the medication that diarrhea may occur. To me, that's oftentimes a sign of success
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showing that the medication is working, but you just may need to decrease the dose in
terms of either the dosing amount or the frequency.
Let's go to poll question number three, and the correct answer is B, there are currently
five FDA-approved medications for the treatment of IBS with constipation.
Okay, let's think about guidelines, and there are IBS guidelines from the two major GI
societies. One, the ACG, American College of Gastroenterology, published in 2021, and
two, the AGA, the American Gastroenterological Association, published by Lin Chang
and colleagues in 2022.
Now, guidelines are just guidelines. Remember that guidelines are meant for the
general population but may not always apply to a specific patient in your office that
day. And generally, these guidelines match up pretty well, and this slide is meant to
highlight the fact that generally the AGA guidelines and ACG guidelines are pretty
similar. Regarding, as an example, antispasmodics, quality of evidence is low. I don't
generally recommend them. Lubiprostone has a moderate level of evidence from both
societies. There is one distinction here. The ACG guidelines came out in 2021 and we
were not able to look at the data for plecanatide yet, so you'll notice that that is missing
here, but the AGA did have access to that data a year later and gave it a moderate
level of evidence. I've already mentioned that tegaserod is safe and can be effective,
but it's not commercially available. Again, the ACG guidelines came out a little bit
earlier than the AGA guidelines, we could not include tenapanor in our analysis;
however, the AGA gave it a moderate quality of evidence.
Let's briefly think about novel therapies, because we've now talked about things we
shouldn't use. We've talked about over-the-counter regimens, and we've talked about
the five FDA-attributed medications, but many patients ask what else is out there and
they've been doing some research on their own. So let's briefly go through five things:
the vibrating capsule, fecal transplant, neuromodulators, brain-gut behavioral therapy,
and virtual reality. The vibrating capsule is being used to treat chronic constipation, so
note chronic constipation, not IBS with constipation, but your patients may ask about
this. It has been shown in a very nice study published in Gastroenterology to help
symptoms across constipation, but it may not and probably won't help abdominal pain.
Again, the cardinal symptom of IBS.
What about a fecal transplant? Many patients ask about this, because I've already
mentioned that changes in the gut microbiome can affect the gut, which can actually
affect the brain. But the data here is very mixed. A nice study published in the
American Journal of Gastroenterology several years ago showed that two studies
showed some modest benefit, but two studies did not show any benefit. So I do not
recommend the use of a fecal transplant outside of a research study for the treatment
of IBS. There are some dangers associated with this, so do not recommend this to your
patient unless they're involved in a research study.
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Neuromodulators, this is a brain-gut disorder, so can we affect the brain? This is a very
nice study from Alex Ford just published in the fall of 2023, looking at the use of low dose
amitriptyline in primary care practice for all IBS patients, including IBS with constipation,
who had basically failed over-the-counter agents or dietary interventions. The key point
here is that low dose of 20 milligrams or 30 milligrams each night led to a significant
improvement in global IBS symptoms, pain, spasms, cramps, bloating. Much better than
placebo, so feel confident using low dose amitriptyline, a neuromodulator to help this
brain-gut disorder.
What about gut directed psychotherapies? Whether it's hypnotherapy or cognitive
behavioral therapy or mindfulness or relaxation training, the data here is we don't have
a lot of data, but the data, especially for CBT, is very good with a number needed to
treat of four. The teaching point here is feel confident recommending these because
this will help this disorder of gut-brain interaction, may help with hypervigilance, may
help with patients who catastrophize, may help ongoing visceral hypersensitivity and
anxiety. And don't save this for a last-ditch effort, feel very comfortable recommending
this early on along with FDA approved medications.
What about virtual reality? There's a real heightened sense of awareness that this may
be a game changer for these disorders of gut-brain interaction. Why might they work?
Well, because this immersive therapy can affect the brain, that may help tamp down
some of the signals from the brain to the gut, but also tamp down some of these
afferent signals from the gut to the brain. We have a nice published study looking at the
role of virtual reality for functional dyspepsia, a positive study, and there's now an
ongoing study for IBS with constipation, so stay tuned in about a year for new results.
Module 3: Patient-Provider Communication
Dr. Lacy: Now, let's focus, in the last few minutes, talking about patient-provider
communication. We have poll question number four. I'll leave this on the screen for a
minute. The correct answer is C, effective management of patients with IBS includes a
patient-centered approach with an emphasis on communication and joint decision-
making. This is so critical to establish that really good working relationship between the
patient and the healthcare provider. As I already mentioned, patients want to give you
their story and they will give you the correct diagnosis if we listen, but we have to take
in account. We have to give them time, we have to consider their background, we
have to consider their history and their gender and their medical literacy so that we
can really get that story out, work with that patient, and come up with a joint program.
Let's go back to Regina and talk to her about what she considers that ideal patient
experience and how it worked for her when she was working with her doctors.
Regina: My experience would be to have my doctor actively listen to me, as I'm
explaining all of my symptoms, and to have some empathy for what I am actually
going through, and also being prepared for my appointment, like reviewing my chart
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before I get there, have some type of knowledge or background about my illness. I'd
like them to be able to give me knowledge on my medications and procedures and
nutrition, anything that could possibly help me with whatever issue I have going on with
my IBS. Most importantly, acknowledge that I actually have an issue. I don't want to be
dismissed, that it's just something that I am going through and it's really not that bad. It is
not psychosomatic, it is real, and just realizing that it really does affect all the aspects of
my life.
Dr. Lacy: Wow, this is great. We should really reflect on this because we're hearing from
a patient with many years of symptoms, who saw many providers, who tried many
medications, received some conflicting advice, confusing advice. This is what the
patient wants.
How do we make this happen in the clinic? How do we create that shared
understanding of patients’ IBS symptoms? We just heard from Regina about eliciting the
patient's perspective and understanding the patient's beliefs. Some questions you might
want to use in your clinic visit is, "What do you think is the cause of your illness?" And I ask
patients that. "What do you think is going on? This is not a trick question. I want to know
what you know and what do your family and friends think about your condition?" I ask
them, "How do these symptoms affect your life?"
I want to know what's going on. Does it affect their work life, home life, social life, sex
life? I want to ask, "What are you concerned about in terms of your IBS symptoms?" And
then as we start thinking about a pathway forward in terms of treatment, it's important,
this is no longer a paternalistic system. We can't just tell patients what to do. It doesn't
work. We need to involve the patient on multiple levels, amd part of that is setting
realistic goals. I tell patients, "We can't cure IBS, but we also can't cure diabetes or high
blood pressure. We treat it and I'll do the best job I can to treat your symptoms as best I
can." I want to make sure I use the patient's words, so when I come back to their
symptoms, "What's your most bothersome symptom?" Maybe it's that burning sensation.
How do we treat it? We get patients involved in the decision-making. So, "We have five
FDA-approved medications. Which ones have you used before? Let's think about cost.
Let's think about safety. Let's think about efficacy." As we're doing that, I ask about
maybe there are some barriers to the plan, maybe insurance or finances are an issue
and they can't receive linaclotide or lubiprostone or tenapanor as examples, or they
just can't take a medicine twice a day for whatever reason. Let's identify those possible
barriers to the treatment plan. And of course, I really try to encourage questions. "What
do you think about this?" "Is this something we can do together?" "What do you think is a
reasonable follow-up plan?"
Emphasizing this again, if I were to hone this down and think about five key aspects of
patient care. We need to listen. Don't be the average healthcare provider who
interrupts the patient after 18 seconds. Remember, they may have waited weeks or
months to see you. Let them tell their story. Educate the patient to their condition. We
heard that from Regina. She wants to be educated about the disease state, why it
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happened, what treatment options are available out there and medications or diet.
Reassure them. I tell my patients, "IBS never turns to anything serious. It does not lead to
cancer. It does not shorten lifespan." Make that confident diagnosis at the first visit,
which we've discussed. Then of course our real goal is how can we improve symptoms?
All right, so making that diagnosis and initiating treatment is critical and that confident
diagnosis is important. We've discussed addressing goals of the patient. I've given up
guessing what patients want, what their goal is. I ask each patient point-blank, "If you
had to fix one thing, what would you fix today? What is your goal? What's the most
important thing we need to address today?" We discussed reviewing concerns,
reviewing treatment options together, and really for IBS with constipation, focus on the
most bothersome symptom. For some people, it's pain. For some patients it's
constipation. For other patients, it may be bloating. So don't lump them all together. As
you're having this discussion, remember, use clear language. Let's improve our
communication. You don't want to be the patient where you're told, "Well, Mrs. Jones,
maybe you have IBS," and, "It could possibly be that," and, "Might be consistent with
this," and, "I think I saw somebody once with this before." You don't want to say that.
What you want to say is, "Mrs. Jones, you have IBS. This is common. It affects up to 10%
of the population. It never leads anything bad. We can confidently make a diagnosis
and fortunately we have a number of great treatment options. Let's discuss that." Be
confident in your ability because you know an awful lot, especially if you just went
through this lecture today.
In summary, IBS is a subtype of IBS characterized by constipation and recurrent
abdominal pain. It has a substantial impact on patients and the healthcare system. We
are fortunate that we have five FDA approved treatment options, including the
secretagogues, lubiprostone, linaclotide and plecanatide, and a new kid on the block,
an NHE3 inhibitor, tenapanor. In terms of IBS-C patient-centered care, patients, families
and the healthcare team need to collaborate together. They need to communicate to
make management decisions that are tailored to the individual patient. This is
personalized care, and as we've learned from Regina, patient education is critical to
effective care in IBS with constipation and can be achieved by individualized learning,
stimulating interest, and including members of the patient's community. Regina, any last
comments to our listeners today?
Regina: I just hope that everybody can get the help that they need and to not give up.
There is help out there. I also would love to have the medical community and just
community in general to realize that this is a chronic illness, and it does affect people
and it affects them all through their lives. Every aspect of their life gets affected and
there is help out there. They just have to stay strong and stay with it.
Dr. Lacy: Wonderful, Regina. I like that a lot. A key message here is don't give up.
Patients shouldn't give up, and healthcare providers shouldn't give up as well. We need
to personalize treatment and really to improve symptoms. Thank you for joining us
today. We really appreciate you taking time out of your busy day to listen to this
seminar. In four weeks, you'll receive a follow-up survey to see if you've been able to
IBS-C Patient POV
Page 12 of 12
implement any of your intended changes as a result of what you've learned here
today. We're excited and I think Regina is excited as well to see the impact of this
educational activity on patient care and IBS with constipation. And if you have any
questions at all about any of the information presented today, please send us an email
to devi@cmespark.com. Thank you again. I'm Brian Lacy, Professor of Medicine at Mayo
Clinic and, Regina, thank you so much for your great insights today.
Regina: Thank you for having me.

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Irritable Bowel Syndrome with Constipation: Patient POV CME Program Transcript

  • 1. IBS-C Patient POV Page 1 of 12 Patient POV: Incorporating Shared Decision Making in IBS-C Management Module 1: Introduction and Diagnosis Brian Lacy, MD, PhD, FACG: Welcome. My name is Brian Lacy. I'm a Professor of Medicine at Mayo Clinic. Today's discussion is that of Patient Point of View: Incorporating Shared Decision Making in IBS with Constipation Management. And this is jointly sponsored by the American Gastroenterological Association and CME Spark. And I am absolutely delighted to have Regina Ciavarella joining us today. Do you want to say hello, Regina? Regina Ciavarella: Thank you, Dr. Lacy. Yes, my name is Regina Ciavarella. I'm a patient advocate. Dr. Lacy: Wonderful. So that's going to provide a great perspective for our discussion today. Our disclosures are noted here and the objectives for our presentation are listed here. And in brief, we want to discuss the diverse pathophysiologic mechanisms of IBS with constipation. We'll discuss efficacy and safety data and we're going to discuss strategies to optimize patient-provider communication regarding IBS with constipation. Let's begin briefly with an overview and remember that IBS—irritable bowel syndrome— is a disorder of gut-brain interaction, abbreviated as DGBI. And these DGBIs were formerly called functional bowel disorders. These arise due to dysfunction in the brain- gut axis illustrated here on the right side of the screen, and this is a bidirectional pathway from the brain to the gut and from the gut to the brain. The underlying pathophysiology of DGBI is that of a perceptive abnormality, and really the predominant symptom is that of abdominal pain. I like this slide a lot illustrating how external events: stress, emotion, anxiety, can affect the brain, which can affect the gut. Of course, changes in the gut, which could include changes in the gut microbiome, can then affect the brain. Now how common are these DGBIs, formerly called functional bowel disorders? I like this slide because it illustrates how very common these disorders are. On the very inner ring are located countries. So this is a survey study of 33 countries involving more than 80,000 patients. On the second inner ring this lists the prevalence of IBS. So if we use the U.S. as an example, the prevalence of IBS in the U.S. is over 5%. But if we look at any disorder of gut-brain interaction, we recognize that the prevalence in the United States is over 40% and that's quite common throughout the world. I already briefly mentioned the epidemiology of IBS. We know that the worldwide prevalence is about 4.1 to 4.6% using the Rome IV criteria. Those are a bit more strict than the Rome III criteria where the worldwide prevalence was about 10%. As mentioned, the prevalence of IBS in the United States is over 5% and in many clinic populations it's about 10%. So that means about 1 in 10 patients in a GI clinic likely comes in with symptoms of IBS. This is a disorder more frequently identified in women and in younger patients than older patients. That being said, I refer to this as an equal
  • 2. IBS-C Patient POV Page 2 of 12 opportunity offender. Regardless of race, ethnicity, religion, or socioeconomic status, IBS affects all of these patients. Now how impactful is IBS? We can think about the impact on patients, and we can think about the impact of IBS in terms of the healthcare system. But this slide really illustrates how impactful IBS is in terms of patients. If we think about just a single question of “how bothersome is this to you?” And we think about patients with IBS and constipation shown in blue, 53% said this was extremely bothersome and 36% said it was somewhat bothersome. So that's 89% of patients think that their IBS symptoms of constipation are either extremely or somewhat bothersome. On the right-hand side of this slide, this is a very interesting study by Sarah Ballou coming from Boston. They asked, "What would you give up to be symptom-free of your IBS-C symptoms for one month? What would you give up?" 62% said they'd give up all alcohol. 58% said they'd give up all caffeine, that morning coffee or afternoon coffee as well. 42% said they'd abstain from sex for a month if they could be symptom-free and a quarter said they'd give up their cell phone service. The economic burden is huge for patients with IBS with constipation. If we compare patients with IBS and constipation to age- and gender-matched controls, costs are nearly double. In addition, we recognize that these patients are more frequently seen in the office. They're more frequently going to the emergency room, and they're using more medicines and are even hospitalized for their IBS with constipation symptoms. So a huge impact to patients and a huge impact to the healthcare system. Let's now shift to our patient, Regina. Could you chime in and discuss your journey? Regina: Yes. I have had IBS-C for most of my life. I have been having chronic constipation since I was a young child. I have been to many primary care physicians, and they've all told me basically, "Drink more water, take over-the-counters, enemas, eat more fiber, eat less fiber, try more greens, drink this laxative tea." I mean you've name it, I've done it. My flares are basically 15 to 16 days without going to the bathroom, which makes me not be able to eat or swallow anything. Also makes a lot of nausea and the vomiting. I have gone to the doctor, I have been told, I've had colonoscopies, a couple of colonoscopies. I have been told that I have, obviously, constipation. I've had kinky intestines. It wasn't until my second one that I went back that I was severely impacted and she told me that I definitely have the IBS-C, which to be honest, I was very glad that my colonoscopy came out normal but even more ecstatic when I found out that there is actually a name to what I have that I have been suffering for all of these years. I have had tests done to see how the muscles in my colon, my rectum work. Yeah, I have tried it all. I have been on different medications. Some of them have worked, some of them have not worked at all. Some have worked for a little while. Ones that did
  • 3. IBS-C Patient POV Page 3 of 12 work were such horrific diarrhea that I really just could not live my life without... I had to stay in this house. I was also told to take magnesium, but the amount of magnesium that I have to take is enough probably to really affect me and make me very, very sick, so I was told to stop taking that. So basically, I was told that my brain just does not tell my gut. They're not on the same wavelength and they're not sending the right messages. Dr. Lacy: Wonderful, Regina, that's helpful. I want to point out two really important pieces of information. One is, it sounds like you were reassured when you received good news with the colonoscopy, but more importantly, it sounds like one of the best pieces of news you got was that somebody finally gave you your diagnosis. Is that true? Regina: That's true. I was very relieved that there was actually a name to what was happening to me. Dr. Lacy: Wonderful. You could imagine that as a patient struggling with these symptoms and trying so many medications and getting conflicting advice, if you don't have a name for what you have, that could be very frustrating, couldn't it? Regina: It's horrible. It's absolutely frustrating, and just knowing that there is no, you feel like there's no help, you feel alone and it really does cause depression, you don't know what to do anymore. Dr. Lacy: Great. So important points, and we're going to come back to that because I think you're going to highlight some of the great points that in terms of communication and how maybe healthcare providers can communicate better and what points they should communicate to their patients regarding the diagnosis of IBS with constipation. So, thank you. Let's think about the pathophysiology of IBS. Certainly, when I see a patient with IBS in clinic, I'd like to briefly go through this because I think it points out how complex this diagnosis and disease state can be, but it also explains to the patient maybe why it developed. And we know that in about 25 to 30% of patients there may be a genetic predisposition to develop IBS, not a guarantee, but a predisposition. Then we know that there may be environmental factors, and we know that in some households, different factors may play a role in developing IBS and patients as young children or adolescents may even be rewarded for having symptoms of pain or bloating or constipation. We know that there may be what I call insults to the GI tract, and we know that for many patients it's not a single insult, but it's a case of food poisoning. It's some prior infection, it's a history of abuse and that can be emotional, physical, sexual, financial abuse. That can all lead to these pathophysiologic events of abnormal central processing of sensations. Remember, IBS is a disorder of visceral hypersensitivity. Patients sense things differently in their GI tract.
  • 4. IBS-C Patient POV Page 4 of 12 Dr. Lacy: We know that there may be changes in the motor function of the GI tract as well. There may be changes in the gut microbiome and changes in intestinal permeability, and all of that can lead to these symptoms, which of course can be exacerbated by food. We know that 60 to 80% of patients report a worsening of symptoms with different types of food. Of course, with ongoing psychological distress, it can exacerbate symptoms leading to a visit with a primary care provider or a gastrointestinal specialist. So how do we make the diagnosis of IBS with constipation? And here's our first polling question. I'll just leave this on the screen and now let's review the answer. And the correct answer is C. A colonoscopy is not required to make the diagnosis of IBS in all patients and is not recommended by the American College of Gastroenterology guidelines. How do you make a positive diagnosis of IBS? I think there are five key features. One is to take that great clinical history. Remember William Osler told you that 95% of the time, patients will give you the correct diagnosis by taking that careful history, including looking for allergies and adverse drug reactions. And as an example, for many of our providers listening in today, when you see a patient who has 10 or 15 different drug allergies or side effects, typically that's not a true allergic reaction. It just shows that they are sensitive to medications as well. Make sure you take that great surgical history, ask about diet, ask about ongoing psychological distress, and ask about those alarm or warning signs, which I'm going to come back to. Don't forget a careful physical examination reassures the patient. For some of your patients who maybe you've seen for a while, remember new things develop, new organic processes develop, and that exam can identify an organic process and distinguish it from a disorder of gut-brain interaction. Of course, as Regina highlighted, sometimes patients with IBS and constipation may have an overlapping pelvic floor disorder and that can be identified with a digital rectal exam. We don't have a great biomarker for IBS, but using the Rome IV criteria with a good history and limited laboratory test is probably the best biomarker that we have. As we've mentioned to some degree with a test question, a colonoscopy is not required in all patients. What about those alarm features? We ask about unintentional weight loss more than 10% in the last three months. We ask about blood in the stools not caused by hemorrhoid or a known anal fissure. We think about fever and anemia or symptoms that awaken the patient at night and obviously that physical examination looking for a mass, ascites or lymphadenopathy. And we ask about a family history of colorectal cancer, polyposis syndromes, celiac disease or inflammatory bowel disease. Of course, if the answer is yes to any of these, it may change your test strategy. The Rome IV criteria, I'm sure all of us are quite comfortable with this. We think about recurrent abdominal pain at least one day per week on average in the last three
  • 5. IBS-C Patient POV Page 5 of 12 months. Remember, abdominal pain does not have to be present every day, just one day per week on average associated with either defecation or associated with a change in stool frequency or change in stool form. Like all other Rome criteria, we want symptoms to be active in the last three months and symptoms should have started approximately six months ago. It's the chronicity that's so important for the diagnosis of IBS. I'd like to show this slide because remember that these disorders of IBS and chronic constipation or functional constipation exist on a spectrum. As Regina highlighted earlier, she had symptoms of chronic constipation dating way back, and that might involve Bristol stool form type 1 or 2 shown on the left. But as you start increasing your level of pain shown on the X-axis, that's where you would be confidently diagnosed with IBS and constipation. Similarly, although not a topic for discussion today, if you have loose watery bowel movements but no abdominal pain, so Bristol stool form 6 or 7, you'd be diagnosed correctly with functional diarrhea, but as you have more abdominal pain, then you'll be confidently diagnosed and correctly diagnosed with IBS and diarrhea. Bloating and distension is quite common in patients with IBS, especially IBS with constipation affecting 60 to 70%, but it's not part of the Rome criteria because it's so nonspecific. I mentioned limited diagnostic tests and what we recommend both from the Rome committee and from the ACG guidelines is in the appropriate patient remember what I call "The 4 C's." It's an easy way to remember. If not recently performed, a CBC, a CRP, C-reactive protein for patients with IBS and possible diarrhea symptoms, get a fecal calprotectin, and celiac serologies. But remember, if somebody just had recent laboratory tests and they're normal, you probably don't need to do all these laboratory tests. As I've already stated, there's no role for a colonoscopy in all your patients. Reflect back on some of the patients you've seen with IBS in their 20s or 30s. Almost all the time colonoscopies are normal. As Regina pointed out, fortunately she had two separate colonoscopies, and both were normal. A great take home message is at that first visit, make a confident diagnosis of IBS, the history, the background, the exam, the Rome IV criteria and limited diagnostic testing, and then start to initiate treatment right away. That will instill confidence in your patient. When we think about this positive diagnostic approach, it's really important because this improves communication between patients and providers. During this visit, we want to educate our patient. We want to reassure them, we want to start treatment as soon as we can, and we don't need to wait until all testing is completed. Remember too, that tests can be expensive, and tests carry some risks, so we really don't want to do unnecessary testing in all these patients.
  • 6. IBS-C Patient POV Page 6 of 12 Module 2: Treatment Dr. Lacy: All right, so how can we treat IBS with constipation? Let's do this second poll question, and I'll leave this on the screen for a second for you to read. And the correct answer is D, tenapanor improves symptoms of IBS with constipation by decreasing absorption of sodium from the small intestine and colon. Let's think about IBS-C treatment options. I want to think about it in three different ways. One, let's discuss agents with limited utility that we probably just shouldn't be using. Let's think about over-the-counter agents, because Regina pointed out that she'd used a variety of different medications, sometimes getting conflicting advice, and let's look at prescription medications and their mechanisms of action and review efficacy and safety. This is from the ACG guideline published in 2021, therapies with limited utility. Loperamide for IBS with diarrhea has very low quality of evidence. Polyethylene glycol shown here is safe and it's very effective for patients with chronic constipation. But remember, the primary symptom for patients with IBS is abdominal pain. The secondary most common symptom is bloating and polyethylene glycol does nothing for either of those two symptoms. There's very little data for prebiotics and synbiotics, I don't recommend it. There are now 53 published studies in IBS looking at probiotics, and these are marginally better than placebo, so I do not routinely recommend them. And antispasmodics may help intermittent abdominal pain but are not good for chronic pain, and we know with the Rome criteria, pain is a chronic condition in patients with IBS and chronic constipation. What about OTC agents? I'm going to come back to fiber in a second, but there is some good data for fiber. Laxatives may help occasional constipation, but generally do not improve abdominal pain or bloating. Again, cardinal symptoms of IBS constipation, Docusate or Colase is not very effective at all, and actually in one study compared to placebo, it was no better than placebo and I do not recommend it. Fiber for IBS. We have 15 randomized controlled studies involving nearly a thousand patients and consistently fiber is better than placebo. It's not a miracle drug, but it's certainly better and there's a strong recommendation with a moderate quality of evidence. But it's important to point out that this should be soluble fiber such as psyllium, not insoluble, and bran does not help and it makes things worse, so do not recommend bran. Now let's look at FDA-approved treatments for IBS with constipation. We're fortunate that we have five FDA-approved medications. I'm going to go through this in three separate ways so you'll see a little bit of repetition here. We have lubiprostone, a chloride type two channel activator. Note that is technically only approved for women and not men with IBS and constipation; although it did work in men, it's not approved for men.
  • 7. IBS-C Patient POV Page 7 of 12 We have two GC-C agonists, guanylate cyclase-C agonists, linaclotide and plecanatide. We have a sodium hydrogen isoform exchanger inhibitor, Tenapanor, and we have tegaserod. I'm not going to mention tegaserod much more, although it is FDA approved and does help patients, it is no longer commercially available. It's not a safety issue, it's a commercial availability issue, so we really won't focus on that right now. How do these agents work? If we think about tenapanor, kind of the new kid on the block, this is a sodium hydrogen exchanger isoform three inhibitor, and it creates an ion gradient that promotes water and sodium secretion into the intestinal lumen that stimulates peristalsis, and it also improves visceral pain. Lubiprostone, as I mentioned, is a type-two chloride channel activator and also creates an ion gradient through secretion of chloride, again, increasing intestinal movement and improving visceral pain. And the two GC-C agonists, linaclotide and plecanatide, act on the GC-C, guanylate cyclase receptor. And again, this stimulates fluid movement through the GI tract and improves visceral pain. Using the mechanism of action, we can categorize three of these agents as secretagogues: lubiprostone, linaclotide and plecanatide, because they all increase fluid secretion into the GI tract, thus increasing intestinal motility. Then I want to focus on the new kid in the block, tenapanor, this sodium hydrogen isoform exchanger type- three because it does work differently working on the sodium hydrogen isoform exchanger. This is important to point out because for patients who may have tried other agents such as lubiprostone, linaclotide or plecanatide and may not have had improvement in their symptoms, we now have a new medication with a new mechanism of action. Now, does this medication, tenapanor work? Well, looking at data from a 26-week trial involving 620 patients, we find that tenapanor, shown here in black, at 50 milligrams twice daily compared to placebo, had a significant improvement in the overall treatment response during this trial period, and that means an improvement in both abdominal pain and an improvement in constipation symptoms measured by one complete spontaneous bowel movement per week more compared to baseline. If we look at abdominal pain as a single indicator, patients treated with tenapanor, shown in black, were more likely to have an improvement in their chronic abdominal pain symptoms compared to the patients treated with placebo, shown in white. And similarly, if we look at constipation symptoms using complete spontaneous bowel movement as the indicator, once again, patients treated with tenapanor were more likely to respond than patients treated with placebo. In terms of side effects, diarrhea was a common side effect, and we expect that of agents used to stimulate the GI tract. This is no surprise. As Regina highlighted earlier, she had had side effects of diarrhea with several different medications. One way for healthcare providers to explain that to patients is one, explain early on when you start the medication that diarrhea may occur. To me, that's oftentimes a sign of success
  • 8. IBS-C Patient POV Page 8 of 12 showing that the medication is working, but you just may need to decrease the dose in terms of either the dosing amount or the frequency. Let's go to poll question number three, and the correct answer is B, there are currently five FDA-approved medications for the treatment of IBS with constipation. Okay, let's think about guidelines, and there are IBS guidelines from the two major GI societies. One, the ACG, American College of Gastroenterology, published in 2021, and two, the AGA, the American Gastroenterological Association, published by Lin Chang and colleagues in 2022. Now, guidelines are just guidelines. Remember that guidelines are meant for the general population but may not always apply to a specific patient in your office that day. And generally, these guidelines match up pretty well, and this slide is meant to highlight the fact that generally the AGA guidelines and ACG guidelines are pretty similar. Regarding, as an example, antispasmodics, quality of evidence is low. I don't generally recommend them. Lubiprostone has a moderate level of evidence from both societies. There is one distinction here. The ACG guidelines came out in 2021 and we were not able to look at the data for plecanatide yet, so you'll notice that that is missing here, but the AGA did have access to that data a year later and gave it a moderate level of evidence. I've already mentioned that tegaserod is safe and can be effective, but it's not commercially available. Again, the ACG guidelines came out a little bit earlier than the AGA guidelines, we could not include tenapanor in our analysis; however, the AGA gave it a moderate quality of evidence. Let's briefly think about novel therapies, because we've now talked about things we shouldn't use. We've talked about over-the-counter regimens, and we've talked about the five FDA-attributed medications, but many patients ask what else is out there and they've been doing some research on their own. So let's briefly go through five things: the vibrating capsule, fecal transplant, neuromodulators, brain-gut behavioral therapy, and virtual reality. The vibrating capsule is being used to treat chronic constipation, so note chronic constipation, not IBS with constipation, but your patients may ask about this. It has been shown in a very nice study published in Gastroenterology to help symptoms across constipation, but it may not and probably won't help abdominal pain. Again, the cardinal symptom of IBS. What about a fecal transplant? Many patients ask about this, because I've already mentioned that changes in the gut microbiome can affect the gut, which can actually affect the brain. But the data here is very mixed. A nice study published in the American Journal of Gastroenterology several years ago showed that two studies showed some modest benefit, but two studies did not show any benefit. So I do not recommend the use of a fecal transplant outside of a research study for the treatment of IBS. There are some dangers associated with this, so do not recommend this to your patient unless they're involved in a research study.
  • 9. IBS-C Patient POV Page 9 of 12 Neuromodulators, this is a brain-gut disorder, so can we affect the brain? This is a very nice study from Alex Ford just published in the fall of 2023, looking at the use of low dose amitriptyline in primary care practice for all IBS patients, including IBS with constipation, who had basically failed over-the-counter agents or dietary interventions. The key point here is that low dose of 20 milligrams or 30 milligrams each night led to a significant improvement in global IBS symptoms, pain, spasms, cramps, bloating. Much better than placebo, so feel confident using low dose amitriptyline, a neuromodulator to help this brain-gut disorder. What about gut directed psychotherapies? Whether it's hypnotherapy or cognitive behavioral therapy or mindfulness or relaxation training, the data here is we don't have a lot of data, but the data, especially for CBT, is very good with a number needed to treat of four. The teaching point here is feel confident recommending these because this will help this disorder of gut-brain interaction, may help with hypervigilance, may help with patients who catastrophize, may help ongoing visceral hypersensitivity and anxiety. And don't save this for a last-ditch effort, feel very comfortable recommending this early on along with FDA approved medications. What about virtual reality? There's a real heightened sense of awareness that this may be a game changer for these disorders of gut-brain interaction. Why might they work? Well, because this immersive therapy can affect the brain, that may help tamp down some of the signals from the brain to the gut, but also tamp down some of these afferent signals from the gut to the brain. We have a nice published study looking at the role of virtual reality for functional dyspepsia, a positive study, and there's now an ongoing study for IBS with constipation, so stay tuned in about a year for new results. Module 3: Patient-Provider Communication Dr. Lacy: Now, let's focus, in the last few minutes, talking about patient-provider communication. We have poll question number four. I'll leave this on the screen for a minute. The correct answer is C, effective management of patients with IBS includes a patient-centered approach with an emphasis on communication and joint decision- making. This is so critical to establish that really good working relationship between the patient and the healthcare provider. As I already mentioned, patients want to give you their story and they will give you the correct diagnosis if we listen, but we have to take in account. We have to give them time, we have to consider their background, we have to consider their history and their gender and their medical literacy so that we can really get that story out, work with that patient, and come up with a joint program. Let's go back to Regina and talk to her about what she considers that ideal patient experience and how it worked for her when she was working with her doctors. Regina: My experience would be to have my doctor actively listen to me, as I'm explaining all of my symptoms, and to have some empathy for what I am actually going through, and also being prepared for my appointment, like reviewing my chart
  • 10. IBS-C Patient POV Page 10 of 12 before I get there, have some type of knowledge or background about my illness. I'd like them to be able to give me knowledge on my medications and procedures and nutrition, anything that could possibly help me with whatever issue I have going on with my IBS. Most importantly, acknowledge that I actually have an issue. I don't want to be dismissed, that it's just something that I am going through and it's really not that bad. It is not psychosomatic, it is real, and just realizing that it really does affect all the aspects of my life. Dr. Lacy: Wow, this is great. We should really reflect on this because we're hearing from a patient with many years of symptoms, who saw many providers, who tried many medications, received some conflicting advice, confusing advice. This is what the patient wants. How do we make this happen in the clinic? How do we create that shared understanding of patients’ IBS symptoms? We just heard from Regina about eliciting the patient's perspective and understanding the patient's beliefs. Some questions you might want to use in your clinic visit is, "What do you think is the cause of your illness?" And I ask patients that. "What do you think is going on? This is not a trick question. I want to know what you know and what do your family and friends think about your condition?" I ask them, "How do these symptoms affect your life?" I want to know what's going on. Does it affect their work life, home life, social life, sex life? I want to ask, "What are you concerned about in terms of your IBS symptoms?" And then as we start thinking about a pathway forward in terms of treatment, it's important, this is no longer a paternalistic system. We can't just tell patients what to do. It doesn't work. We need to involve the patient on multiple levels, amd part of that is setting realistic goals. I tell patients, "We can't cure IBS, but we also can't cure diabetes or high blood pressure. We treat it and I'll do the best job I can to treat your symptoms as best I can." I want to make sure I use the patient's words, so when I come back to their symptoms, "What's your most bothersome symptom?" Maybe it's that burning sensation. How do we treat it? We get patients involved in the decision-making. So, "We have five FDA-approved medications. Which ones have you used before? Let's think about cost. Let's think about safety. Let's think about efficacy." As we're doing that, I ask about maybe there are some barriers to the plan, maybe insurance or finances are an issue and they can't receive linaclotide or lubiprostone or tenapanor as examples, or they just can't take a medicine twice a day for whatever reason. Let's identify those possible barriers to the treatment plan. And of course, I really try to encourage questions. "What do you think about this?" "Is this something we can do together?" "What do you think is a reasonable follow-up plan?" Emphasizing this again, if I were to hone this down and think about five key aspects of patient care. We need to listen. Don't be the average healthcare provider who interrupts the patient after 18 seconds. Remember, they may have waited weeks or months to see you. Let them tell their story. Educate the patient to their condition. We heard that from Regina. She wants to be educated about the disease state, why it
  • 11. IBS-C Patient POV Page 11 of 12 happened, what treatment options are available out there and medications or diet. Reassure them. I tell my patients, "IBS never turns to anything serious. It does not lead to cancer. It does not shorten lifespan." Make that confident diagnosis at the first visit, which we've discussed. Then of course our real goal is how can we improve symptoms? All right, so making that diagnosis and initiating treatment is critical and that confident diagnosis is important. We've discussed addressing goals of the patient. I've given up guessing what patients want, what their goal is. I ask each patient point-blank, "If you had to fix one thing, what would you fix today? What is your goal? What's the most important thing we need to address today?" We discussed reviewing concerns, reviewing treatment options together, and really for IBS with constipation, focus on the most bothersome symptom. For some people, it's pain. For some patients it's constipation. For other patients, it may be bloating. So don't lump them all together. As you're having this discussion, remember, use clear language. Let's improve our communication. You don't want to be the patient where you're told, "Well, Mrs. Jones, maybe you have IBS," and, "It could possibly be that," and, "Might be consistent with this," and, "I think I saw somebody once with this before." You don't want to say that. What you want to say is, "Mrs. Jones, you have IBS. This is common. It affects up to 10% of the population. It never leads anything bad. We can confidently make a diagnosis and fortunately we have a number of great treatment options. Let's discuss that." Be confident in your ability because you know an awful lot, especially if you just went through this lecture today. In summary, IBS is a subtype of IBS characterized by constipation and recurrent abdominal pain. It has a substantial impact on patients and the healthcare system. We are fortunate that we have five FDA approved treatment options, including the secretagogues, lubiprostone, linaclotide and plecanatide, and a new kid on the block, an NHE3 inhibitor, tenapanor. In terms of IBS-C patient-centered care, patients, families and the healthcare team need to collaborate together. They need to communicate to make management decisions that are tailored to the individual patient. This is personalized care, and as we've learned from Regina, patient education is critical to effective care in IBS with constipation and can be achieved by individualized learning, stimulating interest, and including members of the patient's community. Regina, any last comments to our listeners today? Regina: I just hope that everybody can get the help that they need and to not give up. There is help out there. I also would love to have the medical community and just community in general to realize that this is a chronic illness, and it does affect people and it affects them all through their lives. Every aspect of their life gets affected and there is help out there. They just have to stay strong and stay with it. Dr. Lacy: Wonderful, Regina. I like that a lot. A key message here is don't give up. Patients shouldn't give up, and healthcare providers shouldn't give up as well. We need to personalize treatment and really to improve symptoms. Thank you for joining us today. We really appreciate you taking time out of your busy day to listen to this seminar. In four weeks, you'll receive a follow-up survey to see if you've been able to
  • 12. IBS-C Patient POV Page 12 of 12 implement any of your intended changes as a result of what you've learned here today. We're excited and I think Regina is excited as well to see the impact of this educational activity on patient care and IBS with constipation. And if you have any questions at all about any of the information presented today, please send us an email to devi@cmespark.com. Thank you again. I'm Brian Lacy, Professor of Medicine at Mayo Clinic and, Regina, thank you so much for your great insights today. Regina: Thank you for having me.