February 28, 2022
11 min read
Berry reports consulting for Oshi Health. Brenner reports consulting for Allergan and Ironwood Pharmaceuticals. Chey reports no relevant financial disclosures. Keefer reports financial relationships with AbbVie, Lilly, Pfizer, Takeda and Trellus Health. Scarlata reports consulting for Activia, A2 Milk Company, Beckon and Gastro Girl, serving as a paid board member/advisory board member for FODY Food Company and GI OnDemand and holding stock in Epicured LLC and Fody Foods.
According to the International Foundation for Gastrointestinal Disorders, irritable bowel syndrome is estimated to effect 10% to 15% of the population worldwide, making it the most prevalent functional GI disorder.
While the exact pathogenesis of IBS remains largely unknown, scientific evidence points toward disturbances in gut, brain and nervous system interaction that can cause changes to normal bowel function and produce symptoms ranging from mild inconvenience to severe debilitation.
As knowledge of IBS has progressed, the traditional focus on abnormalities in motility and visceral sensation has evolved to include psychosocial distress and food as the most important triggers that worsen symptoms. Although one or more of these factors are demonstrable among most patients with IBS, none can account for symptoms in all.
“The diagnosis of IBS relies on the identification of characteristic symptoms and the exclusion of other organic diseases,” William D. Chey, MD, FACG, of Michigan Medicine, and colleagues wrote in a JAMA IBS clinical review. “Management of patients with IBS is optimized by an individualized, holistic approach that embraces dietary, lifestyle, medical and behavioral interventions.”
The burden of IBS can be measured in a variety of ways with studies consistently demonstrating impairment and decreased quality of life among sufferers with treatment strategies difficult to validate over time due to inconsistent response across the population.
“Though strategies for managing IBS have evolved, one guiding principle remains true: There is no one-size-fits-all treatment strategy. IBS care in 2022 and beyond no longer relies on just the GI doctor but is a ‘team sport’ that involves a multidisciplinary, integrative care team of dietitians, behavioral therapists and maybe even complimentary alternative medicine providers,” Chey said during his J. Edward Berk Distinguished Lecture at the American College of Gastroenterology Annual Scientific Meeting 2021.
In identifying how to best provide care, Healio Gastroenterology spoke with experts across the field on their approach to the treatment of IBS; evolving management strategies, including integrative care; and what advice they give for this special group of patients.
Ask a GI Doctor: Pharmacologic Management
When discussing the pharmacologic management of IBS, the ultimate goal is to target the underlying cause(s) of symptoms.
“We know that disorders of gut-brain interaction like IBS are biopsychosocial disorders. There are many factors involved in the development of IBS symptoms and these differ between individuals. Thankfully, there are now pharmaceuticals proven to improve multiple symptoms,” Darren M. Brenner, MD, associate professor of medicine and surgery at Northwestern University Feinberg School of Medicine, told Healio Gastroenterology. “I like to say that currently available pharmaceuticals have allowed us to move the needle from treating a predominant symptom to global symptoms. Consequently, we find ourselves for the first time able to recommend against the use of less effective therapies.”
While emerging pharmaceuticals have advanced over time, the next step in pharmacologic treatment progression is precision medicine: identifying the underlying causes of IBS, developing diagnostic biomarkers for them and targeting treatment for these causes rather than the symptoms themselves. Understanding the underlying mechanism of action for treatments, and how they work within the GI tract, also aids in explaining how certain therapies are improving the pathophysiology of each patient’s syndrome course.
Following the need for more precise medicine is the need for more head-to-head trials, as the lack of data can prove to be problematic for making prescription recommendations when there are multiple therapeutics in one class. Often, decisions come down to personal preference and drug cost.
When it comes to Brenner’s usual plan of attack, he often sees pharmacologic interventions as complementary to other tools in the IBS management arsenal.
“I like starting with dietary and behavioral interventions as initial strategies, as IBS is generally a disorder that effects a younger population. If they work, there is the potential for avoiding long-term use of medications. I am a proponent of the low FODMAP diet as a proof-of-concept, not a long-term diet; like all IBS treatment strategies, this diet also requires personalization,” Brenner said. “I am also a firm believer in behavioral interventions, including cognitive behavioral therapy (CBT) and gut-directed hypnosis. However, I am also fully cognizant that behavioral interventions require buy-in from patients: If patients do not believe these treatments are going to be effective, it usually renders them ineffective, and they should be avoided.”
This is not to say that Brenner does not believe in the benefits of traditional therapeutics; the treatment decision should be agreed upon by the practitioner and patient after an educated discussion. Though dietary and behavioral management strategies have been highly effective in most, some patients will still opt for medication.
Despite the lack of direct comparison and need for more head-to-head drug trials, there are many different therapeutics to choose from. The decision is typically made based on the IBS subtype.
“At times this can be frustrating for patients, as symptom improvement may require cycling though one or a combination of treatments until the right ones are identified,” he added. “It is key to educate your patients on the benefits and risks of each therapeutic and to explain the educated trial and error process. Knowing this in advance reduces patient frustration when initial interventions are ineffective.”
The future of care relies on precision and designing an algorithm for medication choice based on a patient’s personal indications.
“Don’t get frustrated. When it comes to pharmaceuticals, we are not yet as precise as we would like to be,” Brenner concluded. “Believe that your practitioner has a method to their madness.”
Ask a GI Dietitian: Dietary and Nutritional IBS Management
The convoluted and highly individualized nature of an IBS diagnosis has made management more difficult. In past scenarios, where pharmacological intervention has faltered, the offerings for patients have been scarce — until now.
“IBS is a complex condition and patients are really suffering,” Kate Scarlata, MPH, RDN, founder of For a Digestive Peace of Mind, said. “Having evidence-based diet interventions for IBS symptom management is relatively new in clinical practice. It is utilizing nutrition to help manage symptoms, which may include the three-phase low FODMAP diet or modifying other digestive system triggers, such as excess alcohol or fat or adjusting fiber intake.”
Like IBS management strategies as a whole, dietary intervention must be chosen carefully with each individual’s best interests and health history in mind. Though there are a plethora of dietary intervention strategies to choose from, the effectiveness and popularity of the low FODMAP diet has been proven time and time again, while also being backed by robust research and evidence.
According to results from a network meta-analysis, Christopher J. Black, MBBS, MRCP, and colleagues found the low FODMAP diet correlated with a reduced failure to improve global IBS symptom occurrence compared with all other intervention strategies (RR = 0.97; 95% CI, 0.48-0.91). Further, it was also most effective for combatting abdominal pain, bloating or distension severity. Additional research from the Domino study reported on by Karen Van Den Houte, PhD, at Digestive Disease Week 2021 found app-based, low FODMAP intervention was significantly more likely to lead to an improvement in overall IBS symptoms (> 50 point reduction in IBS symptom severity score) at 8 weeks compared with otilonium 60 mg (71% vs. 61%) with durable benefits seen at 6 months.
“If you’re using the low FODMAP diet, remember that elimination is the beginning not the end,” Chey said at ACG. “If they do not respond to FODMAP elimination, you should take them off the diet and move on to some alternative strategy. On the other hand, if the patients do experience improvement, they should undergo a systematic reintroduction of foods containing individual FODMAPs. This process allows a provider to customize and liberalize a low FODMAP diet plan for each individual patient.”
Initial assessment for dietetics looks at a wide range of factors, Scarlata said, noting the importance of asking about a patient’s relationship with food. Additional assessments include screening for malnutrition and food insecurity, self-identified food triggers, disordered eating and practicality. The main goal is to provide quality, evidence-based interventions based off particular diagnoses, taking into account potential overlapping conditions and IBS mimickers.
“GI dietitians provide tailored nutrition interventions that incorporate the patient’s clinical data, nutritional intake, socioeconomics and lifestyle to ensure a feasible and nutritionally adequate plan to manage GI symptoms,” Scarlata previously wrote for Healio Gastroenterology. “A collaborative care process in treating patients with GI disorders allows the dietitian to fulfill gaps in the patient’s medical history that may or may not have been divulged or missed in the GI visit. Together, providers can piece together the patient’s full clinical picture to provide a better assessment and multifaceted approach to care.”
Ask a Therapist: Behavioral Management
According to the American Journal of Gastroenterology, advances in the understanding of the brain-gut-microbiome axis, as well as behavioral intervention science, have shown that psychotherapies effective for the treatment of depression, anxiety and chronic pain can be adapted to specifically manage IBS symptoms, including abdominal pain, altered bowel habits and quality of life. These advances, coupled with real-world data, supported the latest ACG guideline which recommended the use of brain-gut behavior therapies for the management of IBS.
“This was a huge accomplishment [for the ACG] to recommend the use of behavioral therapies earlier on in the care pathway,” Laurie Keefer, PhD, director of psychobehavioral research in gastroenterology at Mount Sinai in New York City, said. “We call them brain-gut behavior therapies because they target the cause of IBS or one of the main causes of IBS: brain-gut dysregulation. We are talking about managing IBS from the gut to the brain, that is what these behavioral therapies are focused on.”
In conjunction with pharmacology or dietary intervention, the benefits of behavioral therapy for the management of IBS outweigh the costs, Keefer continued. Adding a behavioral specialist to the medical care team allows for more succinct collaboration for the patient without referring them to community mental health providers without explanation.
The evaluation and application of which behavior therapy to use relies first on the extent of brain-gut dysregulation; how deeply rooted unhelpful coping strategies are indicates how much effort is needed to alter behaviors. While digital therapeutics may be an efficient route to take for newly diagnosed, highly motivated or symptomatically mild patients, those with increased brain involvement with evidence of pain catastrophizing, fear of symptoms or avoidance behaviors may require more personalized cognitive behavior therapy (CBT) to challenge their beliefs, build back self-confidence and reframe ideas about their symptoms.
“Patients have to understand that the brain-gut pathway is not just the gut, and it is not just the brain; there are things they can do in the brain that help with the gut and vice versa,” Keefer said. “They have to really buy into that before we even introduce the concept of changing their thoughts, behaviors or feelings.”
Keefer’s main ingredient for therapeutic management is piecing together each individual patient’s story to understand the context of their symptoms in day-to-day life, acknowledging how the problems started, why they continue and how to make improvements. Rather than simply going through common CBT exercises blindly, a GI psychologist provides insight into how these factors come together and which approach will best aid in alleviating the underlying brain-gut issue.
“It is the integration — it is the doctor and dietitian talking with the behaviorist that, in my opinion, drives the outcomes,” Keefer concluded. “The behavior change techniques themselves don’t drive the outcomes; it is looking at the patient in context together through the same lens as a care team. That is the point of integrated care.”
The Integrative Care Model
Although proven to be effective, psychological, behavioral and dietary therapies in an integrated approach have not routinely been provided to patients with IBS or functional GI disorders.
The MANTRA study, an open-label, single-center, pragmatic trial, found that the integrative care model improved symptom severity, psychological state and quality of life among 188 patients with functional GI disorders compared with standard care alone (84% responders vs. 57% responders; P = .001). Specifically, among patients with IBS (n= 65%), integrated care correlated with a greater reduction in IBS symptom severity score (> 50 point reduction: 66% vs. 38%; P = .017) and a lower cost per successful outcome.
“The biggest attractors for integrated care are two main things: one, it tremendously expands the number of treatment options and increases the likelihood that you are going to be able to find something that is effective for that individual patient,” Chey said. “The second thing, which we have not done a good job at until recently, is it meets the patient where they are. If patients want a diet solution or they want a behavioral solution, we should have evidence-based options to satisfy those requests.”
Like other approaches to management, Chey’s first step in implementing integrative care is verification that a patient’s most troublesome symptoms line up with an IBS diagnosis. From understanding the individual phenotype, he identifies whether symptoms most closely relate with either food or stress and anxiety; the choice of one over the other guides the specific approach to care he employs sooner rather than later.
“The notion of integrated care really embraces the fact that IBS treatment extends beyond just medications. For years, gastroenterologists have focused on identifying patients’ predominant symptoms and then choosing medical therapy based upon the clinical phenotype,” Chey said. “While that is still relevant and the medications are still very useful, we figured out over time that the medications don’t work for everybody, and a growing number of patients are looking for solutions that extend beyond medications.”
The Future of IBS Management
While the data shows that an integrated team of dietitians and psychologists working alongside gastroenterologists significantly improves outcomes in IBS, the vast majority of patients are still unable to access these services.
“Patients with IBS routinely undergo repeated endoscopy and imaging without access issues, yet most have no way to see a dietitian or psychologist,” Sameer K. Berry, MD, MBA, a fellow in gastroenterology at the University of Michigan, said. “We need to flip this paradigm.”
Operationalizing different treatments for IBS and scaling integrated care relies on reducing access barriers. Much of this is already happening by supplementing face-to-face care with digital health. Digital health tools in IBS can include mobile apps that track diet and symptoms; FDA-approved digital therapeutics that provide app-guided behavioral interventions, such as CBT; at-home diagnostics for bloodwork, stool and breath testing; and virtual-care delivery platforms that connect patients to a multidisciplinary care team from the comfort of their home. These digital health tools are being designed to address access problems, including improved convenience and significantly reduced cost to patients.
As these tools continue to evolve, the benefits extend beyond the individual patient and reduce total cost to the health care system. “Those of us studying the development and implementation of digital health tools in IBS have started to realize that the direct and indirect cost of IBS in the United States has likely been grossly underestimated,” Berry said. “A significant portion of care utilization by these patients may not be associated with an ICD code for IBS. For example, colonoscopies may be ordered as ‘screening’ to avoid patient copay, when in reality they are being ordered to work up symptoms of IBS.”
The lack of access to evidenced-based interventions, such as dietitians and psychologists, also leads to overutilization of expensive medications and even unnecessary surgery in some patients. The suffering these patients endure also impacts the workplace.
“IBS is the second leading cause of workplace absenteeism, after the common cold,” Berry noted. “And patients do not always feel comfortable discussing this disease with their employer.”
Digital health interventions are quickly supplementing in-person care delivered by gastroenterologists and will need continued collaboration with physicians. “Twenty-five percent of the U.S. population struggles with a GI condition,” Berry added. “They are suffering and seeing a gastroenterologist once every three months is not the solution.
“However one feels about digital health, whether skeptical or incredibly supportive, I would argue we all need to be on the same page about trying novel approaches, because the status quo is not working. As gastroenterologists, it is our responsibility to rigorously evaluate and study these new tools and work with these companies to help improve care for our patients.”
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