An Evidence-based Approach to Irritable Bowel Syndrome. Robert Baldor, MD, FAAFP

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1 An Evidence-based Approach to Irritable Bowel Syndrome Robert Baldor, MD, FAAFP

2 Robert Baldor, MD, FAAFP Professor and Vice Chair, Department of Family Medicine and Community Health/Director, Community-Based Education, Office of Undergraduate Medical Education/Director of Health Policy Education, Meyers Primary Care Institute/Medical Director, Center for Developmental Disabilities Evaluation and Research at the Eunice Kennedy Shriver Center, University of Massachusetts (UMass) Medical School, Worcester Dr. Baldor has been teaching for 30 years and practices family medicine at the UMass Memorial Medical Center, Worcester. A member of the Massachusetts Governor s Commission on Intellectual Disability, he has been recognized in The Best Doctors in America: Northeast Region and is a past-president of the Massachusetts Academy of Family Physicians. He publishes and presents regularly on a variety of family medicine topics and is an associate editor for The 5-Minute Clinical Consult. Dr. Baldor practices family medicine with a special interest in developmental and intellectual disabilities. Throughout the years, he has spoken on a variety of primary care topics at the AAFP's annual meeting.

4 Objectives 1. Apply evidence-based diagnostic criteria to evaluate patients with recurrent/episodic abdominal pain for IBS. 2. Establish referral and follow-up protocols for patients exhibiting red flags for which endoscopic evaluation should be considered. 3. Develop treatment plans that involve positive patient-physician communication, shared decision making, and follow-up strategies that result in symptom relief and improved quality of life. 4

5 Irritable Bowel Syndrome.Epidemiology Common in Western Europe and North America; less so in Asia Estimated at 11% worldwide Patients often present between years of age Decrease in reporting in older patients 1.5 times more common in women than in men Clin Epidemiol. 2014; Aliment Pharmacol Ther 2006

6 Misconceptions versus Reality Misconceptions Purely a psychological-based diagnosis Unknown mechanism(s) Difficult to diagnose/ diagnosis of exclusion Reality A REAL disorder and multifactorial Majority do not have psychological comorbidities Serotonin implicated in pathogenesis Diagnosis can be made accurately in primary care

7 Patient Perceptions of IBS Knowledge Perceptions Desired Information Combination of abdominal Pain and constipation And/or diarrhea And/or bloating Triggers include stress at work, relationships, combination of other (emotional) factor Am J Gastroenterol. 2007

8 Patient Perceptions of IBS Knowledge Perceptions Desired Information Combination of abdominal Pain and constipation And/or diarrhea And/or bloating Can develop into Colitis Surgical problem Malnutrition Cancer Triggers include stress at work, relationships, combination of other (emotional) factor Will worsen with age Am J Gastroenterol. 2007

9 Patient Perceptions of IBS Knowledge Perceptions Desired Information Combination of abdominal Pain and constipation And/or diarrhea And/or bloating Can develop into Colitis Surgical problem Malnutrition Cancer What foods to avoid? What causes IBS? Triggers include stress at work, relationships, combination of other (emotional) factor Will worsen with age Coping strategies to reduce symptoms Am J Gastroenterol. 2007

10 Primary Care Perceptions PCPs were less likely than GI to believe that IBS was related to physical or sexual abuse, previous infection, or learned behavior,..but were more likely to state that diet caused IBS. A study found that PCPs in the Netherlands considered smoking, caffeine, diet, hasty lifestyle, and lack of exercise as potential triggers for IBS symptoms, while PCPs in the UK considered food, infection, and travel as other possible triggers Gastroenterology Fam Pract. 2009

11 Quality of Life Patients with IBS have same physical QOL scores as patients with diabetes, and lower physical QOL scores than patients with depression and GERD Psychological QOL scores are lower than patients with chronic renal failure, and can be so severe as to raise risk of suicidal behavior Aliment Pharmacol Ther Gastroenterology Aliment Pharmacol Ther. 2007

12 Health-Related Quality of Life A negative impact on HRQOL in most patients Failure to recognize impact undermines the physician-patient relationship and lead to dissatisfaction with care Imperative that PCPs: Identify the predominant IBS symptom (C or D or M?) Gauge symptom severity Understand the negative impact on HRQUOL, especially relative to the psychological impact

13 Associated Conditions.. GI motility disorders Dyspepsia, GERD, cyclic vomiting, gastroparesis, etc. Psychiatric disorders Anxiety, depression, somatoform disorders, PTSD Chronic back pain Fibromyalgia, chronic fatigue syndrome Chronic headaches, migraines Chronic pelvic pain men and women Functional urinary symptoms (e.g., interstitial cystitis) Dysmenorrhea Sexual dysfunction

14 In Practice.. Most cases of IBS are diagnosed by gastroenterologists Most research is done by gastroenterology Most patients with IBS are managed by primary care Imperative that primary care has optimal understanding and evidence behind diagnosis and treatment

15 The Diagnosis of IBS Take a careful history Look for warning signs Perform a thorough exam Use the Rome IV criteria Classify into the appropriate subtype Perform limited diagnostic tests

16 Rome IV Criteria for IBS Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following criteria: Related to defecation Associated with a change in frequency of stool Associated with a change in stool form/appearance Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis 16

17 Key Points in the History Onset of symptoms (chronicity) Is abdominal pain present? Is constipation or diarrhea present? Other GI symptoms (think overlap) Presence of common non-gi symptoms Prior tests? Prior treatments?

18 The Physical Exam Confirmation that complaints are taken seriously Reassurance of absence of concerning physical exam findings Identify other causes of symptoms

not investigated Rectal bleeding Weight loss Family

19 Alarm Features for Chronic Constipation New onset > 50 years > 45 years if African-American Severe symptoms not investigated Rectal bleeding Weight loss Family history of organic GI disease Palpable abdominal/rectal mass

20 Pretest Probability of Organic Disease Organic Disease IBS Patients Controls Colitis/IBD Colorectal cancer (varies with age) Lactose malabsorption Thyroid dysfunction Celiac disease Celiac disease: antibodies Celiac disease: confirmed Am J Gastroenterol Gastroenterology. 2011

21 Rome IV: Limit Diagnostic Testing Not all patients require testing In the appropriate patient, consider CBC, ESR, or CRP, fecal calprotectin Celiac serologies Limited role for colonoscopy in most patients

22 Severe constipation/poor treatment response Colonoscopy if not indicated sooner. Barium enema for obstruction/megacolon Radiopaque Sitz-Markers to measure transit time markers ingested, KUB in 5 days retention >20% markers indicates slow transit markers seen exclusively in distal colon/rectum suggests pelvic floor dysfunction 22

23 To evaluate defecation Balloon expulsion Defecography using a barium paste. Anorectal manometry Biofeedback with artificial silicon stool Enck. Dig Dis Sci

24 Managing IBS: What Do Patients Want? They want you to listen Understand their history (symptoms, work, home) A positive diagnosis Review diagnostic criteria and results with patients Education about their condition Address questions, concerns & uncertainty of IBS Reassurance Symptom improvement

25 Treatment Symptom Improvement 25

26 Probiotics: Putative Mechanisms of Action Competitive inhibition Barrier protection Immune effects Anti-inflammatory effects Production of various substances Enzymes, Short chain fatty acids, bactericidal agents Ability to alter local ph and physiology Provides nutrition to colonocytes Clin Gastroenterol. 2006

27 Antidepressants Conditional Recommendations: Low quality evidence Use TCAs Low dose; IBS-D Do not use SSRIs No proven benefits Gastroenterology

28 Pharmacologic Therapy/Constipation Fiber PEG solution Lubiprostone (chloride channel activator) Linaclotide (guanylate C antagonist) Am J Gastroenterol

29 Fiber supplementation Mild constipation symptoms May or may not help with pain Soluble fiber better than insoluble Start low and titrate slow Gas and bloating are the main side effects Am J Gastroenterol. 2013

30 Fiber from the Store Vegetables Fruits Whole grain foods Bran (hard outer layer of cereal grains) Bloating and gas can be problematic Gradually increase intake to 25 grams/day Less fermentable fiber like wheat bran tends to be better tolerated 30

31 Dried Plums? (large amounts of fiber and sorbitol) 8-week RCT: Dried plums (prunes, 50 g/day or 6 prunes) compared with Psyllium (11 g/day fiber) BID Dried plums resulted in a greater improvement in constipation symptoms compared with psyllium Aliment Pharmacol Ther. 2011

(Citrucel 2gms/ dose) Polycarbophil (Fibercon) Fiber needs to

32 Fiber Products. Moderate evidence Psyllium (Metamucil 2.5gms fiber/dose) Limited evidence Bran methycellulose (Citrucel 2gms/ dose) Polycarbophil (Fibercon) Fiber needs to be accompanied by adequate liquid to be useful - 8oz/2-3gms of added fiber! 32

33 Fiber and Stool Softeners for IBS-C Fiber and stool softeners (docusate) are most useful in patients with mild, infrequent constipation Best evidence for psyllium up to 25 grams/day Their role in patients with significantly delayed colon transit is limited Fiber may worsen symptoms in patients with significantly delayed colon transit

34 AGA Guidelines for IBS-C Use laxatives (PEG) Conditional recommendation; low quality evidence Use linaclotide Strong recommendation; high quality evidence Use lubiprostone Conditional recommendation; moderate quality evidence Gastroenterology 2014

35 Chloride Channel Activators Increased secretion of Cl - ions into small bowel Na + and water follow softer, bulkier stool Linaclotide (Linzess, Constella) mcg qday Lubiprostone (Amitiza) 24 mcgs BID 35

36 Polyethylene Glycol (PEG) 17gm QD Large, chemically inert polymer, w/ substantial osmotic activity Bowel flora unable to metabolize Pulls water into colon to soften and increases fecal bulk (takes 2-4 days to work) First used in a balanced electrolyte solution for colon cleansing (Golytely) 36

37 Long-term Laxative Concerns No evidence for addiction No evidence for tolerance No evidence for dependence No evidence for harm from stimulant use, melanosis coli may develop, a benign condition Am J Gastroenterology

38 Pharmacologic Therapies IBS/D Antispasmodics Loperamide Diphphenoxylate/Atropine Bile acid sequestrants Cholestyramine Other medications Alosetron Eluxadoline Rifaximin

39 Antispasmodics Conditional recommendation; low quality evidence For postprandial abdominal pain Not effective for chronic abdominal pain Avoid in the elderly Am J Gastroenterol. 2013

40 Loperamide* for IBS-D Low doses (2mg once or twice daily) may be effective to decrease stool frequency and improve stool consistency 1 2 RCTs in IBS (N=42) show efficacy for diarrhea 2,3 No impact on abdominal discomfort, bloating, or global IBS 2,3 Adverse effects: dizziness, abdominal pain/bloating, constipation, dry mouth, fatigue 1 *FDA-approved for diarrhea, but not for IBS-D 1.US FDA. CDER. Loperamide NDA Scand J Gastroenterol Suppl Scand J Gastroenterol Suppl. 1987

41 Diphenoxylate-Atropine* for IBS-D A synthetic opiate agonist similar to meperidine Atropine is added to discourage deliberate abuse or overdose of diphenoxylate Schedule V controlled substance First approved by FDA in 1960 No prospective studies *FDA approved for diarrhea, but not IBS-D Ther Adv Gastroenterol. 2009

42 Bile Acid Sequestrants* for IBS-D *Off-label use, not FDA approved for IBS-D 20% - 30% of patients with IBS-D or functional diarrhea have bile acid malabsorption (BAM) 10% IBS-D with evidence of severe BAM Bile acids accelerate colonic transit, increase stool frequency, and reduce consistency Cholestyramine may improve symptoms Aliment Pharmacol Ther. 2009;. Dig Dis Sci. 2012

43 Alosetron (Lotronex) for IBS-D mg QD to BID Serotonin (5-HT 3 ) antagonist Reduces stool frequency and abdominal pain; improves urgency Women with chronic, severe IBS-D who have failed other treatments Patient education regarding possible serious adverse effects 0.95 cases of ischemic colitis/1000 patients-years 0.36 cases of severe constipation/1000 patient-years Am J Gastroenterol SafetyInformationforPatientsandProviders/UCM pdf

44 Eluxadoline (Viberzi) for IBS-D 100mg BID Mu (µ) opioid agonist/ Delta (δ) opioid antagonist Low systemic absorption and bioavailability Low potential for drug-drug interactions Nausea and constipation common side effects No signs of dependence or withdrawal

45 Rifaximin (Xifaxan) for IBS-D 550mg TID x 14 days Bacteriostatic: inhibits DNA-dependent RNA polymerase Used to treat travelers diarrhea Evidence for small bowel bacterial overgrowth in IBS-D Glucose/lactulose breath test to Dx bacterial overgrowth Used to treat significant diarrheal episodes

46 AGA IBS-D Treatment Guideline Use rifaximin Conditional recommendation; moderate quality evidence Not approved by FDA, costs may be high, no evidence to support repetitive treament Use alosetron Conditional recommendation; moderate evidence Use loperamide Conditional recommendation; very low quality evidence American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology 2014;147(5):

47 Fecal Transplant? Maybe of benefit No data as of yet Ongoing clinical trials 47

48 Low FODMAP diet? Fermentable oligosaccharides, disaccharides, monosaccharides & polyols! Lactose (milk, yogurt, ice cream) Fructose (fruits, high-fructose corn syrup, honey) Sorbitol, mannitol (sugar-free gums and candies) Fructans (wheat, onions, garlic) GOS (beans, hummus, soy milk) 48

49 Practice Recommendations IBS-C Constipation is a multi-symptom condition Constipation is due to slow colon transit and/or disordered defecation Diet and lifestyle changes help with most mild, moderate, or intermittent constipation symptoms, and should always be tried first

50 Start with Lifestyle Changes Exercise, increase fluids and fiber to 25 grams/day over a period of 6 weeks. Fiber must be accompanied by sufficient fluid Initial approach fruits and vegetables Add commercial bulking agents Am J Gastroenterol. 1999; G Nutr

51 Practice Recommendations IBS-C Constipation is a multi-symptom condition Constipation is due to slow colon transit and/or disordered defecation Diet and lifestyle changes help with most mild, moderate, or intermittent constipation symptoms, and should always be tried first Laxatives including osmotics, stimulants, and presecretory agents improve symptoms in many patients Biofeedback and physical therapy are the preferred treatments for dyssynergic defecation and have modest results When patients fail to respond to laxatives, diagnostic testing can help to determine the etiology of constipation symptoms

52 Practice Recommendations IBS-D Exercise/stress reduction Low FODMAP diet Probiotic (especially for bloating) Antispasmodic agent or TCA (pain) Loperamide or cholestyramine (diarrhea) Month-long trials 52

53 Practice Recommendations IBS-D Trial of medications Alosetron Eluxadoline Rifaximin Based on patient preference & costs Avoid Narcotics 53

54 Cure of refractory IBS is not possible But we can help patients manage symptoms Multidisciplinary team best PCP GI Behaviorist Nutritionist 54

55 55 The End!h

56 References 1. Weinberg DS, et al. American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology 2014;147(5): Wong BS, et al. Dig Dis Sci. 2012;57: Eswaran S, et al. Am J Gastroenterol. 2013;108: Ford AC, et al. Am J Gastroenterol. 2014;109: American College of Gastroenterology Task Force on Irritable Bowel Syndrome; Am J Gastroenterol Cash, BD, et al. Gastroenterology. 2011;141:

Irritable Bowel Syndrome Now. George M. Logan, MD Friday, May 5, :35 4:05 PM

Irritable Bowel Syndrome Now. George M. Logan, MD Friday, May 5, :35 4:05 PM Irritable Bowel Syndrome Now George M. Logan, MD Friday, May 5, 2017 3:35 4:05 PM Dr. Logan indicated no potential conflict of interest to this presentation. He does not intend to discuss any unapproved/investigative