Improving Primary Care Management of IBS D through Early Diagnosis and Personalized Treatment

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1 Improving Primary Care Management of IBS D through Early Diagnosis and Personalized Treatment Provided by Integrity Continuing Education, Inc. Supported by an educational grant from Salix Pharmaceuticals, Inc., a division of Valeant Pharmaceuticals North America LLC. 1 Faculty Affiliation Albena Halpert, MD Associate Professor of Medicine Division of Gastroenterology Boston University School of Medicine Boston, Massachusetts Pentucket Medical Associates Haverhill, Massachusetts 2 1

2 Faculty Disclosures Consultant: Allergan, Shire 3 Learning Objectives Apply an approach to the diagnosis of irritable bowel syndrome with diarrhea (IBS D) that is consistent with current evidence based guidelines Identify strategies for encouraging effective providerpatient communication to improve assessment of disease burden in patients with IBS D Summarize current evidence regarding the efficacy and safety of available options for the treatment of IBS D 4 2

3 Overview of IBS Most frequently diagnosed functional GI disorder in primary and secondary care practices Affects ~15% 2% of global populations Characterized by abdominal discomfort or pain accompanied by altered bowel function in the absence of structural or biochemical abnormalities Subtypes include IBS with constipation (IBS C), IBS D, mixed IBS (IBS M), and un subtyped IBS depending on the predominant stool pattern Associated with high medical costs, frequent doctor visits, missed workdays, and an overall detrimental impact on HRQOL GI, gastrointestinal; HRQOL, health related quality of life. Lacy BE. Int J Gen Med. 216;9: Patient identified Factors that Contribute to Disease Burden Respondents (%) Social limitations Cannot leave home Work/school limitations Limitations in thinking Trouble sleeping Nausea Limitations in home activities Poor quality of life Incontinence Other troubles IBS Patients: Their Illness Experience and Unmet Needs Survey Report, International Foundation for Functional Gastrointestinal Disorders (IFFGD); corner/146 resources/survey corner/36 results unmet needs survey.html. 6 3

4 Healthcare Provider Understanding of the Burden of IBS How well do you think your healthcare professional understands how bothersome your symptoms are? 18% 31% Extremely well Very well Somewhat well Not very well Not at all 29% 17% 5% AGA. IBS in America. Available at: aga ibs in america survey/docs/survey findings pdf pdf. 7 Pathogenesis of IBS EXTRINSIC FACTORS Psychological Psychological stress, abuse (sexual, stress, physical), abuse smoking, (sexual, diet physical), smoking, diet Infection, dysbiosis Adapted from: Gazouli M, et al. Nat Rev Gastroenterol Hepatol. 216;13(2):

5 Pathogenesis of IBS EXTRINSIC FACTORS INTRINSIC FACTORS Psychological stress, abuse (sexual, physical), smoking, diet Genes Infection, dysbiosis Gut microbiota CNV, copy number variation; mirna, micro ribonucleic acid; SNP, single nucleotide polymorphism. Adapted from: Gazouli M, et al. Nat Rev Gastroenterol Hepatol. 216;13(2): Pathogenesis of IBS EXTRINSIC FACTORS INTRINSIC FACTORS CENTRAL NEUROBIOLOGICAL/BEHAVIORAL INTERMEDIATE PHENOTYPE Psychological stress, abuse (sexual, physical), smoking, diet Genes HPA Brain gut axis Emotional regulation Visceral sensation/ pain modulation Infection, dysbiosis Gut microbiota Spinal afferents GI transit secretion PERIPHERAL INTERMEDIATE PHENOTYPE HPA, hypothalamo pituitary adrenocortical [system]. Adapted from: Gazouli M, et al. Nat Rev Gastroenterol Hepatol. 216;13(2):

6 Pathogenesis of IBS EXTRINSIC FACTORS INTRINSIC FACTORS CENTRAL NEUROBIOLOGICAL/BEHAVIORAL INTERMEDIATE PHENOTYPE CLINICAL PHENOTYPE Psychological stress, abuse (sexual, physical), smoking, diet Genes HPA Brain gut axis Emotional regulation Visceral sensation/ pain modulation Chronic fatigue, depression, anxiety Migraine, fibromyalgia Infection, dysbiosis Gut microbiota Spinal afferents GI transit secretion Chronic abdominal pain or discomfort and altered bowel habits: IBS PERIPHERAL INTERMEDIATE PHENOTYPE Adapted from: Gazouli M, et al. Nat Rev Gastroenterol Hepatol. 216;13(2): Comorbidities Associated with IBS 91% of patients with IBS reported 1 comorbidity Average number reported was 5 (1 mental, 4 physical) Anxiety, depression, back pain, agoraphobia, tension headache, insomnia were associated with greater illness and symptom burden GERD, gastroesophageal reflux disease. Lackner JM, et al. Clin Gastroenterol Hepatol. 213;11(9):

7 Many Patients with Severe IBS D Remain Undiagnosed Individuals With Severe IBS D (%) Diagnosed (n=194) * Undiagnosed (n=83) * * 61 * * Discomfort/Pain Diarrhea Loose/Mushy Stools Urgency Bloating Individuals Experiencing Extremely Disruptive Symptoms (%) Diagnosed (n=194) * * Undiagnosed (n=83) * * Discomfort/Pain Diarrhea Loose/Mushy Stools Urgency Bloating Score = 6 or 7; range: 1=very mild to 7=very severe; score = 6 or 7, range: 1=not at all disruptive to 7=extremely disruptive; * P<.5 vs. undiagnosed group. Sayuk GS, et al. Am J Gastroenterol. 217;112(6): Screening and Diagnosis 14 7

8 Diagnosis of IBS Rome IV Criteria 1. Symptom onset 6 months prior to diagnosis 2. Recurrent abdominal pain, on average, 1 day/week in the last 3 months with 2 of the following: Related to defecation Associated with a change in stool frequency Associated with a change in stool form (appearance) Lacy BE, et al. Gastroenterology. 216;15(6): Red Flags for Organic Conditions Fever Unexplained weight loss Rectal bleeding or melena Nocturnal diarrhea Unexplained iron deficiency anemia Symptom onset after 5 years of age Severe or progressively worsening symptoms Family history of organic GI diseases (eg, colon cancer, celiac disease, or IBD) Brandt LJ, et al. Am J Gastroenterol. 29;14 (suppl 1):S

9 Typical Features of IBS Loose/frequent stools Constipation Bloating Abdominal cramping, discomfort, or pain Symptoms: Brought on by food intake/specific food sensitivities Dynamic over time (change in pain location, change in stool pattern) Brandt LJ, et al. Am J Gastroenterol. 29;14(suppl 1):S1 S Bristol Stool Form Scale Type Description Image 1 Separate hard lumps, like nuts 2 Sausage shaped but lumpy 3 Like a sausage or snake but with cracks on its surface 4 Like a sausage or snake, smooth and soft 5 Soft blobs with clear cut edges 6 Fluffy pieces with ragged edges, a mushy stool 7 Watery, no solid pieces Available at:

10 Case Study #1: 35 year old Female Clinical presentation and medical history 5 year history of recurrent abdominal pain and diarrhea 3 4 loose bowel movements each day Abdominal pain Associated with bloating and gas Exacerbated by eating Relieved with defecation Episodes are more frequent during times of stress No specific triggers identified No recent travel outside the US No reported weight loss No family history of GI disorders or malignancies 19 Case Study #1 (cont d) Psychosocial effects and social history Sleep quality is impaired GI symptoms are having a negative impact on the patient s ability to concentrate at work Patient reports anxiety about engaging in her usual social activities 2 1

11 Case Study #1 (cont d) Vital signs Normal CV and pulmonary exam Normal Abdominal exam Abdomen is not distended Bowel sounds are normal No organomegaly Mild generalized tenderness Laboratory tests CBC w/diff, TFTs, and CRP are within normal range CBC, complete blood count; TFTs, thyroid function tests; CRP, C reactive protein. 21 Case Study Discussion Individual symptoms have limited accuracy Alarm features are crucial for guidance Disease impact on patient ability to function and QOL are important considerations Recommended diagnostic tests 22 11

12 Rome IV Recommendations for Diagnostic Testing CBC, CRP, and fecal calprotectin to exclude IBD Routine thyroid testing if clinically warranted Celiac tests Stool analysis (bacteria, parasites, and ova) Breath testing to identify carbohydrate malabsorption Colonoscopy 5 years of age* in the absence of warning signs History of colorectal cancer persistent diarrhea that has failed empiric therapy Bile acid malabsorption testing *45 years of age in African Americans. Lacy BE, et al. Gastroenterology 216;15: ; Lacy BE, et al. J Clin Med. 217;6(99): Biomarkers for the Diagnosis of IBS D Type Biomarker Diagnostic Utility Availability # Costeffectiveness Inflammatory (interleukins, cytokines) Low Moderate Moderate Serum Enteroendocrine (serotonin, chromogranin) Low Moderate Moderate Fecal bile acids High Low High Fecal Soluble mediators (proteases, chromogranin, calprotectin) Low Moderate Low Microbiome* Moderate Moderate Low Colonic transit* High Moderate Moderate Visceral hypersensitivity* Low Low Low GI Tract Permeability Moderate Low Moderate Mucosal biomarkers (mast cells, B & T cells, enteroendocrine ; mirnas*) Low Low Low Neurological & Brain imaging Moderate Low Low psychological Psychological markers* Moderate High Low # For availability: high = widely available; moderate=available only in specialized clinics; low = only available in referral labs/center; *application in IBS C as well; IBS (pain). Camilleri M, et al. Expert Rev Gastroenterol Hepatol. 217;11(4):

13 Comparative Positivity Rates for Anti CdtB and Anti vinculin across IBS Subtypes IBS D IBS M IBS C Healthy Control 7 Antibody Positivity Rates (%) Anti CdtB+ Anti vinculin+ Anti CdtB+ or Anti vinculin+ CdtB, cytolethal distending toxin B. Rezaie A, et al. Dig Dis Sci. 217;62(6): The Rome Multi dimensional Clinical Profile Diagnostic (MDCP) Classification Categorical diagnosis Standard symptom based Rome III (or IV) diagnostic criteria Clinical modifiers Subcategorizes categorical diagnosis in ways that potentially affect treatment Impact on daily activities Quantifies overall impact of patient illness on their behaviors and daily functioning to guide treatment Psychosocial modifiers Identifies psychological and psychosocial modifiers and comorbidities that influence patient experience of their illness and affects treatment options Physiological modifiers of function and biomarkers Physiologic parameters that may enhance understanding of the diagnosis or affect treatment Drossman, D. (215) Multi Dimensional Clinical Profile (MDCP): for the Functional Gastrointestinal Disorders. Lucak S, et al. Ther Adv Gastroenterol. 217;1(2)

14 Treatment of IBS D Goals of Therapy 27 Goals of Treatment Improve individual symptoms Ameliorate global symptoms Prevent complications Reduce impact on the individual and society Lacy BE, et al. Therap Adv Gastroenterol. 29;2(4):

15 Case Study #2: 3 year old Male Medical history 2 year history of abdominal pain and diarrhea Intermittent episodes of lower abdominal cramping and bloating associated with 4 5 loose bowel movements occurring 2 3 days per week Abdominal pain occurs shortly after meals or with increased stress, diminishes following a bowel movement Social history Is an investigative journalist at a large metropolitan newspaper Eating habits are unpredictable due to erratic schedule and frequent deadlines Symptoms often interfere with the demands of his job 29 Case Study #2 (cont d) Treatment history Increased fiber intake exacerbates symptoms Low FODMAP diet had only a marginal impact on symptoms Loperamide Effective for reducing fecal urgency and diarrhea Does not relieve pain and bloating Dicyclomine hydrochloride Moderate reduction in the frequency of cramping Occasional diarrhea Drowsiness Confusion FODMAP, fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; PCP, primary care provider. 3 15

16 Case Study Discussion Inadequate symptom control/response to conventional therapies is common Newer pharmacologic management strategies Potential role of combining therapies Consideration of adverse effects Psychological interventions 31 Treatment of IBS D Pharmacologic Options 32 16

17 Conventional Pharmacotherapies for the Treatment of IBS D Class (Agents) Evidence Efficacy Common AEs Antidiarrheals (diphenoxylate hydrochloride/ atropine sulfate and loperamide) Very low Beneficial for diarrhea, but not global symptoms or pain Constipation Antispasmodics (eg, hyoscyamine sulfate and dicyclomine hydrochloride) Low Some agents offer benefits for global symptoms and pain Dry eyes/mouth Sedation Constipation AE, adverse events. Chey WD, et al. JAMA. 215;313(9): Newer Agents for the Treatment of IBS D Class (Agent) Alosetron Eluxadoline Putative Mechanism of Action Inhibits GI motility via antagonism of 5 HT 3 receptors of the enteric nervous system and possibly within the central nervous system Inhibits gastric emptying, increases sphincter tone, and induces stationary motor patterns via interactions with opioid receptors (agonism at μ and κ receptors and antagonism at δ receptors) Rifaximin Is a broad antibiotic against GI aerobic and anaerobic Gram positive and Gram negative bacteria (may allow resetting of the microbiota) Alters the inflammatory environment and bacterial end products in patients with various GI disorders Cremonini F, et al. J Neurogastroenterol Motil. 23;15(1): Pimentel M. Aliment Pharmacol Ther. 216;43 (suppl 1): Holzer P. Regul Pept. 29;155(1 3):

18 Impact of Alosetron Treatment in Women with Severe IBS D Workplace Productivity Social/Leisure Activity Mean (SE) Lost Workplace Productivity (h) h Baseline Week 12 * 11. h 11.1 h *** 21.1 h Mean (SE) Number of Days days Baseline Week 12 ** 6.7 days 5.6 days ** 7. days PBO.5 mg QD 1 mg QD 1 mg BID PBO.5 mg QD 1 mg QD 1 mg BID Alosetron Alosetron Alosetron treatment resulted in improvements in HRQOL, restriction of daily activities, and treatment satisfaction over PBO in women with severe IBS D *P<.5; **P<.1; ***P<.1. BID, twice daily; PBO, placebo; QD, once daily. Cremonini F, et al. Aliment Pharmacol Ther. 212;36(5): Adverse Events of Alosetron Placebo (n=176) *In 43/44 patients, these events were associated with other medical conditions..5 mg QD (n=175) Alosetron 1 mg QD (n=172) 1 mg BID (n=176) Most common AEs (%) Constipation Abdominal pain Nausea Sinusitis Headaches AEs for symptoms of potential ischemic colitis* (%) Any event Bloody diarrhea or rectal bleeding Worsening of abdominal pain < Bloody diarrhea or rectal bleeding and worsening of abdominal pain 1 2 <1 Krause R, et al. Am J Gastroenterol. 27;12(8):

19 Alosetron: Black Box Warnings Infrequent, but serious, GI adverse reactions (eg, ischemic colitis, serious complications of constipation) reported: some have resulted in hospitalization and, rarely, blood transfusion, surgery, or death Prescribing physicians must be enrolled in Prescribing Program Indicated only for women with severe IBS D who have not responded adequately to conventional therapy Discontinue immediately in patients who develop constipation or symptoms of ischemic colitis; do not resume in those who develop ischemic colitis Adapted From: Lotronex [package insert]. San Diego, CA: Prometheus Laboratories Inc.; Eluxadoline Treatment Results in Sustained Reduction of IBS D Symptoms over 6 Months 1 Placebo Eluxadoline, 75 mg Eluxadoline, 1 mg 8 Patients (%) ** ** * ** 26.7 ** 31. n=427 n=426 n=427 n=381 n=382 n=382 n=88 n=86 n=89 IBS 31 Trial IBS 32 Trial Pooled Data Eluxadoline treatment resulted in more patients reporting a 3% reduction in abdominal pain score and a stool consistency score <5 on 5% of the days Represents composite primary efficacy endpoint. *P<.; ** P<.1. Lembo AJ, et al. N Engl J Med. 216;374(3):

20 Early Response Predicts Sustained Response to Eluxadoline in Patients with IBS D 1 Placebo BID Eluxadoline 75 mg BID Eluxadoline 1 mg BID Responders (%) n=89 n=88 n=86 n=11 n=184 n=198 n=11 n=184 n=198 n=11 n=184 n=198 n=11 n=184 n=198 Weeks 1 4 Responders Weeks 1 12 Responders Weeks 1 26 Responders Weeks 9 12 Responders Weeks Responders Weeks 1 4 Responders Over two thirds of patients who responded over the first month retained a positive response over 6 months of treatment with eluxadoline Chey WD, et al. Aliment Pharmacol Ther. 217;45(1): Eluxadoline Improves Symptoms of IBS D Independent of Prior Loperamide Use Placebo BID Eluxadoline 75 mg BID Eluxadoline 1 mg BID Placebo BID Eluxadoline 75 mg BID Eluxadoline 1 mg BID Responders (%) Δ = 14.3% Δ = 13.6% * * Δ = 16.8% Δ = 12.5% Responders (%) Δ = 14.1% Δ= 9.3% Δ = 17.6% Δ= 9.8% (n=166) (n=198) (n=174) (n=116) (n=96) (n=122) No Adequate Symptom Control Adequate Symptom Control (n=166) (n=198) (n=174) (n=116) (n=96) (n=122) No Adequate Symptom Control Adequate Symptom Control Lacy BE, et al. Am J Gastroenterol 217; 112:

21 Adverse Events of Treatment with Eluxadoline AEs SAEs Patients Reporting AEs (%) <1 <2 <12 <26 Patients Reporting SAEs (%) Placebo BID (n=975) Eluxadoline 75 mg BID (n=87) Eluxadoline 1 mg BID (n=132) <1 <2 <12 < Study Interval (weeks) Study Interval (weeks) SAEs, serious adverse events. Lembo AJ, et al. N Engl J Med. 216;374(3): Cash BD, et al. The American Journal of Gastroenterology. 217;112(2): Rifaximin Treatment Is Associated with Sustained Reduction of IBS Symptoms over 12 Weeks TARGET 1 and 2 Trials Patients with Adequate Relief (%) Day Doubleblind treatment phase Placebo 1 week follow up (no study medication) Rifaximin P= Week Two weeks of treatment with rifaximin resulted in a greater percentage of patients achieving adequate relief of global IBS symptoms Pimentel M, et al. N Engl J Med. 211;364(1):

22 Repeat Treatment with Rifaximin Is Safe and Effective in Patients with IBS D 2 week treatment Treatment free observation 2 week treatment Treatment free observation Mean Change From Baseline in Abdominal Pain Scores * * * * * * * * Rifaximin 55 mg TID Placebo * * * * Weeks * Statistically significant difference vs placebo. TID, three times daily. Lembo A, et al. Gastroenterology. 216;151(6): Safety and Tolerability of Rifaximin AE, n (%) Open Label Population Rifaximin, 55 mg TID (n=2579) Double Blind Population Rifaximin 55 mg TID (n=328) Placebo (n=38) Any AE 822 (31.9) 14 (42.7) 14 (45.5) Drug related AE 85 (3.3) 6 (1.8) 8 (2.6) Serious AE 28 (1.1) 4 (1.2) 4 (1.3) Lembo A, et al. Gastroenterology. 216;151(6):

23 Most Common Adverse Effects Observed with Rifaximin Treatment AE, n (%) Most common AEs Open Label Population Rifaximin, 55 mg TID (n=2579) Double Blind Population Rifaximin 55 mg TID (n=328) Placebo (n=38) Nausea 52 (2.) 12 (3.7) 7 (2.3) Upper respiratory tract infection 41 (1.6) 12 (3.7) 8 (2.6) Urinary tract infection 35 (1.4) 11 (3.4) 15 (4.9) Nasopharyngitis 36 (1.4) 1 (3.) 9 (2.9) Alanine aminotransferase increased 24 (.9) 9 (2.7) 4 (1.3) Blood creatinine phosphokinase increased 31 (1.2) 9 (2.7) 3 (1.) Bronchitis 15 (.6) 9 (2.7) 5 (1.6) Aspartate aminotransferase increased 24 (.9) 7 (2.1) 4 (1.3) Diarrhea 2 (.8) 7 (2.1) 3 (1.) Influenza 33 (1.3) 7 (2.1) 2 (.6) Sinusitis 34 (1.3) 7 (2.1) 7 (2.3) Headache 42 (1.6) 4 (1.2) 9 (2.9) Arthralgia 17 (.7) 3 (.9) 8 (2.6) Lembo A, et al. Gastroenterology. 216;151(6): Treatment of IBS D Nonpharmacologic Options 46 23

24 Soluble Fiber Supplementation Improves Global Symptoms of IBS Risk Ratio Study or Subgroup M-H, Random, 95% CI Soltoft, (.7, 2.4) Manning, (.42, 1.74) Kruis, (.78, 1.37) Lucey, (.2, 2.75) Rees, (.39, 1.91) Bijkerk, (.71, 1.) Subtotal (95% CI).9 (.79, 1.3) Heterogeneity: r 2 =.; 2 =2.76, d.f.=5 (P=.74); I 2 =% Test for overall effect: Z=1.47 (P=.14) Ritchie, (.37,.97) Longstreth, (.69, 1.92) Arthurs, (.39, 1.43) Nigam, (.45,.88) Prior, (.75, 1.5) Jalihal, (.11, 2.59) Bijkerk, (.74, 1.4) Subtotal (95% CI).83 (.73,.94) Heterogeneity: r 2 =.1; 2 =7.32, d.f.=6 (P=.29); I 2 =18% Test for overall effect: Z=2.8 (P=.5) Risk Ratio M-H, Random, 95% CI Bran Ispaghula Note: Details regarding study weight calculations available in the original publication. M H, Mantel Haenszel. Moayyedi P, et al. Am J Gastroenterol. 214;19(9): Benefit of a Gluten Free Diet in Patients with IBS D IBS Symptom Severity Score P<.1 (ANOVA) Week Week 2 Week 4 Week 6 Time Period on GFD A dietitian led GFD provided sustained benefit to patients with IBS D. The symptoms that improved differed in magnitude according to HLA DQ status. ANOVA, analysis of variance; GFD, gluten free diet; HLA, human leukocyte antigen. Aziz I, et al. Clin Gastroenterol Hepatol. 216;14(5):

25 Treatment with Bifidobacterium infantis Capsule Reduces Symptoms of IBS Mean Difference vs Placebo (%) Abdominal pain/discomfort.29 Bloating distension.33 Urgency.29 Incomplete evacuation Straining Overall.45 *.39 *.36 * *P<.3 vs placebo. Whorwell PJ, et al. Am J Gastroenterol. 26;11(7): A Diet Low in FODMAPs Reduces Symptoms in Patients with IBS Diet Sham Diet (n=53) Low FODMAP Diet (n =51) P IBS SSS a Total score 224 (89) 173 (95).1 Pain severity 4 (23) 33 (24).62 Days of pain 44 (29) 3 (27).1 Distension severity 4 (24) 29 (25).2 Satisfaction with bowels 53 (17 42 (23).2 Affecting life 47 (21) 4 (2).22 Change in IBS SSS 44 (72) 117 (86).1 Gastrointestinal Symptom Rating Scale Severity Scores b Abdominal pain 1.1 (.6).9 (.7).1 Heartburn.2 (.3).2 (.5).872 Acid reflux.2 (.5).2 (.4).515 Nausea.3 (.5).3 (.4).535 Borborygmi 1. (.7).7 (.6).3 Bloating 1.1 (.7).8 (.7).1 Belching.6 (.7).5 (.6).31 Flatulence 1.3 (.7).9 (.6).1 Constipation.3 (.4).2 (.4).559 Diarrhoea.3 (.5).2 (.5).257 Loose stool.7 (.7).5 (.6).8 Hard stool.2 (.2).2 (.3).166 Urgency.7 (.6).6 (.7).1 Incomplete evacuation.7 (.7).5 (.6).39 Tiredness 1.3 (.7) 1. (.8).67 Overall symptoms 1.2 (.6) 1. (.6).2 Stool output Stool consistency c 4.3 (1.1) 3.9 (1.).8 Normal consistency (proportion) e 61 (3) 67 (26).2 Stool frequency d 12.9 (7.4) 14. (8.5).843 Staudacher HM, et al. Gastroenterology 217;153:

26 Impact of Psychological Intervention on IBS Symptoms Treatment Modality Studies (n) Psychological Therapies/Controls (n/n) Relative Risk (95% CI) P Value Total psychological therapies 1232/ (.61.76) <.1 CBT 9 349/261.6 (.44.83).2 CBT via internet 2 71/69.75 ( ) NS Self administered/minimal contact CBT 3 73/71.53 ( ) NS Relaxation training or therapy 6 133/ ( ) NS Hypnotherapy 5 141/ (.63.87).2 Multicomponent psychotherapy 5 168/ (.62.83).1 Multicomponent psychotherapy via telephone 1 64/62.78 (.64.93).8 Dynamic psychotherapy 2 138/135.6 (.39.93).2 Stress management 2 59/39.63 ( ) NS Mindfulness meditation 1 36/39.57 ( ) NS CBT, cognitive behavioral therapy; CI, confidence interval, NS, not significant. Ford A, et al. Am J Gastroenterol. 214;19: ; Lucak S, et al. Ther Adv Gastroenterol. 217;1(2) Considerations for Long term Management 52 26

27 Improving Physician Patient Communication: Encouraging Patients to Speak Up Early Talk to healthcare providers about recurring abdominal pain and bowel symptoms rather than suffering in silence or taking advice from non healthcare professionals Completely Instead of just saying I have constipation or I have diarrhea, tell healthcare providers about the full extent of symptoms, how they impact life, and what approaches have been tried to manage them Often Inform healthcare providers if symptoms return despite treatment efforts so they can assess alternatives AGA. IBS in America: Survey Highlights Physical, Social and Emotional Impact. Available at: in america surveyhighlights physical social and emotional impact 53 Patient Misconceptions Regarding the Natural History of IBS 1 Patients Either in Agreement or Unsure (%) Develop Colitis Develop Malnutrition 67.3 Require Surgery 57.7 Develop Cancer Halpert A, et al. Am J Gastroenterol. 27;12(9): Halpert A, et al. Dig Dis Sci. 21;55(2):

28 Additional IBS Resources International Foundation for Functional Gastrointestinal Disorders Institute for Functional Medicine Irritable Bowel Syndrome Association IBS Page (list of IBS websites) 55 Summary IBS D is a commonly occurring functional bowel disorder that has a pervasive negative impact on the physical, social, and economic well being of affected individuals Diagnosis is based upon a thorough clinical history and physical examination, in conjunction with application of the Rome IV criteria Treatment options include several pharmacologic and nonpharmacologic strategies that have shown efficacy at reducing IBS D symptoms and improving QOL Long term management should be highly individualized and include education and support to promote disease understanding, ensure adherence, and guide therapeutic expectations 56 28

29 Questions & Answers 57 Thank You! 58 29

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