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  • IBS is one of over 20 functional gastrointestinal (GI) disorders.1 The functional GI disorders vary clinically and are characterized by chronic or recurrent symptoms not explained by structural or biochemical abnormalities. It appears that these disorders relate to abnormalities in motility and/or afferent sensitivity as modulated by the central nervous system.2
    IBS is defined as a functional bowel disorder in which abdominal pain is associated with a change in bowel habit with features of disordered defecation.3
    Features of disordered defecation include3
    Urgency
     Altered stool consistency
     Altered stool frequency
     Incomplete evacuation
    References:
    1. Drossman DA, Thompson WG, Talley NJ, Funch-Jensen P, Janssens J, Whitehead WE. Identification of sub-groups of functional gastrointestinal disorders. Gastroenterol Int. December 1990;3:159-172.
    2. Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999;13(suppl 2):3-14.
    3. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Müller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999;45(suppl 2):1143-1147.
  • IBS is one of over 20 functional gastrointestinal (GI) disorders.1 The functional GI disorders vary clinically and are characterized by chronic or recurrent symptoms not explained by structural or biochemical abnormalities. It appears that these disorders relate to abnormalities in motility and/or afferent sensitivity as modulated by the central nervous system.2
    IBS is defined as a functional bowel disorder in which abdominal pain is associated with a change in bowel habit with features of disordered defecation.3
    Features of disordered defecation include3
    Urgency
     Altered stool consistency
     Altered stool frequency
     Incomplete evacuation
    References:
    1. Drossman DA, Thompson WG, Talley NJ, Funch-Jensen P, Janssens J, Whitehead WE. Identification of sub-groups of functional gastrointestinal disorders. Gastroenterol Int. December 1990;3:159-172.
    2. Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999;13(suppl 2):3-14.
    3. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Müller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999;45(suppl 2):1143-1147.
  • Prevalence estimates from surveys among American adults suggest that up to 20% of the population report symptoms consistent with IBS.1 These surveys have shown that, in general, female patients outnumber male patients 3:1.2
    Irritable bowel syndrome is the most common functional bowel disorder,3 the most common GI diagnosis among US gastroenterology practices,4 and is one of the top 10 reasons for primary care physician visits.5
    Estimates of prevalence of IBS are, however, diverse. This is likely to be a consequence of the differences between epidemiological studies (e.g., the use of different diagnostic criteria, selected populations, and the source of the data).2,6
    References:
    1. Camilleri M, Choi M-G. Review article: irritable bowel syndrome. Aliment Pharmacol Ther. 1997;11:3-15.
    2.Sandler RS. Epidemiology of irritable bowel syndrome in the United States.Gastroenterology. August 1990;99:409-415.
    3.Thompson WG, Creed F, Drossman DA, Heaton KW, Mazzacca G. Functional bowel disease and functional abdominal pain. Gastroenterol Int. 1992;5:75-91.
    4.Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. April 1991;100:998-1005.
    5.Physician Drug & Diagnosis Audit (PDDA), April 1999, Scott-Levin.
    6.Drossman DA, Li Z, Andruzzi E, et al. US householder survey of functional gastrointestinal disorders—prevalence, sociodemography, and health impact. Dig Dis Sci. September 1993;38:1569-1580.
  • IBS can cause great discomfort and can affect an individual for many years. The symptoms can be either persistent or recurrent and may vary over time.1
    Patients suffer from altered bowel habits accompanied by pain or discomfort, which can significantly disrupt their daily lives.2
    Current treatment options include
    Dietary restrictions—avoiding fatty foods or lactose3
    Supplementing diet with fiber3,4
    Pharmacologic agents—antidiarrheals,3 laxatives,3 antispasmodics,3 tricyclic antidepressants, and SSRIs4
    Psychotherapy—hypnotherapy, relaxation exercises, psychological treatment3,4
    Success of current treatment options in addressing multiple symptoms of IBS has been limited.5
    References:
    1. Hahn B, Watson M, Yan S, Gunput D, Heuijerjans J. Irritable bowel syndrome symptom patterns: frequency, duration, and severity. Dig Dis Sci. December 1998;43:2715-2718.
    2.Hahn BA, Yan S, Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion. 1999;60:77-81.
    3.Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999;13(suppl 2):3-14.
    4.American Gastroenterological Association. Medical position statement: irritable bowel syndrome. Gastroenterology. June 1997;112:2118-2119.
    5.Klein KB. Controlled treatment trials in the irritable bowel syndrome: a critique. Gastroenterology. July 1988;95:232-241.
  • In the United States, IBS accounts for an estimated 2.4 to 3.5 million physician visits per year and an estimated 2.2 million prescriptions.1
    Talley et al conducted a community survey to assess the direct medical costs of IBS in the United States over a period of one year. Of over 4,000 people sent questionnaires, 74% responded, and, based on their replies, respondents were classified as2
    Subjects with symptoms compatible with IBS (abdominal pain more than 6 times in the prior year in combination with any 2 or more of the Manning criteria)
    Control subjects (no GI symptoms in the prior year)
    Subjects with some GI symptoms (abdominal pain or disturbed defecation in the prior year who failed to meet the criteria for IBS)
    They found that direct one-year medical charges for a patient with IBS were, on average, $742 (based on charges in 1992), compared with $429 for one without IBS and $614 for a person with some GI symptoms. Extrapolation of these findings to the US white population, based on 1992 costs, showed an annual charge of over $8 billion resulting from IBS.2
    References:
    1.Sandler RS. Epidemiology of irritable bowel syndrome in the United States. Gastroenterology. August 1990;99:409-415.
    2.Talley NJ, Gabriel SE, Harmsen WS, Zinsmeister AR, Evans RW. Medical costs in community subjects with irritable bowel syndrome. Gastroenterology. December 1995;109:1736-1741.
  • The impact of productivity is measured not only in terms of how businesses are affected by the high rate of absenteeism but also by the impact of consulters on the healthcare system.1
    The purpose of the US Householder Survey reported by Drossman et al was to provide national data for the United States on the frequency and sociodemographic features of functional GI disorders and their relationship to absenteeism from work or school and healthcare use. A random sample of US householders was surveyed.1
    The survey showed that in the previous year, patients with IBS had missed about 3 times as many days from work or school because of illness compared with those with no evidence of functional GI disorder (mean values: 13.4 days vs 4.9 days; P=0.0001). In addition, a higher proportion of those with IBS reported that they currently were too sick to work or to go to school compared with those without IBS (11.3% vs 4.2%).1
    Drossman et al also found that persons with IBS were significantly more likely to see physicians for complaints unrelated to the GI tract (3.9/year vs 1.8/year; P=0.0001) as well as for GI complaints (1.6/year vs 0.1/year; P=0.0001) than were persons with no evidence of functional GI disorders.1
    Reference:
    1.Drossman DA, Li Z, Andruzzi E, et al. US householder survey of functional gastrointestinal disorders—prevalence, sociodemography, and health impact. Dig Dis Sci. September 1993;38:1569-1580.
  • It is increasingly being recognized by physicians and healthcare workers that IBS can have a significant impact on patients’ quality of life. Such factors as physical functioning, mental health, and interaction with family and friends are key contributors to a patient’s sense of well-being and health.1 Studies have shown that IBS can affect sleep,2 employment,3 sexual function, leisure and travel,4 and can cause depression and anxiety.2
    Patients with IBS have worse health-related quality of life than national norms; have worse health-related quality of life for most domains than patients with diabetes; and have health-related quality of life generally comparable to patients with clinical depression.1
    References:
    1.Wells NEJ, Hahn BA, Whorwell PJ. Clinical economics review: irritable bowel syndrome. Aliment Pharmacol Ther. 1997;11:1019-1030.
    2.Sjödin I, Svedlund J. Psychological aspects of non-ulcer dyspepsia: a psychosomatic view focusing on a comparison between the irritable bowel syndrome and peptic ulcer disease. Scand J Gastroenterol. 1985;20(suppl 109):51-58.
    3. Hahn BA, Yan S, Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion. 1999;60:77-81.
    4.Dancey CP, Backhouse S. Towards a better understanding of patients with irritable bowel syndrome. J Adv Nurs. September 1993;18:1443-1450.
  • It is increasingly being recognized by physicians and healthcare workers that IBS can have a significant impact on patients’ quality of life. Such factors as physical functioning, mental health, and interaction with family and friends are key contributors to a patient’s sense of well-being and health.1 Studies have shown that IBS can affect sleep,2 employment,3 sexual function, leisure and travel,4 and can cause depression and anxiety.2
    Patients with IBS have worse health-related quality of life than national norms; have worse health-related quality of life for most domains than patients with diabetes; and have health-related quality of life generally comparable to patients with clinical depression.1
    References:
    1.Wells NEJ, Hahn BA, Whorwell PJ. Clinical economics review: irritable bowel syndrome. Aliment Pharmacol Ther. 1997;11:1019-1030.
    2.Sjödin I, Svedlund J. Psychological aspects of non-ulcer dyspepsia: a psychosomatic view focusing on a comparison between the irritable bowel syndrome and peptic ulcer disease. Scand J Gastroenterol. 1985;20(suppl 109):51-58.
    3. Hahn BA, Yan S, Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion. 1999;60:77-81.
    4.Dancey CP, Backhouse S. Towards a better understanding of patients with irritable bowel syndrome. J Adv Nurs. September 1993;18:1443-1450.
  • Transcript

    • 1. AA Alosetron 2000 6/26 IBS Burden of IllnessIBS Burden of Illness Ian M. Gralnek, MD, MSHSIan M. Gralnek, MD, MSHS Director, UCLA Center for the Study ofDirector, UCLA Center for the Study of Digestive Health Care Quality andDigestive Health Care Quality and OutcomesOutcomes Department of MedicineDepartment of Medicine University of California at Los AngelesUniversity of California at Los Angeles
    • 2. AA Alosetron 2000 6/26 Reference: Thompson et al.Reference: Thompson et al. GutGut. 1999;45(suppl 2):1143-1147.. 1999;45(suppl 2):1143-1147. Hallmark Symptoms of IBSHallmark Symptoms of IBS • Chronic or recurrent GI symptomsChronic or recurrent GI symptoms – lower abdominal pain/discomfortlower abdominal pain/discomfort – altered bowel function (urgency, alteredaltered bowel function (urgency, altered stool consistency, altered stoolstool consistency, altered stool frequency, incomplete evacuation)frequency, incomplete evacuation) – bloatingbloating • Not explained by identifiableNot explained by identifiable structural or biochemicalstructural or biochemical abnormalitiesabnormalities
    • 3. AA Alosetron 2000 6/26 Key Facts About IBSKey Facts About IBS • 4-20% of the US population report4-20% of the US population report symptoms consistent with IBSsymptoms consistent with IBS1,21,2 • Affects predominantly femalesAffects predominantly females (~70% of sufferers)(~70% of sufferers)33 • Can cause great discomfort,Can cause great discomfort, sometimes intermittent orsometimes intermittent or continuous, for many decades in acontinuous, for many decades in a patient’s lifepatient’s life44 • Can significantly disrupt daily lifeCan significantly disrupt daily life55References: 1.References: 1. Drossman et al.Drossman et al. Dig Dis SciDig Dis Sci 1993;38(9):1569-80. 2. Talley et al.1993;38(9):1569-80. 2. Talley et al. Am J EpidAm J Epid 1995;142:76-831995;142:76-83 33. Sandler.. Sandler. GastroenterologyGastroenterology. August 1990;99:409-415.. August 1990;99:409-415. 4.4. Hahn et al.Hahn et al. Dig Dis Sci.Dig Dis Sci. December 1998;43:2715-2718.December 1998;43:2715-2718. 5.5. Hahn et al.Hahn et al. DigestionDigestion. 1999;60:77-81.. 1999;60:77-81.
    • 4. AA Alosetron 2000 6/26 Key Facts About IBSKey Facts About IBS (continued)(continued)•Treatment optionsTreatment options11 – dietary modificationdietary modification – fiber supplementsfiber supplements – pharmacologic agentspharmacologic agents •Success of treatment options inSuccess of treatment options in addressing multiple symptoms ofaddressing multiple symptoms of IBS has been limitedIBS has been limited22 References:References: 1.1. Drossman.Drossman. Aliment Pharmacol TherAliment Pharmacol Ther. 1999;13(suppl 2):3-14.. 1999;13(suppl 2):3-14. 22. Klein.. Klein. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1988;13(suppl 2):15-30.1988;13(suppl 2):15-30.
    • 5. AA Alosetron 2000 6/26 Other 88% 12% IB S 28% OtherOther FunctionaFunctiona ll 13%13% Other GIOther GI 15%15% IBD 14% PepticPeptic 20%20% Liver 10% Primary CarePrimary Care PracticePractice11 GastroenterologyGastroenterology PracticePractice22 Prevalence of IBS DiagnosisPrevalence of IBS Diagnosis References:References: 1.1. Everhart et al.,Everhart et al., GastroenterologyGastroenterology, 1991:100; 998-1005., 1991:100; 998-1005. 22. Mitchell et al.,. Mitchell et al., GastroenterologyGastroenterology, 1987; 92:1282-4., 1987; 92:1282-4. IB S
    • 6. AA Alosetron 2000 6/26 Burden of Illness in IBSBurden of Illness in IBS Direct MedicalDirect Medical CostsCosts ProductivityProductivity LossLoss HealthHealth RelatedRelated Quality ofQuality of LifeLife
    • 7. AA Alosetron 2000 6/26 References:References: 1.1. Talley et al.Talley et al. GastroenterologyGastroenterology. December 1995;109:1736-1741.. December 1995;109:1736-1741. 2.2. Drossman et al.Drossman et al. Dig Dis SciDig Dis Sci. September 1993;38:1569-1580.. September 1993;38:1569-1580. Direct Medical CostsDirect Medical Costs Associated with IBSAssociated with IBS • IBS sufferers incur 74% more directIBS sufferers incur 74% more direct healthcare costs than non-IBS sufferershealthcare costs than non-IBS sufferers11 • Extrapolated to US population; IBSExtrapolated to US population; IBS results in upward of $8 billion in directresults in upward of $8 billion in direct medical costs annuallymedical costs annually11 • IBS patients have more physician visitsIBS patients have more physician visits for both GI and non-GI complaintsfor both GI and non-GI complaints22
    • 8. AA Alosetron 2000 6/26 Productivity BurdenProductivity Burden (US Population)(US Population) 00 22 44 66 88 1010 1212 1414 IBSIBS (n=606)(n=606) ControlControl (n=1625)(n=1625) DaysperyearDaysperyear PP=0.0001=0.0001 Absenteeism from work or schoolAbsenteeism from work or school during the last 12 monthsduring the last 12 months Reference:Reference: Drossman et al.Drossman et al. Dig Dis Sci.Dig Dis Sci. September 1993;38:1569-1580.September 1993;38:1569-1580.
    • 9. AA Alosetron 2000 6/26 Multidimensional ConstructMultidimensional Construct PhysicalPhysical PsychologicaPsychologicall SocialSocial What is HRQOL?What is HRQOL?
    • 10. AA Alosetron 2000 6/26 Why Measure HRQOL?Why Measure HRQOL? •Physiologic endpointsPhysiologic endpoints ≠≠ functional status and well-beingfunctional status and well-being •Can help define burden of diseaseCan help define burden of disease •HRQOL outcomes matter toHRQOL outcomes matter to patientspatients
    • 11. AA Alosetron 2000 6/26 30 40 50 60 70 80 90 Role-Role- PhysicalPhysical BodilyBodily PainPain VitalityVitality SocialSocial FunctioningFunctioning Role-Role- EmotionalEmotional MentalMental HealthHealth MeanSF-36score US NormUS Norm IBSIBS Adapted from Wells et al.Adapted from Wells et al. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1997;11:1019-1030.1997;11:1019-1030. Impact of IBS on Quality of LifeImpact of IBS on Quality of Life Compared with US NormsCompared with US Norms GeneralGeneral HealthHealth PhysicalPhysical FunctioninFunctionin gg 100
    • 12. AA Alosetron 2000 6/26 30 40 50 60 70 80 90 MeanSF-36score US Norm Diabetes type II IBS Clinical depression Adapted from Wells et al.Adapted from Wells et al. Aliment Pharmacol Ther.Aliment Pharmacol Ther. 1997;11:1019-1030.1997;11:1019-1030. Impact of IBS on Quality of LifeImpact of IBS on Quality of Life Compared with Other MedicalCompared with Other Medical ConditionsConditions Role-Role- PhysicalPhysical BodilyBodily PainPain VitalityVitality SocialSocial FunctioningFunctioning Role-Role- EmotionalEmotional MentalMental HealthHealth GeneralGeneral HealthHealth PhysicalPhysical FunctioninFunctionin gg 100
    • 13. AA Alosetron 2000 6/26 Whitehead et al.,Whitehead et al., Dig Dis SciDig Dis Sci, November 1996; 41:2248-2253., November 1996; 41:2248-2253. CH F 30 40 50 60 70 80 90 100 Role-Role- PhysicalPhysical BodilyBodily PainPain VitalityVitality SocialSocial FunctioningFunctioning Role-Role- EmotionalEmotional MentalMental HealthHealth GeneralGeneral HealthHealth PhysicalPhysical FunctioningFunctioning MeanSF-36ScoreMeanSF-36Score IBS Impact of IBS on Quality of LifeImpact of IBS on Quality of Life Compared with Other MedicalCompared with Other Medical ConditionsConditions
    • 14. AA Alosetron 2000 6/26 HRQOL and Burden of Disease inHRQOL and Burden of Disease in IBSIBS Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In, 2000 (In Press)Press)AIM: To compare the impact of IBS onAIM: To compare the impact of IBS on patients’ quality of life with thatpatients’ quality of life with that previously observed in the generalpreviously observed in the general population and in selected chronicpopulation and in selected chronic diseasesdiseases • 877 adult IBS patients meeting Rome877 adult IBS patients meeting Rome criteria or ≥3 Manning criteriacriteria or ≥3 Manning criteria • Administered the SF-36Administered the SF-36
    • 15. AA Alosetron 2000 6/26 HRQOL and Burden of Disease inHRQOL and Burden of Disease in IBSIBS• Compared to SF-36 data in theCompared to SF-36 data in the general population and in patientsgeneral population and in patients with chronic diseaseswith chronic diseases – GERDGERD – End-Stage Renal DiseaseEnd-Stage Renal Disease – DiabetesDiabetes – Clinical DepressionClinical Depression • Adjusted for Age and GenderAdjusted for Age and Gender • Adjusted for Multiple ComparisonsAdjusted for Multiple Comparisons
    • 16. AA Alosetron 2000 6/26 HRQOL in IBS Patients is SignificantlyHRQOL in IBS Patients is Significantly Worse Compared to U.S. PopulationWorse Compared to U.S. Population Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press), 2000 (In Press) US Pop. (n = 2474) 30 40 50 60 70 80 90 Role-Role- PhysicalPhysical ** BodilyBodily PainPain** VitalityVitality** SocialSocial FunctioningFunctioning** Role-Role- EmotionalEmotional** MentalMental HealthHealth** GeneralGeneral HealthHealth** PhysicalPhysical FunctioningFunctioning** *p<0.001 MeanSF-36ScoreMeanSF-36Score IBS (n = 877)
    • 17. AA Alosetron 2000 6/26 HRQOL in IBS Patients is SignificantlyHRQOL in IBS Patients is Significantly Worse Compared with GERDWorse Compared with GERD Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press), 2000 (In Press) 30 40 50 60 70 80 90 Role-Role- PhysicalPhysical ** BodilyBodily PainPain** VitalityVitality** SocialSocial FunctioningFunctioning** Role-Role- EmotionalEmotional** MentalMental HealthHealth** GeneralGeneral HealthHealth** PhysicalPhysical FunctioningFunctioning *p<0.001 MeanSF-36ScoreMeanSF-36Score GERD (n = 516)GERD (n = 516) IBS (n = 877)IBS (n = 877)
    • 18. AA Alosetron 2000 6/26 HRQOL in IBS Patients Compared withHRQOL in IBS Patients Compared with Other DiseasesOther Diseases Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press), 2000 (In Press) 30 40 50 60 70 80 90 Role-Role- PhysicalPhysical BodilyBodily PainPain VitalityVitality SocialSocial FunctioningFunctioning Role-Role- EmotionalEmotional MentalMental HealthHealth GeneralGeneral HealthHealth PhysicalPhysical FunctioningFunctioning MeanSF-36ScoreMeanSF-36Score ESRD (n = 165) IBS (n = 877) Diabetes (n = 541) Depression (n = 502)
    • 19. AA Alosetron 2000 6/26 0 10 20 30 40 50 60 US Pop. (n=2474) GERD (n=471) DEPRESSION (n=502) IBS (n=858) DIABETES (n=541) ESRD (n=165) * P < 0.002 - Significantly different from IBS* P < 0.002 - Significantly different from IBS * * * * SF-36 Physical ComponentSF-36 Physical Component Summary ScoresSummary Scores Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press), 2000 (In Press)
    • 20. AA Alosetron 2000 6/26 0 10 20 30 40 50 60 US Pop. (n=2474) DIABETES (n=541) GERD (n=471) ESRD (n=165) IBS (n=858) DEPRESSION (n=502) * * * * * * P < 0.002 - Significantly different from IBS SF-36 Mental ComponentSF-36 Mental Component Summary ScoresSummary Scores Gralnek IM et al.,Gralnek IM et al., GastroenterologyGastroenterology, 2000 (In Press), 2000 (In Press)
    • 21. AA Alosetron 2000 6/26 IBS Burden of IllnessIBS Burden of Illness Significant Disease BurdenSignificant Disease Burden • Increased Direct Medical CostsIncreased Direct Medical Costs • Reduced ProductivityReduced Productivity • Impact on Quality of LifeImpact on Quality of Life