# Presentation: 802493

## IBS Burden of Illness

**Ian M. Gralnek, MD, MSHS**
**Director, UCLA Center for the Study of **
**Digestive Health Care Quality and Outcomes**
**Department of Medicine**
**University of California at Los Angeles**

**Notes:**
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.

## Hallmark Symptoms of IBS

**Hallmark Symptoms of IBS**

**Chronic or recurrent GI symptoms**
**lower abdominal pain/discomfort**
**altered bowel function (urgency, altered stool consistency, altered stool frequency, incomplete evacuation)**
**bloating**
**Not explained by identifiable structural or biochemical abnormalities**

**Notes:**
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.

## Key Facts About IBS

**4-20% of the US population report symptoms consistent with IBS****1,2**
**Affects predominantly females (~70% of sufferers)****3**
**Can cause great discomfort, sometimes intermittent or continuous, for many decades in a patient’s life****4**
**Can significantly disrupt daily life****5**

**References: 1.** Drossman et al. *Dig Dis Sci* 1993;38(9):1569-80. 2. Talley et al. *Am J Epid* 1995;142:76-83  **3**. Sandler. *Gastroenterology*. August 1990;99:409-415. **4.** Hahn et al. *Dig Dis Sci.* December 1998;43:2715-2718. **5.** Hahn et al. *Digestion*. 1999;60:77-81.

**Notes:**
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.

## Key Facts About IBS (continued)

**Treatment options****1**
**dietary modification**
**fiber supplements**
**pharmacologic agents**
**Success of treatment options in addressing multiple symptoms of IBS has been limited****2**

**References:** **1.** Drossman. *Aliment Pharmacol Ther*. 1999;13(suppl 2):3-14. **2**. Klein. *Aliment Pharmacol Ther.* 1988;13(suppl 2):15-30.

**Notes:**
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.

## Prevalence of IBS Diagnosis

**Other**
**88%**

**12%**

**IBS**

**28%**

**Other Functional**
**13%**

**Other GI**
**15%**

**IBD**
**14%**

**Peptic**
**20%**

**Liver**
**10%**

**Primary Care **
**Practice****1**

**Gastroenterology **
**Practice****2**

**Prevalence of IBS Diagnosis**

**References:** **1.** Everhart et al., *Gastroenterology*, 1991:100; 998-1005. **2**. Mitchell et al., *Gastroenterology*, 1987; 92:1282-4.

**IBS**

## Burden of Illness in IBS

**Direct Medical Costs**

**Productivity Loss**

**Health Related Quality of Life**

## Direct Medical Costs Associated with IBS

**Direct Medical Costs Associated with IBS**

**IBS sufferers incur 74% more direct healthcare costs than non-IBS sufferers****1**
**Extrapolated to US population; IBS results in upward of $8 billion in direct medical costs annually****1**
**IBS patients have more physician visits for both GI and non-GI complaints****2**

**Notes:**
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.

## Productivity Burden(US Population)

**Absenteeism from work or school ****during the last 12 months**

**Reference:** Drossman et al. *Dig Dis Sci.* September 1993;38:1569-1580.

**Notes:**
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.

## What is HRQOL?

**Physical**

**Psychologica****l**

**Social**

**What is HRQOL?**

## Why Measure HRQOL?

**Physiologic endpoints ******** functional status and well-being **
**Can help define burden of disease**
**HRQOL outcomes matter to patients**

## Impact of IBS on Quality of Life Compared with US Norms

**30**

**40**

**50**

**60**

**70**

**80**

**90**

**Role-Physical **

**Bodily Pain**

**Vitality**

**Social Functioning**

**Role-Emotional **

**Mental Health**

**Mean SF-36 score**

**US Norm**

**IBS**

- Adapted from Wells et al. *Aliment Pharmacol Ther.* 1997;11:1019-1030.

**Impact of IBS on Quality of Life ****Compared with US Norms**

**General Health**

**Physical****Functioning**

**100**

**Notes:**
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.

## Impact of IBS on Quality of Life Compared with Other Medical Conditions

**30**

**40**

**50**

**60**

**70**

**80**

**90**

**Mean SF-36 score**

**US Norm**

**Diabetes type II**

**IBS**

**Clinical depression**

- Adapted from Wells et al. *Aliment Pharmacol Ther.* 1997;11:1019-1030.

**Impact of IBS on Quality of Life ****Compared with Other Medical Conditions**

**Role-Physical **

**Bodily Pain**

**Vitality**

**Social Functioning**

**Role-Emotional **

**Mental Health**

**General Health**

**Physical****Functioning**

**100**

**Notes:**
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.

## Impact of IBS on Quality of Life Compared with Other Medical Conditions

**CHF**

**Role-****Physical **

**Bodily****Pain**

**Vitality**

**Social Functioning**

**Role-****Emotional**** **

**Mental Health**

**General Health**

**Physical****Functioning**

**Mean SF-36 Score**

**IBS**

**Impact of IBS on Quality of Life ****Compared with Other Medical Conditions**

## HRQOL and Burden of Disease in IBSGralnek IM et al., Gastroenterology, 2000 (In Press)

**AIM: To compare the impact of IBS on patients’ quality of life with that previously observed in the general population and in selected chronic diseases**
**877 adult IBS patients meeting Rome criteria or ≥3 Manning criteria**
**Administered the SF-36**

## HRQOL and Burden of Disease in IBS

**Compared to SF-36 data in the general population and in patients with chronic diseases**
**GERD**
**End-Stage Renal Disease**
**Diabetes**
**Clinical Depression**
**Adjusted for Age and Gender**
**Adjusted for Multiple Comparisons**

## HRQOL in IBS Patients is Significantly Worse Compared to U.S. Population

- Gralnek IM et al., *Gastroenterology*, 2000 (In Press)

## HRQOL in IBS Patients is Significantly Worse Compared with GERD

- Gralnek IM et al., *Gastroenterology*, 2000 (In Press)

**Role-****Physical********* **

**Bodily****Pain*******

**Vitality*******

**Social Functioning*******

**Role-****Emotional********* **

**Mental Health*******

**General Health*******

**Physical****Functioning**

***p<0.001**

**Mean SF-36 Score**

**GERD (n = 516)**

**IBS (n = 877)**

## HRQOL in IBS Patients Compared with Other Diseases

- Gralnek IM et al., *Gastroenterology*, 2000 (In Press)

**Role-****Physical **

**Bodily****Pain**

**Vitality**

**Social Functioning**

**Role-****Emotional**

**Mental Health**

**General Health**

**Physical****Functioning**

**Mean SF-36 Score**

**ESRD (n = 165)**

**IBS (n = 877)**

**Diabetes (n = 541)**

**Depression****(n =  502)**

## SF-36 Physical Component Summary Scores

*** P < 0.002 - Significantly different from IBS**

*****

*****

*****

*****

**SF-36 Physical Component Summary Scores**

- Gralnek IM et al., *Gastroenterology*, 2000 (In Press)

## SF-36 Mental Component Summary Scores

*****

*****

*****

*****

*****

*** P < 0.002 - Significantly different from IBS**

**SF-36 Mental Component Summary Scores**

- Gralnek IM et al., *Gastroenterology*, 2000 (In Press)

## IBS Burden of Illness

**Significant Disease Burden**
**Increased Direct Medical Costs**
**Reduced Productivity**
**Impact on Quality of Life**