1. health and fitness
2. disease
3. ibs and crohn's disease

Irritable Bowel
Syndrome in Women:
The Unmet Needs
A Report from the Society for Women’s Health Research
©December 2002
Society for Women’s Health Research
1828 L Street, NW, Suite 625
Washington, DC 20036
Phone: (202) 223-8224
Fax: (202) 833-3472
www.womens-health.org
Irritable Bowel Syndrome in Women: The Unmet Needs is funded by Novartis Pharmaceuticals Corporation.
Irritable Bowel
Syndrome in Women:
The Unmet Needs
A Report from the Society for Women’s Health Research
FOREWORD
In 2001, the Institute of Medicine (IOM) issued its landmark report Exploring the Biological
Contributions to Human Health: Does Sex Matter? The report, which was initiated and cosponsored by the Society for Women’s Health Research, examined the state of knowledge of
sex-based biology and gender-based medicine and made recommendations for advancing an
appropriate research agenda for this emerging field.
The report validated what the Society has long advocated: sex must be considered in all
aspects and at all levels of biomedical research and health care. Among its findings, the
report identified barriers to the advancement of knowledge about sex differences in health
and illnesses that can impede the proper diagnosis and treatment of conditions that affect
women solely, predominately, or differently.
Irritable Bowel Syndrome (IBS) is just one of the many disorders that takes an excessive toll
on women. Of the millions of IBS sufferers in the United States, approximately 60% to
75% are women. IBS can impact every aspect of a woman’s health—physical health,
emotional health, and economic health. This report outlines misconceptions about this
disabling condition and discusses unmet needs of patients; gaps in our knowledge; areas for
further research; and the need for patient and physician education.
Scientists still do not understand fully why IBS affects more women than men. But with
the advancement of the field of sex-based biology, the answers are within our reach.
Sincerely,
Phyllis Greenberger, MSW
President and CEO
Society for Women’s Health Research
The Society for Women’s Health Research is the nation’s only not-for-profit organization whose sole mission is to improve
the health of women through research. The Society advocates increased funding for research on women’s health, encourages
the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of
women in medical research studies.
ii
PREFACE
Women’s health research has emerged from its early emphasis on reproduction to address a much
more complex array of women’s health issues. We now understand how sex plays a major
role in the underlying causes and effects of heart disease, musculoskeletal disorders, and
metabolic/digestive disorders. Among the latter, irritable bowel syndrome (IBS) is one of the
least understood and most frustrating—for patients as well as for the medical community.
Approximately 60% to 75% of Americans with IBS are women. Despite research to date,
scientists are still unable to explain the predominance of IBS in women. Since the National
Institutes of Health mandated that women be included in clinical trials in 1990, differences
in the way disease states manifest in men and women have been noted. Sex differences in
reproductive hormones, pain perception, stress response, and gastrointestinal function may
partially explain a woman’s increased susceptibility to IBS. Despite these findings, definitive
evidence explaining the true reasons why IBS affects women more often than men remains
elusive. In addition to these findings, cultural differences in health-care–seeking behaviors
and differences in reporting habits and symptom-response profiles between the sexes also
have been observed. A closer examination of the differences in presentation of IBS in women and
men is clearly warranted. This report attempts to capture the unmet needs of women with IBS.
Experts now understand that IBS has a complex biologic basis with a physiologic cause, yet
most Americans still do not recognize IBS as a common medical disorder. This lack of
awareness was confirmed in a telephone survey of 1,000 adults conducted in May 2002 (see
the Appendix for a brief overview of the methodology). Participants were asked to rank 5
conditions (asthma, coronary heart disease, depression, diabetes, and IBS) in order of their
prevalence. Although IBS affects approximately 1 in 6 Americans, only 1.2% of respondents
correctly identified IBS as the most prevalent of these 5 conditions.
Although the consequences of IBS for patients may not always be obvious to health care
providers or the general public, its impact on people living with the symptoms of abdominal pain
or discomfort, bloating, and constipation or diarrhea, is all too real. There is a growing body
of medical literature that describes the many ways IBS can significantly reduce a person’s
quality of life, causing as much distress as do conditions such as asthma and migraine headaches.
Discomfort from the symptoms of IBS may be intolerable for many patients, yet few medical
treatments provide adequate relief for the multiple symptoms of this troubling disorder.
Instead, IBS remains underrecognized, and diagnosis can be elusive as patients shuffle from
physician to physician in search of relief from these often debilitating symptoms. These
patients struggle with pain, isolation, and frustration. Physicians and other health care
providers (eg, physician assistants, nurse practitioners, nurses) themselves often struggle to
identify the disorder and, once they do so, they have a limited array of treatment options
from which to choose.
iii
A disturbing picture emerges of IBS patients who must plan their days around their access
to a bathroom. They often miss social events, work or school. They also visit physicians
more frequently than do healthy individuals. The societal toll mounts dramatically—the
condition costs the United States health care system as much as $30 billion annually in
direct and indirect costs.1,2
This report offers a timely and compelling look at the significant impact of IBS symptoms on
patient’s lives; unmet needs of IBS patients; the urgency to help remove the communication
barriers between physicians and patients with a common language to describe IBS and
its symptoms; and the need for greater public understanding of the heavy burden IBS
places on women.
iv
Irritable Bowel Syndrome in Women: The Unmet Needs
A Report from the Society for Women’s Health Research
Table of Contents
Foreword ........................................................................................................................ii
Preface ..........................................................................................................................iii
Introduction....................................................................................................................1
Patient and Physician Surveys ........................................................................................3
The Physical Impact of IBS ............................................................................................4
IBS and Quality of Life ................................................................................................12
The Economic Impact of IBS ........................................................................................16
The Challenges of Diagnosis and Treatment..................................................................18
Bridging the Gap Between Patients and Physicians: A Prerequisite for Progress ..........24
Educational Needs: Many Gaps Remain........................................................................26
Conclusion ....................................................................................................................27
Appendix
Biology of IBS: The Role of Serotonin....................................................................29
Methodologies for the Patient and Physician Surveys ............................................30
Methodology for the Omnibus Survey....................................................................31
References ....................................................................................................................32
v
INTRODUCTION
Irritable bowel syndrome (IBS) is a clinical gastrointestinal (GI) disorder with no definitive
biochemical or structural changes, physical findings, or gold standard diagnostic tests (eg,
blood tests, x-rays) to identify its presence.3,4 Therefore, it is evaluated and diagnosed based
primarily on the nature and pattern of symptoms.3 IBS is characterized by abdominal pain
or discomfort, bloating, and constipation, diarrhea, or both in alternation.5
IBS often goes unrecognized or untreated because its impact on patients’ lives is grossly
underestimated. IBS is a medical disorder with a physiologic basis. While the pathophysiology of IBS is complex and incompletely understood, symptoms of IBS (such as abdominal
pain/discomfort, bloating, and constipation or diarrhea) seem to be influenced by an
imbalance of chemicals in the GI tract, which may lead to altered movement of food
and waste through the digestive system, increased perception of pain in the abdominal
area, and altered movement of fluid in the digestive tract (see Appendix). Research of the
role of neurotransmitters, such as serotonin, in IBS shows promise in terms of explaining
the mechanisms of IBS and for developing therapies.6,7 Treatments targeting individual
symptoms—for example, antispasmodics, laxatives/fiber products, and antidiarrheals—were,
until recently, the only options.8 Consensus recommendations on IBS from the American
College of Gastroenterology (ACG) suggest there is little evidence to support the efficacy
of these agents for the entire IBS symptom complex.9 New medications that target
multiple symptoms of IBS recently have been approved by the Food and Drug
Administration (FDA). Their mechanism of action is linked to the pathophysiology of IBS.
“
IBS is a real medical
problem in need of real
medical treatment.
”
– Dr. G
Current understanding of IBS and its treatment options and management recommendations
is a critical aspect of caring for IBS patients, and these topics are widely addressed in
various publications. The majority of published medical articles on IBS tend to focus on
diarrhea as the more prevalent and disabling form of IBS. Yet IBS with constipation, diarrhea,
or constipation and diarrhea in alternation each affect about one third of patients. The lack
of existing literature regarding IBS with constipation is one important reason why some
sections of this report emphasize that subtype.
The purpose of this report is to highlight many issues facing women with IBS. It is not
intended to provide a comprehensive overview of IBS or clinical recommendations for its
management and treatment. Recent telephone surveys explored patients’ and physicians’
thoughts, feelings, and perceptions of the complex physical, quality-of-life, and economic
dimensions of IBS. These surveys also helped to uncover communication gaps that exist
between patients and physicians.
Because women are reported to suffer from IBS twice as often as men10,11 and given the need
for more balanced coverage of IBS with constipation, select sections of this report discuss the
unmet clinical needs of women suffering from IBS with constipation. The report provides
1
a snapshot of the disorder’s impact on patients’ lives and highlights the communication
gaps that complicate the diagnosis and treatment of IBS. Findings from these surveys
underscore the need for further awareness and education to help close those gaps, which will
allow patients to partner with the health care team in developing individualized treatment
strategies. Thus, the likelihood of a positive treatment outcome will be increased.
The Society acknowledges that additional research needs to be conducted for all subtypes of
IBS as well as for IBS in men. This report is just a first step towards a better understanding
of the issues all patients with IBS face.
This report is part of a public education campaign funded by Novartis Pharmaceuticals
Corporation. This report was prepared by ApotheCom Associates LLC, and it was reviewed
and revised by experts identified by the Society for Women’s Health Research and Novartis.
2
PATIENT AND PHYSICIAN SURVEYS
Purpose
Three surveys were recently conducted to gain further insight into the impact of irritable
bowel syndrome (IBS) in the United States, including the symptoms, treatments, attitudes,
and behaviors of patients; the unmet clinical and educational needs of patients and physicians;
perception gaps between patients and physicians; and limitations of treatment options.
Two in-depth surveys were conducted from June through August 2000—a Gastrointestinal
(GI) Sufferer Study, with 1,013 sufferers of functional GI disorders, and a Physician Study,
with 711 primary care physicians and gastroenterologists. The third survey, the IBS
Medications Side Effects Study, was conducted in January 2002, with 668 patients diagnosed
with either IBS with constipation or alternating IBS. The methodology for these surveys are
described in the Appendix.
Much of the data discussed in this report were drawn from the women who participated in
these surveys. When available, data solely regarding women are presented. These “womenonly” data were comparable with the total population of male and female participants. The
survey findings reinforce the conclusion that IBS has a significant physical, quality-of-life,
and economic impact and presents many challenges for both physicians and patients. This
report integrates the results from these surveys with published literature. It provides a broad
view of the effects of this often overlooked and underappreciated disorder on the patients
who suffer from it and the physicians who are challenged to diagnose, treat, and manage it.
Considerations
These surveys, which were commissioned by Novartis Pharmaceuticals Corporation, are
subjective and based on the opinions of the patients and physicians who participated in the
studies. This report interprets their results in the context of other published research.
The Physician Study revealed important trends that may also be applied to physician assistants,
nurse practitioners, or nurses who play a key role in the initial assessment and ongoing
management and education of IBS patients. These vital members of the health care team
also offer valuable insights, guidance, and reassurance.
For example, the positive role nurses can play in the care of women with IBS recently was
documented in a presentation at the Digestive Disease Week conference in May 2002. The study
(enrolling 103 women ages 20–45 years) evaluated effects of implementing a comprehensive
self-management program run by a nurse therapist (including stress management, diet,
cognitive restructuring, and relaxation). Compared with the other treatment groups—
patients receiving a one-time brief self-management consultation or patients receiving
usual care—those patients participating in the comprehensive program realized greater
improvement in their IBS symptoms.12
Lack of efficacy of conventional IBS options often leads IBS patients to seek a holistic
approach from alternative care providers such as homeopaths, herbalists, acupuncturists,
and hypnotherapists.13-15 This health care segment needs to be evaluated in future surveys.
3
THE PHYSICAL IMPACT OF IBS
IBS Primarily Affects Women
Irritable bowel syndrome (IBS) is more common than many realize. It affects 10% to 20% of
the adult American population16-18 and is the most common gastrointestinal (GI) disorder
diagnosis made by gastroenterologists.19
In the United States, 60% to 75% of IBS sufferers are women.5,10,11,20 Multiple factors may
account for this observation, including cultural differences in health-care–seeking behaviors.
For example, in some non-Western countries, such as India and Sri Lanka, IBS is reported
more frequently in men.21
Sex differences in symptom-reporting habits also have been noted. Women tend to report
IBS symptoms to physicians more readily than men. Treatment response profiles also differ
between women and men, and certain symptoms seem to manifest more commonly in
women (eg, distension).22
Physiologic differences between the sexes have also been noted. Hormonal differences
between women and men may affect the function of the gut and the perception of pain. For
example, compared with women, men seem to be less sensitive to pain that is induced by
stretching of the colon (via balloon distension). Further, animal studies have suggested that
estrogen may lead to increased sensitivity of the gut.22,23
Exploration of the differences between the sexes in the activity of hormones of the enteric
nervous system (relating to the intestines) and their interplay with the central nervous system
is an important research need.22 Additional clinical gaps include the lack of investigation
of the effects of reproductive hormones on the physiology and symptoms of IBS24 and
the influence of inflammation and enteric infections on sensitizing the female gut, which
may predispose women to IBS symptoms.3 Further research is needed to understand the
differences observed between the sexes.
4
IBS Primarily Affects Younger Women
Symptoms of IBS typically occur in women between the ages of 30 and 50.5 In the GI
Sufferer Study, the average age at which symptoms appeared was 29 years (Fig. 1). Prevalence
is reported to decrease after age 60.5
≥ 45 years
35–44 years
19%
36%
15%
30%
< 21 years
21–34 years
Average age at symptom onset = 29
Figure 1. IBS typically affects younger women (GI Sufferer Study: women only; all IBS subtypes).
Each Form of IBS Occurs with Equal Frequency
Although IBS with diarrhea is often perceived as the primary IBS subtype, each form of
IBS—with constipation, with diarrhea, or with both in alternation—affects about one third
of patients.16 The GI Sufferer Study confirmed that IBS with constipation occurs about as
frequently as IBS with diarrhea (Fig. 2).
Women Afflicted with Each
IBS Subtype (%)
40
32%
33%
35%
20
0
IBS with
Constipation
IBS with
Diarrhea
Alternating IBS
Figure 2. IBS with constipation affects women about as often as IBS with diarrhea (GI Sufferer
Study: women only; all IBS subtypes).
5
IBS is a Chronic Condition
“
I missed more days
and weeks from work
when I was younger
Many IBS patients live with this disorder for years. A survey of 350 IBS patients (276
women, 74 men) was recently conducted by the International Foundation for Functional
Gastrointestinal Disorders (IFFGD). Approximately half of the participants (42%) were
diagnosed with IBS at least 10 years before the survey, and almost two thirds had the
condition for 5 years or longer.25
A recent survey of 1,597 IBS patients (1,230 women, 367 men) from the United Kingdom
revealed similar results. Respondents had lived with the disorder for an average of 16.6 years.26
In the GI Sufferer Study, the average duration of IBS was 11 years (Fig. 3).
because [IBS] has
gone on in my life for
1–3 years
11+ years
28%
33%
over 30 years.
”
39%
– Tara P, IBS patient
4–10 years
Average IBS duration = 11 Years
Figure 3. IBS is often chronic, lasting for many years (GI Sufferer Study: women only; all
IBS subtypes).
6
IBS Causes Frequent and Debilitating Symptom Recurrences
For many patients, IBS symptoms recur frequently, greatly diminishing physical, social, and
emotional well-being. In the IFFGD survey, almost three fourths (70%) of the surveyed
patients suffered from symptoms more often than once a week, and about half (47%)
experienced symptoms daily. Approximately one quarter of the study sample regarded their
symptoms as ongoing or continuous.25
In the survey of IBS sufferers from the United Kingdom, more than half (57%) of the 1,454
participants who commented on frequency of symptoms reported experiencing symptoms daily,
25% experienced symptoms on a weekly basis, and 14% experienced symptoms monthly.26
In the GI Sufferer Study, women with IBS were disturbed by GI symptoms an average of
194 days each year—equivalent to about 16 days each month (Fig. 4). The average woman
with IBS experienced symptoms about every other day. Approximately one quarter of
patients reported GI symptoms every day of the year. These findings demonstrate that IBS
has a significant impact on women’s lives.
31 to < 90 days
90–364 days
25%
28%
< 30 days
19%
28%
Every Day
Average no. of days with symptoms = 194
Figure 4. Number of days per year women with IBS suffer from GI symptoms. One in 4 women
experience symptoms daily (GI Sufferer Study: women only; all IBS subtypes).
7
The IBS Symptom Complex Varies
The clinical presentation of IBS is varied.4 The abdominal pain or discomfort associated
with IBS can be generalized (eg, occurring anywhere in the abdominal area), or localized
(eg, concentrated in one spot), and often occurs in the lower part of the abdomen. The pain
is usually relieved after a bowel movement.4 Other GI symptoms common to patients with
IBS include bloating and abdominal distension.4
The primary bowel symptom, which can vary over time, establishes the IBS symptom
subgroup classification: IBS with constipation, IBS with diarrhea, or IBS with alternating
bowel function.6,27 Those with constipation as the primary bowel symptom may have infrequent
bowel movements, hard/lumpy stools, and often strain and feel a sense of incomplete emptying
after a bowel movement, whereas those who have IBS with diarrhea often experience urgency.4,28
In addition to GI symptoms, backache, fatigue, and headache are commonly reported.
Women with IBS tend to have difficulty falling and staying asleep and also may complain
of upper GI symptoms, such as heartburn and indigestion.4,24
“
I never feel 100%.
I have a very sensitive
lower abdomen. The
Lembo and colleagues recently conducted a survey of 443 new IBS-patient referrals to a tertiary
care center. About two thirds of enrollees were women.29 The survey focused on assessing
the subjective rating of various sensory symptoms of IBS—abdominal pain, bloating, fullness,
sensation of gas—for the previous 2 weeks; the degree to which patients were bothered by
altered bowel habits was not assessed. In this survey the most common viscerosensory
symptoms were gas (66%), bloating (63%), abdominal pain (49%), abdominal fullness
(41%), and fullness in the rectum (45%).
In the GI Sufferer Study the hallmark symptoms of IBS—abdominal pain/discomfort,
bloating, and constipation or diarrhea—were among the most commonly cited (Fig. 5).
Constipation- and diarrhea-associated symptoms were reported with similar frequency.
abdominal bloating
makes wearing items
with a waist
Abdominal pain/discomfort
80%
Gas/gas pain
79%
Sudden urges to have a bowel movement
67%
Diarrhea
66%
Bloating/distension
uncomfortable
”
and irritating.
– Amy H, IBS patient
63%
Constipation
57%
Straining
56%
Heartburn/acid reflux
56%
Rectal pain
40%
Figure 5. Women report a wide range of IBS symptoms. Percentages refer to women who experience
symptoms once a month or more (GI Sufferer Study: women only; all IBS subtypes).
8
Women Consider IBS Symptoms Severe and/or Bothersome
IBS is overwhelmingly described as a very painful, bothersome condition. In the IFFGD
survey, 43% of the respondents rated their symptoms as severe, and 40% rated them as
moderate. Thirty-nine percent of participants rated the pain from their symptoms as very
severe or extreme.25
In the survey by Lembo and colleagues, the majority of respondents in a referral center rated
their symptoms as moderate (35%), severe (49%), and very severe (12%).29
The findings from the GI Sufferer Study concur with these results (Fig. 6): 88% of women
surveyed considered their IBS symptoms bothersome. Sixty percent of patients regarded
recurrences as extremely/very severe.
How Bothersome Is IBS?
Not Bothersome
How Severe Are IBS Symptoms?
Somewhat Severe
12%
32%
88%
Bothersome
Not Severe
8%
60%
Extremely/Very Severe
Figure 6. The majority of afflicted women consider their IBS symptoms bothersome and severe
(GI Sufferer Study: women only; all IBS subtypes).
Women Rate a Variety of IBS Symptoms as Most Bothersome
While many publications have evaluated the overall severity of IBS symptoms, few studies
have focused on patient ratings of specific IBS symptoms. Further attention and research in
this area is warranted.
In the survey by Lembo and colleagues that assessed the bothersomeness of sensory but not
bowel symptoms, 48% of the 443 respondents considered discomfort from bloating-type
symptoms (gas, bloating, fullness, distension) as most bothersome, followed by abdominal
pain (29%), incomplete evacuation (16%), and extra-abdominal symptoms of chest pain or
pressure and nausea (7%).29
9
Data from the GI Sufferer Study suggest that abdominal pain/discomfort is the symptom that
most frequently prompts patients with IBS with constipation initially to seek medical care.
In the GI Sufferer Study, abdominal pain/discomfort, bloating, and constipation or diarrhea
were among the IBS symptoms women considered extremely/very bothersome (Fig. 7).
Mean # of Days per Year
Constipation
65%
103
Diarrhea
65%
88
Sudden urges to have a bowel movement
63%
120
Rectal pain
62%
99
Straining
61%
108
Abdominal pain/discomfort
60%
109
Heartburn/acid reflux
60%
136
Bloating/distension
59%
118
57%
Gas/gas pain
141
Figure 7. Women with IBS view a variety of IBS symptoms as bothersome. Percentages refer to
women who rate symptoms extremely/very bothersome (based on percentage of patients experiencing
symptoms, presented in Figure 5) {GI Sufferer Study: women only; all IBS subtypes}.
IBS with Constipation Is as Bothersome as Is IBS with Diarrhea
Women Rating Each IBS
Subtype as Bothersome (%)
In the GI Sufferer Study, a similar proportion of women who have IBS with constipation
found their overall condition to be extremely or very bothersome compared with those who
have IBS with diarrhea (Fig. 8). This observation dispels the misperception that IBS with
diarrhea is the most severe and bothersome IBS subtype.
60
52%
45%
46%
41%
42%
38%
40
20
13%
13%
10%
0
IBS with Constipation
IBS with Diarrhea
Extremely/very bothersome
Alternating IBS
Somewhat bothersome
Not very/not at all bothersome
Figure 8. Women rated IBS with constipation and IBS with diarrhea as similarly bothersome
(GI Sufferer Study: women only).
10
IBS Commonly Occurs with Other Disorders
IBS patients (both women and men) are about twice as likely as persons without IBS to be
diagnosed with various non-GI disorders. In fact, they visit physicians for non-GI related
symptoms 3 times as often as those without IBS.30,31 Other medical conditions that commonly afflict IBS patients include fibromyalgia (49%), chronic fatigue syndrome (51%),
and chronic pelvic pain (50%).30 Because these observations are based on diagnosed IBS
patients, when IBS sufferers without a formal IBS diagnosis are considered, the frequency of
comorbidity is likely to be higher than is currently estimated.
Numerous studies during the past 30 years have documented psychiatric disorders in patients
with IBS, particularly depression and generalized anxiety disorder. Prevalence of comorbid
IBS and psychiatric disorders ranges from 54% to 94%.30 Psychologic disturbances are
infrequently seen in primary care settings but are common in IBS patients presenting to
tertiary care centers.32 A definitive link between psychologic symptoms and specific IBS
complaints has not been demonstrated.30 However, given the distressing nature of IBS
symptoms, physicians should be aware that IBS symptoms may amplify patients’ stress and
anxiety and diminish their ability to cope.
Stress
Fibromyalgia
Anxiety
IBS
Chronic Fatigue
Syndrome
Depression
Chronic
Pelvic Pain
11
IBS AND QUALITY OF LIFE
The Quality of Life of Patients with IBS Is Lower
Than That with Other Chronic, Episodic Conditions
Formal studies using validated research instruments have demonstrated decreased quality of
life in patients with irritable bowel syndrome (IBS).33-36 For example, a recent study
compared the health-related quality of life (HRQOL) of patients with IBS with that of
United States population norms and with patients with selected diseases that are chronic,
episodic, associated with acute symptom flare-ups, and prevalent among similar populations. Results revealed that, overall, patients with IBS experience a poorer HRQOL
compared with United States population norms and patients with gastroesophageal reflux
disease (GERD), asthma, or migraine (Fig. 9).33
IBS
United States general population
Migraine
Asthma female (age 15-34)
GERD
90
Quality of Life Score
80
70
60
50
40
ea
M
en
ta
lH
ot
Em
le
Ro
lth
l
na
io
ni
io
un
ct
ci
al
F
ra
ne
ng
y
lit
ta
ea
lH
Vi
lth
in
Pa
ly
Ge
Bo
Ph
le
Ro
di
So
Ph
ys
ic
al
F
un
ct
io
ys
ni
ic
ng
al
30
Quality of Life Categories
Figure 9. The HRQOL of IBS patients is poorer compared with United States population norms
and patients with GERD, asthma, and migraine. Adapted from Frank L et al.33
12
IBS Negatively Impacts Patients’ Daily Routines, Social Lives,
and Emotional Well-Being
The fear of debilitating symptom recurrences prevents many IBS patients from leading
productive, fulfilling lives, as follows:
• IBS has a significant negative impact on patients’ social lives, often preventing them from
participating in sports/recreational activities and family gatherings. Anxiety and embarrassment related to IBS symptoms lead many patients to cancel travel plans or to decline
leisure activities such as dining out or attending sleepovers.37
– More than two thirds of respondents (68%) to the International Foundation for
Functional Gastrointestinal Disorders (IFFGD) survey reported missing an average of
11 or more activities or social occasions within 3 months—equivalent to about 1
missed activity per week.25
• IBS often is not viewed as a serious medical condition, leading to a lack of sympathy from family
members, friends, and coworkers. Symptoms are often equated to a simple stomachache.37
• Sexual intercourse often can be painful for IBS patients—a possible manifestation of
increased pain perception. Syndrome-associated fatigue or discomfort, embarrassment, or low
self-esteem can also decrease or eliminate sexual desire. Embarrassment or fear of symptoms
can prevent patients from pursuing personal relationships, and symptoms can cause stress
and discord with spouses or other family members.37
– In the United Kingdom-based survey conducted by Silk and colleagues, of 1,204
respondents who were married or living with someone, 19% reported experiencing
problems in maintaining a physical relationship with their partner because of IBS, and
45% believed that IBS negatively affected their sex lives.26
“
Simple daily activities
that many take for
granted are beyond
the reach of my IBS
patients—they can’t
sleep, eat, or just socialize
”
with friends.
– Dr. Y
13
For one third of respondents in the Gastrointestinal (GI) Sufferer Study, symptoms restricted
participation in sports and recreational activities and interfered with intimacy or patients’
sex lives. On average, IBS symptoms caused women to change social plans or alter personal
activities (such as travel plans) 3 days per month. That translates into 18 disrupted weekends
per year or more than 1 month per year (36 days) of canceled or altered activities.
“
I don’t always feel like
participating in family
Half of the women interviewed said that IBS limits their diet, and almost one third reported
frequenting restaurants less often because of symptoms (Fig. 10). Two thirds of survey
respondents reported having bathroom anxiety (always needing to know the location of
the nearest bathroom).
I always need to know there is a bathroom nearby
66%
My symptoms interfere with my sleep
functions. Socially, I
am restricted whenever
food is involved.
”
– Pam L, IBS patient
56%
I have dietary limitations
50%
My symptoms interfere with my sex life/intimacy
35%
I participate in sports/recreational activities
less often because of my symptoms
34%
I go out socially less often
because of my symptoms
31%
I go to restaurants less often
because of my symptoms
31%
I travel out-of-town less often
because of my symptoms
24%
Figure 10. IBS symptoms commonly disrupt womens’ personal lives and lower their self-esteem
(GI Sufferer Study: women only; all IBS subtypes).
14
IBS-related symptoms strongly contribute to patients’ emotional and interpersonal problems.
In the GI Sufferer Study, two thirds of the women surveyed reported that they would feel
better about themselves if they did not have symptoms, more than half reported extreme
embarrassment caused by disease-related symptoms, and about a quarter of the women
experienced anxiety about the potential negative effect IBS symptoms might have on their
relationships with friends and family (Fig. 11).
My symptoms make me irritable/grumpy
77%
I would feel better about myself
if I didn't have symptoms
66%
I have been extremely embarrassed
because of my symptoms
57%
I would have more control over
my life if not for my symptoms
56%
My family/friends never really understand
the severity of my symptoms
39%
I don't feel like a normal person
I never really feel clean
I worry about what this condition is doing
to my relationships with family/friends
36%
27%
22%
Figure 11. IBS symptoms negatively affect many aspects of womens’ lives (GI Sufferer Study:
women only; all IBS subtypes).
15
THE ECONOMIC IMPACT OF IBS
IBS Commonly Limits or Results in Decreased Work and School Productivity
Irritable bowel syndrome (IBS)-related symptoms can translate into a serious economic impact
on society, limiting patients’ educational opportunities and disrupting their professional
development. About one quarter (26%) of respondents to the International Foundation for
Functional Gastrointestinal Disorders (IFFGD) survey reported missing school or work as
a result of IBS symptoms.25
“
• IBS symptoms often cause patients to take time off from work, which can impair their
work productivity and decrease their likelihood of earning a promotion.36
It is…embarrassing to
try to explain to my
employer the reason I’m
taking off from work.
I usually just say an
“upset stomach” because
people don’t really
understand IBS, and
saying that I’m so
constipated that I can
hardly move or walk
is so embarrassing.
”
– Grace H, IBS patient
16
• At the workplace, patients often hide their condition by avoiding use of the bathroom for
as long as possible. However, suppressing IBS symptoms often leads to worsening pain.37
It is difficult to prepare reliable cost estimates related to work absenteeism, which may
account for the lack of published data regarding IBS-related unemployment and disability
claims. This may be due in part to reluctance among employees to cite IBS as the reason for
their absence, or the lack of recognition of IBS as a reason for disability.
In the survey by Silk and colleagues, more than half (53%) of the 695 employed respondents
were embarrassed to use the bathroom at work. Thirty-two percent of these individuals
reported passing up job promotion opportunities that involved attending many meetings
and presentations, and 12% reported giving up work altogether.26
In the Gastrointestinal (GI) Sufferer Study, women reported missing about 1 workday or
school day each month (12 days per year) due to IBS and being less productive than usual
for an additional 4.2 days per month (50 days per year). These findings reinforce the serious
impact IBS has on patients’ professional and educational opportunities.
The Overall Financial Burden of IBS in the United States Is High
Health care costs of IBS and associated productivity losses due to IBS symptoms amount to
approximately $30 billion annually in the United States,1,2 which is comparable with the costs
associated with hypertension, migraine, or asthma.38-40 The financial burden of IBS actually
may be underestimated because these figures do not account for the cost of prescription
medications or out-of-pocket charges that are not covered by insurance companies (eg,
alternative therapies or over-the-counter [OTC] medications).
“
Patients spend
money on numerous
Health Care
Costs
Productivity
Losses
medications that have
minimal effect. Not
to mention that my
IBS patients lose
Numerous factors contribute to high health care costs associated with the disorder. The
chronic and complex nature of IBS symptoms combined with the inconsistent use of diagnostic
guidelines in clinical practice leads to repeated visits to multiple health care providers and
a long lag time from symptom onset to formal diagnosis. The limitations of treatment
options are another major factor in the perpetuation of this ongoing cycle of events. Patients
often switch from one drug class to another or use several drugs concomitantly in the attempt
to find relief, increasing the likelihood of drug-related adverse effects—for which more
medications may need to be taken.41
countless days at work
Findings from the National Ambulatory Medical Care Survey and data from the National
Disease and Therapeutic Index show that IBS results in 2.4 to 3.5 million physician visits
annually.42 In the United States, an estimated 2.2 million prescriptions are written by
physicians each year to treat IBS symptoms.5 Prescription drug costs for lower-GI symptoms
are consistently higher for patients with IBS than they are for matched population controls.43
condition.
and spend valuable
time and energy to
cope with their
”
– Dr. V
Although not captured in official cost estimates, expenses associated with OTC product
purchases or consultations with alternative care providers (eg, homeopaths, herbalists,
acupuncturists, hypnotherapists) and purchases of alternative remedies also must be considered
because many patients with IBS make a substantial investment in these approaches.13-15, 25
17
THE CHALLENGES OF DIAGNOSIS AND TREATMENT
Diagnostic Guidelines for IBS Are Used Inconsistently
“
Careful symptom
evaluation can lead
to an accurate
diagnosis, which
can make or break
a patient’s quest
for managing
”
their IBS.
– Dr. R
Currently, ROME II criteria, primarily implemented in epidemiologic and clinical research
studies, provide guidance on identifying appropriate patients for irritable bowel syndrome
(IBS) clinical trials.44 The ROME III criteria are under development (www.romecriteria.org)
and represent ongoing efforts to refine this definition. Additionally, the evidence-based
medicine consensus on IBS published by the American College of Gastroenterology (ACG)
provides a practical symptom-based approach to IBS diagnosis using criteria outlined by
ROME. The evidence reviewed supports the fact that, when followed, a symptom-based
approach is reliable: IBS patients who do not have alarm symptoms (such as recurring fever,
family history of colon cancer) are not more likely than people without IBS to develop most
organic (structural) diseases.9
Despite the current recommendations for a step-wise, symptom-based approach to making
a positive IBS diagnosis45,46 (compared with conducting exhaustive tests to exclude other
possible causes), physicians generally do not use the diagnostic criteria consistently and often
struggle to make a diagnosis in everyday clinical practice.
Patients with IBS often endure symptoms for months or years before consulting a health
care provider. In the Gastrointestinal (GI) Sufferer Study, women reported that about 1.9
years elapsed from the time their symptoms began to the time they visited a health care
professional. After reporting their symptoms, almost 10 months (0.8 years) passed before they
received an official diagnosis. This may in part be due to patients’ symptoms initially not being
recognized as a serious medical condition, or this may be due to the overlapping nature
of the symptoms associated with other GI disorders. In total, 2.7 years elapsed from the
emergence of IBS symptoms to the delivery of a formal IBS diagnosis (Fig. 12).
Doctor
Consultation
Symptom
Onset
Diagnosis
0.8 Years
1.9 Years
2.7 Years
Figure 12. On average, 2.7 years elapse from the time women with IBS notice symptoms to the time
they receive an official IBS diagnosis (GI Sufferer Study: women only; all IBS subtypes).
This underscores the need for an aggressive and comprehensive professional and patient
education effort reinforcing the availability and utility of a symptom-based approach to
simplify IBS diagnosis.
18
After Diagnosis, Women with IBS Encounter Significant Barriers to
Obtaining Effective Treatment
Although patients hope their symptoms will be relieved once a formal diagnosis of IBS is
made, their expectations are often left unmet. Frustrated by persisting symptoms after trying
various medications, women with IBS often find themselves switching health care providers
in their continual quest for relief.42
Women in the GI Sufferer Study commonly described difficulty gaining adequate relief of
symptoms. More than one quarter of patients consulted 3 to 4 physicians for their condition
(Fig.13). More than three quarters reported seeing more than 1 physician for their IBS symptoms.
1 Physician
5 or More Physicians
23%
29%
2 Physicians
15%
27%
3–4 Physicians
Figure 13. Women typically consult more than 1 physician regarding IBS symptoms (GI Sufferer
Study: women only; all IBS subtypes).
IBS patients frequently consult alternative medicine providers to help them manage their
symptoms. For example, a recently conducted survey of 96 patients with IBS (67 women,
29 men) evaluated the use of alternative medicine for IBS symptoms.13 Findings revealed
that 16% of survey responders had consulted an alternative medicine practitioner such as
a homeopath, herbalist, osteopath, or acupuncturist. This shows that the actual number
of health care professionals from whom IBS patients seek help may be underestimated.
19
Women with IBS Try Many Treatment Options in Their Search for Relief
The incomplete relief achieved with treatment options often drives IBS patients to attempt to
self-manage their condition. Commonly used GI medications, such as laxatives/fiber supplements
and antidiarrheals, are generally indicated for disease states other than IBS and are prescribed
to treat a single symptom such as constipation or diarrhea.47 The ROME II criteria and the
ACG consensus on IBS stress that the goal of IBS therapy is improvement in global IBS
symptoms, including abdominal pain/discomfort, bloating, and altered bowel habits. They
reinforce the concept that treating the bowel habit alone without addressing other symptoms
is a suboptimal approach.9
Collectively, respondents to the International Foundation for Functional Gastrointestinal
Disorders (IFFGD) survey reported using a total of 281 different treatments to control
IBS symptoms including dietary and herbal supplements as well as prescription and overthe-counter (OTC) medications. Prescription drugs were used by 90% of people with
IBS; OTC laxatives and OTC antidiarrheals were taken by 79% and 65% of survey
respondents, respectively.25
In the GI Sufferer Study, women with IBS with constipation took a remarkable variety
of medications—including prescription and OTC laxatives/fiber supplements, anti-anxiety
agents, and antidepressants—to help alleviate their symptoms. An average of 1.9
prescription and OTC medications were used in the previous 12 months (by both the
women and men surveyed). The sheer variety of agents strongly suggests that no single
agent relieves the multiple symptoms of IBS. Women surveyed also reported using numerous
nondrug approaches such as relaxation techniques and natural remedies. Most commonly,
they used OTC medications (66%) and dietary modifications (60%) (Fig. 14).
66%
OTC medications
60%
Diet
50%
Exercise
40%
Relaxation
Prescription medications
Natural remedies
35%
32%
Figure 14. Women with IBS with constipation used a variety of IBS treatments during
a 12-month period (GI Sufferer Study: women only; IBS with constipation).
20
Patients with IBS with Constipation Are Generally Dissatisfied
with Treatment
IBS patients were largely dissatisfied with the effectiveness of agents in alleviating their
symptoms. In the IFFGD survey, fewer than one third of participants reported that they
were satisfied with these medications or remedies. Dissatisfaction related primarily to lack
of efficacy. Figure 15 depicts the percentages of IBS patients (current medication users)
rating prescription and OTC medications as ineffective or somewhat effective.25
Prescription Medications
22%
33%
Ineffective
Somewhat effective
OTC Medications
40%
33%
Ineffective
Somewhat effective
Figure 15. Many IBS patients are dissatisfied with the relief achieved with OTC or prescription
medications. Percentages refer to efficacy ratings by current medication users, which was
previously discussed on page 20 (IFFGD survey: women and men [women-only data not available];
all IBS subtypes).
21
Patients Rating Each Treatment Option (%)
In the IBS Medications Side Effects Study, the majority of patients were either not satisfied
or somewhat satisfied with the symptom relief achieved with available prescription and
OTC medications (Fig. 16). Patients gave particularly low satisfaction scores to products
commonly used to treat IBS with constipation, including OTC laxatives/fiber supplements,
prescription laxatives, and OTC stool softeners. While many patients find relief of individual
symptoms from available medications, the data demonstrate that patients with IBS with
constipation still have a need for relief of multiple symptoms.
100
80
60
48%
44%
40
38%
40%
36%
34%
40%
37%
34%
32%
29%
22%
20
20%
28%
18%
0
OTC Laxative/ Prescription
Prescription
Fiber Supplement Laxative
Antidepressant
Not very/not at all satisfied
Somewhat satisfied
OTC Stool
Softener
Prescription
Anti-anxiety
Extremely/very satisfied
Figure 16. Patients with IBS with constipation vary in their satisfaction ratings for prescription
and OTC medications (IBS Medications Side Effects Study: women and men [women-only data
were not available]; IBS with constipation).
Adverse effects of medications commonly contribute to patients’ dissatisfaction with therapy.
Although most therapeutic options have positive benefits for some patients with IBS, they
typically only relieve individual symptoms or are used to treat only one subtype of IBS.
Further, some medications taken to relieve a single symptom can be associated with adverse
effects that aggravate or mimic existing IBS symptoms. For example, while fiber products
can be effective for treating IBS-related constipation, for some people a diet high in
fiber (>20 g/day) can worsen or can cause bloating or gas.8 Tricyclic antidepressants and
antispasmodics can make symptoms worse in those with constipation because of the
anticholinergic side effects.9
Sixty-two percent of IFFGD survey respondents taking prescription drugs reported
adverse effects of their medication. Almost half of these patients (45%) viewed the medicationrelated adverse effects as moderate or severe. Surveyed prescription drug users reported
at least one of the following adverse effects: constipation, gas, cramps, bloating, nausea,
appetite change, weakness, dizziness, drowsiness, dry mouth, weight change, headache, or
low sex drive.25 Some of these medication-related adverse effects mirror IBS symptoms.
22
In the IBS Medications Side Effects Study, many of the IBS patients with constipation
experienced adverse effects from medications, including abdominal cramping, bloating,
drowsiness, and dizziness. For example, approximately 60% of survey respondents taking
OTC laxatives (n = 112), prescription laxatives (n = 59), or prescription antidepressants
(n = 87) and close to 70% of patients taking prescription anti-anxiety medications (n = 88)
experienced adverse effects. Additionally, nearly 40% of respondents taking OTC fiber
supplements (n = 263) and 50% of patients taking prescription antispasmodics (n = 189)
also reported adverse effects. Most of the survey respondents considered these adverse effects
to be mild or moderate. A limitation of these findings is the fact that the degree to which
these reported adverse effects were truly caused by the medications could not be assessed.
“
When I have to resort
to a harsh laxative or
enema ... I have to
endure the additional
abdominal pain and
cramps from a laxative
while shocking my
system into a bowel
movement and racing
”
to the bathroom.
– Nicole K, IBS patient
23
BRIDGING THE GAP BETWEEN PATIENTS AND
PHYSICIANS: A PREREQUISITE FOR PROGRESS
Physicians and Patients Often Disagree on the Overall Severity of IBS
The current gaps in perception of the impact of irritable bowel syndrome (IBS) symptoms
on sufferers’ lives and well-being are a major barrier to effective treatment. Raising health care
provider awareness of patient-perceived distress is an important step in overcoming this barrier.
The Physician Study exclusively enrolled primary care providers and gastroenterologists,
but other health care team members, including physician assistants, pharmacists, nurse practitioners, and nurses, are an integral part of the IBS management team. Research is ongoing to
capture the perceptions of these health care professionals and to compare them with those of
IBS patients.48-50
Findings from the Gastrointestinal (GI) Sufferer Study and the Physician Study illustrate
important differences between patients’ and physicians’ perceptions of IBS. The most critical
finding from these studies is that physicians tend to overestimate the severity of IBS with
diarrhea and underestimate the severity of IBS with constipation (Fig. 17). Similar
percentages of patients with IBS with constipation and IBS with diarrhea self-rated their
symptoms as extremely/very severe (53%–57%). In contrast, the majority of physician
responders felt that IBS with diarrhea is a more severe condition than is IBS with constipation. This finding reinforces the need to raise awareness that IBS with constipation is
equally as severe as is IBS with diarrhea.
Patients and Physicians
Rating Symptoms as
Extremely/Very Severe (%)
77%
80
60
54%
57%
53%
77%
62%
53%
54%
39%
40
20
0
IBS with Constipation
Patients' perceptions
with definitive diagnosis
IBS with Diarrhea
Patients' perceptions
with probable diagnosis
Alternating IBS
Physicians' perceptions
Figure 17. Physicians tend to overestimate the severity of IBS with diarrhea and underestimate
the severity of IBS with constipation (GI Sufferer Study and Physician Study: women and men
[women-only data were not available]).
24
Physicians’ and Patients’ Perceptions of the Causes of IBS May Differ
The GI Sufferer Study and Physician Study revealed that patients and physicians differ in
their opinions regarding the primary and secondary causes of IBS symptoms (Fig. 18).
Respondents were asked to rate the degree to which they felt various causative factors contributed to their IBS symptoms. Although a prepared list of causes was provided, participants had the opportunity to add factors not appearing on the list. (Physician responses
reflect causes of IBS and chronic constipation.)
Although IBS is caused by a true physiologic dysfunction,51,52 many patients and health care
professionals believe other factors are involved. While both patients and physicians rated
stress as a major culprit, patients felt that food was also an important factor. Physicians
noted anxiety/depression as a contributor to symptoms. Interestingly, both patients with a
definitive and a probable diagnosis held similar views regarding the factors involved in
IBS symptoms. These findings highlight the fact that many physicians and patients are
unaware of the underlying physiologic abnormalities in IBS. Educational efforts to raise
awareness of IBS as a medical condition with a physiologic basis are crucial.
“
I drink plenty of
water, moderately
exercise, and eat fiber,
etc to attempt some
Patients' Perceptions*
Primary Factors
53%
62%
Food
Secondary Factors
GI condition/problem
Anxiety/depression
Heredity
Patients' perceptions
with definitive diagnosis
of the suggestions
58%
54%
Stress
that doctors have
47%
38%
made over the years,
36%
39%
31%
30%
but nothing helped
Patients' perceptions
with probable diagnosis
”
my IBS.
– Susan T, IBS patient
Physicians' Perceptions*
Stress
Primary Factors
82%
Anxiety/depression
Secondary Factors
Food
GI condition/problem
79%
59%
55%
*Causes of chronic constipation and IBS.
Figure 18. Patients’ and physicians’ perceptions of the factors exacerbating IBS often differ
(GI Sufferer Study and Physician Study: women and men [women-only data were not available]).
25
EDUCATIONAL NEEDS: MANY GAPS REMAIN
“
When you have a
chronic illness that
has a strong hold on
someone’s quality of
life, you have to spend
time with them.…
This is a real medical
problem that has
become part of their
life. Unfortunately,
sometimes the physicianpatient dialog isn’t
as good as it
”
should be.
26
– Dr. R
A survey by O’Sullivan and colleagues explored the educational needs of patients with irritable
bowel syndrome (IBS). The survey recruited 212 patients referred to a gastroenterology
outpatient clinic in Ireland. Seventy respondents had a clinically confirmed diagnosis of IBS;
59 patients (84%) were women. The remainder of the patients had ulcerative colitis or
Crohn’s disease.53
Survey results revealed that the majority of IBS patients (77%) felt inadequately educated
about many aspects of IBS. Their primary concerns included the connection between IBS
and cancer or other threatening diseases, the effect of dietary habits on IBS symptoms (eg,
the role of fiber in aggravating symptoms), and the cause and prognosis of IBS.53 These
results reinforce the strong need to educate physicians and patients that IBS is caused by a
true physiologic dysfunction and is a medical disorder.
Investigators also found that poorly informed IBS patients required longer consultations
than those who were well informed about IBS. Therefore, it was suggested that patients
who lack disease knowledge are more likely to seek follow-up consultations with physicians
than those who feel comfortable with the information they receive. Thus, enhancing patient
education efforts may have a positive effect on decreasing the current economic burden of
IBS.53 Physician assistants, nurse practitioners, and nurses can often play an integral role in
achieving this goal.
Several investigators have noted the great need for a strong physician–patient relationship.
In one United Kingdom-based study, more than 80% of patients with IBS accessed their
information from sources outside of the physician’s office including family, friends, and
women’s journals. Because opinions and perceptions about IBS may differ depending on the
source, patients are likely to feel confused and frustrated.54
It is important to note, however, that these data are from countries in which the standards
for patient education are different from those in the United States and, therefore, may not
represent the United States in general. Hence, further research into the educational needs
of IBS patients in the United States is warranted.
CONCLUSION
This report provides a snapshot of the physical, quality of life, and economic impact irritable
bowel syndrome (IBS) has on women. It portrays these aspects through the eyes of IBS
patients suffering with symptoms and through the physicians struggling to diagnose and
to treat the disorder. Market research survey results revealed that once symptoms emerge, it
may take more than 2 years before an IBS diagnosis is made. However, the assurance of a
definitive diagnosis does not guarantee relief of symptoms because of the limited effectiveness
and adverse effects of prescription and over-the-counter therapies used to treat IBS. The
inadequacies of approaches mean that patients often try multiple medications and/or seek care
from multiple health care providers.
This report is intended to help raise awareness about how patients think, feel, and live with
IBS and to provide insights into physicians’ beliefs and attitudes regarding this disorder.
Understanding these elements should help put into perspective the vast amount of published
literature discussing the causes of IBS, options for management, and recommendations for
treatment. Clearly, additional research is needed to help further address the many clinical
gaps that remain.
This report focuses on women because of the higher prevalence of IBS in women compared
with men5,10,11 and because differences in physiology, symptoms, psychosocial factors, and
treatment response between the sexes may shape the definition and treatment of IBS in
women.24 Research initiatives exploring currently untapped areas in women’s health (eg, the
influence of reproductive hormones on the physiology and symptoms of IBS, and the
influence of inflammation and enteric infections on sensitization of the female gut)3 are
essential to advancing our understanding of this disorder.
Fortunately, important strides have been made in defining IBS as a medical disorder with
a physiologic cause. The limitations of conventional medications underscore the need for
treatment options that effectively target the underlying causes of IBS (altered intestinal
movement, increased pain perception, and altered movement of fluids through the
digestive tract) to help patients manage the multiple symptoms associated with each IBS
subtype. It is hoped that using published consensus recommendations for making a positive
IBS diagnosis and using an evidence-based approach to manage IBS will make
diagnosing and treating the disorder a simpler and quicker process. Critical is an aggressive
and comprehensive professional and patient education effort that stresses the importance of a
strong patient-physician relationship and reinforces the utility of a symptom-based approach.
27
IBS
awareness
programs
Consistent use of
symptom-based
diagnostic criteria
Treatment
of the multiple
symptoms of IBS
Patient
education
Proactive
physician-patient
communication
Large perception gaps continue to exist. For example, physicians often perceive IBS with
constipation as less severe than IBS with diarrhea. Survey results have shown that IBS with
constipation is equally prevalent and bothersome as is IBS with diarrhea, which stresses the
importance of educational initiatives geared at raising awareness about IBS with constipation.
This report serves as a good starting point toward a greater understanding of the unmet
needs associated with women with IBS.
28
APPENDIX
Biology of IBS: The Role of Serotonin
Irritable bowel syndrome (IBS) is a multifactorial condition. Biologic, psychologic, and
environmental factors can act simultaneously to cause gastrointestinal (GI) dysfunction
(Fig. 19).16 Three major physiologic abnormalities contribute to IBS symptoms:
– altered motility (altered movement of food and waste through the digestive system)
– visceral hypersensitivity (an increased perception of pain in the abdominal area)
– altered intestinal secretion (altered movement of fluid in the digestive tract)
Psychologic
Environmental
Physiologic
IBS
Altered Motility
Visceral Hypersensitivity
Altered Intestinal Secretion
Abdominal Pain
Bloating
Altered Bowel Habit
(constipation and/or diarrhea)
Figure 19. IBS is a multifactorial condition.
29
Serotonin, commonly referred to as hydroxytryptamine (5-HT), is a naturally occurring
chemical in the body that helps the digestive system function normally.7 The physiologic
abnormalities in IBS may be related to an imbalance of serotonin in the gut, an improper
reaction of the digestive system to serotonin, or a faulty communication network between
serotonin in the gut and the brain and spinal cord (known as brain-gut axis dysfunction).6,7
Serotonin plays a major role in
– modulating intestinal movement
– modulating perception of pain
– mediating secretion in the GI tract (release of water, which ultimately helps to
soften stools)
A greater understanding of brain-gut axis dysfunction and the role of serotonin in the physiology
of IBS has helped to establish IBS as real disease of the digestive tract and has led to a new
focus on medications directed at the underlying causes and multiple symptoms of IBS.8
Methodologies for the Patient and Physician Surveys
Novartis Pharmaceuticals Corporation engaged Lieberman Research Inc to conduct surveys
from June through August 2000 and in January 2002.
• GI Sufferer Study: This was a 1-hour, in-depth telephone survey with 1,013 GI sufferers
aged 18 and older screened from a nationally projectable random-digit dial sample who
had not been diagnosed with an organic GI disease and had a specified GI disorder. The
sample of 1,013 patients included both diagnosed (self-reported physician diagnosis) and
undiagnosed sufferers identified via responses to the Rome II criteria for IBS (n=411),
chronic constipation (n=207), functional dyspepsia (n=190), or bloating (n=205).
The IBS sample included 122 sufferers with constipation as the predominant bowel
symptom, 125 with diarrhea as the predominant symptom, and 164 who had alternating
constipation and diarrhea.
• Physician Study: A 55-minute telephone market survey focusing on IBS (all subtypes)
and chronic constipation symptoms, causes, treatments, and effectiveness of treatments. The
sample of 711 physicians included 509 primary care physicians, 181 gastroenterologists,
and a small sample of obstetricians/gynecologists and pediatricians.
The objectives of these 2 surveys were to understand IBS symptoms and treatment options;
to provide basic category information about the GI market; to identify attitudes, behaviors,
and unmet needs of consumers and physicians with regard to functional GI disorders; to
identify the common themes and gaps between physicians and consumers; to develop a
meaningful model for segmenting physicians and consumers; and to provide input for the
development of improved patient and physician education and communications.
30
• IBS Medications Side Effects Study: From a self-selected group of IBS sufferers who
responded to an online survey, patients were asked to participate in the Side Effects Study.
An online panel was used to select patients diagnosed with IBS. Sufferers were asked
whether they experience constipation predominantly (IBS with constipation), diarrhea
predominantly (IBS with diarrhea), or both with equal frequency (alternating IBS).
Sufferers of IBS with constipation were the primary targets of this study; those with
alternating IBS were a secondary target. Therefore, the self-reported sufferers of IBS
with diarrhea were not included in the study.
A total of 668 patients meeting survey criteria (504 with a diagnosis of IBS with constipation
and 164 with alternating IBS) completed a 20-minute survey focusing on treatments used
for IBS, satisfaction and efficacy of treatments, and side effects experienced. Of the sufferers with
IBS with constipation, 60% reported having taken medications and 59% had severe symptoms.
Of the IBS alternators, 65% had taken medications and 67% reported severe symptoms.
Methodology for the Omnibus Survey
Novartis Pharmaceuticals Corporation engaged TeleNation (a national survey company)
to conduct a telephone survey in May 2002.
A single-stage, random-digit dial sample technique was used to select 1,000 residential
telephone numbers in the contiguous United States. One thousand adults (480 men and
520 women) were interviewed by telephone regarding their perceptions of IBS and other
chronic conditions.
31
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34
ADVISORY PANEL
Lin Chang, MD
Associate Professor of Medicine
C.N.S. Center for Neurovisceral Sciences and Women’s Health
CURE: Digestive Disease Research Center
UCLA School of Medicine
Los Angeles, California
Margaret M. Heitkemper, RN, PhD
Director, Center for Women’s Health Research
Biobehavioral Nursing & Health Systems
University of Washington
Seattle, Washington
Susan Lucak, MD
Assistant Professor of Clinical Medicine
New York Presbyterian Hospital
New York, New York
Josh Ofman, MD, MSHS
Assistant Professor of Medicine
and Health Services Research
Cedars–Sinai Medical Center
Beverly Hills, California
Jacqueline Wolf, MD
Associate Professor of Medicine
Harvard Medical School
Beth Israel Deaconess Medical Center
Boston, Massachusetts
35
ABOUT THE SOCIETY
FOR WOMEN’S HEALTH RESEARCH
The Society for Women’s Health Research is the nation’s only not-for-profit organization
whose sole mission is to improve the health of women through research. The Society was
founded in 1990 when it brought to national attention the need for the appropriate inclusion
of women in major medical research studies and the resulting need for greater funding for
research on conditions experienced by women.
The Society initiated and cosponsored the groundbreaking Institute of Medicine report
Exploring the Biological Contribution to Human Health: Does Sex Matter, which underscored
the need to better understand the importance of sex differences and how to translate that
knowledge into improved medical practice and therapies.
The Society works to increase public and private funding for research on women’s health,
to promote the inclusion of women in medical research studies, and to encourage the
scientific examination of the basic biologic and physiologic differences between men and
women. The emerging field of sex-based biology explores these differences and their effect
on both health and the diagnosis and treatment of disease.
History
The Society was the force behind many major advances in women’s health including
increased federal funding for women’s health research, passage of the federal law requiring
women to be included in federally funded medical research, and establishment of the Office
of Research on Women’s Health at the National Institutes of Health. It was also responsible
for the strengthened guidelines from the United States Food and Drug Administration to
include women in all phases of drug testing. The current public awareness of gaps in
women’s health research is largely due to the ongoing efforts of the Society.
Outreach
One of the Society’s priorities is to promote and support the efforts of basic and clinical
researchers in the emerging field of sex-based biology. The Scientific Advisory Meetings
bring together representatives of scientific, medical and health specialty organizations for
updates on research in sex-based biology. Basic research into the molecular and cellular biology
of sex differences is the focus of the Society’s Annual Conferences on Sex and Gene
Expression (SAGE). The Society cosponsors a scholars’ grant program to support the scientific
and academic advancement of young physician researchers. In addition, the Society’s Isis
Fund for Women’s Health Research sponsors collaborative networks to foster interdisciplinary
basic and clinical research in areas related to improving women’s health, specifically sex-based
biologic differences and their impact on health and disease. The Society works with policy
makers, researchers and the public to increase public dialog and to change public policies on
women’s health research issues. The Society’s Women’s Health Research Coalition of leaders
from health, medical, and scientific organizations supports increased research funding for, and
expansion of, sex-based research at academic research institutions.
36
BOARD OF DIRECTORS
Chair
Denise Faustman, MD, PhD
Associate Professor, Medicine
Harvard Medical School
Director, Immunology Laboratory
Massachusetts General Hospital
Kathleen B. Drennan
Chief, Global Marketing &
Strategic Business Development
Patient Quest, an Omnicom company
Gail Evans
Atlanta, Georgia
Immediate Past Chair
Gloria Sarto, MD, PhD
Professor, OB/GYN
Co-Director, National Center
of Excellence in Women’s Health
University of Wisconsin
James R. Gavin III, MD, PhD
Senior Scientific Officer
Howard Hughes Medical Institute
Vice Chair
Nanette Wenger, MD
Professor of Medicine
Department of Cardiology
Emory University School of Medicine
Secretary/Treasurer
Irma Goertzen, RN, MA
President and CEO
Magee-Women’s Hospital
Magee-Women’s Research Institute
Florence Haseltine, PhD, MD
Founding President
Bethesda, Maryland
Janet Henrich, MD
Associate Professor
Medicine and OB/GYN
Yale University School of Medicine
Ellen Leibenluft, MD
Clinical Associate Professor Psychiatry
Georgetown University Medical Center
Janet Belle, RN
Basking Ridge, New Jersey
Celia Maxwell, MD, FACP
Assistant Vice President, Health Affairs
Director, Women’s Health Institute
Howard University
Mary Berg, PharmD
Professor, College of Pharmacy
University of Iowa
Carmen Sapienza, PhD
Professor
Temple University Medical School
Colleen Conway-Welch, RN, PhD
Professor and Dean
Vanderbilt University
School of Nursing
37