Integrative Approaches to Managing Irritable Bowel Syndrome (IBS)

This project will test the effectiveness of an integrative medicine approach in treating
irritable bowel syndrome (IBS). Over the course of 18 months, we will recruit 85 participants
with IBS in New York City. These participants will be randomized to either a 4-week
group-oriented treatment intervention incorporating a low FODMAP (fermentable
oligosaccharides, disaccharides, monosaccharides and polyols) diet and mind-body therapies
followed by an 8-week health coaching follow-up period or a waitlist control group. At the
end of the 12-week study period, waitlist subjects will be offered the four-week nutrition
and mind-body intervention. Over the 12-week study period, we will examine and report on the
impact of this treatment intervention on IBS symptoms and quality of life in this population.
The investigators will collect data on IBS outcomes as well as on depression and stress.

The hypothesis is that participants will report decreased symptoms and improved function and
quality of life as a result of the four-week nutrition and mind-body intervention and 8-week
health coaching follow-up period. The goal of this project is to develop a low-cost,
effective integrative intervention for IBS, which can be replicated in settings across the
U.S.

Objectives The purpose of this project is to examine whether a low cost, group-oriented
integrative medicine approach to irritable bowel syndrome improves participant outcomes. The
intervention will combine nutrition counseling on the low FODMAP diet and mind-body training
with follow-up health coaching.

The hypothesis is that participants will report decreased symptoms as measured by the IBS
Symptom Severity Score and improved function and quality of life as a result of the
intervention when compared to usual care.

Background Irritable bowel syndrome (IBS) is a chronic debilitating functional
gastrointestinal disorder that has a profound effect on the quality of life (QOL) of
individuals with IBS. The estimated prevalence of IBS in the general population ranges from
3% to 20%, with most studies estimating that IBS affects 10% to 15% of the general
population. Despite its high level of prevalence, the exact causes of IBS are not well
understood. Researchers believe that IBS is caused by a wide variety of mental and physical
health problems including hypersensitivity, brain-gut signal issues, bacterial
gastroenteritis, depression, anxiety, food sensitivity, body chemical imbalances, and/or
genetics.

Background: Low FODMAP Diet for IBS More than 60% of IBS patients report worsening of
symptoms after meals, 28% of these within 15 minutes after eating and 93% within 3 hours. The
role of diet in inducing or exacerbating IBS systems has been explored for decades. Numerous
studies have examined the role of lactose intolerance and fructose malabsorption in IBS.
Additional research on oligosaccharides and the incompletely absorbed sugar alcohol polyols,
sorbitol, and mannitol, has revealed a role in IBS symptoms. Grouping of these poorly
absorbed, short chain carbohydrates- fermentable oligosaccharides, disaccharides,
monosaccharides and polyols- according to their chain length resulted in the acronym FODMAP,
and in 2005, the first paper describing the FODMAP hypothesis was published. Evidence
continues to accumulate that the consumption of FODMAPs may contribute to symptoms in
individuals with IBS.

FODMAPs are poorly absorbed, osmotically active, and increase delivery of water and
fermentable substrates to the proximal colon and are rapidly fermented by bacteria. The poor
absorption and fermentation of the short chain carbohydrates contributes to the bloating,
distension, abdominal pain, and flatulence of individuals with IBS. In a comparison of
standard dietary advice versus FODMAP for individuals with IBS, a low FODMAP diet showed
significantly greater reduction in abdominal pain, bloating, and flatulence compared to the
standard dietary advice group. A high FODMAP diet altered the pattern of gas production,
induced prolonged hydrogen production in the intestine that was greater in individuals with
IBS versus healthy controls, influenced the amount of methane produced, and induced
gastrointestinal and systemic symptoms in individuals with IBS. A low FODMAP diet reduced
abdominal pain, bloating, flatulence, and diarrhea in individuals with inflammatory bowel
disease. In a prospective study of 90 patients with IBS followed for 15 months, a low FODMAP
diet significantly decreased abdominal pain, bloating, flatulence, and diarrhea, with greater
improvement with greater dietary adherence.

Background: Mind-Body Therapies for IBS Psychological therapies or mind-body therapies such
as hypnosis, biofeedback, and psychotherapy represent some of the most effective treatments
for IBS and are especially useful for motivated patients with moderate to severe IBS.

The scientific evidence involving mind-body therapies for IBS began in 1927 when American
researcher, Dr. Edmund Jacobson, conducted the first randomized trial using progressive
relaxation for IBS treatment and found significant benefit. In recent years, a vast majority
of research surrounding mind-body approaches for IBS has come from a research group at
University Hospital in South Manchester, UK led by Dr. Peter Whorwell. In 1984, the Whorwell
group developed a hypnosis procedure specifically for treating IBS called "gut directed
hypnotherapy". The intervention consists of seven half-hour sessions of decreasing frequency.
In addition, patients are all given self-hypnosis tapes for daily practice. A 2005 review
published by the American Society of Clinical Hypnosis examined 14 studies measuring efficacy
and mechanism of hypnosis for IBS treatment (12 of the 14 studies utilized an adaptation of
the Whorwell group procedure). Based on the studies investigated, the review concluded
"hypnosis consistently produces significant results and improves the cardinal symptoms of IBS
in the majority of patients." A separate 2006 review conducted by researchers at the
University of Birmingham in England, concluded that existing scientific evidence suggest that
hypnosis is effective in the treatment and management of IBS (10 of the 18 studies examined
indicated significant benefit).

Regarding long-term benefit, the existing scientific evidence is supportive of mind-body
approaches for IBS treatment. A long-term follow-up study of IBS patients (n=204) treated
with hypnosis revealed that of the 71% who initially responded to hypnosis, 81% maintained
their improvement overtime while the remaining 19% reported only slight deterioration in
their IBS symptoms. Also important was that patients reported to be using fewer medications
to manage IBS following hypnosis treatment. In their conclusion, the study authors determined
that the benefits of hypnosis seemed to last for up to 5 years after treatment. A 1989
comparative study from England determined that hypnosis for treatment of IBS in groups of up
to 8 patients was as effective as individual therapy.

Inclusion Criteria:

- IBS diagnosis> 12 months in duration

- Over 18 years of age

- English speaking

Exclusion Criteria:

- Active major psychiatric illness which would potentially interfere with participation
in the study 2. Pregnancy 3. Active eating disorder