A Study On The Effect of Aegle Marmelos Intervention in IBS

A study on the
Effect of Aegle Marmelos (Stone Apple)

Powder Intervention in Irritable Bowel
Syndrome.
Prepared by
C.Tamil Selvam
Enrolment No. 11C9170016
Under the Guidance of
Dr.M.Ramadas Maganti MD. (AY)
A project report Submitted towards Partial Fulfilment of the Requirement of
PG Diploma in Nutrition and Dietetics

Awarded by Madurai Kamaraj University
Meenakshi Mission Hospital and Research Centre

Madurai
Dec 2011
ACKNOWLEDGEMENTS:
The researcher wishes to thank and express a deep sense of gratitude to his guide
Dr. M.Ramadas Maganti MD (AY), Professor & HOD, Department of Kaya
Chikitsa (General Medicine), Sri Jayendra Saraswathi Ayurveda College and
Hospital, Chennai, for his guidance, invaluable suggestions, encouragement and
commendable support.
The researcher wishes to extend his hearty thanks to Dr. S. Balamohan PhD.,
Director, School of Computer Applications, SSM college of Engeneering,
Komarapalayam, for his assistance with statistical analysis.
The researcher likes to acknowledge Prof. N. Chitra, Principal, Meenakshi
Mission Hospital and Research Centre for extending her support throughout the study.
The researcher extends a warm appreciation and heartfelt thanks to his fellow
Colleagues and their staffs for contributing subjects and resources for the study.
The researcher wishes to thank all the subjects for their willingness and co-
operation to participate in this study.
The researcher extends a warm appreciation and heartfelt thanks to his parents,
his staffs & friends who have been encouraging and very supportive during the entire
course of this study.
Above all, the researcher would like to thank God Almighty for His unfailing
love and support throughout and ever.

Certification by the Guide
I hereby certify that the thesis entitled “A study on the Effect Of Aegele
Marmelos (Stone Apple) Powder intervention in Irritable Bowel Syndrome”
submitted by C.Tamil Selvam for the degree of PG Diploma In Nutrition and
Dietetics of Madurai Kamaraj University is the result of his original and independent
work done during November2011 under my supervision and has not previously formed
the basis for the award of any degree, diploma, associate ship, fellowship or any other
such similar title.
Guide
Date:
Dr. M.RAMADAS MAGANTI MD (AY),
Professor & HOD,
Department of Kaya Chikitsa,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai

Faculty of Health Science
Madurai Kamaraj University, Madurai
Recommendation
This is to certify that the Project Report Titled
A study on the Effect of Aegle marmelos (Stone Apple) Powder

intervention in Irritable Bowel Syndrome
Prepared by
C.Tamil selvam
Dr.M. Ramadas Maganti MD (AY)
Has been prepared and submitted as approved by this institution. This Project Report is
forwarded to Madurai Kamaraj University, Madurai.
Place: Madurai Principal
Date: MMHRC
Faculty of Health Science
Madurai Kamaraj University, Madurai
Approval
This is to certify that the Project Report Titled
A study on the Effect of Aegle marmelos (Stone Apple) Powder

intervention in Irritable Bowel Syndrome
Prepared by
C.Tamil selvam
Dr.M. Ramadas Maganti MD (AY)
Submitted Towards partial fulfillment of the requirement of the degree “PG Diploma in
Nutrition and Diettetics” has been approved by the following the panel of Examiners:
S.no. Name Designation Signature Date
1.
2.
3.
Table of Contents:
1. Introduction and Methodology
1.1 Introduction
1.2 Background of the Study
1.3 Purpose and Objectives
1.4 Organization of the Paper
1.5 Methodology
1.5.1 Research Design
1.5.2 Source of Data
1.5.3 Sample Size
1.5.4 Sampling Technique
1.5.5 Data Collection Method
1.5.6 Analysis of Data
1.6 Scope of the Study
2. Literature Survey
2.1 Definitions and Meanings
2.2 Disease Review
2.3 Review of Irritable Bowel Syndrome
2.4 Drug Review
3. Analysis of data
3.1 About the Region/Organization under Study
3.2 Duration of Study
3.3 Data collection Method
3.4 Experimental Methodology
3.5 Pre-study Analysis of Personal Data of the subjects
3.6 Pre-study analysis of Clinical data of the subjects
3.7 Post study analysis of Clinical Data

4. Comparison and Findings
4.1 Comparative Analysis of Data
4.2 Findings
4.3 Suggestions
5. Conclusion
Bibliography
Appendices
APPENDIX-A- Questionnaire-A
APPENDIX-B- Questionnaire-B
APPENDIX-C- DASS
APPENDIX-D- Diet Tips & FODMAPs chart
APPENDIX-E- Statistical Analysis.

List of Illustrations:
Table Title Page no.
no.
1 The methodology of an experimental pre & posttest design 7
2 Biophysical model depicted by George Engel 13
3 Abnormal gut motor & sensory activity 21
4 Schematics of the role of CNS factors in the pathogenesis of IBS 24
5 Age wise distribution of 50 subjects 50
6 Sex wise distribution of 50 subjects: 51
7 Showing religion wise distribution of 50 patients 52
8 Occupation wise distribution of 50 subjects 53
9 Marital status wise distribution of 50 subjects 54
10 Educational status wise distribution of 50 subjects 55
11 Habitat wise distribution of 50 subjects 56
12 Socio-economic status wise distribution of 50 subjects 57
13 Diet wise distribution of 50 subjects 58
14 Exercise pattern wise distribution of 50 subjects 59
15 Appetite wise distribution of 50 subjects 60

16 Addiction wise distribution of 50 subjects 61
17 Sleep wise distribution of 50 subjects 62
18 Menstrual & obstetric history wise distribution of 50 subjects 63
19 Occupational history wise distribution of 50 subjects 64
20 Marital history wise distribution of 50 subjects 65
21(a) Family history wise distribution of 50 subjects 67
21(b) Emotional make up of family members 67
22 Social situation wise distribution of 50 subjects 68
23 Depression anxiety and stress wise distribution of 50 subjects 69
24(a) Chief complaints wise distribution of 50 subjects 71
24(b) Associated symptoms 71
25 Intensity of abdominal pain wise distribution of 50 subjects 72
26 Frequency of passing motions wise distribution of 50 subjects 73
27 Degree of passing of mucous in stools wise distribution of 50 74
subjects
28 Gas and flatulence wise distribution of 50 subjects 75
29 Post study-chief complaint wise distribution of 50 subjects 77
30 Post study analysis of subjects showing response to the 78
treatment on abdominal pain

31 Response to the treatment on frequency of motion 79
treatment on passing of mucous in stools
treatment on the treatment on gas and flatulence
34(a) Chief complaints wise comparison of pre & post-study data 84
34(b) Mean Difference before and after study 85
35 Response to the intervention on abdominal pain 86
36 Response to the intervention on frequency of motion 87
37 Response to the intervention on passing of mucous in stools 88
38 Response to the intervention on gas and flatulence 89

List of tables:
Table Title Page no.
no.
1 Manning’s criteria for diagnosis of IBS 28
2 Recommended tests for IBS 29
3 Vernacular names of Aegle marmelos 36
4 Nutritional value of bael fruit (% or per 100g) 41
5 Age wise distribution of 50 subjects 50
6 Sex wise distribution of 50 subjects: 51
7 Religion wise distribution of 50 patients 52
8 Occupation wise distribution of 50 subjects 53
9 Marital status wise distribution of 50 subjects 54
10 Educational status wise distribution of 50 subjects 55
11 Habitat wise distribution of 50 subjects 56
12 Socio-economic status wise distribution of 50 subjects 57
13 Diet wise distribution of 50 subjects 58
14 Exercise pattern wise distribution of 50 subjects 59
15 Appetite wise distribution of 50 subjects 60
16 Addiction wise distribution of 50 subjects 61
17 Sleep wise distribution of 50 subjects 62
18 Menstrual & obstetric history wise distribution of 50 subjects 63
19 Occupational history wise distribution of 50 subjects 64
20 Marital history wise distribution of 50 subjects 65
21 Family history wise distribution of 50 subjects 66

22 Social situation wise distribution of 50 subjects 68
23 Depression anxiety and stress wise distribution of 50 subjects 69
24 Chief complaints wise distribution of 50 subjects 70
25 Intensity of abdominal pain wise distribution of 50 subjects 72
26 Frequency of passing motions wise distribution of 50 subjects 73
27 Degree of passing of mucous in stools wise distribution of 50 74
subjects
28 Gas and flatulence wise distribution of 50 subjects 75
29 Post study-chief complaint wise distribution of 50 subjects 76
treatment on abdominal pain
31 Response to the treatment on frequency of motion 79
treatment on passing of mucous in stools
treatment on the treatment on gas and flatulence
34(a) Chief complaints wise comparison of pre & post-study data 82
34(b) Statistical analysis showing the mean difference of the 85
percentage of people who reported of having complaints before
and after the study:
35 Response to the intervention on abdominal pain 86
36 Response to the intervention on frequency of motion 87
37 Response to the intervention on passing of mucous in stools 88
38 Response to the intervention on gas and flatulence 89

Abbreviations:
AT- After Treatment
BD- Bis in die (twice daily)
BT- Before Treatment
CNS- Central Nervous System
DASS- Depression Anxiety Stress Scales.
FMRI- Functional magnetic resonance imaging.
FODMAP- Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols.
GIT- Gastro intestinal Tract.
IBS- Irritable Bowel syndrome.
OCD- Obsessive Compulsive Disorder.
SD- Standard Deviation.
t - Student's 't' test
p – Probability
Abstract:
An experimental study was conducted in 50 subjects to test the efficacy of Stone
Apple fruit (Aegle marmelos) powder intervention in reducing the symptoms of irritable
bowel syndrome. There were 22 females and 28 males aged between 20-60 years, who
had increased frequency of motion, abdominal pain, mucous in stools, gas formation,
anorexia, irritability, painful defaecation and others. Psychological symptoms included
depression, lack of concentration, insomnia, stress. These patients were dispensed
powder of dried unripe fruit of Stone apple at a dose of 5 gms with 150 ml of buttermilk
twice daily, for 15 days along with Ayurvedic medication for psychological support. At
the end of 15 days most of the patients had relief from the symptoms. The average relief
was moderate with a percentage of 48%.These results indicate that Stone apple Fruit
powder supplementation gives good relief from the symptoms of irritable bowel
syndrome. No side effects or undesirable events were seen in any of the participants
during the entire period of the study.
1
CHAPTER ONE
INTRODUCTION AND METHODOLOGY
TABLE OF CONTENTS:
S.No. Heading Page No.
1 Introduction 2
1.2 Background of the Study 4
1.3 Purpose and Objectives 5
1.4 Organization of the paper 5
1.5 Methodology 6
1.51. Research Design 6
1.5.2 Source of Data 7
1.5.3 Sample size 7
1.5.4 Sampling Technique 7
1.5.5 Data collection method 8
1.5.6 Analysis of Data 9
1.6 Scope of the study 9

1. Introduction:
Today stress has become an inevitable part of modern life. According to
several major studies, stress induced dysfunctions lead to an annual $17 billion in
decreased productivity. Worse, this is a growing problem.
Stress is chain of non-specific physical and psychological events triggered
any time, our bodies have to adapt to change. The typical “Flight or Fight”
syndrome tends to speed up our cardiovascular system and slow down our
digestive tract.
Appropriate stress has many positive effects which keep us functioning,
alert and safe. However, sustained stress leads to increased risk for a variety of
illness: hypertension, u l c e r , colon trouble, heart disease, high cholesterol,
depression, insomnia, irritability, asthma, headache, backache and many minor
illnesses.
In the incessant quest for material comforts man has been loosing his
health. The basic reason why man is reeling under myriad problems is because
he has not been following the codes of healthy living. He has disregarded the
codes for the bodily health as well as healthy mind also. Indian medicine has
already considered this problem in depth in the light of its comprehensive
psychosomatic approach towards the entire problem of health and medicine.
Irritable Bowel Syndrome (IBS) is one of the most common complaints that
account for 23% of the patients visit to the physician. Although not a life-
threatening illness, irritable bowel syndrome causes great distress to those
afflicted and the physician feels frustrated and helpless in attempting to treat it
(Jewell DP et al., 1985).
2
The diagnosis usually follows the failure of a consultant surgeon to find
“anything wrong” in a patient complaining of bowel symptoms. IBS is a chronic
relapsing disorder of gastrointestinal function, the main features are abdominal pain
associated with an altered bowel habit (may present with diarrhea or constipation or
intermittently both) in the absence of any structural pathology. The intermittent nature
of symptoms without evidence of physical deterioration and the relation to stress
suggest the diagnosis. Abnormal psychiatric features are recorded in up to 80% of
IBS patients. Irritable bowel s yndrom e patients have been found to have
depressive psychosis, depressive neurosis, anxiety neurosis and hysterical neurosis
(MacDonald AJ et al., 1980; 136:276). However, no single psychiatric diagnosis
predominates.
Irritable Bowel Syndrome is a functional gastrointestinal tract disorder
associated with abdominal pain, disturbed defecation with bloatedness or distension of
the abdomen (Thomson WG et al., 1989; 2:92). Irritable bowel syndrome can be
characterized as a chronic disorder of intestinal motility in the absence of structural
changes in the gut (Fielding JF et al., 1981; 74:143). The diagnosis of irritable bowel
syndrome is usually made after excluding other diseases of the gastrointestinal tract
(Moreno-Osset E et al., 1991; 23(8 Suppl 1):41).
Patients with irritable bowel syndrome may also have a broad range of
non-gastrointestinal symptoms such as fatigue, urologic dysfunction and
gynaecological complaints. Moreover , ill-health, stress is a common complaint
encountered by the physicians in patients with irritable bowel syndrome. Psychological
factors also play an important role in irritable bowel syndrome. A close association
between psychological disorders and irritable bowel syndrome has been noted for
several years (Chaudhary NA et al., 1962; 123:307).

3
Proper history and physical examination findings often lead to proper
diagnosis, thus avoiding unnecessary laboratory investigation ( Verne GN et al., 1997;
102 (3):197)
The present study was undertaken to assess the therapeutic effect of Aegle
marmelos (stone apple) unripe fruit‟s dry powder in patients suffering from Irritable
Bowel Syndrome.
1.2 Background of the Study
Gastrointestinal disorders were among the ten most frequently reported medical
conditions for using Complementary and Alternative Medicines. The reasons may be
due to the recurrent characteristics of the diseases and dissatisfaction with
conventional treatments, especially for functional conditions such as irritable bowel
syndrome (IBS).
Irritable bowel syndrome (IBS) is a common condition often seen in medical
clinics. It is characterized by abdominal pain or discomfort with defecation, bloating,
and changes in bowel habits, and no specific disorder to point to as the cause. IBS is
more common in women (14-24%) than men (5-19%). It usually starts between the
age of 30 and 50 and it is rare for it to start in old age. Studies also suggest that at any
one time, 10-15% of the whole population have irritable bowel syndrome. However,
only a small percentage of these people will seek professional help because of the
recurrent characteristics of the disease and dissatisfaction with conventional
treatments. Therefore, it is essential to choose and recommend less expensive, easily
available and readily acceptable natural alternative supplements along with simple
dietary modifications which help in effective control of IBS.
4
1.3 Purpose and Objectives:
1.31. Purpose of the study:
The present study will bring to limelight, the effect of Aegle marmelos (Stone
Apple) fruit powder supplementation on combating the symptoms of Irritable Bowel
Syndrome. If the present study indicates a significant decrease in the symptoms of
IBS, the importance of Stone apple fruit powder intervention as an effective
supplementation can be emphasized. This supplementation may be advocated in order
to prevent the symptoms associated with IBS, and thereby the quality of the life of the
patients can be significantly improved.
1.3.2 Objectives of the study:
i. To elicit information regarding age, sex, lifestyle pattern and dietary practices
of people with IBS with the help of a questionnaire.
ii. To evaluate the effect of Stone apple powder supplementation in combating the
symptoms of IBS before and after the supplementation period.
1.4 Organization of the paper:
Chapter two consists of Literature survey pertaining to Irritable Bowel
Syndrome with detailed references relating to the Symptoms, clinical features,
Pathophysiology, Diagnosis, Investigations, Differential diagnosis, Various Treatment
modalities and detailed review of the study drug Aegele maemelos.
Chapter three contains detailed methodology of the study conducted deep
analysis and statistical representation of the collected data in the form of bar graphs
and illustrations.
Chapter four focuses on comparison and analysis of pretest and posttest data of
the study, the findings inferred and various suggestions are also included.
000019
The whole study has been summarized in Chapter five.
1.5 Methodology:
A research cannot be conducted absolutely; the researcher has to proceed in a
systematically planned direction with the help of the number of steps in sequence. To
make the research systemized, the researcher has to adopt certain methods. The
methods adopted by the researcher for completing the project are called Research
methodology.
In other words research methodology is simply the plan of action for a research
which explains in detail how data is to be collected analyzed and interpreted.
Data becomes information only when a proper methodology is adopted, thus
we can say methodology is a tool which processes the data to reliable information. The
present chapter attempts to highlight the research methodology adopted in this project.
1.5.1 Research Design:
A research design is an arrangement of condition for collection and analysis of
data in a manner that aims to combine relevance to the research purpose with both
genders.
The present study was designed to investigate the effect of Stone Apple fruit
powder supplementation on combating the symptoms of Irritable Bowel Syndrome.
The study was an Experimental Pre-posttest design study design without a control
group. The duration of the study was 15 days.
6
Fig. 1 showing the methodology of an Experimental pre & Posttest design:
1.5.2 Source of data:
Patients in and around Chennai visiting clinics of the researcher, his colleagues
and his Guide fulfilling the criteria had been selected irrespective of their age, sex,
religion, etc.
1.5.3 Sample size
In this study, 28 males and 22 females making it a total of 50 patients with
Irritable Bowel Syndrome were selected. The study was carried out between 16-Nov-
2011 to 30-Nov-11 for a total period of 15 days. Due to the small sample size male and
female cases were clubbed in the present series of investigation.
1.5.4 Sampling Technique:
1.5.4.1Selection Criteria:
The patients were selected based on the diagnosis made using Rome III Diagnostic
Criteria for Irritable Bowel Syndrome.
 Diagnostic criterion*
Recurrent abdominal pain or discomfort** at least 3 days per month in the last
3months associated with two or more of the following:
i. Improvement with defecation
ii. Onset associated with a change in frequency of stool
iii. Onset associated with a change in form (appearance) of stool

7
* Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to
diagnosis
** “Discomfort” means an uncomfortable sensation not described as pain.
In pathophysiology research and clinical trials, a pain/discomfort frequency of at least
3 days a week during screening evaluation is recommended for subject eligibility.
1.5.4.2 Exclusion Criteria:
The Patients diagnosed with the following were excluded from the study:
i. Amoebic dysentery
ii. Ulcerative colitis IBD & Intestinal tuberculosis
iii. Mal absorption syndrome
iv. Malignancy
v. Lactase deficiency diarrhoea
vi. Hyperthyroidism
vii. Diabetes
1.5.5 Data collection method
1.5.5.1Survey Method:
Survey method is the systematic gathering of data from the respondent. With
the aid of a systematically prepared questionnaire It is the most commonly used
method of primary data collection this is widely used because of its.
 Extreme flexibility
 Reliability
 Easy understanding.
The main purpose of survey is facilitating, understanding or enables prediction of
8
some aspects of the population being surveyed.
1.5.5.2Questionnaire:
A systematic questionnaire named as Questionnaire-A in English was used to
elicit information regarding relevant aspects like age, personal habits & dietary habits
(A copy of the questionnaire is presented in Appendix A).
A systematic questionnaire named as Questionnaire-B in English was used to
elicit regarding the relevant aspects like signs and symptoms, type of onset of the
disease etc. before and after the study period. (A copy of the Questionnaire is
presented in Appendix B).
Depression Anxiety Stress Scales – DASS was used to elicit information
regarding Depression Anxiety & Stress levels of the subjects. (A copy is presented in
Appendix C)
1.5.6 Analysis of Data:
The data obtained were subjected to the following statistical tests:
a. Arithmetic mean
b. Students „t‟ test
(The details regarding the statistical tests are given in Appendix E)
1.6 Scope of the Study:
This study will explore the benefits of Aegle marmelos (Stone Apple) fruit
powder as a viable supplementation for combating the symptoms and increasing the
quality of life of patients suffering from Irritable Bowel Syndrome, which is one of the
most neglected functional disorder of the Gastro intestinal system, the reasons being
the recurrent characteristics of the disease and dissatisfaction with conventional
treatments.
9
CHAPTER TWO
LITERATURE SURVEY
TABLE OF CONTENTS:
S.no. Heading Page No.
2.1 Definitions and Meanings 10
2.2 Disease Review 10
2.3 Review of Irritable Bowel Syndrome 15
2.4 Drug Review 36

2.1 Definitions and Meanings:
2.1.1 Etymology:
IRRITABLE – abnormally sensitive to stimuli
BOWEL - intestine
SYNDROME – symptom complex
IBS is conceptualized as a „cluster of bowel syndrome‟ in which bowel is irritable or
hypersensitive to emotional, mechanical, or chemical stimuli, most of all emotional.
2.1.2 Synonyms:
This is a common syndrome often called by a large variety of names, like spastic
colitis, irritable colon syndrome, nervous diarrhea, mucus colitis, colon neurosis. The
principal abnormality is a disturbance of bowel motility which is modified by
psychosocial factors. These terminologies are inadequate because they describe only
some possible etiological influences (such as nervous factors) or some signs (e.g.
spasticity) they also ignore the fact that other areas of the gut are also involved in this
disease. The other terminologies like Nervous colitis, Spastic colitis and Mucus colitis
are also not correct because there is no inflammation.
2.2 Disease Review:
2.2.1 Historical Perspective:
IBS is a common syndrome often called by a large variety of names, like
spastic colitis, irritable colon syndrome, nervous diarrhoea, mucus colitis, colon
neurosis.
White, Cobb, and Jones in a psychosomatic medicine monograph in 1939 and
White and Jones in a more recent paper, considers mucous colitis as a bodily reaction
rather than a disease entity. They point out that the manifestations are manifold and
10
inconstant and are often overshadowed by other symptoms.
They consider that mucous colitis is probably reasonable for the removal of
more un-diseased appendices than any other cause and that more than half of the
patients initially labeled as chronic gallbladder disease are eventually identified as
having unstable colon.
2.2.2 Modern Review of Functional disorders of GI Tract:
“The abdomen is the sounding board of the emotion” and more than any other systems
it reflects disturbances in the emotional sphere.
A functional disorder is a medical condition that impairs the normal function of
a bodily process, but where every part of the body looks completely normal under
examination, dissection or even under a microscope. This stands in contrast to a
structural disorder in which some part of the body can be seen to be abnormal.
Generally, the mechanism that causes a functional disorder is unknown, poorly
understood, or, occasionally, unimportant for treatment purposes.
Just to list Functional disorders of the gastrointestinal tract would require much space,
a few of them are:
i. Peculiar or metallic tastes
ii. Burning of the gums & tongue
iii. Throat sensations
iv. Swallowing difficulties
v. Functional indigestion especially to faulty & greasy foods,
belching attacks, nervous vomiting
vi. Anorexia & Chronic diarrhea
vii. Constipation
viii. Irritable Bowel Syndrome with upper gastrointestinal

11
symptoms.
ix. Pruritus of the anus is just some of the many “functional”
disorders encountered.
More serious psychosomatic problems are anorexia nervosa, cardio spasm,
peptic ulcer, a host of disorders in connection with gall tract disease (with & without
stones), and ulcerative colitis.
2.2.2.1 Psychosomatic disease:
Stress is unique in the category of diseases. It has no biological carrier such as
a germ or virus. Rather, it is the result of how our mind and body functions and
interacts. It is psychosomatic in the true sense of the word – psyche meaning „mind‟
and soma meaning „body‟. It is the consequence of how we regulate, or to put it more
appropriately, how we do not regulate, the mental and physical functioning of our
being.
Psychosomatic disorders (a term coined by Heinroth, 1918) are those disorders
in which psychosocial factors are important. A narrow but more practical definition
would include those physical disorders which are either initiated or exacerbated by the
presence of meaningful psychosocial environmental stressor.
Franz Alexander, the father of psychosomatic medicine, gave his specificity
hypothesis, which said that if a specific environmental stressor or emotional conflicts
occurs, it results in a specific illness in a genetically predetermined organ.
George Engel, in 1977, gave a bio psychosocial model to explain the complex
interaction between biological, psychological and social spheres resulting in a
psychosomatic illness. This viewpoint has become very popular. It can be depicted in a
diagram, which is given below-

12
Fig. 2 Showing Biophysical model depicted by George Engel
2.2.2.2 A Bio psychosocial Model for Psychosomatic Illness:
It is the „disease‟ created by the abuse of our mind and body and can lead to
totally different symptoms in different people. There is general agreement that a high
percentage of diseases afflicting mankind are psychosomatic and that their primary
causes are our thoughts, attitudes and beliefs. When we speak of psychosomatic nature
of a disease, we basically mean that the major source of the disease lies in one‟s
emotional, mental or perceptual and behavioral habits. In other words, the way that we
have been conditioned to react to our environment has resulted in internal
physiological changes which either evolve into disease or allow disease states to exist.
It is established that which disease occurs and which internal process is involved, is the
consequence of a very complex interaction of psychological, constitutional or genetic
and environmental factors. The pattern will be unique for each individual. For
example, one person may suppress anger and eventually develop the mental
dysfunction of depression; another may suppress anger and eventually develop
migraine headache. However, even though the development of the specific

13
psychosomatic disease is unique to each individual, the underlying principles are the
same.
Emotional stress
Physiological stress
Eventual breakdown of the target organ system (disease)
Psychosomatic diseases appear to progress through four distinct phases:
i. Psychic phase – This phase is marked by mild but persistent psychological and
behavioral symptoms of stress such as irritability, disturbed sleep, loss of
appetite, etc.
ii. Psychosomatic phase – If the stress condition continues, these symptoms
become more pronounced, along with the beginnings of generalized
physiological symptoms such as occasional hypertension and tremors.
iii. Somatic phase – This phase is marked by increased function of the organs,
particularly the target, or involved organ. At this stage, one begins to identify
the beginnings of a disease stage.
iv. Organic phase – This phase is marked by the full involvement of a so- called
disease state, with physiological changes such as an ulcerated stomach or
chronic hypertension becoming manifest. There are many examples of
psychosomatic diseases which are directly related to stress. These include
ulcer, cancer, bronchial asthma, migraine, chest pain, IBS, etc. The list is
almost endless. It is still not known why one organ system is affected by stress
and not another. Certainly, genetic factors, diet and conditioned learning are all
involved, but the key lies in one‟s mental structures. In other words, it can be
14
said that stress is at the root of all psychosomatic diseases regardless of the
organ system involved.
2.3 Review of Irritable Bowel Syndrome (IBS):
 ICD-10 (International Classification of Diseaes10th Revision 1992) lists these
disorders under (F40-F48: Neurotic, Stress-Related and Somatoform
Disorders)
 IBS is a gastrointestinal disorder characterized by altered bowel habits and
abdominal pain in the absence of detectable structural abnormalities.
 No clear diagnostic markers exist for IBS, so all definitions of the disease are
based on the clinical presentation.
2.3.1. Rome III Criteria* for the Diagnosis of IBS:
Recurrent abdominal pain or discomfort** at least 3 days per month in the last
3months associated with two or more of the following:
i. Improvement with defecation
ii. Onset associated with a change in frequency of stool
iii. Onset associated with a change in form (appearance) of stool
* Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to
diagnosis.
** “Discomfort” means an uncomfortable sensation not described as pain.
In pathophysiology research and clinical trials, a pain/discomfort frequency of at least
3 days a week during screening evaluation is recommended for subject eligibility.
 IBS is one of the most common conditions encountered in clinical Practice but
one of the least well understood.
 Patients with IBS may fall into two broad clinical groups
i. Patients have abdominal pain associated with altered bowel habits that include
15
constipation, diarrhea, or both.
ii. Patients have painless diarrhea (<20% of patients).
2.3.2 Epidemiology:
Although IBS is recognized widely as one of the most commonly encountered
gastrointestinal disorder, yet reliable data about prevalence is not available because the
disease is not fatal, not reportable, is widespread in general population and over 90%
of the patients never get hospitalized. Population surveys show that it is the second
most common cause of absenteeism from work, after common cold. Also, there is
evidence that 15% of general populations have some symptomatology suggestive of
IBS but they do not seek medical attention. In fact, only 20% of patients who qualify
for the diagnosis seek medical advice for the same. IBS is the most common cause of
referral to gastroenterologists accounting for 20-50% of all referred patients.
2.3.3 Clinical Features:
The clinical features of IBS can be broadly categorized under two groups
i. Physical clinical features
ii. Psychological clinical features.
2.3.3.1 Physical Clinical Features:
i. Abdominal pain:
 Abdominal pain in IBS is highly variable in intensity and location.
 Pain in IBS is localized to the hypogastria in 25%, the right side in 20%, to the
left side in 20%, and the epigastria in 10% of patients.
 Pain is variously described as vague, bloating, crampy, burning, dull, aching,
knife like sharp or steady pain.
 It may be mild, moderate or severe and localized or diffuse. Acute episodes of
severe, sharp knife like pain may be superimposed with constant or intermittent
16
dull aching pain. Pain may be mild enough to be ignored or it may interfere
with daily activities.
 Despite this, malnutrition due to inadequate caloric intake is rare with IBS.
 Sleep deprivation is also unusual because abdominal pain is almost uniformly
present only during waking hours. However, some patients do complain of
waking up because of pain but closer questioning usually reveals that these
patients are depressed and awakening is more because of depression than pain.
 Pain is often exacerbated by eating or emotional stress and relieved by passage
of flatus or stool.
ii. Altered Bowel Habits:
Alteration in bowel habits is the most consistent clinical feature in IBS.
Symptoms usually begin in adult life. Only a small number have lifelong bowel
irregularity. This disturbance in bowel function is gradually progressive, eventually
developing a characteristic pattern, which for most, is one of these symptoms
predominating. The frequency and quality of each symptom although highly variable
from individual to individual are fairly consistent for a specific patient.
ii a)In the constipation predominant group:
 At first, constipation may be episodic but eventually it becomes continuous and
increasingly intractable to treatment with laxatives.
 Stools are usually hard with narrow caliber (described as pencil thin or ribbon
like), possibly reflecting excessive dehydration caused by prolonged colonic
retention and spasm. Barium enema shows exaggerated haustrations.
 Most patients also experience a sense of incomplete evacuation, thus leading to
repeated attempts at defecation in a short time span.
 Patients whose predominant symptom is constipation may have weeks or

17
months of constipation interrupted with brief periods of diarrhea.
 Increased beta-adrenergic sensitivity correlates with visceral hypersensitivity in
patients with constipation-predominant irritable bowel syndrome.
Autonomic imbalance has been proposed to be a pathophysiological factor for irritable
bowel syndrome (IBS).
A study was conducted to assess beta- adrenergic abnormalities in IBS and to
evaluate their relationship to visceral hypersensitivity and other symptoms of IBS
patients. Sixteen IBS patients and 16 control subjects were recruited into this study.
Participants were asked to complete a questionnaire regarding bowel symptoms and in
order to study beta-adrenergic sensitivity, isoproterenol stimulation tests were
performed and visceral hypersensitivity was evaluated by barostat test. Results showed
that beta- adrenergic activity and rectal sensitivity were more pronounced in IBS
patients than in normal control patients (P< 0.01). Although both IBS subgroups also
exhibited more pronounced beta-adrenergic sensitivity than did the controls (P <0.05),
a significant correlation between beta-adrenergic activity and maximally tolerable
pressures on the barostat test was found only in IBS-C patients (P = 0.03, R = 0.855).
In addition, patients with "hard or lumpy" stools exhibited a higher degree of beta-
adrenergic activity (P = 0.00). So the study concluded that increased beta- adrenergic
activity significantly correlated with visceral hypersensitivity in constipation-
predominant IBS and symptoms of hard or lumpy stools in IBS patients.1

1 Dig Dis Sci. 2005 Aug; 50(8):1454-60 Park JH, Rhee PL, Kim HS, Lee JH, Kim YH, Kim JJ, Rhee JC, Kang EH, Yu BH
(Department of Medicine and Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Kangnam-Ku,
Seoul, Korea.)
18
ii b)In the diarrhea predominant group:
 Diarrhea resulting from IBS usually consists of small volumes of loose stools,
and most patients have stool volumes of <200 ml.
 Evacuation is often preceded by extreme urgency or tenesmus, occurring
typically in the morning or after meals.
 The initial stool may be normal in consistency, being followed rapidly by a
movement of softer ill formed stool. Generally, the first stool has the maximum
volume and the subsequent stools are smaller in volume.
 Nocturnal diarrhea does not occur in IBS.
 Diarrhea may be aggravated by emotional stress or eating.
iii. Gas and Flatulence:
 Patients with IBS frequently complain of abdominal distention and increased
belching or flatulence, all of which they attribute to increased gas.
 Although some patients with these symptoms actually may have a larger
amount of gas, quantitative measurements reveal that most patients who
complain of increased gas generate no more than a normal amount of intestinal
gas.
 Most IBS patients develop symptoms even with minimal gut distention,
suggesting that the basis of their complaints is reduced tolerance of distention
rather than an abnormal quantity of intraluminal gas.
 In addition, patient with IBS tend to reflux gas from the distal to the more
proximal intestine, which may explain the belching.
19
iv. Mucous in stool:
 Stool may be accompanied by passage of large amounts of mucus, but this
mucus is just an exaggeration of normal; hence the term mucous colitis has
been used to describe IBS. This is a misnomer, since inflammation is not
present.
 Bleeding is not a feature of IBS unless hemorrhoids are present, and Mal
absorption or weight loss does not occur.
v. Upper Gastrointestinal Symptoms:
 Between 25-50% patients with IBS complain of dyspepsia, heartburn, nausea,
and vomiting. This suggests that areas of the gut other than the colon may be
involved.
 Some patients of IBS have been wrongly diagnosed to be having an acute attack
of appendicitis and even surgery has been performed on them. It is because of
this varied presentation that the word “Syndrome” has been affixed to this
disease entity.
vi. Extra-intestinal symptoms:
Dysmenorrhoea is noted in as many as 90% of patients with IBS, urinary
frequency in 65% and dyspareunia in 33%. Migraine is also very commonly
associated. This shows that IBS is possibly associated with autonomic disturbance as
well. (CMJ Vol. X No.1 April 2004).
2.3.3.2 Psychological features:
Symptoms of IBS appear after or during period of stress and emotional tension.
Patients with IBS report increased frequency of stressful life experiences. The
particular vulnerability of intestine (rather than skin, bronchi or vascular systems) to
stressful conflicts may originate during early life as a result of visceral responses that
20
are learnt through social reinforcement (secondary gain). Alternatively, patients with
IBS may have an inherited or otherwise abnormal myoelectric and motor abnormality.
Abnormal psychological features are noted in 70-90% patients with IBS. The most
common are depression, anxiety and somatization of the affect. Literature suggests that
psychological factors contribute to the onset and exacerbation of symptoms. The
emotional stress can trigger hyper motility in normal subjects as well as in patients
with IBS and the threshold is lower in patients with IBS.
2.3.4 Pathophysiology:
The pathogenesis of IBS is poorly understood, although roles of below factors have
been proposed.
i. Abnormal gut motor & sensory activity
ii. Central neural dysfunction
iii. Luminal factors
iv. Psychological disturbances & stress
i. Abnormal gut motor & sensory activity:
Fig.3 Showing Abnormal Gut motor & sensory activity:
21
 Colonic myoelectrical and motor activity under un stimulated conditions are
generally normal, but abnormalities are more prominent under stimulated
condition in IBS.
 IBS patients may exhibit increased recto sigmoid motor activity for up to 3hrs
after eating.
 Provocative stimuli also induce exaggerated colonic motor responses in IBS
patients compared to healthy volunteers. For example, inflation of rectal
balloons both in diarrhea and constipation predominant IBS patients leads to
marked distention-evoked contractile activity, which may be prolonged.
 As with studies of motor activity, IBS patients frequently exhibit exaggerated
sensory responses to visceral stimulation. Postprandial pain has been
temporally related to entry of food bolus into the cecum in 74% of patients.
 Exaggerated symptoms can be induced by visceral distention in IBS patients.
 Rectal balloon inflation produces both non-painful and painful sensation at
lower volumes in IBS patients than in healthy controls without altering rectal
tension, suggestive of visceral afferent dysfunction in IBS.
 Visceral hyperalgesia of IBS – appears to be selective for mechanoreceptor-
activated stimuli, as perception of intestinal mucosal electrical stimulation is
normal in IBS. (Similar studies show gastric and esophageal hypersensitivity in
patients with non-ulcer dyspepsia and non-cardiac chest pain, raising the
possibility that these conditions have a similar pathophysiologic basis).
 In contrast to their enhanced gut sensitivity, IBS patients do not exhibit
heightened sensitivity elsewhere in the body.
 Thus the afferent pathway disturbances in IBS appear to be selective for
22
visceral innervation, with sparing of somatic pathways.
The mechanisms responsible for visceral hypersensitivity are unclear. These
exaggerated responses may be due to:
 Increased end organ sensitivity with recruitment of silent nociceptor (a receptor
for pain caused by injury, physical or chemical, to body tissue).
 Spinal hyper excitability with activation of neurotransmitters – nitric oxide or
other spinal hyper excitability.
 Endogenous modulation of caudad nociceptive transmission (cortical and
brainstem)
 Over time the possible development of long-term hyperalgesia due to
development of neuroplasticity, resulting in permanent or semi-permanent
changes in neural responses to chronic or recurrent visceral stimulation.
The volume of cerebral cortical activity response to equal subluminal distention
pressures in IBS patients is significantly larger than in controls, documenting the
existence of hypersensitivity of the neural circuitry in this patient group irrespective of
stimulus-related cognitive processes.2
2 Gastroenterology. 2006 Jan; 130(1):26-33Comment: Novel evidence for hypersensitivity of
visceral sensory neural circuitry in irritable bowel syndrome patients. Lawal A, Kern M,
Sidhu H, Hofmann C, Shaker R.
23
ii. CNS Factor in the pathogenesis of IBS:
The role of central nervous system (CNS) factors in the pathogenesis of IBS is
strongly suggested by-
 The clinical association of emotional disorders and stress with symptom
exacerbation.
 Therapeutic response to therapies that act on cerebral cortical sites.
 PET- Positron emission tomography has shown alterations in regional cerebral
blood flow in IBS patients.
Fig.4 Showing the Schematics of the role of CNS factors in the Pathogenesis of
IBS
24
 In healthy individuals, rectal distention increase blood flow in the anterior
cingulated cortex, a region with abundance of opiate receptors, which when
activated, may help to reduce sensory input.
 In contrast IBS patients exhibit no increased blood flow in the anterior cingulated
gyrus but show activation of the prefrontal cortex, either in response to rectal
activation or in anticipation of rectal distention.
 Activation of the frontal lobes may activate a vigilance network within the brain
that increases alertness. The anterior cingulated cortex and prefrontal cortex
appear to have reciprocal inhibitory associations.
 In patient with IBS, the preferential activation of the prefrontal lobe without
activation of the anterior cingulated cortex may represent a form of cerebral
dysfunction leading to the increased perception of visceral pain.
 Abnormal forebrain activity in functional bowel disorder patients with chronic
pain.
Abnormal cortical pain responses in patients with fibromyalgia and conversion
disorder raise the possibility of a neurobiological basis underlying so-called
"functional" chronic pain.
A study was conducted by using percept-related fMRI to test the hypothesis
that patients with a painful functional bowel disorder do not process visceral input or
sensations normally or effectively at the cortical level.
Methods: Eleven healthy subjects and nine patients with irritable bowel syndrome
(IBS) underwent fMRI during rectal distensions that elicited either a moderate level of
urge to defecate or pain. Subjects continuously rated their rectal stimulus-evoked urge
or pain sensations during fMRI acquisition. fMRI data were interrogated for activity
related to stimulus presence and to specific sensations.

25
Results: In IBS, abnormal responses associated with rectal-evoked sensations were
identified in five brain regions. In primary sensory cortex, there were urge-related
responses in the IBS but not control group. In the medial thalamus and hippocampus,
there were pain-related responses in the IBS but not control group. However,
pronounced urge- and pain-related activations were present in the right anterior insula
and the right anterior cingulate cortex in the control group but not the IBS group.
Conclusions: Percept-related fMRI revealed abnormal urge- and pain-related
forebrain activity during rectal distension in patients with irritable bowel syndrome
(IBS). As visceral stimulation evokes pain and triggers unconscious processes related
to homeostasis and reflexes, abnormal brain responses in IBS may reflect the sensory
symptoms of rectal pain and hypersensitivity, visceromotor dysfunction, and abnormal
introspective processing. 3
Subtle involvement of the parasympathetic nervous system in patients with
irritable bowel syndrome. reactivity to food intake, measured as muscle sympathetic
nerve activity, is normal in IBS patients. The lower DB (Deep breathing) ratio and
higher LF/HF (Heart rate) ratio during food intake in IBS patients is an indication of a
reduced parasympathetic reactivity. These results suggest that reduced baseline
activity as well as responsiveness of the parasympathetic system could play a role in
the pathogenesis of IBS.4
3 Kwan CL, Diamant NE, Pope G, Mikula K, Mikulis DJ, Davis KD.Institute of Medical Science,
University of Toronto, Ontario, Canada).
4 (Clin Auton Res. 2006 Feb; 16(1):33-9. Rudolf Magnus Institute of Neuroscience, Dept. of Clinical
Neurophysiology, University Medical Centre Utrecht, Utrecht, the Netherlands.)
26
iii. Luminal factor:
 Methane, a gas produced by enteric bacteria, slows Intestinal transit and
augments small intestinal contractile activity.5
iv. Psychological factors:
 Abnormal psychiatric features are recorded in up to 80% of IBS patients;
however, no single psychiatric diagnosis predominates.
 IBS prevalence rates are significantly higher for OCD (Obsessive-compulsive
disorder) patients than control subjects Irritable bowel syndrome. IBS occurs
more frequently in psychiatric patients, especially those with anxiety and mood
disorders.6
 An association between prior sexual or physical abuse and development of IBS
has been reported. Forms of sexual abuse associated with IBS include verbal
aggression, exhibitionism, sexual harassment, sexual touching and rape.
 The pathophysiologic relationship between IBS and sexual or physical abuse is
unknown. However, physical and sexual abuse may result in hyper vigilance to
body sensations at the CNS level and visceral hypersensitivity at the gut level.
Thus patients with IBS frequently demonstrate increased motor reactivity of the colon
and small bowel to a variety of stimuli and altered visceral sensation associated with
lowered sensation thresholds. These may result from CNS (enteric nervous system)
deregulation.
5 Cedars-Sinai Medical Center, Burns and Allen Research Institute and UCLA Geffen School of
Medicine, Los Angeles, California, USA. Am J Physiol Gastrointest Liver Physiol. 2005 Nov 17
6. CNS Spectr. 2006 Jan; 11(1):21-5. Department of Psychiatry, Duke University Medical Center,
Durham, NC 27705, USA. pmasand@psychme.net)
27
2.3.5 Diagnosis:
IBS diagnose relies on recognition of positive clinical features as well as
meticulous exclusion of certain other disorders. A careful history and physical
examination are frequently helpful in establishing the diagnosis.
Table 1. Showing Manning’s Criteria for diagnosis of IBS:
a) Supporting the diagnosis of IBS
Lower abdominal pain

i. Aggravated by meals
ii. Relieved by defaecation
iii. More frequent bowel movements with onset of pain d) Loose
stools with onset of pain
iv. Does not awaken the patient
 Visible abdominal distension
 Small stool (with constipation or diarrhea)
 Chronic symptoms consistent in pattern but variable in intensity
 Symptoms worsen with period of stress
b) Against the diagnosis of IBS

 Onset in old age
 Steady progressive course
 Frequent awakening by symptoms
 Fever
 Rectal bleeding
 Steatorrhoea
 Dehydration
 New symptom after long period
28
These symptoms classically start in the adolescence and then subsequently
from a pattern of either predominant diarrhea or constipation which is almost peculiar
to that patient. This criterion is called as the Manning’s Criteria.
If on investigation, any of the following laboratory features is abnormal, the
diagnosis of IBS has to be revised.
2.3.6 Recommended Laboratory Tests for IBS:
Because IBS is in part a diagnosis of exclusion, certain diagnostic test should
be performed routinely; others may be required depending on the specific presenting
symptoms.
Table-2 Showing Recommended Tests for IBS:
i. Recommended for all patients:
Investigations Conditions to Rule Out

Haematology: Anemia, inflammation. (TLC,
DLC, ESR)
Stool for occult blood Any cause of GI bleeding
Flexible sigmoidoscopy Obstruction
Lactose Lactose intolerance test

ii Recommended when indicated by history:
Investigations Conditions to Rule Out

Stool (microbiology) Amoebiasis, Clostridium difficile
Anal canal pressure or Pelvic floor muscle dyssynergia
EMG
Endoscopy Peptic ulcer disease
Glucose breath test Bacterial overgrowth syndrome
Small bowel X-Rays Inflammation bowel disease
Colonoscopy Right colonic disease
29
The following are the laboratory features against the diagnosis of IBS.
 Elevated ESR
 Leukocytosis
 Blood, pus or fat in stool
 Stool weight more than 200 gm/day
 Persistent diarrhea during 48 hours of fasting
 Hypokalaemia
 Manometry failure to show spastic response to rectal distention
2.3.7 Differential Diagnosis:
Because the major symptoms of IBS – abdominal pain, abdominal bloating,
and alteration in bowel habits-are common complaints of many GI organic disorders.
The list of differential diagnosis is long. The quality, location and timing of pain may
be helpful in suggesting specific disorders.
 Pain due to IBS that occurs in the epigastric or periumbilical area must be
differentiated from biliary tract disease, peptic ulcer disorder, intestinal ischemia
and carcinoma of the stomach and pancreas.
 If pain occurs mainly in the lower abdomen, the possibility of diverticular disease
of the colon, inflammatory bowel disease (including ulcerative colitis and
Crohn‟s disease) and carcinoma of the colon must be considered.
 Postprandial pain accompanied by bloating, nausea and vomiting suggests gastro
-paresis or partial intestinal obstruction. Intestinal infestation with Giardia
lamblia or other parasites may cause similar symptoms.
 When diarrhea is the major complaint, the possibility of lactase deficiency,
laxative abuse, malabsorption, hyperthyroidism, inflammatory bowel disease and
30
infectious diarrhea must be ruled out.
 On the other hand constipation may be a side effect of many different drugs, such
as anticholinergic, antihypertensive and antidepressant medications.
 Endocrinopathies such as hypothyroidism and hypoparathyroidism must also be
considered in the differential diagnosis of constipation, particularly if other
systemic signs or symptoms of these endocrinopathies are present.
 In addition, acute intermittent porphyria and lead poisoning may present in a
fashion similar to IBS. These possibilities are suspected on the basis of their
clinical presentations and are confirmed by appropriate serum and urine tests.
2.3.8 Treatment:
2.3.8.1 Patient Counseling and Dietary Alterations:
 Reassurance and careful explanation of the functional nature of the disorder
and of how avoid obvious food precipitants are important first steps in patients
counseling and dietary change. Information related to the disease, might help
with IBS to perceive less pain and more vitality and thereby experience a
higher quality of life.
 Practical Implication: A course of instruction for patients with IBS may be of
benefit for the patients, and could be a part of a multicomponent approach in
the treatment of this patient group.
 Occasionally, a meticulous dietary history may reveal substances (such as
coffee, disaccharides, legumes and cabbage) that aggravate symptoms. As a
therapeutic trial, patients should be encouraged to eliminate any food stuffs that
appear to produce symptoms.
 FODMAPs (Fermentable Oligo-, Di- and Mono-saccharides and Polyols) are
31
known to cause GI discomfort in susceptible individuals. A low FODMAP diet
has widespread application for managing functional GI disorders such as IBS
and IBD.7
2.3.8.2Stool Bulking Agents:
 High –fiber diets and bulking agents, such as bran or hydrophilic colloid, are
frequently used in treating IBS.
2.3.8.3Antispasmodics:
 Anticholinergic drugs may provide temporary relief for symptoms such as
painful cramps related to intestinal spasm.
2.3.8.4Antidiarrheal Agents:
 When diarrhea is severe, especially in the painless diarrhea variant of IBS,

small doses of diphenoxylate (Lomotil), 2.5 to 5 mg every 4 to 6 hour can be
prescribed. Patients who have diarrhea with stressful situations may be given
these drugs. But it is only as temporary management; the final goal of
treatment is gradual withdrawal of medication with substitution of a high-
fiber diet.
IBS symptoms did not improve with probiotic treatment with L. reuteri. A strong
placebo effect and a lack of uniformity of the IBS population may have hindered a
clearer demonstration of the effect.8
2.3.8.5Drug Antidepressants:
 Antidepressant e.g. Imipramine
 Trycyclic agent
 Selective serotonin reuptake inhibitors e.g. fluxetine, paroxetine and sertraline
7 "Evidence-based dietary management of functional gastrointestinal symptoms: The FODMAP

approach" Gibson PR, Shepherd SJ. (Feb 2010).. J Gastroenterol Hepatol. 25 (2): 252–8.
8 Clin Nutr. 2005 Dec;24(6):925-31. Epub 2005 Jul 27. The Department of Gastroenterology, Sourasky
Medical Center, Meir Hospital, Tel-Aviv University, Israel.
32
2.3.8.6 Hypnosis for irritable bowel syndrome:
 The empirical evidence of therapeutic effects. The median response rate to
hypnosis treatment is 87%, bowel symptoms can generally be expected to
improve by about half, psychological symptoms and life functioning improve
after treatment, and therapeutic gains are well maintained for most patients for
years after the end of treatment.9
 Hypnosis subjects improved more in quality of life scores compared to
controls. Anxiety predicted poor treatment response. Hypnosis responders
remained improved at 6-month follow-up. Although response rate was lower
than previously observed in therapist-delivered treatment, hypnosis home
treatment may double the proportion of IBS patients improving significantly
across 6 months.10
2.3.8.7Antiflatulence Therapy:
Patients should be advised to eat slowly; not chew gum or drink carbonated beverages;
and avoid artificial sweeteners, legumes and food of the cabbage family.
Simethicone, antacids and activated charcoal have all been tried, usually with
disappointing results.
9 Int J Clin Exp Hypn. 2006 Jan 54(1):7-20. University of North Carolina at Chapel Hill, Chapel Hill,
North Carolina 27599, USA. William_Whitehead@med.unc.edu
10 Int J Clin Exp Hypn. 2006 Jan; 54(1):85-99.
33
Treatment strategies are focused on specific symptoms, potential underlying
disorders in stress responsiveness, and predisposing psychological features. Although
only two medications, tegaserod for constipation-predominant IBS and alosetron for
diarrhea-predominant IBS, are specifically indicated.11
2.3.8.8 Future directions in medical treatment of IBS:
Medications that blunt the visceral hyperalgesia of IBS are in development. Such
“anti-afferent” agents might act via one or more mechanisms, including -
i. Modification of release of pain-inducing mediators in the gut wall.
ii. Blockade or activation of peripheral afferent nerve receptors.
iii. Inhibition of afferent nerve transmission.
iv. Modification of afferent activity in the CNS.
These include the kappa opioid compounds and serotonin receptor (5HT3)
antagonists such as alosetron and octreotide. Such compounds have been shown to
reduce severity and perception of painful mechanical visceral stimulation in patients
with IBS. Additional clinical studies of this group of compounds may lead to new
therapeutic approaches for the treatment of IBS.
11 Curr Gastroenterol Rep. 2005 Aug;7(4):249-56. VA Greater Los Angeles Healthcare System,
CURE Building 115, Room 223, 11301 Wilshire Boulevard, Los Angeles, CA 90073, USA.
34
2.3.8.9 Other Therapy:
It has been shown that acupuncture relieves symptoms of abdominal pain and
bloating in patients with irritable bowel syndrome (IBS). However, the mechanism of
beneficial effects of acupuncture still remains unproven. A study was conducted to
investigate the mechanisms of the antinociceptive effects of acupuncture in conscious
dogs. The increase in mean arterial blood pressure (MAP) caused by rectal distension
as an index of visceral pain was evaluated. Electroacupuncture (EA; 10Hz) at ST-36
(lower leg), but not at BL-21 (back), significantly reduced the increase in MAP in
response to rectal distension (30 and 40 cm3). The antinociceptive effect of EA at ST-
36 was abolished by pretreatment with naloxone (a central and peripheral opioid
receptor antagonist) but not by naloxone methiodide (a peripheral opioid receptor
antagonist). These results suggest that EA at ST-36 may reduce visceral pain via
central opioid pathway. Acupuncture may be useful to treat visceral hypersensitivity in
IBS patients.12
12 Dig Dis Sci. 2005 Jul;50(7):1264-70. Department of Surgery, Duke University and Durham
Veterans Affairs Medical Center, Durham, North Carolina 27705, USA.
35
2.4 Drug Review:
Stone Apple Aegle marmelos(Linn.) Correa ex Roxb., A plant of Indian origin
having tremendous therapeutic potential is not fully utilized. It belongs to family
Rutaceae, the family of citrus fruits. It is known with different names in different
languages.
2.4.1Vernacular names:
Table-3. Showing Vernacular Names of Aegle Marmelos:
Language Name
Hindi Bel, Beli, Belgiri
Sanskrit Bilva, Shivadruma, Shivaphala, Vilva
English Bael, Bengal quince, Golden apple,
Stone Apple
Urdu Bel, Bel Kham
Assamese Bel
Marathi Bel
Gujrati Bilivaphal
Malyalam Marredy
Oriya Belo
Tamil Vilvam, Vilva maram
Telugu Bilva, Bilva pandu
Bael is known in India from prehistoric time and has been mentioned in the
ancient system of medicine. It has a great mythological significance also. Every part of
plant such as fruit, seed, bark, leaf and root are important ingredients of several
36
traditional formulations. Due to its curative properties, it is one of the most useful
medicinal plants of India. It is utilized in day-to-day life in various forms. The products
obtained from bael, being highly nutritive and therapeutic are getting popularized in
Indian as well as in international market.
Bael plant acts as a „Sink‟ for chemical pollutants as it absorbs poisonous gases
from atmosphere and make them inert or neutral. It is a member of plant species group
known as „Climate Purifiers‟, which emit greater percentage of oxygen in sunlight as
compared to other plants.
2.4.2 Origin and Distribution:
The Bael tree has its origin from Eastern Ghats and Central India. It is indigenous
to Indian subcontinent and mainly found in tropical and subtropical regions. The tree is
also found as a wild tree, in lower ranges of Himalayas up to an elevation of 500 meters.
Bael is found growing along foothills of Himalayas, Uttar Pradesh, Bihar, Chattisgarh,
Uttaranchal, Jharkhand, Madhya Pradesh, and The Deccan Plateau and along the East
Coast.
In Bangladesh, the tree has been used for fertility control and antiproliferative
and in Sri Lanka it has been used for its hypoglycemic activities.
2.4.3 Bael in Mythology:
Hindus hold the tree in great venerations. It is one of the most sacred trees of
India. The leaves are ternate and hence one of the vernacular names is Tripatra. It is
generally cultivated near temples and is offered to Lord Shiva, whose worship cannot be
completed without the leaves of this tree. Lord Shiva is believed to live under the Bael
tree. It is also called Shivadurme, the tree of Shiva. According to Hindu mythology, the
tree is another form of Lord Kailashnath. It is also sacred to Parvati and is the Vilva
37
rupra, one of the Patricas, or nine forms of Goddess Kali. The planting of this tree by
the waysides gives long life. Its leaves are also used as enchantments. It is incumbent
upon all Hindus to cultivate and cherish this tree and it is sacrilege to cut it down. The
mentions of plant have also been found in ancient Indian scriptures such as Vedas and
Purana like Yajurveda and Mahabharata.
2.4.4 Cultivars:
In India, the plant is widely cultivated particularly in Uttar Pradesh and Bihar. So
far around twelve distinct cultivars, viz. „Basti No.1‟, „Kagzi Gonda‟, „Gonda No.1‟,
‘Gonda No.2‟, „Gonda No.3‟, „Kagzi Etawah‟, „Sewan Large‟, „Mirzapuri‟, „Deoria
Large‟, „Chakaiya‟, „Baghel‟ and „Lamba‟ have been reported. Out of these four
cultivars „Kagzi Etawah‟, „Sewan Large‟, „Mirzapuri‟ and „Deoria Large‟ have been
found to be superior and excellent in taste and other qualities.
2.4.5Chemical composition:
Various chemical constituents like alkaloids, coumarins and steroids have been
isolated and identified from different parts of tree, such as leaves, fruits, wood, root and
bark.
i, Coumarins
Marmelosin, marmesin, imperatorin, marmin, alloimperatorin, methyl ether,
xanthotoxol, scoparone, scopoletin, umbelliferone, psoralen and marmelide27.
Marmenol, a 7-geranyloxycoumarin [7-(2, 6-dihydroxy- 7-methoxy-7-methyl-3-
octaenyloxy) coumarin] has been reported.
ii, Alkaloids
Aegelin, aegelenine, marmeline, dictamine, fragrine (C13H11O3N),
Omethylhalfordinine,O isopentenylhalfordinol27, N-2-[4-(3‟, 3‟- dimethylallyloxy)
38
phenyl] ethyl cinnamide,N-2-hydroxy-2-[4-(3‟,3‟-dimethylallyloxy) phenyl]ethyl
cinnamide, N-4methoxystyryl cinnamide, N-2- hydroxy-2- (4-hydroxyphenyl) ethyl
cinnamide29, 30, O- (3,3-dimethylallyl) halofordinol, N-2- ethoxy-2-(4-methoxy phenyl)
ethyl cinnamide, N-2-methoxy-2-[4-(3‟,3‟- dimethylallyloxy)phenyl] ethylcinnamide, N-
2-methoxy-2-(4-methoxyphenyl)- ethylcinnamide.
iii, Polysaccharides
Galactose, arabinose, uronic acid and L-rhamanose are obtained on hydrolysis.
iv, Tannins
The maximum tannin content in bael fruit was recorded in the month of January.
There is as much as 9% tannin in the pulp of wild fruits, less in cultivated type. Tannin is
also present in leaves as skimmianine.
v. Carotenoids
Carotenoids are responsible for imparting pale colour to fruit. Marmelosin,
skimmianine and umbelliferone are the therapeutically active principles of bael plant.
Minor constituents like ascorbic acid, sitosterol, crude fibres, tannins, α-amyrin,
carotenoids, and crude proteins are also present. Roots of the tree have also been found
to contain psoralen, xanthotoxin scopoletin and tembamide. Compounds such as
praealtin D, trans-cinnamic acid, 4- methoxy benzoic acid, betulunic acid, and montanin
have also been reported.
 Seed Oil
Composed of palmitic, stearic, oleic, linoleic and linolenic acid have been
reported.
2.4.6 Utilization:
 Every part of the bael tree is utilized for various purposes. The wood is
yellowish or grayish white, hard lustrous, aromatic when freshly cut. It takes a
39
fine polish and is suitable for house building, cart construction, agricultural
implements, carving, pestles, tool handles, combs, etc., .
 The twigs and leaves are used as fodder. The twigs are also used as tooth
brushes or chew-sticks.
 Sweet-scented water is distilled from the flowers. Leaf juice is applied to the
body before taking a bath to remove bad smell.
 The most valuable part of the tree is the fruit. A yellow dye is obtained from the
unripe rind, which is used with myrobalans in calico printing.
 The sweet aromatic fruit pulp is very nutritious, which is used for making
sharbat.
 Mixed with lime the pulp makes tenacious cement, which is used for the
construction of wells.
 It is also employed as a varnish (where a polished surface is required) for
pictures and adds brilliancy to water colour paints.
 The pulp is often used as a substitute for soap for washing clothes as it has
detergent properties.
 The dried fruits, after separating the pulp from the rind, are used as pill boxes
for keeping valuable medicine, sacred ashes and snuff balls.
 Gum from stem is non-edible but acts as a good adhesive and used often for
book binding.
 The tree has been identified as suitable windbreak or wind barrier.
 In Indonesia, it is a common practice to take bael fruit in breakfast either by
cutting or breaking open the soft fruits and eating the pulp of fruit dressed in
palm sugar.
40
 The fruits carry large quantity of tenacious transparent gluten, which becomes
hard on drying but continues to be transparent and when ripe and mixed with
juice of tamarind, forms an agreeable drink. These drinks are consumed less as
food or refreshment than for their medicinal effects.
 Mature (full grown) but still unripe fruits are made into jam with addition of
citric acid. The pulp is also converted into marmalade or syrup, which is used as
food material as well as a therapeutic agent in relieving diarrhoea and dysentery.
 A firm jelly is made from the pulp alone or combined with guava to modify the
astringent flavour. The pulp is also pickled.
2.4.7 Nutritional value:
Physico-chemical studies have revealed that bael fruit is rich in mineral and vitamin
contents26, 39, 40. Major components of nutritional importance are listed in Table 1.
Table 4: Nutritional value of Bael fruit (% or per 100g)
Components Value (%)

Water (moisture) 64.2
Protein 1.8
Fat 0.2
Mineral 1.5
Fibre 2.2
Carbohydrate 30.6
Calcium 0.09
Phosphorus 0.05
Potassium 0.6
Iron 0.3
Vitamin A (IU) 186
Vitamin B1 0.01
Nicotinic acid 0.9
Riboflavin 1.2
Calcium 0.09
Vitamin C 0.01
Calorific value 129
41
2.4.8 Medicinal Uses:
 Diarrhoea and Dysentery- The unripe or half ripe fruit is the most effective
remedy for chronic diarrhoea and dysentery without fever. Best results are
obtained by the use of dried fruit or its powder. The fruit, when it is still green, is
sliced and dried in the sun. The dried fruit slices are reduced into powder and
preserved in air-tight bottles. The unripe fruit can also be baked and taken with
jaggery or brown sugar. The fruit appears to have little effect in acute dysentery
when there is definite sensation to defecate without the significant amount of
faeces, blood and mucus alone are passed. The powdered drug is specially
recommended in sub-acute or chronic dysentery. After the use of the fruit powder
in these conditions, the blood gradually disappears and the stools resume a more
feculent and solid form. The mucus also disappears after continued use for some
time. It is also a valuable remedy for chronic dysenteric conditions characterized
by alternate diarrhoea and constipation. Its use has also been reported in the cases
of amoebic dysentery. It is used in the treatment of Irritable Bowel Syndrome.
 Hypoglycemic/ Antidiabetic activity Leaf extract has been used in Ayurveda as a
medicine for diabetes. It enhances the ability to utilize the external glucose load
in the body by stimulation of glucose uptake similar to insulin46, 47. Bael extract
significantly lowers blood urea and cholesterol in experimental diabetic animals8.
Extract also decreases oxidative stress in experimental diabetic animals as
indicated by significant reduction in lipid peroxidation, conjugated diene and
hydroperoxide level and increased levels of superoxide dismutase, catalase,
glutathione peroxidase and glutathione levels in serum as well as liver. Juice of
leaves is employed as anti-diabetic drug in Unani system of medicine also.
42
 Anticancer activity: Bael inhibited in vitro proliferation of human tumour cell
lines including the lecukenic K562, T-lymphoid Jurhat, Beta-lymphoid Raji,
Erythro leukemic HEL20. Extract of A. marmelos is antiproliferative but it
produces effect on MCF-7 and MDA-MB-231 breast cancer cell line when it is in
high concentration.
 Cardioprotective effects: The leaf extract has preventing effects in isoprenaline
(isoproterenol) - induced myocardial infarction in rats. The activity of creatine
kinase and lactate dehydrogenase was significantly increased in serum and
decreased significantly in heart of isoprenaline-treated rats. Use of Bael as
cardiac depressant and in palpitation has also been reported.
 Antispermatogenic activity- The leaf extract possesses anti-spermatogenic
activity as it resists the process of spermatogenesis and decreases sperm motility
in rats. Leaves were used for fertility control in Bangladesh.
 Antimicrobial/Antifungal activity-Bael extract manifests antiviral and
antimicrobial activities. It has been found active against various species such as
Staphylococcus aureus, S. epidermidis, Proteus vulgaris, Escherichia coli,
Salmonella typhimurium and Bacillus subtilis. It has also been used for Ranikhet
disease virus and intestinal parasites. The essential oil isolated from the leaves of
Bael exhibits variable efficiency against different fungal isolates and causes
concentration as well as time dependent inhibition of spore germination of all the
fungi tested, including most resistant fungus, Fusarium udum.
 Radioprotective effect: Treatment with extract of bael reduces the severity of
symptoms of radiation induced sickness and increases survival in mice. The radio
protective action might be due to free-radical scavenging and arrest of lipid
43
peroxidation accompanied by an elevation in glutathione concentration in liver,
kidney, stomach and intestine.
 Antipyretic and Analgesic activities: Bael extract exhibits antipyretic, anti-
inflammatory and analgesic activities, as it has shown a significant inhibition of
the carrageenan induced paw odema, cotton-pellet granuloma and paw itching in
mice and rats. It is also used as febrifuge in night and intermittent fever.
 Constipation: Ripe fruit is regarded as best of all laxatives. It cleans and tones up
the intestines. Its regular use for two to three months helps in evacuation of even
the old accumulated faecal matter from the bowels. For best result, it should be
taken in the form of Sharbat, which is prepared from the pulp of the ripe fruit.
After breaking the shell, the seeds are removed and contents are then taken out
with the help of a spoon and passed through a sieve. Milk and sugar may be
added to make it more palatable. The pulp of ripe fruit can also be taken with the
spoon without addition of milk and sugar. About 60g of the fruit/edible part is
sufficient for an adult.
 In Burn cases: the traditional healers of southern Chhattisgarh use dry powder of
fruit with mustard oil for the treatment of burn cases. One part of powder and two
parts of mustard oil are mixed and are applied externally.
 Peptic ulcer: An infusion of leaves is an effective remedy for peptic ulcer. The
leaves are soaked overnight in water. This water is strained and taken as a drink
in the morning. The pain and discomfort are relieved when this treatment is
continued for a few weeks. The fruit taken in the form of beverage has also great
healing properties on account of its mucilage, which forms a coating on the
stomach mucosa and thus helps in the healing of ulcers.
44
 Respiratory infections: Medicated oil prepared from leaves gives relief from
recurrent cold and respiratory infections. The juice extracted from leaves is
mixed with equal quantity of sesame oil and heated thoroughly, a few seeds of
black pepper and half a teaspoonful of black cumin are added to the hot oil, and
then it is removed from the fire and stored for use when necessary. A teaspoonful
of this oil should be massaged onto the scalp before a head bath. Its regular use
builds up resistance against cold and cough. A common practice in South India is
to give the juice of leaves to bring relief from wheezing cough and respiratory
spasm. The leaf juice is mixed in warm water with a little pepper and is given as
a drink.
 Miscellaneous properties Bael leaves are useful in jaundice and in the treatment
of wounds. The extract of leaves is beneficial in the treatment of leucorrhoea,
conjunctivitis and deafness. Fruits give feeling of freshness and energy. It is used
as carminative and astringent and used in thyroid related disorders. It is also used
in treatment of snakebite. It is a cardiac stimulant. Applications have also been
reported in anaemia, fractures, swollen joints, pregnancy troubles, typhoid, coma,
colitis, bleeding sores and cramps. It is also used as anthelmintic. It is used in
treatment of acute shigellosis, as diuretic, in gonorrhoea and in conjuctivitis. The
powder is used as stomachic.
45
2.4.9 Summary of drug Review:
Looking upon wide prospects and potential of bael for various purposes, it is
worthwhile to cultivate this plant on large scale especially on unproductive and
wasteland. This will help in financial upliftment of poor and landless farmers.
Furthermore, systematic and scientific research is required to explore the maximum
potential of this under-utilized Plant of Panacea for human and environmental well-
being.
46
CHAPTER THREE
ANALYSIS OF DATA
TABLE OF CONTENTS:
3.1 About the Region under Study 47
3.2 Duration of Study 47
3.3 Data collection Method 47
3.4 Experimental Methodology 48
3.5 Pre-study Analysis of Personal Data of 50

the subjects
3.6 Pre-study analysis of Clinical data of 69

the subjects
3.7 Post study analysis of Clinical Data 76

3. Analysis of Data:
3.1 About the Region:
The study consisted of participants in and around Chennai visiting clinics of the
researcher, his colleagues and his guide.
3.2 Duration of the Study:
The study was carried out for a period of 15 days from 16 Nov 2011 to 30 Nov 2011.
3.3 Data collection method:
3.3.1 Survey using Questionnaire:
A systematic questionnaire named as Questionnaire-A in English was used to
elicit information regarding relevant aspects like age, personal habits & dietary habits,
history (A copy of the questionnaire is presented in Appendix A).
A systematic questionnaire named as Questionnaire-B in English was used to
elicit regarding the relevant aspects like signs and symptoms, type of onset of the disease
etc. before and after the study period. (A copy of the format is presented in Appendix B)
DASS (Depression Anxiety and Stress scales) was used to elicit Depression
Anxiety and Stress levels of the subjects. (A copy of the format is attached in Appendix
C)
47
3.4 Experimental Methodology:
3.4.1Test material:
Dried unripe fruits of stone apple was procured from raw drugs store and then
powdered and packed as packets weighing 150 gms each.
3.4.2Orientation of the subjects:
Individual consent was obtained from each subject for their willingness to
participate in the study; the subjects were briefed about the significance of this study by
the investigator. They were instructed that they would be required to fill up the
questionnaires, on the first day and last day of the study/supplementation period, and
were advised to consume 5 gms of the powder along with 150ml butter milk twice daily
after breakfast and dinner for 15 days
Subjects were asked to follow specific dietary modifications as advised during
the diet counseling session.
Psychological support was given in the form of Ayurvedic drug T.Manasamitra
vatakam BD after food daily as a standard for all subjects as IBS has a strong
psychological correlation.
Subjects were advised to report immediately in case of any adverse reactions or
events incurring during the study period.
3.4.3Method of intake:
The subjects were instructed to consume 5 gms of the powder along with 150ml
butter milk twice daily after breakfast and dinner for a period of 15 days.
48
3.4.4 Pretest Clinical assessment and data collection:
Clinical assessment was done for all the subjects on the first day. The subjects
were briefed about the significance of this study, after which, the questionnaires was
administered to them and were advised to tick the appropriate boxes, translation or
explanation was aptly provided orally for all required subjects. DASS scale was rated by
clinic staffs. The datas were collected for statistical analysis.
Following which each of the subject was given 150 gms packet of powder of the
supplement and were asked to consume as advised during the orientation
3.4.5Diet Counseling:
Diet counseling was given to all the subjects. All the subjects were briefed about
the disease and about the importance of High fiber low residue diet and the role of
FODMAPs in IBS. A simple information pamphlet containing Diet Tips and various
foods to be taken and avoided based on Fodmap content was explained and handed over
to the subjects, and were advised to follow it to the possible extent wherever applicable.
A copy is included in Appendix D.
3.4.6Post-test Clinical assessment and Data Collection:
At the end of the study/supplementation period the subjects were advised to
report back and their current status was scored using the same questionnaire-B. The datas
thus collected were subjected statistical analysis.
49
3.5 Pre-Study Analysis of Personal data of the Subjects:
3.5.1 Age wise distribution of 50 Subjects:
Table -5 Showing age wise distribution of 50 subjects:
Age No. of Subjects %

20-30 10 20
30-40 27 54
40-50 13 26
Maximum (54%) subjects belonged to the age group of 30-40.
Fig. 5 ShowingAge wise distribution of 50 subjects
60
50
40
30
20
10
0
20-30
30-40
40-50
50
3.5.2 Sex wise distribution of 50 subjects:
Table- 6. Showing Sex wise distribution of 50 subjects:
Sex No. of Subjects %
Male 28 56
Female 22 44
Maximum (56%) were males followed by females (44%).
Fig. 6 showing Sex wise distribution of 50 subjects
60
50
40
30
20
10
0
Male Female
51
3.5.3 Religion wise distribution of 50 Subjects:
Table .7 Showing Religion wise distribution of 50 patients:
Religion No. of Subjects %
Hindu 23 46
Muslim 9 18
Christian 17 34
Others 1 2
It is evident from the above table that maximum i.e. 46% patients were Hindus followed
by 34% Christians and 18% Muslims.
Fig .7 Showing Religion wise distribution of 50 subjects
50
45
40
35
30
25
20
15
10
0
Hindu Muslim Christian Others
52
3.5.4 Occupation wise distribution of 50 subjects:
Table- 8 showing occupation wise distribution of 50 subjects:
Occupation No. of Subjects %
Service 14 28
Business 11 22
Retired 2 4
Labour 2 4
Unemployed 6 12
House wife 15 30
Maximum numbers of subjects (30.0%) were house wives followed by 28% service
workers and 22% business.
Fig.8 Showing Occupation wise distribution of 50 subjects
30
25
20
15
10
0
Service Business Retired Labour Unemployed House wife
53
3.5.5 Marital status wise distribution of 50 Subjects:
Table 9 .showing marital status wise distribution of 50 subjects:
Marital status No of Subjects %
Married 37 74
Unmarried 8 16
Widow 3 6
Divorced 2 4
Maximum numbers of patients (74.0%) were married.
Fig. 9 Showing Marital status wise distribution of 50

patients
80
70
60
50
40
30
20
10
0
Married Unmarried Widow Divorced
54
3.5.6 Educational status wise distribution of 50 subjects:
Table 10 -Showing Educational status wise distribution of 50 subjects:
Education No of Subjects %
Uneducated 2 4
Primary 4 8
Secondary 17 34
Higher secondary 13 26
Graduation 14 28
Maximum numbers of patients (28%) were graduated followed by (34%) Secondary

educated.
Fig. 10 showing Educational status wise distribution of 50

subjects
35
30
25
20
15
10
0
Uneducated Primary Secondary Higher Graduation
secondary
55
3.5.7 Habitat Wise Distribution of 50 Subjects:
Table 11-showing habitat wise Distribution of 50 subjects:
Habitat No. of Subjects %
Rural 11 22
Urban 39 78
In present study IBS shows greater prevalence (78.0%) in urban area.
Fig.11 showing Habitat wise distribution of 50 subjects
80
70
60
50
40
30
20
10
0
Rural Urban
56
3.5.8 Socio-economic status wise distribution of 50 subjects:
Table 12- Showing socio-economic status wise distribution of 50 subjects:
Socio-economic status No. of %

Subjects
Poor 11 22
Lower middle 19 38
Middle 17 34
Upper middle 3 6
Majority of patients (38%) belonged to lower middle class followed by (34%) middle
class.
Fig. 12 Socio-economic status wise distribution of 50

subjects
40
35
30
25
20
15
10
0
Poor Lower middle Middle Upper middle
57
3.5.9 Diet wise distribution of 50 Subjects:
Table 13- showing Diet wise distribution of 50 subjects:
Diet No. of Subjects %
Vegetarian 19 38%
Mixed 31 62%
Majority of the subjects (62%) belonged to mixed diet group.
Fig.13 Diet wise distribution of 50 Subjects
70
60
50
40
30
20
10
0
Vegetarian Mixed
58
3.5.10 Exercise Pattern wise distribution of 50 patients:
Table 14-showing Exercise pattern wise distribution of 50 subjects:
Exercise subjects %
Nil 31 62
Less frequent 11 22
Daily 8 16
Maximum subjects (62%) were not doing any form of exercises.
Fig .14 Exercise Pattern wise distribution of 50 subjects
70
60
50
40
30
20
10
0
Nil Less Frequent Daily
59
3.5.11 Appetite wise distribution of 50 Subjects:
Table 15- showing Appetite wise distribution of 50 subjects:
Appetite subjects %
Good 8 16
Moderate 22 44
Poor 20 40
Maximum patients (44%) had Moderate appetite followed by poor appetite (40.0%).
Fig.15 Appetite wise distribution of 50 Subjects
45
40
35
30
25
20
15
10
0
Good Moderate Poor
60
3.5.12 Addiction wise distribution of 50 Subjects:
Table 16- showing Addiction wise distribution of 50 subjects:
Addiction No. of Subjects %
Tobacco 4 8
Smoking 8 16
Panmasala 4 8
Alcohol 6 12
No Addiction 28 56
No Addiction was observed in 56% of the subjects followed by16% smoking, followed
by 12% addiction of Alcohol.
Fig.16 Addiction wise distribution of 50 Subjects
60
50
40
30
20
10
0
Tobacco Smoking Panmasala Alcohol No
Addiction
61
3.5.13 Sleep wise distribution of 50 Subjects:
Table 17- showing Sleep wise distribution of 50 subjects
Sleep No. of Subjects %
Sound 5 10
Moderate 14 28
Disturbed 31 62
Maximum Subjects had disturbed sleep (62%) and Moderate sleep was found in 28% of
patients.
Fig. 17 Sleep wise distribution of 50 patients
70
60
50
40
30
20
10
0
Sound Moderate Disturbed
62
3.5.14 Menstrual & Obstetric history Wise distribution of 50 subjects:
Table 18- showing Menstrual & Obstetric history Wise distribution of 50 subjects:
Menstrual & Obstetric history No. of Subjects %
Regular menses 7 14
Irregular menses 11 22
Hysterectomy 2 4
Menopause 1 2
Infertility 1 2
Insignificant(men) 28 56
22% of the females had irregular menses.
Fig.18 Menstrual & Obstetric history Wise distribution
60
50
40
30
20
10
63
3.5.15Occupational History wise distribution of 50 subjects:
Table 19- showing Occupational History wise distribution of 50 subjects:
Occupational History subjects %
With occupation 23 46
Without occupation 27 54
Attitude towards job Satisfied 10 43.48
Unsatisfied 13 56.52
Relation at work place Satisfied 9 39.13
46% had occupation but amongst them 56.5% had unsatisfactory attitude towards their
job and 60.87 had unsatisfactory relation at workplace.
Fig.19 Occupational History wise distribution of 50 subjects
70
60
50
40
30
20
10
0
With Without Satisfied Unsatisfied Satisfied Unsatisfied
occupation occupation Attitude Attitude Relation at Relation at
towards job towards job work place work place
64
3.5.16 Marital history wise distribution of 50 subjects:
Table 20- showing marital history wise distribution of 50 subjects:
Marital History Subjects %
Widowed 3 6
Divorcee 2 4
Unmarried 8 16
Sterility 1 2
Relation with spouse ( Satisfied 24 64.86

married)
Sexual life ( married) Satisfied 21 56.76
Maximum Subjects among the married group (64.86%) were having satisfied sexual life
followed by satisfactory relation with spouse (56.76%).
Fig. 20-Marital history wise distribution of 50 subjects
70
60
50
40
30
20
10
0
65
3.5.17 Family history wise distribution of 50 subjects:
Table 21- showing Family history wise distribution of 50 subjects:
Family History Number of %

Subjects
Nuclear 27 54
Joint 23 46
Illness of family members 11 22
Death of close family members 7 14
Relation with family members Satisfied 18 36
Unsatisfied 32 64
Emotional make up of Anxious 20 40

family members
Tension 18 36
Depression 13 26
Irritable 17 34
Any mental disorder 3 6
Nothing Specific 14 28
Maximum subjects (54%) belonged to Nuclear family and 64% were having
unsatisfactory relation with family members. Maximum patients were having history of
Anxiety (40%) followed by Tension (36%) in family.
66
Fig. 21 (a) Family history wise distribution of 50 subjects
70
60
50
40
30
20
10
0
Nuclear Joint Illness of Death of Satisfied Unsatisfied
family close family Relation Relation
members members with family with family
members members
Fig. 21 (b) Emotional make up of family members
40
35
30
25
20
15
10
5
0
Anxious Tension Depression Irritable Any mental Nothing
disorder Specific
67
3.5.18 Social situation wise distribution of 50 subjects:
Table 22- Showing Social situation wise distribution of 50 subjects:
Social situation Subjects %
Housing Satisfied 30 60
Unsatisfied 20 40
Social relation Satisfied 22 44
Unsatisfied 28 56
Financial problem Yes 32 64
No 18 36
Maximum patients were having satisfied housing (60.0%) and financial problem was
found in 64% followed by unsatisfied social relation (56%).
Fig. 22 Social situation wise distribution of 50 subjects
70
60
50
40
30
20
10
0
Satisfied Unsatisfied Satisfied Unsatisfied With With out
Housing Housing Social Social Financial Financial
relation relation problems problems
68
3.6 Pre-Study Analysis of Clinical Data of the Subjects:
The pre-study clinical data of the subjects are analyzed as follows.
3.6.1 Depression anxiety and stress wise distribution of 50 subjects:
Table 23- Showing Depression anxiety and stress wise distribution of 50 subjects:
Criteria Subjects %
Depression 43 86
Anxiety 46 92
Stress 48 96
96% of the subjects were stressed (in varying degrees) 92% of the subjects were
suffering from anxiety (in varying degrees)
Fig. 23-Depression anxiety and stress wise distribution
96
94
92
90
88
86
84
82
80
Depression Anxiety Stress
69
3.6.2 Chief complaints wise distribution of 50 subjects:
Table-24 Showing Chief complaints wise distribution of 50 subjects:
Chief complaints No. of %

Subjects
Abdominal pain/discomfort 50 100
Constipation/Diarrhoea/both 50 100
Presence of mucus in stool 49 98
Gas & flatulence 44 88
Difficult stool 27 54
passage
Sense of 39 78
incomplete
evacuation
Associated Abd 42 84
pain/discomfort
symptoms relieved with
defeacation
Dyspepsia 39 78
Heartburn 28 56
Nausea/Vomiting 5 10
Maximum Subjects (100%) were having pain/discomfort in abdomen, (100%) diarrhoea

or constipation, 98% had presence of mucus in stool, gas & flatulence in (88%).
Abd pain/discomfort relieved with defaecation (84%) followed by dyspepsia & sense of
incomplete evacuation (78%) each followed by heartburn found in 56% patients.
70
Fig. 24 (a) Chief complaints wise distribution of 50 subjects
100
98
96
94
92
90
88
86
84
82
Fig. 24 (b) Associated Symptoms
90
80
70
60
50
40
30
20
10
0
71
3.6.3 Intensity of Abdominal pain wise distribution of 50 subjects:
Table -25 showing Intensity of Abdominal pain wise distribution of 50 subjects:
Pain No. of Percentage

Subjects
Nil 0 0
Mild 34 68
Moderate 16 32
Severe 0 0
From the above we can infer that 68% of the subjects had mild degree of abdominal, sever pain
was not reported by anyone.
Fig.25 Intensity of Abdominal pain wise distribution
70
60
50
40
30
20
10
0
Nil Mild Moderate Severe
72
3.6.4 Frequency of passing motions wise distribution of 50 subjects:
Table-26 showing Frequency of passing motions wise distribution of 50 subjects:
Grade No. of Percentage

subjects
0 (2-3/day) 9 18
I(3-6/day) 32 64
II(7-10/day) 8 16
III (10 or more) 1 2
From the above it is inferred that 64% of the subjects were belonging to Grade I,
followed by 18% in grade 0
Fig. 26 Frequency of passing motions wise distribution of

50 subjects
70
60
50
40
30
20
10
0
Grade 0
Grade I
Grade II
Grade III
73
3.6.4 Degree of Passing of Mucous in Stools Wise Distribution of 50 subjects:
Table-27 showing Degree of Passing of Mucous in Stools Wise Distribution of 50

subjects:
Passing of Mucous No. of subjects Percentage
Nil 1 2
Mild 32 64
Moderate 13 26
Severe 4 8
Maximum number of patients 64% was falling under mild category followed by
moderate 28%
Fig. 27 Degree of Passing of Mucous In Stools Wise

Distribution
70
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
74
3.6.5 Gas and Flatulence wise distribution of 50 subjects:
Table-28 Gas and Flatulence wise distribution of 50 subjects
Degree No. of Subjects Percentage
Nil 6 12
Mild 28 56
Moderate 11 22
Severe 5 10
From the above table it is inferred that 56% of the subjects had mild degree of gas and
flatulence followed by 22% falling under the moderate group.
Fig. 28 Gas and Flatulence wise distribution of 50

subjects
70
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
75
3.7 Post study analysis of clinical data:
3.7.1 Post study-Chief complaint wise distribution of 50 subjects:
Table-29 Showing Post study-Chief complaint wise distribution of 50 subjects:
Chief complaints No. of %

Subjects
Abdominal pain/discomfort 22 44
Constipation/Diarrhoea/both 19 38
Presence of mucus in stool 17 34
Gas & flatulence 23 46
Difficult stool 7 14
passage
Sense of incomplete 12 24
evacuation
Associated
Abd pain/discomfort 11 22
symptoms relieved with
defeacation
Dyspepsia 8 16
Heartburn 13 26
Nausea/Vomiting 1 2
76
Fig. 29 Percentage wise Relief of
symptoms analysis- post study
50
45
40
35
30
25
20
15
10
77
3.7.2 Post study analysis of subjects showing response to the treatment on
abdominal pain:
Table-30 showing Post study analysis of subjects showing response to the treatment
on abdominal pain
Pain No. of Subjects Percentage
Nil 28 56
Mild 18 36
Moderate 4 8
Severe 0 0
Maximum number of subjects 56% reported to have nil pain, followed by 36% moderate.
Fig. 30 Post study analysis of subjects showing response to

the treatment on abdominal pain
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
78
3.7.3 Post study analysis of subjects showing response to the treatment on frequency
of motion:
Table -31 showing subjects showing response to the treatment on frequency of

motion:
Grade No. of subjects Percentage
0 (2-3/day) 31 62
I(3-6/day) 17 34
II(7-10/day) 2 4
III (10 or 0 0
more)
From the above table it is inferred that 62% of the patient fell under Grade0 category followed by
Grade I 34%
Fig. 31 Subjects showing response to the treatment on

frequency of motion
80
60
40
20
0
Grade 0
Grade I
Grade II
Grade III
After Treatment
79
3.7.4 Post study analysis of subjects showing response to the treatment on passing of
mucous in stools:
Table-32 showing Post study analysis of subjects showing response to the treatment
on passing of mucous in stools
Degree No. of subjects Percentage
Nil 32 64
Mild 14 28
Moderate 4 8
Severe 0 0
Maximum number of subjects 62% reported nil passing of mucous in stools post study
followed by 28% mild group.

the treatment on passing of mucous in stools
70
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
80
3.7.5 Post study analysis of subjects showing response to the treatment on the
treatment on Gas and Flatulence:
Table -33 showing Post study analysis of subjects showing response to the treatment
on the treatment on Gas and Flatulence
Degree No. of subjects Percentage
Nil 27 54
Mild 18 36
Moderate 5 10
Severe 0 0
Maximum number of subjects 54% reported nil gas and flatulence post study, followed
by 36% falling under mild category.

the treatment on the treatment on Gas and Flatulence
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
81
CHAPTER FOUR
COMPARISON AND FINDINGS
TABLE OF CONTENTS:
4.1 Comparative Analysis of 82
Data
4.2 Findings 90
4.2.1 Pre study general findings 90
4.2.2 Pre-study clinical Findings 91
4.2.3 Post study Effect of 92
Intervention
4.3 Suggestions 94
4.1 Comparative analysis of Data:
4.1.1. Chief complaints wise comparison of Pre & post-study data:
Table-34(a) showing Chief complaints wise comparison of Pre & post-study data:
Before After treatment Difference

Chief complaints treatment
No. of % No. of % No. of %

subjects subjects subjects
who got
relief
Abdominal pain/discomfort 50 100 22 44 28 56
Constipation/Diarrhoea/both 50 100 19 38 31 62
Presence of mucus in stool 49 98 17 34 32 64
Gas & flatulence 44 88 23 46 21 42

Difficult stool 27 54 7 14 20 40
passage
Sense of incomplete 39 78 12 24 27 54
evacuation
Associated Abd 42 84 11 22 31 62
symptoms pain/discomfort
relieved with
defeacation
Dyspepsia 39 78 8 16 31 62
Heartburn 28 56 13 26 15 30
Nausea/Vomiting 5 10 1 2 4 8
 Before the study 100% of the subjects were complaining of Abdominal
discomfort after the study period only 44% of the subjects complained of the
same ,56% of the subjects got relief.

82
 Before the study 100% of the subjects complained of
Constipation/Diarrhoea/both, after the study only 38% of them had the same
complaint, 62% of the subjects got relief.
 Before the study 98% of the subjects were complaining of presence of mucous in
stool, after the study only 34% of them were complaining the same, the
percentage of relief being 64%.
 Before the study 88% of the subjects were complaining of Gas & Flatulence,
after the study only 46% of the subjects complained of the same percentage of
people who got relief was 42%
 Before the study 54% of the subjects were having Difficulty in passing stools,
after the supplementation period only 14% were complaining of the same 40% of
the subjects got relieved of the condition.
 Before the study 78% of the subjects were complaining of sense of incomplete
evacuation, after the study only 24% of them were complaining the same, with
54% of the subjects getting relieved from the condition.
 Before the study 84% of the subjects had abdominal discomfort which relieved
only after defaecating, whereas after the study only 22% complained of the same,
62% of the subjects got relieved.
 Dyspepsia was reported in 78% of the subjects before study, whereas only 16%
of them were complaining of the same after study period, 62% of the subjects
were relieved.
 56% of the subjects reported heart burn before study, after the study only 26% of
them complained of the same, the percentage of relief being30%
 Nausea/vomiting was seen in 10% of the subjects before study, whereas only 2%
of them complained of the same after study 8% of the people got relief.
83
Fig.34(a)- Chief complaints wise comparison of Pre & post-
study data
100
90
80
70
60
50
40
30
20
10
0
Before treatment After Treatment
84
Table-34(b) Statistical analysis showing the mean difference between the chief
complaints reported by subjects before and after the study:
Mean(n=10)
Before After study Mean SD T value P value
study Difference
37.3 13.3 24 23.41 7.78 <0.05
Because the computed t value 7.78 is larger than t-table critical value of 1.833, the null
hypothesis can be rejected and hence the result obtained is statistically significant.
Fig.34(b)Mean Difference before and after syudy
40
35
30
25
20
15
10
5
0
Mean Difference
85
4.1.2. Pre & post-study comparison of the number of subjects based on abdominal
pain:
Table -35: Showing response to the Intervention on abdominal pain
Pain Before study After study
No. of cases Percentage No. of cases Percentage
Nil 0 0 28 56
Mild 34 68 18 36
Moderate 16 32 4 8
Severe 0 0 0 0
Before the study 68% of the subjects were complaining of Mild abdominal pain, post
study 56% reported no pain and 36% of the subjects reported having mild pain.
Fig. 35-Showing response to the intervention on

abdominal pain
70
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
Before treatment After Treatment
86
4.1.2. Pre & post-study comparison of the number of subjects based on the
frequency of passing motions:
Table 36: Showing response to the intervention on frequency of motion
Grade Before Study After Study
No. of Percentage No. of cases Percentage
cases
0 (2-3/day) 9 18 31 62
I(3-6/day) 32 64 17 34
II(7-10/day) 8 16 2 4
III (10 or 1 2 0 0
more)
62% of the subjects got relief (Grade 0) followed by 34% of the subjects falling under
(Grade I).
Fig. 36 Showing response to the intervention on

frequency of motion
70
60
50
40
30
20
10
0
Grade 0
Grade I
Grade II
Grade III
Before Study After Study
87
4.1.3. Pre & post-study comparison of the number of subjects based on Passing of
mucous in stools:
Table-37:Showing response to the intervention on passing of mucous in
stools
Pain Before Study After Study
Nil 1 2 32 64
Mild 32 64 14 28
Moderate 13 26 4 8
Severe 4 8 0 0
64% of the subjects reported to have no passing of mucous in stools after the study
period as opposed to 2% before treatment, only 28% of the subjects reported Mild degree
of mucous in stools as opposed to 64% before the study.
Fig.37 Showing response to the intervention on passing of

mucous in stools
70
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
Before Study After Treatment
88
4.1.4. Pre & post-study comparison of the number of subjects based on Gas &
Flatulence:
Table 38: Showing response to the intervention on Gas and Flatulence
Degree Before Study After Study
Nil 6 12 27 54
Mild 28 56 18 36
Moderate 11 22 5 10
Severe 5 10 0 0
Pre-study data indicates 56% of the subjects under mild category whereas post study data
shows 54% of the subjects coming under Nil category.
Fig.38 Showing response to the intervention on Gas and

Flatulence
60
50
40
30
20
10
0
Nil
Mild
Moderate
Severe
Before study After Study
89
4.2 Findings:
4.21. Pre study general findings:
IBS is widespread in general population, 15% of general populations have some
symptomatology suggestive of IBS but they do not seek medical attention. In fact, only
20% of subjects who qualify for the diagnosis seek medical advice for the same. It
appears to be a great cause of frustration among gastroenterologist that more than half of
all subjects that they investigate have no organic cause to explain their symptoms.
The Findings drawn from the present study has been presented herewith:
 The maximum numbers of subjects (54%) were traced between 30 to 40 years
age and 56% were males
 46% were belonging to Hindu community
 30% were housewives
 74% were married
 34% secondary educated
 78% subjects were from urban area
 38% belonged to lower middle class
 62% were taking mixed type of diet
 62% were not doing any type of physical exercises.
 44% of them reported having moderate appetite.
 No Addiction was observed in 56% of the subjects followed by16% smoking,
followed by 12% addiction of Alcohol.
 Maximum subjects had disturbed sleep (62%) and Moderate sleep was found in
28% of subjects.
 22% of the females had irregular menses.
90
 46% had occupation but amongst them 56.5% had unsatisfactory attitude towards
their job and 60.87% had unsatisfactory relation at workplace.
 Maximum Subjects among the married group (64.86%) were having satisfied
sexual life.
 Maximum subjects (54%) belonged to Nuclear family and 64% were having
unsatisfactory relation with family members. Maximum subjects were having
history of Anxiety (40%) followed by Tension (36%) in family.
 Maximum subjects were having satisfied housing (60.0%) and financial problem
was found in 64% followed by unsatisfied social relation (56%).
4.2.2 Pre-study clinical Findings:
 The survey among the IBS subjects show that the maximum number of subjects
(96%) were stressed, followed by anxiety 92%, followed by depression (86%).
 On the basis of the study chief complaints reported by these subjects were: 100%
having pain in abdomen, with 68% of them having Mild degree followed by 32%
moderate pain
 Diarrhoea or constipation was found in 100% of the subjects with 64% of the
subjects in Grade I category passing 3-6 times motions per day.
 98% had presence of mucus in stool with 64% of them belonging to mild
category followed by 26% of the subjects in moderate category
 Gas & flatulence was reported in 88% of the subjects with 56% of them
belonging to Mild category.
 Abdominal pain/discomfort relieved with defeacation in 84% of subjects.
 Dyspepsia was found 78% followed by Sense of incomplete evacuation in 78%
subjects.
91
4.2.3 Post study Effect of Intervention:
The effect of the therapy was analyzed from the post-study clinical data and the
following findings were drawn:
 Before the study 100% of the subjects were complaining of Abdominal
discomfort after the study period only 44% of the subjects complained of the
same ,56% of the subjects got relieved completely followed by 36% moderate
relief.
 Before the study 100% of the subjects complained of
Constipation/Diarrhoea/both, after the study only 38% of them had the same
complaint, 62% of the subjects got relief (Grade 0) followed by 34% of the
subjects falling under (Grade I).
 Before the study 98% of the subjects were complaining of presence of mucous in
stool, after the study only 34% of them were complaining the same, the
percentage of relief being 64%., followed by 28% of the subjects falling under
mild category as opposed to 32% before treatment.
 Before the study 88% of the subjects were complaining of Gas & Flatulence,
after the study only 46% of the subjects complained of the same percentage of
people who got relief was 42%
 Before the study 54% of the subjects were having Difficulty in passing stools,
after the supplementation period only 14% were complaining of the same 40% of
the subjects got relieved of the condition.
 Before the study 78% of the subjects were complaining of sense of incomplete
evacuation, after the study only 24% of them were complaining the same, with
54% of the subjects getting relieved from the condition.
92
 Before the study 84% of the subjects had abdominal discomfort which relieved
only after defaecating, whereas after the study only 22% complained of the same,
62% of the subjects got relieved.
 Dyspepsia was reported in 78% of the subjects before study, whereas only 16%
of them were complaining of the same after study period, 62% of the subjects
were relieved.
 56% of the subjects reported heart burn before study, after the study only 26% of
them complained of the same, the percentage of relief being30%
 Nausea/vomiting was seen in 10% of the subjects before study, whereas only 2%
of them complained of the same after study 8% of the subjects got relief.
56% relief was observed in abdominal pain or discomfort, 62% in diarrhoea,
64% in mucus with stool, 42% in gas & flatulence.
Regarding associated symptoms 40% of the subjects were relieved of
difficulty in stool passage 54% in sense of incomplete evacuation, 62% in abdominal
pain/discomfort relieved with defecation, 62% in dyspepsia, 30% in heartburn and
8%nausea-vomiting. The mean difference between the percentage of people
reporting complaints before and after the study was 24.
T tests pointed to a score of 7.78 as opposed to the critical t table value of
1.833; hence the null hypothesis can be rejected (Statistical analysis attached in
Appendix-E) and the study was statistically found to be significant (P<0.05).
93
4.3 Suggestions:
 The effect of volatile oil of unripe fruit of stone apple on IBS can be studied.
 A Randomized double blind clinical study can be conducted to explore the effect of
Stone apple powder as a viable supplementation on IBS with a longer
supplementation period and a large study group to avoid bias.
 Since IBS is a complex disease involving psychological factors a multi-dimensional
approach using strict Dietary Modifications, Natural supplements and strong
psychological support can be made and studied on a large scale basis.
94
CHAPTER FIVE
CONCLUSION
5. Conclusion:
The results of the present study have brought to light the favorable effect Aegle
marmelos (Stone apple) powder intervention on combating the symptoms of Irritable
Bowel syndrome. But given the condition that IBS is chronic and recurrent disease, the
symptoms may relapse if the patient stops the medication, and the clinical picture may
vary depending on various parameters like the psychological status, diet and life style
patterns of the subjects, hence it is high time that a multi-dimensional approach using
natural supplements as a part of the treatment for a longer duration of time should be
developed.
As far as the present study is concerned, it can be concluded that Stone apple
powder supplementation has significant positive effect on combating the symptoms of
IBS and since it is completely safe as no adverse reactions were reported either in the
present or earlier studies it can be advocated on a regular basis for sustaining the effect
of the therapy for improving the quality of life of the patients suffering from IBS.
95
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100
APPENDICES
Appendix-A:
Questionnaire-A
ID.NO: Date:
a)Name: b)Age: c)Sex: ☐ M ☐ F
d)Religion: ☐ Hindu ☐ Muslim ☐Christian ☐Others
e)Marital Status: ☐Married☐ Unmarried☐ Widow☐ Divorce
f)Occupation: ☐Service ☐Business ☐Retired☐ Labour☐ Unemployed☐ House wife
g)Educational Status: ☐Uneducated ☐Primary☐ Secondary ☐Higher secondary ☐
Graduation
h)Habitat: ☐Rural☐ Urban
i)Socio economic status: ☐Poor☐ Lower☐ Middle ☐Upper middle ☐Upper
j) Diet: ☐Veg ☐Mixed
k) Exercise Habit: ☐Nil☐ Less frequent☐ Daily
l) Appetite: ☐Good ☐Moderate ☐Poor
m)Addiction: ☐Smoking ☐Alcohol ☐Panmasala ☐Tobacco☐Nil
n)Sleep: ☐Sound ☐Moderate ☐Disturbed
o)Menstrual & Obstetric History: ☐Regular menses ☐Irregular Menses ☐
Hysterectomy ☐Menopause ☐Infertility
101
p)Occupational History: ☐with occupation ☐without occupation
 Attitude towards Job☐ Satisfied ☐Unsatisfied
 Relation at Work place ☐Satisfied ☐Unsatisfied
q)Marital History: ☐Married☐Widowed☐ Divorcee ☐Unmarried
 Relation with Spouse ☐Satisfied ☐Unsatisfied
 Sexual life ☐Satisfied ☐Unsatisfied.
r)Family History: ☐nuclear ☐Joint ☐Illness of family member ☐Death of close
family members
 Relation with family members: ☐Satisfied ☐Unsatisfied
 Emotional make up of family members ☐Anxious ☐Tension ☐Depression
☐Irritable ☐Any mental disorder☐Nothing Specific
s)Social Situation:
 Housing: ☐Satisfied ☐Unsatisfied
 Social relation: ☐Satisfied ☐Unsatisfied
 Financial problem: ☐Yes ☐No
102
Appendix-B:
Questionnaire-B
Name: ID.NO:
Questionnaire-B: Tick the appropriate Boxes.

S.no. Complaint Degree
1 Abdominal pain/Discomfort ☐Nil
☐Mild
☐Moderate
☐Severe
2 Frequency of Diarrhoea or Constipation or ☐Grade 0 (2-3/day)
both
☐Grade I (3-6/day)
☐Grade II (7-10/day)
☐Grade III (10 or more)
3 Presence of mucous in stool ☐Nil
☐Mild
☐Moderate
☐Severe
4 Gas and Flatulence ☐Nil
☐Mild
☐Moderate
☐Severe
5 Associated Symptoms ☐Difficult stool passage
(Tick Multiple if applicable) ☐Sense of incomplete evacuation
☐Abd pain/discomfort relieved
with defeacation
☐Dyspepsia
☐Heartburn
☐Nausea/Vomiting
103
Appendix-C:
Depression Anxiety and Stress Scale (DASS):
The DASS is a 42-item questionnaire which includes three self-report scales designed to
measure the negative emotional states of depression, anxiety and stress. Each of the three
scales contains 14 items, divided into subscales of 2-5 items with similar content. The
Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation,
and lack of interest/involvement, anhedonia, and inertia. The Anxiety scale assesses
autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience
of anxious affect. The Stress scale (items) is sensitive to levels of chronic non-specific
arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated,
irritable/over-reactive and impatient. Respondents are asked to use 4-point
severity/frequency scales to rate the extent to which they have experienced each state
over the past week.
Scoring:
Scores of Depression, Anxiety and Stress are calculated by summing the scores for the
relevant items. The depression scale items are 3, 5, 10, 13, 16, 17, 21, 24, 26, 31, 34, 37,
38, and 42. The anxiety scale items are 2, 4, 7, 9, 15, 19, 20, 23, 25, 28, 30, 36, 40, and
41. The stress scale items are 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, and 39.
Depression Anxiety Stress
Normal 0–9 0-7 0 – 14
Mild 10 – 13 8–9 15 – 18
Moderate 14 – 20 10 – 14 19 – 25
Severe 21 – 27 15 – 19 26 – 33
Extremely 28+ 20+ 34 +
Severe
104
DASS Name: Id.NO:
Please read each statement and circle a number 0, 1, 2 or 3 which indicates how much
the statement applied to you over the past week. There are no right or wrong answers.
Do not spend too much time on any statement.
The rating scale is as follows:
0 Did not apply to me at all
1 Applied to me to some degree, or some of the time
2 Applied to me to a considerable degree, or a good part of time
3 Applied to me very much, or most of the time
1 I found myself getting upset by quite trivial things 0 1 2 3

2 I was aware of dryness of my mouth 0 1 2 3
3 I couldn't seem to experience any positive feeling at all 0 1 2 3
I experienced breathing difficulty (eg, excessively rapid
4 breathing, breathlessness in the absence of physical 0 1 2 3
exertion)
5 I just couldn't seem to get going 0 1 2 3
6 I tended to over-react to situations 0 1 2 3
7 I had a feeling of shakiness (eg, legs going to give way) 0 1 2 3
8 I found it difficult to relax 0 1 2 3
I found myself in situations that made me so anxious I
9 0 1 2 3
was
most relieved when they ended
10 I felt that I had nothing to look forward to 0 1 2 3
11 I found myself getting upset rather easily 0 1 2 3
12 I felt that I was using a lot of nervous energy 0 1 2 3
13 I felt sad and depressed 0 1 2 3
I found myself getting impatient when I was delayed in
14 0 1 2 3
any way (eg, lifts, traffic lights, being kept waiting)
15 I had a feeling of faintness 0 1 2 3
16 I felt that I had lost interest in just about everything 0 1 2 3
17 I felt I wasn't worth much as a person 0 1 2 3
18 I felt that I was rather touchy 0 1 2 3
I perspired noticeably (eg, hands sweaty) in the absence
19 0 1 2 3
of high temperatures or physical exertion
20 I felt scared without any good reason 0 1 2 3
21 I felt that life wasn't worthwhile 0 1 2 3
105
Reminder of rating scale:
0 Did not apply to me at all
1 Applied to me to some degree, or some of the time
2 Applied to me to a considerable degree, or a good part of time
3 Applied to me very much, or most of the time
22 I found it hard to wind down 0 1 2 3
23 I had difficulty in swallowing 0 1 2 3
24 I couldn't seem to get any enjoyment out of the things I did 0 1 2 3
I was aware of the action of my heart in the absence of physical

25 exertion (eg, sense of heart rate increase, heart 0 1 2 3
missing a beat)
26 I felt down-hearted and blue 0 1 2 3
27 I found that I was very irritable 0 1 2 3
28 I felt I was close to panic 0 1 2 3

29 I found it hard to calm down after something upset me 0 1 2 3
I feared that I would be "thrown" by some trivial but

30 0 1 2 3
unfamiliar task
31 I was unable to become enthusiastic about anything 0 1 2 3

32 I found it difficult to tolerate interruptions to what I was doing 0 1 2 3
33 I was in a state of nervous tension 0 1 2 3
34 I felt I was pretty worthless 0 1 2 3

I was intolerant of anything that kept me from getting on
35 0 1 2 3
with what I was doing
36 I felt terrified 0 1 2 3
37 I could see nothing in the future to be hopeful about 0 1 2 3
38 I felt that life was meaningless 0 1 2 3

39 I found myself getting agitated 0 1 2 3
I was worried about situations in which I might panic and

40 0 1 2 3
make a fool of myself
41 I experienced trembling (eg, in the hands) 0 1 2 3
42 I found it difficult to work up the initiative to do things 0 1 2 3
106
APPENDIX -D
DIET TIPS & FODMAPs Chart:
General Tips:
 Inculcate the habit of relaxed eating. Chew the food properly. Do not stuff your
mouth with big pieces of food. Instead, take small bites at a time.
 Drink at least eight glasses of water in a day. Water helps make the bowel
movement smooth.
 Limit your intake of beverages, like coffee and tea. Replace them with diluted
fresh fruit juice (without sugar).
 You may cut the in-between snacks, but never ever skip you meals.
 Reduce the amount of fat in your diet. Avoid eating burgers, pizzas, chocolates
and pastries. Substitute them with fibrous food.
 The gastrointestinal problem would aggravate due to smoking and excess
consumption of alcohol. Therefore, you should get rid of both the habits, if you
are suffering from IBS.
 Include fresh fruits and vegetables in your diet. However, you should stay away
from certain vegetables that aggravate the gastric problem. (See Fodmaps list
below).
107
High fibre foods:
 Legumes - beans. The bean family excels in fibre, especially the soluble,
cholesterol-lowering type.
 Whole Grains - wheat bran and oat bran are present in a variety of cereals and
breads.
 Whole Fresh Fruits - the valuable pectin fibre is found in the skin and pulp. Figs,
prunes and raspberries have the highest fibre content.
 Green Leafy Vegetables - lettuce, spinach, celery, and broccoli are good
examples.
 Root Vegetables - potatoes, turnips and carrots are all excellent sources.
 Since bran can cause rumbling intestinal gas and even some mild cramping, it
should be started in small amounts initially. The amount can be increased as
tolerance is acquired. The goal should be 20 to 35 grams of fibre a day, which
will usually produce 1 to 2 soft and formed stools a day.
108
FODMAPs are an acronym that stands for Fermentable Oligo-, Di- and Mono-
saccharides, and Polyols.
Include these foods in your daily diet on the basis of availability:
Foods suitable on a low-fodmap diet

Fruit Vegetables Grain Milk Other
foods products
Fruits: Vegetables: Cereals Milk Sweeteners
Banana Alfalfa Gluten-free Lactose-free
Blueberry Artichoke bread or cereal milk Sugar*
Boysenberry Bamboo products Oat milk* (sucrose),
Canteloupe Shoots Bread Rice milk Glucose,
Cranberry Bean Shoots 100% spelt Soy milk* Artificial
Durian Bok Choy bread *check for sweeteners
Grape Carrot Rice additives not ending
Grapefruit Celery Oats in „-ol‟
Honeydew Ginger Polenta Cheeses
Melon Green Beans Other Hard cheeses Honey
kiwifruit Lettuce Arrowroot Brie substitutes
Lemon Olives Millet Camembert Golden
Lime Parsnip Psyllium syrup*,
Mandarin Potato Quinoa Yoghurt Maple
Orange Pumpkin Sorgum Lactose-free syrup*,
Passionfruit Red Tapioca varieties Molasses,
Pawpaw Capsicum Treacle
Raspberry (Bell Ice-cream *small
Rockmelon Pepper) substitutes quantities
Star anise Silver Beet Gelati
Strawberry Spinach Sorbet
Tangelo Summer Squash
(Yellow) Butter
Note: if fruit Swede substitutes
is dried, eat Sweet Olive oil
in small Potato
quantities Taro
Tomato
Turnip
Yam
Zucchini
Herbs:
Basil
Chili
Coriander
Ginger
Lemongrass
Marjoram
Mint
Oregano
Parsley
Rosemary
Thyme
109
Avoid these foods to the possible extent:
Eliminate foods containing fodmaps

Excess Lactose Fructans Galactans Polyols
fructose
Fruits: Milk : Vegetables: Legumes Fruits:
Apple Milk from Asparagus Baked Apple
Mango cows, goats Beetroot beans Apricot
Chickpeas Avocado
Nashi or sheep, Broccoli
Kidney Blackberry
Pear Custard Brussels beans Cherry
Watermelon Ice cream, sprouts Lentils Lychee
Sweeteners: yoghurt Cabbage Nashi
Fructose Cheese Eggplant Nectarine
High Soft Fennel Peach
fructose corn unripened Garlic Pear
Plum
syrup cheeses eg. Leek
Prune
Large total Cottage, Okra Watermelon
fructose cream, Onion (all) Vegetables
dose: mascarpone, Shallots Cauliflower
Concentrated ricotta Spring onion Green
fruit sources Cereals : capsicum
Large serves Wheat and rye, (bell
pepper)
of fruit, dried in large
Mushroom
fruit, fruit amounts eg. Sweet corn
juice bread,
Honey : crackers, Sweeteners:
Corn cookies, Sorbitol
syrup couscous, pasta (420)
Mannitol
Fruisana Fruit :
(421)
Custard apple, Isomalt
Persimmon, (953)
Watermelon Maltitol
Miscellaneous : (965)
Xylitol
Chicory, (967)
Dandelion,
Inulin
110
APPENDIX-E:
Statistical Analysis:
i, Arithmetic Mean
x =  x i/ N
Where,
x = Arithmetic mean.
 x = Sum of all values of a variable.
N = Number of observations.
ii, Standard Deviation
2
S.D = (x-x)
n
Where,
S.D = Standard deviation.

2
(x-x) = Deviation of individual values from the mean.
x = Arithmetic mean.
N = Number of observation.
111
Test for Significance:
D= difference between the pairs of variables in the two samples.
∑d= sumo d between the pairs of variables in two samples.
(∑d2)=Square of each difference and sum of the squared value.
(∑d) 2= square of the total of the sum of all differences
N= number of samples
112

A Study On The Effect of Aegle Marmelos Intervention in IBS

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A study on the

Effect of Aegle Marmelos (Stone Apple)

Under the Guidance of

Dr.M.Ramadas Maganti MD. (AY)

A project report Submitted towards Partial Fulfilment of the Requirement of

PG Diploma in Nutrition and Dietetics

Meenakshi Mission Hospital and Research Centre

Dr. M.Ramadas Maganti MD (AY), Professor & HOD, Department of Kaya

Chikitsa (General Medicine), Sri Jayendra Saraswathi Ayurveda College and

Hospital, Chennai, for his guidance, invaluable suggestions, encouragement and

Director, School of Computer Applications, SSM college of Engeneering,

Komarapalayam, for his assistance with statistical analysis.

The researcher likes to acknowledge Prof. N. Chitra, Principal, Meenakshi

operation to participate in this study.

course of this study.

love and support throughout and ever.

Marmelos (Stone Apple) Powder intervention in Irritable Bowel Syndrome”

submitted by C.Tamil Selvam for the degree of PG Diploma In Nutrition and

such similar title.

Dr. M.RAMADAS MAGANTI MD (AY),

Professor & HOD,

Department of Kaya Chikitsa,

Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai

Madurai Kamaraj University, Madurai

This is to certify that the Project Report Titled

A study on the Effect of Aegle marmelos (Stone Apple) Powder

Under the Guidance of

Dr.M. Ramadas Maganti MD (AY)

Place: Madurai Principal

Madurai Kamaraj University, Madurai

This is to certify that the Project Report Titled

A study on the Effect of Aegle marmelos (Stone Apple) Powder

Under the Guidance of

Dr.M. Ramadas Maganti MD (AY)

S.no. Name Designation Signature Date

1.2 Background of the Study

1.3 Purpose and Objectives

1.4 Organization of the Paper

1.5.1 Research Design

1.5.2 Source of Data

1.5.3 Sample Size

1.5.4 Sampling Technique

1.5.5 Data Collection Method

1.5.6 Analysis of Data

1.6 Scope of the Study

2.1 Definitions and Meanings

2.2 Disease Review

2.3 Review of Irritable Bowel Syndrome

2.4 Drug Review

3.1 About the Region/Organization under Study

3.2 Duration of Study

3.3 Data collection Method

3.4 Experimental Methodology

3.5 Pre-study Analysis of Personal Data of the subjects

3.6 Pre-study analysis of Clinical data of the subjects

3.7 Post study analysis of Clinical Data

4.1 Comparative Analysis of Data

APPENDIX-D- Diet Tips & FODMAPs chart

APPENDIX-E- Statistical Analysis.

Table Title Page no.

1 The methodology of an experimental pre & posttest design 7

2 Biophysical model depicted by George Engel 13

3 Abnormal gut motor & sensory activity 21