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EFFECTIVENESS OF HOMOEOPATHIC DRUGS AS

COMPARED TO LIFESTYLE MANAGEMENT IN CASES OF


IRRITABLE BOWEL SYNDROME: A RANDOMIZED
CONTROL TRIAL
A dissertation to be submitted in partial fulfilment for the Award of the Degree
of
DOCTOR OF MEDICINE IN HOMOEOPATHY
PRACTICE OF MEDICINE
Of
DR. BHIM RAO AMBEDKAR UNIVERSITY, AGRA (U.P.)
At
BAKSON HOMEOPATHIC MEDICAL COLLEGE &
HOSPITAL
KNOWLEDGE PARK-1, GREATER NOIDA (U.P.)
By
Dr. Arunima Singh
Session: 2016-2019

Under The Guidance & Supervision Of


Prof. (Dr) Mini Arora, M.D. (HOM.)
PRACTICE OF MEDICINE
BAKSON HOMOEOPATHIC MEDICAL COLLEGE AND
HOSPITAL
Declaration

I hereby, declare that this dissertation titled ‗Effectiveness of homoeopathic


drugs as compared to lifestyle management in cases of irritable bowel
syndrome: A Randomized Control Trial‘ has not been submitted by any other
university for the award of any degree or diploma. Information derived from
published and unpublished works by others have been duly acknowledged in the
text.

Dr. Arunima Singh


Certificate
This is to certify that the dissertation entitled ‘Effectiveness of homoeopathic
drugs as compared to lifestyle management in cases of irritable bowel
syndrome: A Randomized Control Trial’ is a bonafied work of Dr. Arunima
Singh under the guidance of Dr. Mini Arora in partial fulfillment of regulation
of the award of Degree of Doctor of Medicine in Homoeopathy[M.D.(Hom.)]
in Practice of Medicine.

This work has been carried out under my guidance and supervision. I am
satisfied with the authenticity of the experiments, observations and
interpretation embodied in this dissertation.

The work is recommended to the Dr. B.R. Ambedkar University, Agra for the
award of the Degree of Doctor of Medicine in Homoeopathy [M.D.(Hom.)]
in Practice of Medicine.

Date:

Dr. C.P. Sharma


Principal
Bakson Homoeopathic Medical College,
Greater Noida. Uttar Pradesh
Certificate
This is to certify that the dissertation entitled ‘Effectiveness of homoeopathic
drugs as compared to lifestyle management in cases of irritable bowel
syndrome: A Randomized Control Trial’ is a bonafied work of Dr. Arunima
Singh under the guidance of Dr. Mini Arora in partial fulfillment of regulation
of the award of Degree of Doctor of Medicine in Homoeopathy[M.D.(Hom.)]
in Practice of Medicine.

This work has been carried out under my guidance and supervision. I am
satisfied with the authenticity of the experiments, observations and
interpretation embodied in this dissertation.

The work is recommended to the Dr. B.R. Ambedkar University, Agra for the
award of the Degree of Doctor of Medicine in Homoeopathy [M.D.(Hom.)]
in Practice of Medicine.

Date:

Dr. Mini Arora


M.D. (Hom.)
Professor (Department of Practice of Medicine)
Bakson Homoeopathic Medical College & Hospital
Greater Noida, Uttar Pradesh.
Certificate
This is to certify that the dissertation entitled ‘Effectiveness of homoeopathic
drugs as compared to lifestyle management in cases of irritable bowel
syndrome: A Randomized Control Trial’ is a bonafied work of Dr. Arunima
Singh under the guidance of Dr. Mini Arora in partial fulfillment of regulation
of the award of Degree of Doctor of Medicine in Homoeopathy[M.D.(Hom.)]
in Practice of Medicine.

This work has been carried out under my guidance and supervision. I am
satisfied with the authenticity of the experiments, observations and
interpretation embodied in this dissertation.

The work is recommended to the Dr. B.R. Ambedkar University, Agra for the
award of the Degree of Doctor of Medicine in Homoeopathy [M.D.(Hom.)]
in Practice of Medicine.

Date:

Dr. Rashmi Chowdhury


M.D. (Hom.)
(H.O.D) Department of Practice of Medicine
Bakson Homoeopathic Medical College & Hospital
Greater Noida, Uttar Pradesh
Dedicated
To
Dr. Jai Singh
My loving Father for his patience, faith and sincerity with which he
grew me up against all odds as a better human and for being a living
example of a staid and solemn physician working for welfare of the
sick and poor tirelessly.
Acknowledgements
I consider this as my privilege to thank Almighty God, who is responsible for
everything in my life, and I give him all the glory for what little positive attitude
and goodness that I might have today. I thank him for helping me to achieve this
task through the following persons who had been of immense help and a source
of encouragement in my endeavor. This study is a mere attempt in the vast
ocean of knowledge.

I am grateful to Dr. S.P.S. Bakshi, CMD Bakson Group for his blessing and
efforts for promotion of homoeopathy and upcoming Homoeopaths.

I would like to express my sincere and heartfelt gratitude for my respected


teacher and guide, who is an epitome of sincerity, punctuality and accuracy
Dr. Mini Arora M.D.(Hom.), for providing me expert guidance, advice, timely
support and encouragement throughout my course and during this dissertation
work. Without her guidance I would not have completed my study successfully.

It is my radiant sentiment to place on record my best regards to Dr. S.R.


Banerji, M.D.(Hom.) for helping with clinical data collection and Dr. Anuj
kr. Pandey TSU(Uttar Pradesh), for his help in statistical work, which were
very helpful for my study both theoretically and practically.

I perceive this opportunity as a big milestone in my career development I will


strive to use gained knowledge in the best possible way and I will continue to
work on the improvement , in order to attain desired career objectives.

Dr. Arunima Singh

Bakson Homoeopathic Medical College

Greater Noida, Uttar Pradesh


Table of Contents
1. Abstract ........................................................................................................................ 11

2. Introduction .......................................................................................................................... 1

3. Review of literature.............................................................................................................. 2

4. Aim & objective.................................................................................................................. 16

5. Materials and Methodology .............................................................................................. 17

6. Result................................................................................................................................... 26

7. Discussion............................................................................................................................ 31

8. Conclusion .......................................................................................................................... 32

References ............................................................................................................................... 33

APPENDICES ........................................................................................................................ 41

Case 1 ........................................................................................................ 45

Case-2 ........................................................................................................ 53

Diagnostic Criteria’s for Irritable Bowel Syndrome ........................................... 58

Master Chart .............................................................................................. 60


List of Figures

S.No Figures Page No.


1. Figure.3.1 Illustrating IBS conceptual model. IBS, 3
irritable bowel syndrome; CNS, central nervous
system; ENS, enteric nervous system.

2. Figure 3.2 Showing prevalence of IBS in India, 6

3. Fig: 5.1- Detailed description of type of study and 14


selection of treatment and control group for the
study

4. Fig.6.1 showing sociodemographic characteristic 21


of the study participant
5. Fig.6.2 Showing medical as well as past history of 22
study participants
6. Fig. 6.3 showing type of IBS cases identified 23
among both Cases and Controls
7. Fig. 6.4 showing final outcome of the trial 23
List of Tables

S.No. Tables Page No.


1. Table.6.1 Distribution of data for occupation 24
was found to be statistically significant and
fits with the expected outcome variable.

2. Table.6.2 Distribution within cases and 25


controls
1. Abstract

Background- Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to
decreased health-related quality of life and work productivity. Evidence-based treatment
guidelines have not been able to give guidance on the effects of homeopathic treatment for
IBS because no such studies have been carried out to assess the effectiveness of homeopathic
treatment alone for IBS. Two categories .i.e., homoeopathic drug intervention and lifestyle
management were evaluated in this study. In clinical homeopathy a specific remedy is
prescribed for a specific condition. This differs from individualised homeopathic treatment,
where a homeopathic remedy based on a person‘s individual symptoms is prescribed after a
detailed consultation.

Method- This study was planned to understand effectiveness of homoeopathic medicine


over life style modification advice to the patients. Looking at the prevalence of disease and
patient burden, a total of 100 patients was included in the study purposively. So, a total of 50
patient following inclusion and exclusion criteria were given the treatment i.e. taken as Cases
whereas 50 patients were selected randomly were given Placebo with advice on life style
management. All patients with a diagnosis of IBS were eligible for inclusion in this study
regardless of age, gender, race, educational status or duration of IBS.

Result- A descriptive analysis of the overall outcome of the study showed that half of the
(50%) of the cases showed improvement in the condition of their lines who have been given
medicine on the basis of totality of symptom with no advice on life style management but
only one- fourth (38%) of the controls who have been given advice on life style management
as well as placebo prescription showed improvement in their condition which could be other
confounding factors. Half of the controls (46%) have showed a Status quo condition which
could be interpreted as a need of medication for the patients to get relief in their condition.

Conclusion- The analysis of this study found a statistically significant benefit favouring
the homeopathic remedy over lifestyle management. However, these results should be
interpreted with caution due to the low quality of reporting in these studies, a high or
unknown risk of bias and sparse data. Thus it is not possible to be certain whether or not the
trials were able to distinguish between true treatment effects, chance or bias. Furthermore, the
low quality of reporting practice means that it is difficult to assess whether the results would
be replicated in everyday practice, that is, whether the results are externally valid or
generalisable. The low quality of the reporting means that it is not possible to determine
whether or not results are a true reflection of the treatment effect.
2. Introduction

Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal (GI) disorder


characterised by abdominal pain or discomfort and altered bowel habits. The aetiology of IBS
is multi factorial with altered visceral sensitivity, altered gastrointestinal motility, and
psychosocial factors influencing symptom generation. The prevalence of IBS varies
worldwide, affecting 3 to 25% of the population. They make more health care visits. Work
absenteeism due to IBS symptoms is as frequent as that of common cold. Direct and indirect
costs of IBS incur considerable societal economic burden. The definition and diagnostic
criteria of IBS has changed over time. In 1978 Manning et al. presented the first symptom
based criteria for IBS, widely applied later in epidemiological research. In 1989, the Rome
criteria were introduced and later modified as Rome I, Rome II, and Rome III criteria. The
wide variation in the prevalence of IBS may reflect true differences between various
populations and countries. Differences in IBS definitions and study methodologies, however,
hamper reliable comparison between previous studies. The main aim of this thesis was to
assess whether homoeopathy is sufficient enough to relieve cases of IBS as compared to
lifestyle management.

In clinical practice, once a diagnosis of Irritable bowel syndrome has been made, it usually
requires no revision despite prolonged follow up. Usually Irritable bowel syndrome is a
relapsing disorder. The presence of excessive pathological distress or anxiety, as well as a
long duration of complaints, tends to indicate a poorer prognosis. Conventional medical care
for Irritable bowel syndrome has focused on diet and lifestyle management (e.g. exercise and
stress reduction), behavioral treatments, and a range of pharmacological approaches,
particularly antispasmodics. Pharmacological therapies, which often bear significant costs
and side effects, may relieve symptoms temporarily but seldom correct underlying causes.
Hence the present study of a clinical study of Irritable bowel syndrome and its homoeopathic
management is undertaken.

1
3. Review of literature

In medical literature, a description of IBS-type symptoms can be found as early as 18201.The


symptoms included ―occasional pain in the intestines and derangement of their powers of
digestion, with flatulence, and a sense of suffocation‖. Since that, these symptoms have been
given names such as ―spasmodic stricture of the colon‖2, ―mucous colitis‖3, ―neurogenic
mucous colitis‖4, ―colonic spasm‖5, and ―irritable colon syndrome‖6. Nowadays, IBS is
defined as ―a functional bowel disorder in which abdominal pain or discomfort is associated
with defecation or a change in bowel habit, and with features of disordered defecation‖7. The
term ―functional‖ refers to absence of any organic disease, or structural or biochemical
abnormality causing the symptoms. Abdominal pain or discomfort relieved by defecation
indicates a possible colonic source, and appearance of pain associated with a change in bowel
habits is indicative of a change in intestinal transit time, which may be a result of a change in
intestinal motor or secretory function8. Symptoms of IBS follow a chronic relapsing course.

3.1 Pathogenesis-

The pathogenesis of IBS is not fully understood. Abnormal motor function, visceral
hypersensitivity, abnormal central nervous processing of visceral stimuli, gastrointestinal
infections, subtle inflammation, psychosocial factors, abnormal gas handling, alterations in
gut microflora, and genetic factors are possible agents involved in the pathogenesis of
symptoms in IBS9.

The enteric nervous system (ENS) is a neural network coating the GI tract. Together with the
sympathetic and parasympathetic system it forms the autonomic nervous system. The ENS
integrates the contraction of smooth muscles, intestinal transport of water and electrolytes,
intestinal secretion, and intramural blood flow. It contains sensory and motor neurons,
interneurons and several neurotransmitters. It functions semi autonomously, receiving input
from the motor outflow of the sympathetic and parasympathetic systems and sending sensory
information to the central nervous system (CNS)10,11.
According to a biopsychological conceptualisation, the brain-gut interaction between
psychosocial and physiological factors influence GI symptom generation and outcome in
terms of perceived symptom severity and medical care seeking12.

2
Figure.3.1 Illustrating IBS conceptual model. IBS, irritable bowel syndrome; CNS,
central nervous system; ENS, enteric nervous system.

IBS patients have a lower visceral pain threshold for both mechanical distension13,14 and
electrical stimuli15,16 than controls, suggesting that primary afferent neurones (PAN) of the
enteric nervous system are hypersensitive to non-noxius stimuli30. Some studies indicate that
they also have cutaneous hyperalgesia17,18,19.

Depression, anxiety, psychological distress, and stressful life events are more common
among subjects with unexplained medical symptoms and increased use of healthcare
services20. Regardless of healthcare seeking status, an association between IBS and
psychiatric distress has been established21-23. In addition, over-representation of physical or
sexual abuse has been reported in IBS patients24-28. Psychiatric disorders, especially anxiety,
may precede the occurrence of GI symptoms and thus have a pathogenetic role in the
development of IBS, with a link to affective spectrum disorders29-30.
Infectious gastroenteritis precedes the onset of IBS in 6 to 17% of IBS patients48. The
relative risk of developing IBS after infection increases 10 to 12 times compared to
31-32
uninfected controls . An increased number of mucosal lymphocytes, EC cells, higher
levels of pro-inflammatory cytokines, and increased gut permeability are associated with post
32-34
infective IBS . In addition, regardless of a history of gastroenteritis, neuronal
degeneration in the jejunal myenteric plexus has been detected35, as well as activation of the
mucosal immune system, especially in IBS-D36,37. Inflammatory changes in IBS and
functional dyspepsia have even been reported in duodenal mucosa38. A recent study found

3
elevated levels, similar to those in active ulcerative colitis, of faecal human β-defensin-2 in
IBS-D and mixed IBS (IBS-M) patients compared to healthy controls, supporting an
activation of the mucosal innate defence system39. IBS patients also have an increased
frequency of activated T and B cells in their blood, consistent with a low grade
inflammation40,41. One study reported a correlation between the severity of abdominal pain
and activated mast cells in close proximity to mucosal nerve endings, suggestive of a
peripheral mechanism of pain42. Moreover, IBS-D patients have displayed enhanced pro-
inflammatory cytokine release associated with GI symptoms and anxiety43. Abdominal
bloating, reported by up to 96% of IBS patients, is often the most bothersome symptom44.
IBS patients have shown impaired gas transit, without signs of excess intra-abdominal gas.
Bloating alone is associated with visceral hypersensitivity, while patients with bloating and
an increase in girth have normal sensory thresholds suggesting different pathogenetic
mechanisms of the symptoms45. Bloating alone is reported more in IBS-D, while bloating
with an increment in abdominal girth in IBS with constipation (IBS-C)8. Microbial genome
analysis has revealed differences in the intestinal microbiota between IBS patients and
healthy controls as well as between IBS subgroups, suggesting that intestinal bacteria also
play a role in IBS development30,46.
Genetic factors may influence development of IBS. Subjects who have a family member with
GI symptoms are at a more than twofold risk of IBS-type symptoms, but having a spouse
with these symptoms does not increase the risk47. Genetics appear to have a role in functional
bowel disorders, since a concordance of 33% between monozygotic twins and 13% between
dizygotic twins has been reported, referring to a 57% share for genetics and 43% for
environmental factors in a model by Morris-Yates et al.

Food intolerance including lactose malabsorption and IBS


In recent years, dietary fermentable oligo, di, monosaccharide, and polyols (FODMAP) have
been incriminated in contributing to the symptoms of IBS89. However, studies on dietary
FODMAP in the pathogenesis of IBS symptoms and their exclusion in its treatment have
been scant from India, Bangladesh and Malaysia, except for lactose as an isolated FODMAP.
In a multi-centric Indian study, self-reported milk intolerance was present among 32% of
2785 subjects with lower GI symptoms. Patients with IBS-D reported milk intolerance more
often than those with IBS-C90. In a rural community-based study in Bangladesh, a regular
dairy intake was present in 61.7% of 2542 subjects, but 13.8% reported milk intolerance.

4
Among 593 subjects with IBS, 12.6% reported milk intolerance and they showed a higher
frequency of frequent bowel motion and loose or watery stool 91.

However, the diagnostic accuracy of self-reported milk intolerance to diagnose lactose


malabsorption was reported as having a sensitivity, specificity, positive predictive value and
negative predictive value of 53%, 61%, 26% and 55%, respectively, in a case-control study in
India among 112 IBS patients and 53 healthy controls92. In the same study, the frequency of
lactose malabsorption diagnosed either by LHBT or lactose tolerance test was similar among
IBS (82%) and healthy controls (77%). Nevertheless, symptoms of lactose intolerance were
more frequent among IBS (55%) compared to healthy subjects (34%). In an Indian study, the
researchers demonstrated that lactose malabsorption diagnosed using 25-g lactose dose is
clinically more meaningful than that diagnosed using the conventional 50-g lactose dose,
which is quite a non-physiological dose; in fact, lactose malabsorption diagnosed using 25-g
lactose dose was associated with 10 times higher rate of clinical improvement following milk
withdrawal than that diagnosed using 50-g dose93.

More recently, investigators were able to demonstrate a similar frequency of C/T -13910 and
G/A-22018 lactase gene polymorphism between Indian IBS patients and healthy controls94.
These studies indicate that the prevalence of lactose malabsorption is high in South Asians,
with no difference between IBS and non-IBS adults. However, the clinical consequences of
lactose malabsorption are likely to be exaggerated in patients with IBS who often have
underlying abnormalities in motility and visceral sensation and a reduced pain threshold.

3.2 IBS Subtypes

IBS with constipation (IBS-C), stools are usually hard or lumpy, and bowel movement
frequency is less than three per week. Straining during a bowel movement is common. In IBS
with diarrhoea (IBS-D), stools are usually loose, mushy, or watery and bowel movements
take place more than three times a day. In addition, urgency (having to rush to bathroom) is a
common phenomenon. Mixed IBS (IBS-M) applies to subjects expressing both constipation
and diarrhoea variably, for at least 25% of the bowel movements.7IBS can be divided into
three subtypes according to predominant bowel habit.

3.3 Diagnostic Criteria


Diagnostic tests are performed to rule out organic diseases that may produce similar
symptoms to IBS. Negative exclusion diagnosis by means of endoscopic, radiographic, and

5
laboratory investigations is, however, costly and inconvenient for the patient. In order to turn
IBS diagnosis into a positive symptom based diagnosis, Manning et al. introduced the first
symptom-based diagnostic criteria for IBS in 1978 . The more of the six symptoms present,
the more accurately patients with IBS were discriminated from those with organic disease.
Three of the six symptoms were pain related. In their study, 31 of the 32 outpatients with IBS
had abdominal pain, but no information of the duration or frequency was given48. Two of the
six symptoms were present in 94% of patients with IBS and 45% in patients with organic
disease; the sensitivity was 94% and specificity 55%. Three or more criteria had a sensitivity
of 84% and specificity of 76%73. In epidemiological studies, the required number of
Manning symptoms to fulfil IBS criteria has usually been two or three49-50. For population
studies, a cut off of two Manning symptoms have been suggested, because of a lower
prevalence of organic diseases in the general population than among outpatients51.
In 1989, a multinational committee of clinical-investigators published first Rome criteria for
IBS diagnosis52, originally presented at the Thirteenth International Congress of
Gastroenterology held in Rome in 1988. IBS was defined as ―a functional gastrointestinal
disorder attributed to the intestines and associated with symptoms of: (a) abdominal pain,
and/or (b) disturbed defecation, and/or (c) bloatedness or distension‖53. Later, presence of
abdominal pain was suggested as a requirement for the diagnosis, but the decision to do so
was left to the investigator54. Terms such as spastic colon or irritable colon were no longer
recommended. These criteria were revised later and published as the Rome I criteria55 . The
main change from the 1989 criteria was the requirement of abdominal pain for IBS diagnosis.
Rome I criteria consisted of abdominal pain related symptoms and non-pain related
symptoms, later named the IBS supporting symptoms . The Rome I criteria were again
revised, and the Rome II criteria published in 1999 by a Working Team56. The Rome II
criteria were a committee consensus based on research results and expert opinion. The
development process included reviewing and commenting by international experts. In the
Rome II criteria, the second part, i.e. non-pain related symptoms of the Rome I criteria was
deleted, due to poor clustering of these symptoms in factor analyses57,58, their lower
prevalence among males59, and their partial inclusion in the first, pain-related part of Rome I
criteria. In addition, ―discomfort‖ was added to ―pain‖, and symptom duration was extended
from three months to 12 months, with abdominal pain or discomfort present for at least 12
weeks (not necessarily consecutive weeks)
Rome I and Rome II criteria have been developed for both clinical practise and research
purposes, such as epidemiological surveys, pathophysiology research, and therapeutic trials.

6
In 2006, the Rome II criteria were again revised employing a consensus approach, leading up
to publication of the Rome III criteria by the Rome Working Team60. The main change
concerned the time perspective: the diagnostic criteria must be fulfilled for the last three
months instead of 12 months. In addition, symptoms had to have begun at least 6 months
before clinical presentation addressing the chronic nature of symptoms. Despite of wide use
of the Rome criteria in research, their accuracy has received little study. For Rome I criteria,
the sensitivity for detecting IBS was 85% and specificity 71% in a study of 602 patients 61. In
a retrospective study, Rome I criteria had a sensitivity of 65% and specificity of 100%, and
positive predictive value of 100% in the absence of alarm signs62

3.4 Epidemiology

Prevalence-
The incidence of IBS shows a substantial variation ranging between 2 to 70 per 1 000 patient
years63-64. In Western countries, the prevalence of IBS ranges between 3 and 25% of the
population65,66,67. In non-Western countries, both lower prevalence estimates68-71, and similar
rates to Western countries have been reported72.
The prevalence of IBS in India is approximately 4.2%9. There is a perception that IBS is less
of a problem in Asia and its epidemiology to be different. The wide variation in the
prevalence of IBS may reflect true differences between various populations and countries.

Sample Male/female
Ref. Study site Study type Criteria Prevalence
size ratio

Mumbai,
Shah et India Community/healthy
2549 Manning 7.5% 1/0.87
al[9] subjects
Urban

Ghoshal et Multiple
4500 Community Clinical 4.2% 1/0.93
al[10] sites, India

Makharia et Haryana,
4767 Community Rome III 4% 1/1.5
al[11] India

Uttar
Ghoshal et Pradesh,
2876 Community Rome III 6.8% 1/1.09
al[12] India,
rural

7
Figure 3.2 Showing prevalence of IBS in India, [Rahman MM, Mahadeva S, Ghoshal
UC. Epidemiological and clinical perspectives on irritable bowel syndrome in India, Bangladesh and
Malaysia: A review. World J Gastroenterol 2017; 23(37): 6788-6801]

3.5 Comorbidity in IBS


About half of the IBS patients in primary care have at least one comorbid somatic symptom,
and up to 94% of them have a comorbid psychiatric disorder73.The most frequently reported
symptoms include fibromyalgia, headache, back pain, chronic pelvic pain,
temporomandibular joint pain,, dyspareunia, heart palpitation, depression, anxiety, chronic
fatigue syndrome, and somatoformic disorders. Most studies assessing comorbidity in IBS
have been carried out in clinical settings, i.e. among health care users. In a population based
study, IBS non-consulters have also demonstrated higher rates of psychiatric and somatic
comorbidities than population controls74. Similarities occur in the demographic distributions
and psychological profiles among IBS and many comorbid conditions, suggesting a possible
common underlying pathophysiologic mechanism or a common underlying disorder with
different manifestations, but the evidence of such factors is still missing75.

3.6 Psychiatric comorbidity


Depression and anxiety are common societal conditions. In a pan-European study, a 6-month
prevalence rate for depressive disorders was 17%76. In the US, the life-time prevalence of
major depression was 17% in the general population, and 25% had suffered an anxiety
disorder77 In the WHO Collaborative Study, primary health care patients with anxiety
disorders were nine times more likely to develop depression than those with no other illness.
Compared to patients with two or more chronic medical conditions, those with anxiety were
six times more likely to develop depression. In addition, 39% of patients with depression also
had an anxiety disorder, and 44% of those with an anxiety disorder also had depression78.
Patients with depression often present with overlapping somatic symptoms typically
including medically unexplained pain39. Almost 30% of patients with depression also meet
the criteria of IBS79-80. Patients with depression, or anxiety, use more healthcare services than
those without.
Amongst high utilizers of primary healthcare, 24% suffer from major depression, 33% have a
lifetime history of depression, and 40% generalised anxiety disorder. In total, 83% of the high
utilizers have psychiatric condition, including panic disorder, at some time in their lives.

8
3.7 Somatic comorbidity

Almost half of the IBS patients also manifest other GI disorders, such as functional dyspepsia
(FD), GERD, functional constipation, and anal incontinence83. The separation of IBS, FD,
and reflux has been criticised because of the poor clustering of these disorders in factor
analyses and a strong tendency of subjects in epidemiological studies to flux between IBS,
FD, reflux, and unspecified GI symptoms.. A possible common underlying mechanism or
unspecific responses to patho-physiological and psychological disturbances have been
proposed to explain the variety of functional GI symptoms. Up to 87% of the subjects with
IBS also have FD84. Among IBS patients in a tertiary referral centre, IBS-C shows a higher
rate of comorbidity with FD than other subtypes 85. Co-occurrence of IBS and FD in primary
care has been reported to increase referrals to secondary care85. GERD is a common symptom
occurring in about 20% of subjects in the general population. IBS shows a substantial co-
occurrence with GERD, as approximately 40% of IBS healthcare seekers also have
symptoms of GERD86. Anal incontinence following first vaginal delivery has more frequently
been reported (64%) in women with IBS compared to 10% without87, possibly related to
rectal hypersensitivity and hypocompliance, especially in IBS-D88. IBS has also been
associated with a higher rate of abdominal surgery, especially subjects with psychiatric
comorbidity. For example, cholecystectomy rates for IBS patients are three times as high as
those for matched controls13

3.8 Homoeopathic Understanding of Irritable Bowel Syndrome


A good patient-physician relationship is important for satisfactory treatment. The strength of
the physician-patient relationship is inversely proportionate to the number of physician visits;
a positive interaction between the physician and the patient has been associated with a
reduced use of healthcare services. Providing a diagnosis for the patient with an explanation
of the benign nature of the symptoms will reduce fear of a malignant disease, help him or her
to cope with the symptoms, and may even reduce the need for pharmacological treatment.
Factors worsening or triggering the symptoms, such as psychosocial stress or diet should be
reviewed. In primary care, patients often attribute their symptoms to stress, but in secondary
care are more likely to have psychiatric comorbidity, and consider stress unimportant for
symptoms. Patients seem to expect more benefit from advice for diet, lifestyle, and exercise
than from drugs. A total of 60 to 70% of subjects with IBS associate their GI symptoms with
food sensitivity. Dietary triggers reported to exacerbate IBS symptoms include caffeine,

9
lactose, alcohol, fatty food, wheat, corn, citrus, food rich in carbohydrates, and hot spices.
Especially caffeine and lactose may exacerbate symptoms among subjects with IBS-D. A
poor correlation, however, exists between reported lactose intolerance and a true lactose
malabsorption. In addition, lactose restriction among subjects with IBS, reporting symptom
exacerbation after lactose ingestion, does not necessarily improve GI symptoms.
Increasing dietary fibre is generally recommended, though proof of efficacy of symptom
alleviation is limited. Fibre products accelerate stool transit, and they are effective for treating
constipation in IBS, but not pain or diarrhoea. Moreover, insoluble fibre, such as wheat bran
can even worsen symptoms such as abdominal bloating and flatulence. For global symptom
relief in IBS, soluble ispaghula husk seems to increase the rate of adequate relief and alleviate
symptom severity, but insoluble fibre is no more effective than placebo.
In healthy condition of the man the spiritual vital force (autocracy) ,the dynamis that
animates the material body (organism), rules with unbounded sway and retains all the parts of
the organisms in admirable , harmonious ,vital operation , as regards both sensation , and
function so that our in dwelling reason gifted mind can freely employ this living healthy
instrument for higher purpose of our existence.

3.8.1 According To B.K.Sarkar:


Normally life maintains its integrity, which we call health by steadily opposing and within
borders of the organism, reversing the process of outer nature. Whenever these forces of outer
nature are insufficiently opposed by our interior, pathology result.

Disease conditions are produced under following circumstances.

1) An external invading factor of increased strength, may unconditionally over-ride the


body‘s resistance exogenous origin of illness.

2) One or several specific resistance factor is weakened there by allowing for invasion of the
outer infective agent, exogenous in balance with endogenous aetiology.

3) Any function of our system of itself, may be altered in such away as to become similar
instead of opposed to any of the outer inimical processes, thus it spontaneously would create
enclave as it were of a morbid functioning endogenous origin of illness.

10
3.8.2 According To Stuart Close:
Cure from homoeopathic point of view consists in the speedy gentle and permanent
restoration of health or alleviation and obliteration of the disease, in its entire extent shortest
most reliable and safest manner, according to clearly intelligible reasons or principles.

In Homoeopathy, only totality of symptoms of Individual state of each particular patient is


used to cure the disease. So no real cure of miasm can take place without strict particular
treatment (individualization) of each case of disease. Chronic miasms are much hidden and
the symptoms all much more difficult to be ascertained. Lot of questions need to be asked to
trace the picture of diseased i.e. questions about the medical history of one‘s family, mental
delusions, dreams and peculiar symptoms.

3.8.3 According To Dr. Hahnemann:


With the great conscientiousness which should be shown in the restoration of a human life
endangered by sickness more than in anything else, the Homoeopath, if he would act in a
manner worthy of his calling, should investigate first the whole state of the patient, the
internal cause as far a it is remembered, and the cause of the continuance of the ailment, his
mode of life, his quality as to mind, soul and body, together with all his symptoms (see
directions in Organon), and then he should carefully find out in the work on Chronic Diseases
as well as in the work on Materia Medica Pura a remedy covering in similarly, as far as
possible, all the moments, or at least the most striking and peculiar ones, with its own
peculiar symptoms ;and for this purpose he should not be satisfied with any of the existing
repertories, a carelessness only too frequent; for the books are only intended to give light
hints as to one or another remedy that might be selected, but they can never dispense him
from making the research at the first fountain heads.

3.9 Review Methods-


The primary objective of this review was to look for studies in India, low and middle income
countries and various other developing as well as developed countries. Literature from
PubMed and Google scholar were searched by using keywords like, ―homoeopathic
researches on IBS‖, ―lifestyle management in cases of IBS‖, ―Role of homoeopathy in IBS‖,
―Comorbidity in cases of IBS‖, ―prevalence of IBS in India‖, ―Efficacy of homoeopathic
drugs in cases of Irritable bowel syndrome‖, ―stress and irritable bowel syndrome‖. These
articles comprised of quantitative, qualitative as well as mixed method studies. A total of 20
articles were reviewed as part of this study.

11
3.9.1 Why it is important to do this review

Lower gastrointestinal tract disorders account for one in 20 of all general practice
consultations in the India. In addition, gastroenterology problems are the fourth most
common referral to National Health Service (NHS) homeopathic hospitals and one of the
eight most common conditions treated by NHS homeopaths in general practice. People with
IBS are also more likely to use alternative medicine than people with upper gastrointestinal
disorders or Crohn‘s disease. The frequency with which people with IBS consult homeopaths
may be some indication of the value which they place on the homeopathic approach.
Homeopathic treatment may offer a treatment strategy for patients with IBS, but at present it
is not clear if it offers any benefit.

3.9.2. Findings from articles-


It was observed that out of 20 articles, 4 were randomized control trials, 3 observational and 2
pilot studies and rest reviewed articles, 1 was mixed method study. Differences in IBS
definitions and study methodologies, however, hamper reliable comparison between previous
studies During the analysis, it was very noteworthy, that every study that was conducted was
either going on or failed to achieve the expected result, while most works which were
conducted in India only concentrated upon efficacy of homoeopathic drugs in relieving the
symptoms of IBS.

 A protocol for a trial of homoeopathic treatment for Irritable bowel


syndrome. By Emily J Peckham, Clare Relton, Jackie Raw, Clare
Walters, Kate Thomas and Christine Smith.2012

A three armed trial was conducted in this study that compared usual care,
homoeopathic treatment plus usual care and supportive listening plus usual
care. The primary outcome was change in Irritable bowel symptom severity
score between baseline 26 weeks, but, there was no significant statistical
difference found in between three arms.

12
 Homoeopathy for treatment of Irritable Bowel Syndrome. By Peckham
EJ, et al. Cochrane database Syst Rev. 2013.

No conclusion can be drawn from this study due to the low number of
participants and the high risk of bias in this trial. In addition, it is likely that
usual care has changed since this trial was conducted. Further high quality
RCTs are required to assess the efficacy and safety of clinical and
individualised homoeopathy compared to placebo or usual care.

 A clinical study on irritable bowel syndrome and its homoeopathic


management. By Dr. Anjum E.C.
This study hasn‘t mentioned any statistical reference, also, this study has not
specified the intervention, sample analysis and collection etc. hence it doesn‘t
provide much help in the dissertation work.

 The role of diet in Irritable Bowel Syndrome with special reference to Gut
Neuro-endocrine system. By Tarek Ramzi Elia Mazzawi.

The main limitation of this study is the low number of patient cohort studied
and the hazard of selecting a sample of patient that does not present the IBS
patient population. There was no significant difference between the patient
who completed the study and those who did not regarding the age, gender,
symptom and quality of life. Thus, a bias sample selection is highly
improbable.

 A cognitive approach to irritable bowel syndrome. By Sarah Chapman.

Within this thesis the role of cognitive processes in irritable bowel syndrome
is examined. A systematic review and meta-analysis of the rate of the rate of
psychiatric comorbidity in IBS participants, relative to controls, was
performed.

13
3.10. Prevalence-
The prevalence of IBS in India is approximately 4.2%9. There is a perception that IBS is less
of a problem in Asia and its epidemiology to be different. The wide variation in the
prevalence of IBS may reflect true differences between various populations and countries
Approximately 3% to 20% prevalence is reported but it varied according to the criteria for the
diagnosis used. Younger people have a higher prevalence of Irritable bowel syndrome in the
community. Generally, it is believed that Irritable bowel syndrome is uncommon in the
elderly, but population based studies indicate Irritable bowel syndrome increases with
advancing age.

3.11. Gender-
The gender specific prevalence rates are approximately two female to one male in most
studies, and all population based studies reported a female predominance. Healthy women
have greater rectal sensitivity, slower colonic transit, and smaller stool outputs than men,
which may explain why certain symptoms such as straining and passage of hard stools, seem
to be more common in women. Prevalence of Irritable bowel syndrome is generally is similar
in whites and blacks.

3.12. Factors affecting the study in India-


India is a developing nation with variety of medical practices like ayurveda, yoga, unani,
siddha, allopathy, homoeopathy and naturopathy. In India, 5% of its population still lives
extremely below official poverty line. The health care systems are occupied in spreading
awareness about diseases- epidemic, with gross pathology, deficiency diseases and
implementation of proper healthcare. The area of lifestyle disorders has not yet been much
focused upon, whilst the number of lifestyle disorders is increasing gradually. Irritable Bowel
syndrome being one of them has been most ignored condition.
Depression, anxiety, psychological distress, and stressful life events were common among
subjects with unexplained medical symptoms and increased use of healthcare services.
Regardless of healthcare seeking status, an association between IBS and psychiatric distress
has been established. Psychiatric disorders, especially anxiety, may precede the occurrence of
GI symptoms and thus have a pathogenetic role in the development of IBS, with a link to
affective sprectrum disorders.

14
The main aim of this thesis was to assess the prevalence of IBS according to varying
diagnostic criteria in a randomly selected population sample and to compare efficacy of
homoeopathic drugs in eliminating symptoms of IBS without any other lifestyle management
or any cognitive therapies, symptom characteristics, and health care use between subjects
meeting varying IBS criteria and a control population.

3.13. Direct costs


In a review of US and UK studies about the economic impact of IBS, direct annual costs
ranged widely between $348 to $8750 per subject. Comparison between studies is difficult
because of calculation differences for mean costs per subject. Some authors include only
those with non zero charges (i.e. healthcare users), others divide total costs by all participants
even including non-healthcare users. In addition, some only report GI related costs, while
others include all costs irrespective of a particular diagnosis. Different healthcare systems
may also impede comparison. In a comparison between the UK and US, however, the use of
healthcare facilities was largely similar despite differences in healthcare funding.
Hospital inpatient costs for IBS have shown a wide variation between studies. Some studies
report equal costs for IBS and control groups, some higher for IBS, others lower for IBS
group. The share of hospital inpatient costs have ranged between 7 and 70% of direct IBS
costs. Diagnostic testing in IBS is performed to seek or rule out possible organic disease
causing GI symptoms. In the US, almost one quarter of colonoscopies performed on patients
under age 50, are for IBS symptoms. A linear relationship has been detected between levels
of somatisation and the amount of diagnostic testing for GI symptoms in IBS patients. In a
retrospective cohort analysis, colonoscopy or barium enema had been performed on 47% of
patients with IBS.

15
4. Aim & objective

AIM- To study the effect of homoeopathic drugs in cases of Irritable Bowel


Syndrome as compared to life style management.

OBJECTIVE- To study the effectiveness of homoeopathic drugs in cases of


irritable bowel syndrome without any other mode of management.

16
5. Materials and Methodology
Overview Of Study Design
With increasing initiatives to improve the effectiveness and safety of patient care, there is a
growing emphasis on evidence-based medicine and incorporation of high-quality evidence
into clinical practice. Randomised Controlled trails (RCTs) are the gold standard for
evaluating the effectiveness of an intervention. So, this study was planned to understand
effectiveness of homoeopathic medicine over life style modification advice to the patients.

Study Duration-
This study was completed in a duration of 2 years, from January 2017-January 2019

Study Setting-
All the patients who visited Bakson Homoeopathic medical college OPD as well as IPD, who
had followed the inclusion criteria were included in the study.

Sample Size
Looking at the prevalence of disease and patient burden, a total of 100 patients was included
in the study purposively. So, a total of 50 patient following inclusion and exclusion criteria
were given the treatment i.e. taken as Cases whereas 50 patients were selected randomly were
given Placebo with advice on life style management

Sampling Technique-
Simple randomization scheme was adopted for allocating patients with treatment and on the
other side with life style modification advice and prescription of placebo.

Sample population- General OPD


Patients
Patients identified with IBS
following the inclusion and
exclusion criteria

Every alternate patient with IBS


following Inclusion and exclusion
criteria was given treatment and
other was control group as
mentioned

17
Treatment group (n=50) Control group (n=50)
Fig: 5.1- Detailed description of type of study and selection of treatment and control group
for the study
This technique is followed to make study more robust as this will minimise the selection bias
and to assess the real effect of medication over control group. The most straightforward
scheme for allocating patients is simple randomization , with treatment assigned using one of
the methods mentioned previously (eg, computer-generated random sequence). Simple
randomization can result, by chance alone, in unequal numbers in each group—the smaller
the sample size, the larger the likelihood of a major imbalance in the number of patients or
the baseline characteristics in each group. An example of simple randomization would be the
sequence of 20 random numbers generated using a computer program .

Study Population-
All patients with a diagnosis of IBS were eligible for inclusion in this study regardless of age,
gender, race, educational status or duration of IBS. Trials which included IBS patients in
whom 10% or more had unstable psychiatric disorders, ulcerative colitis, Crohn‘s disease,
bowel cancer and pregnant and breastfeeding women were excluded from this study.

Inclusion Criteria-
1. Patients of all age group and both the sexes.

2. Patients irrespective of ethnic group , socio economic status and occupation will be
considered.

3. All cases that fit into Rome‘s criteria.

4. Patient who gave their full consent were taken into study.

Exclusion criteria-
1. Cases which do not fit in the Rome‘s criteria.

2. Cases with symptoms for less than 12 weeks.

3. Cases with abnormalities in lab investigations.

4. Cases with any co-morbidity.

18
Variable
The selected variable are-
OUTCOME VARIABLE EXPOSURE VARIABLE
Current status of disease having following History of any Mental illness
categories as Family history of mental illness
 No Improvement History of any physical illness
 Status quo Type of IBS diagnosed
 Improvement Previous treatment history
Stage at which treatment started

Outcome Variable- This variable is about the resultant global changes in symptoms of IBS
in both groups .i.e. lifestyle management and the homoeopathic intervention, whether how
much improvement a case has or whether it has come to a stand still or there was no change
recored based on which the analysis was done.

Exposure Variable- These variable explains about the factors that were concluded in the
analysis and further calculations in order to find the result as this factors were the most
important factors of a case taken in order to analyse and predict the prognosis of the case and
are also the main parts disease related to which the study was conducted. These also play a
vital role in understanding a case from homoeopathic point of view to obtain the desired
result.

 History of any mental Illness- psychological stress is an important factor for


development of irritable bowel syndrome. More and more clinical evidences
show that IBS is a combination of irritable bowel and irritable brain. The co-
morbidity of IBS and psychological distress is common, and the prevalence of
at least one psychiatric disorder typically ranges from 40% to 60% and has
been reported as high as 80%. A strong correlation can also be observed
between the severity of IBS and its co-morbid psychiatric disorders, especially
depression and anxiety
One review about the psychosocial determinants of IBS, reports a significant
increase in stressor score just before progression from IBS non-patient to IBS
patient. And also major life traumas (e.g., disruption of a close relationship, a
marital separation, a family member leaving home, or break-up of a serious

19
girl/boyfriend relationship) were frequently reported 38 wk prior to onset of
IBS symptoms. In addition, other previous studies have demonstrated that
early adverse life events (EALs) are associated with the prevalence of IBS.
EALs refer to traumatic experiences during childhood (e.g., maladjusted
relationships, severe illness or death of a parent, and physical, sexual or
emotion abuse). In patients, the occurrence of IBS is typically associated with
a higher total early life trauma score and impacted on health related quality of
life. These studies strongly and clearly suggest that psychological or
psychosocial stressors determine the development of IBS. Studies strongly and
clearly suggest that psychological or psychosocial stressors determine the
development of IBS

 Family history of mental illness- If a person has relatives who have a mental
illness, there is a higher chance that they themselves will have one. Like some
physical illness, it is essential to be aware of a family history of mental health,
as they can have a predisposition to mental illness. This does not mean one is
absolutely going to inherit the disease though. Mental health is affected by
genetics, but also by the environment and the situations they find themselves
in. Major depression also known as the major depressive disorder (MDD). A
person with major depression has a constant feeling of sadness and find it
difficult to carry out daily activities such as eating and sleeping. Studies show
that at least 10 percent of individuals in the US are diagnosed with depression
of which around 50 percent of the cause is due to genetic predisposition. In
this case, if a person has a history of depression in their family, that person
will more likely have a high risk of developing major depression in
comparison with an average person. And since IBS does have stronger links to
mental health issue this factor becomes another important variable to account
on.

 History of any physical illness- Its important to know the history of any
physical in order to understand the chonic nature of complain in case of IBS
and whether if, there was any other disease, mainly, any gastro intestinal
disorder that might have contributed to the development of symptoms.
Another factor is to ascertain whether is there any condition which might be

20
persisting alongside the presenting complaints of IBS as any subject who is
involved in the case must not have any other comorbidity to be included in the
study as presence of any somatic comorbidity will be ethically wrong to be put
in any group as it might worsen the case and might prove fatal in certain cases
to as there are many disorders of GIT that have close resemblance to the
presentation of IBS too. Also, it gives us the idea about previous treatment
history of the patient, as there might be a cured case of a GI disorders but a
collateral damage caused by allopathic medication etc.

 Types of IBS diagnosed- IBS can be divided into three subtypes according to
predominant bowel habit. In IBS with constipation (IBS-C), stools are usually
hard or lumpy, and bowel movement frequency is less than three per week.
Straining during a bowel movement is common. In IBS with diarrhoea (IBS-
D), stools are usually loose, mushy, or watery and bowel movements take
place more than three times a day. In addition, urgency (having to rush to
bathroom) is a common phenomenon. Mixed IBS (IBS-M) applies to subjects
expressing both constipation and diarrhoea variably, for at least 25% of the
bowel movements. After a period of constipation, frequency of bowel
movements typically increases leading to a period of diarrhoea. Usually these
periods fluctuate rapidly within hours or a up to week8. Unsubtyped IBS refers
to those not meeting the definition for IBS-C, IBS-D, or IBS-M, while
Alternating IBS is recommended to define those whose IBS subtype changes
to another over a longer, more than one year, period of time.

In most studies, female gender is over-represented amongst IBS populations


by a ratio of 1.5 to 2.0. Some studies, however, report a female to male ratio
closer to one. IBS-C is more common among females than males, while IBS-D
is more common among males. Females more often report bloating and
extraintestinal comorbidity. Pain related symptoms (pain eased after bowel
movement, pain related to change in bowel habits) are equally common in
both sexes84. Symptoms not related to pain (diarrhoea, constipation, bloating,
extraintestinal manifestations), however, are more common among female
patients. Inclusion of non-pain related symptoms may partly account for
female over-representation in IBS by Manning criteria. According to some

21
reports, Manning criteria are less reliable in males. The prevalence of IBS is
highest between 20 to 40 years old, and usually decreases with age. Some
studies report a decrease in IBS prevalence with increasing income, suggesting
that IBS is more prevalent amongst the lower social class. On the other hand,
affluent childhood has also been associated with adult IBS.
 Previous treatment history- As allopathic drugs either palliate or suppress
the basic suffering one or the other issues are reported in patients. Knowing
the history of treatment lets the physician understand the line of treatment for
homoeopathy. Allopathic Drugs can have adverse effects on any part of the
gastrointestinal (GI) tract from mouth to colon. It is essential that a detailed
and accurate drug history is taken in patients presenting with GI complaints.
Many drug-induced effects will regress or heal on cessation of treatment.
NSAIDs are usually associated with gastric and duodenal ulcers but are also
recognised to cause lichen planus in the mouth, oesophageal inflammation and
strictures, and small bowel and colonic ulcers and strictures. A newer class of
anti-inflammatory drugs, have been developed and have a more favourable GI
safety profile than standard NSAIDs. Acute diarrhoea, relapse of
inflammatory bowel disease (IBD), microscopic colitis and acute pancreatitis
are also induced by ingestion of standard NSAIDs. Of the many different
forms of colitis associated with drug ingestion, the most frequent is
pseudomembranous colitis. This is a complication of antibiotics and is caused
by the toxin produced by Clostridium difficile.
 Stage of treatment – depending upon the severity of the presenting symptoms
the stage of the disease has been divided into mild moderate and severe. The
condition of the disease depends upon the chronic nature and severity of the
symptom.

Study Tool
Pre structured validated case sheet that is used in OPD IPD and Popd was used to gather
information Consent from the department head as well as patient was taken prior to including
in the study and study was explained to them using participant information sheet in Hindi
language. Participation was completely voluntarily. It took around 15 minutes to interview
each patient and later on a detailed case taking was done for both cases as well as control
group patients. Data was collected using pen & paper, which was later entered into a database

22
using Excel spread sheet. Sorting of data was done, followed by cleaning and then analysis
using STATA version 14.2

Intervention in Detail
Homeopathy is a popular, albeit controversial form of complementary and alternative
medicine. A UK survey has shown that 1.9% of the population consulted a homeopath in the
12 months prior to the survey and 8.6% had bought an over-the-counter homeopathic
remedy95. Homeopathy is based on treating patients with remedies prepared from substances
that have been highly diluted and succussed (shaken). It was first developed by Samuel
Hahnemann in the 18th century in Germany and works on the principle of ―like cures
like‖whereby a substance thatwould cause symptoms in a healthy person cures those same
symptoms in illness. Homeopathic treatment varies among different practitioners and four
main types can be identified96:
• Individualised (or classical) homeopathy, the type most commonly practised in the UK,
involves a consultation followed by the prescription of a homeopathic medicine
individualised to the patient;
• Clinical homeopathy, where the same homeopathic medicine is used for a group of patients
all presenting with the same clinical condition (e.g. lycopodium for IBS, arnica for bruising);
• Complex homeopathy, where a number of different homeopathic medicines are given either
in a fixed combination or concurrently; and
• Isopathy, where the homeopathic medicine is based on the substance which has led to the
problem (e.g. grass pollen for hay fever).
Homeopathic medicines when prescribed by trained professionals are generally regarded as
safe97.

Types of Interventions- Trials were included if one of the groups in the trial received any
type of homeopathic treatment involving the delivery of a homeopathic remedy (either by a
homeopath following a consultation or studies where a homeopathic remedy was delivered
without a consultation) and the other received placebo, an active comparator treatment, or no
treatment.

How The Intervention Might Work- Homeopathy is based on the ‗law of similars’ i.e. a
substance which causes symptoms in a healthy individual can be used to treat similar
symptoms in a diseased person98. There is significant debate regarding the scientific basis for
homeopathy amongst healthcare practitioners, scientists, politicians and policy makers and

23
the mechanism by which homeopathic remedies may work is not completely understood. The
manufacture of homeopathic medicines involves serial dilution alternating with violent
agitation (i.e. ‗succussion‘). The combination of these two processes is referred to as
‗potentisation‘ or ‗sequential kinetic activation‘99. Many homeopathic medicines are diluted
beyond Avogadro‘s number and therefore fall under the classification of ultra-high dilutions
(UHDs). Avogadro‘s number is the number of molecules in a mole of a substance,
approximately 6.0225 × 1023, which means that a sample diluted beyond 1024 would have
reached a stage where it is very unlikely that there is even a single molecule of the original
substance present. The biological efficacy of UHDs may be dependent on sequential kinetic
activation100, but the mechanism by which sequential kinetic activation enables a UHD to be
biologically active is unknown. A common theory is that it involves stable water structures,
created by interactions between molecules of the biological material and the water it is
dissolved in, allowing the water to retain information about the biological material101.

Data Management and Quality Control


Data collection: Data was collected in hard copy, which was later entered into a database
using Excel spread sheet. Sorting of data was done followed by cleaning and then analyses.
Data was saved by making a backup file. All files were password protected, and have been
stored confidentially with no access to anyone other than the principal investigator.

Statistical test and analysis plan: All analyses was done using STATA version. The
findings of the descriptive analyses were presented as frequencies and percentages. Bivariate
analyses were conducted to look for association between the outcome and various factors
studied. Each variables were compared between the cases and controls and presented in the
form of p-values.

Ethical Consideration-
Respondents have participated in the survey voluntarily. A participant information sheet was
made in local language explaining the purpose of the study for the respondent. Consent was
taken from each respondent. In case respondent was not able to give signature then the
consent was taken from a witness on her behalf. In case the respondent did not want to
answer any question he/she was not forced to reply. Privacy and anonymity of study
participants was maintained and a unique ID was given to maintain anonymity. No identifiers

24
were used anywhere during the analyses of presentation of findings. While classifying cases
and controls no bias was found as it was completely random selection with no identifiers.

25
6. Result

The result section is divided in further 2 section that includes a descriptive section that will
include details of all the participants in the study followed by this an analytical section is
presented that will compare the findings among cases and control group keeping in mind
other confounding factors

Study was conducted to analyse the effect of homoeopathic management over lifestyle
management among patients with Irritable Bowel Syndrome for which data was collected
from OPD, IPD and peripheral outpatient department of Bakson Homoeopathic medical
college and hospital for last 1 year.

Data was successfully collected from a total of 100 patients out of which patients were
randomly given treatment to the case group and placebo with life style management advice to
the control group. These patients were informed about the study using participant information
sheet and were included in the study only after taking their consent.A strict inclusion and
exclusion criteria was followed to select the patient and to guidelines were followed strictly
for randomizing technique.

Following are the result of the study-

1. Descriptive study findings-

1.1 Sociodemographic characteristic of the study participant

Sociodemographic characteristics of Study Participants (%)


84
78
66
58
50 50
42 44 44
38 34
36 36 34
22 20 22 22
16
4
Others
Female
21-35 years

36-45 years

46-70 years

Unmarried

Employed
Male

Unemployed
Married

Age Sex Marital Status Occupation


Cases Controls

26
Fig.6.1 showing sociodemographic characteristic of the study participant

Majority of the study participants belong to the age group of 46-70 years of age as 42% (21)
of cases belong to this category whereas 44% (22) of control group participants falls in this
category. 66% (33) of the cases in study were males whereas an equal representation of sex
fell in the control group. More than half of the study participants were working in both the
cases as well as control group.

1.2 Medical history among Study Participants

Medical history among study participants (%)

82
70
62 64 62
60 60

40 38
36 36
24

History of Family History of Previous Stage at Mild Moderate


any history of any treatment which
Mental mental physical history treatment
illness illness illness started

Cases Controls

Fig.6.2 Showing medical as well as past history of study participants

Majority of study participants 62% (cases) and 82% (Control) had history of mental illness
and one fourth of the controls (24%) had family history of mental illness which is just double
(60%) in cases of randomly selected cases. Majority (70%) of Controls have reported that
they had history of physical illness comparative to cases where only one-fourth have reported
of having history of physical illness.

More than half (64%) of the controls have reported that they have taken treatment earlier but
only 36% of the cases have mentioned that they had taken treatment earlier. Apart from all of
this, more than half (62%) of controls have started treatment in their mild stage of disease as

27
per a criteria by ROMES classification whereas 60% of cases have started treatment in their
moderate stage of disease.

1.3 Type of Cases included in the study

Half of the study participants (Controls- 52%) were diagnosed with Constipation only
whereas among cases an equal distribution was diagnosed in having mixed, diarrhoea and
constipation type of IBS with a proportion being 30%, 36%, and 34% respectively.

Type of IBS identified among study participants (%)

30
Mixed
26

36
Diarrhea
22

34
Constipation
52

Controls Cases

Fig. 6.3 showing type of IBS cases identified among both Cases and Controls

1.4 Outcome of the study- Cases and controls

Final outcome of the study (%)


Cases Controls
50
46

38
30
20

16

NO IMPROVEMENT STATUS QUO IMPROVEMENT

28
Fig. 6.4 showing final outcome of the trial
A descriptive analysis of the overall outcome of the study showed that half of the (50%) of
the cases showed improvement in the condition of their lines who have been given medicine
on the basis of totality of symptom with no advice on life style management but only one-
fourth (38%) of the controls who have been given advice on life style management as well as
placebo prescription showed improvement in their condition which could be other
confounding factors.

Half of the controls (46%) have showed a Status quo condition which could be
interpreted as a need of medication for the patients to get relief in their condition.

2. Analytical study findings-

Chi square test was applied as the dependent variable i.e. outcome of the trail was categorical.
This was done to find out how well the observed distribution of data fits with the distribution
that is expected if the variables are independent.

Table.6.1 Distribution within cases and controls


Distribution of data for occupation was found to be statistically significant and fits with the
expected outcome variable.
Sr. Medical History Case [N=50] Control [N=50] P value
No n (%) n (%)
1. History of any Mental illness
Yes 31(62%) 41 (82%) 0.02
2. Family history of mental illness
Yes 30 (60%) 12 (24%) <0.001
3. History of any physical illness
Yes 18 (36%) 35(70%) <0.001
4. Type of IBS diagnosed
Constipation 26 (52%) 17 (34%)
Diarrhea 11 (22%) 18 (36%) 0.15
Mixed 13 (26%) 15 (30%)
5. Previous treatment history
Yes 18 (36%) 32 (64%) <0.001
6. Stage at which treatment started
Mild 20 (40%) 31 (62%)

29
Moderate 30 (60%) 19 (38%) 0.02
7. Current status of disease
No Improvement 10 (20%) 8 (16%)
Status quo 15 (30%) 23 (46%) 0.25
Improvement 25 (50%) 19 (38%)
Table.6.2 Distribution within cases and controls

Sr. Socio-demographic Case [N=50] Control [N=50] P Value


No characteristics n (%) n (%)
1. Age
21-35 years 18 (36%) 18 (36%)
36-45 years 11 (22%) 10 (20%) 0.96

46-70 years 21 (42%) 22 (44%)


2. Sex
Male 33 (66%) 25 (50%) 0.1

Female 17 (34%) 25 (50%)


3. Marital Status
Married 39 (78%) 42 (84%)
Unmarried 11 (22%) 8 (16%) 0.5

4. Occupation
Employed 29 (58%) 22 (44%)
Unemployed 19 (38%) 17 (34%) 0.02

Others 2 (4%) 11 (22%)


5. Income (monthly)
≤ 5000 22 (44%) 22 (44%)
6000-15000 13 (26%) 16 (32%)
0.54
16000-25000 3 (6%) 5 (10%)
26000 and above 12 (24%) 7 (14%)

30
7. Discussion

This study was conducted at Bakson Homoeopathic Medical College. The purpose was to
ascertain whether Homoeopathic drugs are capable of relieving/curing the case of Irritable
Bowel syndrome without any kind of management or not. The lifestyle in today‘s scenario
has become fast. With growing technology and ease, the pressure of performance has taken a
toll on the human race. The negligence towards health has grown way too much, the stress
quotient is rising rapidly and the dependency on drugs have become commom. Irritable
Bowel Syndrome is one of those disorders which has been misdiagnosed at times and has
been found in much of the population than it was expected.

This RCT compared clinical homeopathic remedy with lifestyle management for treating IBS
irrespective of the type. In analysis of this study, the homeopathic remedies were found to be
significantly more effective than lifestyle management alone for improvement in global IBS
symptoms in follow-up of min. 30 weeks. However, this result should be interpreted with
caution due to the low quality of the reporting in these studies, a high or unknown risk of bias
associated with the trial in this pooled analysis and sparse data. Given the long term nature of
IBS it is not clear how useful the follow up is. As people live with IBS for years, an
evaluation of 30 weeks fails to take into account possible rebound effects or longer term
benefits or adverse events that would be important for patients and practitioners to know
about when they consider the potential benefits associated with the intervention.

The results from the analysis indicate a possible benefit for homeopathic treatment using
clinical homeopathy (non-individualised homeopathic remedies) over placebo for IBS.
However, this result needs to be interpreted with caution. The low quality of the reporting
means that it is not possible to determine whether or not the subjects made any dietry changes
that contributed to relief in complaints or lowered their mental health factors by any means,
to ascertain that the results are a true reflection of the treatment effect. The study was
determined to have an unknown risk of bias for most assessed items.

31
8. Conclusion

The analysis of this study found a statistically significant benefit favouring the homeopathic
remedy over lifestyle management. However, these results should be interpreted with caution
due to the low quality of reporting in these studies, a high or unknown risk of bias and sparse
data. Thus it is not possible to be certain whether or not the trials were able to distinguish
between true treatment effects, chance or bias. Furthermore, the low quality of reporting
practice means that it is difficult to assess whether the results would be replicated in everyday
practice, that is, whether the results are externally valid or generalisable. The low quality of
the reporting means that it is not possible to determine whether or not results are a true
reflection of the treatment effect.

32
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40
APPENDICES

41
Cases Performa
Ref no

Date

Name

Age

Sex

Address-

Occupation

PRESENTING COMPLAINT-

HISTORY OF PRESENTING COMPLAINT-

PAST HISTORY-

FAMILY HISTORY-

PERSONAL HISTORY-

 DIET
 ADDICTION
 SOCIO-ECONOMIC CONDITION
 SEXUAL HISTORY
 OBSTETRIC HISTORY
 CONTRACEPTIVE HISTORY

PHYSICAL GENERALS-

 Appetite
 Thirst
 Desire
 Aversion
42
 Intolerance
 Stools
 Urine
 Perspiration
 Sleep
 Dreams
 Thermal reaction

MENTALS

PHYSICAL EXAMINATION-

GENERAL SURVEY

 Built
 Nutrition
 Pallor
 Icterus
 Cyanosis
 Clubbing
 Oedema
 Pigmentation
 Pulse
 Blood pressure
 Respiratory rate
 Temperature
 Lymphadenopathy
 Ht / wt

SYSTEMIC EXAMINATION

43
 Respiratory system
 Cardiovascular system
 Gastrointestinal system
 Central nervous system
 Locomotor system
 Skin and mucous membrane

PROVISIONAL DIAGNOSIS-

SUGGESTED INVESTIGATION

FINAL DIAGNOSIS

ANALYSIS OF SYMPTOMS

EVALUATION OF SYMPTOMS

MENTALS

PHYSICAL

PARTICULARS

TOTALITY OF SYMPTOMS

REPERTORISATION

REPERTORIAL RESULT

PRESCRIPTION

ADVICE

FOLLOW UPS

44
Case 1
[Intervention]

Ref. no-513/17

Date-10/9/2017

Name – XYZ

Age/Sex – 59/M

Address – Gautam Buddha Nagar

Occupation – LIC agent.

PRESENTING COMPLAINT -

 Pain in lower abdomen, mild in character since 2 months.

 Pain relieved by passing stool.

 Pain aggravated by taking heavy seasoned food, spicy food.

 Altered bowel habits- patient is usually constipated for 3-4 days and then diarrhea sets
in.

HISTORY OF PRESENTING COMPLAINT -

The patient started complaining of dull aching pain in the lower abdomen with altered bowel
habit. Initially, the pain was dull aching & persistent with frequent altered bowel habit, i.e,
diarrhea altered with constipation. The pain becomes worse when the patient is constipated
and it involves both the lower quadrants. The complaints gradually intensified with time.ie,
the pain in both lower quadrants became more persistent and the tendency of altering bowel
habit decreased. The patient is constipated for more than 3 days followed by diarrhea which
is watery, offensive and is associated with tenesmus and burning in the anal orifice. Patient
feels very lethargic after the diarrhea sets in. No associated complain of fever, weight loss.
Patient has history of allopathic treatment.

45
PAST HISTORY -

Acid peptic disease- at age of 30yrs, diagnosed at Navin hospital & was relieved by
allopathic treatment.

Jaundice- at 21 yrs of age,took allopathic treatment.

Chicken pox-14yrs of age.

FAMILY HISTORY -

Father- Suffered from pulmonary Tuberculosis Died.

Wife & Child died in RTA.

Mother – Died of C.A LIVER

PERSONAL HISTORY –

 DIET – Non vegetarian

 ADDICTION – Nothing specific

 SOCIO-ECONOMIC CONDITION- Average.

 SEXUAL HISTORY – Nothing specific

 MARITAL STATUS - Married

PHYSICAL GENERALS -

 Appetite – good

 Thirst – increased, small quantity at short intervals.

 Desire – nothing specific.

 Aversion – Nothing specific.

 Intolerance – spicy, highly seasoned food.

 Stool – constipation, no urge for 2-3 days.

46
 Urine – pale yellow in colour.

 Perspiration – nothing specific.

 Sleep – disturbed.

 Dreams – nothing specific

 Thermal reaction – chilly patient.

MENTALS –

 LIFE SPACE- His wife and child died in a road traffic accident 16 years
back. He was very close to his daughter who died in front of him and he
couldn‘t do anything to save her. He started carrying out his daily activities
but did not talk to anyone not even his only left son. Since then the health
issues began.

 Complaints aggravate on thinking about them.

 Prolonged grief regarding family issues.

 Thinks his disease is incurable.

PHYSICAL EXAMINATION

GENERAL SURVEY

 Built – endomorphic

 Nutrition – good

 Pallor – absent

 Icterus – absent

 Cyanosis – absent

 Clubbing – absent

47
 Oedema – absent

 Pigmentation – absent

 Pulse – 92/min

 Blood pressure – 140/90

 Respiratory rate – 14-15/min

 Temperature – 98°F

 Lymphadenopathy – absent

SYSTEMIC EXAMINATION

1. Respiratory system – No abnormality detected

2. Cardiovascular system – No abnormality detected

3. Gastrointestinal system –

 INSPECTION- Shape of abdomen- scaphoid in shape. Condition of umbilicus-


everted and centrally located. No herniation. No scar and no swelling seen. No visible
pulsation.

 PALPATION- Tenderness present at the hypogastric region. No guarding. No


rigidity present. No organomegaly. No fluid thrill, no shifting dullness present.

 PERCUSSION- No abnormality detected.

 AUSCULTATION- No abnormality detected.

4. Central nervous system – No abnormality detected

5. Locomotor system – No abnormality detected

6. Skin and mucous membrane – No abnormality detected

DIFFERENTIAL DIAGNOSIS

 IRRITABLE BOWEL SYNDROME

48
 ACID PEPTIC DISEASE

 GASTRO-ENTERITIS

 APPENDICITIS

SUGGESTED INVESTIGATION

USG: Whole abdomen

FINAL DIAGNOSIS

IRRITABLE BOWEL SYNDROME

ANALYSIS OF CASE

 Pain in abdomen-relieved by passing stool. COMMON PARTICULAR GENERAL.

 Altered bowel habit- constipation followed by diarrhea. CHARACTERISTIC


PARTICULAR GENERAL.

 Thirst- Small quantity at short intervals. UNCOMMON PHYSICAL GENERAL

 Pain in whole abdomen AGGRAVATED after spicy, highly seasoned food.


COMMON PARTICULAR GENERAL.

 Complaints aggravate when thinking of it. Thinks his disease is incurable and he‘ll die
of the disease. CHARACTERISTIC MENTAL GENERAL.

 Prolonged grief of loosing his wife and child. CHARACTERISTIC MENTAL


GENERAL.

 Complaint started after depressive mental state. CHARACTERISTIC MENTAL


GENERAL.

 PDF- Chilly patient.

EVALUATION OF SYMPTOMS-

MENTAL GENERAL PHYSICAL GENERAL PARTICULARS


 Prolonged grief  Thirst for small  Pain in lower
after death of wife quantity at short abdomen relieved

49
and child. interval. by passing stool.
 Complaint  Intolerance from
aggravate when spicy and oily food.
thinking of it.  Stool: altered
 Feels his disease is constipation and
incurable and he diarrhea.
will die of it.

MIASMATIC ANALYSIS-

SYMPTOMS PSORA SYCOSIS SYPHILIS


 Prolonged
grief,  
depression.
 Complain
aggravated   --
when
thinking of
it.
 Feels his -- -- 
disease is
incurable.
 Thirst-
small -- -- 
quantity at
short
intervals. --  --

 Intolerance
to spicy and
oily food.
 Altered --  

constipation
and

50
diarrhea.
 Pain in   --
lower
abdomen
relieved by
passing
stool

REPERTORIAL RESULTS

 Arsenic.alb:- 9/4

 Plb. :- 5/4

 Ign. :- 7/3

 Nux vom :- 7/3

 Bryonia:- 6/3

PRESCRIPTION-
FOR, Mr. XYZ, 59/M

51
Rx
Arsenic alb . 200.
BD for 3 days
ADVICE-
 No advice given

52
Case-2
Ref. no-

Date-10/9/2015

Name – Mrs. ABC

Age/Sex – 30/F

Address – Gautam Buddha Nagar

Occupation – teacher.

PRESENTING COMPLAINT -

 Constipation with ineffectual urge since 2 years.

 Dull pain in abdomen Pain aggravated by taking heavy seasoned food, spicy food.

 Loss of appetite since 2 months

HISTORY OF PRESENTING COMPLAINT -

Patient has a history of irregular bowel habit since very childhood but since last 2 years the
complaints worsened after her first delivery. There was ineffectual desire to pass stool with
dull pain in abdomen. The pain started getting worse with time. In order to finish her work in
proper time she would suppress her urge to defecate, also with change in place and while
travelling her constipation gets worst. She started taking purgatives but that would bring
temporary relief.

PAST HISTORY -

Jaundice- at 21 yrs of age,took allopathic treatment.

Chicken pox- 14yrs of age.

FAMILY HISTORY -

53
Father- Suffered from pulmonary Tuberculosis, diseased.

Mother – has Rhematoid Arthritis.

PERSONAL HISTORY –

 DIET – Non vegetarian

 ADDICTION – None

 SOCIO-ECONOMIC CONDITION - Average.

 SEXUAL HISTORY – Nothing specific

 MARITAL STATUS – Married

 EDUCATIONAL STATUS – Post Graduate

 ENVIRONMENT AT HOME – Stressful.

PHYSICAL GENERALS -

 Appetite – Decreased

 Thirst – increased, small quantity at short intervals.

 Desire – nothing specific.

 Aversion – Nothing specific.

 Intolerance – spicy, highly seasoned food.

 Stool – constipation, no urge for 1-2 days.

 Urine – pale yellow in colour.

 Perspiration – slightly offensive,

 Sleep – disturbed.

 Dreams – vivid dreams.

 Thermal reaction – chilly patient.

54
MENTALS –

 LIFE SPACE- since early childhood the patient recalls that she had irregular
bowel habits but there were no health issues. After marriage, Since birth of
their first child, the relationship between the patient and her husband got quite
affected. The decline in financial status of the family led her to work extra
time. She feels neglected by her husband and feels she is contributing more in
earnings and keeping the family which leaves no time for her to take care of
herself.

 Complaints aggravate on thinking about them.

 Prolonged grief regarding family issues.

 Thinks her disease is incurable.

PHYSICAL EXAMINATION

GENERAL SURVEY

 Built – endomorphic

 Nutrition – good

 Pallor – absent

 Icterus – absent

 Cyanosis – absent

 Clubbing – absent

 Oedema – absent

 Pigmentation – absent

 Pulse – 92/min

 Blood pressure – 140/90

 Respiratory rate – 14-15/min

55
 Temperature – 98°F

 Lymphadenopathy – absent

SYSTEMIC EXAMINATION

7. Respiratory system – No abnormality detected

8. Cardiovascular system – No abnormality detected

9. Gastrointestinal system –

 INSPECTION- Shape of abdomen- scaphoid in shape. Condition of umbilicus-


everted and centrally located. No herniation. No scar and no swelling seen. No visible
pulsation.

 PALPATION- Tenderness present at the hypogastric region. No guarding. No


rigidity present. No organomegaly. No fluid thrill, no shifting dullness present.

 PERCUSSION- No abnormality detected.

 AUSCULTATION- No abnormality detected.

10. Central nervous system – No abnormality detected

11. Locomotor system – No abnormality detected

12. Skin and mucous membrane – No abnormality detected

DIFFERENTIAL DIAGNOSIS

 IRRITABLE BOWEL SYNDROME

 ACID PEPTIC DISEASE

 GASTRO-ENTERITIS

 APPENDICITIS

SUGGESTED INVESTIGATION

USG: Whole abdomen

56
FINAL DIAGNOSIS

IRRITABLE BOWEL SYNDROME

PRESCRIPTION

Sac/lac 30

Twice a day for a week

57
Diagnostic Criteria’s for Irritable Bowel Syndrome

There are no definite test for diagnosis of irritable bowel syndrome Research has
suggested these guidelines are not always followed.[51] Once other causes have been
excluded, the diagnosis of IBS is performed using a diagnostic algorithm. Algorithms
include the Manning criteria, the obsolete Rome I and II criteria, and the Kruis criteria,
and studies have compared their reliability.[60] The Rome III process was published in
2006 and the Rome IV criteria were published in 2016.

 Rome criteria. These criteria‘s include abdominal pain and discomfort lasting on
average at least one day a week in the last three months, associated with at least two of
these factors: Pain and discomfort are related to defecation, the frequency of defecation
is altered, or stool consistency is altered.

1. Rome I criteria for IBS


At least 3 months continuous or recurrent symptoms of: Abdominal pain or
discomfort which is: Relieved with defecation and/or
Associated with a change in frequency of stool; and/or
Associated with a change in consistency of stool and
Two or more of the following, on at least a quarter of occasions or days:
Altered stool frequency,
Altered stool form (lumpy/hard or loose/watery),
Altered stool passage (straining or urgency, feeling of incomplete evacuation)
Passage of mucus, Bloating or feeling of abdominal distension.
2. Rome II criteria for IBS
At least 12 weeks or more, which need not be consecutive, in the preceding 12
months of abdominal discomfort or pain that has two out of three features:
a. Relieved with defecation; and/or
b. Onset associated with a change in frequency of stool; and/or
c. Onset associated with a change in form (appearance) of stool.
3. Rome III criteria for IBS
Recurrent abdominal pain or discomfort at least three days per month in the last
three months associated with two or more of the following
a. Improvement with defecation

58
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool.
4. Rome IV criteria for IBS
The Rome IV criteria includes recurrent abdominal pain, on average, at least 1
day/week in the last 3 months, associated with two or more of the following
criteria:
a. Related to defecation
b. Associated with a change in frequency of stool
c. Associated with a change in form (appearance) of stool.

 Manning criteria. These criteria focus on pain relieved by passing stool and on having
incomplete bowel movements, mucus in the stool and changes in stool consistency.
The more symptoms you have, the greater the likelihood of IBS. The threshold for a
positive diagnosis varies from two to four of the Manning criteria below.[4]

a. Onset of pain linked to more frequent bowel movements


b. Looser stools associated with onset of pain
c. Pain relieved by passage of stool
d. Noticeable abdominal bloating
e. Sensation of incomplete evacuation more than 25% of the time
f. Diarrhea with mucus more than 25% of the time

59
Master Chart

S.No Name Age/Sex Reg.No Complaint Prescription Advice Remark


(Based on
totality of
symptoms)
1 Gulaal devi 48/F 158/18 Pain in lower abdomen that Carbo veg 200 None given Improvement
radiates to epigastric region
with sour belching.

2 Harlal Yadav 38/F 56/18 Severe pain with nausea and Ars. alb 200 None given Improvement
vomiting.
Complain agg. after meals.

3 Tara Devi 49/F 241/18 Chronic constipation, hard Ars. Alb 200 None given Status Quo
stool and burning pain in
abdomen.
Dysentery, very offensive.
4 Ruhaani 49/F 881/18 Severe pain in abdomen, Carbo veg 200 None given Improvement
Begum agg. after spicy and fried
street food. Burning

60
sensation in epigastric
region. <by taking cold
water.
5 Puroshottam 58/M 97/18 Flatulence with eructations Carbo veg 200 None Improvement
Singh and heaviness. Waterbrash.

6 Ram Lal 35/M 182/18 Constipation followed by Lyco 200 None Improvement
diarrhoea with severe pain
in epigastric region

7 Toofani Chand 40/M 889/18 Chronic constipation with Lyco 200 None Status Quo
hard stools and pain in
hypogastrium.

8 Sohan Sharma 38/M 789/18 Habitual Constipation with Nux Vom. 200 None Status Quo
motions once in 2-3 days.
Stool- Soft in consistency
and unsatisfactory.

9 Sharda Ram 60/M 911/18 Pain in abdomen with Nux Vom. 200 None Improvement
habitual constipation

61
altering with diarrhoea.
10 Malti Devi 58/F 652/18 Nausea and Vomiting Ars. Alb. 200 None Improvement
sensation agg. after meals
with pain in epigastric
region with constipation.

11 Umakant 51/M 18/18 Burning sensation in lower Ignatia 30 None Improvement


Dwivedi abdomen with flatulence
and pain .

12 Shridhar 68/M 992/17 Pain in chest < after meals Phosphorous None Improvement
chaturvedi with excess salivation and 200
acid regurgitation. with
irregular bowel habits.

13 Shanta Ram 49/M 601/17 Irregular bowel habits with Phosphorous None Improvement
flatulence, pain in abdomen 30
and sour eructation followed
by burning sensation in
stomach.

62
14 Madhumati 35/F 452/18 Nausea and vomiting just Ars. Alb 200 None Status Quo
after meals with vertigo
sensation. acid
regurgitation.

15 Sita Devi 30/F 342/17 Constipation with motion on Phosphorous None Status Quo
alternate days. Stool hard 30
and offensive with difficulty
in passing stool.

16 Arashad Khan 45/M 222/17 Depression with Altered Nux Vom. 200 None Improvement
bowel habits. Obstinate
constipation followed by
diarrhoea.

17 Anuj kr 22/M 14/18 Pain in abdomen especially Phosphorous None Improvement


Pandey in epigastric region with 200
severe nausea and vomiting
Agg. after eating spicy oily
and seasoned food..

63
18 Ruchi Singh 29/F 166/18 Flatulence with sour Nux Vomica None Improvement
eructations. Pain and 200
heavinesss in whole
abdomen with constipation.

19 Shamsuddin 45/M 182/17 Burning sensation in Ars. Alb. 200 None Improvement
Md. epigastric region with
flatulence and diarrhoea
altering with constipation.

20 Sudheer 38/M 781/17 Altering bowel habits with Ars Alb None Status Quo
marked anxiety. 200
Frequent stools altering with
constipation.

21 Sameera 39/F 521/18 Depressive mental state Argentum nit. None No change
with marked anxiety. 200
diarrhea with altering
contipation

22 Bhajan Singh 67/M 67/18 Habitual Constipation with Phosphorous None Improvement

64
motions once in 2-3 days. 200
Stool- Soft in consistency,
very offensive and
unsatisfactory.

23 Neerja 25/F 144/18 Pain in Abdomen with Ars. Alb. 200 None Improvement
severe nausea and vomiting
and burning in
abdomen.Agg. after taking
spicy n streetside food.

24 Narmada 25/F 345/17 Acne with constipation Ars.Alb 200 None Status Quo
25 Manisha 28/F 198/17 Headache with disturbed Phosphorous None Improvement
sleep and pain in abdomen 200
with unsatisfactory feeling
after passing stool
26 Rajkumar 70/M 411/18 A diagnosed case of IBS, Sepia 200 None Improvement
Came for homoeopathic
approach
27 Sunil Awasthi 46/M 1123/1 Offensive flatus, bloating of Ars. Alb. 200 None Improvement
7 abdomen with constipation

65
28 Jugal Kishore 55/M 2234/1 A diagnosed case of IBS, China 200 None Status Quo
8 Came for homoeopathic
approach
29 Poonam 60/F 109/17 Disturbed sleep with pain in Ars. Alb. 200 None No change
Pandey abdomen
30 Shagun 48/F 233/18 Irregular bowel habits Merc Sol. 200 None Status Quo

66
Control Group
S.No Name Age/Sex Reg.No Complaints Prescription Advice Remark
1 Nirala devi 48/F 158/18 Constipation with Sac lac Dietary management, Improvement
hard stools and pain Counseling,
in abdomen Daily exercise
2 Namrata 28/F 56/17 Depression with Sac lac Dietary management, improvement
altering bowel Counseling,
habits Daily exercise
3 Bhaghirathi 49/F 241/18 PTSD, altering stool Sac lac Dietary management, Improvement
devi habits, insomnia Counseling,
Daily exercise
4 Chanda devi 49/F 881/18 Insomnia and Sac lac Dietary management, Left
constipation Counseling,
Daily exercise
5 Dharmesh 58/M 97/18 Anxiety disorder Sac lac Dietary management, Improvement
Counseling,
Daily exercise
6 Vishal 35/M 182/17 Irregular bowel Sac lac Dietary management, Improvement
maurya habits with frequent Counseling,
diarrhoea Daily exercise
7 Ram Prasad 40/M 889/18 Constipation with Sac lac Dietary management, Improvement

67
singh pain in abdomen Counseling,
and hard stool Daily exercise
8 Shazam khan 38/M 789/18 Diarrhea, anxiety Sac lac Dietary management, No improvement
neurosis Counseling,
Daily exercise
9 Bhuvneshwar 60/M 911/18 Irregular bowel Sac lac Dietary management, Improvement
yadav habits with pain in Counseling,
abdomen Daily exercise
10 Manjari 58/F 652/18 Hard stools with Sac lac Dietary management, Improvement
yadav flatulence and pain Counseling,
in abdomen Daily exercise
11 Nishant 21/M 18/17 Diarrhea before Sac lac Dietary management, Left
kushwaha exams and tests Counseling,
Daily exercise
12 Najar shah 68/M 992/17 Flatulence with loss Sac lac Dietary management, Left
of appetite and Counseling,
constipation Daily exercise
13 Nirmal dev 49/M 601/18 Depression and Sac lac Dietary management, Status Quo
altering stool habits Counseling,
Daily exercise
14 Rajni shah 35/F 452/18 Constipation post Sac lac Dietary management, Left

68
pregnancy with Counseling,
mood disorders Daily exercise
15 Nishi maurya 30/F 342/18 Acne and hairfall Sac lac Dietary management, Cure
with irregular bowel Counseling,
habits Daily exercise
16 Nandlal 45/M 222/18 Constipation with Sac lac Dietary management, Improvement
singh flatulence Counseling,
Daily exercise
17 Namit biswas 22/M 14/18 Anxiety with Sac lac Dietary management, Status Quo
diarrhoea Counseling,
Daily exercise
18 Manorma das 29/F 166/18 Hairfall, acne and Sac lac Dietary management, Cure
pain in abdomen Counseling,
Daily exercise
19 Balwant 45/M 182/18 PMGH with altering Sac lac Dietary management, Improvement
singh bowel habits Counseling,
Daily exercise
20 Rajkumar 38/M 781/18 Constipation, Sac lac Dietary management, Improvement
bhawani unsatisfactory Counseling,
motions with pain Daily exercise
in abdomen

69
21 Lalita 39/F 521/18 Insomnia with Sac lac Dietary management, Left
maurya altered bowel habits Counseling,
Daily exercise
22 Shanto 67/M 67/18 Flatulence, belching Sac lac Dietary management, Improvement
kumar and diarrhoea Counseling,
Daily exercise
23 Meena yadav 25/F 144/18 Depression, loss of Sac lac Dietary management, Improvement
appetite with Counseling,
constipation Daily exercise
24 Bharat shah 55/F 345/18 Severe pain in Sac lac Dietary management, Improvement
abdomen with Counseling,
constipation Daily exercise
25 Lalit singh 48/M 198/18 Insomnia with Sac lac Dietary management, Improvement
altering bowel Counseling,
habits Daily exercise
26 Ramakant 30/M 4111/18 Motions Sac lac Dietary management, Status Quo
tiwari immediately after Counseling,
meals with anxeity Daily exercise
27 Lallan yadav 46/M 1123/18 Headache with Sac lac Dietary management, Improvement
constipation Counseling,
Daily exercise

70
28 Mantar singh 55/M 2234/18 Headache with Sac lac Dietary management, Improvement
nausea and pain in Counseling,
abdomen Daily exercise
29 Rajta devi 60/F 109/18 Anxiety with pain Sac lac Dietary management, Improvement
in abdomen and Counseling,
diarrhea Daily exercise
30 Sanjana devi 48/F 233/18 Headache with pain Sac lac Dietary management, Status Quo
in abdomen Counseling,
Daily exercise
Dietary management,
Counseling,
Daily exercise

71
Consent Form

72
73

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