Effectiveness Of Nux Vomica In The Homoeopathic Management Of Irritable Bowel Syndrome In Adults : An Experimental Non-Controlled Study

Introduction

Irritable bowel syndrome IBS is 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. It is coded in ICD 11 as DD91.0

The prevalence of IBS within the community is between 10 percent and 25 percent the ratio of females to males in India reversed, i.e. 1 is to 3 to that of the Western countries.

The disorder is usually found in the age group of 15 to  50 years and may also occur in children and elderly.  In a study, prevalence of IBS in India was seen in 12.27 percent of the study population with male-to-female ratio of 1.44 to 1.

Homoeopathic science emphasizes on the psychosomatic aspects along with physical particulars. The study comprises of, management with the help of individualized homoeopathic remedy, when we study an Individual, we not only study the bodily configuration but also the intellectual and emotional as revealed to us though his reaction to the environment. Thus, the characteristics in physical and intellectual and emotional spheres, reveal the individual to us.

To ensure the good improvement, Homeopathy treats in a gentle and most harmless way with permanent restoration of health and annihilate the disease in a whole extent on easily comprehensible principles. Thus, Homeopathy gives more importance to the diseased individual than the disease itself. A homoeopathic physician considers the man as a whole. He considers the life as a trinity of body, mind and soul.

There are various remedies in homoeopathy which are useful in treatment of IBS, most commonly used homeopathic remedies for IBS are nux vomica, sulphur, podophyllum, argentum nitricum, asafoetida, colocynthis, lycopodium, silicea etc. Nux vomica is being used for IBS over many years and is a great remedy for IBS, it demands more work in this area. Hence the study is undertaken to known the effectiveness of NUX VOMICA in cases of Irritable bowel syndrome.

OBJECTIVES

1 Primary Objectives To study the effectiveness of Nux vomica in homoeopathic management of Irritable bowel syndrome in adults

2 Other Objective To assess the patient pre- treatment and post treatment for IBS on IBSSSS scale and to compare the pre- treatment score and post treatment score on IBSSSS scale

3 Other Objective To study drug picture of nux vomicas

METHODOLOGY

I STUDY DESIGN An Experimental non-controlled study.

2 STUDY SETTING Cases will be collected from the OPD of the institute.

3  STUDY POPULATION  Diagnosed patients of irritable bowel syndrome of age group 18 to 50 years of age and those fulfilling the Rome IV criteria with absence of alarm symptoms.

4  DURATION OF STUDY

a. Duration of study  18 months

b. Duration of each case Each case will be studied for 8 months or until remission of symptoms

c. Duration of follow up Each case will be followed up after 15 days or as and when required

d. Clinical outcome assessment will be done at base, 1 month, 3 months, 8 months and at termination of treatment

5 METHODS OF SELECTION OF STUDY SUBJECT  ELIGIBILITY CRITERIA

A. INCLUSION CRITERIA

1. Patients fulfilling the Rome IV criteria and symptoms similar to drug picture of nux vomica

2. Diagnosed patients of age group 18 to 50 years

3. Patients of all the genders

4. Patients from different socio economic backgrounds will be considered.

5. Patients willing to give informed written consent.

B. EXCLUSION CRITERIA

1. Patients with alarm ,red flag symptoms

a. Weight loss

b. Nocturnal symptoms

c. Family history of colon cancer

d. Anemia

e. Rectal bleeding

f. Fever.

2. Pregnant and lactating females.

3. Patients who are already taking other medications.

4. Patients who are immunocompromised

C. SUBJECT WITHDRAWAL CRITERIA

1 Patients who are not willing to continue further, for homoeopathic treatment during ongoing research study

2 Patients with an irregular follow up

3 In medical and surgical emergencies

4 In case of alarm symptoms if any occur during the study.

6  METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA Not Applicable

7 OPERATIONAL DEFINITION: Irritable bowel syndrome IBS is 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

It is coded in ICD 11 as DD91.0

8 SPECIFICATION OF INSTRUMENTS AND RELATED MEASUREMENTS: Entire study will be single examiner study.

1. Case taking Proforma

2. Outcome assessment tool Irritable Bowel Syndrome severity scoring scale IBSSSS Improvement of the patient will be determined from the help of pre validated scale

Classification of IBS severity using this scale is

Outcome assessment criteria

The Outcome will be assessed in terms of:

Improved If  Irritable Bowel Syndrome severity scoring scale is reduced than the previous Irritable Bowel Syndrome severity scoring scale., after taking homeopathic medicines.

Not Improved If  Irritable Bowel Syndrome severity scoring scale remains same after taking homeopathic medicines

 Outcome assessment criteria

The Outcome will be assessed in terms of

Improved If  Irritable Bowel Syndrome severity scoring scale is reduced than the previous Irritable Bowel Syndrome severity scoring scale., after taking homeopathic medicines.

Not Improved  If  Irritable Bowel Syndrome severity scoring scale remains same after taking homeopathic medicines.

SAMPLE SIZE

Though the sample size calculated is 31, but in this study minimum 40 sample sizeis taken

SAMPLING TECHNIQUE Non Probability Purposive Sampling.

3 METHODS OF DATA COLLECTION RELEVANT TO OBJECTIVE

a.      A. Non probability purposive sampling based on Inclusion and Exclusion criteria.

B. 40 cases will be recorded from outpatient department of the  institute.

C. Detailed homoeopathic case taking will be done as per the proforma  will be used for collecting and analysing data prepared to arrive at the  appropriate similimum.

D. Depending on the clinical presentation of the patient and totality erected, the patient will be administered indicated individualised homoeopathic medicine.

E. Posology will be selected as per the requirement of the case.

 4 STUDY INSTRUMENT  DATA COLLECTION TOOLS

1. Complete Homeopathic Case taking proforma to form Totality with Special Emphasis on Individualizing case

2. IBSSSS Scale will be used to assess the severity before and after  the treatment

3. Appropriate reference books like Homoeopathic Materia Medica, Medicine ,Surgery books, Pathology books, different Homoeopathic Journals, research paper will be considered

4**.** Appropriate Software will be used for repertorization of case

5 DATA MANAGEMENT AND ANALYSIS PROCEDURE

1.Framing of totality of symptoms  Will be done as per the principles of homoeopathy.

2.Selection of remedy  Homoeopathic remedy after referring Materia Medica.

3.The Posology Appropriate potency will be selected based on susceptibility of each case. Potency will be changed when required.

4.Duration of study

a.      Duration of study  18 months

b.      Duration of each case Each case will be studied for 8 months  or until remission of symptoms.

c.      Duration of follow up Each case will be followed up after 15 days or as and when required.

d.      Clinical outcome assessment will be done at base, 1 month, 3 months, 8 months and at termination of treatment

2. Normality of numerical data will be checked using Shapiro Wilk test or    Kolmogorov Smirnov test. Depending on the normality of data, statistical tests will be determined