Rajiv Gandhi University of Health Sciences s184

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA, ANNEXURE-II

APPLICATION FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE Dr HARINARAYANAN. A AND ADDRESS FATHER MULLER HOMOEOPATHIC (IN BLOCK LETTERS) MEDICAL COLLEGE AND HOSPITAL, UNIVERSITY ROAD, DERALAKATTE, MANGALORE, KARNATAKA - 575018

PERMANENT ADDRESS Dr HARINARAYANAN. A S/O KRISHNAN A ALINGAL HOUSE VETTOM P.O, TIRUR MALAPPURAM, KERALA - 676102

2. NAME OF THE INSTITUTION FATHER MULLER HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE, MANGALORE

3. COURSE OF THE STUDY & M.D.(HOM) SUBJECT ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY

4. DATE OF ADMISSION TO THE 16/07/2012 COURSE

5. TITLE OF THE TOPIC : “EFFICACY OF HOMOEOPATHY IN METABOLIC SYNDROME – CASE STUDY ”

6. BRIEF RESUME OF THE INTENDED WORK 1 6.1 NEED FOR THE STUDY:

WHO states, Metabolic Syndrome is a group of disease comprising of diabetes, hypertension, hyper lipidemia, and obesity.

It is estimated that around 20 – 25% of the world’s adult population have the metabolic syndrome and they are twice as likely to die from and three times as likely to have a heart attack or stroke compared with people without the syndrome. Metabolic Syndrome is also considered as an emerging epidemic in developing East Asian countries including China, Japan, Korea, and India.

Rapid nutritional and life style transition in urbanized areas in various countries in south Asia are prime reasons for increasing prevalence of Metabolic Syndrome. The clustering of cardio vascular disease (CVD) risk factors that typifies the Metabolic Syndrome is now considered to be the driving force for a new CVD epidemic.

Epidemiologist in India and nutritional agencies such as World Health Organization (WHO) has been sounding an alarm on the rapidly rising burden of CVD for the past 15 years. It is estimated that by 2020 CVD will be the largest cause of disability and death in India, with 2.6 million Indians predicted to die due to CVD.

APHORISM 5

“ Useful to the physician is assisting him to cure are the particulars of the most probable exciting cause of the acute disease, as also the most significant points in the whole history of the chronic disease, to enable him to discover its fundamental cause, which is generally due to a chronic miasm. In these investigations, the ascertainable physical constitution of the patient (especially when the disease is chronic), his moral and intellectual character, his occupation, mode of living and habits, his social and domestic relations, his age, sexual function etc. are to be taken into consideration” 5

Homoeopathically Metabolic Syndrome comes under chronic disease, which occurs due to fundamental cause (Miasm). It has got a special role in developing the disease and its

2 progress. Considering the mortality rate due to consequences of metabolic syndrome is very high in today’s scenario. Hence I think it is right time to evaluate the scope of homoeopathy in this highly burden disease of modern era.

6.2 REVIEW OF LITERATURE:

THE METABOLIC SYNDROME:

The metabolic syndrome consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease and diabetes mellitus. The criteria for the metabolic syndrome have evolved since the original definition by the World Health Organiza- tion in 1998. The major features of the metabolic syndrome include central obesity, hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension2.

The main value of grouping these disorders as a syndrome, however, is to remind clin- icians that the therapeutic goals are not only to correct hyperglycemia but also to manage the elevated blood pressure and dyslipidemia that result in increased cerebrovascular and cardiac morbidity and mortality in these patients4.

In patients with type 2 diabetes excessive production of glucose in the liver and under - utilization of glucose in skeletal muscle result from resistance to the action of insulin. A characteristic feature of type 2 diabetes is that it is often associated with central obesity, hypertension, and dyslipidemia. It has been suggested that coexistence of this cluster conditions, all of which predispose to cardio - vascular disease is a specific entity called as INSULIN RE- SISTANCE SYNDROME / METABOLIC SYNDROME / SYNDROME X1.

EPIDEMIOLOGY

Greater industrialization worldwide is associated with rising rates of obesity, dramati- cally increase prevalence of the metabolic syndrome, especially as the population ages2.

ETIOLOGY

 Insulin Resistance

3  Increased Waist Circumference

 Dyslipidemia

 Glucose Intolerance

 Hypertension

CLINICAL FEATURES

The metabolic syndrome is typically asymptomatic. On physical examination, waist circumference may be expanded and blood pressure elevated. The presence of one or either of these signs should alert the clinician to search for other biochemical abnormalities that may be associated with the metabolic syndrome2.

SYMPTOMS

Having metabolic syndrome means you have three or more disorders related to your metabolism at the same time, including:

1. Obesity: with your body fat concentrated around your waist (having an "apple shape"). For a metabolic syndrome diagnosis, obesity is defined by having a waist circumference of 40 inches (102 centimeters or cm) or more for men and 35 inches (89 cm) or more for women, although waist circumference cutoff points can vary by race.

2. Increased blood pressure: meaning a systolic (top number) blood pressure measurement of 130 millimeters of mercury (mm Hg) or more or a diastolic (bottom number) blood pressure measurement of 85 mm Hg or more.

3. High blood sugar level: with a fasting blood glucose test result of 100 milligrams/deciliter (mg/dL), or 5.6 millimoles per liter (mmol/L), or more.

4. High cholesterol: with a level of the blood fat called triglycerides of 150 mg/dL, (1.7

4 millimoles/liter or mmol/L) or more and a level of high-density lipoprotein (HDL) cholesterol — the "good" cholesterol — of less than 40 mg/dL (1.04 mmol/L) for men or 50 mg/dL (1.3 mmol/L) for women.

Having one component of metabolic syndrome means you're more likely to have others. And the more components you have, the greater are the risks to your health7.

DIAGNOSIS

Several organizations have criteria for diagnosing metabolic syndrome. These guidelines were created by the National Cholesterol Education Program (NCEP) with modifications by the American Heart Association. According to these guidelines, you have metabolic syndrome if you have three or more of these traits:

 Large waist circumference, greater than 35 inches (89 cm) for women and 40 inches (102 cm) for men. Certain genetic risk factors, such as having a family history of diabetes or being of Asian descent — which increases your risk of insulin resistance — lower the waist circumference limit. If you have one of these genetic risk factors, waist circumference limits are 31 to 35 inches (79 to 89 cm) for women and 37 to 39 inches (94 to 99 cm) for men.

 A triglyceride level higher than 150 mg/dL (1.7 mmol/L), or you're receiving treatment for high triglycerides.

 Reduced HDL ("good") cholesterol — less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women — or you're receiving treatment for low HDL.

 Increased blood pressure, meaning a systolic (top number) blood pressure measurement of 130 millimeters of mercury (mm Hg) or more or a diastolic (bottom number) blood pressure measurement of 85 mm Hg or more.

 Elevated fasting blood sugar (blood glucose) of 100 mg/dL (5.6 mmol/L) or higher, or you're receiving treatment for high blood sugar7.

NCEP:ATPIII 2001 IDF Criteria for Central Adiposity

5 Three or more of the following: Waist Circumference Central obesity: Waist circumference rev Women Ethnicity >102 cm (M), >88 cm (F) iou sly Hypertriglyceridemia: Triglycerides dia ≥150 mg/dL or specific medication gn ose Low HDL cholesterol: <40 mg/dL d and <50 mg/dL, respectively, or typ specific medication e 2 Hypertension: Blood pressure ≥130 dia mm systolic or ≥85 mm diastolic or bet specific medication es Men Fasting plasma glucose: ≥100 mg/dL ≥94 cm ≥ 80 cm or specific medication or Europe, Sub- Saharan African, Eastern & Middle Eastern ≥90 cm ≥80 cm South Asian, Chinese, and ethnic South & Central American ≥85 cm Japanese ≥90 cm Two or more of the following: Fasting triglycerides >150 mg/dL or specific medication HDL Blood pressure >130 systolic or >85 mm dias Fasting plasma glucose ≥100 mg/dL or previously diagnosed type 2

6 diabetes(Abbreviations: NCEP:ATPIII, National Cholesterol Education Program, Adult Treatment Panel III; IDF, International Diabetes Foundation; HDL, High-Density Lipopro- tein.)

The diagnosis of the metabolic syndrome relies on satisfying the criteria listed in Ta- ble-1 using tools at the bedside and in the laboratory. Because the NCEP: ATPIII and IDF criteria are similar, either can be used2.

LABORATORY TESTS

Fasting lipids and glucose are needed to determine if the metabolic syndrome is present. The measurement of additional biomarkers associated with insulin resistance must be individualized2.

COMPLICATION

Having metabolic syndrome can increase your risk of developing these conditions:

1. Diabetes

If you don't make lifestyle changes to control your insulin resistance, your glucose lev- els will continue to increase. You may develop diabetes as a result of metabolic syndrome.

2. Cardiovascular disease.

High cholesterol and high blood pressure can contribute to the buildup of plaques in your arteries. These plaques can cause your arteries to narrow and harden, which can lead to a heart attack or stroke7.

TREATMENT

A lifestyle intervention that includes weight reduction, dietary fat restriction, and increased physical activity is the primary approach to the disorder. The next goal is to control the 7 hyperglycemia and lipid parameters2.

HOMOEOPATHIC UNDERSTANDING

Probably the type of glandular imbalance we meet most frequently is diabetes mellitus. We must remember that once insulin therapy is established, it tends to become necessary to the patient and there is little hope of establishing normal balance. Therefore it is more practical to begin treatment by the use of the homoeopathic remedy, for we can always go to insulin later if this is necessary. We find suitable remedies for Sugar in Urine in the repertories, and most of the remedies listed are deep in action or are closely related to emotional states. It is possible that his symptoms are so clearly marked that the indications for a constitutional remedy cannot be overlooked, even though his remedy has not been proven to produce the sugar imbalance3.

6.3 OBJECTIVES OF THE STUDY

1. A clinical understanding about metabolic syndrome in selected subjects.

2. To evaluate the efficacy of homoeopathic treatment in case of Metabolic Syndrome.

7. MATERIALS AND METHODS

7.1. SOURCE OF DATA

The subjects of the study will be selected from the patients with metabolic syndrome attending OPD, IPD, peripheral centers of Fr Muller Homoeopathic medical college hospital as per inclusion criteria.

7.2 METHODS OF COLLECTION OF DATA

The Materials used for the Study:

8 A sample of minimum 30 cases as per the inclusion criteria will be studied, every case will be represented in standardized case record, according to the guidelines given in the SCR cases would be analyzed, totality would be erected and suitable remedy would be administered. Reference from materia medica and repertory will be taken whenever required. The potency selection and repetition of the doses will be done according to the demand of the case, with consideration of potency selection criteria. Each case will be reviewed in every 2 months with estimation of FBS, Lipid Profile and HTN and total duration of study would be 6 months. Follow-ups will be watched and analysed as per the scoring set for each case.

INCLUSION CRITERIA  Those subjects fulfills the Diagnostic criteria according to NCEP : ATP III 2001 and IDF criteria for central adiposity  Subjects belong to both sexes  Subjects belong to all socio economic classes  Age group in between 30 to 50 years.  Had continued homoeopathic treatment for at least 6 months

EXCLUSION CRITERIA

 Subjects presents with complications of Diabetes Mellitus or Dyslipidemia.  Those cases have irregular or very few follow ups.

RESEARCH HYPOTHESIS

Homoeopathy is effective in Metabolic Syndrome.

NULL HYPOTHESIS

Homoeopathy is not effective in Metabolic Syndrome.

METHOD OF ANALYSIS

The collected data will be studied and analysed by using appropriate statistical study based on the disease intensity scoring before and after the treatment.

9 7.3 Does the study require any interventions to be conducted on patients, or other humans (or animals)? If so please describe briefly.

Yes, Fasting Blood Sugar, Lipid Profile, and recording of Blood Pressure.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes, enclosed.

8. LIST OF REFERENCES

10 1. DAVIDSON, Principles and Practice of Medicine, Churchill Livingstone, 20th edition, chapter 21.

2. HARRISON, Principles of Internal Medicine, McGraw – Hill companies, Inc. 17th edition, Chapter 338.

3. ROBERTS H. A, The Principles and Art of cure By Homoeopathy, B.Jain publishers, chapter XXXII.

4. STEPHEN J. MCPHEE, MD Current Medical Diagnosis & Treatment 2008, Mc- Graw – Hill companies, Inc.

5. SAMUEL HAHNEMANN, Organon Of Medicine 6th edition, B.Jain publishers.

6. www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004546

7. www.mayoclinic.com/health/metabolic%20syndrome/DS00522

8. www.emedicine.medscape.com/article/165124

SIGNATURE OF THE 9. CANDIDATE. 10. REMARKS OF THE GUIDE.

11 11. 11.1. NAME AND Dr HERALD ROSHAN PINTO DESIGNATION OF GUIDE BHMS, MD (HOM) DEPT. OF ORGANON OF MEDICINE AND (IN BLOCK LETTERS). HOMOEOPATHIC PHILOSOPHY, FR. MULLER HOMOEOPATHIC MEDICAL COLLEGE, DERALAKATTE, MANGALORE

11.2. SIGNATURE.

11.3. CO-GUIDE. 11.4. SIGNATURE.

11.5. HEAD OF THE Dr SHIVAPRASAD K DEPARTMENT. B.Sc, BHMS, MD (HOM), PROFESSOR & HOD, DEPT. OF ORGANON OF MEDICINE AND HOMOEOPATHIC PHILOSOPHY, FR. MULLER HOMOEOPATHIC MEDICAL COLLEGE, DERALAKATTE, MANGALORE

11.6. SIGNATURE.

12. 12.1. REMARKS OF THE CHAIRMAN & PRINCIPAL.

12.2. SIGNATURE.