TITLE OF THE TOPIC - “EFFICACY OF HOMOEOPATHY IN TREATING TYPE 2 DIABETES MELLITUS, EVALUATED USING GLYCOSYLATED HEMOGLOBIN AND SERUM LIPID PROFILE: AN INVESTIGATIVE STUDY ”
BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR STUDY:
DIABETES MELLITUS is a global endemic with rapidly increasing prevalence in both developing and developed countries. As per the study conducted in 2011 by International Diabetes Federation, there are 366 million people who have Diabetes Mellitus11. Out of that, 61.3 million are Indians11.
People with Type 2 Diabetes have an increased prevalence of lipid abnormalities, contributing to their high risk of cardiovascular diseases (CVD). An early intervention to normalize circulating lipids has shown reduction in cardiovascular complications and mortality.
Glycosylated Hemoglobin (or Glycated Hemoglobin, HbA1c) is a routinely used marker for long-term glycemic control.
This study is an attempt to evaluate the association between HbA1c and various lipid parameters, and to know whether HbA1c can be used as a potential biomarker for predicting dyslipidaemia in Type 2 Diabetic patients in addition to glycemic control.
In the absence of a definitive cure of Diabetes Mellitus, the management relies on controlling the blood sugar levels to as near as normal. Homoeopathy, being a medical system with holistic approach has a comprehensive treatment plan, which is not only limited to glycemic control alone, but also minimizing or preventing the progress of Diabetes Mellitus. The constitutional and organ specific remedies have played a good role in minimizing the complication and improving the sense of well-being as a whole.
Hence, this study is undertaken also to scientifically assess the action of Homoeopathy in Type 2 Diabetes Mellitus using Glycosylated Hemoglobin.
6.2 REVIEW OF LITERATURE:
DIABETES MELLITUS IN BRIEF:
Diabetes Mellitus (DM) is a clinical syndrome characterized by hyperglycemia due to absolute or relative deficiency of insulin. Lack of insulin affects the metabolism of carbohydrate, protein and fat and causes a significant disturbance of water and electrolyte homeostasis2.
Broadly classified into two main forms2:
Type 1 DM - Insulin Dependent Diabetes Mellitus (IDDM) or Juvenile onset diabetes.
Type 2 DM - Non-insulin Dependent Diabetes Mellitus (NIDDM) or Adult onset diabetes.
Type 1 DM results from autoimmune β cell destruction which leads to insulin deficiency. It accounts for approximately 10% of the cases7.
Type 2 DM is a heterogeneous group of disorders characterized by variable degrees of insulin resistance, impaired insulin secretion and increased glucose production. Approximately 80% to 90% of patients have type 2 diabetes7.
RISK FACTORS FOR TYPE 2 DIABETES MELLITUS1:
Family history of diabetes (i.e. parent or sibling with type 2 diabetes)
Obesity (i.e. ≥ 20% desired body weight or BMI ≥ 27 kg/m2 )
Age ≥ 45 yrs
Race /ethnicity (eg., African American, Asian American, Pacific Islander)
Previously identified impaired fasting glucose or impaired glucose tolerance.
History of Gestational Diabetes mellitus or delivery of baby over 9 lbs.
Hypertension (blood pressure ≥140/90mm Hg)
HDL Cholesterol level ≤ 0.90mmol/L (35mg/ dL) and /or a triglyceride level ≥ 2.82mmol/L (250 mg/dL)
Symptoms of diabetes plus random blood glucose concentration ≥ 11.1mmol/L (200mg/dL) or
Fasting plasma glucose ≥ 7.0mmol/L (126 mg/dL) or
Two hour plasma glucose ≥ 11.1mmol/L (200mg/dL) during an Oral glucose tolerance test.
According to American Diabetic Association (ADA), the diagnosis is based on four abnormalities: Hemoglobin A1c, Fasting blood glucose (FPG), random elevated glucose with symptom or abnormal Oral Glucose Tolerance Test (OGTT). Patients with Impaired Fasting Glucose (IFG) and/ or Impaired Glucose Tolerance (IGT) are referred to as having increased risk of diabetes15.
Diagnostic Criteria: The diagnosis of Diabetes Mellitus is easily established when a patient presents with classic symptoms of hyperglycaemia (thirst, polyuria, weight loss, blurry vision) and has a random blood glucose value of 200mg/dL (11.1mmol/L) or higher, and confirmed on another occasion15.
Measurement of glycated hemoglobin is the standard method for assessing long term glycemic control. When plasma glucose is consistently elevated, there is an increase in non-enzymatic glycation of hemoglobin; this alteration reflects the glycemic history over the previous 2 to 3 months, since erythrocytes have an average life span of 120 days1.
In Standardized assays, the A1c approximates the following mean plasma glucose levels: an A1c of 6% is 7.5mmol/L(135 mg/dL); 7% is 9.5mmol/L(170 mg/dL); 8% is 11.5mmol/L(205 mg/dL) etc.[A 1% rise in the A1c translates into a 2.0mmol/L(35 mg/dL) increase in the mean glucose]1.
For people without diabetes, the normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes12.
The test should be done twice yearly in all diabetics, but every 3 months for those who cannot achieve goal glucose levels, or whose treatment has been changed. Most diabetes societies agree that HbA1c levels should be below 6.5- 7% to minimize the risk of diabetes complications, such as kidney failure, blindness, stroke, and heart attack1.
Management of diabetic patient includes diet and lifestyle modifications, oral drug therapy (sulfonylureas, meglitinides, thiazolidinediones, and biguanides) and insulin therapy5.
Diabetes Mellitus is a chronic constitutional disease resulting from multiple causative factors like genetic, sedentary life style, obesity, stressful situations for a long time, etc. In Homoeopathic approach, importance is given on the individual characteristics8. Hence, Constitutional remedies are the best remedies in treating the patient. In cases where in there is paucity of symptoms, or constitutional picture is not clear, we can think of specific remedy. Some of the specifics used in the treatment of Diabetes Mellitus are Abroma augusta, Cephalandra indica, Syzygium jambolanum, Chionanthus virginica, Gymnema sylvestre, Glycerinum, Helonias dioica, Acid phosphoricum, Rhus aromatic etc9.
6.3 Objectives of The Study:
To assess the efficacy of Homoeopathy in Type 2 Diabetes Mellitus, evaluated using Glycosylated Hemoglobin and Serum Lipid Profile.
To evaluate the correlation between HbA1c and various lipid parameters in Type 2 Diabetes Mellitus: Glycosylated Hemoglobin as a dual biomarker.
MATERIALS AND METHODS
7.1 SOURCE OF DATA:
The subjects will be selected from the OPD, IPD and peripheral mobile centers of Father Muller Homoeopathic Medical College, Mangalore.
7.2 METHOD OF COLLECTION OF DATA:
A minimum of 30 cases based on inclusion and exclusion criteria will be selected for the study using purposive sampling technique.
All cases will be taken as per the Standardized Case Record of Father Muller Homoeopathic Medical College and Hospital.
The period of study will be 10 months.
HbA1c tests will be done every 3rd month.
Serum lipid profile will be done every 3rd month.
Homoeopathic prescription will be based on availability of patient specific or characteristic symptoms and if not, on disease specific ones. Due reference to the Homoeopathic Materia Medica and Repertory will be made as required by the case. The potency selection and repetition of the medicine will be done according to the demand of the case.
Diagnosed cases of Type 2 Diabetes Mellitus according to ADA criteria.
Both genders of age group 30 to 70 years.
Cases of Anaemia – iron, B12 or folate deficiency.
Those with abnormal hemoglobin, which behave differently from normal hemoglobin.
Homoeopathy is effective in treating Type 2 Diabetes Mellitus.
HbA1c can be used as a biomarker for dys-lipidaemia.
PLAN FOR DATA ANALYSIS:
The collected data will be analyzed by Mean, Standard deviation, Paired “t” test and by Karl Pearson Co-relation Coefficient.
7.3 Does the study require any interventions to be conducted on patients, or other humans (or animals)? If so please describe briefly.
Yes, HbA1c and serum lipid profile will be done every 3rd month.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
LIST OF REFERENCES
Kasper –Braunwald – Fauci – Hauser – Jameson – “HARRISON’S PRINCIPLES OF INTERNAL MEDICINE” – Sixteenth edition – McGraw Hill Medical Publishing Division ,2005 – pg.no.2152 to 2154, 2172.
Haslett – Chilvers – Hunter – Boon – “DAVIDSON’S PRINCIPLES AND PRACTICE OF MEDICINE” – Eighteenth edition – Churchill Livingstone Elsevier Ltd, 2000 – pg.no.472 to 482,489,490.
Thomas M. Delvin – “TEXTBOOK OF BIOCHEMISTRY WITH CLINICAL CORRELATIONS” – Sixth edition – A John Wiley & Sons, Inc., Publication – pg.no.110.
Jeromy M. Berg – John L.Tymoczko – Lubert Stryer – “BIOCHEMISTRY” – Fifth edition – W.H.Freeman and Company, England – pg.no.858,859.
Praveen Kumar – Michael Clarke – “ KUMAR AND CLARK CLINICAL MEDICINE” – Sixth edition – Elsevier Saunders, 2005 – pg.no.1106 to 1113.
Lawrence M. Tierney, Jr. – Stephen J. Mcphee – Maxine A. Papadakis – “CURRENT MEDICAL DIAGNOSIS & TREATMENT” – 2004 – Forty third edition – Lange Medical Books/ McGraw Hill Companies – pg.no.1151,1152,1159.
Kumar – Abbas – Fausto – “ROBBINS AND COTRAN PATHOLOGIC BASIS OF DISEASE” – Seventh edition – Elsevier Saunders, 2005 – pg.no.1190,1195,1202.
Samuel Hahnemann – “ORGANON OF MEDICINE” – Sixth edition, BJain Publishers (P) Ltd.
Boericke William – “NEW MANUAL OF HOMOEOPATHIC MATERIA MEDICA WITH REPERTORY” Third revised and augmented edition based on ninth edition, B.Jain Publishers (P) Ltd,New Delhi – pg.no.828,1080.
KrishnaDas K V – “TEXTBOOK OF MEDICINE” – Fifth edition – Jaypee Brothers Medical Publishers (P) Ltd,2008 – pg.no.547,551,553.
Homoeopathy For All – The complete health monthly magazine – Vol.13 No.11 (155) November 15, 2012 – 207 Essel House 10, Asafali Road, New Delhi – pg.no.70 to 73.
http://diabetes.webmd.com/guide/glycated-hemoglobin-test-hba1c - Accessed on 12/2/2013.
http://www.health24.com/medical/Tests_Procedures/777-4197,44911.asp - Accessed on 12/2/2013.
http://en.wikipedia.org/wiki/Glycated-hemoglobin - Accessed on 8/1/2013.
http://www.uptodate.com/contents/diagnosis-of-diabetes-mellitus - Accessed on 12/2/2013.
SIGNATURE OF THE CANDIDATE
REMARKS OF THE GUIDE
11.1 NAME AND DESIGNATION OF GUIDE (In block letters)
DR M. K. KAMATH, MD (HOM),
DEPT. OF PRACTICE OF MEDICINE, FATHER MULLER HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE, MANGALORE.