impact of homeopathic medicine -...

Running head: IMPACT OF HOMEOPATHIC MEDICINE 1

Research Proposal: How would a Type 2 diabetic patient’s Hemoglobin A1c and weight

be impacted, if there were an increased concentration on homeopathic medicine vs. the standard

current Diabetic therapy alone?

Deanne Maddox, David Keim, Briana Jones, Emma Kammann

Old Dominion University

IMPACT OF HOMEOPATHIC MEDICINE 2

Abstract

Aim: To assess whether increased homeopathic influence among Type II diabetic patients can

lead to lowered Hemoglobin A1c levels, a decrease in body mass index (BMI), healthier life

choices, and less dependence on pharmaceuticals.

Background: Diabetes in on the rise throughout the nation with nutritional choices becoming a

predecessor. The Hampton Roads area largely promotes prevention of diabetes through pre-

diabetic nutrition and pharmaceuticals such as Metformin. For many patients, insurance will not

cover the cost of pre-diabetic nutrition without an official diagnosis of diabetes. This leaves the

patient to either claim the diagnosis in their medical records or rely on the next cost effective

plan of cheap pharmaceuticals. Local pharmacies such as Harris Teeter supply these medications

for free. This further promotes the cycle of pharmaceutical dependence that plagues our country.

Methods: A randomized pretest posttest control group will be used to measure the effect,

interest, and comprehension of the homeopathic approach to diabetes. Based on the theory of

Risk vs Reward, it is hypothesized that an individual with Type II diabetes would be adherent to

a homeopathic approach instead of prescription intervention, by evidence of lowered

Hemoglobin A1c and BMI. After the Diabetic education intervention, all participants will

verbalize preference for continued care with choices to include prescription or homeopathic

intervention.

Analysis: Participant survey data will be analyzed using inferential statistics. A pretest Likert

scale survey will be used to measure program feasibility and individual need. Hemoglobin A1c

lab work and BMI will be completed as pretest posttest response to intervention. Means of this

data will be compared and a T-Test will analyze for any statistical difference. In correlation with

the Risk vs. Reward theory, if there are significant change between the pretest posttest it would


be concluded that the homeopathic intervention had a positive effect on Type 1 diabetic patients.

This is the expected outcome of this study.

Limitations: Limitations of this research study include participant selection bias and limited

sampling audience.

The Effect of Homeopathic Intervention on a Type 2 Diabetic Patient’s Hemoglobin A1c

With Prevention and Treatment

In many cases, diabetes can be prevented. Lifestyle changes significantly reduce the risk

of developing diabetes – including, but not limited to, reducing caloric intake, and increasing

physical activity. Diet is an essential component of prevention and treatment, as obesity can

increase the disease’s metabolic process. Insulin is used to manage glucose levels; the dose

varies depending on the patient’s target blood glucose level. Glucose levels are influenced by

carbohydrate consumption (American Diabetes Association, 2017). Understanding starch,

sugars, and fiber is essential to diabetes management. People with diabetes should be able to

successfully count the number of carbohydrates consumed during each meal and adjust the dose

of insulin according to their glucose levels (CDC, 2016). Making healthy food choices such

reducing portion size, consuming more vegetables, and increasing physical activity are long term

ways to manage and even reverse diabetes.

Prevention starts before the onset of the disease, a vital component in managing and

treating diabetes. Pre-diabetes prevention measures for patients with higher than normal glucose

levels are non-insulin dependent, homeopathic treatment. The Center for Disease Control offers a

yearlong program encouraging long lasting lifestyle changes. The program teaches healthy eating

habits, ways to increase physical activity, and methods to track food intake. The support group


encourages goal setting, as well as stress coping skills to ensure long-term results from the

program. (CDC, 2016). Prevention programs are not limited to pre-diabetic patients. The

changes that are necessary for diabetic patients to reverse diabetes are discussed in the risk

versus reward section.

Introduction

Diabetes mellitus is a common disease throughout the world. According to the CDC

reports for 2014, there were 29.1 million people with diabetes just in the United States alone

(CDC, 2015). Diabetes is a debilitating disease, if not treated properly, and it can have

devastating effects on the body. Therefore, it is necessary to have in place the best possible

treatment plans for all diabetics. Today, the standard treatment is primarily a change in diet and

medication. In the western hemisphere, some diabetic patients rely on modern medicine alone

for their standard everyday treatment. Some patients do not change their treatment plan

regarding their diet and daily activities. In other areas of the world, people have an increased

concentration on homeopathic approach in addition to their standard treatment. It is then

necessary to research the effects of homeopathic treatments for development of more

comprehensive treatment plans for the diabetic population. We have chosen a small part of the

local area in which to conduct our study. The region of Hampton Roads is located in the western

hemisphere and widely reliant on western medicine. The diabetic population of Hampton Roads

consists over 175,000 people (Hampton Roads Community Health, 2016.). Would there be any

improvements in diabetic type II patient population outcomes, considering their Hemoglobin

A1C and daily weights, with their treatment plans including homeopathic treatment rather than

traditional western medications alone?


Background

Approximately 1.4 million Americans are newly diagnosed with diabetes each year (American

Diabetes Association, 2016.) By the year 2050 it is expected that a third of the population will

be subjected to the diagnosis. A combination of comorbidities and unhealthy lifestyle have set a

nation to face the reality of growing portion size and waist lines. With Diabetes, treatment varies

per type. While type I and type II differ, they are both heavily dependent on diet and exercise.

(Mayo clinic, 2017.) Type I diabetes utilizes insulin, carbohydrate counting, and blood sugar

monitoring. Type II diabetes involves blood sugar monitoring, insulin use, and additional

pharmaceuticals.

In monitoring blood sugars, a specific range is set and the patient is usually self-testing

anywhere between 1-8 times daily, depending on the severity of disease. These patients are also

likely to have their HGBA1c (Hemoglobin A1c) checked every 3-6 months. This gives the

physician an accurate idea of how a patient is controlling their blood sugar levels. Insulin is an

injectable medication used in combination with meals to regulate the blood glucose. It can be

injected or worn around the clock as a pump. Type I diabetics must use insulin to live, while

type II diabetics may or may not need insulin. Oral medication, such as Metformin, can also be

used to help control type II diabetics. While some medications stimulate insulin formation, other

can inhibit it. The correct balance of medications, administered at the correct time in accordance

with food, will keep the diabetic within a stable blood glucose range. Additionally, treatments

explored for type I diabetics include pancreatic transplants; and for type II, bariatric surgery for

weight loss.

Because incidence has become so high, prevention and delaying have now become the

focus for diabetes. Patients are now referred, after close monitoring, to programs based on


lifestyle changes (CDC, 2016.) Unfortunately, even with this intervention, diabetes continues to

grow in numbers. What is the missing link? Why are programs not working? Where are, we

going wrong? The reality becomes that the education provided to the population is not

processing for long term application per patient. Both demographics and lifestyle changes

remain high risk factors (EVMS, 2017) in the population.

Since diabetes is a treatable disease, this leads us to observe the continuing phenomena

from a patient perspective. Why risk the diagnosis of diabetes? It could be that pharmaceuticals,

and dramatically presented lifestyle changes, are not being weighed as beneficial to the patient.

A homeopathic approach to lifestyle changes could be more beneficial in the long term. When

the risk equals or outweighs the reward- in line with the patient’s capabilities- the patient may be

more willing to abide to lifestyle changes. Could the addition of homeopathic techniques make

the difference that people need?

The Population of Diabetes

As of March 2016, it is estimated that 175,000 people have diabetes in the Hampton Roads

area (Hampton Roads Community Health, 2016.) Community medical screenings have been

implemented for those with exceptional need. Local food banks have collaborated with health

organizations to provide screenings and resources like WIC (Women in Crisis programs 2017),

available for those with moderate or less than moderate incomes, providing nutritional support.

Fundraisers and social support are offered through the local American Diabetes Association

(American Diabetes Association, 2017). A plethora of information and opportunity is available;

yet still no decline in prevalence.


The Strelitz Diabetes Center of Eastern Virginia Medical School has described Hampton

Roads as a ‘Hotbed’ for diabetes, focusing research not only on treatment, but also on identifying

biomarkers/ triggers (EVMS, 2017.) Through clinical trials, they can supply critical data for the

population, gaining data to what is pushing the disease, as well as optional treatments/methods of

approach. Their current research identifies risk factors as age, hypertension, race (specifically

Type 2 higher prevalence in Indian, Hispanic, Black, Asian,) family history, weight, activity,

gender (men higher,) and unhealthy eating (EVMS, 2017.)

It is likely, that the addition of the homeopathic approach could be more beneficial to a

Type 2 diabetic patient than the current education and treatment provided. Through the support

of local charities and organizations, nutrition, and exercise classes along with medications

remain at the forefront of the fight against diabetes. The area left lacking is the direct approach

of action, such as cooking classes and mental wellness. Patients also face the obstacle of

insurance coverage.

In personal experience, we have seen insurance companies refuse coverage of prediabetes

nutrition classes, even when ordered by a physician. Companies will not provide coverage until

the patient has been officially diagnosed with diabetes. However, once a patient has been

diagnosed, they remain on a company diabetic registry for 2 years and are subject to 6 month

follow ups, as well as labs. This can be a financial strain for those with high deductibles unable

to afford the follow up visits or medication costs. Many people are caught in a financial gap

where they do not qualify for assistance yet also cannot meet their high insurance costs.

On the pharmaceutical end, companies such as Walmart have begun to provide patients

with low cost $4 copays (Walmart.com, 2017.) This has become an incentive for the use of

pharmaceuticals instead of lifestyle change. When the monthly disease control cost could be $4


versus the cost of eating healthy, people tend to choose the economical route. The first step in

implementing a homeopathic approach is application to the patient. We can no longer hand out

pamphlets and preach to deaf ears hoping for change. Instead of implementing medication

regimens right away, education should start with the basic level of lifestyle including mind,

body, and soul. The mind must be accepting and prepared for action, the body given the right

fuel, and the soul free of turmoil. A patient must be balanced to comprehend the risk and decide

for long term the benefits of reward. Pharmaceuticals and general education of diet and exercise

have been a longtime push in the Hampton Roads area. An in-depth homeopathic approach

could provide more acceptance to the diabetic control lifestyle.

Patient Knowledge of Nutrition and Homeopathic Approach in Relation to Diabetic

Control

Homeopathic treatment of diabetes starts with learning how to properly read food labels,

reducing white sugar intake, increasing physical activity, and increasing fiber intake. Whole

grains and vegetables are lower in glucose and prevent blood sugar spikes (hyperglycemia).

Anti-diabetic medication and insulin treatment control the symptoms of diabetes, but do not cure

the disease. Lifestyle changes can reverse diabetes and result in a life independent from insulin.

Insulin treatments lower glucose levels, increasing the risk of hypoglycemia. Type II diabetes

develops when the pancreas cannot supply enough insulin to maintain homeostasis. The food

consumed is converted into glucose, which the body uses for energy. Excessive glucose is stored

as fat. Homeopathic therapy focuses on the dietary and lifestyle changes that help control blood

glucose naturally; without medication. The changes are gradual, but offer long term health

benefits.


Nutritional labels identify the serving size and the number of servings in the product.

The daily percent values are for the entire day, based on a 2,000-calorie diet. Diabetics should

pay close attention to carbohydrate values, which include sugar, starch, and fiber. Fructose and

lactose are natural forms of sugar and sucrose is a refined sugar. However, nutrition is not

limited to reading labels. For diabetic patients, understanding glycemic index is critical nutrition

topic. Glycemic index measures, on a scale of 0-100, how quickly foods are digested and

absorbed. Rapidly absorbed foods case a sudden increase in blood sugar (Kimball, M., 2013).

Processed foods high in sugar have a higher glycemic index and cause hyperglycemia. Whole,

minimally processed food such as fruits, vegetables, and food high in fiber are absorbed more

slowly and cause a minimal rise in blood glucose. The slow digestion and absorption rate

prolongs the feeling of being satisfied. High fiber, hypoglycemic diets ensure blood

glucose levels are within normal limits, which is essential to managing diabetes.

Risk vs Reward

The process of weaning off anti-diabetic medication can be intimidating, especially for an

insulin dependent diabetic. Before transitioning off insulin, the patient will need to monitor

HGBA1C levels and prepare their body for the transition. The medication dosage should be

decreased slowly and the amount of food consumed during each meal should be closely

monitored (CDC, 2016). This transition should be gradual to minimize any adverse effects.

Patient education and knowledge related to reading nutritional labels is essential. Upon

successful transition, the patient will enjoy a life free of insulin dependence and have a greater

understanding of what foods are necessary to maintain healthy glucose levels. Improved


nutrition and increased physical activity results in weight loss and decreased risk for other

diseases related to obesity and having a sedentary lifestyle (CDC, 2016).

Significance

Diabetes can be a debilitating disease and can cause many harmful effects for any

diabetic patient. Developing the most inclusive care for these patients is crucial for their health.

That is why a thorough assessment should be done in planning the care for these

patients. Thorough research is important regarding potential areas that may be beneficial to the

diabetic patient population and their treatment plans. Therefore, it is essential to research areas

such as the addition of homeopathic treatment on the type II diabetic patient population, to

further the development of more comprehensive treatment plans for diabetic patients.

Methods

Design

A randomized pretest posttest control group will be used to measure the effects, interest,

and comprehension of the homeopathic approach to diabetes. The design is chosen to avoid any

generalization that may occur between current lifestyle changes used in diabetic prevention and a

homeopathic approach; which could happen in the posttest only design. Diabetic patients’

baseline knowledge of lifestyle changes, nutrition, and personal management will be evaluated

through a survey. Subjects will be placed into the control or experimental group through random

assignment. Random assignment will then dictate independent variable manipulation, which will

assist in identifying effects of treatment. Hemoglobin A1c and measurement of BMI pre-and

post-testing will reduce threats to validity of the study. The dependent variable will be the


change in BMI and HgbA1c at the end of the study as compared to before the study.

Intervention of an individualized homeopathic teaching plan (cooking, lifestyle, mental health)

will occur with experimental group only and is representative of the independent variable. The

post test will follow patients over 3 months’ time. Upon completion, there will be an analysis of

HgbA1c, measure of BMI, and interview of lifestyle changes from the start of the study. Based

on the risk vs reward model, it is hypothesized that Type II diabetic patients who participate in

homeopathic teaching (to include cooking, lifestyle, mental health) will adhere to lifestyle

changes preventing/muting diabetes and improving health for a longer period than for those who

do not participate in homeopathic teaching.

Sample

The sample population are individuals in the Hampton Roads area who are currently

diagnosed with Type II diabetes. In utilizing accessible population through EVMS, purposive

sampling will include 400 patients from Eastern Virginia Medical School (EVMS,) Hampton

Roads Community Health (HRCH,) and American Diabetes Association of Norfolk (ADAN.)

To reduce sampling error, participants will be selected based on documented diagnosis of Type

II diabetes only, of adult age, and in the Hampton Roads area.

Procedure

Utilizing a pretest posttest design, the 400 participants from EVMS, HRCH, ADAN will be

randomly assigned to either the experiment or the control group for a total of 50 participants.

The 50 participants will be divided equally and randomly into eight groups. Four groups are to

be assigned to the control group, and four to the experimental group. Once assigned to groups,

participants will complete a Diabetes Health Survey (see Appendix) with focus on current


diagnosis, treatment, lifestyle, and daily living. Each participant will submit to a simple

HGBA1c lab test and BMI measurement for starting values.

The control group will be given journals to document any significant changes and will

follow up through telephone, online, or in office interview over a three-month period time-

continuing their current regiment of treatment with no addition of homeopathic teaching. The

experiment group will receive a journal as well, along with an individualized homeopathic

intervention plan to include weekly one hour sessions in group cooking, shopping healthy

(reading nutrition labels,) and mental health sessions as needed. After three months’ time, the

subjects will receive a lab slip to complete a HGBA1c, BMI measurement, and an in-person

interview to asses mental and general health.

The homeopathic education will include hands on cooking classes, shopping smart field

trips utilizing nutrition label education, group therapy of social interaction and support, group

yoga/exercise, and goal setting. Personal progress and reflection will be reported in each journal

and compared along with HGBA1C and weight results at study’s end for calculating success

rate.

Instruments

Study participants will complete the Diabetes Health Survey 2017 (see Appendix) as a

descriptive study of the sample. Data collected in the survey will highlight areas of need, thus

allowing the research team to manipulate the independent variables to an individualized

intervention that is hypothesized to have a positive impact. The greatest personal risk will be

identified allowing the most comparable impact for highest reward and outcome. Validity and

reliability will remain satisfied with the beginning and end assessment of each patients HGBA1c


value and BMI measurement. Reliability is the consistency of each test, and validity is the

accuracy. The goal after three months is a lower number and weight loss.

Internal consistency and reliability will be kept using local DNV accredited

Laboratories/sites to complete all bloodwork and BMI measurements (DNV Healthcare, 2017.).

The main study variable outcome being nominal subjects will be classified as: above, below, or

in range of their targeted blood glucose and weight level. A review of journals will provide a

predictive validity throughout the study. A Likert-scale response survey will be used to study

and identify subject’s area of need. Three levels of response will include: yes, somewhat, and

no. By using the word somewhat, we avoid forced-choice responses of yes or no (Fain, 2015.)

This provides a more accurate measure for intervention variables as well.

Analysis

Survey data analysis will provide guidance to individualized intervention. While it will

remain verbally anonymous, placement into any specific intervention group would be subjective

to participants. Overall study data will be analyzed as inferential statistics. Utilizing a

randomized pretest posttest control and experimental group, data will be compiled nominally. A

comparison of HGBA1c value along with BMI will serve as statistical implication of the study.

The means of these sets of data will be analyzed for statistical significance in a T-test. Journal

entries will be explored for any outlying data and compiled in a Mann-Whitney U test to

determine significance.

In accordance with the Risk vs. Reward theory, any significant improvement to a patients

HGBA1c or BMI will result in an indication of agreement with the hypothesis. This includes the

control and the experimental group, as both are subjected to intervention although unintentional.


The control group will be utilizing a journal which may bring unprecedented awareness to one’s

health reflecting in unknown intervention. The experimental group will serve as significance;

however, the control may be altered as well (Fain, 2015.) Data and interview responses can be

considered for overall analysis to determine which interventions may provide greatest results in

future studies.

Protection of Human Subjects

Subjects involved in this study are mentally healthy, community dwelling individuals

ages 18-70 diagnosed with Type II Diabetes living in Hampton Roads. Data will be collected

through survey analysis and journal analysis. Risks for participation are extremely low, but may

include psychological upset while answering survey questions or journaling, breech of

anonymity by fellow participants during group interview, and the risk of physical injury that

accompanies any exercise routine. Survey responses and individual interviews will be kept

confidential; however, anonymity will remain among subjects only as far as selection into

intervention groups. Benefits to participating in this study include an individualized

homeopathic health routine and all included instruction free of charge and the potential to better

the diabetes community. All participants must sign an informed consent stating that they

understand they are being asked to participate in a research study, that they understand the risks,

that their information will be kept confidential, and that they can leave the study at any time. All

questions regarding study and interventions will be addressed both in group and individual

interview. Approval for study will be sought through the FDA and EVMS Institutional Review

Board.


Limitations

The limitations of this research study include amount of time conducting research,

participant selection bias, research population size, number of available participants in the

Hampton Road's area, and the inclusion of patient's other health factors contributing to their

illness. Further research studies should be completed for more conclusion and less limitations

for this topic.


References

2014 National Diabetes Statistics Report. (2015, May 15). Retrieved from CDC:

https://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html

American Diabetes Association (ADA). (2017). Norfolk, VA. Retrieved from:

http://www.diabetes.org/in-my-community/local-offices/norfolk-virginia/

American Diabetes Association (ADA). (2016). Statistics About Diabetes. Retrieved from:

http://www.diabetes.org/diabetes-basics/statistics/?loc=db-slabnav

Center for Disease Control and Prevention (CDC). (2016). National Diabetes Prevention

Program. Retrieved from: https://www.cdc.gov/diabetes/prevention/index.html

Det Norske Veritas (DNV). (2017). Healthcare. Retrieved from: http://dnvglhealthcare.com/

Eastern Virginia Medical School (EVMS). (2017). Diabetes Library Display. Retrieved from:

https://www.evms.edu/media/evms_public/departments/internal_medicine/

strelitz_diabetes_center/DIABETES_LIBRARY_DISPLAY.pdf

Eastern Virginia Medical School (EVMS). (2017). Hampton Roads Need for Care. Retrieved

from:https://www.evms.edu/patient_care/specialties/strelitz_diabetes_center_of_western_

tidewater/hampton_roads_and_diabetes/

Eastern Virginia Medial School (EVMS). (2017). Strelitz Diabetes Research. Retrieved from:

https://www.evms.edu/research/centers_institutes_departments/internal_medicine/

divisions/strelitz_diabetes_center/diabetes_research/

Fain, J. A. (2015). Reading, Understanding, and Applying Nursing Research (4th ed.).

Philadelphia: F. A. Davis Company.

Hampton Roads Community Health (HRCH). (2016). Diabetes in Hampton Roads. Retrieved

from: http://hrchc.org/diabetes-in-hampton-roads/


Kimball, M. (2014, February 05). What is Glycemic Index? Retrieved March 01, 2017.

http://www.eatright.org

Mayo Clinic. (2014). Diabetes. Retrieved from: http://www.mayoclinic.org/diseases-

conditions/diabetes/basics/treatment/con-20033091

Walmart. (2017) $4 Generic Drug List. Retrieved from:

http://i.walmart.com/i/if/hmp/fusion/four_dollar_drug_list.pdf

Women in Crisis (WIC). (2017). WIC Programs. Retrieved from: http://www.wicprograms.org/


Appendix

Diabetes Health Survey 2017Instructions-

The following is an anonymous survey designed to explore the patient’s current diabetic health approach and feasibility for improvement.

This survey is meant only to be taken by those who have been diagnosed with Diabetes or Pre-diabetes. Please do not answer the questions for someone you know.

Please mark only one response unless otherwise noted. Demographics:Age:

18-25 26-32 33-40 40+

Gender:

M F

Education:

Did not graduate High School/GED Some college College Graduate

I have been diagnosed as a Type 2 diabetic for:

Less than 1 year 1-2 years 3-5 years More than 5 years

Please read the question and mark the answer that best describes you. Question Yes Somewhat NOMy diabetes/pre-diabetes is currently controlled.I control my diabetes with insulin.I control my diabetes with oral medication.I control my diabetes with exercise and diet.I check my blood sugars 1-2 times daily.I check my blood sugars 3+ times daily.I can afford my health insurance/deductible.My health insurance cost does not deter me from visiting my Physician.I know how to cook healthy.


I understand what good food choices are.I have family support to help deal with my diabetes.My diabetes affects those around me.I cook the same meals for everyone in my household.I can afford to eat healthy.I understand everything my nutritionist tells me.I have a good mindset when it comes to diabetesIt would be beneficial if someone could teach me how to cook healthy meals.I find handouts at the doctor’s office to be very beneficial.I throw handouts I receive from the doctor’s office away often.I know how to exercise and how much I need.If covered by my insurance or free, I would be open to working with someone to make changes and better my situation.My day is normally stress free.My schedule can be hectic.I live in a household of 2 or more.I care for children/pets daily.


Honor Code

“I pledge to support the Honor System of Old Dominion University. I will refrain from any form

of academic dishonesty or deception, such as cheating or plagiarism. I am aware that as a

member of the academic community it is responsibility to turn in all suspected violators of the

Honor Code. I will report to a hearing if summoned.”

Name: Deanne Maddox, David Keim, Briana Jones, Emma Kammann_

Date: 03/25/2017

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