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BaleDoneen Method
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The BaleDoneen Method is a risk assessment and treatment protocol aimed at preventing [[heart attack]] and [[stroke]]. The method also seeks to prevent or reduce the effects of type 2 [[Diabetes mellitus type 2|diabetes]], technically known as [[Diabetes mellitus type 2|diabetes mellitus]] type 2. The method was developed by Dr. Bradley Field Bale, M.D. and [[Amy Doneen|Dr. Amy Lynn Doneen]], [[Nurse practitioner|DNP]].
=== Description ===
Similar to other protocols, the method tests for [[cholesterol]] levels, [[blood pressure]], and diabetes, as well as factors not included in other current protocols, including systemic inflammation, vitamin D deficiency, insulin resistance, elevated levels of lipoprotein(a), and genetic risks, to identify potential root causes of arterial plaque.<ref></ref><ref>Liquid error: wrong number of arguments (1 for 2)</ref>
Testing for plaque includes a [[carotid]] [[intima-media thickness]] test, (CIMT), which measures blood flow through the arteries and the thickness of the arteries.<ref>Liquid error: wrong number of arguments (1 for 2)</ref><ref>Liquid error: wrong number of arguments (1 for 2)</ref> Physician Dr. Jeff Emery wrote that the test "allows us to identify if you are at future risk for a heart attack or stroke."<ref></ref> The American Heart Association has recommended CIMT as "a safe, non-invasive and relatively inexpensive means of assessing subclinical atherosclerosis. The technique is valid and reliable."<ref>Liquid error: wrong number of arguments (1 for 2)</ref> The method also uses the coronary artery calcium score (CAC),<ref>Liquid error: wrong number of arguments (1 for 2)</ref> a measurement of the amount of [[calcium]] in the walls of the arteries that supply the heart muscle, using a [[coronary CT calcium scan]] of the heart.<ref>Liquid error: wrong number of arguments (1 for 2)</ref><ref name=":0">Liquid error: wrong number of arguments (5 for 1)</ref> CAC has been shown to be an independent marker of risk for cardiac events, cardiac mortality, and all-cause mortality.<ref>Liquid error: wrong number of arguments (1 for 2)</ref>
The method uses urine and blood tests to check inflammatory markers, such as a high-sensitivity [[C-reactive protein]] test (CRP) measuring CRP, a protein in found in blood that indicates inflammation throughout the body.<ref></ref> In 2017, results of the CANTOS trial published in the ''New England Journal of Medicine'' demonstrated that anti-inflammatory therapies reduce risk for heart attack, stroke, other cardiovascular events<ref>Liquid error: wrong number of arguments (1 for 2)</ref> and cancer by up to 50%. This discovery was described as "a new era in preventive medicine" by study author [[Paul Ridker|Dr. Paul Ridker]], who said, "For the first time, we've been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk."<ref>Liquid error: wrong number of arguments (1 for 2)</ref>
The method ties results of this testing to considerations of lifestyle, diet, [[Sleep disorder|sleep disorders]], stress levels, genetic factors, and dental care, and personalized treatment targets are set to reduce patients' cardiovascular risk.<ref></ref><ref> The Spokesman-Review|website=www.spokesman.com|access-date=2019-01-18}}</ref> In some cases, these goals exceed those set by standard care. A common protocol for blood pressure indicates that an adult male with a reading of 130/85 is not at risk for a heart attack if the patient is being treated for high blood pressure. However the American Heart Association<ref></ref> and the BaleDoneen Method define safe levels as being below 120/80.
=== Effectiveness ===
Two recent peer-reviewed studies have evaluated the effectiveness of the BaleDoneen Method. In a 2016 retrospective study published in ''Archives of Medical Science'', researchers from the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease analyzed data from 324 patients who had received cardiovascular risk reduction treatments that included lipid-lowering medications, lifestyle modification, and additional therapies for those with insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, and other cardiovascular risks.<ref>Liquid error: wrong number of arguments (1 for 2)</ref> The following outcomes were reported during the first year of treatment with the BaleDoneen Method, compared to baseline:
* A 52.7% decrease in the size of plaque deposits in the carotid arteries
* A 31% drop in triglycerides
* A 25% drop in LDL (bad) cholesterol and 6% rise in HDL (good) cholesterol
* A 5% decrease in systolic blood pressure
This study had several limitations: The researchers report "issues with incomplete clinical data such as family history, obesity, and duration of baseline medication use, which could cause residual confounding." Another limitation was retrospective grouping of treatment groups, which can introduce bias if the groups are incorrectly assigned. Moreover, all of the patients in the study were Caucasian, which may affect or reduce generalization of the study results.
A retrospective of 576 patients treated with the BaleDoneen Method, published in 2015 in the ''Journal of Cardiovascular Nursing'',<ref>Liquid error: wrong number of arguments (1 for 2)</ref> reported statistically significant reductions in CIMT measurements, plaque burden, fasting blood sugar, LDL cholesterol and inflammation over an eight-year period. Limitations of the study include lack of diversity in the study subjects, nearly all of whom were Caucasian, and lack of a comparison group. Randomized controlled clinical trials are needed to compare the effect of the method with standard treatment protocols.
=== Treatments ===
For the treatment of arterial disease, the method uses pharmaceuticals such as [[Statin|statins]], [[baby aspirin]] (low dose aspirin), [[renin–angiotensin–aldosterone system]] inhibitors (RAAS inhibitors), and other drugs that are common tools for most physicians, as well as vitamins,<ref></ref> supplements, lifestyle modification, and a diet based on the patient's DNA.<ref name=":0" /> The method also recommends significant attention to dental care<ref>Liquid error: wrong number of arguments (1 for 2)</ref> to improve heart and circulatory system health, including brushing and [[flossing]] teeth twice a day.<ref name=":0" />
=== Description ===
Similar to other protocols, the method tests for [[cholesterol]] levels, [[blood pressure]], and diabetes, as well as factors not included in other current protocols, including systemic inflammation, vitamin D deficiency, insulin resistance, elevated levels of lipoprotein(a), and genetic risks, to identify potential root causes of arterial plaque.<ref></ref><ref>Liquid error: wrong number of arguments (1 for 2)</ref>
Testing for plaque includes a [[carotid]] [[intima-media thickness]] test, (CIMT), which measures blood flow through the arteries and the thickness of the arteries.<ref>Liquid error: wrong number of arguments (1 for 2)</ref><ref>Liquid error: wrong number of arguments (1 for 2)</ref> Physician Dr. Jeff Emery wrote that the test "allows us to identify if you are at future risk for a heart attack or stroke."<ref></ref> The American Heart Association has recommended CIMT as "a safe, non-invasive and relatively inexpensive means of assessing subclinical atherosclerosis. The technique is valid and reliable."<ref>Liquid error: wrong number of arguments (1 for 2)</ref> The method also uses the coronary artery calcium score (CAC),<ref>Liquid error: wrong number of arguments (1 for 2)</ref> a measurement of the amount of [[calcium]] in the walls of the arteries that supply the heart muscle, using a [[coronary CT calcium scan]] of the heart.<ref>Liquid error: wrong number of arguments (1 for 2)</ref><ref name=":0">Liquid error: wrong number of arguments (5 for 1)</ref> CAC has been shown to be an independent marker of risk for cardiac events, cardiac mortality, and all-cause mortality.<ref>Liquid error: wrong number of arguments (1 for 2)</ref>
The method uses urine and blood tests to check inflammatory markers, such as a high-sensitivity [[C-reactive protein]] test (CRP) measuring CRP, a protein in found in blood that indicates inflammation throughout the body.<ref></ref> In 2017, results of the CANTOS trial published in the ''New England Journal of Medicine'' demonstrated that anti-inflammatory therapies reduce risk for heart attack, stroke, other cardiovascular events<ref>Liquid error: wrong number of arguments (1 for 2)</ref> and cancer by up to 50%. This discovery was described as "a new era in preventive medicine" by study author [[Paul Ridker|Dr. Paul Ridker]], who said, "For the first time, we've been able to definitively show that lowering inflammation independent of cholesterol reduces cardiovascular risk."<ref>Liquid error: wrong number of arguments (1 for 2)</ref>
The method ties results of this testing to considerations of lifestyle, diet, [[Sleep disorder|sleep disorders]], stress levels, genetic factors, and dental care, and personalized treatment targets are set to reduce patients' cardiovascular risk.<ref></ref><ref> The Spokesman-Review|website=www.spokesman.com|access-date=2019-01-18}}</ref> In some cases, these goals exceed those set by standard care. A common protocol for blood pressure indicates that an adult male with a reading of 130/85 is not at risk for a heart attack if the patient is being treated for high blood pressure. However the American Heart Association<ref></ref> and the BaleDoneen Method define safe levels as being below 120/80.
=== Effectiveness ===
Two recent peer-reviewed studies have evaluated the effectiveness of the BaleDoneen Method. In a 2016 retrospective study published in ''Archives of Medical Science'', researchers from the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease analyzed data from 324 patients who had received cardiovascular risk reduction treatments that included lipid-lowering medications, lifestyle modification, and additional therapies for those with insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, and other cardiovascular risks.<ref>Liquid error: wrong number of arguments (1 for 2)</ref> The following outcomes were reported during the first year of treatment with the BaleDoneen Method, compared to baseline:
* A 52.7% decrease in the size of plaque deposits in the carotid arteries
* A 31% drop in triglycerides
* A 25% drop in LDL (bad) cholesterol and 6% rise in HDL (good) cholesterol
* A 5% decrease in systolic blood pressure
This study had several limitations: The researchers report "issues with incomplete clinical data such as family history, obesity, and duration of baseline medication use, which could cause residual confounding." Another limitation was retrospective grouping of treatment groups, which can introduce bias if the groups are incorrectly assigned. Moreover, all of the patients in the study were Caucasian, which may affect or reduce generalization of the study results.
A retrospective of 576 patients treated with the BaleDoneen Method, published in 2015 in the ''Journal of Cardiovascular Nursing'',<ref>Liquid error: wrong number of arguments (1 for 2)</ref> reported statistically significant reductions in CIMT measurements, plaque burden, fasting blood sugar, LDL cholesterol and inflammation over an eight-year period. Limitations of the study include lack of diversity in the study subjects, nearly all of whom were Caucasian, and lack of a comparison group. Randomized controlled clinical trials are needed to compare the effect of the method with standard treatment protocols.
=== Treatments ===
For the treatment of arterial disease, the method uses pharmaceuticals such as [[Statin|statins]], [[baby aspirin]] (low dose aspirin), [[renin–angiotensin–aldosterone system]] inhibitors (RAAS inhibitors), and other drugs that are common tools for most physicians, as well as vitamins,<ref></ref> supplements, lifestyle modification, and a diet based on the patient's DNA.<ref name=":0" /> The method also recommends significant attention to dental care<ref>Liquid error: wrong number of arguments (1 for 2)</ref> to improve heart and circulatory system health, including brushing and [[flossing]] teeth twice a day.<ref name=":0" />
January 18, 2019 at 12:04PM
