Studies & Research Papers

Follow the links below to find important overviews of recent health studies and research that may have implications for our patients. This section may include studies and research about  cardiovascular health, prevention of heart disease and strokes, prevention and treatment of Type 2 diabetes, medications that cause health risks, and other related topics.

These overviews tend to be more comprehensive in nature and in some cases provide the official Bale/Doneen response to recent studies, research, and news.

8-Year Outcomes of a Program for Early Prevention of Cardiovascular Events — A Growth-Curve Analysis by Bradley Bale, MD; Amy Doneen, RN, BSN, MSN, ARNP and other authors. (PDF)
Article published in the Journal of Cardiovascular Nursing. 
Study findings suggest that the Bale/Doneen Method is effective in generating a positive effect on the atherosclerotic disease process by achieving regression of disease in the carotid arteries.

This Whole Thing Seems Fishy — the Bale Doneen Response to Recent Studies Proclaiming Fish Oil Supplements Cause Cancer (PDF)
Recent headlines state: “Omega-3 supplements linked to prostate cancer” – Fox News;  “Hold the salmon: Omega 3 fatty acids linked to higher risk of cancer” – CNN.  This article presents the Bale Doneen response to these findings.

Pet Ownership and Cardiovascular Risk : A Scientific Statement From the American Heart Association (PDF)
Numerous studies have explored the relationship between pet (primarily dog or cat) ownership and CVD, with many reporting beneficial effects.  The purpose of this American Heart Association Scientific Statement is to critically assess the data regarding the influence of pet ownership on the presence and reduction of CVD risk factors and CVD risk.

Recommendation to Discontinue L-carnitine Supplementation Therapy (PDF)
A study was published in Nature Medicine (April 7, 2013) indicating that, in nonvegetarians, consumption of L-carnitine can lead to increased levels of a substance called trimethylamine N-oxide (TMAO) to the arteries.  The April 2013 Journal of Arteriology, published by The Bale/Doneen Method, featured an article recommending the discontinuance of L-carnitine by all patients other than those who are strict vegetarians and have normal F2 isoprostane levels.

Carotid Intima-Media Thickness Testing as an Asymptomatic Cardiovascular Disease Identifier and Method for Making Therapeutic Decisions (PDF)
Amy Doneen and Dr. Bradley Bale were published in Postgraduate Medicine, Vol. 125, Issue 2, March 2013. The article discusses wider use of CIMT testing and better understanding of its use for CVD risk stratification. CIMT testing can allow patients to begin lifestyle and pharmacologic changes early, possibly preventing progression to the high risk category and reducing the risk of future CV events.

Niacin—A Critical Component to the Management of Atherosclerosis (PDF)
Amy Doneen was a primary contributor to this article providing study results about the use of niacin in management of CVD. Published in the Journal of Cardiovascular Nursing, the article discusses contemporary management of dyslipidemia to prevent, reduce, or reverse atherosclerotic cardiovascular disease. The article also shares the importance of effective counseling regarding the highly favorable benefit-risk ratio for niacin and management strategies such as careful dose escalation, follow-up monitoring, regimen adjustments, and the use of treatment adjuncts (eg, aspirin) can improve patient adherence with niacin therapy.

Niacin: Throwing the babyout with the bathwater? (PDF)
Amy Doneen and Dr. Bradley Bale were published in the Journal of Arteriology where they provided an overview and findings of a recent clinical trial. The study confirms that the flushing from Niacin probably isn’t a bad thing and that blocking it with an experimental product can mitigate the very reason why ER -Niacin is necessary. See all study details by clicking the link above.

Inculpatory Evidence: Periodontal Disease Assessment and Treatment is an Essential Element in Cardiovascular Wellness Programs (PDF)– This peer reviewed content is offered as a 2 credit information course designed for dentists, dental hygienists, and dental assistants. Course by Thomas Nabors, DDS; Bradley Bale, MD; and Amy Doneen, ARNP

Appropriate Use Criteria for Carotid Intima Media Thickness Testing (PDF) — a paper issued by the Society of Atherosclerosis Imaging and Prevention, developed in collaboration with the International Atherosclerosis Society.

Clinician Perspective on the Benefits of Niacin Therapy for the Treatment of Dyslipidemia (PDF) — This paper is a summary of an  Expert Roundtable Discussion held on November 23, 2011. Dr. Peter H. Jones from the Baylor College of Medicine moderated the topic “Clinician Perspective on the Benefits of Niacin Therapy for the Treatment of Dyslipidemia and Strategies to Improve Long-Term Adherence to Therapy” with Dr. Bradley Bale and Amy Doneen.

Potential Adverse Cardiovascular Effects From Excessive Endurance Exercise (PDF) — Paper summarizing recent research that shows moderate levels of cardiovascular exercise are superior to heavy or extreme exercising.

Periodontal Disease and CVD (PDF) — White paper issued on April 24, 2012 sharing the Bale/Doneen/Nabors perspective on recent research related to periodontal disease and cardiovascular disease.

FDA Changed to Statin Labeling Related to Memory Loss, Diabetes Risk, and Liver Function Testing (PDF) — The official Bale Doneen response to this February 28, 2012 announcement by the FDA.

Pioglitazone (Actos) and Bladder Cancer (PDF) — A medication often prescribed to diabetics has been linked to bladder cancer. Read the full Bale/Doneen response to this recent news announcement.

AIM HIGH Study Halted — Bale/Doneen Response (PDF) — Recent findings from the AIM HIGH study resulted in a halt to the study. Read the Bale/Doneen response to the study findings and their assessment of implications.

Niacin and Management of Atherosclerosis (PDF) — This paper discusses the importance of niacin in the  prevention, reduction, and reversal of atherosclerosis.

Periodontal Disease and CHD – A Red Flag or Target of Therapy? (PDF) — Amy Doneen presents her perspective of the relationship between periodontal disease and cardiovascular disease.