- Cardiovascular disease is the world’s leading cause of death. Despite significant advances in its diagnosis, robust treatment remains elusive.
- US researchers have developed a pioneering approach to treating and preventing heart attacks and strokes. It’s called the BaleDoneen Method® (BDM) – and could save countless lives.
- Backed by two peer-reviewed studies, BDM identifies oxidative stress as the ‘critical link’ in arterial disease.
- Excitingly, ‘we now live in a time when humans can conquer arterial disease by stopping oxidative stress (SOS)’, say BDM’s co-founders Dr Bradley Bale and Dr Amy Doneen.
Imagine if the many chronic health conditions that harm and kill millions of people every year could be traced back to a single event within the body. Think of the implications – instead of chasing after the myriad outcomes and tackling them with diverse and occasionally successful interventions, we could target the cause.
Two American senior specialists in cardiovascular care have spent the last twenty years combining their different areas of expertise to focus on arterial disease. They have seen how heart attacks, strokes, and other chronic diseases of ageing – such as dementia, heart failure, kidney failure, peripheral arterial disease, erectile dysfunction, and loss of vision – can all be traced back to arterial disease. The team have gone one step deeper and designed a medical approach that addresses a specific source event behind arterial disease. Their robust approach is having a positive impact on cardiovascular disease’s unwanted supremacy as the world’s number one cause of death, disability, and healthcare cost burden.
Dr Bradley Bale and Dr Amy Doneen first met in 1999 over a shared interest in the early detection of cardiovascular disease. Bale was a family physician then, and Doneen was an advanced registered nurse practitioner working towards her doctorate in nursing practice. They both knew that arterial disease was linked to other diseases – and that there was a reason for that. The thousands of kilometres of blood vessels that run throughout our body, connecting our organs, are like the infrastructural network of roads, rail, and pipelines that service every major city. If they’re unhealthy, they don’t operate smoothly, causing blockages and congestion, affecting the organs. For, arguably, the body’s two most important organs, the outcome is an increased risk of heart attack and strokes. Bale and Doneen understood that despite significant advances in diagnosing and treating cardiovascular disease, it remained the leading cause of death and impaired health globally; a different approach to the disease was therefore needed.
“Given the scale and scope of the cardiovascular system, the opportunities for disruption and disease are numerous, but for Bale and Doneen, one event merits special attention.”
The ‘critical link’
Given the scale and scope of the cardiovascular system, the opportunities for disruption and disease are numerous, but for Bale and Doneen, one event merits special attention: oxidative stress (OS). This condition occurs when there is an imbalance between the production of harmful free radicals – highly reactive molecules – and the body’s ability to neutralise or detoxify them. OS affects lipoproteins – the complex fat and protein particles that course through our veins – and the smooth muscle cells in arterial walls. The latter become genetically transformed, generating a sticky substance in the arterial wall resulting in the lipoproteins – cholesterol – getting trapped in them and ultimately causing arterial disease. This encourages further oxidation and triggers the body’s immune response, resulting in inflammation in the artery. The fatty cholesterol deposits build up, producing plaque. When the condition becomes chronic, the arterial walls stiffen and clog, a condition called atherosclerosis.
For Bale and Doneen, oxidative stress is the ‘critical link’ between cholesterol and inflammation; they reveal it as the main driver behind arterial disease. Preventing it is key to addressing the condition and, thus, preventing heart attacks and strokes. So, they have designed a treatment regime that respects the complexities of OS causation but is straightforward enough for fellow medical practitioners to apply and customise to a specific patient’s needs: the BaleDoneen Method®. Importantly, because the method is holistic, it negates the standard siloed approaches to treatment that can sentence patients to a lifetime of being shuttled back and forth between specialists.
SOS – Stop Oxidative Stress
The six-step method first involves educating patients and practitioners on the fact that a blood clot in the arterial system blocks the flow of blood, leading to events like heart attacks and strokes. Additionally, most of these obstructions are silent and lead to the chronic diseases of ageing like dementia, kidney failure, erectile dysfunction, peripheral arterial disease, and vision changes. The second step is the disease diagnosis component which identifies the level of plaque – the tell-tale sign of oxidative stress – in a patient’s arteries. The third step is identifying arterial inflammation (‘fire’) which results from OS. Extinguishing or limiting any future ‘fires’ requires identifying the root cause of OS – the fourth step. Ignore the root cause, and it’s only a matter of time before another, possibly fatal, ‘flare up’ occurs. The fifth step is setting individualised goals of therapy anchored in the sixth step, which is genetics.
“Doctors can now tell patients with
cardiovascular disease that there is a cure.”
With the above knowledge, a practitioner can design an optimal intervention for the patient, providing achievable goals for long-term health. Because numerous sources of oxidative stress are modifiable, including poor diet, physical inactivity, weight problems, sleep disturbances, infection, periodontal disease, gut dysbiosis, vitamin D deficiency, hypertension, nicotine addiction, prediabetes, and various psychosocial issues, treatment can involve any one or a combination of proven interventions, including lifestyle changes and medication. Utilising genetics to provide individualised care to each patient ensures the success of the method.
Impressive results of the BaleDoneen Method®
Since designing the BaleDoneen Method®, Bale and Doneen have encouraged fellow practitioners to apply it to clinical practice, with remarkable results in thousands of patients through primary care and speciality clinics across the United States. Two real-world evidence research studies of data from treatment programmes have also highlighted the method’s success. One, by the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, examined treatment results in a cohort of 324 patients and showed comprehensive reductions in cardiovascular disease risk. Another study by the Texas Tech Health Science Center analysed data from the treatment of 576 patients using the BaleDoneen Method® over eight years. It showed clear regression of disease in the patients’ carotid arteries.
The genius behind the BaleDoneen Method® is two-fold. Firstly, it focuses on shutting down the main source of arterial disease – oxidative stress. Secondly, it encourages doing so through the combination of proven interventions. The results show clear evidence that this procedure halts, regresses, and stabilises arterial disease. Encouraged by the success of their method – not only in treating arterial disease but also in addressing other ancillary diseases, such as type 2 diabetes, kidney disease, dementia and erectile dysfunction – Bale and Doneen published ‘Healthy Heart, Healthy Brain: The Personalised Path to Protect Your Memory, Prevent Heart Attacks and Strokes, and Avoid Chronic Illness’. Earlier this year, it won the 2023 Gold Nautilus Book Award in the Health, Healing and Wellness category and the American Society for Journalists and Authors’ (ASJA) 2023 June Roth Memorial Award for Outstanding Medical Book.
Conquering arterial disease with a new cure
For Bale and Doneen, the awards are exciting, but what encourages them is the growing realisation within their field that oxidative stress is the common denominator leading to arterial disease and its subsequent devastating consequences. Doctors can now tell patients with cardiovascular disease that there is a cure. Through over 20 years of research and the systematic application of their method, Bale and Doneen have managed a seismic shift in cardiovascular care. However, they remain doctors at heart, and so the real testimonial to their impact is in the thousands of people who previously faced severe illness and an early death, who now get to live fuller lives, healthily and more productively, by simply following the treatment that carries their name.
What are some of the challenges you experienced encouraging the adoption of the BaleDoneen Method®, especially in the early years?
Early on, we had excellent peer-reviewed science to back up our statements about what should work, but we did not have real-world evidence proving that the method actually worked. Because of this, it was easy for providers to shrug it off. Now our challenge is getting insurance companies on board. Most providers only order tests and treatments approved by insurance. It is concerning to realise how the insurance companies have become the default medical experts.
How did you deal with those challenges?
Fortunately, we had enough patients who believed in our scientific approach. Over time, we accumulated real-world evidence that our method works. Currently, we are seeking the attention of an insurance company that will realise the huge humanitarian and financial benefit of our method. We are also incorporating our method into select academic institutions.
Has the BDM changed significantly since its early design, and if so, how?
The six fundamental elements have remained the same. However, there have been significant enhancements with each step. For example, it was unknown at first that most obstructions (events like heart attacks) are silent and subsequently lead to small artery damage. Scientists now agree that this microvascular disease is the underlying pathology of most chronic diseases of ageing. In addition, the realisation that most cholesterol particles pass unencumbered through the arterial wall was not known when we started. The fact that they must be captured in the wall by a substance created by genetically transformed contractile smooth muscle cells (cSMCs) generated significant clarification for us on what must be done to shut down arterial disease. Another game changer was learning that the biggest stimulus for the cSMC transformation is OS. Our recent paper linking OS as the critical link between cholesterol and inflammation is garnering huge attention in the medical community.
What myth about cardiovascular disease refuses to go away?
Many people still believe cardiovascular disease is inevitable. The reality is very exciting: a person can live out a long, healthy life without suffering the consequences of arterial disease.
What’s next for the BaleDoneen Method®?
We plan to forge ahead until the BDM is the standard of care around the world.