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David Dunaief

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By Leah S. Dunaief

Leah Dunaief

A local physician had a remarkable result. In clinical practice, he was treating a patient with severe migraines. The patient, 60 years old, had been experiencing migraines for 12 years. Recently they increased in frequency, and he was enduring six to eight debilitating headaches per month, each lasting more than 72 hours.  This equates to 18-24 headache days each month.

For those of us who suffer migraines, we know this must have been horrible. A migraine is not just a bad headache. It is as if a drill were unremittingly penetrating one spot in the head, all the while accompanied by nausea, vomiting and an inability to tolerate light. The aftermath is to feel hung over and unsteady. Migraines steal hours and days from the lives of the afflicted. 

The patient had tried various traditional medications, like zolmitriptan and topiramate to no avail. He also avoided possible migraine triggers like aged cheese, caffeine and red wine without success.

The internist, who specializes in lifestyle medicine, put him on a plant-based, high nutrient diet that he created of essentially low inflammatory foods every day. Hence he named it the LIFE diet, and its centerpiece is composed primarily of dark leafy greens, frozen blueberries, a banana and soy milk in a smoothie. These high fiber ingredients, when reinforced with flax seed meal, and a little pomegranate juice, can be made into a 32-ounce drink by a sturdy electric blender. The diet is further reinforced by eating more nutrient-dense veggies, like spinach, kale, arugula and romaine lettuce, for example, at subsequent meals in the day. These foods are thought to reduce chronic inflammation in the body.

The LIFE diet also limits dairy and red meat, whole grains, starchy vegetables and oils, according to reporter Sarah Jacoby, who interviewed the doctor for “Today” last Thursday, Nov. 18.

The results of the new regimen were dramatic. After two months, the patient was experiencing one headache per month. After three months, the headaches were gone. The patient suffered no further migraines. This result has lasted more than seven years so far.

At this point, the local physician, teaming up with his brother, who is a medical researcher, wrote up the study and sent it to the highly prestigious British Medical Journal or BMJ that publishes medical case studies deemed important. Delighted when it was accepted for publication, the doctor, who is a passionate believer in the healing power of dark green leafy vegetables, was further pleased when he learned that BMJ, considering the study valuable enough, had sent out a press release to publications all over the world with a summary.

The response was overwhelming, a testament to the need for a remedy to a universal malady. As of this writing, more than 40 news outlets across the globe, including UPI and WebMD, have picked up the story, from Europe to the Middle East to Asia and Australia, translating it into a dozen different languages.

“I think this (case report) is a tremendous start in the treatment of migraine headaches,” added the local physician. “This is kind of revolutionary to have the ability to say, ‘Not only does it work, but it works in the worst case scenarios. And it works in a short period of time.’”  He has seen similar results in other of his patients.

Dr. Charles Flippen, professor of neurology at the David Geffen School of Medicine at UCLA, agreed, stating that the change the patient experienced was, “rather impressive,” especially how long the effect has lasted. He added, “Now a large sample is necessary to draw conclusions about the benefits of diet change on migraines or chronic migraines,” as quoted by Sarah Jacoby for “Today.” 

Dr. Dawn Buse, clinical professor in the department of neurology at Albert Einstein College of Medicine in New York said, “There have been some recent studies suggesting that major dietary changes can reduce migraine symptoms,” according to “Today.”

“Even though we don’t know the exact mechanism for migraine, the concept of an inflammatory process as part of the underlying physiology of chronic pain has been around for decades,” explained Flippen. “So the idea that you have a diet that reduces the production of pro-inflammatory substances would fit nicely with our current understanding of migraine … It’s not purely magic that it worked.”

For the doctor, whose work has now circled the globe, the satisfaction is enormous. “I went into medicine to help people. It’s beyond gratifying that I may be helping people to take their lives back by reversing disease with the LIFE diet,” he concluded.  

And the name of the local internist who authored the study that has gone viral: my son and our own columnist, David Dunaief, MD.

Walking for a five-minute duration every 30 minutes can reduce the risk of diabetes. Stock photo
Screening guidelines still miss 15 to 20 percent of cases

By David Dunaief, M.D.

Dr. David Dunaief

Finally, there is good news on the diabetes front. According to the Centers for Disease Control and Prevention, the incidence, or the rate of increase in new cases, has begun to slow for the first time in 25 years (1). There was a 20 percent reduction in the rate of new cases in the six-year period ending in 2014. This should help to brighten your day. However, your optimism should be cautious; it does not mean the disease has stopped growing. It means it has potentially turned a corner in terms of the growth rate, or at least we hope. This may relate in part to the fact that we have reduced our consumption of sugary drinks like soda and orange juice.

Get up, stand up!

It may be easier than you think to reduce the risk of developing diabetes. Standing and walking may be equivalent in certain circumstances for diabetes prevention. In a small, randomized control trial, the gold standard of studies, results showed that when sitting, those who either stood or walked for a five-minute duration every 30 minutes, had a substantial reduction in the risk of diabetes, compared to those who sat for long uninterrupted periods (2).

There was a postprandial, or postmeal, reduction in the rise of glucose of 34 percent in those who stood and 28 percent reduction in those who walked, both compared to those who sat for long periods continuously in the first day. The effects remained significant on the second day. A controlled diet was given to the patients. In this study, the difference in results for the standers and walkers was not statistically significant.

The participants were overweight, postmenopausal women who had prediabetes, HbA1C between 5.7 and 6.4 percent. The HbA1C gives an average glucose or sugar reading over three months. The researchers hypothesize that this effect of standing or walking may have to do with favorably changing the muscle physiology. So, in other words, a large effect can come from a very small but conscientious effort. This is a preliminary study, but the results are impressive.

Do prediabetes and diabetes have similar complications?

Diabetes is much more significant than prediabetes, or is it? It turns out that both stages of the disease can have substantial complications. In a study of those presenting in the emergency room with acute coronary syndrome (ACS), those who have either prediabetes or diabetes have a much poorer outcome. ACS is defined as a sudden reduction in blood flow to the heart, resulting in potentially severe events, such as heart attack or unstable angina (chest pain).

In the patients with diabetes or prediabetes, there was an increased risk of death with ACS as compared to those with normal sugars. The diabetes patients experienced an increased risk of greater than 100 percent, while those who had prediabetes had an almost 50 percent increased risk of mortality over and above the general population with ACS. Thus, both diabetes and prediabetes need to be taken seriously. Sadly, most diabetes drugs do not reduce the risk of cardiac events. And bariatric surgery, which may reduce or put diabetes in remission for five years, did not have an impact on increasing survival (3).

What do the prevention guidelines tell us?

The United States Preventive Services Task Force (USPSTF) renders recommendations on screening for diseases. In 2015, the committee drafted new guidelines suggesting that everyone more than 45 years old should be screened, but the final guidelines settled on screening a target population of those between the ages of 40 and 70 who are overweight or obese (4). They recommend that those with abnormal glucose levels pursue intensive lifestyle modification as a first step.

This is a great improvement, as most diabetes patients are overweight or obese; however, 15 to 20 percent of diabetes patients are within the normal range for body mass index (5). So, this screening still misses a significant number of people.

Potassium’s effect

When we think of potassium, the first things that comes to mind is bananas, which do contain a significant amount of potassium, as do other plant-based foods. Those with rich amounts of potassium include dark green, leafy vegetables; almonds; avocado; beans; and raisins. We know potassium is critical for blood pressure control, but why is this important to diabetes?

In an observational study, results showed that the greater the exertion of potassium through the kidneys, the lower the risk of cardiovascular disease and kidney dysfunction in those with diabetes (6). There were 623 Japanese participants with normal kidney function at the start of the trial. The duration was substantial, with a mean of 11 years of follow-up. Those who had the highest quartile of urinary potassium excretion were 67 percent less likely to experience a cardiovascular event or kidney event than those in the lowest quartile. The researchers suggested that higher urinary excretion of potassium is associated with higher intake of foods rich in potassium.

Where does this leave us for the prevention of diabetes and its complications? You guessed it: lifestyle modifications, the tried and true! Lifestyle should be the cornerstone, including diet and at least mild to moderate physical activity.


(1) cdc.gov. (2) Diabetes Care. online Dec. 1, 2015. (3) JAMA Surg. online Sept. 16, 2015. (4) Ann Intern Med. 2015;163(11):861-868. (5) JAMA. 2012;308(6):581-590. (6) Clin J Am Soc Nephrol. online Nov 12, 2015.

Stock photo
Diabetic retinopathy can lead to blurred vision and blindness

By David Dunaief, M.D.

Dr. David Dunaief

With diabetes, we tend to concentrate on stabilization of the disease as a whole. This is a good thing. However, there is not enough attention spent on microvascular (small vessel disease) complications of diabetes, specifically diabetic retinopathy, which is an umbrella term.

This disease, a complication of diabetes that is related to sugar control, can lead to blurred vision and blindness. There are at least three different disorders that make up diabetic retinopathy. These are dot and blot hemorrhages, proliferative diabetic retinopathy and diabetic macular edema. The latter two are the most likely disorders to cause vision loss. Our focus for this article will be on diabetic retinopathy as a whole and on diabetic macular edema, more specifically.

Diabetic retinopathy is the number one cause of vision loss in those who are 25 to 74 years old (1). Risk factors include duration of diabetes, glucose (sugar) that is not well controlled, smoking, high blood pressure, kidney disease, pregnancy and high cholesterol (2).

What is diabetic macula edema, also referred to as DME? This disorder is swelling, due to extracellular fluid accumulating in the macula (3). The macula is a yellowish oval spot in the central portion of the retina — in the inner segment of the back of the eye — and it is sensitive to light. The macula is the region with greatest visual acuity. When fluid builds up from blood vessels leaking, there is potential loss of vision.

The highest risk factor for DME is for those with the longest duration of diabetes (4). DME is traditionally treated with lasers. But intravitreal (intraocular — within the eye) injections of a medication known as ranibizumab (Lucentis) may be as effective as laser. Unfortunately, many patients are diagnosed with DME after it has already caused vision loss. If not treated after having DME for a year or more, patients can experience permanent loss of vision (5).

In a cross-sectional study (a type of observational study) using NHANES data from 2005-2008, among patients with DME, only 45 percent were told by a physician that diabetes had affected their eyes (6). Approximately 46 percent of patients reported that they had not been to a diabetic nurse educator, nutritionist or dietitian in more than a year — or never.

The problem is that the symptoms of vision loss don’t necessarily occur until the latter stages of the disorder. According to the authors, there needs to be an awareness campaign about the importance of getting your eyes examined on an annual basis if you have diabetes. Many patients are unaware of the association between vision loss and diabetes.

Treatment options: lasers and injections

There seems to be a potential paradigm shift in DME treatment. Traditionally, patients had been treated with lasers. The results from a randomized controlled trial, the gold standard of studies, showed that intravitreal (delivery directly into the eye) injections with ranibizumab, whether given prompt laser treatments or treatments delayed for at least 24 weeks, were equally effective in treating DME (7).

Increased risk with diabetes drugs

Diabetic retinopathy is the number one cause of vision loss in ages 25 to 74. Stock photo

You would think that drugs to treat type 2 diabetes would prevent DME from occurring as well. However, in the THIN trial, a retrospective (backward-looking) study, a class of diabetes drugs, thiazolidinediones, which includes Avandia and Actos, actually increased the occurrence of DME compared to those who did not use these oral medications (8). Those receiving these drugs had a 1.3 percent incidence of DME at year one, whereas those who did not had a 0.2 percent incidence. This incidence was persistent through the 10 years of follow-up.

To make matters worse, those who received both thiazolidinediones and insulin had an even greater incidence of DME. There were 103,000 diabetes patients reviewed in this trial. It was unclear whether the drugs, because they were second-line treatments, or the severity of the diabetes itself may have caused these findings.

This is in contrast to a previous ACCORD eye substudy, a cross-sectional analysis, which did not show an association between thiazolidinediones and DME (9). This study involved review of 3,473 participants who had photographs taken of the fundus (the back of the eye).

What does this ultimately mean? Both of these studies were not without weaknesses. It was not clear how long the patients had been using the thiazolidinediones in either study or whether their sugars were controlled and to what degree. The researchers were also unable to control for all other possible confounding factors (10). Thus, there needs to be a prospective (forward-looking) trial done to sort out these results.


The risk of progression of diabetic retinopathy was significantly lower with intensive blood sugar controls using medications, one of the few positive highlights of the ACCORD trial (11). Medication-induced intensive blood sugar control also resulted in increased mortality and no significant change in cardiovascular events. But an inference can be made: A nutrient-dense, plant-based diet that intensively controls blood sugar is likely to decrease the risk of diabetic retinopathy complications (12, 13).

The best way to avoid diabetic retinopathy is obviously to prevent diabetes. Barring that, it’s to have sugars well controlled. If you or someone you know has diabetes, it is imperative that they get a yearly eye exam from an ophthalmologist so that diabetic retinopathy is detected as early as possible, before permanent vision loss occurs. It is especially important for those diabetes patients who are taking the oral diabetes class thiazolidinediones, which include rosiglitazone (Avandia) and pioglitazone (Actos).


(1) Diabetes Care. 2014;37 (Supplement 1):S14-S80. (2) JAMA. 2010;304:649-656. (3) www.uptodate.com. (4) JAMA Ophthalmol online. 2014 Aug. 14. (5) www.aao.org/ppp. (6) JAMA Ophthalmol. 2014;132:168-173. (7) ASRS. Presented 2014 Aug. 11. (8) Arch Intern Med. 2012;172:1005-1011. (9) Arch Ophthalmol. 2010 March;128:312-318. (10) Arch Intern Med. 2012;172:1011-1013. (11) www.nei.nih.gov. (12) OJPM. 2012;2:364-371. (13) Am J Clin Nutr. 2009;89:1588S-1596S.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician. 

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In recent studies, the Mediterranean-type diet decreased mortality significantly. Stock photo
Many Americans are malnourished

By David Dunaief, M.D.

Dr. David Dunaief

It may come as a surprise, but most of us are malnourished. How could that be, when approximately 70 percent of the U.S. population is overweight or obese? When we think of malnourishment, developing countries come to mind. However, malnourishment is not directly correlated with hunger; it is common at all levels of the socioeconomic scale. The definition of malnourished is insufficient nutrition, which in the U.S. results from low levels of much needed nutrients.

Over the last 30 years, the pace of increase in life expectancy has slowed substantially. In fact, a New England Journal of Medicine article noted that life expectancy may actually decline in the near future (1). 

According to the American Medical Association, almost half of Americans have at least one chronic disease, with 13 percent having more than three (2). The projection is that 157 million Americans will have more than one chronic disease by 2020. Most chronic diseases, including common killers, such as heart disease, stroke, diabetes and some cancers, can potentially be prevented, modified and even reversed with a focus on nutrients, according to the Centers for Disease Control and Prevention (CDC). 

I regularly test patients’ carotenoid levels. Carotenoids are nutrients that are incredibly important for tissue and organ health. They are measurable and give the practitioner a sense of whether the patient may lack potentially disease-fighting nutrients. Testing is often covered if the patient is diagnosed with moderate malnutrition. Because the standard American diet is very low in nutrients, classifying a patient with moderate malnutrition can be appropriate. A high nutrient intake approach can rectify the situation and increase, among others, carotenoid levels.

What is a high nutrient intake and why is it so important?

A high nutrient intake is an approach that focuses on micronutrients, which literally means small nutrients, including antioxidants and phytochemicals — plant nutrients. Micronutrients are bioactive compounds found mostly in foods and some supplements. While fiber is not considered a micronutrient, it also has significant disease modifying effects. Micronutrients interact with each other in synergistic ways, meaning the sum is greater than the parts. Diets that are plant rich raise the levels of micronutrients considerably in patients.

Let’s look at some examples.

A study showed olive oil reduces the risk of stroke by 41 percent (3). The authors attribute this effect at least partially to oleic acid, a bioactive compound found in olive oil. While olive oil is important, I recommend limiting olive oil to one tablespoon a day. There are 120 calories per tablespoon of olive oil, all of them fat. If you eat too much, even of good fat, it defeats the purpose. The authors commented that the Mediterranean-type diet had only recently been used in trials with neurologic diseases and results suggest benefits in several disorders, such as Alzheimer’s. 

In a case-control (compare those with and without disease) study, high intake of antioxidants from food is associated with a significant decrease in the risk of early age-related macular degeneration (AMD), even when participants had a genetic predisposition for the disease (4). AMD is the leading cause of blindness in those 55 years or older. There were 2,167 people enrolled in the study with several different genetic variations that made them high risk for AMD. Those with a highest nutrient intake, including B-carotene, zinc, lutein, zeaxanthin, EPA and DHA, substances found in fish, had an inverse relationship with risk of early AMD. Nutrients, thus, may play a role in modifying gene expression. 

What can we do to improve life expectancy?

In the Greek EPIC trial, a large prospective (forward-looking) cohort study, the Mediterranean-type diet decreased mortality significantly — the better the compliance, the greater the effect (5). 

The most powerful dietary components were the fruits, vegetables, nuts, olive oil, legumes and moderate alcohol intake. Low consumption of meat also contributed to the beneficial effects. Dairy and cereals had a neutral or minimal effect.

Though many Americans are malnourished, nutrients that are effective and available can alter this predicament or epidemic. Hopefully, with a focus on a high nutrient intake, we can re-ignite the pace of increased life expectancy and improve quality of life for the foreseeable future.


(1) N Engl J Med 2005; 352:1138-1145. (2) www.ama-assn.org. (3) Neurology June 15, 2011. (4) Arch Ophthalmol. 2011;129(6):758-766. (5) BMJ. 2009;338:b2337.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.

A diet rich in fruits, vegetables, beans, nuts and oily fish may prevent breast cancer. Stock photo

By David Dunaief, M.D.

NFL players are wearing pink shoes and other sportswear this month, making a fashion statement to highlight Breast Cancer Awareness Month. This awareness is critical since annual invasive breast cancer incidence in the U.S. is 246,000 new cases, with approximately 40,000 patients dying from this disease each year (1). The good news is that from 1997 to 2008 there was a trend toward decreased incidence by 1.8 percent (2).

We can all agree that screening has merit. The commercials during NFL games tout that women in their 30s and early 40s have discovered breast cancer with a mammogram, usually after a lump was detected. Does this mean we should be screening earlier? Screening guidelines are based on the general population that is considered “healthy,” meaning no lumps were found, nor is there a personal or family history of breast cancer.

All guidelines hinge on the belief that mammograms are important, but at what age? Here is where divergence occurs; experts can’t agree on age and frequency. The U.S. Preventive Services Task Force recommends mammograms starting at 50 years old, after which time they should be done every other year (3). The American College of Obstetricians and Gynecologists recommends mammograms start at 40 years old and be done annually (4). Your decision should be based on a discussion with your physician.

The best way to treat breast cancer — and just as important as screening — is prevention, whether it is primary, preventing the disease from occurring, or secondary, preventing recurrence. We are always looking for ways to minimize risk. What are some potential ways of doing this? These may include lifestyle modifications, such as diet, exercise, obesity treatment and normalizing cholesterol levels. Additionally, although results are mixed, it seems that bisphosphonates do not reduce the risk of breast cancer nor its recurrence. Let’s look at the evidence.


Bisphosphonates include Fosamax (alendronate), Zometa (zoledronic acid) and Boniva (ibandronate) used to treat osteoporosis. Do they have a role in breast cancer prevention? It depends on the population, and it depends on study quality.

In a meta-analysis involving two randomized controlled trials, results showed there was no benefit from the use of bisphosphonates in reducing breast cancer risk (5). The population used in this study involved postmenopausal women who had osteoporosis, but who did not have a personal history of breast cancer. In other words, the bisphosphonates were being used for primary prevention.

The study was prompted by previous studies that have shown antitumor effects with this class of drugs. This analysis involved over 14,000 women ranging in age from 55 to 89. The two trials were FIT and HORIZON-PFT, with durations of 3.8 and 2.8 years, respectively. The FIT study involved alendronate and the HORIZON-PFT study involved zoledronic acid, with these drugs compared to placebo. The researchers concluded that the data were not evident for the use of bisphosphonates in primary prevention of invasive breast cancer.

In a previous meta-analysis of two observational studies from the Women’s Health Initiative, results showed that bisphosphonates did indeed reduce the risk of invasive breast cancer in patients by as much as 32 percent (6). These results were statistically significant. However, there was an increase in risk of ductal carcinoma in situ (precancer cases) that was not explainable. These studies included over 150,000 patients with no breast cancer history. The patient type was similar to that used in the more current trial mentioned above. According to the authors, this suggested that bisphosphonates may have an antitumor effect. But not so fast!

The disparity in the above two bisphosphonate studies has to do with trial type. Randomized controlled trials are better designed than observational trials. Therefore, it is more likely that bisphosphonates do not work in reducing breast cancer risk in patients without a history of breast cancer or, in other words, in primary prevention.

In a third study, a meta-analysis (group of 36 post-hoc analyses — after trials were previously concluded) using bisphosphonates, results showed that zoledronic acid significantly reduced mortality risk, by as much as 17 percent, in those patients with early breast cancer (7). This benefit was seen in postmenopausal women but not in premenopausal women. The difference between this study and the previous study was the population. This was a trial for secondary prevention, where patients had a personal history of cancer.

However, in a RCT, the results showed that those with early breast cancer did not benefit overall from zoledronic acid in conjunction with standard treatments for this disease (8). The moral of the story: RCTs are needed to confirm results, and they don’t always coincide with other studies.


We know exercise is important in diseases and breast cancer is no exception. In an observational trial, exercise reduced breast cancer risk in postmenopausal women significantly (9). These women exercised moderately; they walked four hours a week. The researchers stressed that it is never too late to exercise, since the effect was seen over four years. If they exercised previously, but not recently, for instance, five to nine years ago, no benefit was seen.

To make matters worse, only about one-third of women get the recommended level of exercise every week: 30 minutes for five days a week. Once diagnosed with breast cancer, women tend to exercise less, not more. The NFL, which does an admirable job of highlighting Breast Cancer Awareness Month, should go a step further and focus on the importance of exercise to prevent breast cancer or its recurrence, much as it has done to help motivate kids to exercise with it Play 60 campaign.

Soy intake

Contrary to popular belief, soy may be beneficial in reducing breast cancer risk. In a meta-analysis (a group of eight observational studies), those who consumed more soy saw a significant reduction in breast cancer compared to those who consumed less (10). There was a dose-response curve among three groups: high intake of >20 mg per day, moderate intake of 10 mg and low intake of <5 mg.

Those in the highest group had a 29 percent reduced risk, and those in the moderate group had a 12 percent reduced risk, when compared to those who consumed the least. Why have we not seen this in U.S. trials? The level of soy used in U.S. trials is a fraction of what is used in Asian trials. The benefit from soy is thought to come from isoflavones, plant-rich nutrients.

Western vs. Mediterranean diets

A Mediterranean diet may decrease the risk of breast cancer significantly.
A Mediterranean diet may decrease the risk of breast cancer significantly.

In an observational study, results showed that, while the Western diet increases breast cancer risk by 46 percent, the Spanish Mediterranean diet has the inverse effect, decreasing risk by 44 percent (11). The effect of the Mediterranean diet was even more powerful in triple-negative tumors, which tend to be difficult to treat. The authors concluded that diets rich in fruits, vegetables, beans, nuts and oily fish were potentially beneficial.

Hooray for Breast Cancer Awareness Month stressing the importance of mammographies and breast self-exams. However, we need to give significantly more attention to prevention of breast cancer and its recurrence. Through potentially more soy intake, as well as a Mediterranean diet and modest exercise, we may be able to accelerate the trend toward a lower breast cancer incidence.

References: (1) breastcancer.org. (2) J Natl Cancer Inst. 2011;103:714-736. (3) Ann Intern Med. 2009;151:716-726. (4) Obstet Gynecol. 2011;118:372-382. (5) JAMA Inter Med online. 2014 Aug. 11. (6) J Clin Oncol. 2010;28:3582-3590. (7) 2013 SABCS: Abstract S4-07. (8) Lancet Oncol. 2014;15:997-1006. (9) Cancer Epidemiol Biomarkers Prev online. 2014 Aug. 11. (10) Br J Cancer. 2008;98:9-14. (11) Br J Cancer. 2014;111:1454-1462.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.

Full-fat and low-fat cheeses are no better for you than refined grains. Stock photo

By David Dunaief, M.D.

We are constantly redefining or at least tweaking our diets. We were told that fats were the culprit for cardiovascular disease (CVD). That the root cause was saturated fats, specifically. However, a recent study showed the sugar industry had a strong influence on the medical and scientific communities in the 1960s and 1970s, influencing this perception (1).

Why is this all important? Well, for one thing, about one out every two “healthy” 30-year-olds in the United States will most likely develop CVD in their lifetime (2). This is a sobering statistic. For another, CVD is still the reigning notorious champion when it comes to the top spot for deaths in this country. Except, this disease is preventable, for the most part.

What can prevent CVD? You guessed it, lifestyle modifications, including changes in our diet, exercise and smoking cessation. There is no better demonstration of this than what I refer to as the “new” China Study, which was done through the Harvard T.H. Chan School of Public Health. I call it “new,” because T. Colin Campbell published a book in 2013 with the same name pertaining to the benefits of the Chinese diet in certain provinces. However, the wealthier China has become in the last few decades by opening its borders, the more it has adopted a Western hemisphere-type lifestyle, and the worse its health has become overall. In a recent study published in the Journal of the American College of Cardiology, results show that over 20 years the rate of CVD has increased dramatically in China, and it is likely to continue worsening over time (3). High blood pressure, elevated “bad” cholesterol LDL levels, blood glucose (sugars), sedentary lifestyle and obesity were the most significant contributors to this rise. In 1979 about 8 percent of the population had high blood pressure, but by 2010, more than one-third of the population did.

Does this sound familiar? It should, since this is due to adopting a Western-type diet. The researchers highlighted increased consumption of red meat and soda, an increasingly sedentary lifestyle and, unlike us, half the population still smokes. But you can see just how powerful the effects of lifestyle are on the world’s largest population. There were 26,000 people and nine provinces involved.

Cardiologist embraces fat

We are going to focus on one area, diet. What is the most productive diet for preventing cardiovascular disease? In a recent New York Times article, entitled “An Unconventional Cardiologist Promotes a High-Fat Diet,” published on Aug. 23, 2016, the British cardiologist suggests that we should embrace fats, including saturated fats (4). He has bulletproof coffee for breakfast, with one tablespoon of butter and one tablespoon of coconut oil added to his coffee. He also promotes full-fat cheese as opposed to low-fat cheese. These are foods that contain 100 percent saturated fats. He believes dairy can protect against heart disease. Before you get yourself in a lather, either in agreement or in disgust, let’s look at the evidence.

The Cheesy Study

Alert! Before you read any further, know that this study was sponsored by the dairy industry in Denmark. Having said this, this study would presumably agree with the unconventional cardiologist. The results showed that full-fat cheese was equivalent to low-fat cheese and to carbohydrates when it came to blood chemistries for cardiovascular disease, as well as to waist circumference (5). These markers included cholesterol, LDL “bad” cholesterol levels, fasting glucose levels and insulin. There were three groups in this study: those who consumed three ounces of full-fat cheese, low-fat cheese or refined bread and jam. The authors suggested that full-fat cheese may be part of a healthy diet. This means we can eat full-fat cheese, right? NOT SO FAST.

The study was faulty. The control arm was refined carbohydrates. And since both cheeses had similar results to the refined carbohydrates, the more appropriate conclusion is that full-fat and low-fat cheeses are no better for you than refined grains.

What about dairy fat?

In a meta-analysis (involving three studies — the Professional Follow-Up Study and the Nurses’ Health Studies 1 and 2), the results refute the claim that dairy fat is beneficial for preventing CVD (6). The results show that substituting a small portion of energy intake from dairy fat with polyunsaturated fats results in a 24 percent reduction in CVD risk. And doing the same with vegetable fats in replacement of dairy fat resulted in a 10 percent reduction in risk. Dairy fat was slightly better when compared to other animal fat.

This meta-analysis involved observational studies with a duration of at least 20 years and involving more than 200,000 men and women. There needs to be a large randomized controlled trial. But, I would not rush to eat cheese, whether it was the full-fat or low-fat variety. Nor would I drink bulletproof coffee anytime soon.

Saturated fat: not so good

In a recent meta-analysis (involving three studies run by the Harvard School of Public Health), replacing just 5 percent of saturated fats with both mono- and polyunsaturated fats resulted in a substantial reduction in the risk of mortality, 27 and 13 percent, respectively (7). This is a blow to the theory that saturated fats are not harmful to your health. Also, the highest quintile of poly- and monounsaturated fat intake, compared to lowest, showed reductions in mortality that were significant, 19 and 11 percent, respectively. Again, this is an observational conglomeration of studies, using the same studies as with the dairy results above. This analysis suggests that the unconventional cardiologist’s approach is not the one you want to take.

The good news diet!

Here is the good news diet. In a recent randomized controlled trial (RCT), the gold standard of studies, results showed that high levels of polyphenols reduce the risk of cardiovascular disease (8). Polyphenols are from foods such as vegetables, fruits, berries especially and, yes, chocolate. The researchers divided the study population into two groups, high and low polyphenol intake. The biomarkers used for this study were endothelial (inner lining of the blood vessel) dependent and independent vasodilators. The more dilated the blood vessel, the lower the hypertension and the lower the CVD risk. These patients had hypertension, a risk factor for CVD. Those who consumed high levels of polyphenols had higher levels of nutrients such as carotenoids and vitamin C in their blood.

Is fish useful?

In a study, results show that eating a modest amount of fish decreases the risk of death from CVD by more than one-third (9). What is a modest amount? Consume fish once or twice a week. You want to focus on fish that are rich in omega 3s — docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). These are fatty fish with plenty of unsaturated fats, such as salmon. Thus, more of a Mediterranean-style diet, involving fruits and vegetables, as well as mono- and polyunsaturated fats in the forms of olive oil, nuts, avocado and fish may reduce the risk of CVD, while a more traditional American diet, with lots of pure saturated fats and refined carbohydrates may have the opposite effect. The reason we can’t say for sure that pure saturated fat should be avoided is that there has not been a large randomized controlled trial. However, many studies continually point in this direction.

References: (1) JAMA Intern Med. online Sept. 12, 2016. (2) Lancet. 2014;383(9932):1899-1911. (3) J Am Coll Cardiol. 2016;68(8):818-833. (4) NYTimes.com. (5) Am J Clin Nutr. 2016;104(4):973-981. (6) Am J Clin Nutr. Online Aug. 24, 2016. (7) JAMA Intern Med. 2016;176(8):1134-1145. (8) Heart. 2016;102(17):1371-1379. (9) JAMA. 2007;297(6):590.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.

Not all carbs are created equal. Photo by Heidi Sutton

By David Dunaief

It’s a persistent question: Should we minimize our carbohydrate consumption? Unfortunately, it depends on a number of factors including the type of carbohydrate and your family and personal history of chronic disease such as diabetes, cardiovascular disease, obesity, high triglycerides and hypertension. If this seems complicated and confusing to you, you are not alone. We have been bamboozled, railroaded or whatever term you like about carbohydrates for decades.

The body is like a chemistry set in that it turns many different types of carbohydrates into sugar. In other words, most of the sugar we consume is not what we add to food, but rather the food that our bodies turn into sugar. This is what’s so dangerous because it raises our blood sugar level.

The FDA has recently tried to quantify the amount of sugar we should consume on a daily basis (1). The agency recommends that we get no more than 50 grams of ADDED sugar a day. This seems like an easy task, for who would add 14.5 teaspoons of sugar to their food or drink in a day? Ah, but there is a catch: It includes processed foods such as refined carbohydrates and beverages. In fact, one can of soda may be enough to reach the upper limits of this recommendation.

We have been told for years that fats, especially saturated fats, were the enemy. Remember the food pyramid? The USDA had grains as its foundation for the longest time. Why would this be? Well, as it turns out, this is not a conspiracy theory but an actual scheme by the sugar industry to influence what we ate. They blamed fats as the cause for chronic diseases. However, they were very tricky in their approach, influencing scientists in the 1960s and 1970s with a small amount money, as was recently disclosed in a medical journal. We will discuss this in more detail.

Not all carbs are created equal

Carbohydrates come in many different forms. It depends on how much fiber they contain and whether they’re in liquid or solid form (2). Don’t focus on whether the carbohydrates are soluble or insoluble, complex or simple.

What is important is that some carbs don’t raise our blood sugar levels, while others have a much higher propensity to raise them. The carbs that don’t, or are less likely to, include fruits, nonstarchy vegetables, beans, legumes, pasta made from beans and tofu. With these, for the most part, you can eat a plentiful amount and may help prevent and even reverse chronic diseases such as diabetes, cardiovascular disease and obesity. However, carbs that raise our blood sugar are grains, especially refined grains, starchy vegetables like potatoes, fruit juice, sweets, bread, grain pasta, dried fruit, alcohol, soda, condiments and sauces. Let’s look at the evidence.

Sugar industry manipulation

You wouldn’t think we could be fooled by the sugar industry or distracted into thinking that saturated fats are what’s detrimental, not carbohydrates, and in their simplest form, sugars. This is just what the sugar industry did. A recent article in JAMA flushes this out (3).

The Sugar Research Foundation, the predecessor to the Sugar Association, paid three Harvard scientists to focus on fat and cholesterol as contributing factors to the rise in heart disease, not sugar. The resulting low-fat diet craze led to products loaded with sugar, like Snackwell cookies.

How much did they pay the researchers? A paltry $50,000 total in current monetary value. One of the scientists involved became the director of nutrition at the USDA. While the sugar industry and Harvard scientists in the 1960s may have conspired to downplay the dangers of sugar, strong evidence has now come to light that sugar, especially refined sugar, plays a role in heart disease and many other chronic diseases. However, this does not exonerate foods with high levels of saturated fat such as animal products.

We could never fall for this again, right? Well, that is what Coca-Cola was hoping to repeat recently by paying scientists millions of dollars to blame exercise, not diet, for the increase in heart disease, diabetes and obesity (4). This was recently revealed in a New York Times article entitled, “Coca-Cola Funds Scientists Who Shift Blame for Obesity Away From Bad Diets.” The Global Energy Balance Network, a nonprofit advocacy group, was influenced by the funding from Coke. In fact, a 2013 peer-reviewed journal article argued similar ridiculous assertions (5). It was subsequently amended to note the funding by Coca-Cola. The difference is that scientists now have to disclose any paid industry associations when published in a peer-reviewed journal, unlike in the 1960s and 1970s.

Starchy vegetables — be leery!

It is not only refined grains that are a problem. Another is starchy vegetables, in this case potatoes. In a recent study, results showed that potatoes increased the risk of diabetes, while replacing them with whole grains may decrease this risk (6). Those who ate less than two to four servings of starchy vegetables per week had a 7 percent increased diabetes risk, and those who ate at least seven servings per week had a 33 percent increased risk. Those who consumed french fries had even higher risks for diabetes. This was a meta-analysis including data from three prestigious sources, the Health Professional Follow-up Study and The Nurses’ Health Study I and II, involving almost 200,000 men and women across the three studies with a minimum duration of 20 years.

Here is the corker: It did not matter what type of potato they were eating! Although I could not find data that delineated the different types of potato, this may imply sweet potato.

Whole fruit vs. nonstarchy veggies vs. starchy veggies

Many people who want to lose weight find the task to be downright daunting. The following may provide motivation. In a study, results showed that eating whole fruit helped people lose weight. Nonstarchy vegetables also had similar results; however, starchy vegetables caused people to put on the pounds (7). The fruits included berries, pears and apples. The vegetables with the most positive weight-loss impact were cauliflower and soy/tofu. Starchy vegetables included corn and potatoes. This was a meta-analysis involving three studies and over 130,000 men and women.

Clinical example — what a surprise!

In my practice, I had been encouraging patients to eat starchy vegetables that were high in a class of nutrients known as carotenoids. These starchy vegetables include sweet potato, acorn squash, butternut squash, spaghetti squash, pumpkin and corn. Well, it turns out that a number of my patients indeed had higher nutrient levels in their blood, but unfortunately had no decrease in the inflammatory marker, C-reactive protein (CRP), that usually accompanies this effect. Even worse, their triglycerides, insulin levels and HbA1C, a measure of three-month sugars, were actually elevated and they could not lose weight.

The moral of the story is that we don’t have to be on a low-carb diet. Instead, we should focus on consuming carbohydrates that may prevent and reverse disease, such as fruits, nonstarchy vegetables and beans, while trying to minimize those that would potentially have the opposite effect, including starchy vegetables, disappointingly. The response to carbohydrates tends to depend on individuality when it comes to whole grains and starchy vegetables, though those with diabetes, heart disease, obesity and hyperinsulinemia would be advised to minimize their intake. Of course, all of us should minimize our intake of refined grains, sugars and processed foods.

References: (1) FDA.gov. (2) Uptodate.com. (3) JAMA Intern Med. online Sept. 12, 2016. (4) NYTimes.com. (5) PLoS One. 2013 Oct 9;8(10):e76632. (6) Diabetes Care. 2016;39(3):376-384. (7) PLoS Med. 2015;12(9):e1001878.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.

Fruits and vegetables may protect the kidneys. Stock photo

By David Dunaief

Chronic kidney disease is on the rise in this country. In a study that looked at data from the National Health and Nutrition Examination Survey, prevalence of chronic kidney disease (CKD) increased more than 30 percent from 1988 to 2004 (1). Earlier-stage (moderate) CKD is no exception and may not be getting enough attention. In this article, we will look beyond the more obvious causes of moderate chronic kidney disease, like diabetes, smoking, aging, obesity and high blood pressure (2).

Why is earlier-stage CKD so important? It is associated with a 40 percent increased risk of developing cardiovascular events, such as heart attacks (3). It also significantly increases the risk of peripheral artery disease (PAD). Those with decreased kidney function have a 24 percent prevalence of PAD, compared to 3.7 percent in those with normal kidney function (4). Of course, it can lead ultimately to end-stage renal (kidney) disease, requiring dialysis and potentially a kidney transplant.

One of the problems with earlier-stage CKD is that it tends to be asymptomatic. However, there are simple tests, such as a basic metabolic panel and a urinalysis, that will indicate whether a patient may have moderate chronic kidney disease.

These indices for kidney function include an estimated glomerular filtration rate (eGFR), creatinine level and protein in the urine. While the other two indices have varying ranges depending on the laboratory used, a patient with an eGFR of 30 to 59 mL/minute/1.73 m2 is considered to have moderate disease. The eGFR and the kidney function are inversely related, meaning as eGFR declines, the more severe the chronic kidney disease.

What can be done to stem earlier-stage CKD, before complications occur? There are several studies that have looked at medications and lifestyle modifications and their impacts on its prevention, treatment and reversal. Let’s look at the evidence.


Allopurinol is usually thought of as a medication for the prevention of gout. However, in a randomized controlled trial, the gold standard of studies, the results show that allopurinol may help to slow the progression of CKD, defined in this study as an eGFR less than 60 mL/min/1.73 m2 (5).

The group using 100 mg of allopurinol showed significant improvement in eGFR levels (a 1.3 mL/minute per 1.73 m2 increase) compared to the control group (a 3.3 mL/minute per 1.73 m2 decrease) over a two-year period. There were 113 patients involved in this study. The researchers concluded that there was a slow progression of CKD with allopurinol. Allopurinol also decreased cardiovascular risk by 71 percent.

Fibrates are a class of drug usually used to boost HDL (“good”) cholesterol levels and reduce triglyceride levels, another cholesterol marker. Fibrates have gotten negative press for not showing improvement in cardiovascular outcomes.

However, in patients with moderate CKD, a meta-analysis (a group of 10 studies) showed a 30 percent reduction in major cardiovascular events and a 40 percent reduction in the risk of cardiovascular mortality with the use of fibrates (6). This is important, since patients with CKD are mostly likely to die of cardiovascular disease. The authors concluded that fibrates seem to have a much more powerful beneficial effect in CKD patients, as opposed to the general population. So, there may be a role for fibrates after all.

Lifestyle modifications

Fruits and vegetables may play a role in helping patients with CKD. In one study, the results showed that fruits and vegetables work as well as sodium bicarbonate in improving kidney function by reducing metabolic acidosis levels (7). What is the significance of metabolic acidosis? It means that body fluids become acidic and it is associated with chronic kidney disease. The authors concluded that both sodium bicarbonate and a diet including fruits and vegetables were renoprotective, helping to protect the kidneys from further damage in patients with CKD.

Alkali diets are primarily plant-based, although not necessarily vegetarian or vegan-based diets. Animal products tend to cause an acidic environment. The study was one year in duration. However, though the results were impressive, the study was small, with 77 patients.

Sodium rears its ugly head yet again. Red meat is not thought of positively, and animal fat is not far behind. In the Nurses’ Health Study, the results show that animal fat, red meat and salt all negatively impact kidney function (8). The risk of protein in the urine, a potential indicator of CKD, increased by 72 percent in those participants who consumed the highest amounts of animal fat compared to the lowest, and by 51 percent in those who ate red meat at least twice a week. With higher amounts of sodium, there was a 52 percent increased risk of having lower levels of eGFR.

The most interesting part with sodium was that the difference between higher mean consumption and the lower mean consumption was not that large, 2.4 grams compared to 1.7 grams. In other words, the difference between approximately a teaspoon of sodium and three quarters of a teaspoon was responsible for the decrease in kidney function.

In my practice, when CKD patients follow a vegetable-rich, nutrient-dense diet, there are substantial improvements in kidney functioning. For instance, for one patient, his baseline eGFR was 54 mL/min/1.73 m2. After one month of lifestyle modifications, his eGFR improved by 9 points to 63 mL/min/1.73 m2, which is a return to “normal” functioning of the kidney. His kidney functioning after 6 months actually exceeded 90 mL/min/1.73 m2 for eGFR. However, this is an anecdotal story and not a study.

Therefore, it is important to have your kidney function checked with mainstream tests. If the levels are low, you should address the issue through medications and/or lifestyle modifications to manage and reverse earlier-stage CKD. However, lifestyle modifications don’t have the negative side effects of medications. Don’t wait until symptoms and complications occur. In my experience, it is much easier to treat and reverse a disease in its earlier stages, and CKD is no exception.


(1) JAMA. 2007;298:2038-2047. (2) JAMA. 2004;291:844-850. (3) N Engl J Med. 2004;351:1296-1305. (4) Circulation. 2004;109:320–323. (5) Clin J Am Soc Nephrol. 2010 Aug;5:1388-1393. (6) J Am Coll Cardiol. 2012 Nov. 13;60:2061-2071. (7) Clin J Am Soc Nephrol. 2013;8:371-381. (8) Clin J Am Soc Nephrol. 2010; 5:836-843.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.

We should dedicate 33 percent of our lives to sleep to improve brain health. Stock photo

By David Dunaief, M.D.

The brain is the most important and complex organ, yet what we know about the brain is inverse to its prominence. In other words, our knowledge only scratches the surface. While other organs can be transplanted readily, it is the one organ that can’t, at least not yet.

The brain also has something called the blood-brain barrier. This is an added layer of small, densely packed cells, or capillaries, that filter what substances from the blood they allow to pass through from the rest of the body (1). This is good, since it protects the brain from foreign substances; however, on the downside, it also makes it harder to treat, because many drugs and procedures have difficulty penetrating the blood-brain barrier.

Unfortunately, there are many things that negatively impact the brain, including certain drugs, head injuries and lifestyle choices. There are also numerous disorders and diseases that affect the brain, including neurological (dementia, Parkinson’s, stroke), infectious (meningitis), rheumatologic (lupus and rheumatoid arthritis), cancer (primary and secondary tumors), psychiatric mood disorders (depression, anxiety, schizophrenia), diabetes and heart disease.

These varied diseases tend to have three signs and symptoms in common: they either cause an alteration in mental status — cognitive decline, weakness or change in mood – or a combination of these.

Probably our greatest fear regarding the brain is cognitive decline. We have to ask ourselves if we are predestined to this decline, either because of the aging process alone or because of a family history, or if there is a third option, a way to alter this course. Dementia, whether mild or full-blown Alzheimer’s, is cruel; it robs us of functioning. We should be concerned about Alzheimer’s because 5.2 million Americans have the disease, and it is on the rise, especially since the population is aging (2).

Fortunately, there are several studies that show we may be able to choose the third option and prevent cognitive decline by altering modifiable risk factors. They involve rather simple lifestyle changes: sleep, exercise and possibly omega-3s. Let’s look at the evidence.

The impact of clutter

The lack of control over our mental capabilities as we age is what frightens us the most since we see friends, colleagues and relatives negatively affected by it. Those who are in their 20s seem to be much sharper and quicker. But are they really?

In a recent study, German researchers found that educated older people tend to have a larger mental database of words and phrases to pull from since they have been around longer and have more experience (3). When this is factored into the equation, the difference in terms of age-related cognitive decline becomes negligible. This study involved data mining and creating simulations. It showed that mental slowing may be at least partially related to the amount of clutter or data that we accumulate over the years. The more you know, the harder it becomes to come up with a simple answer to something. We may need a reboot just like a computer. This may be possible through sleep and exercise and omega-3s.


I have heard people argue that sleep gets in the way of life. Why should we have to dedicate 33 percent of our lives to sleep? There are several good reasons. One involves clearing the mind, and another involves improving our economic outlook.

For the former, a study shows that sleep may help the brain remove waste, such as those all-too-dangerous beta-amyloid plaques (4). When we have excessive plaque buildup in the brain, it may be a sign of Alzheimer’s. This study was done in mice. When mice were sleeping, the interstitial space (the space between brain gyri, or structures) would increase by as much as 60 percent.

This allowed the lymphatic system, with its cerebrospinal fluid, to clear out plaques, toxins and other waste that had developed during waking hours. With the enlargement of the interstitial space during sleep, waste removal was quicker and more thorough because cerebrospinal fluid could reach much further into the spaces. When the mice were anesthetized, a similar effect was seen as with sleeping.

In a published follow-up study, the authors found that sleep position had an impact on glymphatic transport in rodents. Sleeping in a lateral position, or on their sides, was more effective at clearing waste than prone or supine positions. Of course, the authors note that for rodents a prone position is similar to their awake positions. It would be most like a human sleeping while sitting upright (5).

In another study, done in Australia, results showed that sleep deprivation may have been responsible for an almost 1 percent decline in gross domestic product for the country (6). The reason is obvious: People are not as productive at work when they don’t get enough sleep. Their attitude tends to be more irritable, and concentration may be affected. We may be able to turn on and off sleepiness on an acute, or short-term, basis, depending on the environment, but it’s not as if we can do this continually.

According to the Centers for Disease Control and Prevention, an average of 4 percent of Americans report having fallen asleep in the past month behind the wheel of a car (7). I hope this hammers home the importance of sleep.


How can I exercise, when I can’t even get enough sleep? Well there is a study that just may inspire you to exercise.

In the study, which involved rats, those that were not allowed to exercise were found to have rewired neurons in the area of their medulla, the part of the brain involved in breathing and other involuntary activities. There was more sympathetic (excitatory) stimulus that could lead to increased risk of heart disease (8). In those rats that were allowed to exercise regularly, there was no unusual wiring, and sympathetic stimuli remained constant. This may imply that being sedentary has negative effects on both the brain and the heart.

This is intriguing since we used to think that our brain’s plasticity, or ability to grow and connect neurons, was finite and stopped after adolescence. This study’s implication is that a lack of exercise causes unwanted new connections. Of course, these results were done in rats and need to be studied in humans before we can make any definitive suggestions.

Omega-3 fatty acids

In the Women’s Health Initiative Memory Study of Magnetic Resonance Imaging Study, results showed that those postmenopausal women who were in the highest quartile of omega-3 fatty acids had significantly greater brain volume and hippocampal volume than those in the lowest quartile (9). The hippocampus is involved in memory and cognitive function.

Specifically, the researchers looked at the level of omega-3 fatty acids, called eicosapentaenoic acid and docosahexaenoic acid, in red blood cell membranes. The source of the omega-3 fatty acids could either have been from fish or supplementation. This was not delineated. The researchers suggest eating fish high in these substances, such as salmon and sardines, since it may not even be the omega-3s that are playing a role but some other substances in the fish. It’s never too late to improve brain function. You can still be sharp at a ripe old age. Although we have a lot to learn about the functioning of the brain, we know that there are relatively simple ways we can positively influence it.

References: (1) medicinenet.com. (2) alz.org. (3) Top Cogn Sci. 2014 Jan.;6:5-42. (4) Science. 2013 Oct. 18;342:373-377. (5) J Neurosci. 2015 Aug 5;35(31):11034-11044. (6) Sleep. 2006 Mar.;29:299-305. (7) cdc.gov. (8)J Comp Neurol. 2014 Feb. 15;522:499-513. (9) Neurology. 2014;82:435-442. Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management.

Hormone replacement can have serious consequences. Stock photo

By David Dunaief, M.D.

We are bombarded continually with ads suggesting that men should talk to their doctors about “Low T.” This refers to low testosterone. Is this all hype, or is this a serious malady that needs medical attention? The short answer is it depends on the candidate. The best candidates have deficient testosterone levels and are symptomatic.

Men do go through andropause or have unusually low testosterone (hypogonadism). The formal name for treatment is androgen replacement therapy.

The greatest risk factor for lower testosterone is age. As men age, the level of testosterone decreases. Respectively, 20, 30 and 50 percent of those who are in their 60s, 70s and 80s have total testosterone levels of less than 320 ng/dL (1). However, some of the pharmaceutical ads would have you think that most men over 40 should seek treatment. Treatments offered include gels, transdermal patches and injections.

While real estate is all about “location, location, location,” with testosterone “caution, caution, caution” should be used.

Who are the most appropriate candidates for therapy? Those who have symptoms including lack of sexual desire, fatigue and lack of energy. However, what is scary is that around 25 percent of patients are getting scripts for testosterone without first testing their blood levels to determine if they have a deficiency (2). A simple blood test can measure total testosterone, as well as free and weakly bound levels at mainstream labs.

The number of testosterone scripts increased threefold from 2001 to 2011 for men more than 40 years old (3). Either we have discovered vast numbers of men with low levels or, more likely, marketing has caused the number of scripts to outstrip the need.

What are the risks and benefits of treating testosterone levels? Is testosterone treatment really the fountain of youth? There are benefits reported for those who actually have significantly deficient levels. Benefits may include improvements in muscle mass, strength, mood and sexual desire (4). However, several studies have suggested that testosterone therapy may increase the risk of cardiovascular disease, including stroke, heart disease and even death. These are obviously serious side effects. It also may cause acquired hypogonadism by shrinking the testes, resulting in a dependency on exogenous, or outside, testosterone therapy.

When testosterone is given, it may be important to also test PSA levels (5). If they increase by more than 1.4 ng/ml over a three-month period, then it may be wise to have a discussion with your physician about considering discontinuing the medication. You should not stop the medication without first talking to your doctor, and then a consult with a urologist may be appropriate. If the PSA is greater than 4.0 ng/ml initially, treatment should probably not be started without a urology consult.

How can you raise testosterone levels and improve symptoms without hormone therapy? Lifestyle changes, including losing weight, exercising and altering dietary habits, have shown promising results. Let’s look at the evidence.

Cardiovascular risk

One study’s results showed that men were at significantly increased risk of experiencing a heart attack within the first three months of testosterone use (6). There was an overall 36 percent increased risk. When stratified by age, this was especially true of men who were 65 and older. This population had a greater than twofold risk of having a heart attack. This risk may have to do with an increased number of red blood cells with testosterone therapy. Those who were younger showed a trend toward increased risk but did not meet statistical significance.

When the patient was younger than 65 and had heart disease, there was a significant twofold greater risk of a heart attack; however, those without heart disease did not show risk. This does not mean there is no risk for those who are “healthy” and younger; it just means the study did not show it. This observational study compared over 50,000 men who received new testosterone scripts with over 150,000 men who received scripts for erectile dysfunction drugs: phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil (Cialis) and sildenafil (Viagra). PDE5 inhibitors have not demonstrated this cardiovascular risk.

Unfortunately, this is not the only study that showed potential cardiovascular risks. A 2013 study reinforced these results, showing that there was an increased risk of stroke, heart attack and death after three years of testosterone use (7). Ultimately, it found a 30 percent greater chance of cardiovascular events. What is worse is that risk was significant in both those with a history of heart disease and those without. This was a retrospective study involving 1,200 men with a mean age of 60.

We need randomized controlled trials to make a more definitive association. Still, these are two large studies that suggest increased risk. If you already have heart disease, be especially careful when considering testosterone therapy.

FDA response

The FDA, which approved testosterone therapy originally, is now investigating the possible cardiovascular risk profile based on the above two studies (8). The FDA doesn’t suggest stopping medication if you are taking it presently, but it should be monitored closely. The agency, in the meantime, has issued an alert to doctors about the potential dangerous side effects of androgen replacement therapy. The FDA says that the use of testosterone therapy is for those with low levels and other medical issues, such as hypogonadism from either primary or secondary causes.

Conflicting data

Two newer studies contradict the previous findings and suggest that testosterone supplementation for those who are deficient may not increase the risk of cardiovascular events or death. However, both studies have their weaknesses. One found that, although the cardiovascular events and death increased over the first two months, over the medium (9 months) and long terms (35 months), the risks actually decreased (9). Weaknesses: There was an initial detrimental cardiovascular effect; the study was observational; and the population was not well-defined as to participants’ history of cardiovascular disease or not. The second study was retrospective or backward-looking in time (10). These studies may not change the FDA warnings. What we need is a large randomized controlled trial.

Obesity and weight loss

Not surprisingly, obesity is an important factor in testosterone levels. In a study that involved 900 men with metabolic syndrome — borderline or increased cholesterol levels, sugar levels and a waist circumference greater than 40 inches — those who lost weight were 50 percent less likely to develop testosterone deficiencies. Those who participated in lifestyle modification had a highly statistically significant 15 percent increase in testosterone (11). Also, when men increased their physical activity and made dietary changes, there was an almost 50 percent risk reduction one year out, compared to their baseline at the start of the trial.

Interestingly, metformin had no effect in preventing lower testosterone levels in patients with abnormal sugar levels, but lifestyle modifications did. These patients were relatively similar to the average American biometrics with prediabetes: HbA1c of 6 percent and glucose of 108 mg/dL; a mean of 42-inch waists; and a BMI that was obese at 32 kg/m2. The mean age was between 53 and 54.

If there is one thing that you get from this article, I hope it’s that testosterone is not something to be taken lightly. You can improve testosterone levels if you’re overweight by losing fat pounds. If you think you have symptoms and you might need testosterone, talk to your doctor about getting a blood test before you do anything. It may be preferable to try alternate medications that improve erections such as sildenafil and tadalafil.

References: (1) J Clin Endocrinol Metab. 2001 Feb;86(2):724. (2) J Clin Endocrinol Metab. Online 2014; Jan 1. (3) JAMA Intern Med. 2013 Aug 12;173(15):1465-1466. (4) J Clin Endocrinol Metab. 2000 Aug;85(8):2839. (5) UpToDate.com. (6) PLoS One. 2014 Jan 29; 9(1):e85805. (7) JAMA. 2013;310:1829-1836. (8) FDA.gov. (9) Lancet Diabetes Endocrinol. 2016;4(6):498-506. (10) Eur Heart J. 2015;36(40):2706-2715. (11) ENDO 2012; Abstract OR28-3.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com or consult your personal physician.