More On Pre-Diabetes

On Wednesday May 30, I wrote a blog titled "Beyond Ecstatic!"  The blog was about the value of exercise in reverting a patient with pre-diabetes to normal vascular function.

With 80 million Americans believed to already be pre-diabetic and many more expected to join their ranks, the topic deserves careful consideration. In my practice, I am seeing quite a number of patients who fall into this danger zone.

A new study shows that pre-diabetics who change their lifestyle and lower their blood sugar below 100mg/dl at least once over a three year period after having been diagnosed as pre-diabetic are 24% less likely to progress to full blown diabetes. Those who did not respond to the lifestyle intervention had a 31% increased risk of progressing to diabetes.

As previously discussed, once you have been diagnosed with pre-diabetes, your vascular system has already undergone negative changes likely to lead to increased blood pressure, heart disease, and possibly diabetes. However, intervening at that earlier point can make a world of difference.

Please, please, please, don't wait until something truly bad happens. If you find out that your fasting blood sugar is between 100 and 125 mg/dl, you must take actions, including changing your diet, improving your physical fitness,and managing your stress to avoid progression to full blown diabetes.

An ounce of prevention is worth everything in this case.

What Did Dr. Oz Leave Out About Strontium?

Let me preface today's blog with a head's up that I spent 5 hours researching this subject before writing the blog. It's a little technical, but I thought the detail was important. 

Although I may have a pretty good handle on the subject, I may also have missed something that wasn't available on the internet. Please feel free to comment if you feel I missed something.

Last Thursday, Dr. Oz told his audience about four supplements, extensively researched by his staff, which he highly touts as anti-aging supplements. The four were resveratrol, vitamin D, fish oil, and strontium. Please see my previous blogs about fish oil (Tuesday, April 10, 2012 titled ‘Et tu fish pills?’) and Vitamin D (Tuesday, March 20, 2012 titled ‘What's The Big Deal About Vitamin D? It turns out quite a bit.’   

At a later date, I'll write about resveratrol. In the interim, please note that one of the leading, if not the number one in the world, resveratrol researcher, Depak Das at the University of Connecticut, was dismissed from his university post because he was found to have repeatedly falsified his resveratrol research data. This has thrown the entire field of resveratrol research into dispute and a major conference that was scheduled in India called Resveratrol 2012 was cancelled late last year as he was one of the top experts expected to present. Enough about resveratrol for now; today, let's have some fun with strontium.

Dr. Oz recommended that women take 680 mg of strontium each day separated from the calcium he also recommends they take.  Of course, he made no reference to recent studies that suggest potential harm from taking calcium (see my blog from Friday, May 25, 2012, 'Calcium Pills Raise Concerns -- Again!'). He mentioned on the show that strontium has been studied in Europe and that the studied form is not available in the U.S. 

Here's what he didn’t share. The form of strontium studied in Europe was strontium ranelate, a synthetic salt that combines strontium with ranelic acid.  The studies done in Europe were good studies and one of the studies was published in the New England Journal of Medicine, a peer reviewed prestigious journal published by the Massachusetts Medical Society and associated with Massachusetts General Hospital, the premiere Harvard affiliated public hospital. See reference below.

The study involved the consumption of 2 grams of strontium ranelate each day for a period just short of five years. The strontium clearly increased bone density on scans and decreased fracture risks in post-menopausal women. It was generally well tolerated except for increased nausea and diarrhea during the first three months of administration.  All study participants also consumed calcium and Vitamin D at different dosages.  As a result of the study, the drug was approved and is only available by doctor prescription for dispensing by a pharmacist to people at high risk of fractures in Europe, and requires strict medical supervision. 

Why strict medical supervision? Strontium competes with calcium and magnesium and displaces them. What that does to your bone health and overall health has not been studied and is unknown.  There are reports that it can cause a condition called osteomalacia, which involves the softening of the bones caused by defective bone mineralization secondary to inadequate amounts of available phosphorus and calcium, or because of overactive resorption of calcium from the bone, often as a result of hyperparathyroidism. In other words, taking strontium may interfere with your normal function of calcium uptake by bones.

A review of comments from users found on the internet included, a doctor “urged caution and told me about the deaths due to 'hypersensitivity syndrome' and a second consultant told me she was still not happy with calculation of DEXA scores.” The reference to the DEXA scores is that when doing the diagnostic DEXA Scan tests for osteoporosis, the test results are apparently skewed by the use of strontium.  There were many comments that indicated no problems.

So why isn’t it available in the U.S.? The answer is because the French company that owns the patent has not pursued FDA approval. The apparent reason for this and the one most often cited is that the FDA would require some homegrown research before approving it and the company doesn’t want to foot the bill. So you can’t get it here.

Of course, some entrepreneurial folks decided that if you can get the synthetic strontium ranelate here, they should cook up some strontium citrate because as it has no synthetic compound involved (ranelic acid is synthetic and citrate is not) and therefore can be sold as a supplement here in the U.S.  How did they come up with the recommended 680 mg dose? Apparently, strontium ranelate contains 680 mg of strontium. How much strontium does strontium citrate contain? I can’t tell you.

Also, what’s the difference between the way citrate and ranelate act in your body? I don’t know and nor does anyone else because it hasn’t been studied. Let’s look at an example of two other different chemical molecules binding together. Sodium when combined with chloride becomes sodium chloride, the salt we eat. When sodium is combined with citrate, it becomes monosodium citrate, a salt used to prevent anticoagulation of stored blood. Different chemicals when combined create different compounds.

So what’s the biggest problem with taking strontium citrate to prevent or treat osteoporosis? Beyond some of the concerns cited above, it’s never been studied and reported on in humans.

There was a study begun in the U.S. at University of California Davis Medical Center a few years ago that was meant to be completed and results reported in 2010, but the study, named the Scope Study, has mysteriously disappeared.  I’m not kidding. There are conspiracy theories all over the internet regarding what happened to this study. Some claim the bisphosphonate companies got to them. Just theories with no evidence whatsoever to support them. My experience is when a research institute goes mum on a study, it’s often due to something going wrong with the study.  Nonetheless, the results never came out. That gives me pause to ever recommend such a drug under such circumstances.  

Furthermore, while strontium ranelate was studied with 680 mg of strontium, studies with far less amounts have never been reported. If it is actually good for you, could less work just as well?

Strontium is present in our food supply. For example, it is available in vegetables such as spinach, lettuce, carrots, peas, beans, potatoes and celery. Wheat, barley and other grains used to make bread also have significant levels of strontium. According to one source I found, flour, grains and breads average 2,150 mg per gram of stable strontium.

So as always, before taking a pill containing a super high dose of a mineral which has not been studied for a prolonged period of time, you should increase your intake of foods containing that mineral that have been used for millions of years.

It is important to remember that high-dose strontium is essentially a bone drug, and, as with all bone drugs, it is only indicated when there is a clear high risk of fracture defined as a 20% likelihood of a major osteoporotic fracture over the next 10 years.

The bottom line is that the long-term safety and efficacy of strontium citrate has not been evaluated on humans in large-scale medical trials.

That’s why once again I say shame on Dr. Oz for recommending it to the general population without good science to support what is available in the U.S. It only serves to make people more anxious and confused that maybe they have misssed something. It is often dangerous to experiment on your own body.

By the way, here are the chemical structures for strontium ranelate and strontium citrate. Do they look similar? If no, it's because they are not. One, ranelate binds with two atoms of strontium, while the other, citrate, only binds with one atom.

Strontium Ranelate 

 

Strontium Citrate

MDPrevent

References:

Meunier PJ, Roux C, Seeman E, et al. The effects of Strontium Ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. NEJM 2004 350;459 -68

Reginster JY, Seeman E, DE Vernejoul MC, et al . Tropos Study. J Clin Endocrinol Metab 2004–1774. Strontium ranelate reduces the risk of nonvertebral fractures in post-menopausal women with osteoporosis.

It's Not What You Know That Gets You Into Trouble..."

...It's what you know for sure that does." - Mark Twain

Some readers may ask what makes me a more reliable source of information about dietary supplements that the hundreds of vendors that sell them, the many doctors that recommend them, and the countless users that swear by them?

There is no good answer to that question because given the enormity of medical research and the doubling of medical knowledge every five years, it is impossible for any single individual to claim absolute certainty regarding any aspect of medicine. For example, people who eat poorly do not always die from heart disease and people who eat healthy still develop cancer. That said, I have dedicated the past two years to understanding all that I can about dietary supplements. This includes at least a dozen books regarding nutrition and wellness, and easily over ten thousand studies. I've given a few dozen lectures on the topic and fielded hundreds of questions from my audiences. Over the past year, I've also had detailed discussions with hundreds of patients regarding their supplement usage.

Every day, I learn new things and build on my knowledge. It is an endless process, but I am a truth seeker, first and foremost for my own edification, and then for my family, friends, patients, and the community at large. With no vested interest on either side of the great divide, I can follow where the facts lead.The facts lead me repeatedly that no one should take a supplement without a scientifically validated reason and a known deficiency.

Yesterday, it pained me to write a response to an email I receive from the Harvard Medical School Health Newsletter. I take great pleasure in my Harvard affiliation (the business school) and it is disturbing when something bearing Harvard's name does a disservice to the community. Unfortunately, an article about calcium supplementation appearing in the newsletter provided such a disservice.

Today, many articles focused on nutrition take a piecemeal approach. They focus on one aspect while ignoring another. This particular newsletter was guilty of that sin. An article about getting sufficient calcium in the diet cited fortified fruit juices as a good source.  First, of all I always recommend natural versus fortified sources of any mineral. Second, fruit juices are notoriously unhealthy because they often lack the fiber from the fruit, thereby having been stripped of much of its nutritional value, and juices often have highly concentrated fructose (sugar). Lastly, this article about calcium failed to cite the recent studies regarding the dangers of calcium supplementation.

It's flabbergasting that expected sources of reliable information take the same fluff approach as more notorious sources. If this was a matter of opinion, we could have a healthy debate. Undoubtedly, the facts speak for themselves.

By the way, the best newsletter I read remains the Tuft's University Nutrition Letter.

Dr. Oz, Please Take Note: Routine Usage of Aspirin Can Be Dangerous

On a number of recent Dr. Oz shows, the 'good' doctor recommended the routine usage of 2 baby aspirins. He has recommended it to lower blood pressure, to help with pain at night, improve circulation, etc. In fact, here's a couple of direct quotes from his website.

"Take 2 baby aspirin every night before bed. Make sure to drink a large glass of water. Baby aspirin will help prevent inflammation which increases your risk for heart disease. Aspirin keeps blood platelets from clumping and clotting."

Here's another quote from the website:

"Take 2 baby aspirin a day to help circulation"

It turns out, big surprise, that his advice may be inappropriate. Unquestionably some people at increased risk for heart disease, such as those with a strong family history of it, elevated blood pressure and/or cholesterol may be candidates for baby aspirin, but it is highly dangerous and improper to recommend routine usage.

Why you may ask?  In a large population-based cohort of primary-prevention patients, the use of aspirin was associated with an increased risk of major gastrointestinal bleeding and cerebral bleeding episodes, and this increased rate of bleeding is higher than previously reported in other randomized, prospective clinical trials. So even ignoring this study, aspirin as a major cause of bleeding is well established. In fact, bleeding secondary to aspirin is one of the four top reasons for emergency room
visits in seniors.

 

The study cited above, which was published in the June 6, 2012 issue of the Journal of the American Medical Association, showed that aspirin was associated with a 55% relative increase in the risk of major bleeding, a number that translates to two excess bleeding events for every 1000 patients treated annually. This bleeding rate is roughly equal to the number of major cardiovascular events avoided by the use of aspirin for primary prevention for patients with a 10-year risk in the range of 10% to 20%.  In other words, at this risk range, the risks are equal to the benefit, and below that risk range, the risks outweigh the benefits. You must speak with your doctor to properly qualify and quantify your risk. That is why it is imprudent for Dr. Oz to make such recommendations in a vacuum of knowing to whom he is speaking.

The conclusion of the study: "Elderly patients, patients with a history of major bleeding, or patients taking other drugs that can increase the risk of bleeding are probably not candidates for primary prevention with aspirin."

The take-away here is that advice dispensed by Dr. Oz should be dutifully ignored because no one should be acting on (and no doctor should be giving) specific medical advice delivered over the TV or radio. First the advice giver does not know your personal situation and second, you should not follow such generic advice without first consulting your physician.

 MDPrevent

And The Study Showed What?

Virtually not a day goes by that headlines don't blare the results of some new medical studies.  Just today, two studies caught my attention. One showed that even low-dose aspirin is associated with a significant increased rate of bleeding episodes and another showed that ginseng improved fatigue in cancer patients.

As with all studies, these two demanded closer attention to understand if they were even reliable. They were both pretty good studies but not easily applicable to the layperson. They require further consideration based on personal circumstances.  Today, I want to educate you about any study you may come across.  There are seven questions to ask yourself whenever you see a medical related study. I will present each question with some thoughts.

Was it a study in the laboratory, in animals, or in people?

As far as I am concerned, the only studies that truly matter involve people. That's the only way to know for sure how it will affect most people.

Does the study include enough people like you?

If you are an Asian-American and the study was done in African-Americans, it may not be relevant to you. Likewise, if you are Okinawan and the study was done with Ashkenazi Jews. The most relevant studies for you are the ones done in your ethnic group, age group, gender, economic and social level, health state, and disease state. Notwithstanding, studies done in any humans can be expected to have some relevance to all humans.

Was it a randomized controlled clinical trial involving thousands of people?

These are the gold standard studies and can be best relied upon. They are also very expensive to do, so you don't see them often enough.

Where was the research done?

Better research facilities typically do better research. For example, a study done at a top medical school or large hospital system, may have greater resources to perform complicated experiments or have deeper experience with the subject matter. The best studies involve multiple, quality institutions working together.

If a new treatment was being tested, were there side effects?

Authors report results because of an intended consequence. For example, statins lower cholesterol. But they also increase your risk for diabetes. When results are reported, they often play down side effects but these side effects may be highly problematic for you personally. Therefore, don't just focus on what the main thrust of the study was, but also review what side effects it caused.  Sometimes the cure can be worse than the disease. 

Who paid for the research?

This is a big one. Who controls the results? Is there a conflict of interest? For example, is the Cattle Rancher's Association paying for a study to show the health benefits of meat? If so, do they have final say on withholding negative results? Can they repeat the experiment ten times and report the one time it worked in their favor?  Federal government studies, like the National Institutes of Health, or a large foundation not supported or beholden to industry, are the most reliable sources of funding. With new drugs, it's a different story. Clearly, the study is paid for by the pharmaceutical company and they stand to benefit from positive results. However, the results are reviewed by the FDA and there can be a fair amount of reliance that the process has undergone the necessary scrutiny. Notwithstanding, it is an imperfect process that sometimes goes awry. 

Who is reporting the results?

The source of the news about the study may be the most important fact to consider. News media can often distort study results for a certain newsworthy angle. Never rely solely on one source of news regarding a study. Also, be careful of interpretations of studies. Know who is interpreting it and what dog they have in the fight.

Ultimately, the best approach to understanding the significance of any study is to share it with your doctor and to figure out together if it applies to you. I always say, an educated patient is my favorite kind.

Why We Live Longer Is More Important Than How Long We Live

I recently came across an article written by Michael Wolff that appeared in New York Magazine titled, "Mom, I Love You. I Also Wish You Were Dead. And I Expect You Do, Too." The gist of the article is that there is no good reason to live longer. The author paints a picture that living longer means a more painful, slow death.

It is a frightful article written by someone who is clearly in pain watching his mother suffer from a terminable illness. However, it is also just plain wrong. The fact that the author makes statements with reckless abandonment may be forgiven given his state of mind. But, I don't believe for one moment that what he has to say is true in most cases of extended longevity.  Why? Because the scientific facts speak otherwise.

A recent study from the Longevity Genes Project, launched by the Albert Einstein College of Medicine in New York City, supports my assertion. The results of the study, focused on near-centenarians, showed that the majority of  them were found to be "relaxed, friendly, conscientious and upbeat about life." Importantly, added the authors, "an easy laugh and an active social life were observed to be a group norm, while neuroticism was notably the exception. What's more, feelings were more commonly shared as they arose, rather than stifled and squelched." Not quite the doom and gloom reported by Mr. Wolff.

Mr. Wolff would have his readers believe that dementia strikes virtually everyone as we age. In fact, less than 50% of Americans over 85 develop dementia and about a quarter of all dementias are now directly linked to lifestyle, and thereby, may be preventable. What I think was missed by Michael is that why you live longer is as important as what that life looks like.

If you live longer only due to the miracles of modern science and technology, such a life may not be worth living. The goal is not to be alive at any cost, strapped to money machines that ka-ching with every passing moment. The reason to live longer is to enjoy more healthy years of life free of disability and pain.

A second recent study, that helps confirm healthy living can extend life even in the retirement years, demonstrates how to achieve such a life.  Led by Emily Nicklett, an assistant professor of social work at the University of Michigan School of Social Work, in Ann Arbor, the study, which was designed to explore the impact of exercise and nutrition together, found that women who were both the most physically active and the highest consumers of fruits and vegetables were eight times more likely to be alive after the study's five years of follow-up, compared to women who scored lowest on both counts.


There you have it. By living a healthy lifestyle, the women in the Michigan study avoided premature death and reported living quality lives. It's not surprising because exercise and good nutrition have been shown repeatedly to keep depression, dementia, falls, cancer, diabetes, heart disease, and stroke at bay for long periods of time.

The bottom line is we all eventually die and how we die is often unpredictable. But living a healthy lifestyle increases the probability of enjoying more good years. Michael Wolff ultimately misses the real point. If his mother had taken ill a number of years earlier, would the situation have been any less poignant and painful? Watching a parent suffer at any age is difficult for most children. Having a few more good years with the parent(s) before the process begins is a gift.

So if you want to live a longer, functional, and disease-free life, a word to the wise should be sufficient. Learn how to eat properly and get enough exercise to remain in good form and fitness. Michael Wolff may long for his mother's passing, but I long to keep my patients healthy and enjoying life for many more years because it beats the alternative.

I'm Sorry To Be A Party Pooper, But...

Many people love chocolate for obvious reasons. When they hear it's good for them, that's just frosting on the cake (pun intended). Over the next day or so, you are going to see and hear a tsunami of headlines, yet again, about the heart benefits of eating dark chocolate. The headlines will blare how dark chocolate prevents cardiovascular events.

This breaking news will be the result of a modeling study that predicts that patients with metabolic syndrome who eat dark chocolate every day could have 85 fewer events per a population of 10,000 over 10 years. The study, conducted by Chris Reid, PhD, of Monash University in Melbourne, Australia and colleagues was supported by a grant from a pharmaceutical company.  (For more about metabolic syndrome, please read end of blog).

The researchers used a Markov model to assess health effects and associated costs of daily consumption of plain dark chocolate compared with no chocolate in a population with metabolic syndrome but without diabetes or cardiovascular disease.

That's my first problem with the study.

It wasn't a gold standard randomized double blind controlled study. It wasn't even a good observational study. It was a mathematical calculation, and at that it only showed a benefit of .85 (yes, point eighty five) fewer heart related events per 100 people, and of the heart events, they are predicting .15 fewer events leading to death. That means for every 1000 people who eat the chocolate, there would be 1.5 fewer deaths.

Okay, you say, I get to eat chocolate and maybe I'll be the one guy or gal out of a thousand that benefits from it. So here's my real problem with the study. As a modeling study, it also made assumptions about the type of chocolate that was consumed. The researchers wrote, ""Evidence to date suggests that the chocolate would need to be dark and of at least 60% to 70% cocoa, or formulated to be enriched with polyphenols." There is no reference to the sugar content of the chocolate.

True, dark chocolate in high concentrations (usually over 75% cacao) contains polyphenols, which are healthful antioxidants. However, the sweetness in the dark (or sometimes called bittersweet) chocolate always comes from added sugar of one sort or another. This sugar is usually not healthy and is also fattening.

I know from personal experience that when I added for the purported health benefit (and the taste) one small piece (1/8 of a bar) of dark chocolate a night with 75% cacao (the higher the cacao the more sugar needed to make it enjoyable), my weight started to slightly increase from that one solo change. I stopped the practice.

If you think that this was a study that should make you go out and buy some dark chocolate, here is what the researchers said about their own study.

Reid and colleagues noted that the study was "limited by its reliance on the Framingham algorithm, which may underestimate risk in a high-risk population, and by assumptions about the risk of death following a cardiovascular event." Furthermore, "the study was also limited by the assumption that the benefits of dark chocolate, which have only been observed in short-term trials, extend to 10 years."

By the way, there are many non-processed rich sources of polyphenols in fruits and vegetables such as blueberries, black berries, strawberries, red grapes, eggplant, etc., so you don't need to eat chocolate to get your daily dose.

In conclusion, dark chocolate is better than regular chocolate. The higher the percentage of cacao, the more healthy polyphenols it contains, but watch out for the increase in carbohydrates. Nibble on no more than 1/8 of a bar at any given time. Most importantly, if you want to eat it, do it for the taste, because the heart benefits are still inconclusive.

More on Metabolic syndrome

From PubMed

Insulin resistance syndrome; Syndrome X

Metabolic syndrome is a name for a group of risk factors that occur together and increase the risk for coronary artery disease, stroke and type 2 diabetes .

Causes, incidence, and risk factors

Metabolic syndrome is becoming more and more common in the United States. Some estimate it as affecting 25% of the U.S. population. Researchers are not sure whether the syndrome is due to one single cause, but all of the risks for the syndrome are related to obesity.

The two most important risk factors for metabolic syndrome are:

• Extra weight around the middle and upper parts of the body (central obesity). The body may be described as "apple-shaped."
• Insulin resistance, in which the body cannot use insulin effectively. Insulin is needed to help control the amount of sugar in the body. As a result, blood sugar and fat levels rise.

Other risk factors include:

• Aging
• Genes that make you more likely to develop this condition
• Hormone changes
• Lack of exercise

People who have metabolic syndrome often have two other problems that can either cause the condition or make it worse:

• Excess blood clotting
• Low levels of inflammation throughout the body

Symptoms

• Extra weight around your waist (central or abdominal obesity)

Signs and tests

According to the American Heart Association and the National Heart, Lung, and Blood Institute, metabolic syndrome is present if you have three or more of the following signs:

• Blood pressure equal to or higher than 130/85 mmHg
• Fasting blood sugar (glucose) equal to or higher than 100 mg/dL
• Large waist circumference (length around the waist):
  
  • Men - 40 inches or more
  • Women - 35 inches or more
• Low HDL cholesterol:
  
  • Men - under 40 mg/dL
  • Women - under 50 mg/dL
• Triglycerides equal to or higher than 150 mg/dL

Tests that may be done to diagnose metabolic syndrome include:

• Blood pressure measurement
• Fasting glucose test
• HDL cholesterol level
• LDL cholesterol level
• Total cholesterol level
• Triglyceride level

Treatment

The goal of treatment is to reduce your risk of heart disease and diabetes. Your doctor will recommend lifestyle changes or medicines to help reduce your blood pressure, LDL cholesterol, and blood sugar.
Recommendations include:

• Lose weight. The goal is to lose between 7% and 10% of your current weight. You will probably need to eat 500 - 1,000 fewer calories per day.
• Get 30 minutes of moderate intensity exercise, such as walking, 5 - 7 days per week.
• Lower your cholesterol using weight loss, exercise, and cholesterol lowering medicines, if needed.
• Lower your blood pressure using weight loss, exercise, and medicine, if needed.

Some people may need to take daily low-dose aspirin.
People who smoke should quit.

Expectations (prognosis)

People with metabolic syndrome have an increased long-term risk for developing cardiovascular disease and type 2 diabetes.

Complications

• Atherosclerosis
• Diabetes
• Heart attack
• Kidney disease
• Nonalcoholic fatty liver disease
• Peripheral artery disease
• Stroke