How to Make it Through Sinus Season

Posted on March 6, 2015

How to Make it Through Sinus Season – 2015 Update

Dr. Katz

 

In addition to the instructions below which will help you with keeping your sinuses healthy throughout the winter, this year’s update has some encouraging news from the conventional medical community. Mold or fungus will grow any place that has access to nutrients and moisture. Our sinuses, by design, are moist, and normal mucus contains carbohydrates. It should be no surprise that among the 300,000 species of mold/fungus, there should be many that could inhabit the sinuses. However the conventional definition for fungal sinusitis has five components which include the erosion and destruction of the facial bones. This definition is becoming more liberalized such that fungal sinusitis is being recognized more and more in otherwise healthy people (fungal infections in immunocompromised people has been long-established).

 

With freezing temperatures, four feet of snow on the ground, and relative humidity in the teens, it is time to revisit some time-tested suggestions to limit sinus inflammation, which interferes with quality sleep and health. Failure to get adequate amounts of sleep underlie numerous medical conditions, including hypertension, heart disease, sudden cardiac death, stroke, and resistance to infection.  It is that time of year again, so your local experts – Drs Katz and Nadelberg – have some suggestions.

 

Why are you Miserable?

Your sinuses need moisture; when your sinuses have insufficient moisture, the mucus becomes thick, acidic and sticky and cannot drain.  The sinus membranes can crack and create opportunities for infection. The cold outside air has very low humidity, especially when the temperature is below freezing.  When indoor air is warmed, the relative humidity declines as well.  This applies to all forms of heating – radiator, geothermal, electric, coal, oil, wood stove, or pellet – not just forced hot air. Most furnace humidifiers will only achieve a relative humidity of 30 to 35%, and less on the coldest days. Sinuses need more moisture. Here is your survival guide:

 

Drink Fluids. 

The more fluids one drinks, the thinner and less irritating the mucus becomes.  However, several organs, such as kidneys, heart, and gastrointestinal tract, have a higher priority for fluids you consume.  So while drinking fluids is helpful, it must be augmented with humidification, which adds fluid locally to the sinuses.

 

Humidification

The one spot in which you spend the most time is sleeping in bed.  Night time moisture content drops as outside temperatures decline, so the best payback on humidification is to humidify the area where you sleep.  Desktop humidifiers, for all their inconvenience of frequent refilling, are a great solution.  The best location is near the head of your bed, as the amount of humidity in the air will decrease dramatically each foot further from where you place the humidifier.  Alternatively, you can get a room sized humidifier for the bedroom.  These larger devices require more frequent maintenance in terms of cleaning, filing with water, or replacement filters, but they do work.

 

Nasal Saline

During the day, you can humidify your sinuses with nasal saline.  It comes in small squeeze bottles and can be found at pharmacies.  It produces a fine mist that you can inhale one nostril at a time.  To penetrate your sinuses deeply, you need to bend your head backward.  Some people even lie on a bed with their head over the edge and spray the mist gently, letting gravity help it penetrate.  This is a reversal of everything you learned about keeping water from going up your nose while swimming, but I assure you it can be learned.  For those of you, who keep your head up right, bring along a paper towel or tissue as you will find yourself blowing your nose after the saline.

 

Clean Air

We close our windows, block the drafts from our doors, and seal in any pollutants in the house for the winter. Allergens, dust, and even noxious gases such as nitric oxide all increase inside our houses while pollutants and allergens outside fall to near zero. There are simple filtration units that go under the acronym HEPA (High Efficiency Particle) which contains a box, fan, and a sophisticated paper filter that removes even pollen. The filter paper turns gray as it becomes occluded and must be changed for the device to work, so buy several filters at a time. Most people should concentrate on keeping the bedroom air clean (it’s where one spends the most time). The strategy is to keep the bedroom door closed and leave the filter on all day and night. Pets are basically large dust balls and the more you groom them and keep them out of the bedroom (and off the bed!), the better.

 

Scarves

The lungs exhale about a pint of water a day. A scarf is a great way to get the moisture of exhaled air into the sinuses when walking outdoors. The high collar on a winter parka or shell functions the same way, by directing the moist air from the lungs up towards the nostrils.

 

Steam Where You Can Find It

Steaming up the shower is a great way to moisturize your sinuses (and possibly frizz your hair).  A useful trick is to find moisture in places besides the bathroom and the kitchen.  A lot of older office buildings have hot water systems that will generate steam in a bathroom sink, and many newer office buildings have hot water and ice water outlets in the coffee areas. If you are careful, using two or three paper cups to insulate the hot water from your fingers, a cup of coffee can become brief sinus treatment.

 

Neti Pots

For those of you for whom all the above maneuvers have failed, and you are treating two or three sinus infections per winter, you should read up on Neti Pots.  This is a device made to pour a solution of saline and bicarbonate in your sinuses on one side of your face at a time, and have the solution come out on the opposite side (and sometimes some gets swallowed).  If you have difficulties with nasal saline coming up your nose, the Neti Pots will either be a true challenge or impossible to adapt.  However, there are numerous well-controlled studies in which Neti Pots reduced sinus symptoms and sinus infections, as well as allergies.  I do not endorse them for everyone, but this note would be incomplete without their mention.  For those of you interested in pursuing this further, they can be ordered on the Internet, with instructions, from merchandisers such as Amazon.com

 

If all else fails, and you develop facial tenderness, fever, and drainage becomes foul, you may need a call to the doctor for antibiotics, steroid nasal sprays, and some rest.

 

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The Wrong White Crystals

Posted on March 6, 2015

The Wrong White Crystals: Some Insights into Salt and Sugar

The Bad News on Bread?

 

Writing about the American Diet is maddening. Not a day goes by that a remarkable insight, announced one day, is refuted the next. These are not ignorant armies warring by night, but well-funded industry groups, philosophically invested academics and journalists, and people who consider food a religion, fighting it out for your attention. These activists drown out more informed souls (see previous newsletter about drug companies “crowding out” other research); the public has a hard time finding more accurate and balanced views of diet and health (think Walter Willets at The Harvard School of Public Health).

 

When I was in medical school, caloric restriction was the solution to weight loss. “Calories-in-calories-out” was the dictum.  There was an evolving position that a “low-fat” diet was the way to health. What we have come to understand is that no one thing – calories or fat, or exercise, or supplements, or hormones – will create long term weight loss.  Diets that focus on one thing fail 95% of the time.

 

So it is refreshing to have a review that considers the relationship between 2 major nutrients – salt and sugar- to hypertension. The conclusion of the authors is that sugar is more damaging than salt.  This would explain several key observations. Salt consumption is relatively constant across many populations, though the incidence of blood pressure varies significantly. In populations where salt has been restricted, proportionate improvements in hypertension and reduction in heart disease have not taken place. The linkage between carbohydrate consumption and increased heart disease, even in the absence of a diagnosis of diabetes, grows stronger year-by-year.  At Age Management Boston, we monitor everybody’s insulin on a yearly basis, and motivate patients to take anti-diabetic measures even before sugar rises.

 

The authors of “White Crystals” are saying that sugars increase blood pressure, heart rate, and myocardial oxygen demand. They contribute to inflammation throughout the vascular tree. Sugar and salt are both bad for blood pressure; sugar, however, is the greater evil.

 

Where Does That Leave Bread?

 

Joy of Cooking recipes for bread are basically one part salt, two parts sugar/honey, and four parts flour (which is as glycemic as sugar) with eggs/milk/yeast added. Bread is the largest source of salt in the American diet (Centers for Disease Control) – not potato chips, pizza, or pretzels. The list:

 

1 – Bread and rolls, 7.4%

2 -Cold cuts/cured meats, 5.1%

3 – Pizza, 4.9%

4 -Fresh and processed poultry, 4.5%

5 -Soups, 4.3%

6 -Sandwiches like cheeseburgers, 4%

7 -Cheese, 3.8%

8  -Pasta dishes like spaghetti with meat sauce, 3.3%

9 -Meat dishes like meatloaf with tomato sauce, 3.2%

10- Snacks, including chips, pretzels, popcorn and puffs, 3.1%

 

The CDC does not have a list of foods with high combined sugar and salt (it would be a complicated computation), however, the majority of dishes on the high-salt list are also high in sugars (carbohydrates). Is it any wonder there is an epidemic of hypertension (1/3 of adults) and Type II diabetes (1/10 adults)?

 

If you are not hypertensive or diabetic, reducing bread consumption might reduce future risk in a very marginal way. Some Type II diabetics who give up bread (and don’t substitute another carbohydrate!) experience improved blood sugar control in weeks (and hypertension improves later).

 

Understanding that many will find it hard to give up bread, I will offer advice about consuming bread.  First, try to limit your intake. At a restaurant, put bread on the bread plates and send the extra back to the kitchen. Balance your meal – don’t get the baked potato; get some vegetables.  Dunk your bread in olive oil, rather than use butter. Olive oil will reduce the glycemic impact of the bread by slowing absorption.

 

 

The wrong white crystals: not salt but sugar as etiological in hypertension and cardiometabolic disease

                        James J DiNicolantonio1 and Sean C Lucan2

http://openheart.bmj.com/content/1/1/e000167.full

 

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Was the Death of Robin Williams Preventable? Misperceptions of Suicide

Posted on August 25, 2014

In his piece on Robin Williams, Andrew Solomon of The New Yorker states that every 40 seconds, someone commits suicide. Actually, it’s every second of every day, as people choose the action, or inaction, that will end their lives sooner. When the patient with metastatic melanoma, who is quite capable of getting to the refrigerator, refuses to take food or liquids, she is taking her life. Her body will get the job done for her by starvation and dehydration.  Battling mental illness but physically intact, depressives must come up with active methods to end their lives.

 

Solomon calls Williams’ suicide a “permanent solution to a temporary problem.” Chronic/recurrent depression, however, is not “temporary.” People with chronic/recurrent depression struggle every day to get to the emotional levels of their more normal peers.  Depressives expend their life forces to stay on an even keel, with the result that they suffer increased heart disease and other physical ailments.  The number of suicides is small in comparison to death by these other causes. Suicide among the middle-aged and the elderly is an admission that they have exhausted their vitality—and perhaps all their temporary solutions (therapy, medications, addictions, creativity, marriages, and self-help groups) are no longer adequate to balance their permanent problem.

 

Over 20 years as an emergency physician, talking to those who attempted suicide but lived, I heard people who accepted death as an inevitable part of living. They had booked their departure and missed their connection. Depressed, they had won the daily fights, until overwhelmed; their final action was to abandon the battlefield.  Their spirits were broken; their will was gone.

 

It is not that the “same qualities that drive a person to brilliance may drive that person to suicide.” Actually, depressives find relief demonstrating their talents  – art, writing, making movies, drugs, sex, or risk-taking. When engaging in their chosen line of expression, they restore some of the energy that would otherwise be lost in the daily drain.  Great art (or bad cocaine unfortunately) can be equivalent analgesics.

 

There are some young, impulsive Romeo and Juliet episodes (like prom nights), but suicide notes from the middle-aged and elderly are quite practical and selfless. Consider poet John Berryman’s:

 

O my love Kate, you did all you could.  I’m unemployable & a nuisance. Forget me, remarry, be happy.

 

That is not the last plea of an isolated man, but that of one concerned about his loved one. Indeed, suicides in many societies arise from the notion that the family and the community are better off without the presence of a particular individual.  Perhaps, as in Berryman’s “Dream Song 14”, he lost his “inner resources.”  With no joy in anything anymore, he needed his rest.  Robin Williams, who brought mirth to millions, at the end, may have perceived a family and a world that would have been happier without the Robin Williams he perceived, an exhausted shell of a man.

 

My regret is that his last act had to be solo, with no one there to tell him what a great job he had done in spreading joy to millions. We all have a role in this isolation at the end – assisting suicide is criminal offense. So when Williams was possessed of the fatal moment, he acted alone, first trying a pen knife, before succeeding at slow suffocation. Maybe if he had a chance to consult a doctor/counselor about “how to do it,” there might have been an adjacent conversation about “why to do it?” and a chance to change his mind. As for those who look for a “reason” in his final days, rather you should consider the 10,000 days of struggle before the final day, and marvel at his ability to give so much to the world while engaged in that daily battle against sadness.

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Get off that deadly chair – Sitting too long raises fatality risk, experts say

Posted on June 25, 2014

LONDON (AP) — Here’s a new warning from health experts: Sitting is deadly. Scientists are increasingly warning the public that sitting for prolonged periods of time, even if you also exercise on a regular basis, could be bad for your health. It also doesn’t matter where the sitting takes place; at the office, school, car, or in front of a computer or TV. What matters is just the overall number of hours it occurs.  Research is preliminary, but several studies suggest that people who spend most of their days sitting are more likely to be overweight, have a heart attack, or even die.  In an editorial published this week in the British Journal of Sports Medicine, Elin Ekblom-Bak of the Swedish School of Sport and Health Sciences suggested that authorities rethink how they define  physical activity to highlight the dangers of sitting.  While health officials have issued guidelines recommending minimum amounts of physical activity, they have not suggested that people try to limit how much time they spend in a seated position.

People might get more of a benefit if their exercise were spread across the hours of a day, rather than in a single bout. That wasn’t welcome news for Aytekin Can, 31, who works at a London financial company, and spends most of his days sitting in front of a computer. Several evenings a week, Can also teaches jiu jitsu, a form of Japanese martial arts that involves wrestling, and he also partakes in Thai boxing. “I’m sure there are some detrimental effects of staying still for too long, but I hope that being active when I can helps,” he said. “I wouldn’t want to think that sitting could be that dangerous.”  Still, in a recently published study that tracked more than 17,000 Canadians for about a dozen years, researchers found that people who sat more had a higher risk of death, independent of whether or not they exercised.  “We don’t have enough evidence yet to say how much sitting is considered bad,” said Peter Katzmarzyk of the Pennington Biomedical Research Center in Baton Rouge, who led the Canadian study. “But it seems the more you can get up and interrupt this sedentary behavior, the better.”

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Meat, L-Carnitine, and Heart Disease

Posted on June 5, 2014

  1. I.  Welcome to the Microbiome

Science is full of surprises. Right about the time we developed radio telescopes that can look back 15 billion years to the origin of the galaxy, we discovered that the galaxy we can see is only one third of the universe. Suddenly “dark matter” and “dark energy” surround us, or so it might appear. The reality is they have been there all along.

 

The sequencing of the human genome is a pinnacle of science. While we have identified the 30,000 human genes, we also discovered that “dark regions” make up the majority of our DNA. What we have learned about the 30,000 genes is that they act in combinations that are almost infinite. However, they interact with our environment to the degree that genetics predicts only about 30% of our future health. The genetic/environmental interaction determines the rest. Our understanding of life got more complex when we started sequencing various other species on the planet. A good, red garden tomato has three times the number of genes as Einstein.

 

So what is it in our environment that we interact with? Pesticides? Air pollution? Our food? In each instance, like gazing at stars, we have looked too far afield. We carry within and on our body several pounds of bacteria and fungi with which we interact constantly and intimately – so intimately that we have integrated some nonhuman DNA into our own! A human is roughly 10 billion cells; the microbiological load we carry – the microbiome – is 100 trillion cells. While human DNA is roughly 99% identical from one person to the next, each microbiome is only 50% similar. If we look at evolution, DNA is a cranky, stubborn little computer that reluctantly adapted to prolonged climate, agricultural, and/or predator changes. However, our microbiome can shift dramatically in weeks, and can transfer capabilities to other individuals as well as the next generation through simple contact. Think of DNA as internal, permanent evolution, and the microbiome as external, adaptive evolution, capable of changing multiple times within the life of the individual. Please read “Our Bugs, Ourselves” in the Harvard Health Magazine.

 

II. Is Carnitine in Meat a Principal Cause of Heart Disease? (No!)

Stanley Hazan, of the Cleveland Clinic, published a paper in Nature Medicine which showed that mice, when fed the supplemental protein l-carnitine, produced trimethylamine-N-oxide (TMAO), a known accelerator of atherosclerosis. Further, the paper shows that meat-eating humans produce more TMAO than do vegetarians. Lastly, when the intestinal bacteria of mice were suppressed with antibiotics, their TMAO production did not rise even though the mice were fed l-carnitine. The new theory is that carnitine, via TMAO, changes the metabolism of cholesterol, creating more deposits in artery walls.

 

Is it time for all meat eaters to throw their beef off the cliff?

 

Maybe not; part of Hazan’s study showed a correlation between high blood carnitine levels and heart disease. However, in studies of heart attack, congestive heart failure, and cardiomyopathy, distressed cardiac muscle leaks carnitine, resulting in low intracellular levels and high blood levels. When given more l-carnitine, the stressed myocardium improves. So it begs the question – just how long before an acute event does the leaking begin? Perhaps Dr. Hazan should have measured intracellular l-carnitine?

 

There is extensive research on l-carnitine going back to 1965, demonstrating that it decreases mortality in heart attacks and decreases arrhythmias. It has never been very good for muscle building, but it does help in reducing recovery time between exercise sessions, especially as one ages. Because it is a natural substance, it cannot be patented, and is not attractive to large pharmaceutical firms. The most recent study of l-carnitine, published in the Mayo Clinic proceedings this year, showed improvement in congestive heart failure. There are also children born with a genetic inability to produce l-carnitine.  They lead normal lives with supplementation and have not shown any evidence of increased atherosclerosis after a lifetime of l-carnitine well above normal levels for their protection.

 

This is the typical nutritional mosaic – highly contrasting research findings. The missing piece in this Angel versus Devil piece of metabolism is an understanding of the microbiome.  Carnitine is found in many foods besides red meat, including chicken, pork, milk, and fish. Is it meat consumption alone that creates TMAO-generating bacteria? Or do meat eaters have other evil habits that are responsible? In addition, choline, phoshotidyl-choline, and lecithin have also been linked to TMAO. These proteins are found in hundreds of foods. That would change carnitine from a cause to a marker. Lastly, bodybuilders consume enormous quantities of carnitine in protein shakes, yet have no documented increased risk of atherosclerosis. Are their microbiomes generating an antidote to TMAO that keeps it in balance?

 

My advice is to look at the world wide metabolic ecology and then let our intuition guide us so that we don’t miss the 500 pound gorilla in the middle of the room while distracted by something new and sexy. The theory that meat-containing carnitine creates TMAO which then activates cholesterol is best viewed in reverse.  Numerous groups – Hunza tribesman, Masai herdsman, rural Chinese, all with radically different diets – have almost no heart disease.  They all have total cholesterol far below the Hazan study group.  We know from the Asteroid trial that when total cholesterol gets down towards 130, atherosclerosis reverses.  In point of fact, this is the mammalian “sweet spot” for cholesterol and it applies to elephants, gorillas, and even dogs and cats, who have similar cholesterol levels and no heart disease. At Age Management Boston, we are guided by this data. The average American diet ruins insulin control, leads to metabolic syndrome, numerous inflammatory conditions, and disease. In this context, carnitine in meat is like rearranging the chairs on the Titanic. A healthy diet, adequate sleep, and exercise more than likely create a microbiome that can handle lean meats just fine. And considering the amount of time we have been exposed to meat, there may even be specific DNA adaptations for meat eaters – there are indications the Masai have achieved this.

 

III. Update on the FDA and Compounding Pharmacies

The prescribing of hormones has become more challenging as pharmacies in multiple states, having seen the FDA pressure pharmacy closures, have ceased observing many of the everyday courtesies in medical practice in favor of the “letter of the law.” Prescriptions that could be called in now must be faxed, or even the original mailed. There are three national ID numbers for each physician – and some pharmacists who have known mine for years now insist I use them all. Eventually, Congress will grant the FDA authority over all prescribing including compounding pharmacies. This standardization will work its way into electronic prescribing and this period of turmoil will pass.  But anticipate headlines about FDA inspections, closures, and fines until then.

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Fish Oil Remains Very Good For You

Posted on June 5, 2014

A recent publication in the Journal of the American Medical Association found no benefit of 1 gram daily of fish oil in a review of 20 previous studies. Numerous major news and media outlets are interpreting these results to show that omega-3 is ineffective as a supplement without also presenting the limitations and deficiencies in the analysis itself. Most physicians disagree.

Why such discrepancies? Supplement studies are plagued by what I call dosage dilemmas. They aren’t standardized like pharmaceuticals, so based on how much of which chemical form of a given supplement is used; the amount absorbed can vary by light-years. Thirty years ago, 30 mg of co-enzyme Q10 which was only 10% absorbable showed marginal benefits at best. Four years ago, 1400 mg of a 90% absorbable form a coenzyme Q10 was shown to reduce the progression of Parkinson’s disease.

So while the JAMA study looked at 1 gram of daily fish oil, most of our patients take 2-4 grams daily, and at that level benefits are clear.

James O’Keefe is a Preventive Cardiologist who has published over 200 papers concentrated on the beneficial effects of both nutrition and exercise on cardiovascular health. Below are his comments on this recent newsworthy publication.  As one of the most popular health supplements and one of the most extensively studied, omega-3 has benefited the lives of millions of people.  Dr O’Keefe:

“The item of greatest contention for me, and some fellow physicians, was that the study actually showed a statistically significant reduction in cardiovascular mortality. In addition, borderline significant reductions were seen in all-cause mortality and sudden death. The researchers focused on the lack of statistically significant reduction in all-cause mortality, which led the media to report that omega-3 is not beneficial. However, as noted in the illustration below, the reduction in cardiac death was significant (if the confidence interval line does not cross the 1.0 line the result is by usual standards deemed statistically significant).

Examples of the limitations in the meta-analysis:

  • The dose of omega-3, specifically the beneficial DHA and EPA fats, was less than 1 gram daily, which is not optimal for conferring maximal benefits, especially for lowering triglycerides and reducing inflammation.
  • Many of the studies included in this analysis did not have a long enough follow-up. The average follow-up was only 2 years when prevention studies involving heart and stroke patients typically span 5 years.
  • Researchers picked twenty of the thousands of studies on this topic, as many studies vary with types of patients and the doses of fish oil studied. Omega-3 is nearing the top of the list for most studied substances in modern medicine.
  • Many of the studies covered participants who were already sick, not accounting for the wide range of effects their medications could cause. Heart patients are often prescribed a multitude of drugs, from beta-blockers to diuretics, creating a significant challenge in determining omega-3 effectiveness.
  • Many of the studies didn’t test to see if people were starting out with diets very low in fatty fish and therefore omega-3s. If one is consuming a high daily dose of omega-3 in his or her diet, the benefits of an omega-3 supplement for that person are likely to be less apparent or maybe even nonexistent.

Over the past 40 years, omega-3 essential fatty acids have been demonstrated to provide health benefits in multiple settings for many types of individuals. New studies are continually conducted, thus furthering our understanding of who is most likely to benefit from this nutrient, and what the ideal doses of omega-3 are in targeting various diseases and complaints.

In Good Health,
James O’Keefe, MD, FACC

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The Denmark Lookback

Posted on June 2, 2014

Last year, the American Heart Association and American College of Cardiology released new guidelines for the treatment of an increase in the risk of heart disease with statin lowering drugs like Lipitor. The previous guidelines (Adult Treatment Panel Guidelines (ATP III)) were based upon the levels of blood cholesterol.  The new ACA/AHA Guidelines expanded on the input data to include lifestyle issues like smoking and obesity. The old ATP III Guidelines used a point system; the AHA/ACA guidelines were sufficiently complex to the point where they required a spreadsheet.

 

When the spreadsheet was analyzed, many concluded that even if one had zero increased risk based on ATP III Guidelines, every male over 63 years of age and every female over 71 years of age would receive a recommendation for Lipitor and its ilk.  Many, including Steve Nissen, MD of the Cleveland Clinic, thought this was too aggressive. The authors of the ACA/AHA Guidelines have resisted all calls for revision, expounding doctrine rather than engaging in a scientific debate. Case studies are being published so that practicing physicians can have a “nuts and bolts” comparison of the application of the new and old guidelines and, at least initially, the American Academy of Family Medicine, has not endorsed the ACA/AHA Guidelines.

 

The real conundrum with any new guideline is that one can only judge its effectiveness after it has been in effect for several years. If followed religiously, the new AHA/ACC Guidelines would place between 12 and 20 million more patients on statins.  Since statins are not risk free, that may not be a good idea. (Even if statins were risk free, are they the “best” intervention; does the opportunity cost of statins inhibit the use of something more effective, like exercise and diet?)

 

The ATP III Guidelines were based on the original data of the Framingham Study. However, the Framingham study which started in 1954 did not include the effects of exercise.

 

 

In 1968, the books; Aerobics by Ken Cooper and The Joy of Running by Jim Fixx were published, and the Exercise Era began.  There were no new medications introduced in 1968 (the first major study on niacin was released in 1979, pravastatin (Pravachol), the first statin, wasn’t released until 1988).  The American diet actually got considerably worse starting in 1968 with increasing distribution of trans-fats throughout the food chain (with labeling and restrictions only starting in the late 1990’s), as well as High Fructose Corn Syrup being introduced in 1975. Guidelines that fail to recognize the contribution of exercise will overestimate the population at risk. (People who exercise have a lower risk and lower need for additional medication.)

 

However recalcitrant the AHA and ACC might be (and how they may not fund studies that differ from their points of view, we still have Denmark, a beautiful little nation with windmills, dikes, longstanding computerization of medical records of the entire population, and a highly disciplined medical community that insists on entering accurate diagnosis.) The utility of Denmark’s data is limited only by the size of the population and the size of research budgets.

 

When studies were published in Greece declaring the risk of bleeding ulcers negated the cardiac benefits of aspirin, it was Denmark that had data demonstrating the true baseline risk of GI Bleed was ten times lower than the Greek estimate. This reversed the conclusions about aspirin. Similarly, there was a hypothesis about mercury in vaccines causing autism (which still has proponents). However, one must consider that Denmark had eliminated all mercury from its vaccine supplies 20 years earlier, maintained consistent definitions of autism, and had the same rate of autism as their mercury using neighbors.

 

In reference to the ACA/AHA Guidelines, Maryam Kavousi, M.D., Ph.D., of Erasmus MC-University Medical Center, identified 4,854 Dutch participants from the Rotterdam Study which started in 1990, and which included all the risk factors used by the new ACA/AHA Guidelines. She found that application of the ACC/AHA guidelines recommended treatment for 96.4 percent of men and 65.8 percent of women.

 

With the ACC/AHA approach, predicted risk for heart attack and stroke events was 21.5 percent vs 12.7 percent actual events for men, and 11.6 percent predicted events vs 7.9 percent actual events (for women). In other words, in a real population, statin use would have been excessive.

 

However, to be fair, one must consider the differences between the US population and Denmark. For example, in the US, 30% of the adult population is obese (Body Mass Index over 30) as opposed to only 10% of Danes. In the US, 48% people are aerobically active, in Denmark 60%.  No guideline will produce the identical outcomes in differing populations. However, for a guideline to miss reality by 40% among men and 30% among women is an error much greater than variations between two populations. A Danish researcher commented that the ACA/AHA Guidelines were essentially an age based recommendation for a drug. And this particular drug was observed by the British to have a 10% one year discontinuation rate due to side effects.

 

So the AHA/ACC should have their moment of reflection and revise their guidelines. Statins are beneficial drugs – they lower the risk of colon cancer. While niacin, diet, and exercise are much more effective cardiovascular preventatives.

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Testosterone Safety in the News

Posted on April 24, 2014

Headline: Testosterone Doubles the Incidence of Heart Attack (2014)  Reality: Testosterone Group had 0.7% more Heart Attacks

A paper by Finkle et. al. (Increased Risk of Non-Fatal Myocardial Infarction [Heart Attack] Following Testosterone Therapy Prescription in Men) published in the free-access journal PLOS One examined insurance records of 225,000 men aged 50 to 75 and concluded that the risk of non-fatal myocardial infarction increased during the first 90 days of testosterone therapy, and even more so when the patient had a prior history of cardiovascular disease.  The report of “doubled risk” made every news television show and newspaper, but the actual increase was 7 cases per thousand patients.

 

The anti-pharmaceutical campaign trumpeted the findings, and the anti-aging crowd attacked the study for its limitations (which are discussed in the paper). The Food and Drug Administration reviewed the results and concluded that patients should not stop testosterone without consulting their physician.

 

For comparison, in 2012 another retrospective study was published about aspirin “doubling” the risk of gastrointestinal bleeding. The absolute increase in bleeding from one group to another was 0.19%. The FDA made a similar “not stop” statement about the aspirin study as they did in the testosterone study. I am unaware of any cardiologist who recommended a discontinuation of the drug.

 

Relative risk, the statistic used in the Finkle study, can be 100% greater if for example; a group of one million patients had two cases of something and the comparison group of one million had only one case. It is a valid statistical method for detecting possible relationships, but it can be misleading. When Medicare first published surgical outcome data, Massachusetts General Hospital had relatively poor outcomes; when the data was corrected to account for the complexity of the surgical cases, Massachusetts General had excellent outcomes. The same data can give different conclusions. A quote comes to mind (whose origin is contested between Mark Twain or Benjamin Disraeli), “There are three kinds of lies: lies, damned lies, and statistics.”

 

The Finkle study does indeed demonstrate an increased risk of heart attack during the first 90 days after filling a testosterone prescription. However, some details are missing. It does not show if patients took the prescription, or had blood levels checked before and/or after the prescription. Since the symptoms of low testosterone can resemble depression and/or hypothyroidism, the possibility holds that inadequate evaluations can lead to inappropriate outcomes.

 

Testosterone is enormously beneficial when prescribed in the right dose and for the right reasons:

 

Testosterone administration increases coronary artery diameter and flow, improves symptoms in men with chronic stable angina, and reduces peripheral vascular resistance in chronic heart failure. Animal studies have consistently demonstrated that testosterone is atheroprotective, whereas testosterone deficiency promotes the early stages of atherogenesis.”  (Kelly and Jones – Journal of Endocrinology – 2013)

 

All medications have risks. The short term risk of testosterone increasing the odds of blood clotting has been known for 50 years, so why the recent alarm? Perhaps because the number of testosterone prescriptions has skyrocketed to over one million per year since the “Low-T” campaign began. This creates the possibility that some doctors who don’t appreciate the risks are being pressured to prescribe testosterone. Finkle only found the increased risk in the first 90 days (short term) and no increased risk thereafter.  Kelly and Jones are describing the long-term benefits of testosterone. The correct conclusion is that there might be more short-term risks involved, but that there is a continuously growing understanding of the long-term benefits.

 

The study’s greatest flaw is the choice of the groups that were used for comparison. Finkle had access to almost unlimited data (he actually owns the company that supplied the data), but he chose his groups based on one group receiving prescriptions for testosterone with the other group receiving Viagra type drugs. Why didn’t he choose two groups of men with existing heart disease of equal severity, one who received testosterone prescriptions and one who didn’t?

 

If this was the case, he could have identified the characteristics of the men having the heart attacks in order to help physicians screen them out before treatment, or pursue alternatives. It would have been extremely helpful, for example, to know which men were treated according to the Endocrine Society Guidelines, and if following the Guidelines reduced the risk. As circumspect clinicians, Dr. Nadelberg and I have reviewed our protocols (based on the Guidelines) and they still reflect adequate caution.

 

The other unanswered question is whether the heart attacks in the first 90 days were due to testosterone or was it the natural course of their underlying heart disease? Two groups of equal cardiac severity would have answered this question too.

 

This study leaves us with an increased concern about why these patients were treated the way they were, and until there is a study produced using sounder methodology, we won’t get much else. This is another lost opportunity.

Posted in Health Supplements, Hormone Supplementation Therapy, Medicare, Medications, Preventative Medicine | Tagged , , , | Leave a comment

Niacin Nonsense

Posted on April 5, 2014

For ten years, Merck has been pursuing one of the Holy Grails in pharmaceuticals. Aspirin is one of the most recommended drugs in the world.  Merck has been developing laropiprant to replace aspirin.  But laropiprant was a long shot as it has a paradoxical dose- response relationship; the high dose effects are the reverse of the low dose.  Drugs like this do not do well in the real world because the general population does not necessarily follow the curve observed in the lab. Therefore Merck financed a study called THRIVE with 25,000 participants and the results were dreadful. The lead researcher’s statement was:

 

 “Results from a landmark study of specially formulated niacin (extended-release niacin plus laropiprant, an anti-flushing agent) in high-risk patients appears to have extinguished any clinical role for niacin to reduce the risk of cardiovascular events in these patients.

          Treatment with extended-release niacin plus laropiprant, was associated with an increase in serious adverse events that led to people being hospitalized: a significant increase in hemorrhagic stroke, serious infections, and new onset diabetes.”

 

It is important to understand that niacin-induced flushing can be blocked with aspirin, apple sauce, or quercetin (a protein found in tea, broccoli, blueberries and numerous other foods), along with the avoidance of alcohol and appropriate drug dosing.  Why did Merck believe we need a new pharmaceutical?

Should Merck have succeeded, they would have a $100/month “drug” to replace aspirin, which doesn’t even cost $1/month. Don’t laugh, prescription Niaspan costs $110/month, and it’s over-the-counter Slo-Niacin costs about $14/month. Niaspan sales last year were just under a billion dollars. “FDA Approved” opens insurance reimbursement.

What is a researcher to do when tasked with announcing that a quarter-billion dollar effort on laropiprant has come to naught? Simple, blame it on the niacin! The presentation to the American College of Cardiology was titled “THRIVE May Signal the End for Niacin.”

The evidence of the cardiac and vascular benefits of niacin, along with it’s safety, have been accumulating for 35 years.

Coronary Drug Project – a study published in 1979 within the New England Journal of Medicine demonstrated a decrease in total cardiac mortality of 11% in the niacin group and a decrease in overall mortality of 14% overall.

The HATS (High density lipoprotein Atherosclerosis Study) published in 2002 within the New England Journal of Medicine demonstrated that the niacin group had one cardiac event for the entire trial and that atherosclerotic lesions in some patients’ hearts were reversed, while twenty-five per cent of the control group held cardiac events. The niacin group was followed up five years later and their side effects, such as elevated glucose or uric acid, had all returned to normal.  The effects of niacin are amplified if given alongside a statin (Lipitor) type drug.

The ARBITOR-2 Trial showed reduced carotid atherosclerosis with niacin. The Oxford Study showed MRI regression of carotid plaques in the niacin treated patients.

In all of these studies there were no major adverse effects from niacin. At the same time, by itself, or combined with a statin drug, niacin continued to reduce heart attacks, reverse atherosclerosis, and reduce the risk of strokes. And there is standing evidence that niacin may also reduce the risk of Alzheimer’s, but I will save that for a future newsletter.

It should be reasonably clear that the problem in the THRIVE trial was Merck’s new drug laropiprant, and that niacin’s track record over 35 years exonerates it.

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Featured in Delta Magazine! “Younger and Slimmer You”

Posted on January 20, 2014

Our own Dr.Katz was featured in this article, entitled “Younger and Slimmer You,” found in the Delta Sky Miles magazine! It addresses hormonal balance as a component of healthy aging, a facet of care we handle deftly in our age management practice.

Posted in Age Management, Aging, Hormone Supplementation Therapy | Leave a comment

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