Category Archives: Supplements and Vitamins

Has REDUCE-IT Resurrected Fish OIl Supplements (And Saved Amarin)?

The answers are no and yes.

There is still no reason to take over the counter fish oil supplements.

In fact, a study published Saturday found that fish oil supplementation (1 g per day as a fish-oil capsule containing 840 mg of n−3 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]

did not result in a lower incidence than placebo of the primary end points of major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type.

However, another study  published Saturday (REDUCE-IT) and presented at the annual American Heart Association Scientific Sessions to great fanfare found that an ethyl-ester formulation (icosapent ethyl) of eicosapentanoic acid (EPA, one of the two main marine n-3 fish oils)  reduced major cardiovascular events by 25% in comparison to placebo.

When I wrote about Icosapent ethyl (brand name Vascepa) in a previous blog post in 2015 there was no data supporting its use:

A fish oil preparation, VASCEPA,  available only by prescription, was approved by the FDA in 2012.

Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides(>500 mg/dl).

This is a very small market compared to the millions of individuals taking fish oil thinking that  it is preventing heart disease.

The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.

The company has a study that shows that Vascepa lowers triglycerides in patients with such mildly to moderately elevated triglycerides but the FDA did not approve it for that indication.

Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.

After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.

Data do not exist to say that lowering triglycerides in the mild to moderate range  by any drug lowers heart attack risk.

In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.

Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amarin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.

If he answers no to all of the above then, hopefully, your triglycerides are over 500.

And although elevated triglycerides confer an elevated CV risk nearly all prior trials evaluating different kinds  of triglyceride-lowering therapies, including extended-release niacin, fibrates, cholesteryl ester transfer protein inhibitors, and omega-3 fatty acids have failed to show reductions in cardiovascular events

REDUCE-IT, Amarin trumpeted widely in September (before the actual data was published)  now provides impressive proof that it prevents cardiovascular disease. Has the skeptical cardiologist changed his mind about fish oil?

Vascepa Is Not Natural Fish Oil

Although Amarin’s marking material states “VASCEPA is obtained naturally from wild deep-water Pacific Ocean fish” the active ingredient is an ethyl ester form of eicosapentoic acid (EPA) which has been industrially processed and distilled and separated out from the other main omega-3 fatty acid in fish oil (DHA or docosohexanoieic acid).

Natural fish oil contains a balance of EPA and DHA combined with triacylglycerols (TAGS).

So even if the REDUCE-IT trial results can be believed they do not support the routine consumption of  over the counter fish oil supplements for prevention of cardiovascular disease.

Does REDUCE-IT  Prove The Benefit of Purified High Dose EPA?

REDUCE-IT was a large (8179 patients) randomized, double-blind placebo controlled trial

Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter  and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter  and had been receiving a stable dose of a statin for at least 4 weeks. In 2013 the protocol was changed and required a triglyceride level>200 mg/dl.

Participants were randomized to icosapent ethyl (2 g twice daily with food [total daily dose, 4 g]) or a placebo that contained mineral oil to mimic the color and consistency of icosapent ethyl and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group.

More importantly, the hard end-points of CV death, nonfatal stroke and heart attack were also significantly lower in the Vascepa arm compared to the “placebo” arm.

These results are almost unbelievably good and they are far better than one would have predicted given only a 17% reduction in triglycerides.

This makes me strongly consider prescribing Vascepa (something I heretofore have never done) to my higher risk patients with triglycerides over 200 after we’ve addressed lifestyle and dietary contributors.

Perhaps the high dose of EPA (4 grams versus the 1 gram utilized in most trials) is beneficial in stabilizing cell membranes, reducing inflammation and thrombotic events as experimental data has suggested.

Lingering Concerns About The Study

Despite these great results I have some concerns:

  1. The placebo contained mineral oil which may not have been neutral in its effects. In fact, the placebo arm had a significant rise in the LDL cholesterol.
  2. Enrolled patients were predominantly male and white. No benefit was seen in women.
  3. Higher rates of serious bleeding were noted in patients taking Vascepa
  4. Atrial fibrillation developed significantly more often in Vascepa patients (3.1%) versus the mineral oil patients (2.1%)

Finally, the trial was sponsored by Amarin Pharma. This is an aggressive company that I don’t trust.  The steering committee consisted of academic physicians (see the Supplementary Appendix), and representatives of the sponsor developed the protocol,  and were responsible for the conduct and oversight of the study, as well as the interpretation of the data. The sponsor was responsible for the collection and management of the data. All the data analyses were performed by the sponsor,

After i wrote my negative piece on Vascepa in 2015 a number of Amarin investors attacked me because Vascepa is the only product Amarin has and any news on the drug dramatically influences its stock price. Here is the price of Amarin stock in the last year.

The dramatic uptick in September corresponds to the company’s announcement of the topline results of REDUCE-IT. Since the actual results have been published and analyzed the stock has dropped 20%.

High Dose Purified and Esterified EPA-Yay or Nay?

I would love to see another trial of high dose EPA that wasn’t totally under the control of Amarin and such trials are in the pipeline.

Until then, I’ll consider prescribing Amarin’s pills to appropriate patients* who can afford it and who appear to have significant residual risk after statin therapy*.

But, I will continue to tell my patients to stop paying money for useless OTC fish oil supplements.

Megaskeptically Yours,-

ACP

N.B.* Appropriate patients will fit the entry criteria for REDUCE-IT described below.

Patients could be enrolled if they were 45 years of age or older and had established cardiovascular disease or were 50 years of age or older and had diabetes mellitus and at least one additional risk factor. Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter (1.69 to 5.63 mmol per liter) and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter) and had been receiving a stable dose of a statin for at least 4 weeks;

So either secondary prevention (prior heart attack or stroke) or primary prevention in patients with diabetes and another risk factor.

 

 

Dear CVS, Homeopathy Is Bunk, Stop Selling It!

The skeptical cardiologist has mentioned homeopathy previously in a  post entitled Functional Medicine Is Fake Medicine. but I hadn”t heretofore commented on how pervasive and useless it is.

Science-Based medicine’s Jann Bellamy has recently written about a lawsuit by the Center for Inquiry (CFI) which claims the pharmacy giant CVS is fraudulently deceiving consumers by selling worthless homeopathic redemies.

There is a unanimous scientific consensus that homeopathy is total hogwash. You can read excellent articles at science-based medicine detailing the crazy pseudo-scientific ideas underlying homeopathy here.

The CFI press release summarizes homeopathy as follows:

Homeopathy is an 18th-century pseudoscience premised on the absurd, unscientific notion that a substance that causes a particular symptom is what should be ingested to alleviate it. Dangerous substances are diluted to the point that no trace of the active ingredient remains, but its alleged effectiveness rests on the nonsensical claim that water molecules have “memories” of the original substance. Homeopathic treatments have no effect whatsoever beyond that of a placebo.

Yet, CVS and other large pharmacy chains continue to sell homeopathic rubbish.

I agree with CFI’s Nicholas Little:

If the people in charge of the country’s largest pharmacy don’t know that homeopathy is bunk, they should be kept as far away from the American healthcare system as possible

The lawsuit claims pharmacy chain giant CVS fraudulently deceives consumers in the sale of worthless homeopathic remedies and was filed in late June by the Center for Inquiry (CFI), acting on behalf of the general public. The suit seeks both damages and an injunction against CVS’s deceptive marketing practices in the Superior Court of the District of Columbia, alleging violations of the District’s consumer protection act.

Come on CVS! Get this type of useless pseudo-scientific snake oil out of your stores and start helping your consumers make good choices.

Hogwashingly Yours

-ACP,

Is Your Generic Medication Made In China and Is It Safe?

Last week the FDA recalled several versions of the generic blood pressure medication valsartan which were made in China and contained a carcinogen (see here.)

Since then I  have switched many patients from the bad valsartan to losartan or valsartan from presumably safe manufacturers.

It didn’t really occur to me that this could be just the tip of the iceberg until I received a reader comment which I will copy below.

As I thought about it, I realized that I have no idea where the generic ramipril I am taking is manufactured. It very well could be in China or India.

This recent article from The Epoch Times confirms that Americans are becoming more and more reliant on medications manufactured in China and that many researchers feel this poses a significant security threat.

The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all.

The book, “China RX: Exposing the Risks of America’s Dependence on China for Medicine” by Rosemary Gibson and Janardan Prasad Singh,” details the problem.

It is very hard to find out how many US drugs come from China since drug companies don’t make their sources apparent. In addition, even if the drugs themselves aren’t manufactured in China, Gibson and Singh write

“China is the largest global supplier of the active ingredients and chemical building blocks needed to make many prescription drugs, over the counter products and vitamins.”

Below are the comments of my reader:


This is horrible. We have a problem in the U.S. It is the infiltration of Chinese generics. I had no idea that this generic was being supplied by a Chinese maker. In fact, the bottles I got said “SOLCO” which is based in New Jersey. Now I’m painfully aware that SOLCO Healthcare US which is based in New Jersey, is owned by Zhejiang Huahai Paarmaceutical based in China’s Zhejiang Province. So this is the Chinese company’s subsidiary distributing this drug in the U.S. China has a long history of selling tainted products in the U.S. Chinese drywall, lead-based paint on toys, tainted pet food, etc. Now it is important to understand that 85% of prescriptions filled in the U.S. are generic. And insurance companies will not pay for brand when generic is available. My valsartan was about $30 for 90 days. Diovan is $750. I get it. But when these companies cut corners and people are endangered, something is wrong. I will never ever take another generic drug without first finding out where the product comes from. I know this is not perfect, but it is something. I think the U.S. lawmakers need to do something to make this information more transparent. It baffles me as to how this drug could have been tainted with a highly toxic chemical for so many years (they now say 4 years). This chemical is known to cause liver damage and cancer. Apparently the manufacturer changed the way it made the active ingredient which created this poison by-product. And now who do we hold accountable? How do we get to the bottom of what went wrong, and how to prevent this going forward. We have no way to compel anything in China. All that said, thanks for your information here it is helpful. I worry that the losartan is made by the same company – I will surely investigate.


China is also flooding the American market with useless OTC medications. I realized this when I looked closely at this “motion sickness patch” which is highly rated on Amazon.

It has no active ingredient which could be realistically thought to treat motion sickness yet is featured on Amazon’s motion sickness treatment section and is favorably reviewed by over a thousand users.

 

Unfortunately, in the US now users of medications must be very aware of the source and quality of the products they put in their body. Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Skeptically Yours,

-ACP

Why You Should Ignore “The Plant Paradox” by Steven Gundry

The skeptical cardiologist first encountered the blather of Dr. Steven Gundry while researching and writing a post entitled  The #1 Red Flag of Quackery.

Gundry came across my quack radar screen due to the popularity of his useless supplements and his pseudoscientific justifications. He is also widely described as a cardiologist but he is not, He is (or was) a cardiac surgeon (like, strangely enough, the celebrity prince of quackery, Dr. Oz)

Gundry is also a Goop doctor, which means Gwyneth Paltrow, the  celebrity queen of weird quackery endorses him.

I’ve been meaning to write specifically about his most popular useless supplement, Vital Reds.

In the meantime, Gundry has  come out with a best-selling.  book entitled  “The Plant Paradox: The Hidden Dangers in Healthy Foods That Cause Disease and Weight Gain”.

This book claims to reveal to its readers the great dietary “secret” that is causing almost all chronic diseases. Of course, Gundry is the only person with the brilliance and insight to have recognized this. Only those who are willing to plunk down the money to buy his book will learn this secret and the (mostly gobbledook) science behind it.

This  technique of convincing the naive that only you are aware of the “hidden” factor which is  the cause of their various maladies can probably be considered the #2 Red Flag of Quackery.

The Plant Paradox would have you believe that lectins are the major danger in our diet.

I’ve come across two well-researched pieces which destroy any validity to the concepts put forth by Gundry in The Plant Paradox.

Campbell: Is It Possible Gundry Is Out To Make A Quick Buck?

The first is from T. Colin Campbell of China Study fame. While I don’t agree with his overall dietary philosophy (see here) in his article he has taken the time to read Gundry’s book in detail and address in great detail the multiple bogus claims and the lack of scientific support. Campbell begins:

The claims come fast and furious in this book, stated with a degree of certainty, without nuance, that undoubtedly appeals to many readers. But the referencing is so lacking and sloppy that Dr. Gundry should be embarrassed. The references that are cited in this book do a poor job of trying to justify its claims. And the bulk of the author’s wild claims lack references at all, with several examples of easily verifiable falsehoods. Because his claims are quite profound and novel, referencing of the findings of others and his own results are especially important. This is especially troubling for an author who touts his own research experience.

After debunking Gundry’s lectin claims , Campbell suggests that Gundry’s major goal is selling more useless supplements, including one that will protect readers from the dreaded lectin:

In conclusion, there are many people who desire good health and deserve good information and we resent that they must suffer such poor quality and confusing information under the assumption that it is good science. Is it possible that Dr. Gundry is just out to make a quick buck? He admits that his patients give up to a dozen vials of blood for testing every couple of months at his clinic. Overtesting is common practice in supplement-driven clinics. This extensive testing, (which are another topic), is almost always used to demonstrate some type of nutritional pathology, which of course can only be corrected by taking the suggested supplements. And of course, Dr. Gundry sells supplements, including “Lectin Shield” for about $80 a month. According to his website, “This groundbreaking new formula was created to offset the discomforting effects of lectins (proteins commonly found in plants that make them harder to digest). Lectin Shield works to protect your body from a pile-up of lectins and to promote full-body comfort.”

Are Lectins The Next Gluten?

The second article I highly recommend was written for The Atlantic last year by one of my favorite medical writers, James Hamblin, MD.

Entitled, “Lectins Could Become the Next Gluten“, the article combines a tongue–in-cheek commentary with interviews with scientists who debunk Gundry’s claims. Hamblin also interviews Gundry which is particularly revelatory as to Gundry’s lack of credibility.

Although Gundry claims his writing is not motivated by money, Hambling notes:

Yes, he also sells supplements he recommends. The last 20 or so minutes of his infomercial is a string of claims about how supplies are running low, and it’s important that you act immediately, and that if you do manage to get through to a customer representative you should order as much as you have room to store—the shelf life is great, etc. And the necessity of supplements is the crucial argument of the book. He writes, “Getting all of the nutrients you need simply cannot be done without supplements.”

The GundryMD line of products includes something he invented called vitamin G6. Another is a “lectin shield” that’s “designed to neutralize the effects of lectins.” These are available on his website for $79.99. There you can also get six jars of Vital Reds for $254.70.

Fake Dietary Science Undermines Valid Dietary Recommendations

Hambling closes his piece by noting that book publishers have no accountability for publishing dietary/health misinformation as they are incentivized to publish and profit from the most outrageous claims.

This is a problem much bigger than any plant protein. Cycles of fad dieting and insidious misinformation undermine both public health and understanding of how science works, giving way to a sense of chaos. It seems that every doctor has their own opinion about how to protect your body from calamity, and all are equally valid, because nothing is ever truly known.

Lectiophilically

-ACP

N.B. Gwyneth Paltrow (GOOP) deserves a prominent place in the Quackery Hall of Shame.

Julia Belluz of Vox has a typically spot-on piece about GOOP which begins:

Gwyneth Paltrow has made a career out of selling pseudoscience on her lifestyle website, Goop. Over the years, the actress has proclaimed women should steam their vaginas, that water has feelings, and that your body holds secret organs. Mixed into these absurd assertions is her bogus detox diet and cleansing advice, all of it in service of promoting Goop’s beauty and wellness products

Flaxseed: Plant-Based Omega 3 Super Food or Faux Fish Oil?

Ground flaxseed plus Trader’s Point Creamery full fat plain yoghurt. It’s not pretty but tastes pretty good.

The skeptical cardiologist has a confession to make: he’s been adding ground flaxseed to his typical late morning full fat yoghurt plus berries and almonds.

Adding flaxseed seems dangerously close to dietary behaviour I have been advising against: supplementing instead of eating real food.

Also, I am philosophically opposed to going out of my way to eat any edible that is consistently promoted as a “super food” or a “functional food.” To me, these are meaningless terms and marketing blather

When I began writing this post in 2017 I was getting my flaxseed from Stober Farms (Est. 1901) who had been producing “for over 100 years  the finest flax in the world.”  Stober Farms provided me with “organic Golden Flax Seed which has been Cold-Milled Processed.”

Stober Farms (who have since mysteriously gone into bankruptcy) also informed me:

Flax is digested most effectively when ground. Some grinding methods generate heat when milled, spurring early omega-3 oxidation. Stober Farms uses a unique cold-milled process, which gently grinds the seed without significantly raising the temperature. This proprietary method preserves the nutrients, flavor and extends the shelf life to 22 months.

Honestly, I don’t recall exactly why I began “flaxing” but I suspect I felt it was a good way to boost the fat content in my full fat yoghurt (yes, I am now spelling yoghurt with an h) and berries and perhaps sufficiently satiate me that it would be the only food I would need to consume until dinner or late afternoon.

Two tablespoon (14 grams) is what I typically  imprecisely add. These tablespoons provide 75 kcal of energy which comes from 3 grams of protein, 6 grams of fat, and 4 grams of carbs.  Three of the four carb grams are soluble fibre.

About half of the fat in flaxseed is in the form of alpha-linolenic acid (ALA)(18:3) an omega-3 polyunsaturated (PUFA) fat.  Flaxseed oil contains five times more ALA than walnut oil or canola oil, which are the next highest sources of ALA.

Is Flaxseed A Super Functional Food?

Many seemingly authoritative sites on the internet proclaim that flaxseed is incredibly healthy. For example, Healthline.com’s “Authority Nutrition” (they must be authoritative as authority is in their name)  presents their 10 health benefits of eating flaxseed “backed by science”  and concludes:

They can be used to improve digestive health, lower blood pressure and bad cholesterol, reduce the risk of cancer and may benefit people with diabetes.

But typical of  Authority Nutrition’s overblown claims  these are not truly proven by science. The studies cited are weak; typically short-term tests of biomarkers or animal studies or human studies with very small numbers. Most importantly. these studies , which are often funded by flaxseed promoters are highly likely to be biased in favor of positive results.

Most websites tout the cardiovascular benefits of the omega-3 PUFA in flaxseed, the high percentage of soluble fibre and  the benefits of a chemical which cannot be named (due to a name which is too difficult to pronounce), SDG.

Omega-3 PUFAs and fibre I’ve touched on previously (and positively) but what about the mysterious and unpronounceable SDF. Per a 2010 review article

Flaxseed is the richest source of the lignan secoisolariciresinol diglucoside (SDG). After ingestion, SDG is converted to secoisolariciresinol, which is further metabolised to the mammalian lignans enterodiol and enterolactone. A growing body of evidence suggests that SDG metabolites may provide health benefits due to their weak oestrogenic or anti-oestrogenic effects, antioxidant activity, ability to induce phase 2 proteins and/or inhibit the activity of certain enzymes, or by mechanisms yet unidentified.

Like so many putative wonder phytochemicals, SDG has a “growing body of evidence” for lots of things but actual proof that it does anything worthwhile in humans is lacking and awaits  well done randomized clinical trials

Poorly researched articles on flaxseed are highly likely to tout its anti-inflammatory properties. These properties are seen in rats but unfortunately haven’t been proven in my favorite species, Homo Sapiens ,  Flaxseed doesn’t seem to decrease the inflammatory marker CRP in humans as reported in this systematic review and meta-analysis.

ALA and Cardiovascular Disease

As I’ve indicated in previous posts, evidence supports fatty fish consumption as beneficial in reducing cardiovascular disease presumably by increasing levels of marine omega-3 PUFAs in the body.

The value of fish oil supplementation, however, is not proven (see here).

How does ALA compare to the seafood omega 3s  in preventing cardiovascular disease (CVD)?

In 2012, researchers at the Harvard School of Public Health published a systematic review and meta-analysis of the existing data on ALA and the risk of CVD..

Their introductory paragraph nicely lays out why ALA could be very important to public health:

A large body of evidence supports a potential protective effect of seafood omega-3 (n−3) fatty acids, particularly EPA (20:5n−3) and DHA (22:6n−3), on coronary heart disease (CHD. However, fewer studies have evaluated how the plant-derived omega-3 fatty acid α-linolenic acid (ALA; 18:3n−3) relates to risk of CHD and other cardiovascular disease (CVD) outcomes, and the results have been inconsistent As an essential fatty acid that cannot be synthesized by humans, ALA is mainly consumed from plant sources, including soybeans, walnuts, and canola oil. Compared with seafood omega-3 fatty acids, ALA from plant sources is more affordable and widely available globally. Thus, whether ALA can reduce the risk of CVD is of considerable public health importance.

If plant-derived ALA can provide our omage-3 PUFA needs then perhaps we can stop stripping the ocean of all the menhaden.

In the Harvard analysis when all 27 studies were combined the authors found a significant risk reduction of 14% in CVD events with flaxseed.

There were lots of issues with the data which I won’t bore you with leading the authors to conclude that “ALA consumption may be beneficial “.  They emphasized the need for additional well-designed observational studies and randomized clinical trials in the area.

Since observational studies cannot prove causality, I await a good randomized clinical trial of ALA supplementation before I can recommend ALA supplementing to prevent heart disease.

After Performing This Review Is The Skeptical Cardiologist Still “Flaxing”?

I am. Because I’ve found that when I consume flaxseed I feel 20 years younger, full of vitality. and with a youthful golden sheen to my hair, nails and skin.

Actually, that last sentence is untrue.

I’m still adding ground flaxseed to my yoghurt but not with any expectation that it is reducing my risk of heart attack and definitely not because I perceive it as a super or functional food.

I like the taste, the convenience, and the extra (presumably healthy) calories it provides but I’m still an advocate of just eating real food rather than trying to identify specific nutrients, nutraceuticals or supplements and add them to your diet.

Flaxseedingly Yours,

-ACP

N.B. I did not touch on omega-6/omega-3 ratios in the diet. I’ve been examining that inflammatory (enjoy the pun) topic for years and once I come across a good study that adds to understanding in the area I will likely publish a post on it.

 

Still More Evidence That Fish Oil Supplements Do Not Prevent Cardiovascular Disease

Avid readers of the skeptical cardiologist know that he is not an advocate of fish oil supplements.

One of my first posts (1/2013) was devoted to taking down the mammoth OTC fish oil industry because recent scientific evidence was clearly showing no benefit for fish oil pills.

I concluded:

", the bottom line on fish oil supplements is that  the most 
recent scientific evidence does not support any role for them  inpreventing heart attack, stroke, or death. There are potential 
down sides to taking them, including contaminants and the impact on the marine ecosystem. I don’t take them and I advise my
patients to avoid them (unless they have triglyceride levels 
over 500.)"

Despite a lack of evidence supporting taking them, the fish oil business continues to grow,  buttressed by multiple internet sites promoting various types of fish oil (and more recently krill oil)  for any and all ailments and a belief in the power of “omega-3 fatty acids”.

Another Meta-Analysis Concludes No Benefit To Fish Oil Supplements

A publication this month evaluated the 10 randomized controlled trials involving 77 917 thousand individuals that have studied fish oil supplements in preventing heart disease. The writers concluded that fish oil supplements do not significantly prevent any cardiovascular outcomes under any scenario.

It was written by a group with the ominous title of “The Omega-3 Treatment Trialists’ Collaboration.”

The Omega-3 Treatment Trialists’ Collaboration was established to conduct a collaborative meta-analysis based on aggregated study-level data obtained from the principal investigators of all large randomized clinical trials of omega-3 FA supplements for the prevention of cardiovascular disease, using a prespecified protocol and analysis plan. The aims of this meta-analysis were to assess the associations of supplementation with omega-3 FAs on (1) fatal CHD, nonfatal MI, stroke, major vascular events, and all-cause mortality and (2) major vascular events in prespecified subgroups.

The authors conclusions:

. Randomization to omega-3 fatty acid supplementation (eicosapentaenoic acid dose range, 226-1800 mg/d) had no significant associations with coronary heart disease death (rate ratio [RR], 0.93; 99% CI, 0.83-1.03; P = .05), nonfatal myocardial infarction (RR, 0.97; 99% CI, 0.87-1.08; P = .43) or any coronary heart disease events (RR, 0.96; 95% CI, 0.90-1.01; P = .12). Neither did randomization to omega-3 fatty acid supplementation have any significant associations with major vascular events (RR, 0.97; 95% CI, 0.93-1.01; P = .10), overall or in any subgroups, including subgroups composed of persons with prior coronary heart disease, diabetes, lipid levels greater than a given cutoff level, or statin use.

Nothing. Nada. No benefit.

There is clearly no reason to take fish oil supplements to prevent cardiovascular disease!

American Heart Association Sheepishly Recommends Fish Oil Supplements

If the science was conclusive on this in 2013 why did the American Heart Association (AHA) issue an “advisory” in 2017  suggesting that the use of omega-3 FAs for prevention of coronary heart disease (CHD) is probably justified in individuals with prior CHD and those with heart failure and reduced ejection fractions?

The AHA advisory is clearly misguided and relies heavily in its discussion on a 2012 meta-analysis from Rizos, et al. published in 2012.

Oddly, this is the study that prompted me to write my first fish oil post in 2013

The AHA advisory totally distorts the completely negative conclusions of the Rizos meta-analysis, writing:

A meta-analysis published in 2012 examined the effects of omega-3 PUFA supplementation and dietary intake in 20 RCTs that enrolled patients at high CVD risk or prevalent CHD and patients with an implantable cardioverter-defibrillator (total n=68 680). That meta-analysis demonstrated a reduction in CHD death (RR, 0.91; 95% CI, 0.85–0.98), possibly as the result of a lower risk of SCD (RR, 0.87; 95% CI, 0.75–1.01).11

Strangely enough, if you look at the conclusions of Rizos, et al. they are

No statistically significant association was observed with all-cause mortality (RR, 0.96; 95% CI, 0.91 to 1.02; risk reduction [RD] -0.004, 95% CI, -0.01 to 0.02), cardiac death (RR, 0.91; 95% CI, 0.85 to 0.98; RD, -0.01; 95% CI, -0.02 to 0.00), sudden death (RR, 0.87; 95% CI, 0.75 to 1.01; RD, -0.003; 95% CI, -0.012 to 0.006), myocardial infarction (RR, 0.89; 95% CI, 0.76 to 1.04; RD, -0.002; 95% CI, -0.007 to 0.002), and stroke (RR, 1.05; 95% CI, 0.93 to 1.18; RD, 0.001; 95% CI, -0.002 to 0.004) when all supplement studies were considered.

Nothing. Nada. No significant benefit!

The AHA was so confused by their own advisory that in the AHA news release on the article they quote Dr. Robert Eckel, a past AHA president as saying he remains “underwhelmed” by the current clinical trials.

“In the present environment of evidence-based risk reduction, I don’t think the data really indicate that fish oil supplementation is needed under most  circumstances.”

The end of the AHA news article goes on to quote Eckel as indicating he doesn’t prescribe fish oil supplements and the science advisory won’t change his practice:

Eckel said he doesn’t prescribe fish oil supplements to people who have had coronary events, and the new science advisory won’t change that. “It’s reasonable, but reasonable isn’t a solid take-home message that you should do it,” he said.

AHA: Wrong On Coconut Oil and Fish Oil

It’s hard for me to understand why the AHA gets so many things wrong in their scientific advisories. In the case of the recent misguided attack on coconut oil , their ongoing vilification of all saturated fats, and their support for fish oil supplements I don’t see evidence for industry influence. The authors of the fish oil supplement advisory do not report any financial conflicts of interest.

There is, however, one bias that is very hard to measure which could be playing a role: that is the bias to agree with what one has previously recommended.  The AHA issued an advisory in 2002 recommending that people take fish oil. Changing that recommendation would mean admitting that they were wrong and that they had contributed to the growth of a 12 billion dollar industry serving no purpose.

Personally, I am aware of this kind of bias in my own writing and strive to be open to new data and publications that challenge what I personally believe or have publicly recommended.

In the case of fish oil supplements for preventing cardiovascular disease, however, the most recent data supports strongly what I wrote in 2013:

Don’t take fish oil supplements to prevent heart disease.

Americans want a “magic-bullet” type pill to take to ward off aging and the diseases associated with it. There isn’t one. Instead of buying pills and foods manipulated and processed by the food industry which promise better health, eat real food (including fish) eat a lot of plants and don’t eat too much.

Piscinely Yours,

-ACP

N.B. I have no patients on the two prescription fish oil supplements available, Lovaza and Vascepa. I wrote about Vascepa here

Below is an excerpt:

Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides (>500 mg/dl).

This is a very small market compared to the millions of individuals taking fish oil thinking that  it is preventing heart disease.

The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.

The company has a study that shows that Vascepa lowers triglycerides in patients with such mildly to moderately elevated triglycerides but the FDA did not approve it for that indication.

Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.

After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.

Data do not exist to say that lowering triglycerides in the mild to moderate range  by any drug lowers heart attack risk.

In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.

Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amrin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.

If he answers no to all of the above then, hopefully, your triglycerides are over 500.

.

 

 

 

 

Should You Take An Antioxidant (Supplement or Vitamin) To Prevent Or Treat Heart Disease

Antioxidant-rich foods, vitamins and supplements are incessantly promoted to Americans as effective and safe means to stave off the chronic diseases of aging and even aging itself.

The simple concept that sells billions of dollars of these  products seems logical and seems to be supported by science: damaging and disease-causing  free radicals  are neutralized by super hero antioxidants.  All you have to do to benefit from these disease-fighting agents is identify foods with the highest level of antioxidants or take supplements with super antioxidant vitamins or chemicals.

To remain young  and free of heart disease, cancer and dementia, the glowing marketing material for antioxidant products proclaims,  eat this magical Italian fruit or drink this fruit juice or take this concentrated substance that we have carefully extracted from a super fruit.

Unfortunately, the early hopes that antioxidant therapy would reduce heart disease,in particular, and other chronic diseases of aging in general have been dashed by excellent scientific studies  performed in the 1990s.

For antioxidant vitamins, in particular, which continue to be heavily promoted for heart disease and cancer prevention, over the last 20 years a wealth of studies have accumulated which clearly demonstrate a lack of efficacy.

Despite data clearly showing no benefit in well done randomized trials (and in some cases evidence for harm) sales of antioxidant vitamins C, E and beta-carotene continue to thrive.

Why did scientists strongly believe in the idea that antioxidants in pure and concentrated form would prevent heart disease?

Antioxidants: Free Radical Scavengers

Laboratory and animal studies beginning in the 1950s suggested that excess free radicals generated by oxidative processes could be responsible for the chronic degenerative diseases of aging.

Oxygen, which is essential to animal life, undergoes processing in cells which creates unstable free radicals. Free radicals are short an electron and seek other molecules which can donate an electron and make them more stable. This process is termed oxidation.

The molecules produced by oxidation play an important role in a a number of biological processes such as the killing of bacteria and in cell signaling. These same unstable molecules, however,  have been implicated in a number of deleterious processes as they can participate in unwanted side reactions and create cell damage.

Thus, too many free radicals have been implicated as potentially causal in diseases ranging from cancer to cardiovascular disease to dementia.

Antioxidants can reduce damage from free radical reactions because they can donate electrons to neutralize free radicals or their offspring without forming another free radical.

This observation logically lead to the theory that large amounts of antioxidants taken as an oral supplement or within (either naturally or added artificially)  food and beverages can prevent the free radical damage presumably causing chronic disease  and aging.

Investigators early on identified three vitamins as the most important cellular antioxidants:

  • Vitamin E or  d-alpha tocopherol is a fat soluble vitamin.
  • Vitamin C or ascorbic acid. is a water soluble vitamin, deficiency of which leads to scurvy
  • Beta-carotene is a precursor to vitamin A (retinol)

Early Observational Studies Suggest  Taking An Antioxidant Prevents Heart Disease 

Based on laboratory, animal and human clinical trials many investigators by the early 1990s were convinced that oxidation of LDL cholesterol was the major cause of atherosclerosis and that antioxidant supplementation , in particular Vitamin E, could prevent the heart attacks and strokes caused by atherosclerosis.

The introduction to the landmark Nurses Health Study  summarizes the seemingly compelling evidence leading to these conclusions:

Rapidly growing evidence suggests that oxidation of low-density lipoprotein (LDL) plays an important part in atherosclerosis. As Steinberg et al. have found,1-3 oxidized LDL is taken up more readily than native LDL by macrophages to create foam cells. Also, oxidized LDL is chemotactic for circulating monocytes,4 and it inhibits the motility of tissue macrophages5. It may also be cytotoxic to endothelial cells6 and may increase vasoconstriction in arteries7. Oxidized LDL has been identified in atherosclerotic lesions,8-10 and elevated titers of circulating autoantibodies to epitopes of oxidized LDL are found in patients with atherosclerosis11. Lipid peroxide concentrations have been found to be higher in patients with atherosclerosis12. In addition, the susceptibility of LDL to oxidation was correlated with the severity of atherosclerosis13.

Vitamin E is a potent lipid-soluble antioxidant carried in LDL14,15. It inhibits the proliferation of smooth-muscle cells in vitro,16 and when added to plasma, it increases the resistance of LDL to oxidation17. LDL from volunteers given alpha-tocopherol supplements showed increased resistance to oxidation18

Starting in 1980  the Nurses Healthy Study began gathering information on diet and supplement use in 87,245 female nurses 34 to 59 years of age who were free of diagnosed cardiovascular disease and cancer. Information on diet was assessed every two years  and the participants were monitored for cardiovascular outcomes for 8 years.

High consumers of Vitamin E compared to lower consumers had a 34% lower risk of major coronary disease. Those who took Vitamin E for more than 2 years had a 41% reduction in risk which was significant after adjustment for age, smoking status, risk factors for coronary disease, and use of other antioxidant nutrients (including multivitamins).

After reading this study I and many of my colleagues began recommending that our patients take Vitamin E. These observational trials, however, could only show an association between antioxidants and disease, they didn’t prove causality.

Good Quality Randomized Trials Fail To Show Any Benefit of Antioxidants and Raise Concerns of Possible Danger

Given the strong evidence for antioxidants in reducing heart disease from the observational and laboratory studies the theory that antioxidant supplementation would reduce heart disease needed to be tested in randomized trials.

Fortunately, multiple well done randomized studies have tested whether supplementation with the major proposed antioxidants will reduce heart disease, cancer or mortality.

Sadly, the consensus assessment is that they are useless and in some cases antioxidant vitamin supplementation may increase risks.

The Physicians’ Health Study II is a great example:

Published in 2008, This study randomly assigned 14,641 physicians without heart disease to treatment with vitamin E 400 international units every other daily, vitamin C 500 mg daily, both, or neither; After  eight years, treatment with vitamin E  and Vitamin C either alone or in combination had no effect on major cardiovascular events or all-cause mortality.

Those participants taking Vitamin E had a significant 70% increased risk of hemorrhagic stroke compared to those taking placebo.

After this trial was published I took all my patients off Vitamin E.

Multiple good quality randomized controlled studies of Vitamin E, Vitamin C and beta-carotene in various combinations have also been done on patients who have established coronary heart disease and have shown no benefit in reducing cardiovascular events or mortality. This 2003 Lancet meta-analysis nicely summarizes the data.

These studies strongly called into question the theory that supplementation with antioxidants reduce chronic disease and by 2003 there was a broad consensus among serious scientists, cardiologists and nutritionists that Vitamin E and Vitamin C in various doses and in diverse populations had no benefit in reducing mortality, cardiovascular disease or cancer.

In fact, Vitamin E may increase hemorrhagic stroke and high-dose vitamin E supplementation (≥400 international units/day) may be associated with an increase in all-cause mortality

Studies with beta-carotene overall suggested an increase in overall mortality and one study has shown an increased risk of lung cancer in male smokers who received supplementation.

More recently, a 2012 BMJ meta-analysis   concluded that there was no benefit for any vitamin or antioxidant supplement in reducing cardiovascular risk or mortality.

 

Despite Scientific Studies Showing No Benefit, Antioxidant Sales Continue To Grow

You might conclude that based on high quality studies showing no benefits and potential harm that sales of antioxidants would taper off. Unfortunately, the opposite has occurred.

Nutraceuticals World reported that sales of antioxidant supplements are growing steadily, reaching all time highs.

Combining top antioxidant ingredient sales such as green tea, dark chocolate, superfruit juice and dietary supplements, Euromonitor estimated the combined global sales in these categories totaled $34 billion in 2010. According to Euromonitor, the top antioxidant markets are Japan, the U.S. and China, with sales growing steadily in all five ranked product areas in the past five years. Growth from 2005 to 2010 was 43% in current terms. As a point of comparison, the global organic packaged food and beverage market was only $27 billion.

The Sneakiness of the Nutraceutical Snake Oil Salesmen

The quacks and charlatans that make their living selling useless vitamins, minerals, supplement and nutraceuticals are masters at creating the appearance of a scientific basis for buying their snake oil.

Their promotional material always features references to scientific studies.  Almost invariably, these references do not prove any health benefit for the product being sold.

In cases like antioxidants where initial studies suggest a benefit and subsequent higher quality studies have shown no benefit, only the earlier studies will be quoted.

If relevant negatives studies for an antioxidant are referenced, the talented snake oil salesman will explain to his gullible audience that the lack of efficacy was because the wrong form of the antioxidant was utilized.

Fortunately, for you, the snake oil salesman has developed his own special formulation which is superior. Such formulations are typically described as containing additional ingredients that enhance efficacy. Often, the special formulation is described as somehow better at getting into the body or being absorbed.

None of these special formulations has any scientific support for treating or preventing any disease.

Dr. Mercola, A Master of Pseudoscientific Support For Selling Useless Vitamins

The most successful marketers of useless antioxidant supplements and vitamins convince their audience that they alone have the insight and wisdom to provide the consumer with the knowledge and products they need to be healthy.  To accomplish this, they must create mistrust of standard medical advice and prescription medications, often portraying doctors as ignorant of proper nutrition and hostile to allegedly superior “natural” or alternative cures.

Doctors, in this portrayal, are the enemy, pushing dangerous prescription medications along with unneeded procedures like coronary stents and bypass surgery because we are in the pay of the pharmaceutical and medical device industries.

Joseph Mercola, an osteopath, has created an alternative medicine internet empire by convincing millions to follow his advice and buy his useless supplements. He is arguably the master of alternative medicine misinformation. (See this article to fully understand how dangerous Mercola’s ideas are.)

Hoovers reports that Mercola makes 9.8 million dollars per year selling useless stuff and Alexa describes his website as the top “alternative medicine” website. Mercola sells so much snake oil it is mind-numbing.

Mercola (or more likely his marketing department)  has  an astonishingly long and  detailed  list of reasons why you should buy only his own special formulation of Vitamin E. None of them are supported by scientific references.

-His form is natural versus synthetic.

-Other natural forms of vitamin E come from soy which you should avoid because it is genetically engineered.

-You need all 8 forms of natural vitamin E and they must be balanced in the way that he deems most healthy. His form comes from sunflower seeds.

-Science has ignored the tocotrienol form of Vitamin E but has “started to wake up to the potential benefits.”

-Tocotrienols potentially “help support normal cholesterol levels., protect again  free radical damage and the normal effects of aging” and promote brain health.”

Mercola vitamin E

The average consumer reading this long and complicated discussion is likely to be impressed with the pseudoscientific language, the complicated chemical names, and  the appeal to a more natural approach and has no way of knowing that it is all unsubstantiated marketing hype.

The average consumer is not likely to see buried in small print at the bottom of the page the truth:

*These statements have not been evaluated by the Food and Drug Administration.

These products are not intended to diagnose, treat, cure, or prevent any disease.

Don’t Buy Antioxidant Supplements and Vitamins

What have we learned?

  1. Although early research suggested a role for antioxidant vitamins in preventing heart disease when high quality randomized controlled rials were performed they showed no benefit and in some cases increased risk.
  2. Despite this, antioxidant sales are booming.
  3. Supplement marketers are brilliant at confusing consumers with pseudoscience and sell billions of dollars of useless product.

There is minimal regulation of the nutraceutical/supplement industry. The snake oil purveyors get away with their lies and escape (for the most party) FDA scrutiny by admitting that their products don’t “treat, cure or prevent any disease.”

Rather than hiding this information, at a minimum, they should be forced to put it in large, bold letters at the beginning of every page on their website.

THESE PRODUCTS ARE NOT INTENDED TO TREAT, CURE OR PREVENT ANY DISEASE!

Please don’t buy them any more.

Uncleoxidantly Yours,

-ACP

 

Quackery Promotion By Mainstream Media: Part I, Reader’s Digest and Naturopathy

As the skeptical cardiologist surveys the heart health information available to his patients and the lay public, he sees two broad categories of misinformation.

First we have the quacks and snake oil salesman. These are primarily characterized by a goal of selling more of their useless stuff online.

I’ve described this as the #1 red flag of quackery. Usually I’m inspired to investigate these charlatans because a patient asks me about one of their useless supplements.

The second category is more insidious: the magazine or internet news site seems to have as its legitimate goal, promoting the health of its readers. There is no clear connection to a product.

Web MD, which I wrote about here, is an example of this second type.  Hard copy versions of these types of media frequently make it into doctor’s waiting rooms: not because doctor’s have read and approved what is in them. These companies send their useless and misleading magazines for free to doctor’s offices, and the staff believe it to be legitimate.

How does glaringly inaccurate and often dangerous information get into media that ostensibly has as its goal promoting its readers health? Most likely, it is a result of media’s need  to constantly produce new and interesting ways for readers to improve their health.

Clearly, readers will not continue subscribing, clicking and reading such sources of information if there isn’t something new and exciting that might prolong their lives: gimmicks, miracles cures, and “natural” remedies are more alluring than the well-known advice to exercise more, watch your weight, stop smoking and get a good night’s sleep.

Reader’s Digest and Stealth Quackery

A patient recently brought in a printout of Reader’s Digest’s “40 things cardiologists do to protect their heart” which is typical of the second category.

Reader’s Digest was a staple of my childhood. My parents subscribed to it consistently and I would read parts of it. It was small and enticing. Allegedly its articles were crafted so that they could be read in their entirety during a session in the bathroom.

To this day it has a wide circulation. Per Wikipedia”

The magazine was founded in 1920, by DeWitt Wallace and Lila Bell Wallace. For many years, Reader’s Digest was the best-selling consumer magazine in the United States; it lost the distinction in 2009 to Better Homes and Gardens. According to Mediamark Research (2006), Reader’s Digest reaches more readers with household incomes of $100,000+ than Fortune, The Wall Street Journal, Business Week, and Inc. combined.[2]

Global editions of Reader’s Digest reach an additional 40 million people in more than 70 countries, via 49 editions in 21 languages. The periodical has a global circulation of 10.5 million, making it the largest paid circulation magazine in the world.

Reader’s Digest used to run a recurring educational feature on the various body parts and organs of Joe and Jane which intrigued me.

Here’s the first paragraph of “I am Joe’s heart:”

I am certainly no beauty. I weigh 340 grams, am red-brown in color and have an unimpressive shape. I am the dedicated slave of Joe. I am Joe’s heart.

The health information in this series was generally accurate but the presentation lacks the kind of sizzle that apparently attracts today’s readers.

The article my patient brought to my attention is typical of the mix of good and bad information and fluff that mainstream media can produce to attract followers:

Not So Bad But Not Clearly True Medical Advice

#1. I keep a gratitude journal. An internist “at NYU” is quoted as saying: “Studies have recently shown that expressing gratitude may have a significant positive impact on heart health.”

Fact Check: following the links provided provides no evidence to support this claim.

#2  I get 8 hours of sleep a night, every night.  This cardiologist seems to have been misquoted, because her comment is actually “getting a good night sleep is essential. I make a point of getting seven to eight hours of sleep every night…Poor sleep is linked to higher blood pressure.”

Fact Check. One review noted that:

Too little or too much sleep are associated with adverse health outcomes, including total mortality, type 2 diabetes, hypertensionand respiratory disorders, obesity in both children and adults, and poor self-rated health.

Another broke down mortality according to number of hours of sleep.

A J-shaped association between sleep duration and all-cause mortality was present: compared with 7 h of sleep (reference for 24-h sleep duration), both shortened and prolonged sleep durations were associated with increased risk of all-cause mortality (4 h: relative risk [RR] = 1.05; 95% confidence interval [CI] = 1.02–1.07; 5 h: RR = 1.06; 95% CI = 1.03–1.09; 6 h: RR = 1.04; 95% CI = 1.03–1.06; 8 h: RR = 1.03; 95% CI = 1.02–1.05; 9 h: RR = 1.13; 95% CI = 1.10–1.16; 10 h: RR = 1.25; 95% CI = 1.22–1.28; 11 h: RR = 1.38; 95% CI = 1.33–1.44; n = 29; P < 0.01 for non-linear test)

Thus, in comparison to those who sleep 7 hours, those who sleep 5 hours have a 5% increase in mortality and those who sleep 11 hours have a 38% increase in mortality.

These data are based entirely on observational studies so it is impossible to know if the shortened sleep is responsible for the increased mortality or if some other (confounding) factor is causing both.

My advice: Some people do fine with 6 hours and 45 minutes of sleep. Some require 8 hours 15 minutes for optimal function. Rather than obsessing about getting a specific amount of sleep time, it makes more sense to find our through your own careful observations what sleep time works best for you and adjust your schedule and night time patterns accordingly.

#3. I do CrossFit.

Fact Check. There is nothing to support CrossFit as more heart healthy than regular aerobic exercise (which the vast majority of cardiologists recommend and perform).

#4. I meditate. “Negative thoughts and feelings of sadness can be detrimental to the heart. Stress can cause catecholamine release that can lead to heart failure and heart attacks.”

Fact Check. There is a general consensus that stress has adverse consequences for the cardiovascular system. Evidence of meditation improving cardiovascular outcomes is very weak.

A recent review

Participation in meditation practices has been shown to reduce depression, anxiety, and negative mood and thus may have an indirect positive effect on CV health and well-being. This possibility has led the American Heart Association to classify TM as a class IIb, level of evidence B alternative approach to lowering BP.32

Non randomized, non blinded studies with small numbers of participants have suggested a reduction in CV death in those performing regular TM.

However, we need better and larger studies before concluding there is a definite benefit compared to optimal medical therapy.

Thus far, the recommendations have been pretty mundane: exercise, stress reduction and a good night’s sleep is good advice for all, thus boring.

Seriously Bad Advice From Quacks Mixed In With Reasonable Advice

In order to keep reader’s interest (and reach 45 things) Reader’s Digest is going to need to add seriously bad advice.

My patient had circled #34. “I mix magnesium powder into my water. If sufficient magnesium is present in the body, cholesterol will not be produced in excess.”

This bizarre and totally unsubstantiated practice was recommended by Carolyn Dean MD, ND.

What do we know about Dr. Dean?

-She was declared unfit to practice medicine and her registration revoked by the College of Physicians and Surgeons of Ontario in 1995. From quackwatch.org :

  • After being notified in 1993 that a disciplinary hearing would be held, Dean relocated to New York and did not contest the charges against her.
  • Dean had used unscientific methods of testing such as hair analysis, Vega and Interro testing, iridology and reflexology as well as treatment not medically indicated and of unproven value, such as homeopathy, colonic irrigations, coffee enemas, and rotation diets.

-The initials after her name (ND, doctor of naturopathy) should be considered the second red flag of quackery. See quackwatch.org (here) and rational wiki (here) and the confessions of a former naturopath  (here ) for discussions of naturopathy. As noted at science-based medicine:

Naturopathy is a cornucopia of almost every quackery you can think of. Be it homeopathy, traditional Chinese medicine, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine, it’s hard to think of a single form of pseudoscientific medicine and quackery that naturopathy doesn’t embrace or at least tolerate.

-She has a website (Dr. Carolyn Dean, MD,ND, The Doctor of The Future) where she incessantly promotes magnesium as the cure for all ills.

-She has written a book called “The Magnesium Miracle” (hmm. wonder what that’s about).

-She sells her own (really special!) type of magnesium (see red flag #1 of quackery).

-She writes for the Huffington Post (I’m considering making this a red flag of quackery).

-She is on the medical advisory board of the Nutritional Magnesium Association (an organization devoted to hyping magnesium as the cure for all ills and featuring all manner of magnesium quacks).

Prevention Magazine 

Reader’s Digest is not alone in allowing the advice of pseudoscience practitioners to stand side by side with legitimate sources.

For example, Prevention Magazine in its August 2017 issue highlights “35 All-Time Favorite Natural Remedies” with the subheading

“Go ahead, try them at home: Experts swear by these nondrug cures for back pain, nausea, hot flashes, and other common ailments.”

Who are these “experts”? Let the reader beware because the first quote comes from “Amy Rothenberg, past president of the Massachusetts Society of Naturopathic Doctors.”

Finding The Truth

It’s getting harder and harder for the lay public to sort out real from fake health stories and advice.

When seemingly legitimate news media and widely followed sources like Reader’s Digest and Prevention Magazine  either consciously or inadvertently promote quackery, the truth becomes even more illusive.

Readers should avoid any source of information which

  1. Profits from selling vitamins and supplements.
  2. Utilizes or promotes  naturopaths or other obvious quacks as experts in health advice.

IamJoesfootingly Yours,

-ACP

Treatment of Palpitations Due To Benign PVCs: Potassium, Magnesium and Lifestyle Adjustment

In a previous post, the skeptical cardiologist pontificated on the causes and evaluation of the most common cause of palpitations: premature ventricular contractions or PVCs.

The vast majority of these common extra beats turn out to be benign (meaning not causing death, heart attack or stroke), and most patients with sufficient reassurance of this benignity (often accompanied by significant caffeine reduction), do well. These people usually continue to notice the beats either randomly, or with stress, but they recognize exactly what is going on and are able to say to themselves “there go my benign PVCs again,” and aren’t worried or bothered.

A small percentage of patients that I diagnose with palpitations due to benign PVCs continue to have symptoms.

Part of my initial evaluation involves checking potassium, magnesium, kidney function, and thyroid levels.

Potassium Supplementation For PVCs

Low potassium levels (hypookalemia) have been clearly associated with an increase in ventricular ectopy. Patients who take diuretics like hydrochlorothiazide (HCTZ, often used for high blood pressure) or furosemide (Lasix, often used for leg swelling or heart failure), are at high risk for hypokalemia with potassium levels less than 3.5 meQ/L.

Hypokalemia can also develop if you are vomiting, having diarrhea, or sweating excessively. There are lots of other infrequent causes including excess licorice consumption. The body regulates potassium levels closely, due to its importance in the electrical activities involved in cardiac, muscular and neurological function.

The normal range of potassium (K) is considered to be 3.5 to 5 meq/L , however, I have found that PVCs are more frequent when the potassium is less than 4.

Most of my symptomatic PVC patients with potassium less than 4 find significant improvement with potassium supplementation.  I usually give them a prescription for potassium chloride (KCl) 10-20 meq daily to accomplish raising the level to >4.

An alternative to potassium supplements is ramping up how much
screen-shot-2017-03-02-at-6-18-48-pm screen-shot-2017-03-02-at-6-19-11-pmpotassium you consume in your diet. Most patients I talk to about low K immediately assume they should eat more bananas, but lots of fresh fruit and vegetables contain as much or more K than bananas.

The charts to the right show that a medium tomato contains as much K as a medium banana with a third of the calories. Avocados are a great source of K and contain lots of healthy fat. Yogurt (and I recommend full fat yogurt, of course) is a great source as well.

If you have  kidney disease you are much more likely to develop hyperkalemia, or high K, and you want to avoid these high K foods. Potassium infusions are used as part of a “lethal injection” in executions because extreme hyperkalemia causes the heart to stop beating. (In fact, Arkansas is hurrying to execute 8 men between April 17 and 27 utilizing KCl.  According to deathpenaltyinformation.org: “The hurried schedule appears to be an attempt to use the state’s current supply of eight doses of midazolam, which will expire at the end of April. Arkansas does not currently have a supply of potassium chloride, the killing drug specified in its execution protocol, but believes it can obtain supplies of that drug prior to the scheduled execution dates”)

Lifestyle, Stress  and PVCs

It’s probably time I revealed that I have PVCs. I feel them as a sense that something has shifted inside my chest briefly, like my breath has been interrupted, like my heart has hiccoughed. If I didn’t know about PVCs and hadn’t made the diagnosis very quickly by hooking myself up to an ECG monitor in my office, I know I would have become very anxious about it.

I know exactly what causes them: stress and anxiety. And this is the case for many patients. Stress activates our sympathetic nervous system, causing the release of hormones from the adrenal gland that prepare us for “fight or flight.” These hormones stimulate the heart to beat faster and harder and often trigger PVCs.

I rarely get PVCs these days, as the major source of stress in my personal life has gone away. This is also a typical story my patient’s relate: troubling palpitations seem to melt away when they retire or change to less stressful occupations, or as they recover from depression/anxiety/grief related to death of loved ones, divorce or illness.

You can’t always control external stresses, but several factors in your lifestyle are key to managing how those stresses activate your sympathetic nervous system and trigger troubling PVCs.

Dr. Mandrola lists as Steps 5-8 (Steps 1-4 are reassurance) for PVC treatment his “four legs of the table of health”:

: good food, good exercise, good sleep and good attitude. Cutting back on caffeine and alcohol, looking critically at the dose of exercise, going to bed on time, and smiling are all great strategies for PVCs.

Of these four table legs, I consider regular aerobic exercise the most important, and modifiable factor for PVC reduction.  Aerobic exercise improves mood and increases the parasympathetic (the calming component of the autonomic nervous system) activity, while lowering the output of the sympathetic nervous system.

The three factors that I find essential to handling the demanding and stressful job of being a cardiologist: restful sleep, regular, aerobic exercise and lots of love from my eternal fiancee (who also has occasional PVCs!)

watchos3-breathe-app-animation-wrap
Apple Watch trying to get me to breathe (something I ordinarily don’t do). According to Apple (my comments in parentheses) “Mindfulness is a state of active, open attention on the present. When you’re mindful, you observe your thoughts and feelings from a distance (my favorite way to think and feel) without judging them good or bad (even if I’m thinking about robbing a bank?). Instead of letting your life pass you by, mindfulness means living in the moment (a really boring moment) and awakening to experience (or lack thereof). (Apologies to SH :))

Beyond sleep and exercise there is a plethora of techniques that purport to help individuals deal with stress: yoga, meditation, and progressive muscular relaxation, among them.

Apps touting methods for relaxation abound these days.  My new Apple Watch is constantly advising me to engage in a breathing exercise for a minute at a time. I don’t find any of these techniques helpful for me (I haven’t found a good way to shut my brain down without falling asleep), but they may work for you.

Magnesium, Snake Oil and PVCs

Patients will find that the internet is rife with stories of how this supplement or vitamin or herb dramatically cures PVCs.  You can be assured that a sales pitch accompanies these claims and that the snake oil being promoted has not been proven effective or safe. Because symptomatic PVCs like most benign, common and troubling conditions (lower back pain, fatigue, and nonspecific GI troubles come to mind),  are closely related to mood and wax and wain spontaneously; the placebo effect proves powerful. In such conditions, snake oil and charlatans thrive.

Magnesium is enthusiastically hyped on the internet for all manner of cardiovascular problems including PVCs. Even Dr. Mandrola, who I respect quite a lot as an EP doc who promotes lifestyle change and who is definitely not a quack, lists his step 10 for PVCs (apologetically) as follows:

  • Step 10 (a): Please don’t beat me up on this one. Some patients report benefit from magnesium supplementation. I have found it helpful in my case of atrial premature beats. Let me repeat, I am not promoting supplements. Healthy patients with benign arrhythmia might try taking magnesium, especially at night. Don’t take magnesium if you have kidney disease. And if you take too much, watch out for diarrhea.

Most of the internet’s top quacks, however, greedily market and glowingly swear by magnesium.  A Google search for magnesium cardiovascular disease yields 833,000 entries and the first page is a Who’s Who of quackery, including Dr Mercola (strong candidate for America’s greatest quack), Dr. Sinatra (see here, currently in the semifinals for America’s greatest quack cardiologist), NaturalNews and Life Extension (see here). This totally unsupported and dangerous blather from the Weston Price Foundation is often repeated and is typical:

(magnesium) Deficiency is related to atherosclerosis, hypertension, strokes and heart attacks. Deficiency symptoms include insomnia, muscle cramps, kidney stones, osteoporosis, fear, anxiety, and confusion. Low magnesium levels are found in more than 25 percent of people with diabetes. But magnesium shines brightest in cardiovascular health. It alone can fulfill the role of many common cardiac medications: magnesium inhibits blood clots (like aspirin), thins the blood (like Coumadin), blocks calcium uptake (like calcium channel-blocking durgs such as Procardia) and relaxes blood vessels (like ACE inhibitors such as Vasotec) (Pelton, 2001).

Magnesium levels are very important to monitor in hospitalized and critically ill patients, especially those receiving diuretics and medications that can effect cardiac electrical activity.

However, for individuals with normal diets and palpitations due to PVCs, there is scant evidence that it plays a significant role in cardiovascular health.

The MAGICA study looked at supplementation with both magnesium and potassium (in the active treatment group, daily oral dosing consisted of 2 mg of magnesium-dl-hydrogenaspartate (6 mmol magnesium) and 2 mg of potassium-dl-hydrogenaspartate (12 mmol potassium) daily. The dose was chosen to increase the recommended minimal daily dietary intake of magnesium (12 to 15 mmol) and potassium (20 to 30 mmol) by ∼50% in addition to usual diet ) in 307 patients with more than 720 PVCs per hour and normal baseline K and Mg levels.

The patients receiving magnesium/potassium supplements showed a decrease of 17% in frequency of PVCs but no improvement in symptoms.

A 2012 study in a Brazilian journal evaluated magnesium pidolate (MgP) in 60  patients with both PVCs and premature atrial contractions (PACs). The dose of MgP was 3.0 g/day for 30 days, equivalent to 260 mg of Mg elemental.

93% of patients receiving MgP experienced improved symptoms compared to only 13% of patients recieiving placebo. Both PVC and PAC frequency was reduced in those receiving MGP, whereas they increased by 50% in those receiving placebo.

This small study has never been reproduced, and the main results table makes little sense. It would not have been published in a reputable American cardiology journal and cannot be relied on to support magnesium for most patients with benign PVCs or PACs.

Drug or Ablation Treatment of PVCs: Usually Not Needed

A small percentage of my patients require treatment with beta-blockers which reduces the effects of the sympathetic nervous system on the heart. Very rarely, I will use anti-arrhythmic drugs. And every once in a while, very frequent PVCs resulting in cardiomyopathy require an ablation.

However, the vast majority of patients with benign PVCs, in my experience, feel drastically better with a simple non-pharmacological approach consisting of 4 factors:

  • Reassurance that the PVCS are benign
  • Caffeine (or other stimulant) reduction
  • Lifestyle adjustment with regular aerobic exercise
  • Increased potassium intake to keep K >4

Ectopically Yours

-ACP

 

 

 

How To Spot a Quack Health Site: Red Flag #1, Primary Goal Is Selling Supplements

During the process of compiling the Cardiology Quackery Hall of Shame, the skeptical cardiologist has recognized that the #1 red flag of quackery is the constant promotion of useless supplements.

Such supplements typically:

-consist of “natural” ingredients

-are a proprietary blend of ingredients or a uniquely prepared single ingredient, and are only available through the quack

-have thousands of individuals who have had dramatic improvement on the supplement and enthusiastically record their testimonial to its power

-have no scientific support of efficacy or safety

-despite the lack of scientific data, the quack is able to list a series of seemingly valid supportive “studies”

-aren’t checked by the FDA

-apparently cure everything from heart disease to lassitude

I received an email today from a reader complimenting me on my post on the lack of science behind Dr. Esselstyn’s plant-based diet. The writer thought I would be interested in the work of a  Dr. Gundry.

I found on Dr. Gundry’s website an immediate and aggressive attempt to sell lots of supplements with features similar to what I describe above.

Dr. Gundry’s bio states “I left my former position at California’s Loma Linda University Medical Center, and founded The Center for Restorative Medicine. I have spent the last 14 years studying the human microbiome – and developing the principles of Holobiotics that have since changed the lives of countless men and women.”

Need I mention that “holobiotics” is (?are) not real.

Bonohibotically Yours,

-ACP

After writing this, I googled “red flag of quackery” images in the foolish hope that I might find a useable image. Lo and behold the image I featured in this post turned up courtesy of sci-ence.org. Here it is in all its glory, courtesy of Maki

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