New, stricter blood pressure guidelines based on flawed study

Last month, it was nearly impossible to evade the disturbing headlines proclaiming how even more millions of Americans now need blood pressure treatment. That’s nearly 100 million — or 46 percent — of the U.S. population who are now considered to be in the higher blood pressure category.

I was in the car driving on a long road trip while I heard the news blare on the radio all day long. As soon as I reached my destination, I began digging into this news story immediately.

As it turns out, the American Heart Association (AHA) and the American College of Cardiology (ACA) issued new, stricter blood pressure guidelines. The guidelines are so strict, the number of men under age 45 with a diagnosis of high blood pressure will triple, and the number of women under age 45 will double.

But there was one big problem omitted from the news reports…

The AHA and the ACA issued these new guidelines based on a seriously flawed, two-year-old study that was never even finished! I’ll explain more about that study in a moment. But first, let’s back up…

History of high blood pressure

For years, doctors instructed patients to aim for a blood pressure reading of less than 140/90 mm Hg based on evidence from several studies. Then in 2013, experts relaxed their recommendations even further for systolic blood pressure (the first number) to less than 150 for patients ages 60 and older. Again, they based those recommendations on good science.

As I’ve explained before, as you age, evidence shows that slightly higher blood pressure levels help to support healthy circulation of blood and oxygen to the brain, heart and other tissues. This also means that fewer people would need to take blood pressure drugs — and that’s always a positive thing.

The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) recommended these less aggressive targets. And they were published in the January 16, 2017 issue of the Annals of Internal Medicine and the Annals of Family Medicine.

But thanks to the AHA and ACA’s recommendations, blood pressure targets are being aggressively tightened. High blood pressure will now be defined as 130/80 or above (for anyone with a 10 percent or greater risk for heart attack or stroke).

The AHA and ACA based their new, stricter recommendations on the preliminary findings of the SPRINT study (Systolic Blood Pressure Intervention Trial). The study is two years old, so I’m not even sure why it’s making “news,” or why the organizations relied so heavily upon it? Plus, as I mentioned above, the study suffers from several, major design flaws…

No excuse for no blind controls

First, the study was not blinded. It was “open-label,” meaning both patients and physicians knew exactly which treatment group they were in and which treatment they were getting.

That means that bias and the placebo effect were in full-force in this study, so the expectations of both doctors and patients influenced the outcome.

Why is eliminating bias and the placebo effect so critically important?

For one, there’s no physiologic measurement more subject to bias and the placebo effect than blood pressure.

It’s an exceptionally volatile reading that changes constantly in response to stress, activity and the environment. It also changes when sitting in a doctor’s office or medical clinic. There’s even a name for this effect — “white coat hypertension.”

In my view, bias and placebo effect can account for the entire outcome of this SPRINT study, especially given how minor the results were, as I’ll explain further in a moment.

Unrealistic, perfect conditions throw off results

The second flaw in the study involves how the researchers determined the participants’ blood pressure.

They took the patients’ readings three times, each time after five minutes of quiet rest with no staff in the room. Then, the researchers averaged the numbers.

Indeed, this is the right way to get an ideal measurement.

But when is the last time you had your blood pressure measured that way in a busy medical office or clinic?

A systolic blood pressure reading of 130 under these ideal circumstances in the SPRINT study probably translates to 140 or 150 in a busy, real-world clinic.

So, when practitioners apply this idealized target in real life, patients will be less likely to meet it and in turn, will be overmedicated.

For their third flaw, the researchers used something called a “composite endpoint.” In other words, they didn’t measure a single outcome — like mortality — as researchers are taught to do. For example, a strong study would only measure the effect of achieving 130/80 on mortality rate.

But for the SPRINT study, they used a long, random laundry list, which included various complications of cardiovascular disease.

Researchers sometimes use this approach to magnify the efficacy of a treatment. It’s a well-known statistical “gimmick” used to boost the power of a study so that trials become smaller and less costly, or the results of promising new treatments become available earlier.

So, what were the results?

Doctored results don’t mean much

Patients who had “high” blood pressure — as determined by those first three readings in the doctor’s office — were put on medication. Patients in the most intensive treatment group (who were administered three medications) achieved a 120 systolic reading. And patients in the standard treatment group (who were administered two medications) achieved a 140 reading.

As it turns out, the intensive treatment group had a slightly lower incidence of cardiovascular complications compared to the standard treatment group.

More specifically, the intensive treatment group had a complication (from the random laundry list) at a rate of 1.7 percent per year. And the standard treatment group had a complication rate of 2.2 percent.

So, the participants who received standard treatment lowered their actual risk of suffering from one of those random outcomes by a paltry 0.5 percent.

But considering the large number of patients in the study (more than 9,000), this meager result achieved statistical significance.

When the actual risk reduction is so small, “the number needed to treat” to try and prevent just one bad outcome becomes very large.

So, in this case, to prevent one actual death, 172 patients would have to be intensively treated for three years. And 171 patients would be subjected to multiple toxic, dangerous and potentially fatal side effects, but without any benefit.

Even the study’s authors admitted to these poor numbers, which represents a terrible model for medical practice and public health. But of course, treating large numbers of patients is just what big pharma wants!

Closing the curtains early didn’t hide everything

Once the researchers got an early look at these results, they halted the study early, which achieved one notable goal: it downplayed the dangerous side effects, which typically increase over time.

But even hitting the brakes on the study early couldn’t hide all of its problems…

The researchers observed more serious side effects in the intensive treatment group. This study group experienced dangerously low pressure (hypotension), fainting (causing dangerous falls and fractures), and electrolyte disturbances, which can be fatal. Plus, the incidence of acute kidney injury was twice as high in the intensive treatment group.

Any of these flaws would have (and should have) normally prevented the study from even being funded in the first place…let alone published in the New England of Journal.

It boggles my mind that any organization made up of supposed “experts” would use this flawed, incomplete study to make sweeping, new public health and clinical practice policies.

But it looks like they knew what they were really doing all along…more drugs for more people.

Indeed, when they began the study, the researchers knew what “results” they wanted to achieve — and the sooner the better. Perhaps they were following the old adage, “in the land of the blind, the one-eyed man is king.”

My advice?

1. Stick with the sensible guidelines of achieving a systolic blood pressure of 140 or 150 mm Hg, especially if you’re over 60.

2. Consult with a knowledgeable, realistic doctor. And many are already being skeptical about lowering blood pressure levels based on this old, flawed, incomplete study.

3. Learn more about how to manage stress and practice relaxation using mind-body techniques. Find out which mind-body techniques will work best for you by taking this short quiz or reading my book with Mike Jawer, Your Emotional Type.

4. Get some regular, moderate exercise — preferably outdoors in sunshine and Nature. You only need 25 minutes a day.

5. Follow a healthy, balanced diet, including plenty of fruits (even if you have diabetes) and vegetables. Experts have long recognized the Mediterranean diet for reducing heart disease and many cancers. Traditionally, the Mediterranean diet includes healthy amounts of fruits, vegetables, whole grains, nuts, fish, some red meat, and large amounts of high-quality extra virgin olive oil.

6. Supplement daily. I recommend a high-quality vitamin B complex supplement that contains at least 12 mcg of vitamin B12 as well as 55mg of B6. Additionally, I recommend 10,000 IU of vitamin D per day.

For more drug-free strategies to achieve an optimal blood pressure and improve cardiovascular health, refer to my new Heart Attack Prevention & Repair Protocol. You can learn more about it, or enroll today, simply by clicking here.

 

Sources:

“Don’t let new blood pressure guidelines raise yours,” New York Times (www.nytimes.com) 11/15/2017

“A Randomized Trial of Intensive versus Standard Blood-Pressure Control,” N Engl J Med 2015; 373:2103-2116


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