Posts Tagged ‘Cochrane reviews’

Are Cholesterol Lowering Drugs Right For You?

Written by Dr. Steve Chaney on . Posted in Drugs and Health, Issues

Do Statins Really Work?

Author: Dr. Stephen Chaney

Do statins really work?Statins – those ubiquitous drugs used to lower cholesterol levels – are big business!

Over 20 million Americans are currently being treated with statin drugs at a cost that runs into billions of dollars every year. And cardiologists have just recommended that another 20 million Americans consider using cholesterol lowering drugs. 44% of the men and 22% of the women in this country are now being told that they should be using statin drugs.

Some of my cardiologist friends are so convinced that statin drugs prevent death from heart attacks that they have said, only half-joking, that we should just add statins to the water supply.

Are Cholesterol-Lowering Drugs Right For You?

Is the faith of doctors in the power of statin drugs to prevent death from heart disease justified? To answer that question in full we need to look at people who have already survived a heart attack and people who have never had a heart attack separately.

If you’ve already had a heart attack the evidence is clear cut.

  • If you have had a heart attack, there is good evidence that statins will reduce your risk of dying from a second heart attack.
  • In the technical jargon of the scientific world that is referred to as secondary prevention.

But what about those millions of Americans who are being prescribed statin drugs who have never had a heart attack? This is something we scientists refer to as primary prevention.

What Do The Studies Actually Say About Statins And Primary Prevention?

Here the evidence is not clear at all. Two major reports have cast doubt on the assumption that statins actually do prevent heart attacks in people who have not already had a first heart attack.

In the first study, Dr. Kausik Ray and colleagues from Cambridge University in England performed a meta-analyis of 11 clinical studies involving over 65,000 participants (Ray et al, Arch. Int. Med., 170: 1024-1031, 2010). They focused on those participants in the studies who had not previously had a heart attack (primary prevention).

  • They found that the use of statins over an average of 3.7 years had no statistically significant effect on mortality. In short, statins had no effect on the risk of dying from heart disease or any other cause.
  • Dr. Sreenivasa Sechasai, one of the doctors involved in the study, said “We didn’t find a significant reduction in death despite having such a huge sample size. This is the totality of evidence in primary prevention. So if we can’t show a reduction with this data, it is unlikely to be there.”

The second study was a Cochrane Systemic Review of statins published January 19th, 2011.  It stated that there was not enough scientific evidence to recommend the use of statins in people with no previous history of heart disease with some caveats (see below).

To help you understand the significance of that conclusion, let me give you a bit of background:

  • First you need to understand that the Cochrane Collaboration is an independent, non-profit organization that carefully reviews the scientific evidence behind medical treatments and proposed medical treatments.
  • Cochrane Reviews are considered the “Holy Grail” of evidence-based medicine (ie. medicine based on the best scientific evidence rather than what the pharmaceutical companies would have you believe).
  • So when a Cochrane Review concludes that there isn’t enough evidence to recommend use of statins in patients with no prior history of heart disease that is pretty big news in the medical world.

How Should These Studies Be Interpreted?

Please don’t misinterpret what I am saying. The Cochrane Review said that statin drugs are overprescribed, but it did not say that everyone who has not had a heart attack will not benefit from statins. It said that there are a number of risk factors that need to be considered in evaluating individual patients for statin use.

  • Simply put, that means that it is not as simple as saying that everyone with no previous history of heart disease should not be on statin drugs.
  • If you are currently taking statin drugs and you have no previous history of heart disease, you may want to discuss with your physician whether the Cochrane Review of statin drugs changes their opinion of whether se of those drugs is still warranted for you.
  • But the bottom line is that only your physician is trained to take into account all of the factors that increase your risk of heart disease and the best therapeutic approach for reducing your risk of heart attack.

There Is A Double Standard In The Medical Community

More importantly, these studies highlight the difficulty in showing that anything works when you start out with a healthy group of adults with no prior evidence of disease (primary prevention).

And, the way that doctors have responded to primary prevention studies shows that there is a double standard in how primary prevention trials are interpreted in the medical community. For example:

  • There is no good evidence that statins prevent fatal heart attacks in healthy people.
  • However, because statins do work in high risk patients, most doctors recommend their use by millions of Americans who have never had a heart attack.
  • There is also no good evidence that nutrients like vitamin E and omega-3 fatty acids prevent fatal heart attacks in healthy people.
  • However, there is evidence that both vitamin E and omega-3 fatty acids prevent heart attacks in high risk patients, yet most doctors will tell you they are a waste of money.

It is food for thought.

The Bottom Line

1)    Statin drugs clearly save lives when used by people who have already had a heart attack.

2)    On the other hand, there is no proof that statin drugs prevent heart attacks in people who have not previously had a heart attack

3)    Statin drugs do have side effects. Increased risk of diabetes, liver damage, muscle damage and kidney failure are the best documented, although memory loss has also been reported.

4)    I am not recommending that you stop using statin drugs without consulting your doctor. I am suggesting that you discuss the benefits and risks of statin drug use with your doctor.

5)    Perhaps the most important poin tto come out of these studies is that it almost impossible to prove the benefit of any intervention in a primary prevention trial. If you can’t prove that statins work in healthy people, it is not surprising that it is difficult to prove that other interventions work.

6)   Finally, the way that these studies have been interpreted shows that there is a clear double standard in how the medical community evaluates primary intervention trials.

  • Statin drugs don’t show any benefit in a primary prevention setting, yet most doctors still recommend them.
  • Vitamin E and omega-3 fatty acids don’t show any benefit in a primary prevention setting, and most doctors recommend against them.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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Omega-3 Benefits: Lower High Blood Pressure

Posted July 16, 2019 by Dr. Steve Chaney

What Does the FDA Say About Omega-3 Benefit Claims?

Author: Dr. Stephen Chaney

 

 

Among omega-3 benefits is lower high blood pressure.  That claim can be made according to the FDA. 

lower high blood pressureHeart Disease is still the number 1 cause of death in this country. And, while deaths from heart disease have been declining in recent years, deaths due to high blood pressure have been increasing.  That is concerning because:

High blood pressure is a killer! It can kill you by causing heart attacks, strokes, congestive heart failure, kidney failure and much more.

High blood pressure is a serial killer. It doesn’t just kill a few people. It kills lots of people. The American Heart Association estimates that high blood pressure directly or indirectly caused 410,000 deaths in 2014. That is almost 1 person every second and represents a 41% increase from 2000. It’s because high blood pressure is not a rare disease.

  • 32% of Americans have high blood pressure, also called hypertension, (defined as a systolic blood pressure of 140 mm Hg or more or a diastolic blood pressure of 90 mm Hg or more).
  • Another 33% of Americans have prehypertension (systolic blood pressure of 120-139 mm Hg or diastolic blood pressure of 80-89 mm Hg).

That’s over 65% of Americans with abnormal blood pressure!

High blood pressure is a silent killer. That’s because it is a very insidious disease that sneaks up on you when you least expect it. Systolic blood pressure increases 0.6 mm Hg/year for most adults over 50. By age 75 or above 76-80% of American adults will have high blood pressure.  Even worse, many people with high blood pressure have no symptoms, so they don’t even know that their blood pressure is elevated. For them the first symptom of high blood pressure is often sudden death.

Blood pressure medications can harm your quality of life. Blood pressure medications save lives. However, like most drugs, blood pressure medications have a plethora of side effects – including weakness, dizziness, fainting, shortness of breath, chest pain, nausea, diarrhea or constipation, heartburn, depression, heart palpitations, and even memory loss. The many side effects associated with blood pressure medications lead to poor compliance, which is probably why only 46% of patients with high blood pressure are adequately controlled.

You do have natural options. By now you are probably wondering whether there are natural approaches for controlling your blood pressure that are both effective and lack side effects. The answer is a resounding YES! I’ll outline a holistic natural approach for keeping your blood pressure under control in a minute but let me start with the FDAs recent approval of what they call “qualified claims” that omega-3s lower blood pressure.

 

What Does the FDA Say About Omega-3 Benefits?

omega-3 benefitsIn my book “Slaying The Supplement Myths” I talk about the “dark side” of the supplement industry. There are far too many companies who try to dupe the public by making outrageous and unsubstantiated claims about their products.

Only the FDA stands between us and those unscrupulous companies, and they take their role very seriously. That is why it is big news whenever the FDA allows companies to make health claims about their products.

Even then, the FDA is very cautious. They allow what they call “qualified” health claims. Basically, that means they are saying there is enough evidence that the health claim is probably true, but not enough evidence to say it is proven.

Of course, if you understand the scientific method, you realize there will always be some studies on both sides of every issue. That is why the only health claims the FDA allows are qualified health claims.

With that background in mind, let’s look at the qualified health claims the FDA allows for omega-3 benefits.

  • Since 2004 the FDA has allowed the qualified claim “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
  • A few weeks ago, they added five qualified health claims about omega-3s and blood pressure. The 5 claims are very similar, so I will only list two below for the sake of brevity.
  • “Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease).”
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure.
  • Of course, they add the usual wording about the evidence being inconsistent and inconclusive.

 

Omega-3 Benefits?

measure omega-3 benefits levelWe’ve known for some time that omega-3 fatty acids help lower blood pressure, but two recent studies were instrumental in convincing the FDA to allow these qualified health claims. These studies have highlighted just how strong the effect of omega-3s on lowering blood pressure is.

The first study was a meta-analysis of 70 randomized, placebo-controlled clinical trials of long chain omega-3 (EPA + DHA) supplementation and blood pressure (Miller et al, American Journal of Hypertension, 27: 885-896, 2014 ).

This study showed:

  • In the group with normal blood pressure at the beginning of the study EPA + DHA supplementation decreased systolic blood pressure by 1.25 mm Hg.
  • Given that systolic blood pressure rises an average of 0.6 mm Hg/year in adults over 50, the authors estimated that omega-3 supplementation alone would delay the onset of age-related high blood pressure by 2 years.
  • In the group with elevated blood pressure not taking medication at the beginning of the study, EPA + DHA supplementation decreased systolic blood pressure by an impressive 4.51 mm Hg and diastolic blood pressure by 3.05 mm Hg.
  • The authors noted that this decrease in systolic blood pressure could “prevent an individual from requiring medication [with all its side effects] to control their hypertension” or decrease the amount of medication required.

However, the doses of omega-3s used in these studies ranged from 1 to over 4 grams/day (mean dose = 3.8 grams/day). That sparked a second study (Minihane et al, Journal of Nutrition, 146: 516-523, 2016) to see whether lower levels of omega-3s might be equally effective. This study was an 8-week double-blind, placebo-controlled study comparing the effects of 0.7 or 1.8 grams of EPA + DHA per day (versus an 8:2 ratio of palm and soybean oil as a placebo) on blood pressure.

This study showed:

  • In the group with normal blood pressure at the beginning of the study, EPA + DHA supplementation caused no significant decrease in blood pressure. This could be due to the smaller number of subjects or the lower doses of EPA + DHA used in this study.
  • In the group with elevated blood pressure not taking medication at the beginning of the study, EPA + DHA supplementation decreased systolic blood pressure by 5 mm Hg and, the effect was essentially identical at 0.7 grams/day and 1.8 grams/day.
  • The authors concluded “Our data suggest that increased EPA + DHA intakes of only 0.7 grams/day may be an effective strategy for blood pressure control.”

 

A Holistic Approach to Lower High Blood Pressure

holistic approach to lower high blood pressureThe FDA’s allowed claims about omega-3s are good news indeed, but that’s not the only natural approach that lowers blood pressure. You have lots of other arrows in your quiver. For example:

  • The DASH diet (A diet that has lots of fresh fruits and vegetables; includes whole grains, low fat dairy, poultry, fish, beans, nuts and oils; and is low in sugar and red meats) reduces systolic blood pressure by 5-6 mm Hg. [Low fat, low carb and Mediterranean diets also lower blood pressure, but not by as much as the DASH diet].
  • Reducing sodium by about 1,150 mg/day reduces systolic blood pressure by 3-4 mm Hg.
  • Reducing excess weight by 5% reduces systolic blood pressure by 3 points.
  • Doing at least 40 minutes of aerobic exercise 3-4 times/week reduces systolic blood pressure by 2-5 mm Hg.
  • Nitrates, whether derived from fresh fruits and vegetables or from supplements probably also reduce blood pressure, but we don’t yet know by how much.

If you’ve been keeping track, you’ve probably figured out that a holistic lifestyle that included at least 0.7 grams/day of long chain omega-3s (EPA + DHA) plus the other omega-3 benefits in the list above could reduce your systolic blood pressure by a whopping 18-22 mm Hg.  What

That’s significant because, the CDC estimates that reducing high systolic blood pressure by only 12-13 mm Hg could reduce your risk of:

  • Stroke by 37%.
  • Coronary heart disease by 21%.
  • Death from cardiovascular disease by 25%.
  • Death from all causes by 13%.

 

A Word of Caution

While holistic approaches have the potential to keep your blood pressure under control without the side effects of medications, it is important not to blindly rely on holistic approaches alone. There are also genetic and environmental risk factors involved in determining blood pressure. You could be doing everything right and still have high blood pressure. Plus, you need to remember that high blood pressure is a silent killer that often doesn’t have any detectable symptoms prior to that first heart attack or stroke.

My recommendations are:

  • Monitor your blood pressure on a regular basis.
  • If your blood pressure starts to become elevated, consult with your doctor about starting with natural approaches to bring your blood pressure back under control. Doctors are fully aware of the side effects of blood pressure medications, and most doctors are happy to encourage you to try natural approaches first.
  • Continue to monitor blood pressure as directed by your doctor. If natural approaches are insufficient to bring your blood pressure under control, they will prescribe the lowest dose of blood pressure medication possible to get your blood pressure where it needs to be.
  • Don’t stop making holistic lifestyle choices to reduce blood pressure just because you are on medication. The more you do to keep your blood pressure under control with a healthy diet and lifestyle, the less medication your doctor will need to use (That means fewer side effects).

 

The Bottom Line

Heart Disease is still the number 1 cause of death in this country. And, while deaths from heart disease have been declining in recent years, deaths due to high blood pressure have been increasing. That is why anything we can do lower blood pressure naturally is important. What does the FDA say about omega-3s and blood pressure?

  • Since 2004 the FDA has allowed the qualified claim “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
  • A few weeks ago, they added qualified health claims about omega-3s and blood pressure. For example, they now allow the following claims.
  • “Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease).”
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure.

For more information on the studies that convinced the FDA to allow claims about omega-3s and blood pressure and for a discussion of holistic natural approaches for lowering blood pressure, read the article above.

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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