statins dont work

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Why Statins Won't Be Used in 20 Years Treating the Wrong Cause With the Wrong Drug

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Page 1: Statins Dont Work

Why Statins Won't Be Used in 20 YearsTreating the Wrong Cause With the Wrong Drug

Page 2: Statins Dont Work

"I predict that the statin drug run is about to end, and it will be a hard landing. The thalidomide disaster of the 1950's and the hormone replacement therapy fiasco of the 1990's will pale by comparison to the dramatic rise and fall of the statin industry. I can see the tide slowly turning, and I believe it will eventually crescendo into a tidal wave, but misinformation is remarkably persistent, so it may take years."-Stephanie Seneff

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Goals● Dietary saturated fat and cholesterol do not

cause heart disease● Statins don't work well for prevention and

their side effects outway their benefit (which is easily achieved in other ways)

● Statins work by a different mechanism than lowering cholesterol

● Treatment alternatives

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EpidemiologyOf twenty-five prospective studies examining a link between saturated fat and CHD between 1963 and 2005, six (25-30) found an increased risk of CHD with saturated fat intake, though in two of the studies (29, 30), after adjusting for confounders, such as age and smoking, there was no significant association between saturated fat intake and incidence of CHD. The other nineteen (31-49) studies found no link between CHD and saturated fat. If we take a close look at the four (25-28) that found a connection, one would increase their risk for heart attack by increasing their saturated fat intake by a mere 0.5 to 1.7 percent of calories. On a 2000 calorie diet, that amounts to 1.1 to 3.8 grams of saturated fat. In the Honolulu Heart Program, the difference between saturated fat intake between those who remained free from CHD and those who died of a heart attack was only half of one gram.

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EpidemiologyThe Pukapuka and Tokelau people in the South Pacific have a high saturated fat diet due to coconut intake, but researchers note a complete lack of CVD in these populations despite an average blood cholesterol level of 240 mg/dl in Tokelau (22). The Masai in Africa live on fat-rich milk, meat and blood with an average intake of 300 grams of animal fat daily. Professor George Mann found the Masai to be slim and fit and virtually free of heart disease (23) and despite their very high saturated fat intake, most of them had blood cholesterol levels below 160 mg/dl (24).

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Intervention StudiesRose et. al. (51) compared the effect of corn oil, olive oil and saturated fat on CHD. The corn oil group had significantly increased CHD incidents, deaths and total deaths despite the fact that they had a lower blood cholesterol level than the saturated fat group. The olive oil group didn’t do much better than the corn oil group. Those in the saturated fat group lived the longest.The DART trial (63) had three different groups; a group that ate more fish, one that lowered fat intake while increasing the ratio of polyunsaturated to saturated fat and a group that ate more cereal fiber. They found no mortality change in the low-fat group, a slight increase in mortality in the fiber group and a significantly lowered mortality in the fish group, despite the fact that blood cholesterol levels went up in the fish group.Recently, the Women’s Health Initiative (66) showed no benefit to lowering total fat or saturated fat in the diet in preventing heart disease. In fact, those with existing heart disease were at increased risk for events on the lower fat diet.

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Intervention StudiesIn 2006, after examining all the available clinical evidence, Hayward et. al. reported that,”…current clinical evidence does not demonstrate that titrating lipid therapy to achieve proposed low LDL cholesterol levels is beneficial or safe.”(70)Overall, the dietary intervention trials do not support the diet-heart hypothesis. There are more studies showing no correlation between saturated fat and cholesterol intake and heart disease than studies showing a correlation and several studies show a health benefit for saturated fat intake. Those that do show a correlation are flawed or contain too many variables to give us any definite answers.

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Modified Lipid HypothesisWe know that people with familial hypercholesterolemia have higher rates of heart disease. We also now know that they have a defective LDL receptor gene so that they have difficulty getting cholesterol from the blood into the cells. That is why they have higher than average blood cholesterol levels.Statin trials have shown that coronary events are reduced even if LDL is not lowered (71-76). In the PROSPER trial, those with the highest LDL cholesterol levels lived the longest (77). In the Japanese Lipid Intervention Trial, the highest death rate was seen among those with cholesterol levels below 160 mg/dl. The lowest overall mortality rate was seen in those who had blood cholesterol levels between 200-259 mg/dl and LDL between 120-159 mg/dl. In humans, 20 mg/day for 9 days of atorvastatin administration reduced oxidized LDL, but did not reduce blood levels of LDL (78).

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Modified Lipid HypothesisBased on the evidence, statins appear to exert a positive effect on CHD through some other mechanism besides cholesterol lowering which would imply that the lipid hypothesis is incorrect in its present form. It appears that the presence of oxidized LDL is more important than the amount of cholesterol in the blood.

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Proposed Model for Heart DiseaseLDL receptors normally “receive” LDL particles and remove them from circulation so that they can deliver nutrients and cholesterol to cells, and fulfill their normal roles in the body.If LDL receptor activity is downregulated, LDL particles clear more slowly from and spend more time in the blood. Particles accumulate.When LDL particles hang out in the blood for longer stretches of time, their fragile polyunsaturated fatty membranes are exposed to more oxidative forces, like inflammation, and their limited store of protective antioxidants can deplete.When this happens, the LDL particles oxidize.Once oxidized, LDL particles are taken up by the endothelium – a layer of cells that lines the inside of blood vessels – to form atherosclerotic plaque so they don’t damage the blood vessel. This sounds bad (and is), but it’s preferable to acutely damaging the blood vessels right away.So it’s the oxidized LDL that gets taken up into the endothelium and precipitates the formation of atherosclerotic plaque, rather than regular LDL. OxLDL, poor receptor activity, and inflammation are the problems.

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Evidence for the modified lipid hypothesisThe component of LDL that is the most likely to become oxidized is the polyunsaturated fatty acids (PUFA). LDL from people who consume more PUFA from vegetable and fish oils oxidizes more easily and vitamin E does not help to minimize that oxidation (84). It is the linoleic acid component of oxidized LDL that leads to atherogenesis (85). A 2004 study by Mozaffarian et. al. showed that postmenopausal women who ate more PUFA, had worsening atherosclerosis over time, but for those who ate more saturated fat, the less their atherosclerosis progressed. In the highest intake of saturated fat, atherosclerosis actually reversed over time (86). Herron et. al., in 2004, noted that a high cholesterol diet protects LDL from becoming oxidized (87) and yet another study showed egg consumption to be protective of LDL (88). Milk fat has also been shown to be negatively associated with CVD (89, 90). Polyunsaturated fats have also been shown to increase cancer risk (91-93) and to play a role in acute respiratory distress syndrome (94). Antioxidants have been shown to protect LDL from oxidation (95-96).

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Statins are ineffective In primary prevention, statins do not reduce the risk of

death [2] In predominantly primary prevention, in women of any

age, there is no reduced risk of cardiovascular events with statin treatment [3].

This is also true for men aged 70 or over [3]. In high-risk men aged 30-69 years, about 50 patients

need to be treated for 5 years to prevent one cardiovascular event [3].

1. Dorresteijn JA, Aspirin for primary prevention of vascular events in women: individualized prediction of treatment effects. Eur Heart J 16 November 2011 [Epub ahead of print]

2. Ray KK, et at. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010;170(12):1024-1031

3. Abramson J, et al. Are lipid-lowering guidelines evidence-based? The Lancet 2007:369:168-169

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Statins don’t increase survival in healthy people

Statins have never been shown to be effective in reducing the risk of death in people with no history of heart disease. No study of statins on this “primary prevention population” has ever shown reduced mortality in healthy men and women with only an elevated serum cholesterol level and no known coronary heart disease. (CMAJ. 2005 Nov 8;173(10):1207; author reply 1210.) In fact, an analysis of large, controlled trials prior to 2000 found that long-term use of statins for primary prevention of CHD produced a 1% greater risk of death over 10 years compared to placebo

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Statins don’t increase survival in women

Despite the fact that around half of the millions of statin prescriptions written each year are handed to female patients, these drugs show no overall mortality benefit regardless of whether they are used for primary prevention (women with no history of heart disease) or secondary prevention (women with pre-existing heart disease). In women without coronary heart disease (CHD), statins fail to lower both CHD and overall mortality, while in women with CHD, statins do lower CHD mortality but increase the risk of death from other causes, leaving overall mortality unchanged. (JAMA study)

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Statins don’t increase survival in the elderly

The only statin study dealing exclusively with seniors, the PROSPER trial, found that pravastatin did reduce the incidence of coronary mortality (death from heart disease). However, this decrease was almost entirely negated by a corresponding increase in cancer deaths. As a result, overall mortality between the pravastatin and placebo groups after 3.2 years was nearly identical. This is a highly significant finding since the rate of heart disease in 65-year old men is ten times higher than it is in 45-year old men. The vast majority of people who die from heart disease are over 65, and there is no evidence that statins are effective in this population.

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Do statins work for anyone?

Among people with CHD or considered to be at high risk for CHD, the effect of statins on the incidence of CHD mortality ranges from virtually none (in the ALLHAT trial) to forty-six percent (the LIPS trial). The reduction in total mortality from all causes ranges from none (the ALLHAT trial) to twenty-nine percent (the 4S trial). However, the use of statins in this population is not without considerable risk. Statins frequently produce muscle weakness, lethargy, liver dysfunction and cognitive disturbances ranging from confusion to transient amnesia. They have produced severe rhabdomyolysis that can lead to life-threatening kidney failure. Aspirin just as effective as statins (and 20x cheaper!) Perhaps the final nail in the coffin for statins is that a recent study in the British Medical Journal showed that aspirin is just as effective as statins for treating heart disease in secondary prevention populations – and 20 times more cost effective! Aspirin is also far safer than statins are, with fewer adverse effects, risks and complications.

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How Statins may exert their (small) positive effectStatins target cholesterol synthesis in the liver. By inhibiting cholesterol synthesis, they decrease the level of free cholesterol in the liver just like cholestryamine. Consequently, the liver increases its expression of the LDL receptor in order to take in more cholesterol from the blood.Statins inhibit the synthesis of mevalonate, a compound that eventually, far down in thebiochemical pathway, gets converted to cholesterol. But our cells use mevalonate for many other things, and thus statins have many "pleiotropic" effects. One such effect is to decrease the activation of a little enzyme called Rho, an enzyme that is part of the stress response and almost certainly contributes to both atherosclerosis and thrombosis. On the other hand, statins also decrease the synthesis of coenzyme Q10, a compound that likely protects against heart disease. Thus, statins are likely to have opposing effects on the risk of heart disease through different mechanisms.

So the burden of processing excess fructose is shifted from the liver to the muscle cells, and the heart is supplied with plenty of lactate, a high-quality fuel that does not lead to destructive glycation damage. LDL levels fall, because the liver can't keep up with fructose removal, but the supply of lactate, a fuel that can travel freely in the blood (does not have to be packaged up inside LDL particles) saves the day for the heart, which would otherwise feast off of the fats provided by the LDL particles. I think this is the crucial effect of statin therapy that leads to a reduction in heart attack risk: the heart is well supplied with a healthy alternative fuel.

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Treatment Alternatives“The best six doctors anywhereAnd no one can deny itAre sunshine, water, rest, and airExercise and diet.These six will gladly you attendIf only you are willingYour mind they'll easeYour will they'll mendAnd charge you not a shilling.”-Wayne Fields, What the River Knows, 1990

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DietLow-Carb Diets Benefit Blood Lipids According to many studies, (1, 2, 3) controlled carbohydrate programs reduce markers for cardiac risk, including reducing blood pressure, fasting glucose, triglycerides and inflammation and increasing HDL cholesterol. In one study performed at Stanford, a low carb diet performed better than three other higher-carb, lower-fat diets in nearly all markers of cardiac risk factors.

Various evidence supports this paradigm shift: 1) carbohydrate restriction improves markers of atherogenic dyslipidemia (triglycerides, high-density lipoprotein cholesterol, apolipoprotein B-apolipoprotein A-1 ratio) and reduces the more atherogenic small, dense low-density lipoprotein cholesterol; 2) high amounts of dietary carbohydrates increase de novo fatty acid synthesis and plasma triglycerides; and 3) large, long-term studies of traditional dietary fat reduction continue to fail to demonstrate the predicted improvement in cardiovascular disease risk. Cardiovascular disease is the leading cause of morbidity and mortality in the Western world. It seems appropriate to consider carbohydrate reduction as a useful, if not the preferred, alternative to low-fat diets, which have met with limited success.”CURRENT CARDIOVASCULAR RISK REPORTSVolume 2, Number 2 (2008), 88-94, DOI: 10.1007/s12170-008-0018-zhttp://www.nmsociety.org/low-carb-research.html

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DietA Palaeolithic diet improves glucose tolerancemore than a Mediterranean-like diet in individualswith ischaemic heart diseaseDiabetologia (2007) 50:1795–1807 Metabolic and physiologic improvements fromconsuming a paleolithic, hunter-gatherer type diet“Even short-term consumption of a paleolithic type diet improves BP and glucose tolerance, decreases insulin secretion, increases insulin sensitivity and improves lipid profiles without weight loss in healthy sedentary humans.”European Journal of Clinical Nutrition (2009) 63, 947–955 Osterdahl and coworkers reported a small uncontrolled 3-week study of a Paleolithic diet in 14 healthy subjects in the European Journal of Clinical Nutrition in 2008. They found significant improvements in weight, body mass index, waist circumference, systolic blood pressure, and plasminogen activator inhibitor-1.6

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ExerciseBenefits of Regular Exercise on Cardiovascular Risk Factors

· Increase in exercise tolerance· Reduction in body weight· Reduction in blood pressure· Reduction in bad (LDL and total) cholesterol· Increase in good (HDL) cholesterol· Increase in insulin sensitivity Circulation. 2003;107:e2-e5

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SunshineVitamin D and CVDA number of observational studies have found that low vitamin D levels in the blood are associated with increased risk of CVD. There is increasing evidence that vitamin D reduces the risk of coronary heart disease, peripheral vascular disease, and stroke. Vitamin D levelsThere have been about ten observational studies investigating risk of CVD incidence or death as a function of vitamin D blood levels before diagnosis. Risk drops rapidly for vitamin D increases at low starting levels, then more slowly at higher levels. Risk of CVD drops by about 40% for levels above 40 ng/ml (100 nmol/l) compared to 20 ng/ml (50 nmol/l). How vitamin D worksThere are a number of ways vitamin D might protect against CVD. Vitamin D regulates calcium. By helping calcium move to the bones and teeth rather than the soft tissues, vitamin D may assist the cardiovascular system. In addition, vitamin D has been shown to:· Reduce inflammation· Increase muscle strength and maintain muscle function, which reduces the risk of heart failure.

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AirSmoking cessation “Inflammatory markers may be more accurate indicators of atherosclerotic disease. Inflammatory markers returned to baseline levels 5 y after smoking cessation, consistent with the time frame associated with cardiovascular risk reduction observed in both the MONICA and Northwick Park Heart studies. Our results suggest that the inflammatory component of cardiovascular disease resulting from smoking is reversible with reduced tobacco exposure and smoking cessation.”Bakhru A, Erlinger TP (2005) Smoking Cessation and Cardiovascular Disease Risk Factors: Results from the Third National Health and Nutrition Examination Survey. PLoS Med 2(6): e160. doi:10.1371/journal.pmed.0020160 “The risk decline after smoking cessation occurred for coronary heart disease and total cardiovascular disease within 2 years and for total stroke after 2–4 years. For each endpoint and in both age subgroups of 40–64 and 65–79 years, most of the benefit of cessation occurred after 10–14 years following cessation. Findings imply the importance of smoking cessation at any age to prevent cardiovascular disease in Japanese.”Am. J. Epidemiol. (2005) 161 (2):170-179.doi: 10.1093/aje/kwi027

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AirAir Pollution“Air pollution is a heterogeneous, complex mixture of gases, liquids, and particulate matter. Epidemiological studies have demonstrated a consistent increased risk for cardiovascular events in relation to both short- and long-term exposure to present-day concentrations of ambient particulate matter. Several plausible mechanistic pathways have been described, including enhanced coagulation/thrombosis, a propensity for arrhythmias, acute arterial vasoconstriction, systemic inflammatory responses, and the chronic promotion of atherosclerosis. The purpose of this statement is to provide healthcare professionals and regulatory agencies with a comprehensive review of the literature on air pollution and cardiovascular disease. In addition, the implications of these findings in relation to public health and regulatory policies are addressed. Practical recommendations for healthcare providers and their patients are outlined. In the final section, suggestions for future research are made to address a number of remaining scientific questions.”Circulation.2004; 109: 2655-2671 MeditationTranscendental Meditation Helped Heart Disease Patients Lower Cardiac Disease Risks by 50 PercentPatients with coronary heart disease who practiced the stress-reducing Transcendental Meditation® technique had nearly 50 percent lower rates of heart attack, stroke, and death compared to nonmeditating controls, according to the results of a first-ever study presented during the annual meeting of the American Heart Association in Orlando, Fla., on Nov.16, 2009.

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RestEpidemiological and pathophysiological studies also indicate that there may be a causal link between primary sleep abnormalities (sleep curtailment, shift work, and sleep-disordered breathing) and cardiovascular and metabolic disease, such as hypertension, atherosclerosis, stroke, heart failure, cardiac arrhythmias, sudden death, obesity, and the metabolic syndrome. Curr Probl Cardiol. 2005 Dec;30(12):625-62.

Poor sleep has been linked with high blood pressure, atherosclerosis, heart failure, heart attack and stroke, diabetes, and obesity. The thread that ties these together may be inflammation, the body’s response to injury, infection, irritation, or disease. Poor sleep increases levels of C-reactive protein and other substances that reflect active inflammation. It also revs up the body’s sympathetic nervous system, which is activated by fright or stress.January 2007 issue of theHarvard Heart Letter. Sleeping Less Than Six Hours Each Night Doubles Heart Attack Risk

The study team found that individuals sleeping much more than eight hours each night had a significantly higher prevalence of chest pain or angina and coronary artery disease, a narrowing of the blood vessels that supply the heart with blood and oxygen. The bottom line is simple: controlling the duration of restful sleep in a totally darkened room is a modifiable risk factor that can significantly reduce risk of heart diseases and related chronic illnesses.

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WaterDehydrationDrink at least eight 8-ounce glasses of water every day. One study found that men who drank at least five glasses of water every day had a 51-percent lower risk of heart disease than those who did not. For women, the risk of heart disease was 35 percent lower. FluoridationThe thyroid is particularly affected by fluoride exposure because its store of iodine is depleted. Iodine deficiency depresses the thyroid's metabolic and immune functions, resulting in hypothyroidism and lowered immunity. Lack of iodine shuts down production of thyroxine, the thyroid prohormone that controls metabolism, and, in one way or another, impacts every aspect of health. The resulting hypothyroidism causes weight gain, cold intolerance, dry and prematurely aged skin, depression, constipation, hair loss, memory loss, irritability, increased cholesterol levels, heart disease and loss of libido. Fluoride exposure can come from multiple obvious and not-so-obvious sources. In addition to dental hygiene products and drinking water, many breakfast cereals, juices from concentrate, soda and other processed foods contain alarming levels. Fluoride-containing pesticide use means that the environment is being flooded with fluoride by conventional agriculture (http://www.fluoridealert.org/f-pesticides.htm). Also, many antidepressants contain large amounts of fluoride and are widely prescribed, often for a lifetime of use.http://www.fluoridealert.org/50-reasons.htm

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Helpful SupplementsD3-Vitamin D deficiency has been shown to diminish heart muscle cells contractile function, contribute to endothelial dysfunction, distort heart muscle structure, and increase smooth muscle growth leading to atherosclerotic plaque formation. Low levels of vitamin D have been linked with congestive heart failure and individuals with low serum levels of vitamin D have been found to have higher rates of high blood pressure, diabetes, and triglycerides.MagnesiumMagnesium helps prevent heart attacks, regulates high blood pressure and helps ease heart arrhythmia, in addition to having a great many other vital health benefits. Thanks to today's SAD diet and mineral depleted soils, it is estimated that anywhere from 80 to 95 percent of us are deficient in magnesium. CoQ10-Several research studies reveal that CoQ10 works at a cellular level to protect delicate DNA and reduce dangerous inflammatory levels that are closely linked to heart disease. Further evidence exists to explain how the coenzyme improves blood flow to the heart muscle and enhances vascular elasticity to prevent arterial stiffening, commonly referred to as 'hardening of the arteries'. Scientists have also found that CoQ10 lowers unhealthy levels of oxidized LDL cholesterol by modulating gene signals involved with cholesterol metabolism. Cayenne has a wealth of cardiovascular benefits, including strengthening, stimulating and toning the heart, balancing circulation, and calming palpitations. For more information on this amazing heart healthy herb see: Hawthorn, a favorite of famed Herbalist John Christopher, improves oxygen and blood supply and is rich in flavonoids that protect small capillary vessels from free-radical damage. Hawthorn has been used effectively for angina, arrhythmia, arteriosclerosis, blood clots, and hypertension. Best results are normally seen after a few months, but hawthorn is safe for long-term use. Garlic inhibits bad cholesterol (LDL) production and raises the good kind (HDL). Garlic also lowers blood pressure, prevents blood platelet aggregation, and improves circulation

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Helpful SupplementsPycnogenol is found to be more effective than buffered aspirin in reducing buildup of platelets in the arteries, a major risk factor in heart disease. Cacao is a natural source of theobromine, long considered a heart tonic and mild stimulant. Cacao also contains epicatechin, a flavonol that improves the function of the blood vessels. Cat's claw contains a variety of valuable phytochemicals that inhibit the processes involved in the formation of blood clots. It increases circulation and inhibits inappropriate clotting, helping prevent stroke and reducing the risk of heart attack. Ginkgo has been shown in numerous studies to cause dilation and increase the blood flow in the arteries, capillaries and veins. In addition, it inhibits platelet aggregation, reduces blood clotting and helps protect our vascular walls from free-radical damage. Ginger reduces cholesterol and blood pressure and also prevents blood clots. Similar to garlic, ginger interferes with the long sequence of events necessary for blood clots to form, helping prevent clots that can lodge in narrowed coronary arteries and set off a heart attack. Turmeric lowers blood cholesterol levels by stimulating the production of bile. It also prevents the formation of dangerous blood clots that can lead to heart attack. Alfalfa leaves and sprouts help reduce the blood cholesterol levels and plaque deposits on artery walls.

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Helpful SupplementsAlpha-lipoic acid works with other antioxidants in the body to increase their effectiveness against oxidative stress and helps keep arteries clear by preventing the LDL cholesterol from being incorporated into artery walls. Bromelain is an enzyme found in pineapple. Bromelain may 'thin" the blood and help clear away debris from artery walls. One study demonstrated that bromelain relieves the pain of angina, which is associated with heart disease. Essential fatty acids help prevent unnecessary blood clotting, reduce inflammation, and regulate blood pressure. They are found in black currant seed oil, borage oil, evening primrose oil, fish oil, and flaxseed oil. Pectin is a fiber found in grapefruit, apples and other fruits and vegetables which helps lower LDL cholesterol and sweeps away fatty plaque deposits from the artery walls. Other herbs and supplements that are beneficial for the heart include iodine, motherwort, bilberry, arjuna, fo-ti, citrin, artichoke leaf extract, guggul, cordyceps, L-Carnitine, lecithin, taurine, activated charcoal, barberry, black cohosh, butcher's broom, dandelion, rosemary, chamomile, valerian root, kelp, kola, myrrh, psyllium, passion flower, saffron, skullcap, and tarragon.

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Resourceshttp://bigtimsprimaljourney.com/2012/07/07/question-everything/http://people.csail.mit.edu/seneff/why_statins_dont_really_work.htmlhttp://blog.cholesterol-and-health.com/2011/03/genes-ldl-cholesterol-levels-and.htmlhttp://www.drbriffa.com/category/cholesterol-and-statins/page/2/http://www.westonaprice.org/cardiovascular-disease/dangers-of-statin-drugshttp://chriskresser.com/ten-steps-to-preventing-heart-disease-naturallyhttp://chriskresser.com/the-truth-about-statin-drugshttp://rawfoodsos.com/2011/12/22/the-truth-about-ancel-keys-weve-all-got-it-wrong/http://www.cholesterol-and-health.com/Rho-Activation.html

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Questions?