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Statin Drug Beaten by Alternative Cholesterol Treatment
8/4/2008
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Clinical trial finds that lifestyle changesplus fish oil and a Chinese folk remedy— lowered cholesterol and improved key risk factors more than a statin drug alone.

by Craig Weatherby


New clinical findings show that lifestyle changesplus omega-3s and a natural statin alternativecan lower cholesterol levels more than a common statin drug, while bringing other cardiovascular benefits in the bargain.


These results show that statin drugs are not the only effective way to lower cholesterol levels.


And this fact takes on more significance when you consider that as many as four out of 10 of people prescribed a statin drug stop taking it within one year (Simons LA et al. 1998; Avorn J et al. 1996).


This suggests that a more comprehensive approach, involving lifestyle and diet changeswhich bring many ancillary benefitsmay be more effective than statin drugs in the long run.


Key Points

  • New clinical findings show that lifestyle changes—plus omega-3s and a natural statin alternative—can lower cholesterol levels more than a common statin drug, while reducing other cardio-vascular risk factors.
  • Statins probably reduce cardiovascular risks more by damping inflammation than by lowering cholesterol.

Cholesterol: A red herring?

It’s looking more and more likely that the heart-risk reductions associated with statin drugs relate to these compounds’ anti-inflammatory effects.


Likewise, it is increasingly clear that high cholesterol levels alone have little bearing on any given person’s risk of heart attack or sudden cardiac death.


Instead, it takes a variety of other factors, most tied to chronic inflammation, to turn an essential bodily compoundcholesterolinto a vehicle of vascular damage.


People’s cholesterol profiles matter, but big drops in cholesterol levels have been wildly oversold as cardiovascular cure-alls.


You needn’t take our word for it. Recent articles in The New York Times and The Boston Globe exposed the increasingly dubious cholesterol (and dietary saturated fat) hypothesis of heart disease.


To read these reports, click the links provided at the bottom of our article “Cholesterol Fiasco Undermines Accepted Theory.” And consider the implications of mindless cholesterol-cutting outlined in “Can Radical Cholesterol Cutting Raise Cancer Risks?


Regardless, the results of a small clinical trial offer more evidence that certain foods and lifestyle choices can reduce a variety of cardiovascular risk factors… as well as lowering cholesterol levels.


Because of individual genetics and habits, lowering cholesterol levels may affect some people’s heart-health outcomes more than others’.


The statin-profits scandal:
Drug money talks... loudly

It seems odduntil one recalls the rich flow of drug-firm money to Congressional campaignsthat consumers and taxpayers pay billions to drug companies for copies of an ancient Chinese medicinal food that could be available at much lower cost.


Stupidly, sellers of red yeast rice cannot tell you that the naturally occurring lovastatin in their products reduces heart risks and cholesterol levels, just like its synthetic analog.


In fact, sellers of red yeast rice were forced to remove the naturally occurring lovastatin from their products!


Only companies that can spend the $250 million-plus it takes to pass U.S. drug-approval hurdles can make cholesterol-lowering or cardiac health claims for statins.


Pharmaceutical firms say they needed big profits to pay for the research required to prove that statins work… but they actually spend most of their gains on marketing, not research.


University and government researchers can do the research at lower cost, and often do.


In fact, many of the major drugs on the market flowed out of university and government research subsequently exploited by big pharma firms.


Looking for the culprits in this absurd scenario? Just follow the dollar trail from big drug firms to congress, and consider the pharma-related contracts or careers that key congresspersons, legislative aides, and regulators acquire after they leave office.

Findings favor diet-lifestyle approach over statin treatment

A team led by David Becker, M.D., of the University of Pennsylvania Health System recruited 74 people with elevated cholesterol levelswho were not yet diagnosed with coronary diseaseand randomly assigned them to receive one of two daily treatments:

  • Statin Treatment – Simivistatin (40 mg)
  • Alternative Treatment – fish oil + red yeast rice

After three months, cholesterol levels were slightly lower in the Alternative Treatment group than in the Statin Treatment group (Becker DJ et al. 2008).


People who consumed the fish oil + red yeast rice combination enjoyed an average 42.4 percent drop in total cholesterol, compared to an average reduction of 39.6 percent in the statin group.


And the Alternative Treatment group enjoyed greater reductions in triglyceride levels: an average drop of 29 percent, compared with a statistically non-significant nine-percent fall in the statin group.


The authors attributed these reductions in triglyceride levels to the fish oil part of the combination.


Finally, the Alternative Treatment group enjoyed significantly greater reductions in weight, waist and hip size, and body mass index.


There were no significant differences between the Alternative Treatment and Statin groups in terms of blood pressure, fasting glucose levels, or HDL (“good”) cholesterol levels.


The team’s conclusion seems an obvious one: “…this multi-factorial, alternative approach to lipid lowering has promise for a subset of patients unwilling or unable to take statins.”


As Dr. Becker said, “These results are intriguing and show a potential benefit of an alternative, or naturopathic, approach to a common medical condition.”


But in an interview with WebMD, he added what seems more like an assertion of conventional wisdom than an evidence-based statement: “Statins remain the primary and best treatment for people with high cholesterol, especially if you have known coronary disease.”


Again, we refer you to the links provided at the bottom of our article “Cholesterol Fiasco Undermines Accepted Theory.


The alternative treatments, in detail

Let’s examine the elements that constituted the Alternative Treatment regimen.


Fish oil

The omega-3s in the fish oil given the volunteers are proven to lower blood triglyceride levels, reduce arterial inflammation, and stabilize heart rhythms.


The concentrated fish oil capsules taken by the volunteers provided 3,786 mg of omega-3s (EPA+DHA) per day, which is about ten times more than in the typical fish oil capsule.


Note: All available evidence shows that the high doses typically used in clinical trialsto raise cell membrane levels quicklyare NOT necessary to produce long-term cardiac risk-reduction benefits.


Instead, what matters is the amount of omega-3s in your cells, which can be raised to clinically significant levels in a few weeks or months by taking the modest doses provided by standard fish oil capsules.


Red yeast rice

Red yeast rice is a dietary staple in China, where it is used as a preservative, spice, and food coloring. As the name implies, it is the product of growing a specific yeast (Monascus purpureus) on rice.

Called hong qu in China, red yeast rice has been a traditional medicine for poor circulation, indigestion, and diarrhea for at least 1,200 years, since the Tang dynasty.


Red yeast rice naturally contains lovastatin (monacolin K), whichlike synthetic statin drugscuts cholesterol levels by inhibiting an enzyme called HMG Co-A Reductase (HMGR).


The red yeast rice supplements taken by the volunteers provided 10 to 15 mg of lovastatin, which is less than the usual daily therapeutic dose (20 to 40 mg).


The Alternative Treatment group patients were also enrolled in a three-month lifestyle modification program that involved weekly 3½-hour meetings.


Lifestyle modifications

These were the parts of the lifestyle modification program:

  • A cardiologist stressed the importance of lifestyle changes, and taught the group about coronary plaque formation, preventive measures, and standard cardiac testing techniques.
  • A certified dietitian taught basic principles of nutrition and encouraged the group to follow a Mediterranean diet that was modified by reducing saturated fat and by limiting total fat to less than 25% of daily calorie intake.
  • Sugars and simple carbohydrates were discouraged, and participants were taught how to count calories (There was no formal daily calorie limit).
  • An exercise physiologist instructed the group to gradually increase exercise to five to six times per week.
  • Aerobic exercise was encouraged (i.e., walking, swimming, or jogging for 30 to 45 minutes a day).
  • Patients were exposed to relaxation methods including yoga and tai chi.

Red yeast rice: The suppressed natural statin source

A study conducted by the UCLA School of Medicine examined the use of red yeast rice in 83 people with high cholesterol (Li Z et al. 2005).


The volunteers were randomized to receive 2.4 grams a day red yeast rice or a placebo pill, and they were told to consume a 30-percent fat diet, with no more than 10 percent of as saturated fat and with less than 300 mg of cholesterol a day.


After the 12-week treatment period, there was a significant reduction in total cholesterol, LDL cholesterol, and triglyceride levels, compared with placebo, while levels of HDL (“good”) cholesterol were not affected.


Sadly, as we noted elsewhere in this article, the sellers of red yeast rice were forced to remove the naturally occurring lovastatin from their products in 2007.


We sympathize with the need to ensure potency and purity of supplements that claim, based on sound science, to exert therapeutic effects.


But forcing consumers to give drug companies billions of dollars for copies of a cheap natural compound seems the height of avarice and folly.

Statins: Simply synthetic copies of natural compounds in red yeast rice

Statin drugs are synthetic copies or analogs of the naturally occurring lovastatin in red yeast rice.


In the early 1970’s, Japanese researchers began studying natural statin compounds that appeared to inhibit the body’s cholesterol-making machinery.


Noticing this work, the pharmaceutical company Merck & Co. isolated lovastatin, the first FDA-approved statin, from a mold (Aspergillus terreus). Lovastatin is also produced from another type of red yeast called Monascus ruber.


Top selling statinsthanks to their makers’ bulging advertising budgetsinclude atorvastatin (Lipitor), simivistatin (Zocor), pravastatin (Pravachol), and the synthetic version of lovastatin, sold as Mevacor.


In addition to lovastatin, red yeast rice contains other monacolin-class compounds, which may also inhibit the cholesterol-making HMGR enzyme.


Red yeast rice products containing a higher concentration of monacolins have been developed and marketed as a natural product to lower cholesterol.


But one big problem for sellers of red yeast rice supplementsand their potential consumersis that the primary ingredient in these supplements, lovastatin, is also the active, FDA-approved ingredient in the prescription statin drug Mevacor.


When the FDA discovered that red yeast rice contained a substance found in prescription Mevacor, it banned all such products containing lovastatin.


To us, this sounds like a rule handed down by the mad Queen in Alice’s Wonderland.


Since red yeast rice products can no longer contain lovastatin, it’s unclear what effect red yeast supplements now on the market would have on cholesterol levels.


Needless to say, the red yeast rice supplement used in this FDA-approved clinical trial we report on here was not subject to the ban on lovastatin content.


The problem with all statins: natural and otherwise

We have two problems with the use of any statinsnatural or syntheticto reduce heart risks.


Statins, whether natural or synthetic, reduce internal production of coenzyme Q10, which is critical to energy production in heart muscle cells.


While natural or synthetic statins alike can cause muscle pain and damage in some people, this effect was recently tied to having a certain uncommon genetic profile. Thus, people can now be screened for risk of these adverse effects, and avoid all statins.


Statins’ cardiovascular benefits flow mostly from their anti-inflammatory effects, so it seems likely that they could help prevent or ameliorate other inflammation-related diseases, including Alzheimer’s and diabetes.


But it is not clear that the anti-inflammatory benefits of statinswhether natural or syntheticare worth risking a drop in your co-Q10 levels.


The fact is that many common foods and herbs exert substantial anti-inflammatory effects: impacts that increase when they are combined in a diet based on colorful, anti-inflammatory fruits and vegetables, and food sources of anti-inflammatory omega-3s.



Sources

  • Avorn J, Monette J, Lacour A, et al. Persistence of use of lipid-lowering medications: a cross-national study. JAMA. 1998;279(18):1458-1462.
  • Becker DJ, Gordon RY, Morris PB, Yorko J, Gordon YJ, Li M, Iqbal N. Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial. Mayo Clin Proc. 2008 Jul;83(7):758-64.
  • Li Z, Seeram NP, Lee R, Thames G, Minutti C, Wang HJ, Heber D. Plasma clearance of lovastatin versus chinese red yeast rice in healthy volunteers. J Altern Complement Med. 2005 Dec;11(6):1031-8.
  • Simons LA, Levis G, Simons J. Apparent discontinuation rates in patients prescribed lipid-lowering drugs. Med J Aust. 1996;164(4):208-211.

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