Cholesterol and Blood Circulation Management: Part I

With regards to my last blog postings on 13 Aug 2008, Nerve Impingement and Sudden Cardiac Death? , I had promised to elaborate on whether I would continued with my wife’s Red Yeast Rice medication to lower my blood cholesterol or to take those prescribed by the hospital, which is a Simvastatin (20mg). I would tell you what I would be taking later in my conclusion.

Statin Drugs

Both are statin drugs that are extracted through a fermentation process, though one is done synthetically while the other is naturally occurring. So which one came first, well, it is a little tricky here, like the chicken or the egg poser, you have to see my conclusion.

Red Yeast Rice is a “natural” statin drug rationally explained in Wikipedia and why the FDA is regulating it.

“Red yeast rice when produced using the ‘Went’ strain of Monascus purpureus contains significant quantites of the HMG-CoA reductase inhibitor lovastatin which is also known as mevinolin, a naturally-occurring statin. It is sold as an over the counter dietary supplement for controlling cholesterol (See ref.: Medicine Net). There is strong scientific evidence for its effect in lowering blood levels of total cholesterol, low-density lipoprotein/LDL (“bad cholesterol”), and triglyceride levels (see below). Because an approved drug is identical to the molecule it is therefore regulated as a drug by the Food and Drug Administration (FDA).” (link)

Simvastatin, on the other hand, is

(marketed under the trade names Zocor, Simvastatin, Simlup, Simcard and others) is a hypolipidemic drug belonging to the class of pharmaceuticals called “statins“. It is used to control hypercholesterolemia (elevated cholesterol levels) and to prevent cardiovascular disease. Simvastatin is a synthetic derivate of a fermentation product of Aspergillus terreus. [link]

My Comments (1): Notice the last sentence, “synthetic derivate of a fermentation product..” which would probably drew the irks of the Traditional Chinese Medicine (TCM) community who would want to disassociate the attempt by the giant pharmaceutical companies manufacturing the lucrative synthetic statin drugs, from alluding that fermentation process would result in a “non-natural” product. This argument, albeit with much ambiguity, had been used inconsistently in many of the pro and con news regarding “enhanced’, “adulterated” Red Yeast Rice with lovastatin.

====================

Below are some links from health news portals of which I would only include or highlight significant excerpts, including a warning letter by the United States’s FDA for you to decide who is saying what; and what is what. So here it goes…..

12 DECEMBER 2006

Red yeast rice clinically shown to reduce cholesterol levels just as well as statin drugs (12 Dec 2006, Natural News)

Researchers from the University of Tromso in Norway, Shanghai University of Traditional Medicine and Beijing University of Chinese Medicine conducted a meta-analysis (review of previously conducted research) of 93 randomized trials that tested the effectiveness of three different RYR preparations — Cholestin, Xuezhikang and Zhibituo — on blood cholesterol levels.

Cholestin is a brand name RYR supplement produced by United States-based Pharmanex, while Xuezhikang is produced by mixing rice and red yeast with alcohol, then processing it to remove the majority of the rice gluten.

The researchers assessed the studies’ results for effectiveness in treating hyperlipidemia, a condition in which patients have abnormally high concentrations of lipids (fats) in the blood. They found that all three RYR preparations — Cholestin, Xuezhikang and Zhibituo — significantly reduced total blood cholesterol levels in patients, as well as triglyceride levels and LDL cholesterol levels, while boosting levels of “healthy” HDL cholesterol, compared to placebo. Of the three preparations, Xuezhikang and Zhibituo were found to be the most effective, with little difference between the two.

The RYR preparations were also found to be as effective at lowering lipid cholesterol levels as statin drugs, including pravastatin (brand name Pravachol), simvastatin (Zocor), lovastatin (Mevacor), atorvastatin (Lipitor) and fluvastatin (Lescol). However, unlike prescription statins — which can cause adverse effects such as reduced liver function, muscle damage, depression, pain and sexual dysfunction — the only side effects of the RYR preparations were dizziness and gastrointestinal discomfort.

Red yeast rice has been used for over 1,000 years in China to improve circulation and treat indigestion and diarrhea. It is made from rice fermented by a red yeast known as Monascus purpureus and is frequently used as a food preservative and food color, as well as a spice and a component of rice wine.

According to natural health advocate Mike Adams, author of “The Five Habits of Health Transformation,” red yeast rice contains a wide variety of supportive compounds that aren’t found in the isolated chemical sold as a drug, and the scientific community believes multiple compounds work better in concert than isolated chemicals.

“Pharmaceutical companies actually synthesized statin drugs by discovering and altering a molecule found in red yeast rice,” Adams said. “But red yeast rice does not cause the dangerous side effects of statin drugs, nor does it require a high-priced prescription. It’s safer, more natural and works better.” [link]

===========

25 JANUARY 2008

Warning letter by FDA to Nature’s Way Products, Inc (Springville, Utah) for “adulterating” lovastatin into its Red Yeast Rice products (25 Jan 2008)

January 25, 2008

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Dr. Dirk Reischig
President/Chief Executive Officer
Nature’s Way Products, Inc.
Willmar-Schwabe-Strasse 4
76227 Karlsruhe, Germany

Ref. #: DEN-08-10

Dr. Reischig:

This letter is in reference to the inspection of your firm, Nature’s Way Products, Inc., located in Springville, Utah, conducted by an investigator from the Food and Drug Administration (FDA) on September 10-14, 2007. During the inspection, FDA found that you manufacture the product Red Yeast Rice, and market or distribute the product on your web site, www.naturesway.com on other websites such as www.herbalremedies.com; via your retailer’s guide magazine “Leaf Line”; and at various retail stores.

You promote your Red Yeast Rice product as a dietary supplement. A laboratory analysis conducted by the FDA determined bat your product contains significant levels of lovastatin. Lovastatin is the active ingredient in Mevacor® and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. If consumed as directed, your product provides more than 14 mg lovastatin, which is approximately 4 mg more than the lowest recommended daily dose of lovastatin in Mevacor and its generic counterparts.

Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because your Red Yeast Rice product contains red yeast rice with enhanced or added lovastatin, it cannot be marketed as a dietary supplement. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(ff), specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act, 21 U.S.C. § 355, unless the article in question was marketed as a dietary supplement or food before its approval as a drug, 21 U.S.C. § 321 (ff)(3)(B). FDA approved Mevacor® as a new ding on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date. The Agency’s determinations that lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement and that lovastatin-enhanced red yeast rice is not a dietary supplement was upheld in litigation involving a product called Cholestin.1 ………. [link]

========

18 JULY 2008

Red yeast rice, fish oil fight high cholesterol (18 Jul 2008, Reuters)

Citing the Mayo Clinic Proceedings, July 2008, Reuters reported:

With a grant from the state of Pennsylvania, Dr Becker and his team randomly assigned 74 patients to receive 40 milligrams of simvastatin (Zocor) daily along with printed information on lifestyle changes, or to three capsules of fish oil twice daily and 600 milligrams of red yeast rice daily along with the 12-week lifestyle programme.

LDL cholesterol levels fell by 42.4 per cent in the red yeast rice group and by 39.6 per cent in the simvastatin group, not a statistically significant difference. Triglyceride levels didn’t change in the statin group, but fell 29 per cent in the red yeast rice group, probably because they were taking fish oil, according to Dr Becker and his team.

People in the red yeast rice group lost an average of 4.7 kg, compared to 0.3 kg in the statin group.

… People in the red yeast rice arm of the study were taking the equivalent of 10 to 15 mg of lovastatin, Dr Becker said. ‘This lovastatin dosage is quite small, yet the effects we saw with the red yeast rice were akin to those one would generally see with a much higher dose of lovastatin.’

…. Dr Becker noted that a recent analysis by ConsumerLab found red yeast rice products varied sharply in their potency, and some were contaminated with a toxic byproduct called citrinin. [link]

======

3 AUGUST 2008

Integrative Medicine: Red yeast rice still raising red flags

By Drs. Kay Judge and Maxine Barish-Wreden -
Published 12:00 am PDT Sunday, August 3, 2008

People who look for “natural” ways to lower their blood cholesterol levels often turn to a product called red yeast rice, a food-medicine that has been used for more than a thousand years in China.

If you’re one of them, you will like the results of an intriguing study done in China using 5,000 subjects with a prior history of heart disease, but don’t take that as our final word. Instead, read on to learn about tests of the purity of RYR supplements.

A recent study in China found that people taking this supplement showed a significant reduction in blood lipids as well as recurrent heart disease after 4.5 years, compared with those who were taking a placebo; total mortality was also decreased.

Researchers found that the red yeast rice was well-tolerated, and no major side effects were reported.

The supplements in the study were quite effective, although they contained less lovastatin than what is found in the standard doses of Mevacor. Researchers speculate that other compounds in the RYR besides the monacolin-K help to lower cholesterol, including plant sterols.

Before you run out to the health food store to stock up on red yeast rice, though, we want to make you aware of several reasons why you should be cautious.

Red yeast rice contains chemicals known as monacolins, and as it turns out, Monacolin-K is identical to lovastatin, the cholesterol-lowering statin drug (trade name Mevacor).

As with the prescription drugs, these chemicals may irritate the liver and muscles. For that reason, the Food and Drug Administration advises U.S. consumers not to take red yeast rice.

The FDA staff is concerned that RYR users might not get regular follow-up with doctors – or even alert them that they’re taking it.

To further complicate matters, red yeast rice may also be contaminated by a kidney toxin called citrinin, a chemical produced when rice is fermented by yeast.

Independent testing by Consumer Lab offers reason for concern: The toxin citrinin was found in four of the 10 supplements that were tested.

In addition, all of the products claimed to have the same amount of red yeast rice per pill, but the actual amount measured in each pill varied a hundred-fold.

We suggest you subscribe to Consumer Lab, about $30 a year, for supplement information. The Web site is www.consumerlab.com.

==============

COMMENTS (2)

Well, as you can gauge for yourself, there are real concerns as well as hyped reports apparently coming from competitions over the lucrative cholesterol-controlling trade. It included not only the Traditional Chinese/Herbal Medicinal (vis-a-vis health products) versus purely synthetic giant pharmaceutical companies but also the pharmaceuticals themselves. Basing on the latest health news updates from the internet (8 Aug 2008), not that you would not have guessed already, the STATIN drug market is worth billions of dollars (link), not only through use of its patented brand name, but also subsequent patent for the specific enantiomer that would ensue its continuity for longer period of time. However, certain countries had already rejected the enantiomer patents. (link)

With 2006 sales of US$12.9 billion under the brand name Lipitor (a fully synthetic statin drug by Pfizer), and also the largest selling drug in the world, the ending of its patent in 2011 might see more patients switching from the current Simvastatin (a synthetic statin derivatives from fermentation) under Zocor, Lipex to maybe the currently higher priced Lipitor.

As wikipedia reported:

After doctors and patients began switching by the millions to a cheaper alternative within the same class of drugs called simvastatin, Pfizer launched a campaign including advertisements, lobbying efforts, and a paid speaking tour by Dr. Louis W. Sullivan, a former secretary of the federal Department of Health and Human Services, to discourage the trend.^[2] The main clinical advantage of Lipitor over Simvastatin is that it is not metabolised by certain liver enzymes, and thus its blood concentration is not increased when combined with grapefruit juice which inhibits these enzymes. Simvastatin patients should avoid drinking large amounts of grapefruit juice for this reason. An independent analysis showed that, at commonly prescribed doses, atorvastatin and simvastatin have no statistically significant differences in reducing cardiovascular morbidity and mortality

CONCLUSION

I have yet to commence on the Simvastatin medication although I was prescribed a month’s supply at 20mg given my elevated cholesterol level from my blood test. However, both my parents on Simvastatin and Lovastatin medications for sometime already and they seemed relatively healthy their 82 years old age. However, they were taking relatively low dosage at 30mg and 40mg respectively and other supplements to counter the negative effects of statin drugs.

However, I did try my wife’s Red Yeast Rice from a local reputable distributor for a few days only. I stopped primarily because my nerve impingement persisted and I was now relying of the lower dosage Cardioprin (light aspirin and glycerine) for good blood circulation and analgesic (against nerve impingement). I also had sinus and sneezing for a while after consuming the Red Yeast Rice capsule in an unorthodox manner, meaning, I remove the two-part capsule before ingestion to simply pour the powder into my mouth. However, after I developed immediate sinus symptoms, I thought it could be the trace mycotoxin, Citrinin the fermentation process of the Red Yeast Rice that comes into contact with my nasal cavities. Come to think of it, maybe the authorities should inform the distributors to ensure that pills with possible traces of mycotoxin should not be encapsulated in a two-part gel capsule) that could be easily broken and ingested in this manner. Perhaps the Red Yeast Rice must be ingested directly into the stomach cavity for better neutralisation by the stomach acids. This would have prevented the “accidents” or negative side effects associated with the Red Yeast Rice. Probably wrong method of consumption that could have “magnify” the toxic effect about Red Yeast Rice too.

Nevertheless, importantly, those taking Red Yeast Rice should not be consuming STATIN drugs medications at the same time as it would be tantamount to over dosage, leading to the renal, neural and muscular problems.

Actually I am started on a new form of medications or rather my previous supplements together with new supplements too and therapeutic  exercises for my nerve impingements.

But that’s all for today.

I might find time to write about my supplements tomorrow. In the meantime, wish me good health and yours too.

Chow!

Mikey