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Defining Placebo: the Saint Jude Thaddeus of Medical Terminology

February 15th, 2011 No comments

I have recently begun calling the placebo effect the Saint Jude Thaddeus of Medical Terminology.  This is not because placebo effects are miraculous – although they might sometimes seem to be – but because the placebo effect (or things even remotely connected to it) has gotten a bad rap for something it didn’t do. So what’s the connection to Saint Jude?  Note this excerpt from a traditional prayer:

…faithful servant and friend of  Jesus, the name of the traitor who delivered your beloved Master into the hands of the enemies has caused you to be forgotten by many, but the Church honors and invokes you universally as the patron of hopeless cases and of things despaired of…

stjude Defining Placebo: the Saint Jude Thaddeus of Medical Terminology So basically, Judas Thaddeus got a bad rap because of Judas Iscariot, so much so that there are now two ways of translating the name into English, Judas and Jude. So what does this have to do with placebo?  First we define placebo and placebo effect:

Placebo:
a. a substance having no pharmacological effect but given merely to satisfy a patient who supposes it to be a medicine.
b. a substance having no pharmacological effect butadministered as a control in testing experimentally or clinically the efficacy of a biologically active preparation.
Placebo effect:
a reaction to a placebo manifested by a lessening of symptoms or the production of anticipated side effects.
Hence, what is at play here: first, a true placebo must have NO BIOLOGICAL EFFECT.  You give it and there should be no physiologic change in the body.
Here are some beauts from the article:
In Acupuncture For Chronic Low Back Pain, the authors reviewed clinical trials done to assess if acupuncture actually helps in chronic low back pain. The most important meta-analysis available was a 2008 study involving 6,359 patients, which “showed that real acupuncture treatments were no more effective than sham acupuncture treatments.”
The authors then editorialized: “There was nevertheless evidence that both real acupuncture and sham acupuncture were more effective than no treatment and that acupuncture can be a useful supplement to other forms of conventional therapy for low back pain.”
In Acupuncture For Chronic Low Back Pain, the authors reviewed clinical trials done to assess if acupuncture actually helps in chronic low back pain. The most important meta-analysis available was a 2008 study involving 6,359 patients, which “showed that real acupuncture treatments were no more effective than sham acupuncture treatments.” The authors then editorialized: “There was nevertheless evidence that both real acupuncture and sham acupuncture were more effective than no treatment and that acupuncture can be a useful supplement to other forms of conventional therapy for low back pain.”
Okay, Mr Ho, the author, correctly states that the studies show that real acupuncture and sham acupuncture both have a better effect than no acupuncture.  The problem with this meta analysis is that the definitions of sham are not universal, as correctly pointed out by at least one commenter “japariesw”:
Dear writer (Mr. Ho), this controversy emerges from clinical trials comparing real and sham acupuncture. What you did not elaborate in your article is what is meant by ‘sham’ acupuncture? As acupuncture can be done not merely by piercing needles like in the photo, but also using laser, ultrasound, even with pressure or touch/ stroking the body surface. So, is the ‘sham’ acupuncture really sham? The modality of action is through neurophysicoendocrine pathway, by any modes of stimuli like stroking, piercing, etc. our body will react by showing the therapeutic effects like wellbeing, pain relieving, blood pressure downregulating (for hypertension, but not for normotensive)
So what the commenter is saying is that acupuncture is not just sticking needles in.  I’ve blogged on this topic extensively.  Also, sham still involves either putting needles in, albeit in false points, or stroking the skin.  Either way, neuro pathways are activated and thus, there is still a net physiologic effect.  Yet Mr. Ho says:
First, they admit that pooled clinical trials of the best sort show that real acupuncture does no better than sham acupuncture. This should mean that acupuncture does not work – full stop. But then they say that both sham and real acupuncture work as well as the other and thus is useful. Translation: Please use acupuncture as a placebo on your patients; just don’t let them know it is a placebo.
The authors trotted out the same conclusion after they reviewed an important German trial which also showed acupuncture to be merely a placebo.
Note how Mr. Ho  - loves to hammer the word home: Placebo placebo placebo! Yet there are some points of his that deserve critique.  He says that acupuncture is “no better” than sham.  That is not true.  I’ve seen those studies, they are slightly better than sham.  Second, he says that that “should mean acupuncture does not work” – that is skipping too many steps in the thinking process, and a perfect illustration of my article’s point.
Acupuncture no better than sham = acupuncture is placebo = it doesn’t work. This is their creed.
As long as a physiologic effect is seen, then by definition it cannot be a placebo.  Since there are physiologic effects (albeit different ones, which I mention in my above quoted blog posts) in both sham and real acupuncture, then even sham acupuncture is not a true placebo.
Also, I want to take a closer look at placebo.  By definition it doesn’t mean doing nothing, it means no physiologic effect yet the patient having a perceived OR REAL benefit.  Hence, if I wave my hands and nothing happens it’s not placebo.  If I dress well in clinic, with my dapper tie and crisp white white coat, speak with kind, reassuring words, and the patient already feels a bit better, that’s placebo.  Heck, there is a scene from the first season of Scrubs where the main female character flashes her breasts at a patient and the patient recovers.
And doctors do that all the time – use this placebo effect.  Why? Because a placebo effect is a placebo effect only if there is a perceived or real benefit – it is ERRONEOUS to say that placebo means no effect.
Yet placebo has become a buzzword for skeptics to attack acupuncture despite the fact that it cannot possibly apply to acupuncture.
Ho heaves on:
In any randomized and blinded clinical trial of any mode of treatment for any condition, the finding that the treatment is no better than a placebo always leads to one conclusion only: It is therapeutically useless. Acupuncture, it would seem, is exempted from this rule.
Again, this is true if sham acupuncture is a true placebo, meaning it has no physiologic effect.  Common sense shows that merely touching the skin creates physiologic responses.
The rest of the article by Ho elaborates on the skeptic’s next usual attack on acupuncture and chinese medicine: it is based on astrology and thus cannot work.
For someone with a Chinese surname, I find it appalling that Ho can have such a misconception about what Qi is:
In Chinese cosmology, all life is animated by a numinous force called qi, the flow of which mirrors the sun’s apparent “movement” during the year through the ecliptic. (The ecliptic is the imaginary plane of the earth’s orbit around the sun).
Qi flow does not mirror the sun’s movement.  Duh  See my immediately preceding article for explaining what Qi is.
Moreover, everything in the Chinese zodiac is mirrored on Earth and in Man. This was taught even in the earliest systematised TCM text, the Yellow Emperor’s Canon Of Medicine, thus: “Heaven is covered with constellations, Earth with waterways, and man with channels.”
If we translated channels as blood vessels, which is a possible interpretation, would Ho be so fast as to make a supernatural component?  The mythical author of the Canon was merely using words to help the reader grasp the concept.  Instead of focusing on “waterways” Ho focuses on “constellations”
This means that if there is qi flowing around in the imaginary closed loop of the zodiac, there is qi flowing correspondingly in the body’s closed loop of imaginary meridians as well.
These meridians run from head to toe to form a network interlinking 361 points on the skin. But why are there 361 points? Since the earth takes three minutes under 24 hours to rotate 360 degrees on its axis, the sun appears to revolve through 361 degrees on the ecliptic every 24 hours. Hence 361 points. This factoid alone is sufficient to nail down the acupuncture-astrology linkage.
Since qi flows around in a closed loop, needles can be inserted at one of these points far removed from your site of pain to rechannel qi. If done well, this supposedly can cure your spot of trouble.
Who said there are 361 points?  There are more than 400.  In the Yellow Emperor’s Canon, less than 200 are mentioned.  The point is that it evolved through time, not the product of some mathemagician. Therefore, for Mr. Ho to attempt to use acupuncture point number to try to create a numerology reference is out of date.  Also, no studious TCM practitioner will say that Qi flows in a “closed loop”.  Qi interacts with environment.
It’s arguably OXYGEN or breath.  Would we say oxygen flows in our body in a closed loop?
His last line: “So should doctors check the daily horoscopes of their patients?”
My answer: I certainly don’t.
Poor poor placebo effect, it’s gotten a bad rap.
Maybe we should ask St. Jude to help enlighten the minds who know not the Placebo effect and don’t bother to really learn about TCM before trying to debunk it.
References:
“placebo.” Dictionary.com Unabridged. Random House, Inc. 14 Feb. 2011. <Dictionary.com http://dictionary.reference.com/browse/placebo>
“placebo effect.” Dictionary.com Unabridged. Random House, Inc. 14 Feb. 2011.
Ho, Andy “Pinning down Acupuncture: It’s an Illusion” 13 Feb 2001 <http://www.thejakartaglobe.com/home/pinning-down-acupuncture-its-an-illusion/422438>
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Mainstream Medical Journals say Acupuncture Works; Skeptics Irritated.

September 5th, 2010 No comments

I’m a bit tired so I’ll just quote this article and comment on it:

Outrage over Acupuncture Evidence Attacks NIH (http://www.healthcmi.com/index.php/acupuncturist-news-online/291-outrageacupunctureproofnih)

Doctors from the University of Maryland School of Medicine, Baltimore and the University of Vermont College of Medicine, Burlington published a case vignette in the New England Journal of Medicine recommending acupuncture for the treatment of lower back pain. The article cites that patients with lower back pain account for over $90 billion in annual health care expenses in the US. The doctors conclude that acupuncture is an effective means for treating lower back pain based partly on a recent study of 6,359 patients published in Spine1. For the lower back pain patient in the case study presented, 10-12 acupuncture treatments over an 8 week period are recommended.

Hmmm, why do these names sound familiar?  Oh I recall!  I had cited the University of Maryland Medical Center for it’s excellent website resource on astragalus root (Huang qi) research.  (http://qi-spot.com/2009/10/20/astragalus-root-for-swine-flu/).   Apparently, those guys are quite open minded.

So anyway, what this means is that some doctors published their opinions that acupuncture should be recommended.  Fair enough.  Everyone’s entitled to an opinion, right?  If it’s wrong, let it be proven wrong through tact and reasoning.

NOT.

The pro-acu docs cite extensive evidence:

The doctors cite physiological phenomena that measure the effects of acupuncture. Local anesthesia at needle insertion sites block the the analgesic effects of acupuncture showing that acupuncture is dependent upon neural innervation2. Acupuncture has been proven to cause the release of endogenous opioids in brain-stem, subcortical, and limbic structures3,4. Acupuncture has also been proven to induce the secretion of adrenocorticotropic hormone and cortisol from the pituitary gland thereby creating a systemic anti-inflammatory response5. Functional MRI studies in humans reveal that acupuncture stimulates limbic and basal forebrain areas involved in pain processing6. PET scan MRIs (positron-emission tomography) show that acupuncture increases opioid binding potential in the brain for several days7. Acupuncture has also been proven to mechanically stimulate connective tissues8, release adenosine at the site of needle stimulation9, and increase local blood blow10. The doctors then cite clinical trials showing the efficaciousness of acupuncture in the treatment of thousands of patients10-15.

So what do some skeptics do?  Do they try to base their argument on refuting the evidence?

Despite this overwhelming evidence proving the mechanisms of action and efficaciousness of acupuncture, skeptics were outraged at the publication of an article supportive of acupuncture in the venerable New England Journal of Medicine. An article recently posted in the Forbes “science business” section stated that the article is “embarrassing” and that acupuncture “infiltrates” the University of Maryland Medical School. In the article, the author calls acupuncture “pseudoscience” and states that it is based on “magical thinking of non-existent life-force.” The skeptic author’s only proof of his theory is that one of the many studies cited in the article found that acupuncture was only 47.6% effective for the treatment of lower back pain and that sham acupuncture was 44.2% effective. Therefore, the author concludes that using “toothpicks” randomly on the human body will have the same pain relieving effects as acupuncture. What the author fails to mention in the Forbes attack article is that conventional western medicine therapy (a combination of drugs, physical therapy, and exercise) was only 27.4% effective in that very same study. Should we therefore abolish western medicine by MDs and call it pseudoscience? Acupuncturists have noted that the success of sham acupuncture noted in that particular study of 1,162 patients in Germany reveals that poorly placed acupuncture needles also derive benefit for the patient.

I have already blogged at length on the physiologic differences between sham and real acupuncture (http://qi-spot.com/2010/04/30/definite-proof-acupuncture-more-than-placebo/) and why it SEEMS that acupuncture is hard to validate using holy grail of western medicine studies – the double blind study (http://qi-spot.com/2010/03/30/how-to-research-acupuncture/).

What I also find interesting is the insistence of skeptics that acupuncture works by balancing Qi or something.  That is the lynchpin of their argument.  I can hear it now:

Skeptic: “They believe in some quasi mystical energy flow!  That means acupuncture MUST be quackery!”

Acupuncturist:  ”There are modern, scientifically proven phenomena that explains what we mean by qi flow.  The “needling sensation” is a result of stimulation of nerve fibers, and can be inhibited by certain drugs.  Qi can also be used to mean function, so when “qi” is deficient, one can say there may be decreased circulation to a certain area, or decreased organ function.  An excess of qi can mean a muscle is too tense… (cites more examples)”

Skeptic: (oblivious) “They believe in some quasi mystical energy flow!  That means acupuncture MUST be quackery!”

Acupuncturist:  ”Never mind.”

Seriously, I feel that way sometimes, talking to skeptics.  What’s the point?  You can treat pain in these people and they’ll assign all sorts of reasons EXCEPT the obvious – acupuncture works.

The use of the word “toothpick” also indicates a lack of even a basic awareness of how acupuncture is performed.  You don’t just “prick” people, you insert the needle and manipulate it.

Oh well…

And lastly, a list of references cited by the link I cited…

References

1. Yuan J, Purepong N, Kerr DP, Park J, Bradbury I, McDonough S. Effectiveness of acupuncture for low back pain: a systematic review. Spine 2008;33:E887-E900.

2. Wang SM, Kain ZN, White P. Acupuncture analgesia: I. The scientific basis. Anesth Analg 2008;106:602-10.

3. Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci 2003;26:17-22.

4. Pomeranz B. Scientific research into acupuncture for the relief of pain. J Altern Complement Med 1996;2:53-60.

5. Li A, Lao L, Wang Y, et al. Electroacupuncture activates corticotrophin-releasing hormone-containing neurons in the paraventricular nucleus of the hypothalamus to alleviate edema in a rat model of inflammation. BMC Complement Altern Med 2008;8:20.

6. Dhond RP, Kettner N, Napadow V. Neuroimaging acupuncture effects in the human brain. J Altern Complement Med 2007;13:603-16.

7. Harris RE, Zubieta JK, Scott DJ, Napa- dow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage 2009;47:1077-85.

8. Langevin HM, Churchill DL, Wu J, et al. Evidence of connective tissue involvement in acupuncture. FASEB J 2002;16:872-4.

9. Goldman N, Chen M, Fujita T, et al. Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture. Nat Neurosci 2010 May 30 (Epub ahead of print).

10. Sandberg M, Lundeberg T, Lindberg LG, Gerdle B. Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol 2003;90:114-9.

11. Brinkhaus B, Witt CM, Jena S, et al. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med 2006;166:450-7.

12. Haake M, Muller HH, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, paralel-group trial with 3 groups. Arch Intern Med 2007;167:1892-8. [Erratum, Arch In- tern Med 2007;167:2072.]

13. Cherkin DC, Sherman KJ, Avins AL, et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch In- tern Med 2009;169:858-66.

14. Thomas KJ, MacPherson H, Thorpe L, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ 2006; 333:623. 15. Witt CM, Jena S, Selim D, et al. Prag- matic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol 2006;164:487-96.

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Worth Forwarding.

May 26th, 2010 2 comments

http://nephropal.blogspot.com/2010/05/halloween-comes-early.html

Am tired from travel. But this is worth looking into:

A new study by French and British researchers examined 72 new drug therapy studies to evaluate if there was a spin on the conclusions for the benefit of the drug.

“More than 40% of the reports had spin in at least 2 of these sections in the main text.”

Reuters link

Abstract:

Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes

Isabelle Boutron, MD, PhD; Susan Dutton, MSc; Philippe Ravaud, MD, PhD; Douglas G. Altman, DSc
JAMA. 2010;303(20):2058-2064.

Context Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.

Objective To identify the nature and frequency of distorted presentation or “spin” (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes.

Data Sources March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006.
Study Selection Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P .05).

Data Extraction Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.

Results From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.

Conclusion In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results

Statistical proof of what we’ve been saying all along.  We can make studies say what we want.

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How to Research Acupuncture?

March 30th, 2010 3 comments

A problem with acupuncture is not so much the lack of research – there are kaboodles of it – but the way these researches are conducted.  A recent online conversation I had with a fellow Xavier high school alumnus made this obvious to me.  Here is a quote from an email I wrote which I think summarizes my thoughts on this.

research 300x156 How to Research Acupuncture?

Is there a "proper" way to do acupuncture research?

Anyway here is the text:

(A) major misunderstanding (is) that the idea that acupuncture is like a pill – that can be single blinded (meaning that recipient doesn’t know that they’re getting the real thing or not) or double blinded (pill giver doesn’t know either.)  Obviously, using fake needles or sham treatments would necessitate that the “treatment” giver NOt be blinded.

However, the first difficulty comes in designing an adequate “sham”

First objection: sometimes inserting needles anywhere seem to stimulate an effect as well.

Second objection: even just pretending to insert needles seems to have an effect.  this is the “placebo” being indicated here.

The conclusion skeptics derive from these observations is thus: since inserting a needle into specific “points” doesn’t seem to be much different than inserting anywhere or simulating points without insertion, acupuncture is thus “useless”.

A closer examination of how acupuncture works biophysically (and yes, I do explain this to patients who ask) reveals that it works by simulation of the immune and nervous system.  Chris Kresser’s blog elaborates on this quite well.  Now is this the only way to stimulate the nervous and immune system? No.  Acupuncture evolved from touch/massage.  The question thus begged is, why not just touch?  My answer is that inserting needles saves time and effort.  Imagine if I had to stimulate ten points on a patient with my fingers?  By inserting needles to achieve the same stimulation, I can then leave the patient and attend to another one.

doctoroctopus 300x195 How to Research Acupuncture?

I'll bet Doctor Octopus would make a great masseuse...

So what is my proposal for an appropriate acupuncture “sham” procedure: it must involve NOT triggering the a-delta fibers.  A-delta fibers are the key to the “qi-sensation” or heavy feeling accompanying acupuncture (as opposed to sharp).  Research has shown that acupuncture analgesia is obliterated by blocking the transmission of a-delta fibers.  The best way to do that that i know of is through naloxone.  Hypothetically, a control group would have no treatment, another with conventional treatment, and two experimental groups – both with real acupuncture given by the SAME practitioner (more on this later) but with one blocked by naloxone.  The latter is the “sham”.  ”fake” needles that touch the skin also won’t work because the mere touching of the skin sets off similar reactions in the patient’s central nervous system, albeit to a lesser intensity as with acupuncture.

Now for the importance of the practitioner.  I once gave a lecture in a geriatrics convention and a participant commented to me that he used to practice acupuncture but his practice died out.  He then asked me “what are the points to use for migraine?”  I then said to myself, “kaya pala. (so that’s why…)” What does this incident tell us? Let me illustrate – it also explains to me why it is difficult to formulate studies for acupuncture.

acupucture chinese medicine cartoon 229x300 How to Research Acupuncture?

It's not the size that counts. It's how you use it!

Acupuncture is not just inserting a needle and plugging it into a machine.  Acupuncture involves selecting points (although Chris Kresser disagrees with me there) , choosing how thick the needles are, determining how deep the insertion will be, and trying to control the sensations the patient feels through manipulation of the handle.  About manipulations, there are many which I shan’t specify now.  Suffice it to say that I have personally discovered that errors in any of the above will lead to treatment failure.  It is like surgery, the procedure itself is standard, but a lot also depends on how well the surgeon handles things.  i would normally not be so heretical as to compare something like acupuncture skills to the taxing physical and mental requirements required of a surgeon, but I hope the reader grasps my point (pun intended.)

Another problem is something I have been trying to get to with my earlier comments on different culture and world view.  Chinese medicine diagnoses things in a method somewhat different from western medicine.  I’m not just talking about differences in terminology.  I did touch on this with the example of dyspepsia.  I will try to elaborate more using headache, which is the disease condition that got me into acupuncture in the first place.

Point selection and manipulation in acupuncture depend on too many variables.  Ten people can have headaches.  One will have it in the front, another at the temples, another at the nape.  One will have headache associated with chronic sinusitis, another will have it due to migraines, yet another because he is a computer encoder always looking at CRT screens, another will have it after a flaring temper, yet another associated with menses.  Acupuncture treatment then, will seldom be the same for any two of these patients.

Hence, what would be my suggestion for a proper study?  In addition to the conditions above, we can also add something to make the patients even more homogenous (can never be totally homogenous though) – same race, same diet, same emotional pattern, same job, same associated factors for the headache.  Difficult yes, but necessary because of the nature of proper acupuncture point selection.

Clinical experience has shown that “cookbook” acupuncture, which means taking a western symptom “headache”, or “dysmenorrhea” CAN be effective, but I wouldn’t be surprised if it wouldn’t be AS effective.

What do you guys think?

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Red Yeast Rice for Cholesterol: Fermented Fun!

October 27th, 2009 1 comment

The latest “food fad” for health – at least in the media – is fermented red rice.  Known as hong qu mi (what else? red yeast rice), this popular oriental garnish was featured in an article (http://featuresblogs.chicagotribune.com/features_julieshealthclub/2009/10/red-yeast-rice-for-high-cholesterol.html) for (as you can read in the link) high cholesterol.

When Chicago’s Adele Simmons discovered she had high cholesterol and a blocked artery, she chose a drug-free treatment approach that included red yeast rice, the product of yeast grown on white rice.

The powdery yeast-rice mixture, a dietary stable in many parts of Asia that’s used in traditional Chinese medicine, contains monacolin K, the same ingredient as in the prescription cholesterol drug lovastatin (Mevacor).

But while red yeast rice is available over the counter, don’t take it unless you’re under the care of a physician, said Simmons’ doctor, preventive cardiologist Steve Devries, who is on staff at Northwestern Memorial Hospital.

The drug-like supplement can have side effects (though they’re less likely than with prescription statins) and patients need blood tests to monitor safety.

In fact, Devries said that red yeast rice is a good cholesterol-lowering option in only two situations: “in those who are absolutely philosophically opposed to taking a prescription statin, or in those who have tried to take prescription statins but cannot tolerate them.”

Other key points to remember:

Don’t take red yeast rice when you’re pregnant.The same is true for any prescription statin.

Brands vary by dosage and purity. Devries recommends a specific brand that has been tested by an independent lab and asks patients to use only this brand.

Red yeast is only one option. “Prescription statins are an excellent choice for those in need of cholesterol lowering when lifestyle changes have been tried and found to be inadequate to achieve the desired cholesterol result,” Devries said.

redyeastrice 300x199 Red Yeast Rice for Cholesterol: Fermented Fun!

Red Yeast Rice

Now before I go on to cite other studies I’d like to point out that I believe that the process of fermentation does a lot in terms of preserving what I call “digestive energy.”  This is my personal term for Spleen Qi, which in Chinese medicine is in charge of digestion.  (Hmmm, perhaps another time I’ll talk about the Spleen and western pancreas…)

The thing about Chinese dietary theory is that you can’t just eat anything you want.  Well, you can if your Spleen Qi is as strong as a bull on steroids – but you’ll still wear it down.  The key to maintaining long term health is to make things easier on the Spleen.  This is why raw foods is a no-no in oriental medicine because it takes more fuel to light the fire to burn it down (or is the proper term burn it up?)

Hmmm, another future article idea – Spleen health.

Anyway fermentation is seen as a precursor to digestion.  In fact, the classical chinese words for digestion can be literally translated as “rotting” and “ripening”.  Of course, that doesn’t mean that you should go ahead and ferment everything you eat – Chinese medicine never encourages excessive consumption of one type of flavor or taste.  Variety is the spice of life, as the old saying goes.

So what we have here is a fermented foodstuff, making it easier to digest food, and thus, maintaining Spleen Qi.  I think.

But on to the modern studies.  There is a prepared Chinese medicine made from Red Yeast Rice, known as Xue Zhi Kang:

xuezhikang 300x300 Red Yeast Rice for Cholesterol: Fermented Fun!

Xue Zhi Kang

Derived from red yeast rice, Xue Zhi Kang has been the subject of many a study.  Here are some sample excerpts:

Liu ZG and Yu XY. “Effects of Xuezhikang capsule on blood lipids, platelet activation and coagulation-fibrinolysis activity in patients with hyperlipidemia” Chinese Journal of Integrative Medicine Volume 10, Number 4 / December, 2004 pp. 259-262. 27 October 2009 <http://www.springerlink.com/content/d474443332748t6v/>

Abstract    Objective: To investigate the effects of Xuezhikang capsule (XZK) on blood lipids level, platelet activation and coagulation-fibrinolysis activity in patients with hyerlipidemia.Methods: Seventy-six patients of hyperlipidemia were randomly divided into two groups, the XZK group (n = 38) treated with XZK 600mg, taken two times per day and the Simvastatin (SIM) group (n = 38) treated with SIM 20mg per day, with the treatment lasting 8 weeks for both groups. Levels of fasting serum lipids, including total cholesterol (TC), triglyceride (TG), high and low density lipoprotein cholesterol (HDL-C and LDL-C), plasma GMP-140, fibrinogen (FIB), tissue plasminogen activator (t-PA), plasminogen activator inhibitor type-1 (PAI-) and prothrombin time (PT) were all measured before and 8 weeks after treatment. Data were compared before and after treatment and also compared with those measured in 20 healthy subjects of control.Results: Before treantment the levels of TC, TG and LDL-C were obviously higher and HDL-C level was significantly lower in hyperlipidemia patients than those in healthy subjects (P<0.05 orP<0.01). After 4–8 weeks of XZK treatment, the levels of TC, TG, LDL-C and FIB and activities of GMP-140 and PAI-1 were obviously lowered (P<0.05 orP<0.01). But in the SIM group there was no obvious change in FIB (P>0.05), instead it showed obvious increase of HDL-C and decrease of TC and LDL-C after treatment (P<0.05 orP<0.01).Conclusion: XZK could inhibit platelet activity and improve coagulation-fibrinolysis function, besides its lipids lowering effect. (emphasis mine)

This shows that Xuezhikang works by preventing formation of atherosclerotic plaques, as also seen in this study published in the American Journal of Cardiology:

Lu et al. “Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction.” Am J Cardiol. 2008 Jun 15;101(12):1689-93. Epub 2008 Apr 11.  accessed 27 October 2009 (http://www.ncbi.nlm.nih.gov/pubmed/18549841)

Results of well-controlled prospective clinical trials showed the efficacy of lipid-lowering therapies in the reduction of cardiovascular (CV) events in western populations, but they were not reported with a Chinese population. This multicenter study was conducted to determine the effects of Xuezhikang (XZK), a partially purified extract of red yeast rice, on lipoprotein and CV end points in Chinese patients who experienced a previous myocardial infarction. Nearly 5,000 of these patients with average low-density lipoprotein cholesterol levels at baseline were randomly assigned either to placebo or to XZK daily for an average of 4.5 years. The primary end point was a major coronary event that included nonfatal myocardial infarction and death from coronary heart disease. Frequencies of the primary end point were 10.4% in the placebo group and 5.7% in the XZK-treated group, with absolute and relative decreases of 4.7% and 45%, respectively. Treatment with XZK also significantly decreased CV and total mortality by 30% and 33%, the need for coronary revascularization by 1/3, and lowered total and low-density lipoprotein cholesterol and triglycerides, but raised high-density lipoprotein cholesterol levels. In conclusion, long-term therapy with XZK significantly decreased the recurrence of coronary events and the occurrence of new CV events and deaths, improved lipoprotein regulation, and was safe and well tolerated. (emphasis mine)

Some news articles report similar side effects as statins.  This makes me wonder if there are any differences in side effect profile if taken in raw form as opposed to processed with alcohol into pill form.

Sources:

Deardorff, Julie.  “Red yeast rice: A natural approach to high cholesterol” Chicago Tribune.  26 October 2009.  Accessed 27 October 2009 <http://featuresblogs.chicagotribune.com/features_julieshealthclub/2009/10/red-yeast-rice-for-high-cholesterol.html>

Liu ZG and Yu XY. “Effects of Xuezhikang capsule on blood lipids, platelet activation and coagulation-fibrinolysis activity in patients with hyperlipidemia” Chinese Journal of Integrative MedicineVolume 10, Number 4 / December, 2004 pp. 259-262. 27 October 2009 < http://www.springerlink.com/content/d474443332748t6v/>

Lu et al. “Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction.” Am J Cardiol. 2008 Jun 15;101(12):1689-93. Epub 2008 Apr 11.  accessed 27 October 2009 (http://www.ncbi.nlm.nih.gov/pubmed/18549841)

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