Scientific Proof
Clinical Studies
The clinical studies included in this section attest to both
the safety and effectiveness of Silybin Phytosome, the active
ingredient in Maximum Milk Thistle™.
The reason these studies were originally conducted was to
have Silybin Phytosome introduced as a pharmaceutical drug in
Europe. Unlike here in the U.S., European doctors take botanical
medicine very seriously. Physicians prescribe herbal preparations
on a regular basis for specific conditions and diseases.
The company that patented Silybin Phytosome and the Phytosome®
process had a division that brought herbal preparations to
market as pharmaceuticals. Before all the steps of getting
Silybin Phytosome approved was completed this division was traded
off to another company for a strategically important processing
and manufacturing operation. That is why the product is currently
being marketed as a nutritional supplement. Ah, but what a
nutritional supplement. Especially if you are concerned at
all about your liver in these stressful and toxic times.
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The Drug Master File
The company that developed and patented Silybin Phytosome actually
prepared what is called a "drug master file", which
is simply a collection of toxicology and efficacy studies
that would be submitted to the approving agencies in the event
the company was going to apply for pharmaceutical status for
the substance. The DMF includes 23 pharmacotoxicology (is
it safe?) and pharmacokinetic (how does it work?) studies
along with 17 clinical studies involving humans (does it work
in living test subjects and not just with lab animals or using
tissue samples in petri dishes?). The results of all these
tests and studies were obviously positive or we wouldn’t
be so excited about making this product available to the public.
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Different names?
You will note that in these studies the product is referred
to by different names. This is due to the fact that during
the studies the product was a work in progress and naming
it was not as important as testing it. In fact, it’s
first reference was as IdB 1016. This was the code name based
partially on the name of the division that was researching
it, Inverni della Beffa (IdB). The 1016 was an in-house project
tracking number. Another name was silybin Phytosome®.
silybin Phosphatydilcholine is also mentioned. That’s
where the name Silybin Phytosome came from Sili(bin)+Phos(phatiydilcholine).
In the abstracts we have on this site we inserted the name
Silybin Phytosome in parentheses where appropriate to indicate
product continuity.
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Silybin vs. Silymarin
The company that owns the patent on Silybin Phytosome also developed
a Silymarin Phytosome®.
You might ask, "why isolate one constituent of this herb,
what about the other constituents?" The fact is, the
company discovered in its research that silybin was the most
dramatically effective of the flavanoids that make up the
most beneficial part of the milk thistle plant. And silybin
was so much more active that they decided to focus the bulk
of their research on this most valuable constituent. The Silymarin
Phytosome®is
also available but all of the research on effectiveness have
been done on the silybin Phytosome®
because it was seen to be so much more potent and promising.
This is why we are offering Silybin Phytosome instead of the Silymarin
Phytosome®.
It has more tests proving its value and potency. They even
tested Silybin Phytosome against the world’s largest selling
milk thistle (known as Legalon in Europe and Thisilyn
in the U.S.) and Silybin Phytosome won hands
down, proving itself to be 8-10x more bioavailable.
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Bioavailability
Bioavailable really means more of the product makes it to
where it can be most beneficial. Otherwise most of it would
be passed through your digestive system and end up in your
toilet with a comparatively miniscule, infinitesimal, tiny,
insignificant amount making it to your liver. The
Phytosome® process is really a supercharged delivery system to get more
of the product to where it will potentially do the most good
on a cellular level. When you consider that this creation
process involves the binding of two molecules of one substance
with one molecule of another to enable greater uptake and
assimilability it is quite impressive.
Silybin Phytosome is an awesome marriage of botanical medicine,
chemistry and molecular science. The process that takes place
to accomplish this molecular bonding could only be done by
a company dedicated to high level research and development.
The process is pure, it is powerful, it is very, very exact.
No one would go to all that trouble unless they felt it was
justified by very beneficial results.Look at the studies and
judge for yourself. Or, better yet, try Maximum Milk Thistle™ and see how Silybin Phytosome works for
you.
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Linked to the National Library of Medicine
Incidentally, what you will find in this section of the
website are synopses. Where possible we have provided links
to the official synopses at the National Library of Medicine.
You can follow these links if you so desire. At the NLN you
can even order the full text of the articles or studies for
a price (we chose not to include them here because they are
extremely technical and generally appropriate only for medical
professionals or researchers.) The synopses included here
are essentially an abbreviated version of each study. They
focus on the results or conclusions of the study presented
in plain English.
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