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™ and UltraThistle®.

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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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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