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Silymarin
So, we see this term thrown about, but not too often do we hear, what in the world is this, but somehow, I am sure not many of you know (but your secret’s safe with me). I will allow you now to act smart in front of your friends free of charge with your silymarin knowledge. In short, silymarin is a fancy, shmancy name for a mixture of flavonoid components (i.e. – silybin, silidianin, and silichristine) from milk thistle. The concentration of silymarin is highest in the fruit, but it is also found in the seeds and leaves. Milk thistle extracts standardized for silymarin usually find their way into your favorite supplements at about a 70-80 percent concentration.
Fancy Shmancy, maybe. However, silymarin is at least ten times more potent in antioxidant activity than vitamin E and also increases the liver’s own antioxidant, glutathione (which we have spoken about at great lengths thus far in this series) by OVER 35%!
EVIDENCE-BASED EFFICACY: Positive effects have been seen with 70-80% concentration in treating several types of liver disease, including hepatitis and cirrhosis. The therapeutic effect of milk thistle extracts in these disorders has been confirmed by biopsy as well as by clinical and laboratory data.
Although milk thistle extract has shown benefits in treating acute and chronic viral hepatitis, the results with milk thistle extract are most impressive when looking at studies evaluating its effectiveness in alcohol- or toxic-chemical-induced hepatitis, which is why it applies readily to the post-cycle time frame. For example, in one double-blind study in workers exposed to toxic toluene and/or xylene vapors for five to twenty years, milk thistle extract (Thisilyn) was shown to significantly lower levels of AST and ALT, while significantly improving other blood measurements, such as platelet count, white blood cell count, and percentage of lymphocytes compared to other white blood cells (but it’s use can also create an inaccurate picture for clinician’s, so we must be wary in our question asking during history taking).
Even in cirrhosis of the liver, milk thistle extract has shown some benefits. Although not all studies have shown significant effects, in one controlled study the four-year survival rate was 58% in the milk thistle group compared to 39% in the control group.
There have been no studies to date examining the potential of milk thistle to treat gallstones through it’s ability to increase bile solubility (gallstones form when bile components fall out of solution). When there are drastic body re-composition events, namely fat loss – this is ABSOLUTELY AN IMPERATIVE POINT as gallstones have a tendency to readily form.
FORMS & DOSAGES: Milk Thistle is available as bulk and dried seeds, as tea bags, as a tincture, as a fluid extract, and as a solid extract in tablet and capsule forms. Extracts standardized for silymarin content are preferred as it is the component proposed to be responsible for the extract’s mechanism of action (recall bioflavinoid complex discussed earlier). There is some preliminary data to suggest combinations of Silybin, the key component in silymarin within milk thistle, and phosphatidylcholine would help aid absorption. It is too early to tell and the data available was thus far only published by those with vested interest, so I cannot say definitively. The regular version standardized should be good enough anyway – so why get fancy?
The goal of therapy here will be based on silymarin content. If using the dried seeds, a much lower dose is necessary to see positive effects of the compound.
POTENTIAL SIDE EFFECTS / INTERACTIONS: The earliest side noted is a looser stool (due to increase of bile output). Aside from that, it tends to be a rather safe supplement with a great track record.
If you are taking the following drugs: thyroid hormone, acetaminophen, butyrophenones, phenothiazines, phenytoin, and even alcohol, I advise AGAINST the use of milk thistle as it has a tendency to drive down efficacy of these agents.
Dinoiii’s tip(s):
(1) If loosened stool side effect occurs, it is a good idea to take some sort of fiber source (i.e.- guar gum, pectin, psyllium, and/or oat bran) with your milk thistle dose if it is desired to continue to use the product. This will help aid bile binding preventing irritation.
-----------------------------------------IN-HOUSE STUDY -------------------------------------
Houser, D. The Efficacy of Various OTC Hepatoprotectants in the Post-Cycle time frame following use of C17 alkylated PH/PS – a double-blind, placebo controlled look. (2004) [Unpublished to date-see below]
Study Group: 34 clients in Post-Cycle Therapy after the use of upper-limit dosing of various C17 alkylated PH/PS products. The breakdown of the in-house participants was as follows:
Group A: 15 Solitary M1T (Dosing Parameters: 20 to as high as 60 mg per day x 6-10 week cycles).
Group B: 7 M1T + MD (Dosing Parameters: 12 to as high as 30 mg per day of each x 4-12 week cycles).
Group C: 12 MD + MOHN (Dosing Parameters: 12 to as high as 20 mg per day of each x 4-18 week cycles).
Group A
Study Participants:
5 participants – 600mg NAC
5 participants – 400mg enteric-coated SAMe
3 participants – 600mg NAC + 400mg enteric-coated SAMe
2 participants – placebo-control
“Cliff-Notes” Summary: 4 of 5 participants in SAMe-only group and all 3 participants in NAC + SAMe group had an average 5-day faster return to baseline of AST/ALT elevations than NAC and placebo-control. The addition of NAC in the dual-coverage group seemed to offer no additional benefit without statistically significant results between the two. NAC + placebo-control groups saw no statistically-significant changes in AST/ALT levels. Results seem to suggest SAMe is superior, at least in the post-cycle realm, to NAC in returning transient LFT elevations to baseline INDEPENDENT of cycle length. The essential caveat was the unanswered question in regard is why one of the SAMe-only participants mimicked results of NAC and placebo. Author’s Note: A current follow-up series of serum studies in specific regards to this individual are underway as we speak in hopes of offering answers.
Group B
Study Participants:
3 participants – 600mg NAC
3 participants – 400mg enteric-coated SAMe
1 participant – 600mg NAC + 400mg enteric-coated SAMe
(Author’s Note: not enough participants in this arm for placebo-control)
“Cliff-Notes” Summary: Similar results to Group A were seen in this arm. The SAMe-only and SAMe + NAC participants saw an average 3-day faster return to baseline of AST/ALT elevations. The faster return to baseline of transient LFT elevations was again INDEPENDENT of cycle length. It is truly unfortunate that there was no ability to gain a placebo-control group here, but M1T + MD in a concurrent run was not one of the most popular cycles when these PH/PS products were still being marketed legally. With the support of the first and third arms of the study, some definite inferences can be made. It would appear that the SAMe inclusion is what offered aid in the post-cycle realm for expedited returns to baseline LFT.
Group C
Study Participants:
4 participants – 600mg NAC
4 participants – 400mg enteric-coated SAMe
2 participants – 600mg NAC + 400mg enteric-coated SAMe
2 participants – placebo-control
“Cliff-Notes” Summary: Once again, the SAMe-only and SAMe + NAC participants saw an average 8-day faster return to baseline (inferences about the strength of PH and subsequent elevation in transaminase can likely explain the difference 5 vs. 3 vs. 8 respectively for the three arms) SPECIFICALLY in cycles under 8 weeks. Cycles that extended beyond this time frame tended to exhibit results that were not statistically significant when compared with either the NAC-alone or placebo-control groups. Of note, 2 participants in this arm did NOT see LFT elevation (1 in NAC only and 1 in NAC + SAMe groups). This is likely to be attributed to one of two things: specificity to elevation to particular PH/PS run or irregularly low-level baseline LFTs (of which has not been explored to date due to lack of participant follow-up).
* Author’s note: All information gathered here was done prior to the October 2004 ban. Due to legal issues, follow-ups for replicability are thwarted by the Steroid Control Act of that year. The aforementioned 3-arm study will appear in an upcoming book with complete lab values verified by Quest Diagnostics reports.
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Summary of Hepatoprotectant Use in PCT: Despite certain supplement companies’ claims, the attempts to replicate NAC results in oral (PO) form have been less than stellar and shows these particular supporters simply either not doing their homework or just attempting to “kitchen sink” their products with a bell and whistle. You can get away with very cheap brands quality-tested, but it is imperative to be careful in choosing which brand to go with. Fortunately enough, many brands of SAMe have been tested independently and it would appear this to be the OFFICIAL dinoiii agent of choice at this time, especially post-C17 alkylated oral use.
Quality Dose: 400mg enteric-coated SAMe (keeping in mind concentration of stabilizers we learned about above) two times per day (bid) + Milk Thistle (dose accordingly).
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Dana Houser, MD, MHSA, CISSN
R&D Consultant; Diector of Pharmacovigilance Program MAN Sports, Inc.