Milk Thistle and Hepatitiis

Well it always pays to be skeptical...but each study should live or die on its own merits and quality of design...but you know that already. Have you found any glaring flaws in the current milk thistle study?

What criticism(s) would you lay at the feet of the 'alternative' researchers conducting research into herbal products?

There is some question if the use of 5 times or more of the current dosage would achieve results...it may and it may not....current dosage recommendations provide no better results than a multivitamin.....and if I were to take milk thistle I would take it bound to phosphotidyl choline...much better pharmacokinetics than any other formulation on the market.....

Bob, I can't find the link. I need to announce that, except for the little I've picked up I'm ignorant of pharmacology - there are others very competent at that (would that they recognize their biological/ecological ignorance) - but I sure like to check out their starting material if they own up to it.

The most meaningless phrase uttered by med folks viz herbal medicines is "buy from a reputable source," while having no way to define "reputable source."

Here is the Mayo Clinic view:

http://www.mayoclinic.com/health/sil...nt-milkthistle

....most studies have been small and poorly designed.

I think that leaves it still up in the air on it's efficacy. As I stated earlier, I think you can find a study to conclude whatever you want it to. There are too many random variables to make a cohesive determination IMHO.

sure well i'm holding a book written by C. Norman Shealy MD. PhD and there are many other PhD's who refer to it's history and treating liver disease and Hep C so I don't think you'll have that much trouble finding some.

It's that same story all the time Bob, although clinical studies can be important thay are not the be all and end all(i know it is for you but not me). What you showed me as proof of milk thistles failure, was actually a failed study on Milk thistle and this is becoming a problem with clinical studies period. There are reports written on this problem.
So why would you expect me or anybody else to just blow off testimonials or other claims made by other MD's, PhD's and anecdotal evidences that they base their claims on.

You made the same claims about clinics in Mexico but after doing a google search I found 'Hoxsey Method'. This may not say much to you but it does to me, and there are plenty of link available for more info. Anyway, good luck with the route you have chosen, it's not for me.

Hoxsey Method

The Hoxsey treatments are among the oldest U.S. alternative therapies for cancer and have been some of the most controversial. Like Essiac (see next section), they use a mixture of powerful herbs. These mixtures were probably derived from early Native American Indian medicines, although that connection is not as well established as with Essiac. Some of the same herbs are included in the formulas for both methods.

In the early part of the century Harry Hoxsey, an uncredentialed layman, marketed several cancer treatments in his clinics across the South. He claimed his remedies had been passed down to him by his father and grandfather, and he kept the ingredients secret until 1950. Eventually U.S. authorities shut down Hoxsey's clinics, but the treatment is still available at the Bio-Medical Center in Tijuana, Mexico, which is headed by Mildred Nelson, Hoxsey's former nurse assistant. Hoxsey indicated that some of his herbal components were present to necrotize tumors and others, as purgatives, to carry away the waste.

Hoxsey's remedies basically consist of an external salve and an herbal potion. The external medicine is an escharotic--a kind of burning paste--composed of zinc chloride, antimony, trisulfide, and bloodroot; its purpose is to corrode cancers. The paste is used principally for skin cancer (usually basal cell carcinomas), and many ambitious claims have been made for it. However, few reports on its efficacy (or lack thereof) exist in peer-reviewed literature. Moh's micrographic surgery, an orthodox procedure that bears some relationship to the Hoxsey treatment, is cited (Swanson, 1983): Moh's method consists of the use of zinc chloride paste to "fix" the tumor in place; the tumor is then removed in a series of steps.

The internal medication, which is the primary concern here, is made up of various herbs added to a base of potassium iodide and cascara, which is a bark preparation. The principal herbs are pokeweed root, burdock root, barberry (Berberis), buckthorn bark, stillingia root, and prickly ash. As Patricia Spain Ward noted in a contract report to OTA for its Unorthodox Cancer Treatments project, many of these roots and barks are now known to have anticancer and immunostimulatory effects._ The following items discuss several:

* Pokeweed. Pokeweed root (Phytolacca americana) has several effects on the immune system including stimulation of the production of two cytokines (see the glossary), interleukin 1 (IL-1) and tumor necrosis factor (TNF) (Bodger et al., 1979a, 1979b). Boosting the immune system is generally thought to help the body fight cancer._ Although pokeweed root is poisonous, it apparently has been used without serious toxicity problems since the mid-18th century.

* Burdock root. Burdock root (Arctium lappa) contains what Japanese scientists have called the "burdock factor" (Morita et al., 1984), which is reputed to act as a desmutagen, that is, a substance that reduces mutations. Burdock also has been shown to inhibit HIV, according to the World Health Organization (1989). In Japanese and macrobiotic diets young burdock roots are eaten as a vegetable called "gobo."

* Buckthorn. Buckthorn contains emodin, which has shown antileukemia activity in the laboratory (Kupchan and Karim, 1976).

It is noteworthy that, despite intense opposition, the Hoxsey formula has persisted as a cancer treatment for almost 100 years (Chowka, 1985). Among numerous anecdotal accounts of its effectiveness, some are hard to dismiss out of hand; it therefore warrants investigation. Despite decades of controversy, no clinical trials have ever been performed by either supporters or detractors of the Hoxsey therapies._ But since the Hoxsey formula contains the poisonous substance pokeweed, testing the formula is also a public health concern.

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UK 2005:Treasury Dept./Trade and Industry survey concluded: 3.6 m gay people in the UK/~6% of the total population/1 in 16.66
Biblical Argument for the Acceptance of Homosexuality

Exactly!

Its one thing to state a study is flawed and I thing that is a good thing to be able to do....but you have to back it up with a critique....critiques are great and I look forward to yours......so I'll ask....Why was the study flawed?

before you leap off the brindge and run to mexico here is something from an oncologist who has spent many years tracking down cancer cure claims in the hopes he would find something to treat his patients with....take a look at his site he's done a lot of work in this field...

http://members.bordernet.com.au/~pmoran/

above link is not to this quote below...

The Hoxsey treatment doesn't seem to be doing too well these days ---
Quote ---

The Bio-Medical Center in Tijuana, Mexico

Subjects were 307 new patients treated for cancer during 1992, for 89.6

percent of whom charts were available. 149 patients (54 percent) were

treated for cancer and 43.6 percent of cases were confirmed by pathology

reports. Survival at five years was determined for 57.0 percent; 11.4

percent of the patients studied were living and 45.6 percent deceased.

Since 1963, the Bio-Medical Center has treated cancer patients with a

proprietary herbal tonic, external powders, and a special diet

incorporating yeast tablets, vitamins, and garlic. This treatment,

developed by Harry Hoxsey (1901-1974) in the 1920s, became widely

available in 17 facilities across the U.S. into the 1950s, when the FDA

closed them down. Hoxsey's head nurse, Mildred Nelson, R.N., then

established the Tijuana clinic to carry on his work. Ms. Nelson, who at

first believed Hoxsey was a fraud, became an advocate of his treatment

after her mother recovered from advanced untreatable uterine cancer using

his tonic.

End quote

So only 11.4% of the patients were known to be still living five years
later. This despite the fact that 7.3% of the patients had no evidence of
current cancer when taken on for treatment, and 27% had only locallised
disease, and nearly all also underwent conventional treatment as well. The
most common cancers were breast and prostate which are often compatible with
long survival even after having spread.

Peter Moran

Just a quick run through PubMed netted these:

=======================
Not HepC but a Milk Thistle component definitely has a strong positive effect on a different type of liver disease

Silibinin efficacy against human hepatocellular carcinoma

Silibinin strongly inhibited growth of both HepG2 and Hep3B cells with a relatively stronger cytotoxicity in Hep3B cells, which was associated with apoptosis induction. Silibinin also caused G1 arrest in HepG2 and both G1 and G2-M arrests in Hep3B cells. Mechanistic studies revealed that silibinin induces Kip1/p27 but decreases cyclin D1, cyclin D3, cyclin E, cyclin-dependent kinase (CDK)-2, and CDK4 levels in both cell lines. In Hep3B cells, silibinin also reduced the protein levels of G2-M regulators. Furthermore, silibinin strongly inhibited CDK2, CDK4, and CDC2 kinase activity in these HCC cells. CONCLUSION: Together, these results for the first time identify the biological efficacy of silibinin against HCC cells, suggesting the importance of conducting further investigations in preclinical HCC models, especially on in vivo efficacy, to support the clinical usefulness of silibinin against hepatocellular carcinoma in addition to its known clinical efficacy as an antihepatotoxic agent.

http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_docsum

===========================
New treatments for hepatitis B and C [antigen-specific transfer for A, B & C (chisolm biologicals) and thymate].

One study of 24 patients showed success in using Naltrexone, Alpha Lipoic acid, milk thistle, and Hypercurium in treating hepatitis B and C.

http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_docsum

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

I did find a ton of abstracts indicating that various herbal remedies, including milk thistle, seem to have positive effects on the liver (Hep C as well as other conditions), but what I saw over and over was declarations that some serious double blind studies need to be conducted.

I found mention that NCCAM, National Institutes of Health is conducting such a study which is supposed to last for 2 years. However, I don't know when that began or if the 2 years are up. I'm looking around at http://nccam.nih.gov/clinicaltrials/ to see what I can find out.

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I already pointed that out elsewhere.

I posted the name of Hoxsey treatment so people could do their own search and find more info for themselves and make their own decision.

__________________
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UK 2005:Treasury Dept./Trade and Industry survey concluded: 3.6 m gay people in the UK/~6% of the total population/1 in 16.66
Biblical Argument for the Acceptance of Homosexuality

unfortunatelly cells in a dish on the bench top aren't always and often are not representative of what happens in a living organism....cell culture research should be approached with a great deal of caution and recognition for its strengths and weaknesses....without understanding this you will fall prey to many false claims.....

I already posted the contents of the NCCAM study in the other thread.....

the reputable source market claim is oft misued in herbal medicine circles also....how do they test what they are recommending you buy or use?

here is a repost of the article....

Two-year results of a randomised double-blinded trial evaluating silymarin for chronic hepatitis C

Digestive and Liver Disease
Volume 37, Issue 7 , July 2005, Pages 542-543

G.T. Stricklanda, , , M.D. Tanamlya, F. Tadrosb, S. Labeebc, H. Makldc, D. Nessima, N. Mikhailb, c, L.S. Magdera, N.H. Afdhald, A. Medhatc and M. Abdel-Hamida, b

aDepartment of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD, USA
bNational Hepatology and Tropical Medicine Research Institute, Cairo, Egypt
cAssiut University Faculties of Medicine and Nursing, Assiut, Egypt
dDepartment of Medicine, Harvard University School of Medicine, Boston, MA, USA

Available online 13 April 2005.




Article Outline
Acknowledgements
References


We recently described the study design and 12-month results of a randomised controlled trial (RCT) comparing patient compliance, safety and effectiveness of silymarin with a multi-vitamin placebo in 141 subjects with chronic HCV infections, 90% of whom are infected with genotype-4 [1]. Herein, we report the results of the 24-month evaluation.

The same protocol was followed as reported by Tanamly et al. [1], and none of the subjects living in a rural Egyptian village were treated in the interim with anti-viral agents or other herbal therapies. A detailed history was taken, physical and ultrasound exams were conducted and a blood specimen was drawn 24-months after starting the study.

Serum was tested for (1) antibodies to HCV (anti-HCV) using a third-generation enzyme immunoassay (EIA); (2) HCV RNA using an in-house reverse transcriptase polymerase chain reaction (RT-PCR); (3) alanine aminotransferase (ALT) and (4) serum YKL-40 (human cartilage glycoprotein) and hyaluronic acid (HA) as serum markers for hepatic fibrosis [1]. We used the same criteria for the diagnosis of fibrosis and for classification, i.e. no fibrosis, fibrosis and indeterminate, based on their baseline fibrosis marker score and disease progression. Abdominal ultrasound assessed hepatic morbidity. The subjects’ opinion regarding their health and quality of life (QOL) was assessed with an Medical Outcomes Study 36-item Short Form Health Survey (SF-36 form) adapted for use in mostly illiterate Egyptian farmers and translated into Arabic.

Legalon 140R (Silymarin) was provided in bulk by Madaus AG (Cologne, Germany). It and the multi-vitamin and mineral compound used as a placebo were placed in identical capsules by the Chemical Industries Development Pharmaceutical Co. (CID; Cairo, Egypt) and were dispersed as 1 week supplies by the project nurses. During these weekly visits, the subjects were asked about recent illness, medications taken and tolerance to the supplement or placebo by the visiting nurses. The data were collected, handled and analysed as described [1]. Results of the 24-month follow-up were compared with base-line results, as well as results at 12-month follow-up. Since results at 12- and 24-months were almost identical, most analyses compared the base-line with the 24-month results.

One hundred and forty-one subjects were evaluated. One patient in the silymarin group at the 12-month follow-up was not evaluated and one was added to the placebo group. He had taken the multi-vitamin placebo regularly even though he did not provide a blood sample at 12-months. During the second year, 97.5% consumed >95% of their medication. There was no difference between compliance of the silymarin (97.4%) or placebo (97.6%) groups (P = 0.652). No one discontinued silymarin or placebo because of adverse events. The adverse events index, based on number of weeks with complaint/number of weeks of observation, remained low during the second year and did not differ between the groups. Just as was the case during the 1-year follow-up, less nausea, vomiting, fatigue, weight loss, dark urine and other symptoms were reported by both groups at 2-years than prior to the RCT and there were no significant differences between the two groups at the 24-month follow-up [1].

After 24 months of therapy, 65/68 of the group receiving silymarin still had anti-HCV and 72/73 of those given multi-vitamins were anti-HCV positive (P = 0.56). HCV RNA persisted in 64/68 of the silymarin group and in 71/73 in the multi-vitamin group (P = 0.61). Elevations in ALT were present in 13 of 73 of those receiving vitamins and in 11 of 65 receiving silymarin. These were mild, ranging from 64 to 105, and the percentage with elevations did not differ from those at base-line. When the subjects were stratified according to whether the initial ALT levels were elevated or not, there were no differences between the responses to silymarin and placebo. Progression to fibrosis as measured by serum hepatic fibrosis markers was slightly more, and regression less, in the multi-vitamin group than the silymarin group. However, these differences were not statistically significant (P = 0.15–0.92). Abdominal ultrasound findings of hepatomegaly, splenomegaly, portal vein dilation and a coarse hepatic echogenic pattern were detected in about the same proportion of subjects as during the 12-month evaluation and at a slightly greater frequency than at base-line. These findings were present equally as frequent, i.e. 31–34%, 8–13%, 6–7% and 81%, respectively, in those receiving either silymarin or multi-vitamins (P = 0.24–0.97). All physical and mental health variables as measured by the modified SF-36 questionnaires remained the same at 24-months as at 12-months, being markedly improved over base-line testing [1]. However, there were no significant differences in any of these categories between those receiving silymarin and those receiving placebo (P = 0.12–0.85).

Although we have no objective evidence of improvement in physical and hepatic ultrasound examinations, or serum ALT and hepatic fibrosis marker levels, both the silymarin and vitamin placebo groups had fewer symptoms and reported they felt better than prior to participating in the study. They also had no detectable progression of their liver disease over the 24-months. Silymarin at the standard recommended dose was well-tolerated and caused no side effects; but it did not clear HCV RNA better than the vitamin placebo. Thus, the hepatic status of all 141 subjects remained stable during the second year of the RCT and, although it is not particularly surprising, no one developed clinical complications of chronic HCV infection.

Silymarin is being taken by millions of people, including many with HCV infections, at widely different doses in a haphazard manner for ‘liver support’ [2] and [3]. Experimental studies in vitro and in animal models show it and other milk thistle extracts have pharmacological activities that could benefit patients with liver disease [4]. Hundreds of different silymarin and other milk thistle products are marketed and their purity and standardisation is highly variable. Therefore, we evaluated Legalon, the silymarin compound most widely available and frequently used in clinical trials. However, studies of this community-based cohort will require longer than 24-months to show significant objective improvement, if it occurs. Since 420 mg/day of silymarin has had no side effects, a higher dose could be evaluated in future studies of patients with different stages of HCV infection, e.g. acute hepatitis, early or late stages of chronic hepatitis and cirrhosis. These tedious and time-consuming studies require prolonged observation of cooperative subjects may explain why they have not been conducted previously.
Conflict of interest statement


None declared.

I haven't been able to find any comments by you on the NCCAM study I posted....could you supply a link?

...and I posted some info refuting the Hoxsey treatment efficacy to allow them to make a more informed decision........

sorry i was refering to the first study you posted.
New one looks fine to me I wonder what the next study will say.

I didn't come across concrete results like you found, best I found was a study conducted by W.H.O I think or some other group that said results were difficult to determine and they listed a bunch of reasons with recommendations on how the clinic could improve.

__________________
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UK 2005:Treasury Dept./Trade and Industry survey concluded: 3.6 m gay people in the UK/~6% of the total population/1 in 16.66
Biblical Argument for the Acceptance of Homosexuality

It seems common in these studies for the isolated "active ingredient" in milk thistle (silymarin) to be the only part of the herb that is administered to the participating patients.

I have read repeatedly that, in herbal medicine, the other components of the plant in question often work synergistically with the so called "active" ingredient, causing a much greater effect than when the said active ingredient is isolated and sold as a pill or capsule. (For instance....In this case, ingesting milk thistle seeds would likely be much more effective than popping silymarin pills).

Just as "cells in a dish on the bench top aren't always and often are not representative of what happens in a living organism"....The effect of one isolated ingredient from a living plant might also not be representative of what would happen if the same type of plant were administered more wholly.

I am not pretending to be an expert in the field of herbal medicine (far from it), but I do know that there are many variables that can change the strength of a particular plant's medicinal value, from its freshness, right on down to the time of day it was harvested.

Unless these studies were taking such factors into account, it would seem that the only point they make is that silymarin, as an isolated ingredient, performs little better than the various placebos. They say nothing about the overall validity of milk thistle therapies for treating liver ailments.

If you know of a study that used fresh milk thistle seed, rather than the isolated silymarin ingredient, I would be very interested to give it a read.

Erin

The first item I posted was a review......you did not make any comments on the methodology used to conduct the review so you really did not critique that 'study'....and I always try to find teh concrete results before making any decisions.......another study? I can see changin dosages to see if higher dosages might be effective but there appears to be suficient number of quality studies that indicate there is little benefit in taking milk thistle.....as good as a multivitamin....no sense in performing hte same experiment over and over getting similiar results each time......I do believe that there will be another study using much higher dosages....as there should be,......

I have never heard of anyone using milk thistle seeds....it is always a extract of the active ingredients....the question is how many milk thistle seeds would a individual need to eat to obtain an equivalent dosage of active ingredients.....probably quite large and prohibitive for consumption.....the active ingredients in milk thistle are poorly absorbed since they have difficulty in passing throuhg the stomach intact....typically 20-50% of the dose is absorbed thus the need to consume a concentrated amount....using seeds only would probably result in little active ingredient bein gabsorbed into the systemic circulation......rendering it worthless ....but that is my take based on the available pharmacokinetic information for this herbal preperation....

Maybe, or maybe not. Unless there are studies to back up your above guess, it is only that...a guess. An untested hypothesis, if you will .

I AM in agreement with you, however, that the studies seem to support that milk thistle supplements consisting only of the active ingredient from plants that were harvested long ago, are largely ineffective. That is good information to have and to know (especially when considering spending money on the commercialized stuff...).

However, it would appear that claims undermining the overall efficacy of milk thistle therapies when using a fresh plant more wholly (which is likely how it was used in ages past...) are unsupported.

Again, if you can produce studies that state otherwise, I would be interested to read them.

Erin

Extracts/tinctures from plants have been made for eons.....do you have any info stating or discussing the use of whole seeds for disease treatment...and if so what were the recommended dosages. From this information we may be able to glean what effective dose may be expected to be absorbed from a single dose....but to be fair I'll also poke around a bit and see what I can find....the pharmacokinetics have been tested and documented which is how they know the absorption rates of the active ingredients as well as the degradation within the stomach of the active compounds......consuming something that is unconcentrated will no doubt lead to less being bioavailable....but let's look and see what we can find

You are right, of course. Extracts and tinctures of all sorts HAVE been used for ages. Isolating silymarin from milk thistle is, obviously enough, an example of one such extract.

Not all extracts and tinctures are created equally, however. Some components of a plant might be soluble in water. Others might be soluble in alcohol. Maybe a different preparation method altogether is what is required for a specific plant to be most effective. And on and on. My point is simply that, before one can make statements about the overall validity of a plant's medicinal value, ALL of these variables must be studied and accounted for. Until they are, claims that a particular therapy is altogether ineffective are baseless.

As I stated before, I am not an expert in herbal medicine and would therefore only be repeating information gleaned from the same sources you are likely to find while doing your own poking around. My DH and I are leaving later today for a 4 day trip, so I also don't have the time at the moment to research all of this further. I will look forward to seeing what you come up with though, when we get back.

Erin

If you,or anyone else, can document a different prep being used in traditional medicine practices outside of what is currently utilized then I would consider that a valid criticism of the studies that have been conducted. Without that documentation it would only be speculation at best.

I just don't see the point of going on and on anymore Bob, you posted a poor study and called it proof and I pointed that out. What makes you think i have to comment on anything.
I was also lucky enough to work 8 years for a woman(M.D., PhD, biochemist, phytochemist and vet who only used natural remedies oh and is published 3 or 4 times and writes/has written for several popular journals), she was also lucky enough to have studied under A. Vogel... I get the picture.

So you post a study that says it does nothing and it is quite harmless but in no way shows how it will do in combination with other herbs as would be the case if it were prescribed.
So if it does no harm why are you so relentless about it?
Even if there is the slightest chance for it to do some good for lets say 1% of the population(testimonials) suffering why are you fighting it?

Do you really think that study will be the last?? Do you have any idea how many studies have been done on marijuana and have yet to be done on it.

enough for me.

__________________
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UK 2005:Treasury Dept./Trade and Industry survey concluded: 3.6 m gay people in the UK/~6% of the total population/1 in 16.66
Biblical Argument for the Acceptance of Homosexuality

The review article was well done...how was it a poor study? There is no evidence that adding more herbal combinations to the picture will do anything...sounds like wishful thinking to me! If it does no good why continue to use it or recommended it?...why not be honest about it and say it won't do anything a multivitamin won't do?....because it cuts into the 21 billion supplement market for one reason and the other is because the sites and people promoting its use aren't being honest to their customers and/or people making inquiries.

Testimonials are often wrong because of the post hoc ergo proctor hoc fallacy....if promotion was on a honest level and people were told its a 99% chance this will do nothing for you I might change my mind...but that hasn't even been demonstrated....until then I see no use in using or recommending something that will not help a patient in curing or managing their disease....it is not intellectually honest or morally ethical in my book to do so...I would rather give them real options that will actually help them manage their disease and improve thier quality of life....you have no idea how many patients get their hopes up about this and/or an herbal or alternative cure only to have them completely dashed and demoralized when the test results show it (they) don't and aren't working.....with the disease continuing to progress....I'd rather spend the time and effort (and money) of the patient making real strides in combatting and managing their illness...not pandering false hope about...