Milk Thistle... Hum...

[jepperone]

A copy past by Boobert

Is this an Alternative to treatment or a helper herbal?

A recent study from Columbia University Medical Center on milk thistle gives those who are unsure about using herbal supplements for Hepatitis C reason to reconsider.

by Nicole Cutler, L.Ac.

An estimated four to five million Americans are chronically infected with the Hepatitis C virus (HCV). While approximately half of those with HCV are able to clear it from their liver with the current standard of treatment, the remaining fifty percent must protect their liver from this virus. One of the most advised and respected ways to accomplish this goal is with the herb milk thistle. Despite decades of studies demonstrating milk thistle's ability to protect and support the liver, skeptics have always doubted herbal medicine's potential. New research released from Columbia University Medical Center gives those with Hepatitis C one more reason to supplement with this amazing herb.

For those who are not candidates for, or who don't respond to Hepatitis C treatment, there is little a physician can prescribe to prevent HCV from progressing to advanced liver disease. To prevent further damage to this key organ, alternative medical practitioners often turn to herbal supplements that support the liver via:

1. aiding in detoxification
2. neutralizing threats to the liver (like free radicals)
3. helping liver cells deflect potential hazards

Milk thistle is believed to accomplish all three of these goals. Thus, it is no surprise that those with Hepatitis C choose milk thistle more than any other vitamin or herbal supplement.

A plant native to Europe, milk thistle has a long history of use as a folk remedy for liver and gallbladder disorders. Although milk thistle does not possess antiviral properties, hundreds of studies have concluded that it helps maintain liver health - even in the presence of a liver-damaging virus.

Even with all of the documented benefits of milk thistle, many people remain wary of herbal medicine. This viewpoint could stem from the following:

· Not having enough information - From the moment we are born, our culture is steeped in western medical practices. Learning about herbal medicine requires expanding what we know about human health.

· A trusted physician's influence over their patients - Physicians without training in herbal medicine often discourage their patients from taking herbs because they do not know how they will react with pharmaceuticals.

· Wanting fast results - In lieu of patiently strengthening a weakened body system (as herbs usually do), many people desire a quick fix (as pharmaceuticals usually do).

· Fear of herb quality - Because they are not held to strict government regulation, many herbs are not subject to the same kind of standardization and purification specifications as drugs are. Thus, un-researched herbs have the potential for having contaminants or not being as potent as advertised.

There are admitted limits to both western medicine and herbal medicine. Those whose health seems to benefit the most are individuals who combine the strengths of both disciplines. To evaluate the potential of herbal medicine in the western setting, Elena Ladas, MS, RD, of Columbia University Medical Center and colleagues set out to test whether milk thistle could help treat people with chemotherapy-associated liver problems. As published in the December 2009 edition of the journal Cancer, milk thistle's ability to treat chemotherapy-associated hepatotoxicity was investigated.

Upon administering milk thistle to children who had acute lymphoblastic leukemia with liver toxicity related to chemotherapy, the research team found the following:

· Those who had received milk thistle had improvements in their liver enzymes (significantly lower levels of AST and ALT) compared to the children in the placebo group.

· Milk thistle also seemed to help keep fewer patients from having to lower the dose of their chemotherapy drugs (61 percent vs. 72 percent).

· Milk thistle did not interfere with chemo's cancer-fighting properties.

Ladas' study has little to do with Hepatitis C. However, it does provide those with chronic liver disease more reason to trust milk thistle's ability to safely shield the liver from toxins.

As more professionals in both the fields of western medicine and alternative healthcare recognize how these disciplines can help one another, the use of herbs alongside pharmaceuticals will continue to grow. Western medicine has been making great strides in developing a drug regimen that will see a greater percentage of people triumph over Hepatitis C. Until a cure is ensured for everyone with HCV, people will be searching for ways to keep their liver healthy. Thanks in part to studies like this one from Columbia University Medical Center, supplementing with milk thistle is becoming a standard practice for those with Hepatitis C, both in alternative healthcare environments AND in most western medical physicians' offices.

[Boobert]

I was dx in early 2002 and had my first biopsy late 2002 and was a stage 1 grade 2 probably infected for over 20 years. I started researching anything about liver health. I have been taking milk thistle around 2000 mgs since 2002 plus a few other sups.My GI in 2002 said it couldn't hurt if i wanted to take it. I did, in 2007 my 2nd biopsy reported stage 1 grade 1 after 5 years the stage didn't change and the grade dropped 1. My VL went from over 2000000 to around 500000 my alt went from over 90 to a constant 30ish. My labs have been normal for over 4 years. My GI after the 2nd BX said he started recommending milk Thistle to other patients not wanted to treat right away. He changed his belief. By no means is it a cure, I don't want to start that bs, but I do know it has helped stabilize my labs while I wait for a little better treatment.

[Trish77]

I think this may be as good as the information gets:

http://nccam.nih.gov/health/milkthistle/ataglance.htm

You'd really have to keep digging and make your own determination.  Perhaps anyone who's been taking it could post about that. Lady Lauri posted on the social side that she recommends it and perhaps you might want to drop her a message about it.

[GTBill]

Wow, you guys have to much info for me to digest. Q: should I take milk thistle or not? I am not able to take inteferon/ribavirin  because it makes me cough uncontrollably (and violently). Stage 3 fibrosis with ridging.

[Trish77]

Phase II clinical trial on milk thistle that is recruiting at the moment for those that where treatment has failed them, sponsored by NCCAM and the National Insititute of Diabetes, Digestive and Kidney Diseases.  Those with HCV and kidney diseases have a tough row to hoe, as conventional SOC is often not an option, so not surprised they are partnering in this study.

http://clinicaltrials.gov/ct2/show/NCT00680342?term=%28NCCAM%29+[SPONSOR]+%28milk+thistle%29+[TREATMENT]&rank=1

"Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill)."

If they're going to Phase II and actively recruiting, I would think that something in the science to date makes this worth investigating, even if it's to rule it out as an option for people who need an effective alternative when SOC is not an option for them.

[Proactive]

This doesn't sound like consistent proof
"Dec. 27, 2005 -- If milk thistle curbs liver  disease, science hasn't adequately proven it yet, according to a report in The American Journal of Gastroenterology.
Doctors from California and Europe reached that conclusion after reviewing 13 studies of milk thistle. No significant liver benefits were seen in patients with liver disease who took milk thistle."
but, what do doctors know that we don't, right.

[Proactive]

"Here they are acknowledging the consistent proof that milk thistle helps protect and support diseased livers." That is a bit of a stretch if you ask me...I've still yet to read a conclusive study on the benefits, maybe to the manufacturers, but not to the patients. I suspect, if there was such "consistent proof " as you put it,one would be able to come up with a newer (at least one?) clinical study that isn't 7 years old..

[merryBe]

As in previous clinical studies in ALD, the results obtained by Lieber et al are equivocal with regard to a potential clinical benefit from silymarin as preventive therapy in chronic alcohol use or ALD, at least at the dose used in the current study (39.8 1 5.2 mg/kg/d). The authors report that hepatic histology improved in the silymarin compared with the control group after 3 years. However, the small sample size and lack of statistical comparison limits the interpretation of these data. Nevertheless, the authors should be congratulated for attempting to study the effect of silymarin for ALD in a scientific manner. We hope that future studies would be adequately powered to compare the effect of silymarin using semi-quantitative histopathologic findings as primary endpoints.

There were, however, several favorable changes in the secondary endpoints in the silymarin treated group. Plasma levels of ALT, 4-hydroxynonenal (a marker of lipid peroxidation), procollagen type I and mRNA of[alpha](I) procollagen (2 markers of fibrogenesis) and hepatic total triglycerides were all significantly lower in the silymarin group, thus providing indirect evidence that silymarin is hepatoprotective and may potentially retard progression in ALD. Based on the interesting findings in the current study, additional studies are warranted to determine the optimal dose of silymarin followed by carefully designed clinical trials in ALD.

Note well: They are suggesting subsequent studies to determine optimum dose. Clearly they accept the usefulness of milk thistle for patients with liver disease -- they are treating that as a given. They just want to know how much is best! In the meantime, I recommend you at least take the recommended dose of MMT every day.

REFERENCES

1.  Saller R, Meier R, Brignoli R. The use of silymarin in the treatment of liver diseases. Drugs. 2001; 61:2035-2063.
PubMed Abstract

2.  Arteel GE. Oxidants and antioxidants in alcohol-induced liver disease. Gastroenterology. 2003; 124:778-790.
PubMed Abstract

3.  Flora K, Hahn M, Rosen H, et al. Milk thistle (Silybum marianum) for the therapy of liver disease. Am J Gastroenterol. 1998; 93:139-143.
PubMed Abstract

4.  Koch HP, Ritschel WA. Bioavailability of silymarin, I: Volumes of distribution of silybin, silydianin, and silychristin from in-vitro data (author's transl). Arch Pharm (Weinheim). 1981; 314:515-517.
PubMed Abstract

5.  Mulrow C, Lawrence V, Jacobs B. Milk thistle: Effects on liver disease and cirrhosis and clinical adverse effects. Evidence Report/Technology Assessment No. 21 (Contract 290-97-0012 to the San Antonio Evidence-based Practice Center, based at the University of Texas Health Science Center at San Antonio, and The Veterans Evidence-based Research, Dissemination, and Implementation Center, a Veterans Affairs Services Research and Development Center of Excellence). AHRQ Publication No. 01-E025. Rockville, Maryland: Agency for Healthcare Research and Quality; 2000.

6.  Bunout D, Hirsch S, Petermann M, et al. Controlled study of the effect of silymarin on alcoholic liver disease Rev Med Chil. 1992; 120:1370-1375.
PubMed Abstract

7.  Feher J, Deak G, Muzes G, et al. Liver-protective action of silymarin therapy in chronic alcoholic liver diseases Orv Hetil. 1989; 130:2723-2727.
PubMed Abstract

8.  Pares A, Planas R, Torres M, et al. Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized and multicenter trial. J Hepatol. 1998; 28:615-621.
PubMed Abstract | CrossRef

9.  Benda L, Dittrich H, Ferenzi P, et al. The influence of therapy with silymarin on the survival rate of patients with liver cirrhosis (author's transl). Wien Klin Wochenschr. 1980; 92:678-683.
PubMed Abstract

10.  Ferenci P, Dragosics B, Dittrich H, et al. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J Hepatol. 1989; 9:105-113.
PubMed Abstract

11.  Salmi HA, Sarna S. Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study. Scand J Gastroenterol. 1982; 17:517-521.
PubMed Abstract

12.  Trinchet JC, Coste T, Levy VG, et al. Treatment of alcoholic hepatitis with silymarin. A double-blind comparative study in 116 patients. Gastroenterol Clin Biol. 1989; 13:120-124.
PubMed Abstract

13.  Arteel GE. Oxidants and antioxidants in alcohol-induced liver disease. Gastroenterology. 2003; 124:778-790.
PubMed Abstract

14.  Seeff LB, Lindsay KL, Bacon BR, et al. Complementary and alternative medicine in chronic liver disease. Hepatology. 2001; 34:595-603.
PubMed Abstract | CrossRef

15.  Blumenthal M. Herb sales down 15 percent in mainstream market. HerbalGram. 2001; 51:69.

16.  Lieber CS, De Carli LM. Animal models of chronic ethanol toxicity. In Packer L, ed. Methods in Enzymology: Oxygen Radicals in Biological Systems. part C. Orlando: Academic Press Inc.; 1994:585-594.

Journal of Clinical Gastroenterology 2003; 37(4):278-279

Copyright ) 2003 Lippincott Williams & Wilkins

[merryBe]

a brief synopsis

http://www.mdidea.com/products/herbextract/silymarin/data01.html

it won't cure you, but it has been shown to help detox livers, which gets more important in advanced stage disease...it's the one herb my SOC liver clinic said might not be a bad idea....and they do not push any alternatives so I looked into it first off seeing as how even they were positive about it.

if you don't want to cap your own, lef.org has the most bioavailable form I've found.

some of the research showing no improvement used forms less absorbable...the main effects come when the body absorbs the components regularly.
also studies showed effect was dose related.

Journal of Clinical Gastroenterology 2003; 37(4):278-279
Is Silymarin Hepatoprotective in Alcoholic Liver Disease?

Jose Berger, MF; Kris V. Kowdley, MD

Division of Gastroenterology, University of Washington Medical Center Seattle, Washington.

Reprints: Kris V. Kowdley, MD, University of Washington, 1959 N.E. Pacific Street, Seattle, WA 98195-6174. E-mail: ***@****

Silymarin is the main active complex extracted from the milk thistle (Silybum marianum L.), an annual plant that has been used by herbalists since antiquity. Pharmacologic evidence from numerous studies in the last few decades supports potential therapeutic benefits of milk thistle and silymarin in liver necroinflammation and fibrogenesis given its free-radical scavenging, antioxidant, anti-inflammatory, immunomodulatory, iron chelating, and membrane stabilizing properties as well as its purported ability to selectively stimulate hepatocyte proliferation.1 Current knowledge of the role of oxidative stress in the pathogenesis of alcohol liver disease (ALD), suggests that silymarin's pharmacological properties may have potential therapeutic value in ALD.2

This is a top medical journal for gastroenterologists acknowledging the therapeutic effect of milk thistle.

Since the 1960s, milk thistle products have been prescribed by physicians in Europe for ALD as well as other liver-related conditions. Several European manufacturers have developed pharmaceutical grade milk thistle products standardized to a higher content of silymarin (70%-80%) than in non-standardized herbal preparations ([ap]5%)3, mainly because of silymarin's poor oral bioavailability.4 As part of pharmaceutical development, several clinical studies have been conducted in Europe to assess the efficacy of oral milk thistle products in liver diseases of diverse etiology.

Two key points here. 1.) Milk thistle is prescribed by doctors in other leading industrial countries. 2.) Milk thistle itself is hard to absorb, which is a key reason to choose Maximum Milk Thistle -- proven superior absorption.

Recently, a systematic review sponsored by the Agency for Healthcare Research and Quality (AHRQ) selectively analyzed 16 prospective randomized placebo-controlled European trials in terms of the efficacy and safety of milk thistle products in alcohol, viral or toxin-related liver diseases.5 Six of the selected trials evaluated ALD using various doses of Legalon, a milk thistle product standardized to 80% silymarin manufactured in by Madhaus AG (Cologne, Germany). The reviewers found these trials difficult to interpret due to unclear and variable definitions of disease chronicity and severity. Some of the studies included liver diseases of various etiologies. None of the studies stratified patients by presence or absence of ongoing alcohol consumption or chronic hepatitis C infection as potential confounders. All 6 studies on silymarin and ALD found at least 1 biochemical parameter of liver function or liver histology that improved significantly with silymarin compared with placebo. The parameters that were significant varied from study to study.6-12 Importantly, 1 of the 6 studies showed significant improvement in overall survival among cirrhotic patients treated with silymarin,10 a second study showed a non-statistical trend toward improved survival9 and yet another study showed no improvement in overall survival in silymarin compared with placebo.8 No relationship was found between duration of therapy and improvement in liver function, although 3 of the reports did not clearly describe the duration of therapy.

Here they are acknowledging the consistent proof that milk thistle helps protect and support diseased livers.

The previous data on silymarin in ALD along with current evidence on the potential benefit of antioxidant therapies in ALD,13 justify a more systematic assessment of silymarin in ALD. Furthermore, an evidence-based approach to the evaluation of the safety and efficacy is crucial because at least 1 multicenter survey has shown that milk thistle is the most frequently used supplement in patients with liver disease.14 In 2001, milk thistle products ranked 12th in the list of supplements sold in the US surpassing 7 million dollars.15

It is the most used because it is the best -- and because of its improved absorption, MMT is the best of the best.

In the current issue, Lieber and colleagues report their preliminary findings on the effect of chronic treatment with a standardized silymarin extract in an experimental baboon model that has been extensively validated in ALD by the lead author.16 The silymarin product was provided by Madhaus AG, the manufacturer of Legalon. The primary aim is to determine whether silymarin co-administration with toxic levels of alcohol prevents development of ALD in this animal model. The authors' rationale for using an animal model was to control for alcohol intake and treatment compliance. The authors also state that their study design differs from previous clinical studies that examined the effects of silymarin in patients with established ALD and often consisted of compensated or end-stage cirrhotics. Regardless of the proven validity of the baboon model, this difference in experimental design does place a limitation on our ability to compare results from this study with previous clinical trials. Additionally, the findings of the present study would be difficult to test in humans, given the ethical issues involving the recruitment of patients with ALD who continue to consume significant amounts of alcohol.

According to the authors, silymarin dosing was calculated based on the manufacturer's previous pharmacokinetic studies in humans and on the faster metabolism of silymarin in baboons. However, it is unclear how dosing was calculated in terms of maximizing hepatoprotective effects of silymarin. It is also unclear how the sample size was determined (6 animals in the treatment and control groups) since no power calculations are given in terms of silymarin's effect size.

[Proactive]

"Conclusions

In comparing the clinical data of silymarin users and non-users, the researchers found that "the levels of HCV RNA were not significantly different between silymarin users and non-users," indicating no effect on virus activity. Similarly, the product did not alter serum ALT levels, indicating no effect on hepatic inflammation. However, after adjusting for covariates, the data showed that silymarin users reported less fatigue, nausea, liver pain, anorexia, muscle and joint pain and better general health than non-users.

The better scores in a small number of symptoms among silymarin users compared to non-users are insufficient to support the value of this alternative therapy, the authors conclude. Compelling information can come only if a scientifically valid study is performed. "Currently in progress, therefore, is a properly designed prospective, randomized, controlled trial in which a fully characterized, purified and standardized silymarin formulation is being evaluated," they report.

This trial is supported by the National Center for Complementary and Alternative Medicine (NCCAM) and by NIDDK, NIH. "
http://www.hepcassoc.org/news/article165.html

[Boobert]

This was posted in the living with HCV forum as a supplement and not a cure.

[Trish77]

"A copy past by Boobert

Is this an Alternative to treatment or a helper herbal? "

Is this question yours or part of the article?

It needs to be clearly stated that treatment is the effort to be cured of Hep C.  Milk Thistle wouldn't qualify as an alternative to treatment in that context, would it.  This article doesn't even suggest that Milk Thistle should be taken instead of treatment, only when treatment doesn't work or isn't an option to be able to aid with maintaining the health of the liver.

The only way Milk Thistle is an alternative to treatment is if one decides with all the facts in front of them that they would prefer to try and outlive their HCV and forgo treatment, knowing that this will not cure them and being aware that Milk Thistle has it's limitations and ongoing monitoring of the progression of one's liver disease is essential if choosing to take an alternate route. Not everyone is looking for a cure.  

"There are admitted limits to both western medicine and herbal medicine. Those whose health seems to benefit the most are individuals who combine the strengths of both disciplines. To evaluate the potential of herbal medicine in the western setting,"

"As more professionals in both the fields of western medicine and alternative healthcare recognize how these disciplines can help one another, the use of herbs alongside pharmaceuticals will continue to grow. Western medicine has been making great strides in developing a drug regimen that will see a greater percentage of people triumph over Hepatitis C. Until a cure is ensured for everyone with HCV, people will be searching for ways to keep their liver healthy. "

I would concur with these sentiments.  Sloan Kettering Cancer Centre's website is a source I used frequently while on treatment to come up with supplements that would support my weakened immune system and they have a great database on such things.  I'd recommend it to anyone wondering about a particular herbal. They include information on what studies, if any, have been done.

Trish