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446474 tn?1446347682

AASLD - Milk Thistle Has No Medical Benefit accoring to Study

Herb Favored by Hep C Patients Has No Medical Benefit: Study

NEW YORK (Reuters Health) Nov 10 - "Milk thistle extract, an herbal supplement popular among patients with chronic liver disease, had no benefit for hepatitis C patients, a new study found.

In a randomized multicenter trial, milk thistle-the botanical compound silymarin-did not beat the placebo at improving liver function test results.

"The study was not able to document specific efficacy in hepatitis C virus," said Dr. Henry Bodenheimer, Jr., a hepatologist at the Beth Israel Medical Center in New York City who chaired the study's data safety monitoring committee.

"Milk thistle is also used in many other forms of liver disease, but has not often been systematically studied," Dr. Bodenheimer added in an email to Reuters Health.

Dr. Michael Fried, at the University of North Carolina at Chapel Hill, who led the study, presented the results November 8 at the American Association for the Study of Liver Diseases annual meeting in San Francisco.

Patients take silymarin as an alternative to, or to supplement, conventional HCV therapy, which can be toxic and have a limited effect, Dr. Bodenheimer said.

Accordingly, Dr. Fried's team restricted the study to 154 hepatitis C patients who had not responded to interferon therapies. The patients also had serum alanine aminotransferase (ALT) enzyme levels greater than 65 IU/L, with a median of 106 IU/L. A normal level is 45 IU/L, Dr. Fried's team writes.

The researchers randomly assigned the patients to one of three groups, two of which took high doses of a standardized form of silymarin at 420mg or 700mg three times daily. The third group took a placebo.

The silymarin doses in the study were 4.5-7.5 times higher than customary, the researchers said in their abstract for the meeting. The doses were chosen based on results of an earlier phase I study.

Of the 138 patients who completed the 24-week study, 90% were able to adhere to at least 80% of the pill regimen. In spite of the compliance, however, the mean drop in serum ALT was not significantly different between the three groups. And only two patients in each group met the primary endpoint, either normalization of ALT or a drop of at least 50% from baseline.

Silymarin is a polyphenolic flavenoid that, in vitro, is an antioxidant and anti-inflammatory. Its pharmacokinetics in this study, and its effect on hepatitis C virus RNA, have not yet been reported.

"In my experience, the use of this agent is patient driven rather than being prescribed by physicians," Dr. Bodenheimer said."

Hector
46 Responses
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223152 tn?1346978371
I am actually glad to see a study on this.  I am sure the milk thistle market is quite large and I have always wondered if there is really any benefit.  I am sure those that think it helps will continue to take it and stand by it.  However, I shall not bother with it now.
frijole
Helpful - 0
1894559 tn?1321969656
“Milk Thistle Has No Medical Benefit” – perhaps in regard to improving liver function test results. BUT, milk thistle or silymarin does reduce progression from fibrosis to cirrhosis. Liver health is most important and hepatitis C patients can live with fibrosis their entire life… Reference:
Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial, http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2010.04503.x/pdf

Helpful - 0
Avatar universal
Thx. Hector..I had read this a few days back ,and the sentence that stood out  to me was the last one where the doc said  "this  agent is patient driven"

Will
Helpful - 0
979080 tn?1323433639
thanks Hector,
I was waiting for the results on this study.
Some earlier studies already showed no improvement in liver function
but since the active compound of milk thistle (Silibin) does have a strong
(at least temporary)  anti viral effect when given by IV  , it was still
hoped for that larger oral dosis like 700mg  3x daily would show some effect but apparently not.

b
Helpful - 0
163305 tn?1333668571
I don't believe anything I read from Reuters. They've proved themselves to be inaccurate too many times in the past.
Helpful - 0
1794638 tn?1345155061
I never did take milk thistle, however my GI has been trying to get me to take it for 10 years.    I always did hear good things about it though,  not so sure I believe this information.  
Helpful - 0
446474 tn?1446347682
"Liver health is most important and hepatitis C patients can live with fibrosis their entire life".

I am not sure how you come to take conclusion based on the study? Can you tell me how you came to that conclusion "patients can live with fibrosis their entire life" from this study? When the study Conclusions states "Silymarin use.. has no impact on clinical outcomes."

The HALT C trial included stage 3 (advanced fibrosis) and stage 4 (cirrhosis) patients that failed treatment. For all including those with stage 3 bridging fibrosis "No effect was seen for clinical outcomes." Meaning they progressed to stage 4 and End-Stage Liver Disease at the same rate as those that didn't use Silymarin. Also as the study suggests that future study needs to be conducted to see if the results are "As our results are from an observational study, it is possible that the observed beneficial effect on liver disease progression is due to chance." And "Importantly, our results do not support the use of ad hoc dosing of silymarin by patients
with chronic liver disease."

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"Methods
Patients recorded their use of silymarin at baseline and were followed up
for liver disease progression (two point increase in Ishak fibrosis score
across baseline, year 1.5, and year 3.5 biopsies) and over 8.65 years for clinical outcomes.

Conclusions
Silymarin use among patients with advanced hepatitis C-related liver disease is associated with reduced progression from fibrosis to cirrhosis, but has no impact on clinical outcomes.

In the HALT-C trial, use of silymarin was associated
with Caucasian race, completing college and a higher
SF-36 physical quality of life score, suggesting that
silymarin use might be a marker for a large number of
other lifestyle factors. We adjusted our risk estimates for
these and other possible confounders. After adjustment,
risk estimates were only modestly altered. In addition,
the observed effect of silymarin does not simply reflect a
propensity to use herbal products. Using herbal products,
other than silymarin, had no association with either
histological progression or clinical outcomes in our
study. Nevertheless, as an observational study, the
inverse association observed between silymarin use and
histological progression could reflect another exposure or
chance. We did not have any information on brand or
dosage of silymarin. However, this limitation is reflective
of the difficulty in detailing patient behaviour outside
controlled studies. Many, if not most, patients with currently
incurable liver disease seek alternative, unapproved
therapies that cannot be easily quantified, yet
deserve evaluation.

In summary, among individuals with advanced hepatitis-
C-associated liver disease, we observed an inverse
association between silymarin use and the progression of
liver disease from fibrosis to cirrhosis, but no evidence
for an effect on clinical outcomes. As our results are
from an observational study, it is possible that the
observed beneficial effect on liver disease progression is
due to chance. Future studies with a comprehensive
assessment of silymarin dose are needed to replicate
these findings. Nevertheless, our results provide support
for conducting additional studies of silymarin, including
intervention trials with defined dosage regimens and
standard silymarin product. Such studies would be most
appropriate for patients who have not responded to or
are not candidates for anti-viral therapy and have limited
other treatment options. Importantly, our results do not
support the use of ad hoc dosing of silymarin by patients
with chronic liver disease."

Hector
Helpful - 0
Avatar universal
Thanks for the info Hector!  I've been popping milk thistle ever since I was diagnosed....lol.  Guess it was a waste of money.  I think I will save that money for my upcoming co-pays for treatment.
Helpful - 0
1894559 tn?1321969656
Hector: Thank you for your thoughtful response and additional information. No, I did not base my conclusion "patients can live with fibrosis their entire life" based on this study. I based it on my reading of various studies over the years including work done in Europe.

Yes: 1) silymarin use might be a marker for a large number of other lifestyle factors;  2) quality clinical studies are not available that accurately measure clinical outcomes and quantify the quality of the silymarin used; etc.
There may not be evidence-based studies to prove positive “clinical outcomes” from silymarin use for patients with hepatitis C… But we do know from many observational studies that silymarin is a non-toxic herb and is hepaprotective. This is from hundreds of years of use. If an herb protects the liver and hepatitis C virus damages the liver – it seem appropriate to advocate the ad hoc dosing of silymarin by patients with chronic liver disease.  

And, if we were to explore herbology and phytotherapy in more detail we would see many instances of healing from nature’s herbs – you can call it observational or chance or even placebo effect. The reality is silymarin use: 1) can cause a beneficial effect on liver health;  2) can slow the progression of fibrosis to cirrhosis;  3) can improve clinical outcomes in people with hepatitis C. Can positive results be verified using evidence-based (scientific) evidence? Answer: not at this time. However, this also does not prove that silymarin use is not useful.
Helpful - 0
408795 tn?1324935675
The reality is silymarin use: 1) can cause a beneficial effect on liver health;  2) can slow the progression of fibrosis to cirrhosis;  3) can improve clinical outcomes in people with hepatitis C.
____________________________________________________________
Maybe it can cause a beneficial effect on a normal healthy liver but for my HepC ridden liver it is of no benefit.  The only benefit that MT has is an effect on mental health meaning it will give you a sense that you're taking something that's beneficial to your health and make you feel better especially if you are under a doctor’s care who preaches that information.  Besides that, it would be nice if you reference your ideas to back up what you're saying.  Heck, even the bottle in the upper right hand corner of this page says, "Help Support A Healthy Liver".  
Helpful - 0
979080 tn?1323433639
The key problem I believe is absorption. When given via IV`s Silibin
works like a natural PI.
Helpful - 0
1491755 tn?1333201362
That study said no effect.
Helpful - 0
1689583 tn?1387752394
My hepc doc told me the same thing , save your money
Helpful - 0
Avatar universal
I have to wonder if there isnt some financial interest involved. When I did my first tx my legs broke out in a rash, little red dots that werent raised and did not itch just looked bad. My Dr told me it was from riba and not all that uncommon, and that African people get the same type of rash, only it looked more like figure 8's than round spots. I didnt think much of it. I dated a girl that  was.....well a hippie (no offense) anyway she talked me into puting lavender oil on there, and it was gone in 24hrs. I told the Dr and he laughed it off. I was a little put off as I knew what had caused the change. Being a child of the 60's and 70's I have a very hard time trusting what I am told by anybody with financial interest in anything. Please dont miss the point, I am a very conservative person in my older years, I just dont beleive everything THEY tell me. Food and Drug Administation? Alcohol Firearms and Tobacco? All seems a bit scetchy to me.
Helpful - 0
1523804 tn?1316560909
Worth noting that with all the patients in the test, interferon and riba had no significant benefit either.

So I guess from this trial we can conclude that milkthistle and SOC are equally effective  for a certain percentage of chronic HCV patients in as much as their ALT, AST numbers will not come to normal range by taking either.

As for the rest of HCV  patients, and if there is any other benefit, we still don't know.


"Milk thistle extract, an herbal supplement popular among patients with chronic liver disease, had no benefit for hepatitis C patients, a new study found."

Seems a little broad and general based on this study.


.
Helpful - 0
1116669 tn?1269143266
For whatever it is worth: Dr. Bodenheimer is my hepatologist and is a pretty grounded, open minded, and unprejudiced guy. Although irrelevant to the study per se I thought I would report on one of the reporters. d
Helpful - 0
1765684 tn?1333819168
No financial interest in "nutraceuticals"?

Haha...  That's awesome.  ;)
Helpful - 0
Avatar universal
Little surprise to me....I have come to the belated opinion that maybe about 99.9% of the OTC supplement market, whether vitamin, herbals, minerals, hormonals, etc. etc. are little more than opportunities to drain countless dollars down the toilet each day.  I think recent medical studies are proving this market to be a big marketing con.  I have to admit there were many years when I cam home from GNC with my monthly bag of supplements costing  $200 - $300 dollars.  I was either desperate or just gullible (which I really hate to admit).  I would bet, if I had to bet it all, that taking all the recommended and touted supplements contribute next to nothing to our daily functioning and health.  Of course the OTC Supplement industry has become just that...AN INDUSTRY!  And guess who's getting rich...and healthy?  Not us....THEM!!!  Give me the billions spent on supplements and I will be healthy and happy for sure.   I fear that in this modern world, we are all subjected to constant and countless scams....and unless you really look at it all critically and with a cold rational mind, you can go down almost any strange path just because of great marketing.

Bye-Bye Milk Thistle.  Wonder how much they made off that stuff?

Sorry if I have offended those who disagree....but this ex-supplement freak has seen the light in recent years.  No more scams for me.

DoubleDose
Helpful - 0
979080 tn?1323433639
when following this thread I noticed a tagged ad for
Puritan`s Pride Milk Thistle keeps popping up.  lol
Helpful - 0
1747881 tn?1546175878
Irony at it's best.
Helpful - 0
Avatar universal
There are many more studies that prove MT does help the liver. Including protecting from alcohol and acetaminophen poisoning.
Helpful - 0
Avatar universal
Do you have any of those studies handy? If so could you post them as I've been thinking about starting MT again. thanks, jm
Helpful - 0
163305 tn?1333668571
Silyamarin, the active ingredient is available overseas from a company in Germany. It seems to be accepted there as beneficial to the liver.
Helpful - 0
1689583 tn?1387752394
What natural remedies cured Naomi Judd ?
Helpful - 0
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