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."
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.
“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
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.
"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."
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.
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
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: 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.
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".
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.
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.
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
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.
one of the problems I have with all supplements in the United Sates is that there is no oversight and you do not know what you are getting. Just because it says Milk Thistle, does not mean there is any in there.
Also, there might be many studies that show MT is beneficial, but I have not seen one that was not paid for my one of the herbal companies.
sorry if i enter in this hcv community, liver function tests have extremely very very poor sensibility as regards liver function and i know this because i have advanced cirrhosis and all blood tests normal, dispite this some liver function are not ok and only improving lately after fibrosis is almost gone
anyway these antioxidants combos (only those natural extracted, none synthetic) have antifbrotic effect that you measure by every 4 months monitoring of fibroscan, i got from 16.3kpa to 6.3kpa in less than 18 months by antioxidants and i am hopeful to see also nodules gone in a few years.
the only test, still at statistical gathering values but already proven to work, is the breath test.you can predict death very precise only by this test, blood test sensitivity is ridiculous at death prediction or liver function in depth monitoring.when blood tests are abnormal the liver is already in very bad stage and in any case every doctor uses a mix of many liver parameters exactly to have an idea of function since every single blood test senibility is very poor
by the way the research is also extremely ridiculous,alt cannot be used to measure liver damage any more, dont know about hcv but on hbv they are not used anymore as a mainmean of liver damage since normal alt have liver damage anyway
i also regressed my cirrhosis with abnormal alt at 30-50, studies on cirrhosis regression have already shown no relationship between normal alt and cirrhosis regression.people with low alt may not regress and people with alt 50-60 may regress (of course alt 100 are not good for regression), little more sensibility can be obtained from platlets and PT and of course viral suppression, all other parameters have little effect on fibrosis regression and improvment of liver function (last pages of document posted
as somebody said earlier reuters journalists have same knowledge of medicine as a barman....really the last place where to look at.
also source of these antioxidants is very important because they must be food extracted and food source and extraction standardization is very poor on most supplements.the synthetic ones are cheaper and easy to make standard dose but often very poor effect
in my experience antiviral and virus und made no difference while antioxidants made a hie difference on life quality
I really wander, how comes, that all those previous clinical studies, that has been done many years ago, can wipe out just one article like this. Does that means, that we are all prone to believe in everything we read, and can be manipulated, just like that. I would just like to mention to anyone who is trying to play with our health , can realy face a boomerang.
I still believe in healthy effects on liver, of Milk Thistle!
Now..... if you read through these links you will see that milk thistle seems to have anti-viral properties and indeed IS useful and potentially beneficial to those of us w/ HCV.
You'll also note that the above studies were done with IV milk thistle. The reason being that MT is not well absorbed, but that there are different and more expensive forms which may aid in these benefits being made via oral preparations. ie; the most expensive stuff available will be more beneficial than the cheap stuff one may buy at Walmart.
So I object to the title being used; if they mean oral preparations, they should make that distinction.
If you read the links I provided they say exactly what product was used, whereas the article does not make that clear; Walmart or the same preparations used in Europe?
How would one construct a study on MT?
Well.....given that the drug had proven.....or at least had evidence to have anti viral properties, then one might check viral load of trial participants. Did the study do this? The study provides no data on this, and so one may surmise that they either did not do it or chose to not publish it. Either way, I am not impressed.
The cornerstone of the findings seems to be that the ALT scores see little difference between the control and MT group. The actual scores are not published, nor is the rather large leap of faith that ALT scores prove that Milk thistles benefits (or lack thereof) can be judged upon the one score.
I think I would find the study more compelling if the type of MT was listed, the dosage listed, the scores of each group listed.
I think that knowing that oral uptake of MT is limited, and so that a longer term study might be useful before rendering the verdict that the compound had no medical benefit. What other types of measurement tools might they have used before rendering their edict?
As mentioned, if they meant oral preparations, they should say so.
If they mean that MT is not beneficial to ALT scores. They should be more specific.
"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 preparation they took, for all we know, came from Walmart and was made from stems, not the product used in Europe. Maybe they used the good stuff; we don't know and the article doesn't say.
A good study has many people in it and it lasts years, not weeks. To me it seems to reach a conclusion.....a blanket statement about a compound..... with evidence to have benefit in a short period of time, using possibly inferior MT, and using poor measurement tools to reach ones conclusions.
IMHO...... not all studies are GOOD studies. I am underwhelmed, but with better documentation I might be more impressed with their conclusion.
I'd love to read the actual study instead of an article. and......
"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."
I can't tell, but that means that if there were 2 MT arms, then 4 patients were able to reach the endpoint of;
"either normalization of ALT or a drop of at least 50% from baseline."
One may conclude that there were others in the trial who were "improved" but who did not meet the "primary endpoint", meaning I suppose, that their improvements might be considered ....insignificant?
One has to wonder what would happen over the course of years and what other vital effects could be seen on staging, mortalities, viral load, or other signs of health or co-morbidities that are associated w/ HCV.
It just raises questions for me, rather than confirms much of anything.
Just my 2 cents.
I took 600-700 mg per day during the summer months. 6/28/11 ALT 132 AST 84 Bili. 1.1 On 8/1/11 ALT 98 AST 55 Bili. 0.7 Then I stopped taking it around 8/10/11 to be screened for a trial study. On 8/31/11 I had blood drawn ALT 115 AST 73 Bili. 1.3. It must have been working for me.
However, elevated levels of ALT do not automatically mean that medical problems exist. Fluctuation of ALT levels is normal over the course of the day, and ALT levels can also increase in response to strenuous physical exercise.
I'm not sure that ALT is the gold standard in determining benefit.
I think my response was based somewhat upon a paper (not the actual study itself) which seems to be driving patient use; people read the article and conclude "Oh, I won't take that."
Whereas..... in Europe MT is prescribed by doctors; *not* patient driven.
I think it is entirely fair to say that not all MT is the same; some could be useless.
Life extension has a silymarin product that is very absorbable. If you search their site there are many studies/articles supporting the benefits for the liver.
It must have some type of effect on the liver because it is used for people who overdose with acetaminophen ,alcohol etc.
Hello...Im 13weeks in tx.9 with Victrellis..tested und at week 4. I take my Milk Thistle (cheap stuff) for liver function and psoriasis. This tx is known to make psoriasis worse and it did. I have an advantage, visually in gauging the benefits of MT and I see my flare ups become better with certain brands of Milk Thistle.
Ive never spent more than $15 on a bottle-usually half that, so we are talking cheap stuff. I avoid blends(liver aid and such) as they can have dandelion in it and that can affect people with seasonal allergies like myself negatively. I liked the results with Rexall brand and Spring Valley (walmart). Im a believer in taking milk thistle personally as anything bad for my psoriasis eg: alcohol, sugars, dehydration is also known to be bad for my liver so Im assuming that it works the other way around. If Im improving my psoriasis with nutrients, water, and diet then its probably helping my liver also. Good Luck All!
The issue is that many oral forms of MT are not readily absorbed, therefore perhaps have "no medical benefit". (I think more accurately less medical benefit, due to reduced absorption)
I take issue with the wording of the thread and the wording of the study. If they mean ORAL FORMS of MT perhaps they should say so.
I also question if the simple reading of LFT's in a short period of time definitively proves anything. In all likelihood the effect of a good quality brand of oral MT could have an effect over time. It could have an effect on damage progression over time, it could ward off other extrahepatic/co-morbidity issues, but once again, a long term study was not done and the only litmus test was LFT scores.
The fact that Milk Thistle is also an anti-oxidant could be important, especially over time. It is theorized that this could be one of the components of coffee that help it to both reduce damage progression as well as increase the success rate of TX.
To that end...... if you read the provided links in my earlier post you'll not that IV milk thistle has anti-viral properties and functions as a polymerase inhibitor....... which makes me wonder what the effect would be of adding it to a protease inhibitor w/SOC.
Does it help? Could it hurt? I'd like to see studies on this. One of my friends after failing TX twice, lost weight, boosted her Vit D, added Milk thistle and exercised. On her third TX (SOC; NOT triple therapy) she was an RVR and is now SVR.
Just saying....... what you once were does not always define what you can be.
They are always trying to get us to buy stuff to make us feel better, I can save money on the milk thistle thing, yeah I was a sucker too. I was taking it religously don't feel any better for it. all you can do is have highly nutritious foods and excercise as much as you can if you can. I know for me I so darn tired its hard to even just walk down the block. also becareful of the current treatment that stuff really messed me up and my life, I know have other diseases thanks to interferon and ribavirin, I was much healthier before. Waiting for new treatments now is my only hope and waiting to see what the new guinea pigs say. remember its all about money. You'll be bombarded by products. All you really need is a good juicing machine, you'll feel better. Also if you are male get your testosterone checked the treatment zaps that, I can't even produce it anymore so have to buy it and its expensive, but when I do take it the depression goes and I feel so much better even though im sick my moods are great. Take care and wish you all health.Please don't tell anyone to do treatment at all costs unless they are badly sick, thats up to them and there loved ones, I see so many ppl coming into hep c gorup and the curse out the whole group cause nobody was honest with them abou thow bad this tx can get.
As always, please consult with a doctor before starting any new medication, traditional or alternative or supplement.
Treatment decisions are absolutely between a patient and a doctor, and it isn't up to anyone else to tell them to use traditional treatment, or wait, or try something else, but please understand that some people absolutely need the SOC to live. It's important that people understand that some have minor side effects, and others may have more serious ones, but for some, this is the only chance they have to fight and stay alive.
Well, I beg to differ that it won't make a difference. Not always but absolutley it can! Western medicine vs Eastern medicine vs alternative therapies VS HUGE PHARMACEUTICAL COMPANIES! I will continue to take it @ $15 a month PURE and hoepfully keep liver enzymes as normal as they are. MDs DON'T know it all...Even though they think they do!
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