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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
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
http://en.wikipedia.org/wiki/Alanine_transaminase
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.[1]
=================================
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.
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.[1]
=================================
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.
ALT/AST fluctuate. Also Consider maybe ML prevents the production of ALT/ AST, how exactly does it work?
As the study says it's patients who drive the use. Kind of like saying they know more than scientific studies, and the liver than the AASLD.
As the study says it's patients who drive the use. Kind of like saying they know more than scientific studies, and the liver than the AASLD.
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.
I lean more in agreement w/ Stef on this. I have a number of issues with the article. I have not seen the study and so i will address the issues presented in the article.
I'm not sure if the title of the article is the title of the paper presented but it is a vast oversimplification, poor choice of words, or possibly false.
I believe that milk thistle may have a few possible benefits and I believe if these benefits exist, then some verbiage should be changed in the article.
Milk thistle has been used in various types of liver damage to some benefit, but lets limit this to HCV damage.
Below are links in which milk thistle demonstrated HCV antiviral properties;
http://www.natap.org/2008/HCV/090808_01.htm
http://www.kenes.com/easl2009/Posters/Abstract517.htm
http://www.hcvadvocate.org/news/newsRev/2010/HJR-7.4.html#2
================================
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.
willy
I'm not sure if the title of the article is the title of the paper presented but it is a vast oversimplification, poor choice of words, or possibly false.
I believe that milk thistle may have a few possible benefits and I believe if these benefits exist, then some verbiage should be changed in the article.
Milk thistle has been used in various types of liver damage to some benefit, but lets limit this to HCV damage.
Below are links in which milk thistle demonstrated HCV antiviral properties;
http://www.natap.org/2008/HCV/090808_01.htm
http://www.kenes.com/easl2009/Posters/Abstract517.htm
http://www.hcvadvocate.org/news/newsRev/2010/HJR-7.4.html#2
================================
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.
willy
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!
I still believe in healthy effects on liver, of Milk Thistle!
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
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B_yFgxI8KNcRYTA2OTRkMmUtYzlmOS00MjgyLThmNjgtYWUyOWI1ZTJjYmFm&hl=en_US
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
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