Herbals in clinical trials are not allowed...

[susan400]

I was checking on some more clinical trials today and I did talk to another study nurse (don't have any idea the name of the drug), she was in Gainesville.  Anyhow, of note, she asked me if I was taking any supplemental and/or herbals.  I'm not and I told her that I was not.  But, I want to note, that the nurse at the Vertex study asked me the same question.  Both of these nurses told me that if you are using herbs, that you won't qualify for the clinical trial.  I thought that was interesting.  I just thought that I should put that out there in case anybody is doing herbs and they are contemplating looking into a clinical trial.  She asked me specifically about milk thistle.  I don't take milk thistle so it was not an issue.

Susan

[r4c7]

I'm looking at the Roche PROGRESS trial, and I do take milk thistle and chinese herbs.  However, no one has raised an issue--yet.  

I did ask a resident hepatologist about herbs and whether I would have to discontinue them before entering the trial.  She said she didn't know.  

Anyone else know anything?

Thanks for the post Susan400.

[andiamo]

Milk thistle is on the list of things that may change the exposure to VX 950.  I assume that means VX 950 won't metabolize properly in combination with milk thistle.

[rosebud57]

i don't even know why i am responding to this its not like i really know... but i think that the herbal remedy because they do have some action on the body will muck up their results.  

[Forseegood]

Yeah, milk thistle and some other herbals are known to clean certain liver pathways, etc. that might be good for you ordinarily with liver disease, but like Rosebud says, it could potentially "muck up" their studies cause using them won't give them a clean overview of what their drugs do by by themselves...

here's a brief summary (from the National Cancer Institute) of milk thistle's potential benefits...(this is controversial because we're talking about potentials because not enough non-human studies,)(I can't take it, allergic) once again, I'll say (for the herbal haters out there, ha ha!) this is no cure, just could potentially help...

Laboratory studies demonstrate that silymarin functions as a potent antioxidant, stabilizes cellular membranes, stimulates detoxification pathways, stimulates regeneration of liver tissue, inhibits the growth of certain cancer cell lines, exerts direct cytotoxic activity toward certain cancer cell lines, and may increase the efficacy of certain chemotherapy agents.

[jmjm530]

Thanks for bringing this to our attention, especially to those considering entering a trial.

As to Milk Thistle, the jury appears to be still out, even for those not contemplating treatment,  but for those on or near treatment, many of us here have reported that  their doctors told them to stop taking milk thistle. Since this advice has been given to patients on SOC, I assume it is because it may interfere negatively with the treatment drugs, and hurt their chances of SVR.  

Here's an article from the Advocate on Milk Thistle in general, which adds further confusion to the issue of whether Milk thistle helps or doesn't.  
http://www.hcvadvocate.org/hepatitis/hepC/hs-11.html

Some exerpts from two separate studies:

"...The authors reviewed 13 randomized clinical trials with a total of 915 participants conducted through December 2003. On the whole, milk thistle or its components had no significant effect on all-cause mortality, liver disease complications, or liver tissue health..."

[machineman1989]

Lets keep in mind drug companies are in doctors pockets.Read 15000 a month for a product with a 50/50 chance.Milk Thistle is 30.00.While I am on this thread what else is there to help?

[FlGuy]

If the $15,000 is the cost of hcv treatment - I think that's a little high.  If the 50/50 is the chance of getting to svr with those meds, I think that's a little low.

[Forseegood]

Silymarin Retards the Progression of Alcohol-induced Hepatic Fibrosis in Baboons

Hepatoprotective effects of silymarin in patients with alcoholic liver disease are controversial. For strict control, this evaluation was conducted in non-human primates by researchers at the Bronx VA Medical Center & Mount Sinai School of Medicine, Bronx, New York.

Twelve baboons were fed alcohol with or without silymarin for 3 years with a nutritionally adequate diet.

Silymarin opposed the alcohol-induced oxidative stress (assessed by plasma 4-hydroxynonenal) and the rise in liver lipids and circulating ALT.

Alcohol also increased hepatic collagen type I by 50% over the 3 years with a significant rise in mRNA for alpha 1 (I) procollagen, both prevented by silymarin.

There were corresponding morphologic changes: at 36 months, 2 of 6 animals fed alcohol had cirrhosis and 2 septal fibrosis, with perivenular fibrosis in 2, whereas with alcohol + silymarin, there was only 1 cirrhosis and 1 septal fibrosis, with perivenular fibrosis in 2, and virtually no lesions in the remaining 2.

The authors conclude, "Silymarin retards the development of alcohol-induced hepatic fibrosis in baboons, consistent with several positive clinical trials. The negative outcome observed in other trials possibly reflects poor compliance resulting in irregular or low silymarin intake.

"Thus, in view of the innocuity of silymarin, it might be advisable in future clinical studies to insure the controlled administration of sufficient amounts of silymarin."

10/31/03

Reference

CS Lieber and others. Silymarin Retards the Progression of Alcohol-Induced Hepatic Fibrosis in Baboons. Journal of Clinical Gastroenterology 37(4): 336-339. October 2003.

[Forseegood]

Benefit of Milk Thistle for Liver Disease

    * Sixteen prospective trials were identified. Fourteen were randomized, blinded, placebo-controlled studies of milk thistle's effectiveness in a variety of liver diseases. In one additional placebo-controlled trial, blinding or randomization was not clear, and one placebo-controlled study was a cohort study with a placebo comparison group.
    * Seventeen additional trials used nonplacebo controls; two other trials studied milk thistle as prophylaxis in patients with no known liver disease who were starting potentially hepatotoxic drugs. The identified studies addressed alcohol-related liver disease, toxin-induced liver disease, and viral liver disease. No studies were found that evaluated milk thistle for cholestatic liver disease or primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma).
    * There were problems in assessing the evidence because of incomplete information about multiple methodologic issues, including etiology and severity of liver disease, study design, subject characteristics, and potential confounders. It is difficult to say if the lack of information reflects poor scientific quality of study methods or poor reporting quality or both.
    * Detailed data evaluation and syntheses were limited to the 16 placebo-controlled studies. Distribution of durations of therapy across trials was wide (7 days to 2 years), inconsistent, and sometimes not given. Eleven studies used Legalon

[nygirl7]

Said: Lets keep in mind drug companies are in doctors pockets.Read 15000 a month for a product with a 50/50 chance.Milk Thistle is 30.00.While I am on this thread what else is there to help?


But remember - a 50/50% chance of a CURE.  You get no chance of a cure with milk thistle or any other herb or vitamin or potion in this world.

So that $15,000 (?) a bit high to me too - but - worth every penny for those who do get CURED of this disease.

That's the way to think about it really.  The $30 a month...you don't even know if it's doing anything, really.

[nick m]

On vertex trials no herbs allowed. Its obvious common-sense stuff. For a drug trial they need to ascertain as clearly as possible the efficacy, or not, of the drug they're testing. Naturally, they can do this best without other substances like milkthistle or chinese herbs that may contra-indicate. They brief you on what you can or cannot take when they initially screen you for any drug trial. You don't have to divine it out of the ether (or the internet). Neither is it applied retrospectively. Good to remember too - the trials aren't compulsory. You can just do herbs or colloidal silver or vitamin C. Your choice. best wishes nick

[susan400]

I didn't say that I did milk thistle.  I don't do any herbs, including wacky weed.  Milk thistle aggravates my allergies.  I basically was just warning those who are doing the herbs that if they have any notions of trying to get into a clinical trial, they need to stop their herbs first.

Susan

[Forseegood]

I understood you, I don't do milk thistle too because of my allergies...I was just talking about milk thistle in terms of why it would be exnayed off the list at trials...hope you have a great weekend!