Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.

[Admin]

BACKGROUND: Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases. OBJECTIVES: To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C). SEARCH STRATEGY: TheCochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (December 2003). Manufacturers and researchers in the field were contacted. SELECTION CRITERIA: Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. DATA COLLECTION AND ANALYSIS: The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality. MAIN RESULTS: Thirteen randomised clinical trials assessed milk thistle in 915 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered adequately double-blinded. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50). AUTHORS' CONCLUSIONS: Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.

Rambaldi A, Jacobs B, Iaquinto G, Gluud C.

Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7102, H:S Rigshospitalet,, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, DENMARK, DK-2100.


PMID: 15846671 [PubMed - in process]

[mari]

Thie following is a quote from another are of this site:
"Milk Thistle for the Treatment of Liver Disease - Hepatitis and Beyond:
Milk Thistle has been found in recent years to be a major player in the treatment of Liver Disease. Because it helps lower enzyme levels and facilitates the liver in its process of detoxifying the body. Among all known herbal remedies, Milk Thistle finds its place as the leader in herbs to treat liver disease. Physicians have prescribed Milk Thistle for Hepatitis to keep down inflammation, Cirrhosis to soften the liver, Liver Cancer to aid in detoxification, and many dysfunctions of the Gall Bladder System. It also helps protect the liver for those individuals that are taking prescription medications known to elevate liver enzymes."

Do I take it that Milk thistle is no longer going to be helpful? According to the new post, it pretty much is saying that milk thistle is of no use to Liver disease. Hard to make sense of it when I am having a hard time understanding it. Your insight would be helpful in making me muddle through. Thank you,
Mari

[Admin]

I do my best to try and post all clinical trials and all summary materials that becomes available to the public.  One of the reasons that people see doctors is that "studies" and "reports" although intending to be scientific and logical, often have many holes in them.  A physician is supposed to be able to critically analyze these studies.  So, I'll do my best:

This particular post states:

  The methodological quality was low:  only 23% of the trials reported adequate allocation concealment and only 46% were considered adequately double-blinded.

The abstract also states that:

Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19).

Questions that come up for me are:
1) Did the mortality rates occur during the studies, or were they follow up rates of participants post study?
2) If post study, did they continue to take Milk Thistle?  If so, how much?  If the hepatitis was alcohol induced, did they continue to drink?
3) They do not define a high quality study, nor did they specify what the cause of death was (drugs, car accident, heart attacks?). 
4) They indicated that double blind is high quality, but not what dosage was used for the studies that are "high quality." nor how ill the patients were that joined these studies. 

What jumps out at me as being very positive is:

Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50).

So, to summarize, I post all studies I find.  Some indicate skepticism, which is very healthy, especially where physician's are involved in making decisions for their patients.  Skepticism is the foundation of good science. 

In my work, I have only seen Milk Thistle benefit the liver when taken over a normal course.  It does help keep the inflammation in the liver to a minimum in all studies I have read and in all clients I have worked with, and helps in detoxifying the body so those that are suffering can live a more healthy and happy life.  Many studies even indicate that it protects the liver cells from toxins, helps with pancreatitis, and prostatitis, and...). 

That said, there are skeptics, and the only real truth is how each person's body (and liver) responds.  I hope that this answers your questions.  Let me know if I did not answer your question completely.

[Ray]

what dose should be taken of milk thistle.  The products i have seen vary in strenghts

thank you

Ray

[Admin]

Here you go: Milk Thistle Dosage