Milk Thistle has been marketed as a herbal supplement having a  protecting benefits on the liver, they claim milk
thistle can even regenerate the liver cells in most liver diseases such as cirrhosis (hardening of the liver), jaundice
and hepatitis (inflammation of the liver), cholangitis (inflammation of bile ducts resulting in decreased bile flow). Milk
Thistle is also marketed as a preventative medicine to protect each cell of the liver from incoming toxins and
encourage the liver to cleanse itself of damaging substances, such as alcohol, drugs, medications, mercury and
heavy metals. Milk thistle is also promoted as an agent which can cleanse and detoxify  overburdened and stagnant
livers, strengthen and tonify weak livers.

Milk thistle is also suggested to be used as a gentle and mild laxative, as it may be able to increase bile secretion and
flow in the intestinal tract. This herb is also claimed to be able to lubricate and soften the stools to a mild laxative
effect- a balance between constipation and diarrhea.  However, scientific supports to these claims are limited. In the
following section, we review what scientists found about milk thistle extracts - benefits based on lab studies.
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Milk Thistle Extracts Benefits Clinical Evidence - ZHION.COM
zhion@zhion.com July 27, 2011
Human/Clinical Studies

Current Clinical Trials

Two published case reports describe the use of milk thistle as either a treatment or an adjunctive therapy in individuals
with cancer. One case report describes the use of milk thistle in a 34-year-old woman with promyelocytic leukemia.[1]
The investigators administered 800 mg of silymarin during the patient’s maintenance therapy, which consisted of
treatment with methotrexate and 6-mercaptopurine. During the 4 months of treatment with silymarin, the patient who
previously required intermittent breaks in therapy due to abnormal liver enzyme levels had normal liver enzyme levels
with no further interruption of therapy. A second case report describes a 52-year-old man with hepatocellular carcinoma.
[2] The patient began taking 450 mg of silymarin per day, and spontaneous regression of the tumor was reported in the
absence of initiation of anticancer therapy.

In a double-blind, placebo-controlled trial, 50 children who were undergoing treatment for acute lymphoblastic leukemia
and who had chemotherapy -related hepatotoxicity were randomly assigned to receive silymarin or placebo for a 4-week
period.[3] Four weeks following completion of the intervention, the silymarin group had a significantly lower aspartate
aminotransferase (AST) (P = .05) and a trend towards a significantly lower alanine aminotransferase (ALT) (P = .07).
Fewer chemotherapy dose reductions were observed in the silymarin group compared to the placebo group; however,
the difference was not significant. No adverse events were reported.

Most clinical trials of milk thistle have been conducted in patients with either hepatitis or cirrhosis. Other studies have
investigated milk thistle in patients with hyperlipidemia, diabetes, and Amanita phalloides mushroom poisoning. Ten
randomized trials [3-12] have been reported in patients with hepatitis or cirrhosis, and one randomized trial has reported
the use of silymarin as a prophylaxis to iatrogenic hepatic toxicity.[13] Endpoints for these trials have included serum
levels of bilirubin and/or the liver enzymes AST and ALT, as higher levels are an indicator of liver inflammation, damage,
or disease. The lowering of these serum levels is a sign of an improving condition. In patients with hepatitis A and B,
one clinical trial found silymarin (140 mg daily for 3–4 weeks) resulting in lower levels of AST, ALT, and bilirubin by day
5, compared with a placebo group.[14] In another randomized, placebo-controlled study of patients with viral hepatitis B,
silymarin (210 mg daily) had no effect on course of disease or enzyme levels.[7]

A randomized, controlled trial supported by the National Institute of Diabetes and Digestive and Kidney Diseases
examined patients with chronic hepatitis C who had failed prior antiviral therapy. All patients had advanced chronic liver
disease consisting of histologic evidence of either marked fibrosis or cirrhosis. The Hepatitis C Antiviral Long-Term
Treatment Against Cirrhosis trial used a half dose of pegylated interferon versus no treatment; the treatment was to be
administered for 3.5 years.[12] The aim was to reduce progression of chronic hepatitis C, particularly in the
development of hepatocellular carcinoma. Among 1,145 study participants, 56% had never taken herbals, 21% admitted
past use, and 23% were using herbals at enrollment. Silymarin constituted 72% of the 60 herbals used at enrollment.
Users had significantly fewer symptoms and a better quality of life than nonusers.

Although there are many reports of the use of herbals for the treatment of chronic liver diseases, most treatment trials
have suffered from poor scientific design, uncertainty of the required dosage of herbals, and an insufficient number of
study participants. A recent review of complementary and alternative medications (CAM) to treat liver diseases focused
on the classification, epidemiology, and the philosophy of CAM and reviewed the criteria needed to conduct a
scientifically valid research study focusing on herbal products.[15]

There has been skepticism regarding the evidence that silymarin has a direct impact on the hepatitis C virus (HCV)—
some studies suggest that it does, but most studies are unable to confirm these reports. However, at least two articles in
major journals have suggested that silymarin or its congeners may inhibit HCV. In one report, investigators found that a
standardized silymarin extract inhibited tumor necrosis factor -alpha in anti-CD3–stimulated human peripheral blood
mononuclear cells and nuclear factor-kappa B-dependent transcription in human hepatoma Huh-7 cells.[16] Silymarin
also displayed prophylactic and therapeutic effects against HCV infection and when combined with interferon-alpha, was
more inhibitory of HCV replication than was interferon alone. This indicates that silymarin has anti-inflammatory and
antiviral effects in patients with chronic hepatitis C.

In a case series /phase I study, patients with HCV were treated with intravenous silibinin with and without PEG-interferon
and ribavirin.[17] In the case series, 16 HCV nonresponder patients were administered intravenous silibinin in a dose of
10 mg/kg/day for 7 days. Subjects then began treatment with oral silibinin in combination with PEG-interferon and
ribavirin for 12 weeks. At the end of the study period, all patients were positive for HCV RNA, but 5 of 13 completed
patients had reductions in HCV RNA. Significance was not reported. In the same study, the authors presented results of
a phase I study in which 20 patients were administered 5 mg/kg, 10 mg/kg, 15 mg/kg, or 20 mg/kg of silibinin for 14 days
in combination with PEG-interferon and ribavirin (initiated on day 8). A significant drop in HCV RNA was observed on
day 7 in patients administered the 10 mg/kg, 15 mg/kg, and 20 mg/kg doses of silybinin. Further declines were
observed in HCV RNA with administration of PEG-interferon and ribavirin. Except for mild gastroenteritis, intravenous
silibinin monotherapy was well tolerated.

In patients with chronic liver disease, a randomized, placebo-controlled study found normalization of serum AST, ALT,
and bilirubin levels after 1 month of treatment with the milk thistle chemical, silymarin (140 mg 3 times a day) in
comparison to treatment with a placebo.[18] In one of the largest observational studies involving 2,637 patients with
chronic liver disease, 8-week treatment with 560 mg/day of silymarin resulted in reductions of serum AST, ALT, and
gamma-glutamyltranspeptidase ([GGT], a marker of bile duct disease) and a decrease in the frequency of palpable
hepatomegaly.[19] Thus, people is believed milk thistle has some what benefits on people suffered from chronic liver
disease.

Another published report describes the use of silybinin as the only effective antidote in patients with liver damage from
Amanita phalloides (Fr.) Link poisoning.[20] Patients were administered doses of 35 to 55 mg/kg body weight, with no
reports of adverse events. A recent retrospective review of the treatment for Amanita phalloides poisoning suggests
that silymarin continues to be a promising drug in the treatment of this rare mushroom poisoning.[21] The beneficial
effect of silymarin on liver histology suggests it has a role in the prevention of hepatitis and/or hepatocellular carcinoma;
however, no clinical trials in humans have investigated these uses of the milk thistle chemical - silymarin.

References

1. Invernizzi R, Bernuzzi S, Ciani D, et al.: Silymarine during maintenance therapy of acute promyelocytic leukemia.
Haematologica 78 (5): 340-1, 1993 Sep-Oct.  2. Grossmann M, Hoermann R, Weiss M, et al.: Spontaneous regression
of hepatocellular carcinoma. Am J Gastroenterol 90 (9): 1500-3, 1995. 3. Ladas EJ, Kroll DJ, Oberlies NH, et al.: A
randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute
lymphoblastic leukemia (ALL). Cancer 116 (2): 506-13, 2010.  4. Vailati A, Aristia L, Sozzé E, et al.: Randomized open
study of the dose-effect relationship of a short course of IdB 1016 in patients with viral or alcoholic hepatitis. Fitoterapia
64 (3), 219-28, 1993. 5. Salmi HA, Sarna S: Effect of silymarin on chemical, functional, and morphological alterations of
the liver. A double-blind controlled study. Scand J Gastroenterol 17 (4): 517-21, 1982.  6. Parés A, Planas R, Torres M,
et al.: Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized
and multicenter trial. J Hepatol 28 (4): 615-21, 1998.  7. Flisiak R, Prokopowicz D: Effect of misoprostol on the course of
viral hepatitis B. Hepatogastroenterology 44 (17): 1419-25, 1997 Sep-Oct. 8. Angulo P, Patel T, Jorgensen RA, et al.:
Silymarin in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid.
Hepatology 32 (5): 897-900, 2000. 9. Ferenci P, Dragosics B, Dittrich H, et al.: Randomized controlled trial of silymarin
treatment in patients with cirrhosis of the liver. J Hepatol 9 (1): 105-13, 1989. 10. Lucena MI, Andrade RJ, de la Cruz JP,
et al.: Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-
blind, placebo-controlled clinical study. Int J Clin Pharmacol Ther 40 (1): 2-8, 2002.  11. Velussi M, Cernigoi AM, De
Monte A, et al.: Long-term (12 months) treatment with an anti-oxidant drug (silymarin) is effective on hyperinsulinemia,
exogenous insulin need and malondialdehyde levels in cirrhotic diabetic patients. J Hepatol 26 (4): 871-9, 1997.  12.
Seeff LB, Curto TM, Szabo G, et al.: Herbal product use by persons enrolled in the hepatitis C Antiviral Long-Term
Treatment Against Cirrhosis (HALT-C) Trial. Hepatology 47 (2): 605-12, 2008. 13. Palasciano G, Portincasa P, Palmieri
V, et al.: The effect of silymarin on plasma levels of malon-dialdehyde in patients receiving long-term treatment with
psychotropic drugs. Current Therapeutic Research 55 (5): 537-45. 14. Magliulo E, Gagliardi B, Fiori GP: [Results of a
double blind study on the effect of silymarin in the treatment of acute viral hepatitis, carried out at two medical centres
(author's transl)] Med Klin 73 (28-29): 1060-5, 1978.  15. Azzam HS, Goertz C, Fritts M, et al.: Natural products and
chronic hepatitis C virus. Liver Int 27 (1): 17-25, 2007.  16. Polyak SJ, Morishima C, Shuhart MC, et al.: Inhibition of T-
cell inflammatory cytokines, hepatocyte NF-kappaB signaling, and HCV infection by standardized Silymarin.
Gastroenterology 132 (5): 1925-36, 2007. 17. Ferenci P, Scherzer TM, Kerschner H, et al.: Silibinin is a potent antiviral
agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology 135
(5): 1561-7, 2008. 18. Trinchet JC, Beaugrand M, Callard P, et al.: Treatment of alcoholic hepatitis with colchicine.
Results of a randomized double blind trial. Gastroenterol Clin Biol 13 (6-7): 551-5, 1989. 19. Albrecht M, Frerick H,
Kuhn U, et al.: Therapy of toxic liver pathologies with Legalon®. Z Klin Med 47: 87-92, 1992. 20. Hruby K, Csomos G,
Fuhrmann M, et al.: Chemotherapy of Amanita phalloides poisoning with intravenous silibinin. Hum Toxicol 2 (2): 183-
95, 1983. 21. Enjalbert F, Rapior S, Nouguier-Soulé J, et al.: Treatment of amatoxin poisoning: 20-year retrospective
analysis. J Toxicol Clin Toxicol 40 (6): 715-57, 2002.

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