The Natural Health Bible
The following excerpt about Milk Thistle is from The Natural
Health Bible, From the Most Trusted Source in Health Information,
Here is You're A-Z Guide to Over 200 Conditions, Herbs, Vitamins,
and Supplements.
This
book was published by Prima Health in 1999. The editors are
Steven Bratman, M.D. and David Kroll, Ph.D They are principals
of The Natural Pharmacist. The book is intended to provide
Science-Based Health Information You Can Trust.
This
is one of the most medically conservative of all the natural
health guides on the market today. You must keep in mind that
the authors are medical scientists and are certainly more
skeptical than an herbalist or holistic health practitioner
would be.
They
make a point of balancing the good with the bad. They don't
just mention successful studies, they also mention less impressive
ones. This makes their overall positive assessment of Milk
Thistle particularly more meaningful. And they reference all
of the studies they researched, which is extremely valuable.
Incidentally,
under the dosages heading, the authors specifically mention
the reported superiority of the Phytosome® form of Milk
Thistle extract (as found in Maximum Milk Thistle).
MILK THISTLE (SILYBUM MARIANUM)
Principal
Proposed Uses: Chronic viral hepatitis, acute viral hepatitis, alcoholic
liver disease, liver cirrhosis, mushroom poisoning (special
intravenous form only), protection from liver-toxic medications
Milk
thistle, a spiny-leafed plant with reddish-purple, thistle-shaped
flowers, has a long history of use both as a food and a medicine.
English gardeners at the turn of the century grew Milk Thistle
and used the leaves like lettuce, the stalks like asparagus,
the roasted seeds like coffee, and the roots (soaked overnight)
like oyster plant.
The
seeds, fruit, and leaves of Milk Thistle are used for medicinal
purposes. Over 2,000 years ago, Pliny the Elder reported that
the juice of Milk Thistle could "carry off bile,"
an insight that foreshadowed its modern uses. In Europe, the
herb was widely used through the early twentieth century for
the treatment of jaundice as well as for insufficient breast
milk.
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WHAT IS MILK THISTLE USED FOR TODAY?
Based
on the extensive folk use of Milk Thistle in cases of jaundice,
European medical researchers began to investigate its medicinal
effects. The results led Germany's Commission E to approve
an oral extract of Milk Thistle as a treatment for liver disease
in 1986.
It
is widely used to treat alcoholic hepatitis, alcoholic fatty
liver, liver cirrhosis, liver poisoning, and viral hepatitis,
as well as to protect the liver from the effects of liver-toxic
medications. Milk thistle is one of the few herbs that have
no real equivalent in the world of conventional medicine.
According
to reports and some research evidence that we'll review in
the next section, treatment produces a modest improvement
in symptoms of chronic liver disease, such as nausea, weakness,
loss of appetite, fatigue, and pain. Liver enzymes as measured
by blood tests frequently improve, and if a liver biopsy is
performed, there may be improvements on the cellular level.
Some studies have shown a reduction in death rate among those
with serious liver disease.
The
active ingredients in Milk Thistle appear to be four substances
known collectively as silymarin, of which the most potent
is named silybinin.1 When injected intravenously, silybinin
is one of the few known antidotes to poisoning by the deathcap
mushroom, Amanita phalloides. Animal studies suggest that
Milk Thistle extracts can also protect against many other
poisonous substances, from toluene to the drug acetaminophen.2-8
Silymarin
appears to function by displacing toxins trying to bind to
the liver as well as by causing the liver to regenerate more
quickly.9 It may also scavenge free radicals and stabilize
liver cell membranes.10,11
However,
Milk Thistle is not effective in treating advanced liver cirrhosis,
and only the intravenous form can counter mushroom poisoning.
In
Europe, Milk Thistle is often added as extra protection when
patients are given medications known to cause liver problems.
Milk
thistle is also used in a vague condition known as minor hepatic
insufficiency, or "sluggish liver."12 This term
is mostly used by European physicians and American naturopathic
practitioners-conventional physicians don't recognize it.
Symptoms are supposed to include aching under the ribs, fatigue,
unhealthy skin appearance, general malaise, constipation,
premenstrual syndrome, chemical sensitivities, and allergies.
Milk
thistle is also sometimes recommended for gallstones and psoriasis,
but there is little to no evidence as yet that it really works
for these conditions.
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WHAT IS THE SCIENTIFIC EVIDENCE FOR MILK THISTLE?
There
is considerable evidence from studies in animals that Milk
Thistle can protect the liver from numerous toxins. However,
human studies of people suffering from various liver diseases
have yielded mixed results.
Deathcap
Poisoning
In
Amanita mushroom poisoning, silybinin appears to dramatically
reduce death rates, which are typically from 30 to 50%, down
to less than 10%.13 This mushroom destroys the liver if left
untreated. In conditions like this one, it isn't ethical to
perform double-blind studies. However, Milk Thistle seems
to be so dramatically effective that its value is not disputed.
Chronic
Viral Hepatitis
Preliminary
double-blind studies of people with chronic viral hepatitis
have found that Milk Thistle can produce significant improvement
in symptoms such as fatigue, reduced appetite, and abdominal
discomfort, as well as results on blood tests for liver inflammation.
14,15,16
Acute
Viral Hepatitis
While
good results have been reported in one study of 57 people
with acute viral hepatitis,17 another study of 151 participants
showed no benefit.18
Alcoholic
Liver Disease
A
1981 double-blind study followed 106 Finnish soldiers with
mild alcoholic liver disease. In the treated group, there
was a significant improvement in liver function as measured
by blood tests and biopsy. 19 Another study reported similar
results.20 However, a study of 116 participants showed little
to no benefit,21 as did another study of 72 people followed
for 15 months.22
Liver
Cirrhosis
A
controlled study followed 170 people with liver cirrhosis
for 3 to 6 years. In the treated group, the 4-year survival
rate was 58% as compared to only 38% in the placebo group.23
However, a recently reported 2-year double-blind study of
200 alcoholics with cirrhosis found no benefit.24
Protection
from Medications That Damage the Liver
Numerous
medications can injure or inflame the liver. Preliminary evidence
suggests that milk thistle might protect against liver toxicity
caused by such drugs as acetaminophen, dilantin, alcohol,
and phenothiazines. 25
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DOSAGES
The
standard dosage of Milk Thistle is 200 mg 2 to 3 times a day
of an extract standardized to contain 70% silymarin.
There
is some evidence that silymarin bound to phosphatidylcholine
may be better absorbed.26,27 This form should be taken at
a dosage of 100 to 200 mg twice a day.
Warning: Considering
the severe nature of liver disease, a doctor's supervision
is essential. Also, do not inject Milk Thistle preparations
that are designed for oral use!
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SAFETY ISSUES
Milk
thistle is believed to possess very little toxicity. Animal
studies have not shown any negative effects even when high
doses were administered over a long period of time.28
A
study of 2,637 participants reported in 1992 showed a low
incidence of side effects, limited mainly to mild gastrointestinal
disturbance.29
On
the basis of its extensive use as a food, Milk Thistle is
believed to be safe for pregnant or nursing women and researchers
have enrolled pregnant women in studies.30 However, safety
in young children, pregnant or nursing women, and individuals
with severe renal disease has not been formally established.
No
drug interactions are known. However, one report has noted
that silybinin (a constituent of silymarin) can inhibit a
bacterial enzyme called beta-glucuronidase, which plays a
role in the activity of certain drugs, such as oral contraceptives.31
This could reduce their effectiveness.
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INTERACTIONS YOU SHOULD KNOW ABOUT
If
you are taking:
Oral contraceptives: Milk thistle may reduce their effectiveness.
Medications that could damage the liver: Milk thistle might
be protective.
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References:
1.
Schulz V, et al. Rational phytotherapy. New York: Springer-Verlag,
1998: 215.
2.
Muriel P, et al. Silymarin protects against paracetamol-induced
lipid peroxidation and liver damage. J Appt Toxicol 12: 6439-6442,
1992.
3.
Paulova J, et al. Verification of the hepatoprotective and
therapeutic effect of silyrnarin in experimental liver injury
with tetrachloromethane in dogs. Vet Med (Praha) 35(10): 629-635,
1990.
4.
Skakun NP, et al. Clinical pharmacology of Fegalon (review
of the literature). Vrach Delo 5: 5-10, 1988.
5.
Tuchweber B, et al. Prevention of silybin of phalloidin-induced
acute hepatotoxicity. Toxicol Appl Pharmacol 51(2): 265-275,
1979.
6.
Boari C, et al. Toxic occupational liver diseases. Therapeutic
effects of silymarin. Minerva Med 72(40): 2679-2688,1981.
7.
Szilard S. Protective effect of Legalon in workers exposed
to organic solvents. Acta Med Hung 45(2): 249-256,1988.
8.
Rui YC. Advances in pharmacological studies of silymarin.
Mem Inst Osivaldo Cruz 86(Suppl. 2): 79-85, 1991.
9.
Schulz V, et al. Rational phytotherapy. New York: Springer-Verlag,
1998: 216.
10.
Hikino H, et al. Natural products for liver disease. As cited
in Wagner H, et al. Economic and medicinal plant research,
Vol 2. New York: Academic Press, 1988: 39-72.
11.
Muzes G, et al. Effects of silymarin (Legalon) therapy on
the antioxidant defense mechanism and lipid peroxidation in
alcoholic liver disease (double-blind protocol). Orv Hetil
131(16): 863-866, 1990.
12.
Giannola C, et al. A two-center study on the effects of silymarin
in pregnant women and adult patients with so-called minor
hepatic insufficiency. Clin Ther 114(2): 129-135,1985.
13.
Schulz V, et al. Rational phytotherapy. New York: Springer-Verlag,
1998: 218.
14.
Berenguer J, et al. Double-blind trial of silymarin vs. placebo
in the treatment of chronic hepatitis. Munch Med Wochenschr
119: 240-260, 1977.
15.
Buzzelli G, et al. A pilot study on the liver protective effect
of silybin-phosphatidylcholine complex (IdB 1016) in chronic
active hepatitis. Int J Clin Pharmacol Ther Toxicol 31(9):
456-460, 1993.
16.
Liruss F, et al. Cytoprotection in the nineties: Experience
with ursodeoxycholic acid and silymarin in chronic liver disease.
Acta Physiol Hung 80(1-4): 363-367,1992.
17.
Magliulo E, et al. Results of a double blind study on the
effect of silvinarin in the treatment of acute viral hepatitis,
carried out at two medical centers. Med Klin 73:28-29,1060-1065,1978.
18.
Bode JC, et al. Silymarin for the treatment of acute viral
hepatitis? Report of a controlled trial. Med Min 72(12): 513-518,
1977.
19.
Salim H, et al. Effect of silymarin on chemical, functional
and morphological alterations of the liver. ScandJ Gastroenterol
17: 517-521, 1982.
20.
Feher J. Liver protective action of silymarin therapy in chronic
alcoholic liver diseases. Orv Hetil 130(51): 2723-2727,1989.
21.
Trinchet JC. Treatment of alcoholic hepatitis with silymarin.
A double-blind comparative study in 116 patients. Gastroenterol
Clin Biol 13(2): 120-124, 1989.
22.
Bunout D, et al. Controlled study of the effect of silymarin
on alcoholic liver disease. Rev Med Chil 120(12): 1370-1375,
1992.
23.
Ferenci P, et al. Randomized controlled trial of silymarin
treatment in patients with cirrhosis of the liver. J Hepatol
9: 105-113, 1989.
24.
Pares A, et al. Effects of silymarin in alcoholic patients
with cirrhosis of the liver: Results of a controlled, double-blind,
randomized and multicenter trial. J Hepatology 28: 615-621,
1998.
25.
Brinker F. Herb contraindications and drug interactions, 2nd
ed. Sandy, Oregon: Eclectic Medical Publications, 1998: 103.
26.
Schandalik R, et al. Pharmacokinctics of silybin in bile following
administration of silipide and silymarin in cholecsytectomy
patients. Arneimittelforschung 42(7): 964-968,1992.
27.
Barzaghi N, et al. Pharmacokinetic studies on IdB 1016, a
silybin-phosphatidylchohne complex in healthy human subjects.
Eur J Drug Metab Pharmacokinet 15(4): 333-338, 1990.
28.
Awang D. Milk thistle. Can Pharm J 422: 403-404, 1983.
29.
Albrecht M. Therapy of toxic liver pathologies with Legalon.
Z Klin Med 47(2): 87-92, 1992.
30.
Giannola C, et al. A two-center study on the effects of silymarin
in pregnant women and adult patients with so-called minor
hepatic insufficiency. Clin Ther 114(2): 129-135,1985.
31.
Kim DH, et al. Silymarin and its components are inhibitors
of beta-glucuronidase. Biol Pharm Bull 17(3): 443-445,1994.
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