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.
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 ULTRA 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.
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.
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
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!
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.
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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