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Milk Thistle

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Milk Thistle

Related Terms

  • Silymarin
  • Silibinin

Uses

Principal Proposed Uses

The milk thistle plant commonly grows from 2 to 7 feet in height, with spiny leaves and reddish-purple, thistle-shaped flowers. It has also been called wild artichoke, holy thistle, and Mary thistle. Native to Europe, milk thistle has a long history of use as both a food and a medicine. At the turn of the twentieth century, English gardeners grew milk thistle to use its leaves like lettuce (after cutting off the spines), the stalks like asparagus, the roasted seeds like coffee, and the roots (soaked overnight) like oyster plant. The seeds and leaves of milk thistle were used for medicinal purposes as well, such as treating jaundice and increasing breast milk production.
German researchers in the 1960s were sufficiently impressed with the history and clinical effectiveness of milk thistle to begin examining it for active constituents. In 1986, Germany's Commission E approved an oral extract of milk thistle as a treatment for liver disease. However, the evidence that it really works remains incomplete and inconsistent.

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. It is currently used to treat alcoholic hepatitis , liver cirrhosis , liver poisoning, and viral hepatitis , as well as to protect the liver in general from the effects of liver-toxic medications. However, despite this wide usage, there is no definitive evidence that it is effective.
Standardized milk thistle extract is known as silymarin. Silymarin itself is a mixture of at least seven chemicals. The most active of these chemicals is commonly known as silibinin. But, silibinin too is, in fact, a mixture, comprising the two related substances silibinin A and silibinin B. 48 When injected intravenously, silibinin is thought to act as an antidote 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. 2-7 One animal study suggests that milk thistle can also protect against fetal damage caused by alcohol. 8
Silibinin is hypothesized 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 act as an antioxidant and also stabilize liver cell membranes. 10,11
In Europe, milk thistle is often added as extra protection when patients are given medications known to cause liver problems. However, milk thistle failed to prove effective for preventing liver inflammation caused by the Alzheimer's drug Cognex (tacrine). 12
Milk thistle is also used in a vague condition known as minor hepatic insufficiency, or "sluggish liver." 13 This term is mostly used by European physicians and American naturopathic practitioners—conventional physicians in the US 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 may also offer some protection to the kidney. 14
Highly preliminary evidence hints that milk thistle might help reduce breast cancer risk. 15 Milk thistle is sometimes recommended for gallstones and psoriasis , but there is little to no evidence as yet that it really helps these conditions.
In one small, placebo-controlled trial, the topical application of milk thistle with methylsulfonylmethane (MSM) for 1 month appeared to be effective in the treatment of 46 subjects with the skin condition rosacea . 50
A small preliminary study investigated whether milk thistle can help to relieve obsessive compulsive disorder (OCD). 52 Thirty-five adults with OCD were randomized to receive milk thistle (600 mg/day) or the medication fluoxetine (30 mg/day), which is commonly used to treat OCD. At the end of the 8-week trial, researchers did not find any significant differences between the two groups.
Two, small randomized, placebo-controlled trials (with a total of 89 people) found that milk thistle helped to improve blood sugar control in people with type 2 diabetes . 55

What Is the Scientific Evidence for Milk Thistle?

As noted above, 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 often yielded mixed results. A 2007 review of published and unpublished studies on milk thistle as a treatment for liver disease caused by alcohol or viral hepatitis concluded that benefits were seen only in low-quality trials, and, even in those, milk thistle did not show more than a slight benefit. 49

Acute Viral Hepatitis

A 21-day, double-blind, placebo-controlled study of 57 people with acute viral hepatitis found significant improvements in the group receiving milk thistle. 20 In another study, 105 people with acute hepatitis receiving milk thistle (140 mg, 3 times daily) showed modest improvement in some symptoms compared to those taking a placebo for 4 weeks. 53 On the other hand, a 35-day study of 151 individuals thought to have acute hepatitis found no benefit with milk thistle, but this study has been criticized for failing to document that the participants actually had acute hepatitis. 21,22

Chronic Viral Hepatitis

Inconsistent evidence exists regarding whether milk thistle is helpful for chronic viral hepatitis B or C. 17-19,44,46,51 The herb does not appear to affect levels of virus in the body, but might help protect the liver from damage and improve some symptoms.

Alcoholic Hepatitis

A double-blind, placebo-controlled study performed in 1981 followed 106 Finnish soldiers with alcoholic liver disease over a period of 4 weeks. 23 The treated group showed a significant decrease in elevated liver enzymes and improvement in liver histology (the microscopic structure of liver tissue), as evaluated by biopsy in 29 subjects.
Two similar studies provided essentially equivalent results. 24,25 However, a 3-month, randomized, double-blind study of 116 people showed little to no additional benefit, perhaps because most participants reduced their alcohol consumption and almost half stopped drinking entirely. 26 Another study found no benefit in 72 patients followed for 15 months. 27 It is undoubtedly more effective for people with alcoholism to quit drinking than to continue drinking and take milk thistle!

Liver Cirrhosis

A double-blind, placebo-controlled study of 170 people with alcoholic or non-alcoholic cirrhosis found that in the group treated with milk thistle the 4-year survival rate was 58% as compared to only 38% in the placebo group. 28 This difference was statistically significant.
A double-blind, placebo-controlled trial that enrolled 172 people with cirrhosis for 4 years also found reductions in mortality, but they just missed the conventional cutoff for statistical significance. 29 A 2-year, double-blind, placebo-controlled study of 200 individuals with alcoholic cirrhosis found no reduction in mortality attributable to the use of milk thistle. 30 However, in a analysis of 19 randomized trials, researchers concluded that milk thistle was significantly more effective at reducing mortality from liver cirrhosis (mostly alcohol-related) compared to placebo, but no more effective at reducing mortality from any cause. 51
Other double-blind studies of people with various forms of cirrhosis have looked at changes in tests of liver function rather than mortality. Some found benefit 42,43 , while others did not. 16,45

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 drugs such as acetaminophen , alcohol, phenothiazines , and phenytoin ( Dilantin ). 31,32 However, according to a 12-week, double-blind study of 222 people, milk thistle does not seem to prevent the liver inflammation caused by the Alzheimer's drug tacrine (Cognex). 33

Dosage

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. 34,35 This form should be taken at a dosage of 100 mg 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!

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. 36
A study of 2,637 participants reported in 1992 showed a low incidence of side effects, limited mainly to mild gastrointestinal disturbance. 37 However, on rare occasions severe abdominal discomfort may occur. 38
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. 39 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 silibinin can inhibit a bacterial enzyme called beta-glucuronidase, which plays a role in the activity of certain drugs, such as oral contraceptives. 40 This could theoretically reduce their effectiveness.

Interactions You Should Know About

If you are taking:
  • Medications that could damage the liver, such as acetaminophen, phenytoin (Dilantin), alcohol, and phenothiazines: Milk thistle might be protective for some of these drugs.
  • Oral contraceptives : Milk thistle might reduce their effectiveness.

References

1 Schulz V, Hansel R, Tyler VE. Rational Phytotherapy: A Physicians' Guide to Herbal Medicine. 3rd ed. Berlin, Germany: Springer-Verlag; 1998:215.

2 Muriel P, Garciapina T, Perez-Alvarez V, et al. Silymarin protects against paracetamol-induced lipid peroxidation and liver damage. J Appl Toxicol. 1992;12:439-442.

3 Paulova J, Dvorak M, Kolouch F, et al. Verification of the hepatoprotective and therapeutic effect of silymarin in experimental liver injury with tetrachloromethane in dogs [in Czech]. Vet Med (Praha). 1990;35:629-635.

4 Skakun NP, Moseichuk IP. Clinical pharmacology of legalon [in Russian]. Vrach Delo. 1988;5:5-10.

5 Tuchweber B, Sieck R, Trost W. Prevention of silybin of phalloidin-induced acute hepatotoxicity. Toxicol Appl Pharmacol. 1979;51:265-275.

6 Boari C, Montanari FM, Galletti GP, et al. Toxic occupational liver diseases. Therapeutic effects of silymarin [in Italian]. Minerva Med. 1981;72:2679-2688.

7 Szilard S, Szentogyorgyi D, Demeter I. Protective effect of Legalon in workers exposed to organic solvents. Acta Med Hung. 1988;45:249-256.

8 La Grange L, Wang M, Watkins R, et al. Protective effects of the flavonoid mixture, silymarin, on fetal rat brain and liver. J Ethnopharmacol. 1999;65:53-61.

9 Schulz V, Hansel R, Tyler VE. Rational Phytotherapy: A Physicians' Guide to Herbal Medicine, 3rd ed. Berlin, Germany: Springer-Verlag; 1998:216.

10 Hikino H, Kiso Y. Natural products for liver disease. Econ Med Plant Res. 1988;2:39-72.

11 Muzes G, Deak G, Lang I, et al. Effects of silymarin (Legalon) therapy on the antioxidant defense mechanism and lipid peroxidation in alcoholic liver disease [in Hungarian]. Orv Hetil. 1990;131:863-866.

12 Allain H, Schuck S, Lebreton S, et al. Aminotransferase levels and silymarin in de novo tacrine-treated patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 1999;10:181-185.

13 Giannola C, Buogo F, Forestiere G, et al. A two-center study on the effects of silymarin in pregnant women and adult patients with so-called minor hepatic insufficiency [in Italian]. Clin Ther. 1985;114:129-135.

14 Sonnenbichler J, Scalera F, Sonnenbichler I, et al. Stimulatory effects of silibinin and silicristin from the milk thistle Silybum marianum on kidney cells. J Pharmacol Exp Ther. 1999;290:1375-1383.

15 Zi X, Feyes DK, and Agarwal R. Anticarcinogenic effect of a flavonoid antioxidant, silymarin, in human breast cancer cells MDA-MB 468. Clin Cancer Res. 1998;4:1055-1064.

16 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. 2002;40:2-8.

17 Berenguer J, Carrasco D. Double-blind trial of silymarin vs. placebo in the treatment of chronic hepatitis. Munch Med Wochenschr. 1977;119:240-260.

18 Buzzelli G, Moscarella S, Giusti A, 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. 1993;31:456-460.

19 Lirussi F, Okolicsanyi L. Cytoprotection in the nineties: Experience with ursodeoxycholic acid and silymarin in chronic liver disease. Acta Physiol Hung. 1992;80:363-367.

20 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 [translated from German]. Med Klin. 1978;73:1060-1065.

21 Bode JC, Schmidt U, Durr HK. Silymarin for the treatment of acute viral hepatitis? Report of a controlled trial [translated from German]. Med Klin. 1977;72:513-518.

22 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 [translated from German]. Med Klin. 1978;73:1060-1065.

23 Salmi HA, Sarna S. Effect of silymarin on chemical, functional and morphological alterations of the liver. A double-blind controlled study. Scand J Gastroenterol. 1982;17:517-521.

24 Feher J, Desk G, Muzes G, et al. Liver protective action of silymarin therapy in chronic alcoholic liver diseases [in Hungarian]. Orv Hetil. 1989;130:2723-2727.

25 Fintelmann V, Albert A. Proof of the therapeutic efficacy of LegalonŴ for toxic liver illnesses in a double-blind trial [translated from German]. Therapiewoche. 1980;30:5589-5594.

26 Trinchet JC, Coste T, Levy VG, et al. Treatment of alcoholic hepatitis with silymarin. A double-blind comparative study in 116 patients [translated from French]. Gastroenterol Clin Biol. 1989;13:120-124.

27 Bunout D, Hirsch SB, Petermann MT, et al. Controlled study of the effect of silymarin on alcoholic liver disease [translated from Spanish]. Rev Med Chil. 1992;120:1370-1375.

28 Ferenci P, Dragosics B, Dittrich H, et al. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J Hepatol. 1989;9:105-113.

29 Benda L, Dittrich H, Ferenzi P, et al. The influence of therapy with silymarin on the survival rate of patients with liver cirrhosis [translated from German]. Wien Klin Wochenschr. 1980;92:678-683.

30 Pares 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. 1998;28:615-621.

31 Brinker F. Herb Contraindications and Drug Interactions: With Appendices Addressing Specific Conditions and Medicines. 2nd ed. Sandy, OR: Eclectic Medical Publications; 1998:103.

32 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. Curr Ther Res. 1994;55:537-545.

33 Allain H, Schuck S, Lebreton S, et al. Aminotransferase levels and silymarin in de novo tacrine-treated patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 1999;10:181-185.

34 Schandalik R, Gatti G, Perucca E. Pharmacokinetics of silybin in bile following administration of silipide and silymarin in cholecystectomy patients. Arzneimittelforschung. 1992;42:964-968.

35 Barzaghi N, Crema F, Gatti G, et al. Pharmacokinetic studies on IdB 1016, a silybin-phosphatidylcholine complex in healthy human subjects. Eur J Drug Metab Pharmacokinet. 1990;15:333-338.

36 Awang D. Milk thistle. Can Pharm J. 1993;126:403-404.

37 Albrecht M, Frerick H, Kuhn U, et al. Therapy of toxic liver pathologies with Legalon [in German]. Z Klin Med. 1992;47:87-92.

38 Adverse Drug Reactions Advisory Committee. An adverse reaction to the herbal medication milk thistle ( Silybum marianum ). Med J Aust. 1999;170:218-219.

39 Giannola C, Buogo F, Forestiere G, et al. A two-center study on the effects of silymarin in pregnant women and adult patients with so-called minor hepatic insufficiency [in Italian]. Clin Ther. 1985;114:129-135.

40 Kim DH, Jin YH, Park JB, et al. Silymarin and its components are inhibitors of beta-glucuronidase. Biol Pharm Bull. 1994;17:443-445.

41 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. 2002;40:2-8.

42 Lang I, et al. Hepatoprotective and immunological effects of antioxidant drugs. Tokai J Exp Clin Med. 1990;15:123-127.

43 Lang I, et al. Immunomodulatory and hepatoprotective effects of in vivo treatment with free radical scavengers. Ital J Gastroenterol. 1990;22:283-287.

44 Gordon A, Hobbs DA, Bowden DS et al. Effects of Silybum marianum on serum hepatitis C virus RNA, alanine aminotransferase levels and well-being in patients with chronic hepatitis C. J Gastroenterol Hepatol. 2006;21:275-80.

45 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. 2000;32:897-900.

46 Torres M, Rodriguez-Serrano F, Rosario DJ et al. Does Silybum marianum play a role in the treatment of chronic hepatitis C? P R Health Sci J. 2006;23:69-74

47 Huseini HF, Larijani B, Heshmat R et al. The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial. Phytother Res. 2006 Oct 30. [Epub ahead of print]

48 Kroll DJ, Shaw HS, Oberlies NH. Milk thistle nomenclature: why it matters in cancer research and pharmacokinetic studies. Integr Cancer Ther. 2007;6:110-119.

49 Rambaldi A, Jacobs B, Gluud C. Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. Cochrane Database Syst Rev. 2007;CD003620.

50 Berardesca E, Cameli N, Cavallotti C, et al. Combined effects of silymarin and methylsulfonylmethane in the management of rosacea: clinical and instrumental evaluation. J Cosmet Dermatol. 2008;7:8-14.

51 Saller R, Brignoli R, Melzer J, et al. An updated systematic review with meta-analysis for the clinical evidence of silymarin. Forsch Komplement Med. 2008;15:9-20.

52 Sayyah M, Boostani H, Pakseresht S, Malayeri A. Comparison of Silybum marianum (L.) Gaertn. with fluoxetine in the treatment of obsessive-compulsive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2010;34(2):362-365.

53 El-Kamary SS, Shardell MD, Abdel-Hamid M, et al. A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis. Phytomedicine. 2009;16(5):391-400.

54 Hutchinson C, Bomford A, Geissler CA. The iron-chelating potential of silybin in patients with hereditary haemochromatosis. Eur J Clin Nutr. 2010;64(10):1239-1241.

55 Suksomboon N, Poolsup N, Boonkaew S, Suthisisang CC. Meta-analysis of the effect of herbal supplement on glycemic control in type 2 diabetes. J Ethnopharmacol. 2011;137(3):1328-1333.

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