Monograph: Milk Thistle
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Date:
2018-08-28
See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
NHPID name
Silybum marianum ( Germplasm Resources Information Network Taxonomy )Proper name(s)
Silybum marianum ( USDA 2008 )Common name(s)
- Blessed milk thistle ( Unavailable )
- Gundagai thistle ( Unavailable )
- Holy thistle ( Unavailable )
- Lady's thistle ( Unavailable )
- Mary's thistle ( McGuffin et al. 2000 )
- Mary thistle ( Unavailable )
- Milk thistle ( McGuffin et al. 2000 )
- St. Mary's thistle ( Unavailable )
- Variegated thistle ( Unavailable )
Source material
Route Of administration
OralDosage form(s)
- Due to poor water solubility of silymarin, infusions and decoctions are not permitted for "hepatoprotectant/liver protectant and/or support of liver function" claims (Blumenthal 2003).
- The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
- This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.
Use(s) or purpose(s)
Statement(s) to the effect of:
- (Traditionally used in Herbal Medicine as a) hepatoprotectant/ liver protectant. (Bradley 2006, Hoffmann 2003, Blumenthal et al. 2000, Mills and Bone 2000, Ellingwood 1983[1919], Felter and Lloyd 1983[1898], Wren 1907)
- (Used in Herbal Medicine to) help(s) to support liver function. (Velussi et al. 1997, Feher et al. 1989, Salmi and Sarna 1982, Magliulo et al. 1978)
- Used in Herbal Medicine to help relieve digestive disturbances/dyspepsia. (Blumenthal et al. 2000, Mills 1993)
Dose(s)
Adults:
Dose(s):
1 Day per day
Duration of use
Liver protectant: Use for at least 3 weeks to see beneficial effects. (Flora et al. 1998, Magliulo et al. 1978) Support liver function: Use for at least 3 weeks to see beneficial effects. (Flora et al. 1998, Magliulo et al. 1978)Risk information
Statement(s) to the effect of:
Caution(s) and Warning(s):- Consult a health care practitioner/health care provider/health care professional/ doctor/ physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional / doctor/ physician prior to use if you are pregnant. (Brinker 2010, Mills et al. 2006)
Non-medicinal ingredients
Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.Specifications
- The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
- The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).
- The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs : (i) 'Milk-thistle Fruit' of the British Pharmacopoeia, (ii) 'Milk-Thistle Fruit', 'Milk Thistle Dry Extract, Refined and Standardised' from the European Pharmacopoeia, or (iii) 'Milk Thistle', "Powdered Milk Thistle', 'Powdered Milk Thistle Extract', 'Milk Thistle Capsules', 'Milk Thistle Tablets' from the US Pharmacopoeia.
References cited
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Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
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Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
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Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
-
Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
-
Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Accessed 2015 June 4]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
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Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
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Fehér J, Deak G, Muzes G, Lang I, Niederland V, Nekam K, Karteszi M. 1989. [Liver-protective action of silymarin therapy in chronic alcoholic liver diseases]. Silymarin kezelés májvédő hatása idült alkoholos májbetegségben. Orvosi Hetilap 130(51):2723-2737 (in Hungarian).
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Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
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Flora K, Hahn M, Rosen H, Benner K. Milk thistle (Silybum marianum) for the therapy of liver disease. American Journal of Gastroenterology 1998;93:139-143
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Geier J, Fuchs T, Wahl R. [Anaphylactic shock due to an extract of Silybum marianum in a patient with immediate-type allergy to kiwi fruit] Anaphylaktischer schock durch einen Mariendistel-Extrakt bei soforttyp-allergie auf Kiwi. Allergologie 1990;13:387-388 (in German)
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Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
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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 centers.] Zur Wirkung von Silymarin bei der Behandlung der akuten Virushepatitis. Medizinische Klinik 1978;73(28-29):1060-1065 (in German)
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McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
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Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
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Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
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Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
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Mills S. The Essential Book of Herbal Medicine. Toronto (ON): Arkana; 1993.
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Mironets VI, Krasovskaia EA, Polischuk II. [A case of urticaria during carsil treatment]. Vrachebnoe Delo 1990;7:86-87 (in Russian)
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Salmi HA, Sarna S. Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study. Scandinavian Journal of Gastroenterology 1982;17(4):517-521
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USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
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Velussi M, Cernigoi AM, De Monte A, Dapas F, Caffau C, Zilli M. 1997. Long-term (12 months) treatment with an anti-oxidant drug (silymarin) is effective in hyperinsulinemia, exogenous insulin need and malondialdehyde levels in cirrhotic diabetic patients. Journal of Hepatology 26(4):871-879.
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Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.
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Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.
References reviewed
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ADRAC 1999: Adverse Drug Reactions Advisory Committee. An adverse reaction to the herbal medication milk thistle (Silybum marianum). The Medical Journal of Australia 170(5):218-219.
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Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (GB): The Pharmaceutical Press.
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Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1998.
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BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
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BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
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Bradley PJ, Denneby C, Ramirez G, Sapp J, Lawrence VA. 2002. Milk thistle for the treatment of liver disease: a systematic review and meta-analysis. The American Journal of Medicine 113(6):506-515.
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Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
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Bunout D, Hirsch S, Petermann M, de la Maza MP, Silva G, Kelly M, Ugarte G, Iturriaga H. 1992. [Controlled study of the effect of silymarin on alcoholic liver disease]. Estudio controlado sobre el efecto de la silimarina en la enfermedad hepatic alcoholica. Revista Médica de Chile 120(12):1370-1375 (abstract only; article in Spanish).
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Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
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EMEA 1999. European Medicines Agency. Summary Report on Silybum marianum. London (UK): EMEA Committee on Veterinary Medicinal Products, August 1999. Available from: http://www.emea.europa.eu/pdfs/vet/mrls/066599en.pdf [Accessed 22 September 2008].
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European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
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Fehér J, Láng I, Nékám K, Gergely P, Mũzes G. 1990. In vivo effect of free radical scavenger hepatoprotective agents on superoxide dismutase (SOD) activity in patients. The Tokai Journal of Experimental and Clinical Medicine 15(2,3):129-134
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Ferenci P, Dragosics B, Dittrich H, Frank H, Benda L, Lochs H, Meryn S, Base W, Schneider B. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. Journal of Hepatology 1989;9(1):105-113
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Fetrow CW, Avila JR. Professional's Handbook of Complementary and Alternative Medicines, 3rd edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2004.
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Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
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Johnston DE. 1999. Special considerations in interpreting liver function tests. American Family Physician 59(8):1-11.
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Lucena MI, Andrade RJ, de la Cruz JP, Rodriguez-Mendizabal M, Blanco E, Sanchez de la Cuesta F. Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-blind, placebo-controlled clinical study. International Journal of Clinical Pharmacology and Therapeutics 40(1):2-8.
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mbaldi A, Jacobs BP, Iaquinto G, Gluud C. 2007. Milk thistle for alcoholic and/or hepatitis B or C virus liver disease (review). Cochrane Database of Systematic Reviews Issue 4. Art. No.:CD003620. DOI: 10.1002/14651858.CD003620.pub3.
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McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
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Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
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Parés A, Planas R, Torres M, Caballeria J, Viver JM, Acero D, Panés J, Rigau J, Santos J, Rodés J. Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized and multicenter trial. Journal of Hepatology 28(4):615-621.
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Small E, Catling PM. 1999. Canadian Medicinal Crops. Ottawa (ON): National Research Council of Canada Monograph Publishing Program, NRC Research Press.
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Somogyi A, Ecsedi GG, Blazovics A, Miskolczi K, Gergely P, Fehér J. 1989. Short term treatment of type II hyperlipoproteinaemia with silymarin. Acta Medica Hungarica 46(4):289-295.
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Strickland GT, Tanamly MD, Tadros F, Labeeb S, Makld H, Nessim D, Mikhail N, Magder LS, Afdhal NH, Medhat A, Abdel-Hamid M. 2005. Two-year results of a randomised double-blinded trial evaluating silymarin for chronic hepatitis C. Digestive and Liver Disease 37(7):542-543.
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Szilard S, Szentgyorgyi D, Demeter I. 1988. Protective effect of Legalon in workers exposed to organic solvents. Acta Medica Hungarica 45(2):249-256.
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Tanamly MD, Tadros F, Labeed S, Makld H, Shehata M, Mikhail N, Abdel-Hamid M, Shehata M, Abu-Baki L, Madhat A, Magder LS, Afdhal NH, Strickland GT. 2004. Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: study description and 12-month results. Digestive and Liver Disease 36(11):752-759.
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Tanasescu C, Petrea S, Baldescu R, Macarie E, Chiriloiu C, Purice S. 1988. Use of the Romanian product silimarina in the treatment of chronic liver diseases. Médecine Interne 26(4):311-322.
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The United States Pharmacopeia and the National Formulary (USP 31/NF 26). 2008. Rockville (MD): United States Pharmacopeial Convention, Inc.
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Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.
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Torres M, Rodriguez-Serrano F, Rosario DJ, Rodriguez-Perez F, Toro DH. 2004. Does silybum marianum play a role in the treatment of chronic hepatitis C? Puerto Rico Health Sciences Journal 23(2 Supp):69-74.
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Trinchet JC, Coste T, Levy VG, Vivet F, Duchatelle V, Legendre C, Gotheil C, Beaugrand M. 1989. [Treatment of alcoholic hepatitis with silymarin. A double-blind comparative study in 116 patients]. Traitement de l'hépatite alcoolique par la silymarine. Une étude comparative en double insu chez 116 malades. Gastroentérologie Clinique et Biologique 13(2):120-124 (article in French).
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Whittington C. 2007. Exacerbation of hemochromatosis by ingestion of milk thistle. Canadian Family Physician 53(10):1671-1673.
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Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
Appendix 1: Examples of dosage preparations, frequencies of use and directions for use
Dried fruit/seed:
4-9 g, per day (Mills and Bone 2000)
Infusion:
- 3.5 g dried fruit/seed, 3 to 4 times per day (Blumenthal et al. 2000)
- Directions for use: Pour 150 ml of boiling water on dried fruit/seed and steep for 10 to 15 minutes. Drink one half hour before meals (Blumenthal et al. 2000).
Decoction:
- 3 g dried fruit/seed, 3-4 times per day (Blumenthal et al. 2000)
- Directions for use: Place dried fruit/seed in 150 ml of cold water, bring to a boil and simmer for 20 to 30 minutes (Blumenthal et al. 2000).
Fluid extract:
4-9 g dried equivalent, per day (1:1, 4-9 ml)(Mills and Bone 2000)
Tincture:
2-4 g dried equivalent, 3 times per day (1:5, 25% alcohol, 10-20 ml) (Mills 1993)
Preparations providing the following quantities of silymarin (calculated as silibinin/silybin):
- 420 mg per day (Williamson 2003, Salmi and Sarna 1982)
- 200-400 mg per day (Blumenthal et al. 2000)
- 140 mg, 1-2 times per day (Mills and Bone 2000)
- 200 mg, 3 times per day (Velussi et al. 1997)
- 140 mg, 3 times per day (Feher et al. 1989, Magliulo et al. 1978).