Legalon Evidence Review
At www.natrx.com.au we aim to offer natural therapies with the best available research. We intend that these products and the information about their evidence will assist the safe and effective prescribing of natural therapies.
Purchase Legalon, Ingredients & Dosage Information
|Legalon ||Legalon MZ 80 Silybum marianum – extract MZ80 (St Mary’s thistle) equiv. to dry fruit 7.2g standardised to Silymarin 140mg) |
|Product Specific Evidence ||Strong evidence for Legalon compared to placebo to improve 4 year survival rate for adults with alcoholic cirrhosis rated as Child’s Class A; but no effect for more severe cirrhosis Child’s Class B & C and non-alcoholic cirrhosis.(1-3) Strong evidence for Legalon compared to placebo to improve Liver Function Tests for adults with chronic alcoholic liver disease.(4-6) Strong evidence that abstaining from alcohol has a greater effect that Legalon compared to placebo to improve Liver Function Tests and liver biopsy histology in adults with alcoholic hepatitis.(7) Moderate evidence for Legalon compared to placebo to improve glucose control in non-insulin dependent diabetics with alcoholic cirrhosis.(8) |
|General Evidence ||Strongest evidence for supporting liver function and reducing liver damage caused by Amanita phalloides poisoning (a mushroom) and alcohol and grade Child 'A' liver cirrhosis.(9) |
Conflicting evidence for viral hepatitis. May improve liver function tests, but no effect on viral load or liver histology with hepatitis B or C infection.(10,11)
|Comments ||An injectable form of Legalon is manufactured for emergency treatment of hepatotoxicity from mushroom poisoning. |
The exact mechanisms of action are yet to be completely understood, but appear to be multitarget.(12,13)
1. Ferenci P, Dragosics B, Dittrich H, et al. Randomised conrtolled trial of silymarintreatment in patients with cirrhosis of the liver. J of Hepatology. 1989;1:105-113.
2. Benda L, Dittrich H, Ferenci P, Frank H, Wewalka F. The efficacy of silymarin and the survival of patients with hepatic cirrhosis. Wien Klin Wochenschr. 1980;92(19):678-983.
3. 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 of Hepatology. 1994;28(4):615-621.
4. Feher J, Deak G, Muzes G, et al. The hepatoprotective effect of treatment with silymarin in patients with chronic alcoholic liver disease. Orvosi Hetilap. 1989;130(51):2723-2727.
5. Bunout D, Hirsch S, Petermann M, et al. Effects of silymarin on alcholholic liver disease (a controlled trial). Rev Medica de Chile. 1992;120(12):1370-1375.
6. Fintelmann V, Albert A. The therapeutic activity of Legalon in toxic hepatic disorders demonstrated in a double blind trial. Therapiewoche. 1980;30(35):105-113.
7. Trinchet J, Coste T, Levy V, et al. Treatment of alcoholic hepatitis with silymarin: comparative double-blind trial in 116 patients. Gastroenterologie Clinique et Biologique. 1989;13(2):120-124.
8. Velussi M, Cernigoi A, DeMonte A, Dapas F, Caffau C, Zilli M. Long-term (12 month) treatment with an anti-oxidant drgue (sliymarin) is effective on hyperinsulinemia, exogenous insulin need and malondialdehyde levels in cirrhotic diabetes patients. J of Hepatology. 1997;26(4):871-879.
9. Saller R, Brignoli R, Melzer J, Meier R. An updated systematic review with meta-analysis for the clinical evidence of silymarin. Forsch Komplement Med (2006). Feb 2008;15(1):9-20.
10. Mayer KE, Myers RP, Lee SS. Silymarin treatment of viral hepatitis: a systematic review. J Viral Hepat. Nov 2005;12(6):559-567.
11. Liu J, Manheimer E, Tsutani K, Gluud C. Medicinal herbs for hepatitis C virus infection: a Cochrane hepatobiliary systematic review of randomized trials. Am J Gastroenterol. Mar 2003;98(3):538-544.
12. Saller R, Melzer J, Reichling J, Brignoli R, Meier R. An updated systematic review of the pharmacology of silymarin. Forsch Komplementmed. Apr 2007;14(2):70-80.
13. Pradhan SC, Girish C. Hepatoprotective herbal drug, silymarin from experimental pharmacology to clinical medicine. Indian J Med Res. Nov 2006;124(5):491-504.
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DEFINITION OF EVIDENCE
Product Specific Evidence means that the exact herb or supplement is the same as the one used in the clinical trial/s.
General Evidence refers to research about the all the different preparations of the herb or supplement.
Levels of Evidence
Therapies are ranked according their strength of evidence.
Strongest Evidence is a systematic review of all the research on a subject. A meta-analysis is one technique for combining the results of many clinical trials.
Strong Evidence consists of at least one well conducted double-blind, randomised, controlled clinical trial.
Medium Evidence is a well designed controlled trial that is not randomised, or blinded.
Weak Evidence includes the opinions of respected experts that are based on clinical experience, descriptive studies, or reports from other expert committees. The traditional use of natural therapies where collective expert knowledge is passed down for many generations is another example.
Weakest Evidence is patient testimonials, case reports, animal and cell experiments and expert opinions that are based on little proof of evidence.