Four controlled studies examined the effectiveness of silymarin in treating viral hepatitis: three in acute infections and one in chronic infections10-13. In a double-blind, placebo-controlled study of 57 patients with acute viral hepatitis (A or B), patients were randomized to receive 420 mg silymarin daily or placebo for 3 weeks. In the group receiving Silybum marianum (active ingredient), 40% showed normalization of total bilirubins and 82% of hepatic transaminases (ASL and ALT), while in the placebo group these values were reduced by 11% and 52%, respectively. Statistical analysis showed a difference between branch and bilirubin values in favor of silymarin5. Another double-blind, placebo-controlled study examined the use of silymarin in the treatment of chronic hepatitis (with or without cirrhosis) over a 12-month period. It was observed that patients treated with silymarin extract (420 mg/day) showed improvement in hepatic archella as assessed by biopsies13. You should not take two doses at the same time or an extra capsule to make up for the missed dose. In addition, this remedy can also be used in combination with other drugs to improve the symptoms of chronic inflammatory liver disease and cirrhosis. The increase in protein synthesis by silymarin is due to the stimulation of RNA polymerase I, an enzyme located in the cell nucleus. This causes an increase in ribosomal RNA formation with increased synthesis of structural and functional proteins (enzymes).
The result is an increase in the liver`s ability to rebuild and regenerate. If you forget to take a dose, take the medicine as soon as possible. If you are too close to the time of the next dose, wait and take only one dose. Do not take two doses at the same time or an extra dose to make up for the missed dose. Legalon® is a hepatoprotector used to treat digestive disorders associated with liver disease and toxic liver damage, and as a supportive treatment for chronic inflammatory liver disease and cirrhosis. Legalon contains a substance called silymarin, which has a powerful antioxidant effect. Thus, this substance can eliminate free radicals from liver cells and prevent further injury. Storage Care Store the product in its original packaging at room temperature (15? C to 30? C). Before use, observe the appearance of the drug. If it is on its expiry date and you notice a change in appearance, contact your pharmacist to find out if you can use it.
Silybum marianum extract (L.) Gaertn is standardized to contain between 75.0 and 80.9% silymarin, which is a mixture of flavonoid compounds silibinin, isosilibinin, silidian and silicistina. 1. WHO monographs on selected medicinal plants. Fructus mariae silybi. [Online]. 2004. Vol. 2 [cited 2009 Oct 5].
Available at: URL: apps.who.int/medicinedocs/en/d/Js4927e/29.html#Js4927e.29. 2. Milk thistle fruit. In: M Blumenthal (Hrsg.). The full German Commission and monographs: Therapeutic Guide for Herbal Medicines. Austin: American Botanical Council; 1998. pp. 169-0;350;563-5.
3. Silymarin. In: MEDITEXT® Medical Managements. [Online]. Available from: Greenwood Village: Thomson Healthcare; regularly updated. [Accessed 13 April 2011]. 4. Milk thistle. Fashionable. Opinions about AltMedDex®.
[Online]. Available from: Greenwood Village: Thomson Healthcare; regularly updated. [Accessed 13 April 2011]. 5. Fintelmann V, et al. The therapeutic activity of Legalon® in toxic liver disease was demonstrated in a double-blind study. Therapy Week 1980;30:5589–94. 6. Feher J, et al. Hepatoprotective activity of silymarine therapy in patients with chronic alcoholism. Orv Heil 1989;130: 2723 -2727.
7. Ferenci P, et al. Randomized controlled trial of treatment with silymarine in patients with cirrhosis of the liver. J hepatol 1989; 9(1):105-13. 8. Salmi HA, Sarna S. Effect of silymarin on chemical, functional and morphological changes in the liver. A double-blind controlled study. Scand L Gastroenterol 1982; 17(4):517-21. 9. Trinchet JC et al. Treatment of alcoholic hepatitis with silymarin.
A double-blind comparative study in 116 patients. Clinical Gastroenterology and Biology, 1989, 13:120-124. 10. Magliulo E et al. (Results of a double-blind study on the effect of silymarin in the treatment of acute viral hepatitis conducted in two medical centres. Med Kin 1978;73(28-29):1060-5. 11. Cavalieri S. Legalon Controlled Clinical Trial. Gazzette Medica Italiana, 1974, 133:628. 12. Plomteux G et al.
Hepatoprotective effect of silymarine in acute viral hepatitis in humans. International Research Communications Systems, 1977, 5:259-261. 13. Kiesewetter E et al. Results of two double-blind studies on the efficacy of silymarine in chronic hepatitis. Liver, stomach, intestines, 1977, 7:318-323. 14. Szilárd S et al. Protective effect of legalon® in workers exposed to organic solvents. Acta Medica Hungarica, 1988, 45:249-256.
15. Palasciano G et al. The effect of silymarin on plasma malondialdehyde levels in patients receiving long-term treatment with psychotropic drugs. Current Therapeutic Research, 1994, 55:537-545. According to the World Health Organization and Commission E herbal monographs, Silybum marianum extract (L.) Gaertn (silymarin) is approved for the treatment of various liver diseases, including cirrhosis, alcoholic hepatitis, hepatitis due to exposure to toxic substances, and acute and chronic viral hepatitis1-4. The main side effects of Legalon include skin allergies, difficulty breathing, abdominal pain and diarrhea. In addition, silymarin stimulates protein production in affected liver cells and normalizes phospholipid metabolism, stabilizes the membrane of liver cells and repairs damage. Legalon is innovative for people who are allergic to every component of the formula. Also, its use during pregnancy and lactation should be avoided. In addition, silymarin stimulates protein synthesis in liver cells that already have damage and normalizes phospholipid metabolism. The end result is that the cell membrane is stabilized by reducing and preventing the release of enzymes into the cytoplasm of the liver cell (e.g. transaminases).
Silymarin restricts the entry of certain hepatotoxic substances into the cell (phalloides fungal poison of the amanita). The increase in protein synthesis by silymarin is due to the stimulation of RNA polymerase I, an enzyme located in the cell nucleus. This leads to an increase in ribosomal RNA formation with increased synthesis of structural and functional proteins (enzymes). The result is an increase in the liver`s ability to rebuild and regenerate. This product contains sorbitol. The additive effect of drugs containing simultaneously sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in oral medicinal products may affect the bioavailability of other concomitant oral medicinal products. Legalon is an agent containing silymarin, a substance that protects liver cells from toxic substances. Therefore, it can be used not only in the treatment of certain liver problems, but also to protect the liver in people who take large amounts of alcoholic beverages. Unless there is other advice from a doctor, the herb is safe, therapeutic Splan recommends starting treatment by taking one capsule three times a day. For the maintenance dose, the indication of the document is to take one capsule twice a day.
Administration of the preparation does not require special precautions. Animal fertility studies conducted with Legalon® have shown no evidence of adverse effects associated with reproduction, fetal/embryonic development, childbirth and the puerperium. There has been no experience with Legalon® in men during pregnancy and lactation. Therefore, in such cases, Legalon® should only be used under medical supervision. In another study of 36 patients with the same type of liver disease, patients treated with silymarin (Silybum marianum (active substance)) showed a significant reduction in pathological liver parameters (transaminases, gamma-GT and bilirubin) compared to placebo6. In a randomised study compared to placebo, the effect of silymarin 420 mg/day on the treatment of 170 patients with alcohol-induced non-alcoholic cirrhosis was determined over an average period of 41 months. The ±4-year survival rate was 58±9% in the silymarin group and 30±0% in the placebo group (p=0.036). No adverse events were reported during treatment.7 The effects of silymarin on chemical, functional and morphological changes in the liver were studied in a double-blind controlled study involving 106 patients with liver disease with elevated levels of transaminases.
A total of 97 patients completed the four-week treatment with silymarin 420 mg/day (47 cases) or placebo (50 cases). The silymarin group showed a statistically larger and statistically significant decrease in transaminases and total simic bilirubin than the control group.8 To date, no symptoms associated with overdose have been reported. In case of accidental ingestion of doses well above the recommended doses, seek immediate medical attention. Do not take any action without first consulting a doctor. There is no specific antidote. Tell your doctor about the medicine you are taking, the dose (amount) and the symptoms you are experiencing.
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