Research
Milk Thistle
127 peer-reviewed studies curated from PubMed and Semantic Scholar.
Studies
Sorted by quality and recency
Efficacy of various plant-derived interventions in the prevention of radiation dermatitis in breast cancer patients: a systematic review and network meta-analysis of randomised controlled trials.
Systematic review and network meta-analysis of 18 RCTs involving 2177 patients to evaluate plant-derived substances for preventing radiation dermatitis in breast cancer patients. Silymarin (milk thistle) showed the greatest efficacy in preventing grade ≥2 radiation dermatitis compared to standard care.
Silymarin for adults with metabolic dysfunction-associated steatotic liver disease.
This meta-analysis evaluated the benefits and harms of silymarin monotherapy and silymarin complex in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). The analysis included 17 RCTs with 2069 participants. The evidence suggests that silymarin monotherapy may decrease liver enzymes compared to no intervention or placebo, but the certainty of evidence is low to very low. The benefits and harms of silymarin in MASLD remain unclear due to insufficient power and heterogeneity across studies.
Nephroprotective Effects of Silymarin: A Systematic Review and Meta-Analysis.
Systematic review and meta-analysis of clinical trials assessing the nephroprotective effects of silymarin. The meta-analysis showed a significant reduction in serum creatinine levels, particularly in patients with drug-induced acute kidney injury, but not in those with chronic kidney disease.
Effects of natural extract interventions in prostate cancer: A systematic review and network meta-analysis.
Systematic review and network meta-analysis of 28 studies involving 1,566 prostate cancer patients, evaluating 16 natural extract treatments. Silybin, alone or with selenium, was found to be effective in reducing serum PSA and IGF-1 levels, with silybin alone also impacting IGFBP-3 levels. The study highlights potential benefits of silybin for prostate cancer patients, though further evidence is needed to confirm safety.
Evaluation of the effect of herbal agents as management of radiodermatitis in breast cancer patients: A systematic review and meta-analysis.
Systematic review and meta-analysis evaluating the effectiveness of herbal agents in managing radiodermatitis in breast cancer patients. Silymarin showed positive effects in ameliorating radiodermatitis, while calendula and aloe vera lacked sufficient evidence for efficacy.
Silymarin seed extract supplementation enhances the growth performance, meat quality, and nutrients digestibility, and reduces gas emission in broilers
A feeding trial with 1,088 Ross 308 broiler chicks evaluated the effects of silymarin seed extract supplementation on growth performance, nutrient digestibility, and meat quality. Silymarin supplementation increased body weight, nutrient digestibility, and cecal Lactobacillus counts, while reducing gas emissions. Meat quality traits such as water holding capacity and drip loss were improved.
Effect of Milk Thistle Plant on Breast Milk Volume: A Systematic Review
Systematic review of clinical trials on the effect of milk thistle on breast milk volume. The review included 4 eligible articles with a total sample size of 294, showing that milk thistle positively affects milk production in new mothers without serious side effects.
Silibinin: a toxicologist's herbal medicine?
This commentary reviews studies on silibinin, the active component of milk thistle, used for hepatic disorders. Despite numerous publications, the mortality rate from Amanita mushroom ingestion remains around 10%. The systematic review suggests silibinin or penicillin is superior to routine care in reducing fatalities, but no quality randomized trial confirms its utility.
Pharmacological prevention strategy for capecitabine-induced hand-foot syndrome: A network meta-analysis of randomized control trials.
Network meta-analysis of randomized control trials to identify the best preventive regimen for capecitabine-induced hand-foot syndrome. Topical silymarin was found to have the best preventive ability compared to placebo, with pyridoxine and celecoxib also showing effectiveness.
Coadministration of silymarin with iron chelators in transfusion-dependent β-thalassemia patients: a systematic review and meta-analysis for effect on iron overload.
Systematic review and meta-analysis evaluating the efficacy of silymarin in combination with iron chelators on iron overload in transfusion-dependent β-thalassemia patients. The combination therapy showed significant improvement in serum ferritin levels but did not significantly decrease liver iron concentration.
Prophylactic Therapy of Silymarin (Milk Thistle) on Antituberculosis Drug-Induced Liver Injury: A Meta-Analysis of Randomized Controlled Trials.
Meta-analysis of five RCTs with 1198 patients evaluating silymarin's effect on preventing antituberculosis drug-induced liver injury (anti-TB DILI). Silymarin significantly reduced the occurrence of anti-TB DILI and improved liver function in patients undergoing anti-TB drugs.
The therapeutic effect of silymarin in the treatment of nonalcoholic fatty disease: A meta-analysis (PRISMA) of randomized control trials.
Meta-analysis of 8 RCTs involving 587 patients assessing the therapeutic effect of silymarin in nonalcoholic fatty liver disease. Silymarin significantly reduced AST and ALT levels compared to control, indicating positive efficacy in reducing transaminases levels in NAFLD patients.
Effects and tolerance of silymarin (milk thistle) in chronic hepatitis C virus infection patients: a meta-analysis of randomized controlled trials.
Meta-analysis of five RCTs evaluating the efficacy and safety of silymarin in chronic hepatitis C virus-infected patients. No significant differences were found in serum HCV RNA or ALT levels between silymarin and placebo groups. Silymarin was well tolerated, but no evidence of beneficial effects was reported based on intermediate endpoints.
Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.
Meta-analysis of 18 RCTs assessing milk thistle in 1088 patients with alcoholic and/or hepatitis B or C virus liver diseases. Milk thistle showed no significant effect on overall mortality or liver disease complications, but reduced liver-related mortality in all trials. The methodological quality of trials was low, and high-quality trials did not confirm the mortality benefit.
Milk thistle for alcoholic and/or hepatitis B or C liver diseases--a systematic cochrane hepato-biliary group review with meta-analyses of randomized clinical trials.
Meta-analysis of 13 randomized clinical trials assessing milk thistle in 915 patients with alcoholic and/or hepatitis B or C liver diseases. Milk thistle showed no significant effects on all-cause mortality or liver histology, but liver-related mortality was reduced in all trials, though not in high-quality trials. No significant increase in adverse events was associated with milk thistle.
Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.
Meta-analysis of 13 RCTs assessing milk thistle in 915 patients with alcoholic and/or hepatitis B or C virus liver diseases. Milk thistle showed no significant effect on overall mortality or liver histology, but reduced liver-related mortality in all trials, though not in high-quality trials. No significant increase in adverse events was observed.
Therapeutic Efficacy of Silymarin, Vitamin E, and Essential Phospholipid Combination Therapy on Hepatic Steatosis, Fibrosis, and Metabolic Parameters in MASLD Patients: A Prospective Clinical Study.
Prospective clinical study evaluating the combination of silymarin, vitamin E, and essential phospholipids in 190 MASLD patients over 6 months. Significant reductions in liver enzymes, lipid profiles, and blood glucose levels were observed, indicating positive effects on liver steatosis and fibrosis.
Promising efficacy of oral nano-silymarin formulation on prevention of vancomycin-induced nephrotoxicity: a randomized, triple-blinded, placebo-controlled clinical trial.
This randomized, triple-blinded, placebo-controlled clinical trial evaluated the preventive effects of nano-silymarin against vancomycin-induced nephrotoxicity in 60 patients. The study found that AKI incidence was significantly lower in the nano-silymarin group, and serum creatinine and urea levels were better managed compared to the placebo group, suggesting nephroprotective effects.
Silybum marianum Extract: A Highly Effective Natural Alternative to Retinoids to Prevent Skin Aging Without Side Effects.
The study compared Silybum marianum extract (SME) to retinol and bakuchiol for anti-aging effects on skin. SME significantly increased collagen III and hyaluronic acid levels, showing stronger anti-wrinkle effects than bakuchiol and similar efficacy to retinol, with enhanced safety. In a placebo-controlled study with 57 volunteers, SME showed no reported discomfort, unlike retinol.
Nutraceutical blends predict enhanced health via microbiota reshaping improving cytokines and life quality: a Brazilian double-blind randomized trial.
This double-blind randomized trial assessed the effects of two nutraceutical formulations, NSupple and NSupple_Silybum, on gut microbiota, cytokines, and quality of life in overweight/obese volunteers over 180 days. The NSupple_Silybum group, containing silymarin, showed positive modulation of gut microbiota, improved sleep patterns, quality-of-life perception, cytokines expression, and anthropometric parameters.
Novel nutraceutical supplements with yeast β-glucan, prebiotics, minerals, and(silymarin) ameliorate obesity-related metabolic and clinical parameters: A double-blind randomized trial.
Double-blind randomized trial evaluating a novel nutraceutical supplement with yeast β-glucan, prebiotics, minerals, and silymarin in sedentary volunteers with BMI ≤34.9 kg/m². The study found reductions in waist circumference, waist-to-height ratio, waist-to-hip ratio, and improvements in biomarkers associated with NAFLD and endocrine hormones over 180 days.
Effect of 8 Weeks milk thistle powder (silymarin extract) supplementation on fatty liver disease in patients candidates for bariatric surgery
RCT of 52 morbidly-obese patients with NAFLD undergoing bariatric surgery, testing 8 weeks of Silymarin supplementation. Significant improvements were found in AST/ALT ratio, BMI, and sonographic grading, but not in fibroscan staging, Fib-4, and NAFLD scores.
New therapy for chemotherapy-induced hepatic failure in leukemia; a randomized double-blind clinical trial study
This randomized double-blind clinical trial studied the efficacy of milk thistle in 93 acute lymphoblastic leukemia patients with chemotherapy-induced hepatotoxicity. Milk thistle significantly reduced ALT and AST serum levels compared to placebo over 70 days, indicating improved liver function.
Silymarin in Combination with Vitamin C, Vitamin E, Coenzyme Q10 and Selenomethionine to Improve Liver Enzymes and Blood Lipid Profile in NAFLD Patients
RCT of 81 NAFLD patients comparing a supplement combination (silymarin, vitamin C, vitamin E, coenzyme Q10, selenomethionine) to lifestyle modification. The supplement group showed significant improvements in liver enzymes, lipid profile, and ultrasound results, with good tolerability and no adverse events reported.
Comparison of Silymarin, Penicillin, N-acetylcysteine in Patient with Amatoxin Poisoning: A Systematic Review
Systematic review evaluating the clinical efficacy of silymarin, penicillin, and N-acetylcysteine in treating amatoxin poisoning. The review included 13 retrospective studies, with silymarin showing clinical superiority in several comparisons. The evidence suggests considering combinations of agents for amanita poisoning treatment.
Effects of milk thistle meal on performance, ileal bacterial enumeration, jejunal morphology and blood lipid peroxidation in laying hens fed diets with different levels of metabolizable energy.
This study evaluated the effects of milk thistle meal on performance, blood biochemical indices, ileal bacterial counts, and intestinal histology in laying hens. Dietary supplementation of milk thistle meal improved feed conversion ratio, reduced ileal Escherichia coli enumeration, and enhanced villus height-to-crypt depth ratio. It also decreased serum cholesterol, triglyceride, and MDA concentrations while increasing blood high-density lipoprotein content and goblet cell numbers.
Effect of silymarin on biochemical indicators in patients with liver disease: Systematic review with meta-analysis.
Systematic review and meta-analysis of randomized controlled trials evaluating the effect of silymarin on serum levels of ALT, AST, and γGT in patients with liver diseases. Silymarin minimally reduced ALT and AST levels, but without clinical relevance. No significant change in γGT levels was observed.
An updated systematic review with meta-analysis for the clinical evidence of silymarin.
Systematic review and meta-analysis of 19 clinical trials on silymarin for liver diseases. Evidence for therapeutic effect in toxic liver diseases is scarce. Silymarin reduced aspartate aminotransferase in alcoholic liver disease and showed a reduction in liver-related mortality in liver cirrhosis compared to placebo.
An updated systematic review of the pharmacology of silymarin.
This systematic review examines the pharmacology of silymarin, a mixture of flavonolignanes from milk thistle. It discusses silymarin's effects on transporters, receptors, antioxidant properties, and potential antitoxic effects. The review highlights silymarin's potential in cancer models and its skin protective properties against UV damage.
Silymarin treatment of viral hepatitis: a systematic review.
Systematic review of silymarin for chronic viral hepatitis B and C treatment. Silymarin decreased serum transaminases in some studies but did not affect viral load or liver histology. No studies investigated silymarin with conventional hepatitis treatments.
Novel Micellar Formulation of Silymarin (Milk Thistle) with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
This double-blind, randomized, crossover human trial evaluated the pharmacokinetics and tolerability of a novel micellar milk thistle formulation designed to enhance silymarin absorption compared to a standard formulation. The micellar formulation showed significantly higher bioavailability, with increased Cmax and AUC, and faster absorption. No adverse events or significant safety concerns were observed.
Adjunctive silymarin supplementation and its effects on disease severity, oxidative stress, and inflammation in patients with Alzheimer's disease.
This randomized, single-blind clinical trial evaluated the effect of silymarin on oxidative stress, inflammation, and disease severity in 33 Alzheimer's patients. Silymarin supplementation significantly decreased catalase and MDA serum levels and improved MMSE scores, suggesting its effectiveness as an adjunct drug and antioxidant in Alzheimer's disease.
Nutraceutical composition (yeast β-glucan, prebiotics, minerals, and silymarin) predicts improvement of sleep quality and metabolic parameters: A randomized pilot study.
A randomized pilot study investigated the effects of a 90-day nutraceutical composition containing yeast β-glucan, prebiotics, minerals, and silymarin on sleep quality and metabolic parameters in 22 young adults. Results showed improvements in sleep quality, reduced BMI, waist circumference, and improved metabolic and inflammatory markers.
Consumption of Sylimarin, Pyrroloquinoline Quinone Sodium Salt and Myricetin: Effects on Alcohol Levels and Markers of Oxidative Stress-A Pilot Study.
RCT investigating the effects of a product containing silymarin, pyrroloquinoline quinone sodium salt, and myricetin on alcohol metabolism and oxidative stress in 20 wine-drinking subjects. Si.Pi.Mi intake reduced circulating ethanol and improved oxidative stress biomarkers, suggesting better alcohol metabolism and oxidative balance.
Silymarin in combination with hair follicle transplantation as a potential treatment for refractory vitiligo: A double-blind randomized controlled trial.
This randomized controlled trial evaluated the efficacy of oral silymarin combined with hair follicle transplantation versus follicle transplantation alone in 20 patients with refractory vitiligo over 3 months. The silymarin group showed significant improvements in Vitiligo Extent Tensity Index and perifollicular pigmentation compared to the control group.
The Synergic Effect of a Nutraceutical Supplementation Associated to a Mediterranean Hypocaloric Diet in a Population of Overweight/Obese Adults with NAFLD
RCT of 68 overweight/obese adults with NAFLD comparing a Mediterranean-hypocaloric-diet with and without nutraceutical supplementation (Vitamin E, L-glutathione, silymarin). The nutraceutical group showed significant improvement in hepatic steatosis and nutritional parameters, suggesting enhanced efficacy of dietary intervention with supplements.
Antioxidative effects of silymarin on the reduction of liver complications of fingolimod in patients with relapsing-remitting multiple sclerosis: A clinical trial study.
RCT evaluating the effects of silymarin on reducing liver complications of fingolimod in 48 patients with relapsing-remitting multiple sclerosis. Silymarin significantly reduced ALT and AST levels, decreased malondialdehyde, and increased total antioxidant capacity and total thiol groups compared to placebo.
Silymarin in non-cirrhotics with non-alcoholic steatohepatitis: A randomized, double-blind, placebo controlled trial.
This randomized, double-blind, placebo-controlled trial assessed the safety and efficacy of silymarin in non-cirrhotic patients with NASH. Participants were randomized to receive Legalon® 420 mg, 700 mg, or placebo for 48 weeks. The study found no significant benefit of silymarin on histological improvement in NAS compared to placebo, indicating no effect on liver health.
The Long-Term Efficacy of a Galactagogue Containing Sylimarin-Phosphatidylserine and Galega on Milk Production of Mothers of Preterm Infants.
This RCT investigated the efficacy of a galactagogue containing silymarin-phosphatidylserine and galega on milk production in mothers of preterm infants. Results showed that mothers receiving the galactagogue reported higher rates of exclusive human milk administration at 3 months postpartum compared to placebo.
A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis.
A randomized, double-blind, placebo-controlled trial of 99 patients with NASH assessed the efficacy of silymarin (700 mg, 3 times daily for 48 weeks). Silymarin did not significantly reduce NAS scores by 30% or more compared to placebo but showed potential in reducing liver fibrosis. It was safe and well tolerated.
Silymarin, Olibanum, and Nettle, A Mixed Herbal Formulation in the Treatment of Type II Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.
RCT of 60 patients with type II diabetes mellitus evaluating the antihyperglycemic effects of a mixed herbal formulation containing silymarin, olibanum, and nettle. The herbal group showed significant reductions in serum fasting blood glucose, glycosylated hemoglobin, and triglycerides compared to placebo after 90 days.
A double-blinded randomized controlled trial of silymarin for the prevention of antituberculosis drug-induced liver injury
A double-blind randomized placebo-controlled trial evaluated the efficacy of silymarin in preventing antituberculosis drug-induced liver injury (antiTB-DILI) in tuberculosis patients. Silymarin reduced the incidence of antiTB-DILI compared to placebo, with a 28% lower risk. The study suggests silymarin's benefit may be due to superoxide dismutase restoration.
Effect of Silymarin Administration on Cisplatin Nephrotoxicity: Report from A Pilot, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
Pilot, randomized, double-blinded, placebo-controlled clinical trial evaluating the effects of oral silymarin 420 mg daily on cisplatin-induced nephrotoxicity. Silymarin did not prevent cisplatin-induced urine electrolyte wasting or renal function impairment. No adverse reactions were reported.
Phytoestrogens/insoluble fibers and colonic estrogen receptor β: randomized, double-blind, placebo-controlled study.
A randomized, double-blind, placebo-controlled trial assessed the effect of a dietary intervention containing milk thistle extract, secoisolariciresinol, and oat fiber on estrogen receptor beta and biological parameters in patients with sporadic colonic adenomas. The intervention showed significant increases in ER-beta protein and mRNA levels, suggesting a potential role in controlling apoptosis.
Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial.
RCT of 154 patients with chronic hepatitis C infection previously unsuccessfully treated with interferon-based therapy. Participants received 420-mg or 700-mg silymarin or placebo for 24 weeks. Silymarin did not significantly reduce serum ALT levels or HCV RNA levels compared to placebo.
Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.
This paper describes a multicenter, randomized, double-masked, placebo-controlled Phase II trial to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. The study highlights the challenges of conducting clinical trials with botanical products, focusing on silymarin's safety and efficacy in this context.
Effects of silymarin on gossypol toxicosis in divergent lines of chickens.
This study investigated the effects of silymarin on gossypol toxicosis in chickens. Despite silymarin's known hepatoprotective qualities, it did not alleviate the clinical effects of gossypol toxicosis, as chickens on gossypol and gossypol-silymarin diets stopped gaining weight and showed elevated liver enzyme activities and substantial lipidosis.
A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL).
A double-blind RCT of milk thistle in 50 children with acute lymphoblastic leukemia and hepatic toxicity. No significant differences in liver function tests were observed at Day 28, but the MT group had a significantly lower AST and a trend toward lower ALT at Day 56. In vitro, MT showed no antagonistic interactions with chemotherapy agents and a modest synergistic effect with vincristine.
A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis.
RCT assessing the safety and efficacy of silymarin in patients with acute clinical hepatitis. Silymarin was well tolerated and led to quicker resolution of symptoms related to biliary retention, such as dark urine, jaundice, and scleral icterus. However, it did not significantly reduce direct bilirubin, ALT, or AST levels.
Herbal product use by persons enrolled in the hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial.
Observational study within the HALT-C Trial examining silymarin use among 1145 participants with chronic hepatitis C. Silymarin users had similar alanine aminotransferase and HCV levels to nonusers but reported fewer symptoms and better quality-of-life indices. The study suggests potential benefits of silymarin, though results are confounded by self-motivated and uncontrolled use.
The pharmacokinetics of silymarin is altered in patients with hepatitis C virus and nonalcoholic Fatty liver disease and correlates with plasma caspase-3/7 activity.
The study investigated the pharmacokinetics of silymarin flavonolignans in liver disease patients compared to healthy volunteers. It found altered pharmacokinetics in patients with hepatitis C virus and nonalcoholic fatty liver disease, with higher exposure levels in these patients. Caspase-3/7 activity correlated with silymarin exposure and was highest in the HCV cirrhosis cohort.
Assessing the clinical significance of botanical supplementation on human cytochrome P450 3A activity: comparison of a milk thistle and black cohosh product to rifampin and clarithromycin.
RCT assessing the effects of milk thistle and black cohosh supplementation on CYP3A activity in healthy volunteers. Midazolam pharmacokinetics was unaffected by milk thistle or black cohosh, indicating no clinically relevant effect on CYP3A activity.
Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: study description and 12-month results.
A double-blinded RCT evaluated silymarin versus multivitamin supplements in 177 residents with chronic hepatitis C. After 12 months, both groups reported feeling better, but there were no differences in symptoms, quality-of-life scores, or markers of liver health between the groups. Silymarin was well-tolerated but showed no effect on hepatitis C virus viremia or liver fibrosis markers.
Influence of Milk Thistle on the Production Performance of Broilers
The study evaluated the influence of milk thistle on the production performance of broilers. 300 Vencobb 430Y broiler birds were divided into five groups, with groups B, C, D, and E receiving varying percentages of milk thistle. Results showed significantly higher live weights, gain in weight, and improved feed conversion ratios in treatment groups compared to the control, indicating milk thistle's positive impact on broiler growth performance.
Enhancing growth performance and innate immunity in broiler chickens through combined probiotic and herbal supplementation
The study evaluated the effects of dietary supplementation with probiotics and medicinal herbs (milk thistle, nettle, and dandelion) on broiler chickens. Combined supplementation improved growth performance and innate immune parameters, suggesting potential as a natural alternative to antibiotics.
Development and Characterization of Silibinin-Loaded Nanoemulsions: A Promising Mucoadhesive Platform for Enhanced Mucosal Drug Delivery
The study developed and characterized silibinin-loaded nanoemulsions for mucosal delivery, enhancing solubility by 625 times compared to water. The nanoemulsions showed excellent stability, solubilization capacity, and strong mucoadhesive interactions, indicating potential for effective mucosal drug delivery.
Effect of irrigation and bio-fertilizers on morphological and bio-chemical traits of milk thistle
The study assessed the effect of irrigation type and biofertilizers on milk thistle's seed yield, oil yield, and fatty acids in Iran. The interaction of irrigation and biofertilizer was significant for several traits, and biofertilizers improved most morphological and biochemical traits compared to the control.
Development of solid dispersion system from milk thistle dry extract by solvent method
The paper discusses the development of a solid dispersion system (SDS) from milk thistle dry extract using the solvent method to increase the bioavailability of silymarin. The study found that using polyvinylpyrrolidone vinyl acetate in the SDS significantly increased the silybin releasing-degree and bioavailability compared to the control sample.
Phytochemical Profiling of the Methanol Extracts of Silybum marianum (Milk Thistle) by FTIR and GCMS Analysis
The study conducted FTIR and GCMS analysis on the methanol extracts of Silybum marianum (milk thistle) to profile its phytochemical compounds. The analysis identified various functional groups and phytocompounds, highlighting the presence of silymarin, which is known for its liver-protective properties.
Chemical Standardization of Milk Thistle (Silybum marianum L.) Extract Using UHPLC-MS/MS and the Method of Standard Addition
The study developed a UHPLC-MS/MS method for the chemical authentication and standardization of milk thistle silymarin. It validated the method using standard addition to account for matrix effects, finding it suitable for standardizing silymarin in support of preclinical and clinical studies.
ANALYSIS OF THE PHARMACEUTICAL MARKET OF PREPARATIONS CONTAINING EXTRACTIVE BIOLOGICALLY ACTIVE SUBSTANCES OF MILK THISTLE SPOTTED (SILYBUM MARIANUM)
The paper analyzes the pharmaceutical market of preparations containing extractive biologically active substances of milk thistle in Volgograd. It highlights the use of milk thistle in herbal remedies for hepatopathologies and notes the presence of over-the-counter medications and dietary supplements containing milk thistle extract.
Hepatic fatty acids profile, oxidative stability and egg quality traits ameliorated by supplementation of alternative lipid sources and milk thistle meal.
This study assessed the effects of milk thistle meal (MTM) on egg quality traits, oxidative stability, blood biochemical parameters, and liver health indices in laying hens. Different levels of MTM were tested with various dietary fat sources. Results showed that MTM reduced hepatic lipid percentage and improved eggshell strength and thickness. Fish oil and MTM supplements improved internal egg quality traits and eggshell quality, respectively.
Development of the Composition and Technology of a Granular Dosage form Based on a Thick Milk Thistle Extract and Ademetionine
The study developed a combined granular dosage form containing a thick extract of milk thistle and ademetionin, aimed at hepatoprotective activity. The process involved traditional percolation and HPLC analysis for silybin. Validation studies confirmed the accuracy and precision of the method.
Superior silybin bioavailability of silybin-phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets in healthy volunteers.
A prospective, balanced, blind, single-dose, two-way crossover study in 23 healthy volunteers compared the bioavailability of silybin-phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets. The study found that plasma levels of silybin were higher after administration of the silybin-phosphatidylcholine complex capsules.
Semen quality, antioxidant status and reproductive performance of rabbits bucks fed milk thistle seeds and rosemary leaves.
RCT investigating the effects of milk thistle seeds and rosemary leaves on reproductive performance and semen quality in rabbit bucks. Milk thistle at 10g/kg and rosemary at 5g/kg diets significantly improved semen quality, fertility, and testosterone levels compared to control.
Relative Bioavailability of Silybin A and Silybin B From 2 Multiconstituent Dietary Supplement Formulations Containing Milk Thistle Extract: A Single-dose Study.
This randomized, open-label, crossover pharmacokinetic study compared the bioavailability of silybin A and silybin B from two milk thistle-containing dietary supplements, Product B and IsaGenesis, in 12 healthy volunteers. The IsaGenesis soft gel formulation showed significantly higher absorption and bioavailability of silybin A and B compared to the powdered Product B.
Effect of Oral Silymarin Administration on Prevention of Radiotherapy Induced Mucositis: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
This randomized, double-blinded, placebo-controlled clinical trial evaluated the efficacy of oral silymarin in preventing radiotherapy-induced mucositis in patients with head and neck cancer. Silymarin significantly reduced the severity and delayed the occurrence of mucositis compared to placebo over a 6-week period.
A Presurgical Study of Oral Silybin-Phosphatidylcholine in Patients with Early Breast Cancer.
This presurgical study investigated the distribution of silybin in breast tissue of 12 early breast cancer patients taking silybin-phosphatidylcholine orally for 4 weeks. Silybin levels were measured in plasma, urine, and breast tissue, showing selective accumulation in tumor tissue. No toxicity or significant changes in IGF-I, nitric oxide, or Ki-67 were observed.
The effects of milk thistle (Silybum marianum) on human cytochrome P450 activity.
The study investigated the effect of a standardized milk thistle supplement on major P450 drug-metabolizing enzymes in nine healthy volunteers over a 14-day period. Milk thistle extract produced no significant influence on CYP1A2, CYP2C9, CYP2D6, or CYP3A4/5 activities.
Immunomodulatory effects of silymarin in patients with β-thalassemia major.
RCT investigating the immunomodulatory effects of silymarin in patients with β-thalassemia major. Silymarin treatment decreased serum TNF-α and neopterin levels, and increased production of IFNγ and IL-4, suggesting stimulation of cell-mediated immune response.
A phase I dose-finding study of silybin phosphatidylcholine (milk thistle) in patients with advanced hepatocellular carcinoma.
Phase I dose-finding study of silybin phosphatidylcholine in patients with advanced hepatocellular carcinoma. The study aimed to determine the maximum tolerated dose, but it could not be established. Serum concentrations of silibinin and its metabolite increased, but all participants died within 23 to 69 days, likely from hepatic failure.
Effect of milk thistle on the pharmacokinetics of darunavir-ritonavir in HIV-infected patients.
Open-label, fixed-sequence study investigating the interaction of milk thistle (silymarin) with darunavir-ritonavir in 15 HIV-infected patients. Silymarin was added to the antiretroviral treatment for 14 days. The study found that coadministration of silymarin with darunavir-ritonavir is safe and does not require dose adjustment.
Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C.
The study examined the pharmacokinetics of silymarin flavonolignans in patients with nonalcoholic fatty liver disease (NAFLD) and hepatitis C virus (HCV). Plasma concentrations of silybin A and B were higher in NAFLD compared to HCV, suggesting potential differences in efficacy. NAFLD patients showed higher flavonolignan plasma concentrations and more extensive enterohepatic cycling.
The safety and efficacy of a silymarin and selenium combination in men after radical prostatectomy - a six month placebo-controlled double-blind clinical trial.
A six-month placebo-controlled double-blind clinical trial in 37 men post-radical prostatectomy assessed the effects of a silymarin and selenium combination. The treatment improved quality of life scores, decreased LDL and total cholesterol, and increased serum selenium levels, with no adverse events reported.
A study of high-dose oral silybin-phytosome followed by prostatectomy in patients with localized prostate cancer.
RCT investigating the effects of high-dose oral silybin-phytosome in prostate cancer patients undergoing prostatectomy. Six patients received 13 g daily for 14-31 days. High blood concentrations of silibinin were achieved, but low levels were observed in prostate tissue. No significant changes in IGF-I and IGFBP-3 levels were noted. One patient experienced a grade 4 thromboembolic event, while other toxicities were mild.
The iron-chelating potential of silybin in patients with hereditary haemochromatosis.
Crossover study in 10 patients with hereditary haemochromatosis testing silybin's effect on iron absorption. Silybin reduced the postprandial increase in serum iron compared to water and tea, suggesting potential as an adjunct treatment for haemochromatosis.
Combined effects of silymarin and methylsulfonylmethane in the management of rosacea: clinical and instrumental evaluation.
Double-blind, placebo-controlled study of 46 patients with stage I-III rosacea treated with a topical silymarin/methylsulfonylmethane (S-MSM) combination for 1 month. Significant improvements were observed in skin redness, papules, itching, hydration, and skin color.
Silybin treatment is associated with reduction in serum ferritin in patients with chronic hepatitis C.
RCT of 37 patients with chronic hepatitis C and Batts-Ludwig fibrosis stage II, III, or IV, randomized to 3 doses of a silybin and soy phosphatidylcholine complex (IdB 1016) for 12 weeks. Significant decrease in serum ferritin was observed, indicating reduced body iron stores, especially in patients with advanced fibrosis stage.
The effect of silymarin on oral nifedipine pharmacokinetics.
RCT examining the effect of silymarin on the pharmacokinetics of nifedipine in 16 healthy male volunteers. The study found that silymarin co-administration did not considerably change the extent of absorption or metabolism of nifedipine but may decrease the absorption rate. Silymarin is not a potent CYP3A4 inhibitor in vivo.
Bioavailability of a silybin-phosphatidylcholine complex in dogs.
The study tested the bioavailability of a silybin-phosphatidylcholine complex (SPC) in dogs compared to a standardized silymarin extract. Eight beagles were dosed with SPC and showed significantly higher Cmax, Tmax, and AUC0-24 h values for total silybin compared to the standardized extract, indicating enhanced bioavailability.
A phase I and pharmacokinetic study of silybin-phytosome in prostate cancer patients.
Phase I trial assessing the toxicity and pharmacokinetics of high-dose silybin-phytosome in prostate cancer patients. Thirteen patients received 2.5-20 g daily in three divided doses over 4-week courses. The most common adverse event was hyperbilirubinemia, with no objective PSA responses observed. The recommended phase II dose is 13 g daily.
Effect of milk thistle (Silybum marianum) and black cohosh (Cimicifuga racemosa) supplementation on digoxin pharmacokinetics in humans.
RCT with 16 healthy volunteers assessing the effect of milk thistle and black cohosh supplementation on digoxin pharmacokinetics. No statistically significant effects on digoxin pharmacokinetics were observed following supplementation with either milk thistle or black cohosh, although digoxin AUC(0-3) and AUC(0-24) approached significance following milk thistle administration.
Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.
A randomized controlled trial with 16 healthy participants examined the effect of milk thistle on the pharmacokinetics of indinavir. The study found no significant differences in indinavir levels between the milk thistle and control groups. A meta-analysis of three trials also showed a non-significant pooled mean difference in indinavir levels.
Coadministration of milk thistle and indinavir in healthy subjects.
Sequential crossover trial in 10 healthy subjects to determine if milk thistle (silymarin) alters the pharmacokinetics of indinavir. Silymarin was administered for 14 days, and indinavir's pharmacokinetic parameters were evaluated before and after. Silymarin had no apparent effect on indinavir plasma concentrations.
Effect of milk thistle on the pharmacokinetics of indinavir in healthy volunteers.
Prospective open-label drug interaction study with 10 healthy volunteers to evaluate the effect of milk thistle on the pharmacokinetics of indinavir. Milk thistle did not significantly alter the overall exposure of indinavir, with a 9% reduction in AUC8 and a 25% decrease in the trough level (C8).
Two high-performance liquid chromatographic assays for the determination of free and total silibinin diastereomers in plasma using column switching with electrochemical detection and reversed-phase chromatography with ultraviolet detection.
The paper describes the development of two stereoselective HPLC assays for determining free and total silibinin diastereomers in human plasma. These assays were applied in a pharmacokinetic study of silymarin in human volunteers.
Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver.
RCT of 170 patients with cirrhosis comparing 140 mg silymarin three times daily to placebo over a mean observation period of 41 months. The 4-year survival rate was significantly higher in silymarin-treated patients (58%) compared to the placebo group (39%). Treatment was particularly effective in patients with alcoholic cirrhosis and those initially rated 'Child A'.
Silymarin (Milk Thistle) Treatment of Adults With Gambling Disorder: A Double-Blind, Placebo-Controlled Trial.
Double-blind, placebo-controlled trial of silymarin (milk thistle) in 43 adults with gambling disorder over 8 weeks. Silymarin did not statistically differentiate from placebo on outcome measures, with a robust placebo response observed.
The Role of Milk Thistle ( Silybum marianum ) on Cisplatin‐Induced Genotoxicity in Albino Rats
The study investigated the effects of milk thistle flower extract on cisplatin-induced kidney damage in male albino rats. Milk thistle extract reduced serum creatinine and blood urea levels, decreased bone marrow DNA single stranded breaks, and prevented DNA damage caused by cisplatin.
The effect of milk thistle (Silybum marianum), methionine, tocopherol acetate, and ascorbic acid in a feed supplement on rats' morphological and biochemical blood parameters under carbon tetrachloride poisoning
The study investigated the effects of the 'Silimevit' feed supplement, containing milk thistle, methionine, tocopherol acetate, and ascorbic acid, on rats under carbon tetrachloride-induced oxidative stress. The supplement normalized blood morphology and liver protein synthesis in intoxicated rats by days 25 and 30 of the experiment.
Microbially produced vitamin B12 contributes to the lipid-lowering effect of silymarin
The study investigates the role of gut microbiota in the lipid-lowering effect of silymarin. It finds that silymarin induces microbial shifts and bacterial B12 production, which contribute to liver fat reduction in male rats. Fecal microbiota transplantation confirms protective roles against liver fat accumulation, and human data show negative association between serum B12 changes and triglyceride fluctuations.
Modulation of Insulin Resistance by Silybum marianum Leaves, and its Synergistic Efficacy with Gymnema sylvestre, Momordica charantia, Trigonella-foenum graecum Against Protein Tyrosine Phosphatase 1B
The study evaluated the efficacy of Silybum marianum leaf extract on inhibiting PTP1B activity, a negative regulator of insulin signaling, and its synergistic effect with Gymnema sylvestre, Momordica charantia, and Trigonella foenum graecum. S. marianum showed dose-dependent inhibition of PTP1B and increased glucose uptake efficiency in yeast cell lines. The combination of extracts showed higher PTP1B inhibition than metformin.
THE INHIBITORY EFFECT OF SILYBUM MARIANUM (MILK THISTLE) SEEDS EXTRACT ON SERUM ALBUMIN GLYCATION BY GLUCOSE, FRUCTOSE AND GALACTOSE
In vitro study investigating the ability of Silybum marianum (Milk thistle) extract to inhibit glycation of bovine serum albumin by glucose, fructose, and galactose. The extract inhibited glycation processes, particularly with glucose and galactose, in a dose- and time-dependent manner.
Effects of Dietary Milk Thistle (Silybum marianum) Supplementation in Ducks Fed Mycotoxin-Contaminated Diets
The study investigated the health protective effects of dietary milk thistle seed, oil, and seed cake in ducks fed diets contaminated with deoxynivalenol and zearalenone. Milk thistle supplements were effective in preventing histopathological changes caused by these mycotoxins, with milk thistle oil showing the most positive effects on vacuolar hepatocyte degeneration.
Inhibition of UGT1A1*1 and UGT1A1*6 catalyzed glucuronidation of SN-38 by silybins.
The study evaluated the inhibitory effects of silybins on UGT1A1*1 and UGT1A1*6 catalyzed glucuronidation of SN-38, the active form of irinotecan. Silybin A and B potently inhibited SN-38 glucuronidation, with potential clinically significant herb-drug interactions via UGT1A1 inhibition.
Effect of Milk Thistle (Silybum marianum (L.) Gaertn) Seed Extract on Bacterial Activities and Growth of Human Liver Cancer Cells
The study investigates the antibacterial and anticancer activities of milk thistle seed extract. The extract showed strong inhibition against Staphylococcus aureus and Salmonella enterica and demonstrated high anticancer activity against human liver cancer cells.
Physiologically Based Pharmacokinetic Modeling Framework for Quantitative Prediction of an Herb–Drug Interaction
The study used physiologically based pharmacokinetic (PBPK) modeling to predict herb-drug interactions involving silibinin, a semipurified milk thistle preparation. Simulations showed minimal interaction between high-dose silibinin and the drugs midazolam and (S)-warfarin, with a proof-of-concept clinical study confirming these findings.
A sensitive LC-MS/MS assay for the simultaneous analysis of the major active components of silymarin in human plasma.
The study describes a novel LC-MS/MS method for simultaneous analysis of silymarin constituents in human plasma, including silychristin, silydianin, silybin A and B, isosilybin A and B, and taxifolin. The method was applied to plasma samples from subjects treated with the milk thistle extract Legalon.
Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients.
Prospective study evaluating a silymarin-based cream (Leviaderm®) for preventing radiodermatitis in breast cancer patients undergoing radiotherapy. The silymarin-based cream significantly prolonged the median time to toxicity and reduced the incidence of grade 2 and 3 skin toxicities compared to standard care.
Impact of Milk Thistle Cake as the Natural Antioxidant Source on the Mitigation of Oxidative Effects in Goat Milk Induced by Oxidized Linseed Oil
This study investigated the use of milk thistle cake as a natural antioxidant in the diet of dairy goats to mitigate oxidative effects in milk caused by oxidized linseed oil. The experimental group fed with milk thistle cake showed improved milk antioxidant potential and reduced oxidative degradation, demonstrating its benefits in goat nutrition.