Fruits Of Silybum Marianum Research Articles

53728 Reflectance confocal microscopy and clinical evaluation of a product containing Silybum marianum fruit extract (SMFE) in monotherapy for acne vulgaris treatment: a prospective study

53728 Reflectance confocal microscopy and clinical evaluation of a product containing Silybum marianum fruit extract (SMFE) in monotherapy for acne vulgaris treatment: a prospective study

52237 Multi-omics and integrative approach to understand microcomedone ecosystem and evaluate the pharmaco-clinical efficacy of an acne prone skin product containing Silybum Marianum Fruit Extract

52237 Multi-omics and integrative approach to understand microcomedone ecosystem and evaluate the pharmaco-clinical efficacy of an acne prone skin product containing Silybum Marianum Fruit Extract

Treatment of cows with liver pathology using a liposomal drug based on extract from the fruits of Silybum marianum

After labor, dairy cows are often diagnosed with fatty liver disease. The objective of our study was to identify the efficacy of a liposomal drug based on extract from seeds of Silybum marianum (L.) Gaertn., including tocopheryl acetate, lecithine, squalene, and Twin-80, which was intramuscularly administered to dairy cows to recover the functional state and structure of the liver from the disorder. The experiment involved clinically healthy cows and cows suffering disorders in the main functions and the structure of the liver. The sick cows were treated with intramuscular injections of the drug. Three-time administration of the liposomal drug, with two days interval between each dose, improved the functional condition and the structure of the damaged liver. Biochemical assays of blood of the cows after treatment revealed improvement of the bile-forming and bile-removing functions of the liver, and also removal of cholestasis, as evidenced by decreased concentrations of uric acids, total and conjugated bilirubin, and lower activity of gamma-glutamyl transpeptidase in serum. Intramuscular injections of the drug in the sick animals reduced the activities of the hepatospecific mitochondrial enzyme glutamate dehydrogenase in the blood serum, and also the indicatory enzymes aspartate aminotransferase and alanine aminotransferase, indicating recovery of the structure of hepatocytes and cessation of cytolysis. After treatment, the sick cows were observed to have upward tendencies in albumin and glucose, which may be interpreted as recovery of the protein-synthesizing and carbohydrate functions of the liver. However, three-time intramuscular injection of the S. marianum-based liposomal drug did not lead to complete recovery of the functions and the structure of hepatocytes in the cows suffering fatty liver disease, and therefore further research should be carried out, with longer and more complex therapeutic approaches.

Reflectance confocal microscopy and clinical evaluation of a product containing Silybum marianum fruit extract in monotherapy for acne vulgaris treatment: A prospective study

AbstractBackgroundAcne is a common pilosebaceous unit chronic inflammatory disease, with a multifactorial pathogenesis. It involves several processes: increased sebum production, alteration of the follicular keratinization process and bacterial colonization by Cutibacterium acnes.ObjectivesTo evaluate the effectiveness of reflectance confocal microscopy (RCM) in evaluating the reduction of mild to severe acne lesions in patients treated with an investigational product containing Silybum marianum fruit extract (SMFE).MethodsSubjects previously examined for counting acne lesions were topically treated in the face, with an investigational product containing SMFE in monotherapy over the course of 60 days (n = 31). They were examined for counting acne lesions. Efficacy and quality of life, tolerability, and safety assessments were performed. The infundibular diameter (ID) measurement of normal and acne skin areas was analyzed using RCM.ResultsThe RCM data statistical analysis allowed us to identify two ID patterns, 300–750 µm, with a reduction of 33.33% (p < 0.05) and 900–1050 µm with 73.16% (p < 0.05) reduction after 60 days. The noninflammatory lesions had a mean variation of −44.51% and −67.82% after 30 and 60 days, respectively (t test: p < 0.05 and p < 0.001 after Bonferroni's correction). The inflammatory lesions had a mean variation of −69.31% and −79.40% after 30 and 60 days (t test: p < 0.05 and p = 0.118 after Bonferroni's correction).ConclusionsThe authors demonstrated the effectiveness of the monotherapy scheme with an investigational product containing SMFE through the statistically significant results obtained by the RCM in acneic and nonacneic skin, in addition to the reduction in the number of noninflammatory at the end of the 60 days of clinical follow‐up. Furthermore, the monotherapy scheme with the investigational product proved safe, with no serious adverse events during the entire clinical study. In summary, the use of RCM proved to be effective in assessing the therapeutic response in patients with moderate to severe acne.

QUALITY ASSESSMENT OF SILYBUM MARIANUM FRUITS GROWN IN THE REPUBLIC OF BURYATIA

Introduction. Medicines of plant origin are widely used in the complex therapy of various diseases. Among the medicines of plant origin used for the treatment of chronic liver diseases, the most popular are preparations based on Silybum marianum (L.) Gaertn.). The aim of this work was to Silybum marianum fruits to evaluate the possibility of obtaining raw materials of pharmacopoeial quality in the dry-steppe zone of the Republic of Buryatia. Material and methods. The object of the study was Silybum marianum fruits of the varieties Debut and Start, obtained from experimental fields in Ivolginsky district of the Republic of Buryatia, as well as samples of Silybum marianum fruits received for analysis at the Testing Center of FGBNU VILAR from different regions of the Russian Federation. Results. As a result of the research it was found that climatic and geographical conditions of the dry-steppe zone of the Republic of Buryatia allow successful cultivation of Silybum marianum and obtaining raw materials (fruits) of pharmacopoeial quality. Conclusion. Silybum marianum fruits obtained from plants of the Start variety are not inferior to similar raw materials harvested in other regions of the Russian Federation in the content of the sum of flavolignans.

Beneficial effects of silibinin on serum lipids, bile acids, and gut microbiota in methionine-choline-deficient diet-induced mice.

Silibinin (SIL) is a flavonoid lignin isolated from the fruit and seeds of silybum marianum that exhibits good therapeutic potential for NASH. However, the effects of SIL on serum lipids, bile acids (BAs), and gut microbiota (GM) in NASH mice remain unknown. The present work aimed to explore the beneficial effects of SIL supplementation on serum lipids, bile acids, and gut microbiota in MCD mice. After male C57BL/6 mice were fed with a methionine-choline deficient (MCD) diet and simultaneously gavaged with SIL (20 mg/kg. d) for 8 weeks, the pathological changes of liver tissue were observed by oil red O, haematoxylin-eosin, and Masson tricolor staining; the levels of serum AST and ALT, and liver TG and MDA were detected by assay kits; metabonomics and 16S rDNA sequencing were used to analyze the composition of serum lipids and BAs and the abundance of GM; and the mRNA expression levels of hepatic genes related to BAs homeostasis were detected by RT-qPCR. The results indicated that SIL treatment decreased the levels of 26 lipids (including four arachidonic acids, seven FFAs, 12 acyl carnitines, and three GPs) and two BAs (23-DCA, GLCA), while Dubosiella increased the levels of 10 lipids (including TxB3, PG16:0_18:1, Cer t18:0/24:0 and 7 TGs), five BAs (β-MCA, α-MCA, UDCA, 3-oxo-DCA and HCA), and two GMs (Verrucomicrobiota and Akkermansiaceae) of MCD mice, but had no significant effect on the mRNA expression of CYP7A1, CYP27A1, Bsep, Mrp2, Ntcp, or Oatp1b2. Therefore, influencing GM composition and then regulating the levels of serum lipids and BAs through enterohepatic axis should be an important mechanism of SIL-induced alleviative effect on MCD mice. More importantly, we found that SIL had a good coordination in regulating the abundance of GM and the contents of serum lipids and BAs in MCD mice, that is, when the abundance of probiotics was up-regulated, the content of beneficial unsaturated fatty acids in serum was up-regulated, while the serum levels of harmful lipids and BAs were down-regulated. The alleviating effect of SIL on NASH may be closely related to the correction of intestinal bacteria disorder, serum bile acid, and lipid metabolic disturbance in mice.

Potential antibacterial and antioxidant inhibitory activities of Silybum marianum mediated biosynthesised He-Ne laser

A potentially beneficial method in laser irradiation is currently gaining popularity. The biosynthesis of low-power lasers has also been applied to the therapy of disease in biological tissues. This study used laser pre-treatments of Silybum marianum (S. marianum) fruit extract as a stabilising agent to bio-fabricate a low-power laser. The silybin A and silybin B of the S. marianum fruit, which are derived from seedlings before S. marianum undergoes therapy with an He-Ne laser at various intervals, were assessed for their expressive properties in this study. The findings revealed that 6-min laser pre-treatments increased silybin A + B and bacterial inhibition and improved the medicinal property of S. marianum. The analysis of the reaction records was performed using ultraviolet–visible spectroscopy. The minimum inhibitory concentration (MIC) limit for the sphere dispersion approach’s antimicrobial effect on the microorganisms under investigation was 50 to 100 g/mL. With an IC50 of 0.69 mg/mL, the laser-treated S. marianum (6 min) demonstrated radical scavenging activity. At MIC concentration, the laser-treated S. marianum (6 min) did not exhibit cytotoxicity in the MCF-7 cell line. Additionally, Salmonella typhi, methicillin-resistant Staphylococcus aureus (MRSA), and E. coli were more susceptible to the antimicrobial effects of ethanolic fruit extract with a greater silybin level. It was observed that the laser-treated S. marianum (6 min) showed beneficial antioxidant and antibacterial properties and could be employed without risk in several medical applications.

990 An integrative approach to understand microcomedone ecosystem and demonstrate the pharmaco-clinical efficacy of an acne prone skin product containing Silybum Marianum Fruit Extract

990 An integrative approach to understand microcomedone ecosystem and demonstrate the pharmaco-clinical efficacy of an acne prone skin product containing Silybum Marianum Fruit Extract

Tolerability and effectiveness of a dermocosmetic product containing Silybum marianum fruit extract in adolescents and young adults with acne-prone skin: An international, phase IV, longitudinal study.

Dermocosmetic products are often used to maintain or enhance the tolerance and effectiveness of medical anti-acne therapies. Recent discoveries about the pathophysiology of acne-prone skin indicate that skincare products may help maintain homeostasis around the sebaceous gland progenitor cells, thereby preventing microcomedone formation. To evaluate the tolerance and effectiveness of a dermocosmetic product containing Silybum marianum fruit extract (SMFE) in adolescents and young adults with acne-prone skin. This real-life, international, observational, multicenter study was conducted in patients aged 12-25 years with mild-to-moderate acne. Patients (N=4230) used the product twice daily for 8-12 weeks, either alone before ("initial group") or after an anti-acne therapy ("maintenance group"), or in association with their usual prescribed anti-acne therapies ("association group"). The tolerance, effectiveness, and cosmetic properties of the product were assessed. Patient quality of life (QoL) was also evaluated. Dermatologists rated the tolerance of the product as "good" or "very good" in about 95% of the patients and the effectiveness of the product as "effective" or "highly effective" in about 80% of the patients, with a significant reduction in the mean global evaluation of acne (GEA) grade (-36% ± 39%, p < 0.0001) at study end. The QoL of most patients (80%) improved by the end of the study, and the majority (79% to 94%) appreciated the cosmetic properties of the product. Overall, the product was a clinical success in >84% of patients. This dermocosmetic product can be used by adolescents and young adults with acne-prone skin to limit the initial or chronic use of medical anti-acne therapies.

Development of an Effective Acne Treatment Based on CBD and Herbal Extracts: Preliminary In Vitro, Ex Vivo, and Clinical Evaluation.

Acne vulgaris, the most common form of acne, is characterized by a mixed eruption of inflammatory and noninflammatory skin lesions primarily affecting the face, upper arms, and trunk. The pathogenesis of acne is multifactorial and includes abnormal keratinization and plugging of the hair follicles, increased sebum production, proliferation and activation of Cutibacterium acnes (C. acnes; formerly Propionibacterium acnes, P. acnes), and finally inflammation. Recent studies have found that cannabidiol (CBD) may be beneficial in the treatment of acne. The aim of this study was to explore natural plant extracts that, when combined with CBD, act synergistically to treat acne by targeting different pathogenic factors while minimizing side effects. The first stage of the study investigated the capacity of different plant extracts and plant extract combinations to reduce C. acnes growth and decrease IL-1β and TNFα secretion from U937 cells. The results found that Centella asiatica triterpene (CAT) extract as well as silymarin (from Silybum marianum fruit extract) had significantly superior anti-inflammatory activity when combined with CBD compared to either ingredient alone. In addition, the CAT extract helped potentiate CBD-induced C. acnes growth inhibition. The three ingredients were integrated into a topical formulation and evaluated in ex vivo human skin organ cultures. The formulation was found to be safe and effective, reducing both IL-6 and IL-8 hypersecretion without hampering epidermal viability. Finally, a preliminary clinical study of this formulation conducted on 30 human subjects showed a statistically significant reduction in acne lesions (mainly inflammatory lesions) and porphyrin levels, thereby establishing a tight correlation between in vitro, ex vivo, and clinical results. Further studies must be conducted to verify the results, including placebo-controlled clinical assessment, to exclude any action of the formulation itself.

Long-Term Use of Silybum marianum fruit extract Contributes to Homeostasis in Acne-Prone Skin-A 12-Month Follow-Up International "Real Life" Cohort Study.

Homeostasis in the differentiation programme of sebaceous stem cells has been identified as a key step in comedogenesis and should be a target for acne-prone skin care. To report on a multicentre, year-long/real-life use study of a patented natural product containing S. marianum fruit extract proven to modulate molecular actors in the initial steps of comedogenesis. An open-label multicentric international study, with a 12 month follow-up, included 54 teenage and young adult subjects with mild to moderate facial acne. The study was aimed at reproducing a real-life use context. Total lesion count mean was 88.3 at inclusion. There was a sustained, highly significant decrease over the months of clinical lesion counts (45.6% improvement after 6 months and 59.6% at 12 months) and on other efficacy markers, associated with a significant decrease in global microcomedone quantity on cyanoacrylate superficial skin surface biopsies. Importantly, the study protocol allowed the dermatologist to prescribe, if needed as in real life, any of the acne drugs registered in the acne guidelines. The exposure to these acne drugs during the whole year was calculated as a percentage of S. marianum fruit extract/352 days of use and happened to be very limited at less than 4%, which indicates a marginal contribution to the sustained clinical improvement. (Oral and local acne treatments: Lymecycline 1.46%; Doxycycline 0.24%; Adapalene 0.16% or gel association with Benzoyl peroxide 1.17%; Clindamycin 0.04%; Benzoyl peroxide 1.5%; Erythromycin 0.75%). The tolerance with daily S. marianum fruit extract long-term use was good. The association with routine prescription acne drugs when needed, even if limited, does not allow a full evaluation of the intrinsic quantitative efficacy of S. marianum fruit extract in lesion reduction. This open, real-life, year-long multicentre study confirms a previous 48-week proof of concept study and qualifies the use of S. marianum fruit extract as a "field-dermo cosmetic" contributing to homeostasis of acne-prone skin in association with acne drugs.

Moringa oleifera Leaf Extract Enhanced Growth, Yield, and Silybin Content While Mitigating Salt-Induced Adverse Effects on the Growth of Silybum marianum

Silybin A and B are two major hepatoprotective flavonolignans produced predominantly in Silybum marianum fruits. Similar to other plant secondary metabolites, silybin production is enhanced by biotic or abiotic stresses under the expanse of plant growth and yield. In this study, a novel strategy for enhancing silybin production was investigated by applying a natural plant growth enhancer, moringa leaf extract (MLE), to the S. marianum plants cultivated under salinity abiotic stress. The experiment was conducted using a split-plot design with salinity as the main factor and MLE concentrations as the sub-factor. The individual and combined effects of salinity and MLE on the growth, yield, and silybin content of S. marianum were recorded. The MLE at concentrations of 5 g/L or 10 g/L was applied as foliar spray to S. marianum plants, which were irrigated with either tap water or saline (2000 ppm or 4000 ppm). Our results revealed that 10 g/L MLE effectively enhances the growth, yield, and silybin (A + B) content in S. marianum plants not exposed to salinity stress. On the other hand, for plants that were exposed to 4000 ppm salinity, the application of MLE was able to alleviate the salinity-induced adverse effects on some of the plant growth parameters but did not significantly increase their silybin (A + B) compositions. The current study also indicated that the increase in silybin contents was accompanied by the upregulation of the chalcone synthase 1 and 3 genes, which have been implicated in the synthesis of silybin.

Comparative Analysis of Silybum Marianum Fruit Extracts and Thyme Oil Samples Using NMR-based Multivariate Statistical Methods

Comparative Analysis of Silybum Marianum Fruit Extracts and Thyme Oil Samples Using NMR-based Multivariate Statistical Methods

Lipid Droplet Proteins in Acne Skin: A Sound Target for the Maintenance of Low Comedogenic Sebum and Acne-Prone Skin Health

In adipocytes and sebocytes, lipid droplet proteins control the storage of lipids in organized droplets and their release on demand. The contribution of lipid droplet proteins to the pathogenesis of acne is plausible because they control the levels of comedogenic free fatty acids. The expression of two lipid droplet proteins, CIDEA and PLIN2, was analyzed in the skin of patients with acne by immunohistochemistry and western blotting. The design of clinical protocols allowed correlating the expression of CIDEA and PLIN2 with both comedogenesis and the release of free fatty acids. Both proteins were detected by immunohistochemistry in the sebaceous glands of patients with acne, with a disturbed expression pattern of PLIN2 compared with that in the controls. Higher levels of PLIN2 and CIDEA, as detected by western blotting in the infundibulum, significantly correlated with lower ongoing comedogenesis over 48 weeks of Silybummarianum fruit extract application. Accordingly, free fatty acid release from sebum triglycerides was significantly decreased, as shown with two distinct methods. The data are consistent with the expected role of PLIN2 and CIDEA in the prevention of comedogenic free fatty acid release. Modulation of PLIN2 and CIDEA expression appears as a sound target for the maintenance of low comedogenic sebum and acne-prone skin health.

Silibinin ameliorates depression/anxiety-like behaviors of Parkinson's disease mouse model and is associated with attenuated STING-IRF3-IFN-β pathway activation and neuroinflammation

Depression and anxiety are common neuropsychiatric symptom of Parkinson's disease (PD), reflecting reduced quality of life in patients with PD. Silibinin (silybin), a flavonoid extracted and isolated from the fruit of Silybum marianum (L.) Gaertn, is widely used for the treatment of hepatic diseases. We report here that silibinin shows anti-depressant and anti-anxiety effects on 1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced model mice with PD. All the results of open field test, elevated plus maze test, tail suspension test and forced swimming test demonstrated that silibinin administration significantly attenuated MPTP-induced depression/anxiety. Hematoxylin-eosin (HE) staining and Nissl staining results showed that MPTP injection caused the damage of hippocampal neurons, but this was ameliorated by oral administration of silibinin. Silibinin significantly restored hippocampal levels of 5-hydroxyptramine (5-HT) and noradrenaline (NA), two important neurotransmitters for regulating mood, which decreased in MPTP-injected mice. Neuroinflammation, as reflected by the increased expressions of IL-1β, TNFα and IFN-β, was marked in the hippocampus of MPTP-treated mice, accompanying increased stimulator of interferon genes (STING) and interferon regulatory factor-3 (IRF3). Silibinin administration, however, down-regulated the levels of IL-1β, TNFα and IFN-β, as well as STING and IRF3, protecting MPTP-induced PD model mice. These findings indicate that silibinin has a potential of being further developed as a therapeutic for depression and anxiety in PD.

Silybin Alleviates Experimental Autoimmune Encephalomyelitis by Suppressing Dendritic Cell Activation and Th17 Cell Differentiation.

Silybin, a peculiar flavonoid compound derived from the fruit and seeds of Silybum marianum, exhibits strong anti-inflammatory activities. In the present study, we found that silybin effectively alleviated experimental autoimmune encephalomyelitis (EAE), an animal model of multiple sclerosis (MS), via inhibition of dendritic cell (DC) activation and Th17 cell differentiation. Silybin treatment greatly ameliorated the disease severity and significantly declined inflammation and demyelination of the central nervous system (CNS) of EAE mice. Consistent with the disease development, silybin-treated bone marrow-derived DCs (BM-DCs) exhibited reduced costimulatory molecules (e.g., CD80 and CD86) and MHC II expression. These results demonstrated the distinguished bioactivity of silybin for suppressing DC activation, inhibiting pathogenic Th17 inflammatory cell responses, and, eventually, alleviating EAE severity. Taken together, our results show that silybin has high potential for the development of a novel therapeutic agent for the treatment of autoimmune diseases such as MS.

The pharmacological properties of silymarin and its constituents

Silymarin is a standardized extract obtained from the seeds and fruits of Silybum marianum L., or commonly called milk thistle, a member of Carduus marianum family that contains mix of flavonolignans. Some epidemiological and preclinical studies revealed that S. marianum L. has been used for herbal remedies for centuries for its pharmacological activity. In this review, pharmacological studies in vitro and in vivo of silymarin are discussed thoroughly stressing on antioxidant, antimicrobial, antiviral, and anti-carcinogenic aspects of silymarin. In addition, the protective influences of silymarin on some organs such as heart, liver, bone, and neuron tissue are reviewed as well. This review would be useful for further study regarding the potential of natural plant, notably silymarin, and its therapeutic potential in the prevention and treatment of diseases.

Silybum marianum glycerol extraction for the preparation of high-value anti-ageing extracts

Silybum marianum fruit is rich in silymarin, a flavonolignan mixture with hepatoprotective properties, whose favourable effects on skin make it a valuable ingredient in cosmetic products. The scope of the present study is to compare the efficiency of classic ethanol/water maceration with the maceration using mixtures of water with glycerol, a non-toxic, biodegradable, and affordable solvent, available from renewable sources. Furthermore, a glycerol-based ultrasound-assisted extraction (UAE) method was developed and optimized for silymarin content and antiradical activity. The prepared extracts were tested for their antioxidant and cosmeceutical activity. Maceration with glycerol/water mixtures was somewhat less efficient than the ethanol/water maceration. However, the extraction efficiency was significantly improved by means of ultrasonication. When UAE was conducted with 40 % (w/w) glycerol during 60 min at 80 °C the amount of extracted silymarin in the extracts was similar to that in the ethanol/water macerates (107.19 μg/mL vs. 116.17 μg/mL, respectively). Antiradical activity of the extracts was related to the silymarin content. The prepared extracts displayed mild Fe2+ chelating activity and hindered heat-induced degradation of polyunsaturated fatty acids, as well as elastase activity. Glycerol showed additive effects on the anti-tyrosinase activity of the extracts and was responsible for anti-inflammatory activity in the heat-induced coagulation assay. The presence of zinc, magnesium and other minerals with beneficial skin-related properties in S. marianum fruit further substantiate its use in cosmetics. The results indicate that glycerol extraction of S. marianum eliminates the need and energy necessary for solvent removal and enhances the desired functional and anti-ageing properties of the prepared extracts.

Systematic review of pharmacokinetics and potential pharmacokinetic interactions of flavonolignans from silymarin.

Silymarin is an extract from the seeds (fruits) of Silybum marianum that contains flavonolignans and flavonoids. Although it is frequently used as a hepatoprotective agent, its application remains somewhat debatable, in particular, due to the low oral bioavailability of flavonolignans. Moreover, there are claims of its potential interactions with concomitantly used drugs. This review aims at a systematic summary and critical assessment of known information on the pharmacokinetics of particular silymarin flavonolignans.There are two known major reasons for poor systemic oral bioavailability of flavonolignans: (1) rapid conjugation in intestinal cells or the liver and (2) efflux of parent flavonolignans or formed conjugates back to the lumen of the gastrointestinal tract by intestinal cells and rapid excretion by the liver into the bile. The metabolism of phase I appears to play a minor role, in contrast to extensive conjugation and indeed the unconjugated flavonolignans reach low plasma levels after common doses. Only about 1%-5% of the administered dose is eliminated by the kidneys. Many in vitro studies tested the inhibitory potential of silymarin and its components toward different enzymes and transporters involved in the absorption, metabolism, and excretion of xenobiotics. In most cases, effective concentrations are too high to be relevant under real biological conditions. Most human studies showed no silymarin-drug interactions explainable by these suggested interferences. More interactions were found in animal studies, likely due to the much higher doses administered.

Efficacy and safety of milk thistle preventive treatment of anti-tuberculosis drug-induced liver injury: A protocol for systematic review and meta-analysis.

Background:Tuberculosis is an infectious disease caused by mycobacterium tuberculosis. It may occur in multiple parts and organs of the patients body, and the lung is the most common. It is a major health threat worldwide. Hepatotoxicity is a common adverse reaction of commonly used clinical anti-tuberculosis drugs, as well as one of the important factors leading to poor prognosis of tuberculosis. Milk thistle is a traditional Chinese medicine extract derived from the mature fruit of Silybum marianum. Clinical practice shows that milk thistle has a good anti-liver injury effect and can be used to prevent anti-tuberculosis drug-induced liver injury. However, there is a lack of evidence-based medicine. The research carried out in this protocol is to systematically evaluate the efficacy and safety of milk thistle preventive treatment of anti-tuberculosis drug-induced liver injury, and to improve the evidence-based basis for clinical application of milk thistle in the preventive treatment of anti-tuberculosis drug-induced liver injury.Method:Computer search of English databases (PubMed, the Cochrane Library, Embase, Web of Science) and Chinese databases (CNKI, VIP, Wanfang, China Biology Medicine disc (CBMdisc)) was performed. From the establishment of database to October 2020, 2 researchers independently extracted and evaluated the data included in the randomized controlled clinical research of milk thistle preventive treatment of anti-tuberculosis drug-induced liver injury, and used RevMan5.3 software to conduct a meta-analysis of the included literature.Result:In this research, the efficacy and safety of milk thistle preventive treatment of anti-tuberculosis drug-induced liver injury were evaluated by indicators such as the incidence of liver injury, bilirubin levels, and liver enzyme levels.Conclusion:In this research, reliable evidence-based evidence for the clinical application of milk thistle in the preventive treatment of anti-tuberculosis drug-induced liver injury was provided.OSF Registration number:DOI: 10.17605/OSF.IO/VC3RM.