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New meta-analyses, RCTs and systematic reviews that we monitor daily in PubMed. Independently indexed, not editorially curated.
Journal of cosmetic dermatology · 2025
Hair loss is a global concern for both men and women. This study assessed the efficacy and safety of a proprietary extract of bioactive fatty acids from saw palmetto for treating self-perceived thinning hair in healthy adult male and female subjects. In this 6-month, randomized, double-blind, placebo-controlled study, subjects were randomized to receive active treatment (n = 40) or placebo (n = 20). Half of the enrolled subjects were female. Subjects took one oral dose of their assigned treatment daily. Assessments were performed at baseline, Day 56 and Day 90. Preliminary 90-day results are presented here. The active group showed significant improvement in terminal hair count from baseline in anterior (p < 0.0007) and posterior (p < 0.0005) areas. Compared to placebo, the improvement was also significant in the anterior (p < 0.05) and posterior (p < 0.03) areas. Anterior vellus hair count improved significantly versus baseline (p < 0.0005) and placebo (p < 0.01). Posterior vellus hair count showed significant within-group growth (p < 0.05). Total hair count was significantly greater than baseline for anterior (p < 0.001) and posterior (p < 0.0005) and significantly greater for anterior (p < 0.005) and posterior (p < 0.05) compared to placebo. Total terminal hair counts improved 7-fold, and total hair count improved 12-fold compared to placebo. A significant reduction in hair shedding was observed in the active group versus baseline (p < 0.05). No meaningful improvements were observed in the placebo group, and no adverse events were reported. These preliminary results indicate the daily administration of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair. Clinicaltrials.gov identifier: NCT06920758.
Frontiers in nutrition · 2025
In recent years, androgenetic alopecia (AGA) has emerged as a significant public health concern due to its high prevalence and progressive nature. In addition to progressive scalp thinning and hair loss, patients often experience psychological distress and diminished quality of life. While standard treatments such as finasteride and minoxidil are effective, their side effects and adherence issues limit long-term use, making the exploration of safe and accessible intervention strategies essential. Dietary supplements, claimed to promote hair growth by inhibiting androgen pathways and improving the follicular microenvironment, have become an attractive adjunct for both clinicians and patients due to their low cost and ease of use. However, existing studies have limitations, including the diversity of supplements, small sample sizes, and the lack of direct comparisons among different supplements, making it unclear how they compare in terms of efficacy and safety. This study aims to use a network meta-analysis (NMA) to compare the effectiveness and safety of various dietary supplements based on outcomes such as hair density and terminal hair density, providing evidence-based support for clinical decision-making. A systematic search was conducted in English-language databases such as PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the use of dietary supplements for treating AGA. Stata 16.0 software was used for network meta-analysis, and Revman 5.4 software was utilized for evaluating study quality and bias risk; additionally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was applied to rate the certainty (quality) of evidence for the included studies. A total of 19 RCTs involving 1,658 AGA patients were included, with 894 patients in the supplement group and 764 in the control group. Sixteen dietary supplements were investigated. Results showed that compared with placebo, standardized plant extracts (Nutrafol), apple extract (AMSbzs, AMS), tocotrienols, pumpkin seed oil (PSO), and a compound extract of Cistanche and Laminaria (MK-R7) significantly improved hair density. Multi-component supplements (ALRV5XR), standardized plant extracts (Nutrafol), and probiotics effectively increased terminal hair density. In blind doctor assessments, PSO, capsaicin-isoflavones (CI), saw palmetto extract (ESR), Omega 3&6, Lambdapil, Nutrafol, and Multi-component supplements (AGA-P) showed higher hair regeneration scores than placebo or conventional treatments. No significant differences were found between interventions in terms of the terminal-to-vellus hair ratio. Overall, all dietary supplements were found to be well-tolerated. Dietary supplements have a positive impact on hair density, terminal hair density, and blind doctor evaluations in patients with androgenetic alopecia, with good tolerability. They may serve as beneficial adjuncts or alternatives to conventional treatments. Future large-scale, high-quality RCTs are needed to verify these findings. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251130173, Identifier CRD420251130173.
Journal of cosmetic dermatology · 2026
Hair loss remains a global concern for both men and women. This study assessed the efficacy and safety of a proprietary extract of bioactive fatty acids from saw palmetto (Serenoa repens) for treating self-perceived thinning hair in healthy adult men and women (SEREVELLE, Valensa International; Eustis, FL). This 6-month, randomized, double-blind, placebo-controlled study assessed the beneficial effects of daily active treatment (n = 40) vs. placebo (n = 20) on several hair growth parameters. Active treatment of SEREVELLE significantly outperformed placebo on all primary endpoints at Day 180. Mean (SD) change in baseline total terminal hair count was +18.6 (29.6) with active vs. -10.1 (30.5) with placebo (p < 0.001; 283% greater improvement). Total vellus hair count increased +6.6 (15.6) vs. -2.1 (15.7) (p < 0.05; 414% greater improvement). Total hair density rose +25.1 (27.7) vs. -12.2 (38.8) (p < 0.001; 306% greater improvement). Subgroup analyses at Day 180 corroborated these advantages: across populations, between-group differences in mean change favored active for subgroup of men, with total terminal hair count (p = 0.003), total vellus hair count (p < 0.001), and total hair density (p < 0.001). In menopausal women, active produced significant placebo-adjusted gains in total terminal hair count (p < 0.05) and total hair density (p < 0.01), with a nonsignificant numerical advantage for total vellus hair count. There were no treatment-related adverse events. The daily use of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair.
Naunyn-Schmiedeberg's archives of pharmacology · 2025
Nephrotoxicity is one of the most common complications of vancomycin use in clinical practice. Silymarin has potential to be a renoprotective agent for nephrotoxic drugs due to its antioxidant, anti-inflammatory, and anti-apoptotic effects. The aim of this clinical study is evaluating the potential effects of silymarin on preventing vancomycin nephrotoxicity. A multicenter, randomized, double-blinded, placebo-controlled, clinical trial was conducted on patients with the indication of systemic vancomycin for at least 7 days. Patients were screened daily and those who met the inclusion criteria were selected and randomly assigned into either silymarin or placebo groups. Accordingly, 140 mg silymarin tablet (Livergol®) or placebo was given orally three times daily. Silymarin or placebo were provided in conjunction with vancomycin for at least 7 days. If vancomycin therapy was extended beyond 7 days, the administration of silymarin or placebo was continued until the end of vancomycin treatment. Malondialdehyde, glutathione, and total antioxidant capacity were measured in the serum on days 0 and 7. A trough level of vancomycin was assessed 30 min before the fifth dose of vancomycin. Acute kidney injury (AKI) was monitored in each patient daily during the course of vancomycin treatment. The causality assessment of all identified cases of vancomycin associated AKI was performed by the Naranjo scale. The primary endpoint was vancomycin nephrotoxicity. It was defined based on the KDIGO 2012 criteria for AKI as either an increase of 0.3 units or more in serum creatinine level during 48 h or 50% (1.5-fold) or more during 7 days compared to baseline values. During the study period, 34 patients in the silymarin group and 32 patients in the placebo group completed the clinical trial. Demographic, baseline clinical, and laboratory characteristics were comparable between placebo and silymarin groups. The number of patients with AKI on days 5, 6, 7, 11,12, 13, and 14 in the placebo group was significantly higher than that in the silymarin group (p-value < 0.05). The incidence of acute tubular injury on the day  5 and 7 of vancomycin treatment was significantly lower in the silymarin group (p-value = 0.005 and p-value = 0.032, respectively). Antioxidant indexes including serum total antioxidant capacity and glutathione significantly increased in the silymarin group (p-value < 0.001 for both indexes). In contrast, serum malondialdehyde as an end product of lipid peroxidation pathway significantly decreased in the silymarin group during 7 days (p-value < 0.001). The results of the present pilot, clinical trial suggested that silymarin co-administration may prevent vancomycin nephrotoxicity.
Nutrients · 2024
Non-alcoholic fatty liver disease (NAFLD) has recently emerged as a challenging metabolic disorder with a strong emphasis on its prevention and management. Polyphenols, a group of naturally occurring plant compounds, have been associated with a decreased risk of various metabolic disorders related to NAFLD. The current systematic review aims to critically assess evidence about the ameliorative effect of polyphenol supplementation on NAFLD patients. A PRISMA systematic search appraisal was conducted in PubMed, Scopus, Web of Science Core Collection, and all relevant studies published prior to April 2024 and met the inclusion criteria were included. Twenty-nine randomized clinical trials (RCTs) comprised 1840 NAFLD patients. The studies primarily examined eleven phenolic compounds, including turmeric, curcumin, resveratrol, genistein, catechin, green tea extract, hesperidin, and silymarin. Turmeric and curcumin decreased liver enzymes, inflammatory cytokines, lipid profile, insulin resistance, and NAFLD score, while resveratrol did not present consistent results across all the studies. Most studies on silymarin showed a reduction in liver enzymes and lipid profile; however, no changes were observed in inflammatory cytokine levels. The dietary supplementation of hesperidin and naringenin or green tea extract caused improvements in liver enzyme, lipid profile, and inflammatory cytokine, while genistein supplementation did not modulate blood lipid profile. In conclusion, dietary supplementation of polyphenols could potentially prevent and ameliorate NAFLD. Still, the inconsistent results across the included RCTs require further clinical research to establish optimal dosage and duration.
BMC complementary medicine and therapies · 2025
Nonalcoholic steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by damage and inflammation of hepatocytes. Some medicinal plants have shown antioxidant and anti-inflammatory effects on liver cells. We aimed to investigate the hepatoprotective effect of Heptex® capsules containing 200 mg of Dukung Anak (a powdered extract from aerial parts of Phyllanthus niruri) and 100 mg of Milk Thistle (a powdered extract from fruits of Silybum marianum) in patients with an apparent risk factor for NASH. This was a phase II, randomized, double-blind, placebo-controlled, three-arm, interventional clinical trial. Patients were randomized in a 1:1:1 ratio to receive placebo, low dose (one capsule) of Heptex®, or high dose (two capsules) of Heptex®. After 36 weeks, liver enzymes, Fib-4 score, lipid profile, CAP score, and kPa score were evaluated. Patients were monitored for safety throughout the treatment duration. A total of 146 patients were enrolled in the study. A significant decrease was observed in ALT levels in the low-dose group (57 IU/L to 40 IU/L, p = 0.026) and the high-dose group (61 IU/L to 47.5 IU/L, p < 0.0001) and in AST levels in the high-dose group (43.5 IU/L to 32 IU/L, p = 0.001), with no significant difference between the relative percent change in ALT (p = 0.465) or AST (p = 0.632) between the three groups. No significant difference was revealed between the three groups regarding the median change in Fib-4 score at the end of treatment (p = 0.985). No significant change in the lipid profile was observed in any of the three groups except for the total cholesterol level, which significantly decreased from 210 IU/L to 187 IU/L, p = 0.031 in the low-dose group. Heptex® capsules were safe and well tolerated over a treatment period of 36 weeks. However, the hepatoprotective effect in patients at risk of NASH still needs further assessment using more accurate investigation tools, a larger sample size, and/ or higher doses of the combination. Retrospectively registered (registration date: 25/04/2022; trial registration number: NCT05343780).
Diabetes research and clinical practice · 2025
This study aims to evaluate the effect of silymarin on insulin resistance and insulin sensitivity through a systematic review and meta-analysis of randomized controlled trials (RCTs). We searched PubMed, Embase, Web of Science, and Cochrane Library up to September 2024 for relevant RCTs. The intervention required silymarin supplementation for at least 4 weeks. Primary outcomes were homeostatic model assessment of insulin resistance (HOMA-IR) and fasting insulin (FI), while secondary outcomes included quantitative insulin sensitivity check index (QUICKI). Bias risk was assessed using Cochrane RoB 2. Subgroup analyses were based on disease type, duration, and dosage. Sensitivity and publication bias analyses were conducted using Egger's and Begg's tests. Statistical analysis and meta-analysis were performed using Stata 15.1. Six studies with 673 participants from Iran, Egypt, and Italy were included. All studies had low risk of bias. Meta-analysis showed that Silybum marianum significantly improved HOMA-IR (WMD = -2.29, 95 % CI: -4.55 to -0.03, p = 0.047) but had no effect on FI (WMD = -2.56, 95 % CI: -7.60 to 2.48, p = 0.862). Subgroup analyses revealed improvements in HOMA-IR for T2DM and diabetics with alcoholic cirrhosis, but no effect in non-alcoholic fatty liver disease (NAFLD) patients. QUICKI did not show significant changes in any group. Only one study reported changes in QUICKI. The results indicated that, compared to the placebo, silymarin improved insulin sensitivity in patients with type 2 diabetes mellitus (T2DM). In conclusion, the results of this study indicate that there is limited evidence supporting the effectiveness of silymarin in improving HOMA-IR and FI levels in metabolic diseases, and it generally does not appear to significantly improve these parameters. Future studies should aim to increase the number of high-quality RCTs to further validate the efficacy and safety of silymarin, as well as to explore its underlying mechanisms.
Molecular nutrition & food research · 2025
This study explores the effects of a nutraceutical blend with prebiotics, β-glucans, essential minerals, and silymarin on gut microbiota, inflammation, and sleep quality in obesity through microbiota reshaping and metabolic improvements over 90 days. A double-blind, randomized trial was conducted on 77 participants divided into two groups receiving either a standard nutraceutical blend (NSupple) or a silymarin-enriched blend (NSupple_Silybum). Fecal and plasma samples were collected at baseline and post-supplementation for gut microbiota, metabolic, and inflammatory marker analysis. The results showed a reduction in body weight, waist-to-height ratio, total cholesterol, and fractions in the NSupple_Silybum group. There was a dysbiosis recovery shown by the increase in beneficial gut bacteria, such as Lentisphaerae phylum, Lactobacillus and Faecalibacterium genera, and Faecalibacterium prausnitzii in the NSupple group, with a concurrent reduction in Adlercreutzia and Sutterella in the NSupple_Silybum group. Both groups demonstrated improved inflammatory profiles by the reduced TNF-α/IL-10 ratio, reduced cortisol levels, and reduced Firmicutes/Bacteroides ratio. Additionally, improvements in sleep quality were associated with reductions in pro-inflammatory cytokines and improved microbiota composition. The nutraceutical blend reshaped gut microbiota, enhanced anti-inflammatory species, and improved metabolic and sleep parameters, highlighting its potential as a nutritional strategy for managing obesity and reducing inflammation.
Naunyn-Schmiedeberg's archives of pharmacology · 2025
Flavonoids in fruits, vegetables, and plant-based drinks have potential neuroprotective properties, with clinical research focusing on their role in reducing oxidative stress, controlling inflammation, and preventing apoptosis. Some flavonoids, such as quercetin, kaempferol, fisetin, apigenin, luteolin, chrysin, baicalein, catechin, epigallocatechin gallate, naringenin, naringin, hesperetin, genistein, rutin, silymarin, and daidzein, have been presented to help heal damage to the central nervous system by affecting key signaling pathways including PI3K/Akt and NF-κB. This review systematically analyzed articles on flavonoids, neuroprotection, and brain and spinal cord injury from primary medical databases like Scopus, PubMed, and Web of Science. Flavonoids enhance antioxidant defenses, reduce pro-inflammatory cytokine production, and aid cell survival and repair by focusing on specific molecular pathways. Clinical trials are also exploring the application of preclinical results to therapeutic approaches for patients with spinal cord injury and traumatic brain injury. Flavonoids can enhance injury healing, reduce lesion size, and enhance synaptic plasticity and neurogenesis. The full potential of flavonoids lies in their bioavailability, dose, and administration methods, but there are still challenges to overcome. This review explores flavonoid-induced neuroprotection, its clinical implications, future research opportunities, and molecular mechanisms, highlighting the potential for innovative CNS injury therapies and improved patient health outcomes.
Cardiovascular & hematological disorders drug targets · 2025
Non-alcoholic steatohepatitis (NASH) is a progressive liver disease marked by inflammation and fibrosis, stemming from non-alcoholic fatty liver disease (NAFLD). Despite its rising predominance, current therapeutic medications are limited in efficacy and safety. Recent attention has shifted towards herbal therapies as potential adjuncts or alternatives in NASH management, given their anti-inflammatory, antioxidant, and phospholipid-controlling characteristics. This research study attempted to assess critically existing literature on the efficacy of herbal interventions while managing NASH. The main goal was to assess the possible medicinal advantages of different herbs, highlight their mechanisms of action, and identify gaps in current research to guide future studies. A systematic review of peer-reviewed articles using databases, like PubMed, Scopus, and Google Scholar, was conducted. It included studies that investigated the effects of herbal extracts (e.g., silymarin, curcumin, berberine) on NASH-related outcomes, such as liver function, fibrosis, lipid metabolism, and inflammatory markers. The review identified several herbs with promising therapeutic effects on NASH. Silymarin showed consistent improvements in liver enzymes and fibrosis markers. Curcumin and berberine were effective in reducing inflammation of the liver and oxidative damage. However, the heterogeneity in research designs, dosages, and outcome measures has limited the generalizability of findings. Herbal therapies hold potential as complementary treatments for NASH, with evidence supporting their role in improving liver function and reducing inflammation. To prove their safety and effectiveness, however, greater sample numbers and longer follow-up times are required in standardised clinical studies.
BMC complementary medicine and therapies · 2025
It is widely believed that Silybum marianum (Silymarin) alleviates liver injury arising from various etiologies with different degrees of damage through its anti-inflammatory and antioxidant activities. This meta-analysis investigated the effects of silymarin administration on serum levels of liver enzymes including AST, ALT and ALP. From inception to November, 2023, a comprehensive literature search was conducted. Inclusion criteria for this study were randomized trials that provided sufficient data for each group at the beginning and end of the follow-up period. Ultimately, 55 studies with a total of 3545 patients were included. Comprehensive Meta-Analysis (CMA) V4 software was used for meta-analysis. Begg's funnel plot symmetry status, Begg's rank correlation, and Egger's weighted regression tests were used to examine potential publication bias. According to the findings of this meta-analysis silymarin administration showed a significant reduction in AST (SMD [95% CI]: - 0.670 [- 0.931, - 0.408], p-value = 0.000), and ALT (SMD [95% CI]: - 0.912 [- 1.177, - 0.646], p-value = 0.000) levels. While it had no statistically significant effect on ALP level (SMD [95% CI]: - 0.236 [- 1.929, 1.458], p-value = 0.159). Meta-regression analysis showed that there is no significant association between dose, age, BMI, treatment duration and hepatoprotective effects of silymarin. In subgroup analysis, a greater reduction in liver enzymes levels was observed in patients under 50 years old. The subgroup analysis was also showed significant decrease in AST and ALT levels for patients with BMI less than 30, while silymarin treatment had no significant effects on AST and ALT levels in patients with BMI ≥ 30. Silymarin at a dose of less than 400 mg and treatment duration ≤ 2 months showed greater decreasing effects on AST and ALT levels compared to its high doses and longer treatment duration. AST and ALT levels significantly decreased in patients with NAFLD and viral hepatitis, while it had no significant hepatoprotective effects in patients with drugs induced liver injury and alcohol-related liver disease. Modifying the dose and treatment duration with silymarin is recommended in patients with various causes of liver damage.
Phytotherapy research : PTR · 2025
The comprehensive management of cardiovascular risk factors, including blood glucose, blood lipids, and blood pressure in type 2 diabetes mellitus (T2DM), is essential to prevent cardiovascular complications. Consequently, there is an urgent need to explore improved clinical treatment strategies by comparing the efficacy of various interventions. To assess the efficacy of herbal phytochemicals in regulating cardio-metabolic risk factors among patients with T2DM. A systematic literature review of the English language literature from inception to March 31, 2024, was conducted using PubMed, Embase, and Cochrane Library databases. The included literature focused on treating patients with T2DM using herbal phytochemicals. ADDIS and Revman were used to conduct Bayesian network and pairwise meta-analyses, respectively, and the surface under the cumulative ranking curve was used to obtain the ranking order of different herbal phytochemicals. This study included 17 studies involving 1,337 participants. Resveratrol was generally the most effective, followed by silymarin. Compared with the placebo, resveratrol significantly improved HOMA-IR, total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), systolic blood pressure (SBP), and diastolic blood pressure (DBP) (P < 0.05); silymarin significantly improved fasting plasma glucose (FPG), HOMA-IR, and hemoglobin A1c (HbA1c) (P < 0.05). For HbA1c, silymarin was more effective than resveratrol (MD -2.08, 95%Cl -3.50 to -0.72) (P < 0.05). For body mass index (BMI), curcumin was more effective than resveratrol (MD -1.27, 95%Cl -2.43 to -0.03) (P < 0.05). Curcumin, resveratrol, silymarin, and berberine can effectively improve cardio-metabolic risk factors in T2DM, and different herbal phytochemicals have different clinical advantages. The therapeutic potential of resveratrol is significant in the regulation of blood glucose, blood lipids, and body weight, silymarin exhibited the best effect in reducing blood glucose, berberine could lower blood glucose and regulate blood lipids, and curcumin had a definite therapeutic effect on weight loss. However, further validation of these findings is necessary through extensive clinical studies with larger sample sizes.
The Cochrane database of systematic reviews · 2025
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a major public health challenge, with approximately 32.4% of adults globally diagnosed with the condition and a steadily increasing prevalence. Currently, no specific medicines are approved to manage MASLD effectively. Silymarin, a common herbal agent with antioxidant, anti-inflammatory, and antifibrotic properties, presents potential therapeutic benefits for MASLD in both its monotherapy and complex forms (complexation with solubilising agents, such as vitamin E, phosphatidyl choline, etc.). To evaluate the benefits and harms of silymarin monotherapy and silymarin complex in adults with MASLD. We searched CENTRAL, MEDLINE, Embase, LILACS, Web of Science, three Chinese regional bibliographic databases, and two trial registries; we also performed reference checking and contacted trial authors for relevant studies (search date: 15 May 2024). We included randomised clinical trials comparing silymarin monotherapy or silymarin complex versus no intervention, placebo, or other interventions in adults with MASLD. We excluded quasi-randomised and observational studies. There were no restrictions on the publication language, date, or status. Critical outcomes were the proportion of people with serious adverse events, all-cause mortality, and quality of life. Some of the most important outcomes were liver enzymes (i.e. alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transpeptidase (GGT)), and the proportion of people with adverse events considered non-serious. We analysed these outcomes at the end of treatment and during maximal follow-up. We assessed the risk of bias using the RoB 2 tool. We conducted meta-analyses of available data at maximal follow-up, using the random-effects model as our primary analysis. We calculated risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, both with 95% confidence intervals (CI). For rare events, we used the Peto odds ratio (OR) and 95% CI. When meta-analysis was not feasible, we synthesised the data narratively. We used GRADE to assess the certainty of evidence for prespecified outcomes. We included 17 RCTs with 2069 participants having MASLD (78 participants were diagnosed with MASLD, 423 with metabolic-associated steatohepatitis (MASH), and the diagnosis of 1568 participants was not classified). Four trials were multicentre and 13 were single-centre trials. Twelve trials were conducted in Asia, four in Europe, and one in North America. Silymarin monotherapy (nine trials) and silymarin complex (eight trials) were compared with no intervention, placebo, or other interventions. The number of participants ranged from 36 to 494 (median: 90). Participants' mean age was 43.2 years with a mean proportion of males of 55.6% in the trials reporting on this. The follow-up ranged from four weeks to 48 weeks. The evidence suggests that silymarin monotherapy versus no intervention or placebo may result in little to no difference in serious adverse events (Peto OR 1.55, 95% CI 0.26 to 9.28; 4 trials, 304 participants; low-certainty evidence). The evidence is very uncertain about the effect of silymarin monotherapy versus no intervention or placebo on non-serious adverse events (RR 1.29, 95% CI 0.88 to 1.89; 4 trials, 282 participants; very low-certainty evidence). Silymarin monotherapy versus no intervention or placebo may decrease ALT (MD -7.21 U/L, 95% CI -10.62 to -3.80; 6 trials, 409 participants; very low-certainty evidence) and GGT (MD -8.30 U/L, 95% CI -12.43 to -4.17; 1 trial, 45 participants; very low-certainty evidence), but the evidence is very uncertain. We did not perform a meta-analysis for AST due to considerable heterogeneity (I2 = 77%). The evidence is very uncertain about the effect of silymarin monotherapy versus other interventions on serious adverse events (Peto OR not estimable, no events observed; 1 trial, 45 participants; very low-certainty evidence), non-serious adverse events (RR 0.67, 95% CI 0.08 to 5.88; 1 trial, 45 participants; very low-certainty evidence), ALT (MD -0.89 U/L, 95% CI -3.78 to 2.00; 2 trials, 111 participants; very low-certainty evidence), AST (MD 0.09 U/L, 95% CI -3.94 to 4.12; 2 trials, 111 participants; very low-certainty evidence), and GGT (MD 2.79 U/L, 95% CI -1.04 to 6.62; 1 trial, 45 participants; very low-certainty evidence). The evidence is very uncertain about the effect of silymarin complex versus no intervention or placebo on serious adverse events (Peto OR not estimable, no events observed; 2 trials, 179 participants; very low-certainty evidence), ALT (MD -1.10 U/L, 95% CI -8.12 to 5.92; 4 trials, 309 participants; very low-certainty evidence), AST (MD 0.84 U/L, 95% CI -1.03 to 2.71; 4 trials, 309 participants; very low-certainty evidence), GGT (MD -1.21 U/L, 95% CI -6.76 to 4.35; 3 trials, 249 participants; very low-certainty evidence), and non-serious adverse events (RR 0.73, 95% CI 0.42 to 1.27; 2 trials, 157 participants; very low-certainty evidence). Silymarin complex versus other interventions probably results in little to no difference in serious adverse events (Peto OR not estimable, no events observed; 3 trials, 920 participants; moderate-certainty evidence). The evidence suggests that silymarin complex may result in little to no difference in GGT (MD 11.60 U/L, 95% CI -12.11 to 35.31; 1 trial, 126 participants; low-certainty evidence). We did not perform meta-analyses for ALT, AST, and non-serious adverse events due to considerable heterogeneity (I2 = 77%, I2 = 82%, and I2 = 90%, respectively). None of the trials included in the comparisons reported all-cause mortality and quality of life. The benefits and harms of silymarin in adults with MASLD are unclear. Although one trial reported the occurrence of serious adverse events, none were deemed to be related to the study drugs. When compared with no intervention or placebo, silymarin monotherapy, rather than silymarin complex, may decrease liver enzymes. However, neither silymarin monotherapy nor silymarin complex showed a reduction in liver enzyme levels compared with other interventions. The certainty of evidence for these findings varied from low to very low due to insufficient power, serious risk of bias, and moderate-to-substantial heterogeneity across studies. Well-designed clinical trials that consider people-related important clinical outcomes, such as all-cause mortality and quality of life, are needed. This Cochrane review had no dedicated funding. Protocol available via doi.org/10.1002/14651858.CD015524.
Asia Pacific journal of clinical nutrition · 2025
To compare the effectiveness of silymarin or its combination with lifestyle modifications, Mediterranean hypocaloric diets, and medications for improving nonalcoholic fatty liver disease (NAFLD). PubMed, Embase, Cochrane Library, Web of Science, and Clin-icalTrails.gov were used to identify relevant studies. The treatment arm was silymarin or its combination with Mediterranean hypocaloric diets, medications, or lifestyle modifications. The comparators were placebo, Mediterranean hypocaloric diets, medications, and lifestyle modifications. This meta-analysis included 25 studies with 2283 patients. Total cholesterol levels were reduced by silymarin+Mediterranean hypocaloric diets (SMD: -0.39 (-0.81, 0.03), p=0.072) or medications [SMD: -1.12 (-1.67, -0.58), p<0.001]. Triglyceride levels were decreased by silymarin combined with the medication [SMD: -0.92 (-1.98, 0.14), p=0.080]. Low-density lipoprotein cholesterol levels were reduced by silymarin alone [SMD: -0.25 (-0.48, -0.03), p=0.027]. The combination of silymarin with Mediterranean hypocaloric diets [SMD: -0.47 (-0.90, -0.04), p=0.031] or lifestyle modifications [SMD: -0.88 (-1.09, -0.66), p<0.0001] decreased alanine aminotransferase levels. Aspartate aminotransferase levels were reduced by a combination of silymarin and life-style modifications [SMD: -0.72 (-1.49, 0.05), p=0.061] or medications [SMD: -1.41 (-2.24, -0.59), p=0.005]. Silymarin (2.5 times) or silymarin plus lifestyle modifications (39%) reduced the hepatic steatosis rate in patients with NAFLD. The silymarin use increased the rate of patients with adverse effects [RR:1.98 (1.11, 3.54)]; gastrointestinal problems were the most common adverse effects. Despite the overall advantages of therapies, different interventions showed different effects on markers in patients with NAFLD. These results highlight the need for more research to fully comprehend the features of the intervention.
Naunyn-Schmiedeberg's archives of pharmacology · 2026
Vancomycin is widely used for methicillin-resistant Staphylococcus aureus infections. However, it is associated with nephrotoxicity, which is mostly induced by the creation of free radicals in the kidney. Several studies indicated the antioxidant effect of silymarin, particularly nano-formulations with high oral bioavailability. The aim of this study was to evaluate the potential preventive effects of silymarin against vancomycin-induced nephrotoxicity. In this randomized, triple-blinded, placebo-controlled clinical trial, 60 patients who fulfilled the inclusion criteria were randomly assigned to placebo and nano-silymarin (Sinalive® 70 mg twice daily) groups in 1:1 ratio, and received them for a maximum of 14 days beside vancomycin. Patients' serum creatinine (Scr) and urea and incidence of AKI were assessed on days 3, 7, 10, and 14. The trough level of vancomycin was evaluated 30 min before the fourth dose of vancomycin. AKI incidence was significantly lower in the nano-silymarin group (P < 0.001). The comparison of serum creatinine between the placebo and treatment group showed no significant difference on days 0, 3, 7, and 14; but it was significant on days 10 (P = 0.045). The same finding was found about urea serum levels (P = 0.005 and .016, on days 10 and 14 respectively). Moreover, Scr and urea levels increased considerably in the placebo group during the study (P < 0.001) but not in the silymarin group. Our data suggested that nano-silymarin can be nephroprotective and has a preventive effect against vancomycin nephrotoxicity. However, further human studies are needed to prove these effects. It was registered at the Iranian Registry of Clinical Trials (IRCT20200408046990N9, 2022-04-06).
Biochemistry. Biokhimiia · 2025
Kidney dysfunction could impose a heavy burden on patients and society by progressing to chronic kidney disease (CKD) and end-stage renal disease, which emphasizes the importance of a search for novel agents capable of slowing down kidney disease progression or ameliorating disease outcome in patients. One of the candidates for nephroprotective agents is silymarin, a flavonoid with the anti-oxidant and anti-inflammatory properties from the milk thistle plant. We performed a systematic review of articles from Scopus, PubMed, and Web of Science that compared the nephroprotective effects of silymarin in treated and control groups (studies conducted in animals or cells were excluded). We also performed a meta-analysis of changes in the serum creatinine level and ran a subgroup analysis on the silymarin dosage, treatment duration, patients' age, and type of kidney disease. Quality assessment of the articles was performed with the ROB2 tool. We identified 10 relevant clinical trials; meta-analysis was performed on 7 studies and showed a significant effect of silymarin on the reduction of serum creatinine levels (Hedges' g, -1.23; 95% CI, -2.02 to -0.43; p = 0.0024; I2 = 93.40%). Analysis of the subgroups revealed a significant creatinine reduction in patients with the drug-induced acute kidney injury (AKI) (p = 0.003), but not with CKD (p = 0.3065). The daily silymarin dose of 280 mg was ineffective (p = 0.2375) in reducing the creatinine levels. Despite the limitations, such as a small number of analyzed articles and their heterogeneity, we found that silymarin administration in the drug-induced AKI could provide a nephroprotective effect by lowering the serum levels of creatinine.
Explore (New York, N.Y.) · 2025
Maintenance-phase Chemotherapy-induced hepatotoxicity is concerned in pediatric Acute Lymphoblastic Leukemia (ALL). Traditional Persian Medicine (TPM) recommends Naqu Fawakeh, a fruit-based infusion, for liver inflammation. This study compare the effect of Naqu Fawakeh and silymarin on Chemotherapy side effects. In this triple-blind, randomized clinical trial, 82 children aged 5-17 years received either Naqu Fawakeh (n = 44) or silymarin (n = 38) for eight weeks. Both groups were administered by 5 mL (<30 kg body weight) and 10 mL (≥30 kg), three times daily after meals. Liver enzymes (AST, ALT) and chemotherapy-related symptoms (nausea, vomiting, constipation, thirst) were assessed before and after the intervention. No placebo group was included due to ethical considerations. Both interventions significantly reduced liver enzyme levels, with a greater effect in the Naqu Fawakeh group. The mean difference between groups was significant for ALT (P = 0.029). ALT decreased significantly in the Naqu Fawakeh group (P < 0.001) and in the silymarin group (P = 0.005); AST also decreased in both groups (Naqu Fawakeh: P = 0.005; silymarin: P = 0.011). Both treatments reduced nausea and vomiting within and after 24 h, as well as thirst, though the between-group mean difference was significant only for thirst (P = 0.001). Reductions in nausea and thirst were consistently greater in the Naqu Fawakeh group. No adverse renal or hematologic effects were observed. Therfore Naqu Fawakeh, as a safe and supportive therapy, is more effective than silymarin in reducing liver enzyme. Further studies are confirmed findings.
Frontiers in oncology · 2025
Radiation dermatitis (RD), a common adverse event among breast cancer patients undergoing post-surgical radiotherapy, may be mitigated through the application of plant-derived substances possessing radioprotective effects. However, comprehensive evaluations comparing the efficacy of different plant-derived compounds are not yet available. The objective of this study is to perform a network meta-analysis (NMA) to evaluate the efficacy of diverse plant-derived substances in preventing RD in patients with breast cancer. A systematic search was conducted to identify randomized controlled trials (RCTs) published up to April 2025 that investigated the use of plant-derived substances for the prevention of RD in patients with breast cancer. Two authors individually screened the articles, gathered pertinent information, and conducted quality assessments of the studies that were included.Data were synthesized and analyzed using Stata version 15.1. In our NMA, we included 18 RCTs involving 2177 patients and 18 different treatment arms. Regarding the primary and secondary outcomes, Sylimarin derived from Silybum marianum L.(Milk thistle) (SUCRA = 0.934) and Cichorium intybus L.(Chicory) root extract (SUCRA = 0.72) demonstrated the greatest efficacy in mitigating the occurrence of grade ≥2 and grade ≥3 RD. Furthermore, Silymarin (RR = 0.05, 95% CI [0.00, 0.87]) exhibits greater efficacy compared with the standard of care (SOC) in preventing grade ≥2 RD. However, no intervention demonstrated superiority over SOC in preventing grade ≥3 RD. Silymarin has shown promise as treatment for the prevention of grade ≥2 RD in patients undergoing radiotherapy. Future studies with larger sample sizes are needed to substantiate the efficacy of various plant-derived substances. https://www.crd.york.ac.uk/prospero/, identifier CRD420251063723.
Food & function · 2024
Garlic (Allium sativum L.) is a popular spice that is widely used for food and medicinal purposes and has shown potential effects on diabetic kidney disease (DKD). Nevertheless, systematic preclinical studies are still lacking. In this meta-analysis and systematic review, we evaluated the role and potential mechanisms of action of garlic and its derived components in animal models of DKD. We searched eight databases for relevant studies from the establishment of the databases to December 2022 and updated in April 2023 before the completion of this review. A total of 24 trials were included in the meta-analysis. It provided preliminary evidence that supplementing with garlic could improve the indicators of renal function (BUN, Scr, 24 h urine volume, proteinuria, and KI) and metabolic disorders (BG, insulin, and body weight). Meanwhile, the beneficial effects of garlic and its components in DKD could be related to alleviating oxidative stress, suppressing inflammatory reactions, delaying renal fibrosis, and improving glucose metabolism. Furthermore, time-dose interval analysis exhibited relatively greater effectiveness when garlic products were supplied at doses of 500 mg kg-1 with interventions lasting 8-10 weeks, and garlic components were administered at doses of 45-150 mg kg-1 with interventions lasting 4-10 weeks. This meta-analysis and systematic review highlights for the first time the therapeutic potential of garlic supplementation in animal models of DKD and offers a more thorough evaluation of its effects and mechanisms to establish an evidence-based basis for designing future clinical trials.
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP · 2024
To use Allium sativum oil as non-vital pulpotomy medicament in primary teeth by evaluating its antibacterial effect (Colony-Forming Units/ml- CFU/ml), against Streptococcus mutans and Lactobacillus acidophilus. A double-blinded, randomised controlled trial. Place and Duration of the Study: Paediatric Dentistry Department, de' Montmorency College of Dentistry, Lahore in collaboration with the Microbiology Department, Lahore General Hospital, from October 2022 to February 2023. Forty patients aged between 4 to 8 years, each containing at least one non-vital primary molar, were randomly divided into Group A (Formocresol) and Group B (Allium sativum oil) using the lottery method. Non-vital pulpotomy (NVP) was performed by removing the coronal necrotic pulp. Sterile paper points were dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments were placed over the root canal orifices and filled temporarily. Patients were recalled after one week. Samples were again taken, and the tooth was restored. Comparison was made between bacterial count at baseline and after one week of treatment, and it was expressed as CFU/ml. There was a significant reduction in median Streptococcus mutans and Lactobacillus acidophilus bacterial count in each group after one week of treatment (p <0.001). Formocresol showed a higher average reduction (30300 ± 14060) compared to Allium sativum oil (24850 ± 9121). However, statistically, the difference was insignificant (p = 0.314) indicating both the medicaments possessed comparable antibacterial effects. Allium sativum oil was found an effective alternative to Formocresol. Formocresol, Allium sativum, Non-vital pulpotomy, Primary teeth, Randomised controlled trial.