NICEVIVA
DRUG INTERACTION RECORDED 1 Prescription Drug Interaction(s) Reported — Review the pharmacokinetic interaction matrix below before use.
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MONOGRAPH SPEC LATEST 2026

Berberine (Metabolism)

WEIGHT METABOLISM · Evidence Monograph

Berberine (Metabolism) is an evidence-graded weight metabolism monograph evaluated across 21 peer-reviewed PubMed studies (5 meta-analyses, 0 systematic reviews, and 4 randomized controlled trials, encompassing n = 5,747 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 21 Studies
Meta-Analyses · Reviews 5 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 4 RCTs (3 Double-Blind)
Cumulative Participants n = 5,747
Reported Trial Dosages 1200 mg · 600 mg · 2550 mg
Trial Duration Range 12 weeks · 8 weeks · 5 weeks
Reading Time ~11 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 21 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (1200 mg · 600 mg · 2550 mg) over a structured 12 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
liver (PubMed clinical endpoint)
gut (PubMed clinical endpoint)
01

What Is Berberine (Metabolism) & Why Does Form Matter?

Berberine (Metabolism) is classified under WEIGHT METABOLISM and has been investigated across 21 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (1200 mg, 600 mg, 2550 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Berberine (Metabolism) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (4 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Berberine (Metabolism) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Berberine (Metabolism) an overall evidence rating of GRADE High (4.0 / 4.0) based on 21 PubMed studies: 5 meta-analyses, 0 systematic reviews, and 4 randomized controlled trials (3 double-blind, n = 5,747 total participants).

Representative peer-reviewed findings include: • PMID:41087029 (2026) — "Gut microbiota-mediated berberine metabolism ameliorates cholestatic liver disease by suppressing 5-hydroxytryptamine production." (CONCLUSIONS: BBR is transformed by gut microbiota to ameliorate CLD via inhibiting 5-HT, suggesting potential novel strategies for further clinical use.) • PMID:30790325 (2019) — "Metabolism-based herb-drug interaction of Corydalis Bungeanae Herba with berberine in vitro and in vivo in rats." (Mao X(1), Zhao H(1), Wang Q(1), Li H(1), Yang L(1), Hu Z(1), Zhang F(1), Guo X(1), Peng Y(1), Zhe) • PMID:27070564 (2016) — "In Vivo and in Vitro Study on Drug-Drug Interaction of Lovastatin and Berberine from Pharmacokinetic and HepG2 Cell Metabolism Studies." (CONCLUSIONS: From the in vivo pharmacokinetics study and the HepG2 cell metabolism study in vitro, berberine could be an inducer for the metabolism of lovastatin according to our previous research on berberine induction effects on HepG2 cells, which may be relevant to the fact th)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)MD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 37598753-0.21 (-0.72–-0.33)PMID 37522683-0.25PMID 35623810-0.44 (-1.67–0.89)-2.1Null (0)1.3Metric: MD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 1200 mg · 600 mg · 2550 mg · 750 mg over 12 weeks · 8 weeks · 5 weeks · 30 days. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

• [MAJOR] Cyclosporine / Metformin / CYP3A4: Pharmacokinetic or pharmacodynamic interaction reported in clinical literature (PMID:16231263, PMID:22183189). Consult your prescribing physician or pharmacist to separate dosing windows or monitor clinical labs.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (1200 mg · 600 mg · 2550 mg) and re-evaluate efficacy after 12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist before use if taking Cyclosporine / Metformin / CYP3A4.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (21 Studies) · 10 Quantitative Analyses

01
CLINICAL STUDY Clinical and molecular hepatology (2026) PMID: 41087029 ↗
Gut microbiota-mediated berberine metabolism ameliorates cholestatic liver disease by suppressing 5-hydroxytryptamine production.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Clinical and molecular hepatology. Key conclusion: CONCLUSIONS: BBR is transformed by gut microbiota to ameliorate CLD via inhibiting 5-HT, suggesting potential novel strategies for further clinical use.
View Original PubMed Abstract ↓

Comment in Clin Mol Hepatol. 2026 Jul;32(3):1397-1399. doi: 10.3350/cmh.2025.1329. BACKGROUND/AIMS: Cholestatic liver disease (CLD) is a pathological condition characterized by impaired bile formation, secretion, and excretion. However, the key pathophysiological mechanisms of CLD remain elusive, and therapeutic efficacy is unsatisfactory. METHODS: We administered berberine (BBR) or dihydroberberine (dhBBR) in bile duct ligation-, ANIT-, and mdr2-/- CLD mouse models to evaluate the anti-CLD effect. We conducted fecal microbiota transplantation to determine the role of gut microbiota in BBR's effect. We conducted a randomized, controlled clinical trial to evaluate the effects of BBR in patients with CLD. RESULTS: Oral BBR alleviates cholestatic liver injury in multiple mouse models. Gut microbes can transform BBR into dhBBR, which suppresses 5-hydroxytryptamine (5-HT) production in gut enterochromaffin cells by antagonizing tryptophan hydroxylase 1 (TPH1) activity and downregulating Tph1 transcription. This further ameliorates CLD by interrupting the 5-HT/5-HTR axis. A clinical study validated that BBR improved blood biochemical indicators in patients with CLD and decreased 5-HT levels. CONCLUSIONS: BBR is transformed by gut microbiota to ameliorate CLD via inhibiting 5-HT, suggesting potential novel strategies for further clinical use.

02
CLINICAL STUDY Biomedical chromatography (2019) PMID: 30790325 ↗
Metabolism-based herb-drug interaction of Corydalis Bungeanae Herba with berberine in vitro and in vivo in rats.
Clinical Trial Synthesis 2019 Clinical Study published in Biomedical chromatography. Key conclusion: Mao X(1), Zhao H(1), Wang Q(1), Li H(1), Yang L(1), Hu Z(1), Zhang F(1), Guo X(1), Peng Y(1), Zhe
View Original PubMed Abstract ↓

2. Biomed Chromatogr. 2019 Jul;33(7):e4514. doi: 10.1002/bmc.4514. Epub 2019 Mar 19. Metabolism-based herb-drug interaction of Corydalis Bungeanae Herba with berberine in vitro and in vivo in rats. Mao X(1), Zhao H(1), Wang Q(1), Li H(1), Yang L(1), Hu Z(1), Zhang F(1), Guo X(1), Peng Y(1), Zhe

03
CLINICAL STUDY Molecules (Basel, Switzerland) (2016) PMID: 27070564 ↗
In Vivo and in Vitro Study on Drug-Drug Interaction of Lovastatin and Berberine from Pharmacokinetic and HepG2 Cell Metabolism Studies.
Clinical Trial Synthesis 2016 Clinical Study published in Molecules (Basel, Switzerland); statistical significance reported at p = 0.01. Key conclusion: CONCLUSIONS: From the in vivo pharmacokinetics study and the HepG2 cell metabolism study in vitro, berberine could be an inducer for the metabolism of lovastatin according to our previous research on berberine induction effects on HepG2 cells, which may be relevant to the fact th
View Original PubMed Abstract ↓

BACKGROUND: We assumed that the pharmacokinetics of lovastatin could be changed by the induction effect of berberine. METHODS: An UPLC-MS/MS method was developed and validated for the pharmacokinetics tudy of lovastatin to investigate the in vivo drug-drug interactions between lovastatin and berberine. SD male rats were random divided into lovastatin group and berberine induced prior to lovastatin group for the in vivo pharmacokinetic studies. Meanwhile HepG2 cells were induced by berberine for three days to study the metabolism of lovastatin. RESULTS: The AUC (p < 0.01) and Cmax (p < 0.01) could be significantly decreased in the berberine-induced group in vivo, and the metabolic activity of HepG2 cell ccould be increased by berberine induction in vitro. The metabolism parameters of lovastatin such as CL, Vmax and Km were increased after the induction of berberine. From the pharmacokinetic study of lovastatin induced with berberine, we obtained pharmacokinetic parameters which are compliance with the metabolic parameters of lovastatin in HepG2 cells with berberine induction in vitro. CONCLUSIONS: From the in vivo pharmacokinetics study and the HepG2 cell metabolism study in vitro, berberine could be an inducer for the metabolism of lovastatin according to our previous research on berberine induction effects on HepG2 cells, which may be relevant to the fact that berberine possesses induction effects through the CYP 450 3A4 enzyme.

04
CLINICAL STUDY PloS one (2011) PMID: 21483731 ↗
Antimicrobial and efflux pump inhibitory activity of caffeoylquinic acids from Artemisia absinthium against gram-positive pathogenic bacteria.
Clinical Trial Synthesis 2011 Clinical Study published in PloS one. Key conclusion: CONCLUSIONS/SIGNIFICANCE: These techniques facilitated the direct analysis of the active components from plant extracts, as well as dramatically reduced the time needed to analyze the compounds, without the need for prior isolation.
View Original PubMed Abstract ↓

BACKGROUND: Traditional antibiotics are increasingly suffering from the emergence of multidrug resistance amongst pathogenic bacteria leading to a range of novel approaches to control microbial infections being investigated as potential alternative treatments. One plausible antimicrobial alternative could be the combination of conventional antimicrobial agents/antibiotics with small molecules which block multidrug efflux systems known as efflux pump inhibitors. Bioassay-driven purification and structural determination of compounds from plant sources have yielded a number of pump inhibitors which acted against gram positive bacteria. METHODOLOGY/PRINCIPAL FINDINGS: In this study we report the identification and characterization of 4',5'-O-dicaffeoylquinic acid (4',5'-ODCQA) from Artemisia absinthium as a pump inhibitor with a potential of targeting efflux systems in a wide panel of gram-positive human pathogenic bacteria. Separation and identification of phenolic compounds (chlorogenic acid, 3',5'-ODCQA, 4',5'-ODCQA) was based on hyphenated chromatographic techniques such as liquid chromatography with post column solid-phase extraction coupled with nuclear magnetic resonance spectroscopy and mass spectroscopy. Microbial susceptibility testing and potentiation of well know pump substrates revealed at least two active compounds; chlorogenic acid with weak antimicrobial activity and 4',5'-ODCQA with pump inhibitory activity whereas 3',5'-ODCQA was ineffective. These initial findings were further validated with checkerboard, berberine accumulation efflux assays using efflux-related phenotypes and clinical isolates as well as molecular modeling methodology. CONCLUSIONS/SIGNIFICANCE: These techniques facilitated the direct analysis of the active components from plant extracts, as well as dramatically reduced the time needed to analyze the compounds, without the need for prior isolation. The calculated energetics of the docking poses supported the biological information for the inhibitory capabilities of 4',5'-ODCQA and furthermore contributed evidence that CQAs show a preferential binding to Major Facilitator Super family efflux systems, a key multidrug resistance dete

05
CLINICAL STUDY Journal of agricultural and food chemistry (2003) PMID: 12952418 ↗
Isoflavones as potentiators of antibacterial activity.
Clinical Trial Synthesis 2003 Clinical Study published in Journal of agricultural and food chemistry. Key conclusion: argenteus contains a weak antibacterial and also MDR pump inhibitors, which increase its potency.
View Original PubMed Abstract ↓

Isoflavones isolated from Lupinus argenteus were found to potentiate the antibacterial activity of alpha-linolenic acid, also found in the same plant. The isoflavones also potentiated the activity of the natural plant antibiotic berberine and the synthetic fluoroquinoline antibiotic norfloxacin. The isoflavones increased the uptake of berberine into Staphylococcus aureus cells, indicating that they may be inhibiting a multidrug resistance pump (MDR). Thus, L. argenteus contains a weak antibacterial and also MDR pump inhibitors, which increase its potency.

06
CLINICAL STUDY Pharmacology & toxicology (2001) PMID: 11393582 ↗
Protective effect of berberine on cyclophosphamide-induced haemorrhagic cystitis in rats.
Clinical Trial Synthesis 2001 Clinical Study published in Pharmacology & toxicology. Key conclusion: In conclusion, our findings suggest that berberine could be a potential effective drug in the treatment of cyclophosphamide-induced cystitis, and provides us with the bright hope in the prevention and treatment of cyclophosphamide urotoxicity.
View Original PubMed Abstract ↓

The urotoxicity of cyclophosphamide and the protective effect of the herb berberine were investigated in this study. Administration of 150 mg/kg cyclophosphamide intraperitoneally caused a serious haemorrhagic cystitis in rats after 12 hr, including bladder oedema, haemorrhage, and dramatic elevation of nitric oxide metabolites (nitrite+nitrate) in urine and in plasma. To explore whether cyclophosphamide-induced cystitis could be prevented by berberine, rats were pretreated with a single dose or two doses of berberine at 50, 100, or 200 mg/kg intraperitoneally then challenged with cyclophosphamide (150 mg/kg, intraperitoneally). The results indicated that pretreatment of rats with berberine could reduce cyclophosphamide-induced cystitis in a dose-dependent manner. Furthermore, we found that two doses of berberine showed greater protection against cyclophosphamide urotoxicity than when given a single dose. In addition, our data shows that a single dose of 200 mg/kg berberine, or two doses of 100, and 200 mg/kg berberine could completely block cyclophosphamide-induced bladder oedema and haemorrhage, as well as nitric oxide metabolites increase in rat urine and plasma. In conclusion, our findings suggest that berberine could be a potential effective drug in the treatment of cyclophosphamide-induced cystitis, and provides us with the bright hope in the prevention and treatment of cyclophosphamide urotoxicity.

07
RANDOMIZED TRIAL (RCT) European journal of nutrition (2025) PMID: 39998703 ↗
The efficacy and safety of berberine in combination with cinnamon supplementation in patients with type 2 diabetes: a randomized clinical trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in European journal of nutrition; statistical significance reported at p = 0.031. Key conclusion: CONCLUSION: Twelve weeks of berberine plus cinnamon consumption reduced blood FBS, HbA1c and LDL-C concentration in patients with diabetes.
View Original PubMed Abstract ↓

BACKGROUND: Diabetes is a serious global health issue and increases the risk of several chronic diseases. However, if hyperglycemia and other metabolic abnormalities related to diabetes are controlled, fewer micro- and macrovascular complications may occur. OBJECTIVE: To investigate whether daily supplementation with berberine in combination with cinnamon could have effect on cardiometabolic risk factors, such as impaired glucose regulation, dyslipidemia, and hypertension in patients with diabetes. METHODS: Patients with type 2 diabetes were recruited to participate in a parallel, double-blind, placebo-controlled, randomized study. Participants were randomized into berberine in combination with cinnamon supplementation or placebo group. Participants were then asked to take a divided daily dose of 1200 mg berberine and 600 mg cinnamon or placebo for 12 weeks. ANCOVA was then performed to evaluate the differences between the two groups, controlling for the respective baseline values. RESULTS: At the end of study, fasting blood sugar (FBS) (P = 0.031) and hemoglobin A1C (HbA1c) (P = 0.013) were significantly lower in participants taking berberine plus cinnamon than those taking the placebo capsules. The results of the serum lipid profile also indicated a significant difference in the level of low density lipoprotein cholesterol (LDL-C) (P = 0.039), while no difference was observed in the levels of total cholesterol, high density lipoprotein cholesterol (HDL-C), and triglycerides between the study groups. In addition, there was no difference in other measured metabolic and anthropometric parameters between the two groups. CONCLUSION: Twelve weeks of berberine plus cinnamon consumption reduced blood FBS, HbA1c and LDL-C concentration in patients with diabetes. © 2025. Springer-Verlag GmbH Germany, part of Springer Nature.

08
CLINICAL STUDY Clinical and translational science (2025) PMID: 39943692 ↗
The Pharmacokinetic Interaction Between Metformin and the Natural Product Goldenseal Is Metformin Dose-Dependent: A Three-Arm Crossover Study in Adults With Type 2 Diabetes.
Clinical Trial Synthesis 2025 Clinical Study published in Clinical and translational science. Key conclusion: The decreasing effect of goldenseal on metformin systemic exposure with increasing metformin dose, coupled with no changes in renal excretion and elimination half-life, indicated that both the pharmacokinetic goldenseal-metformin interaction and the nonlinear absorption of metfor
View Original PubMed Abstract ↓

Pharmacokinetic drug interactions can lead to unexpected changes in plasma concentrations of the object drug, potentially increasing the risk for adverse effects and/or decreasing therapeutic efficacy. The botanical product goldenseal was previously shown to decrease metformin systemic exposure in healthy adults. This three-arm, open-label, crossover clinical study assessed the pharmacokinetic goldenseal-metformin interaction in adults with type 2 diabetes stabilized on therapeutic doses of metformin (500-2550 mg daily). The aggregate pharmacokinetic data indicated no clinically meaningful interaction as determined by the metformin area under the plasma concentration-time curve (AUC) geometric mean ratio [90% confidence interval] of 0.93 [0.86-1.01] laying within the predefined no-effect range (0.80-1.25). However, metformin AUC decreased by ~20%, 14%, and 0% after goldenseal coadministration at low (500-750 mg), moderate (1000-1500 mg), and high (2000-2550 mg) metformin doses, respectively; renal clearance and half-life remained unchanged throughout. The exploratory pharmacodynamic endpoint, HbA1c, decreased on average from 6.8% to 6.5%, regardless of the effects of goldenseal on metformin pharmacokinetics. The decreasing effect of goldenseal on metformin systemic exposure with increasing metformin dose, coupled with no changes in renal excretion and elimination half-life, indicated that both the pharmacokinetic goldenseal-metformin interaction and the nonlinear absorption of metformin are governed by saturable, intestinal transport mechanism(s). The disconnect between changes in metformin systemic exposure and therapeutic effects emphasizes the need to evaluate clinical biomarkers to comprehensively assess drug interaction risks, particularly those involving natural products. Healthcare providers may consider cautioning patients about supplementing metformin pharmacotherapy with goldenseal to avoid risks for undesired changes in glycemic control. Trial Registration: ClinicalTrials.gov identifier: NCT05081583. © 2025 The Author(s). Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and

09
CLINICAL STUDY Nutrients (2025) PMID: 39940310 ↗
Evaluating Bioactive-Substance-Based Interventions for Adults with MASLD: Results from a Systematic Scoping Review.
Clinical Trial Synthesis 2025 Systematic Review published in Nutrients involving n = 25 participants. Key conclusion: Conclusions: This scoping review highlights a range of bioactive substances used in the treatment of MASLD.
View Original PubMed Abstract ↓

Objective: Metabolic dysfunction-associated steatotic liver disease (MASLD) is a chronic condition affecting a broad population. This review aimed to identify and summarize the current evidence on bioactive-substance-based interventions for adults with MASLD, formerly known as nonalcoholic fatty liver disease (NAFLD), covering publications from 2000 to 2023. Methods: A search was conducted across six databases (MEDLINE, CINAHL, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, Food Science Source, and SPORTDiscus) for randomized controlled trials and other study types (e.g., prospective cohort studies and systematic reviews), reflecting the scoping nature of this review. The search was limited to studies in adults (>18 years old), with an intervention of interest and at least one comparator group. Results: A total of 4572 articles were retrieved, with 201 full-text articles screened for eligibility. Of these, 131 primary studies and 49 systematic reviews were included in the scoping review. The most studied bioactive substances were Curcumin (Turmeric) (n = 25), Silymarin (Milk Thistle) (n = 17), Resveratrol (n = 10), Coffee (n = 7), Green Tea (n = 5), and Berberine (n = 5 each). Moreover, 46 studies reported on 36 other bioactive substances with 2 or fewer articles each. Among the included systematic reviews, 13 focused on Curcumin, 12 on Coffee or Tea, 10 on bioactive substance combinations, 6 on Resveratrol, and 2 each on Silymarin and Artichoke Leaf. The included studies showed substantial heterogeneity in reported outcomes, which primarily focused on hepatic health, body weight, adverse events, glycemic control, blood lipids, and body composition. Conclusions: This scoping review highlights a range of bioactive substances used in the treatment of MASLD. While evidence is abundant for bioactive substances like Curcumin and Silymarin, further research and synthesis of findings is necessary to establish the clinical efficacy of all bioactive substances.

10
CLINICAL STUDY American journal of cardiovascular drugs (2024) PMID: 39297910 ↗
A Clinicians Guide to Recommending Common Cholesterol-Lowering Dietary Supplements.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in American journal of cardiovascular drugs. Key conclusion: Nonetheless, there is a need for alternative therapies that can safely and effectively reduce cardiovascular risk.
View Original PubMed Abstract ↓

The US dietary supplement (DS) market has expanded exponentially since 1994, with an estimated 50,000-80,000 individual products currently available. Many DS claim cholesterol or cardiovascular benefits. Overall, well-designed randomized controlled trials (RCTs) with DS are lacking, while studies with favorable results are commonly performed outside of the USA, resulting in inconsistent findings. The expansion of the DS market has limited the ability of the Food and Drug Administration to regulate and prevent substandard products. Eicosapentaenoic acid and docosahexaenoic acid are components of DS fish oil. Recent RCTs utilizing prescription fish oil have provided mixed findings and small but significant safety concerns. Hence, the role of DS fish oil is limited and no longer recommended by major cardiovascular guidelines. Concerns have also been observed from RCTs utilizing prescription niacin, resulting in a negligible role for DS niacin in lipid management. Red yeast rice has demonstrated significant low-density lipoprotein cholesterol (LDL-C) reductions in studies performed worldwide, including the USA. However, quality concerns and inconsistent study results have been reported on multiple occasions. Other common DS have produced modest reductions in LDL-C and may provide other cardiometabolic benefits, including garlic, phytosterols, psyllium, and berberine. Yet inconsistent study results and quality concerns continue to be reported for most. Nonetheless, there is a need for alternative therapies that can safely and effectively reduce cardiovascular risk. However, until DS routinely match label claims and are free of contaminants, the agents have a limited role in clinical practice. © 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

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