Clinical role of a fixed combination of standardized Berberis aristata and Silybum marianum extracts in diabetic and hypercholesterolemic patients intolerant to statins
Open accessAbstract
BACKGROUND: Statin intolerance is a medical condition often leading patients to nonadherence to the prescribed therapy or to a relevant reduction of the statin dosage. Both situations determine a totally or partially uncontrolled lipid profile, and these conditions unquestionably increase the risk of cardiovascular events. METHODS: We enrolled hypercholesterolemic, type 2 diabetic patients complaining of intolerance to statins. Some of them had reduced the statin dose 'until the disappearance of symptoms'; others had opted for treatment with ezetimibe; and yet others were not undergoing any treatment at all. All patients of the three groups were then given a fixed combination of berberine and silymarin (Berberol(®)), known from previous papers to be able to control both lipidic and glycemic profiles. RESULTS: The tested product both as a single therapy and as add-on therapy to low-dose statin or to ezetimibe reduced triglycerides, low-density lipoprotein cholesterol, fasting blood glucose, and glycosylated hemoglobin in a significant manner without inducing toxicity conditions that might be somehow ascribed to a statin-intolerant condition. CONCLUSION: Our study demonstrates that use of Berberol(®), administered as a single or add-on therapy in statin-intolerant subjects affected by diabetes and hypercholesterolemia is a safe and effective tool capable of improving the patients' lipidic and glycemic profiles.
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The other prospective cohort study compared statin-based therapy combined with a herbal tincture (Berberis aristata and Silybum marianum) to ezetimibe and the herbal tincture, and found no significant difference in incidence of muscle symptoms.
“The other prospective cohort study compared statin-based therapy combined with a herbal tincture (Berberis aristata and Silybum marianum) to ezetimibe and the herbal tincture, and found no significant difference in incidence of muscle symptoms [37].”
From Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis (2025) · cites this paper as [37]
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Experimental — accuracy not yet measured23 studies were included for data extraction, with 9 RCTs analyzed quantitatively.
“23 studies were included for data extraction [20–26,35–50], with 9 RCTs analyzed quantitatively.”
The two prospective cohort studies were both of low quality, mainly due to concerns regarding residual confounding and ascertainment of outcomes.
“The two prospective cohort studies were both of low quality, mainly due to concerns regarding residual confounding and ascertainment of outcomes (S2 File) [37,39].”
We included eight retrospective cohort studies and two prospective cohort studies.
“We included eight retrospective cohort studies [35,38,39,41,42,44,45,50] and two cohort prospective studies [36,37] (S4 File, Table 2).”
Three studies reported the incidence of muscle symptoms, five studies provided data on treatment discontinuation due to muscle symptoms, and eight studies reported on effectiveness.
“Three studies reported the incidence of muscle symptoms [36–38], five studies provided data on treatment discontinuation due to muscle symptoms [36,37,39,42,45], and eight studies reported on effectiveness [35–37,39,41,44,45,50].”
The studies varied in minimum number of previously tried statin or various creatinine kinase thresholds.
“The studies varied in minimum number of previously tried statin [35,39,40,46] or various creatinine kinase thresholds [37,43].”
In the control group receiving only berberine/silymarin, LDL-C fell significantly by 17% at 6 months and 26% at 12 months.
“In the control group, in which only berberine/silymarin was administered, there was also a significant reduction of LDL-C (À17% [p < 0.01] and À26% [p < 0.05], respectively, after 6 and 12 months) (148).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [148]
In 45 patients with type 2 diabetes, hypercholesterolemia, and statin intolerance, berberine/silymarin with statins improved LDL-C by 15% and 28% at 6 and 12 months, and with ezetimibe by 20% and 33%.
“The intake of berberine/ silymarin with statins led to an improvement of lipid parameters (LDL-C À15% and À28%, respectively, after 6 and 12 months; p < 0.01) and also when added to ezetimibe (LDL-C À20% and À33%, respectively, after 6 and 12 months; p < 0.01).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [148]
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“…five studies provided data on treatment discontinuation due to muscle symptoms [36,37,39,42,45], and eight studies reported on effectiveness [35–37, The first prospective cohort study compared 5 mg rosuvastatin to 10 mg rosuvastatin and found similar muscle symptoms, discontinuation rate and…”
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- Authors
- Di Pierro, F., Bellone, I., Rapacioli, G., & Putignano, P.
- Affiliations
- Azienda Ospedaliera San Gerardo (IT)
- Venue
- Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
- Publisher
- Informa UK Limited
- Published
- 2015-02
- Volume
- 8
- Pages
- 89
- ISSN
- 1178-7007 (ISSN-L)
- PMC
- PMC4322873
- OpenAlex
- W2061617975
- Cited by
- 48
- References
- 24
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 3 · 2023: 5 · 2022: 4 · 2021: 7 · 2020: 4 · 2019: 5 · 2018: 4 · 2017: 4 · 2016: 6 · 2015: 3
- FWCI
- 4.09
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Diabetes Metabolic Syndrome and Obesity (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Pharmacology › Berberine and alkaloids research
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Keywords
- Berberis aristata, Silybum marianum, silymarin, berberine, statin intolerance, hypercholesterolemia, type 2 diabetes, ezetimibe, lipid profile, glycemic control, LDL cholesterol, triglycerides, HbA1c, adjunctive therapy
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