Gynecology & Obstetrics
Open Access

Abstract

Clinical Effects of Isoflavones and Berberine (Estromineral Lipid) in Menopausal Women with Borderline Dyslipimia

Vincenzo De Leo, Valentina Cappelli, Claudio Benvenuti and Estronet Study Group

Objective: During the menopause, oestrogen deficiency brings about changes in the lipid profile which increase the cardiovascular (CV) risk. The use of food supplements together with a healthy lifestyle and a varied, balanced diet is a logical approach for improving CV disease prevention.

A combination of nutraceuticals (EL) based on berberine (a natural extract that reduces total cholesterol and triglycerides), soya isoflavones (SI), Lactobacillus sporogenes and vitamin D₃ was compared with the same formulation without berberine (E) in menopausal women with borderline dyslipidaemia.

Method: Randomised, controlled, parallel-group multicenter study in menopausal women with Tot-C >200 and <260 mg/dl on a controlled low-fat diet or not on treatment with lipid-lowering agents.

The study treatments were: 1 tablet of EL (Estromineral Lipid) or E (Estromineral®) daily by mouth for 3 months. Typical menopausal symptoms, CV and metabolic parameters were evaluated at baseline and at the end of treatment.

Results: Fifty-nine gynecology centers treated 535 women, 287 with EL and 248 with E; mean age 53.8 years and body mass index 25.4 kg/m², in the menopause for 3.8 years, 6.7% with previous hormone replacement therapy use.

After 3 months, EL significantly reduced Tot-C (-9.2% vs. -4.9%; p<0.01), LDL-C (-16.7% vs. -9.9%; p<0.05) and triglycerides (-13.3% vs. -6.3%; p<0.06) compared with E.
Hot flushes, night sweats, palpitations, decrease in libido and vaginal dryness decreased significantly compared with baseline with both treatments (p<0.0001).
Three cases with EL (dyspepsia, gastric pain and erythema) and 1 case with E (gastric pain) experienced nonserious adverse events.

Conclusion: Berberine in EL and the SI in both formulations significantly improved, respectively, the lipid profile and vasomotor symptoms in menopausal women. EL has the rationale for a complete prevention of menopausal risk: osteoporosis (vitamin D₃, calcium and folic acid), genitourinary dystrophy (SI) and CV diseases (berberine).