Gynäkologie und Geburtshilfe
Offener Zugang
ISSN: 2161-0932
ISSN: 2161-0932
Vincenzo De Leo, Valentina Cappelli, Claudio Benvenuti und 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).