Clinical Activity of the Combination of Isoflavones, Agnus Castus and Magnolia (Estromineral Serena Plus) in the Menopause

Introduction: The gradual menopausal decline in oestrogens impairs function of the hypothalamic and limbic systems and, therefore, thermoregulation, vasomotor stability, mood regulation and psychological wellbeing. The significantly reduced dopaminergic activity and melatonin secretion increased in hot flushes, psychological symptoms and poor sleep quality. When hormone replacement therapy (HRT) is contraindicated or refused, dietary supplements are a possible alternative. This pilot study in menopause collected clinical data on a combination of soy isoflavones, magnolia, and agnus castus. Method: Women in the menopause with moderate hot flushes (>5/day) and altered mood or sleep, have been treated with ESP (Estromineral Serena Plus, Meda Pharma) containing soy isoflavones, Lactobacillus sporogenes, extracts of Magnolia officinalis and Vitex agnus-castus and vitamin D3 for 12 weeks. Kupperman Index was evaluated at baseline, after 4, 8 and 12 weeks. The doctor and the woman gave their overall opinion at the end of treatment. Results: Fifty-three women were treated, average age of 53 years, in the menopause for 2.8 years, with prior use of HRT in 32%. Hot flushes, night sweats, insomnia, irritability, anxiety, palpitations, vaginal dryness, dyspareunia and libido loss showed a gradual and significant improvement during ESP treatment. Unexpected events appeared in 4 cases, 2 of which were suspended. The doctor’s final opinion was good/excellent in 84% of cases. Conclusions: This observational study provides the first data on the safety and the clinical effect of ESP in menopause disorders. The synergy of soy isoflavones, extract of Magnolia officinalis bark and extract of Vitex agnus-castus L. fruits is targeted on significantly reducing vasomotor symptoms, anxiety, irritability and insomnia. Further studies are needed to confirm these preliminary outcomes.