Introduction: Falling oestrogen levels in the perimenopause alter the function of dopamine, melatonin and neuropeptides, and therefore affect thermoregulation, vasomotor stability, mood regulation, quality of sleep and psychological wellbeing. When Hormone Replacement Therapy (HRT) is not appropriate, taking food supplements can be useful. A new food supplement for the menopause (ESP), which contains soy isoflavones, Magnolia and Agnus castus extracts, acts on the vasomotor and psycho affective symptoms and has shown interesting preliminary clinical results. This study, with a controlled design, confirms the clinical activity of ESP in symptomatic postmenopausal women.
Method: Menopausal women with more than five moderate hot flushes a day and with changes in mood or sleep were enrolled in a randomised, controlled, parallel-group, multicentre study. Women on active treatment for climacteric symptoms were excluded. Eligible women were assigned to three months ’ oral treatment with one tablet/day of ESP (Estromineral Serena Plus, Meda Pharma, Mylan Group), containing soy isoflavones (SI), Lactobacillus sporogenes (Ls), extracts of Vitex agnus-castus and Magnolia officinalis, vitamin D3 and calcium, or with E (Estromineral, Meda Pharma, Mylan Group), containing SI, Ls, vitamin D3 and calcium. At baseline and after one, two and three months, we evaluated the Kupper man Index (KI) score and symptoms present, and any adverse reactions were recorded. At the end of the study, the physicians expressed their clinical judgement and the women self-evaluated their treatment.
Results: Across 68 centres, 588 women were treated, 354 with ESP and 234 with E. They had a mean age of 53.0 years and had been menopausal for 2.8 years, and 32% had used HRT in the past. KI score, hot flushes, night sweats, palpitations, loss of libido, vaginal dryness, dyspareunia, insomnia, irritability, anxiety and sexual activity improved to asignificantly greater extent with ESP than with E (p<0.01). During the study, five cases (one withdrawal) in the E group and three cases (one withdrawal) in the ESP group experienced adverse events possibly related to the treatment.
Conclusion: The results confirm the synergistic effect of the nutraceutical combination Agnus castus, soy isoflavones and magnolia extract on vasomotor and psycho behavioural symptoms in postmenopausal women, with excellent compliance and safety.
Published Date: 2020-07-27; Received Date: 2020-07-11