ABSTRACT
Background: The aim of this study was to assess the efficacy and safety of a new herbal preparation (Menopause Relief EP®), the hybrid combination of Actaea racemosa L. (black cohosh, BC) and Rhodiola rosea L. (RR) root extracts, compared with the most effective dose of BC extract in women with menopausal complaints. Methods: A total of 220 women were randomly assigned to receive two capsules either BC (6.5 mg), BC500 (500 mg), Menopause Relief EP® (206,5), or placebo once per day for 12 weeks. The efficacy endpoints were relief of menopausal symptoms, measured using the Kupperman Menopausal Index (KMI), Menopause Relief Score (MRS), and menopause Utian Quality of Life (UQOL) index. Results: The menopause symptom relief effects of RR-BC were significantly superior in all tests to the effects of BC and placebo after their repeated administration for 6 and 12 weeks. There was no statistically significant difference between the effects of BC and BC500 over time. RR-BC significantly improved the QOL index in patients, compared to BC, BC500, and placebo, mainly due to the beneficial effects on the emotional and health domains. Conclusions: BC is more effective in combination with RR in relief of menopausal symptoms, particularly psychological symptoms.
ABSTRACT
A prospective study was carried out in 110 adolescents (13-19 years), 90 patients with polycystic ovary syndrome (PCOS) (study group) and 20 healthy adolescents (control group). The study group was divided into two: Group I - patients without insulin resistance (n = 30) and Group II - patients with insulin resistance (n = 60). Group I was treated with oral contraceptives (OCs), while Group II was divided into treatment subgroups of 20 patients each: Subgroup A received OCs; Subgroup B - myo-inositol; subgroup C - OCs + myo-inositol. Data were analyzed at baseline, 3 and 6 months of treatment. Results showed average anti-Mullerian hormone (AMH) levels were significantly higher in PCOS patients (11.8 ± 5.3 ng/ml) than in controls (2.98 ± 4.5 ng/ml). After treatment, in Group I and Group II Subgroup A: AMH, luteinizing hormone (LH), free testosterone (FT), total testosterone (T), Ov/v, antral follicle count (AFC), and Ferriman-Gallwey modified scale (mFG) significantly decreased, homeostatic model assessment-insulin resistance (HOMA-IR), body mass index (BMI) did not change significantly. In Group II Subgroup B only HOMA-IR and BMI significantly decreased; in Subgroup C all the parameters decreased significantly. The correlation between AMH and hormonal, morphological characteristics of ovaries were established. The results indicate that AMH could possibly be a valuable marker for the diagnosis of PCOS in adolescents, and for the assessment of treatment efficacy as well.