Возможности медикаментозной коррекции климактерического синдрома у больных онкологическими заболеваниями органов репродуктивной системы

Abstract

Aim: To assess the severity of menopausal symptoms and quality of life in patients with iatrogenic menopause depending on the therapy. Design: A randomised parallel group clinical study. Materials and methods. The study enrolled 60 patients of reproductive age with iatrogenic menopause following bilateral ovariectomy who had a history of reproductive tumours. The patients were randomised into 2 groups. Group 1 (n = 34) was treated with escitalopram as follows: 5 mg once daily — 7 days, 10 mg once daily — 2 weeks, then 10 mg daily (subgroup 1а) or 20 mg daily (subgroup 1b) — 12 weeks. A dose of 20 mg daily was used where the frequency and severity of menopausal symptoms did not fall below 50 % in 3 weeks with a dose of 10 mg daily. Group 2 patients (n = 26) were prescribed an herbal product called cimicifuga racemosa essence (BNO 1055) at a dose of 6.5 mg 1 tablet once daily for 15 weeks. The patients' condition was assessed using a daily hot flash questionnaire; Quality of Life Questionnaire SF-36; Greene Climacteric Scale; and Insomnia Severity Index. Results. The number of hot flushes reduced in all subgroups; however, the reduction was statistically significant only in subgroup 1a. Greene Climacteric Scale showed that following 15 weeks of therapy in subgroup 1a there was significant reduction in the intensity of menopausal symptoms, anxiety and depression, improved somatic signs, reduced severity of vasomotor symptoms, and improved libido vs. baseline. Subgroup 1b patients demonstrated statistically significant reduction in menopausal symptoms and anxiety. Group 2 had marked reduction in menopausal symptoms and depression. Intergroup comparison demonstrates that the most marked effect from the therapy on menopausal symptoms, anxiety, depression and severity of vasomotor symptoms was observed in subgroup 1а vs. subgroup 1b and group 2. Quality-of-life assessment showed significant improvement in the physical component in group 2 patients, while psychological improvements were better in subgroup 1а after 15 weeks of therapy. Subgroup 1a patients had significant reduction in Insomnia Severity Index, while subgroup 1b and group 2 patients did not demonstrate any significant reduction in this parameter. Conclusion. Patients, for whom hormonal menopause therapy is contraindicated, including patients with hormone-driven malignancies, require therapy to improve their quality of life, manage their menopausal syndrome, correct psychoemotional state and improve sleep. The study demonstrated efficacy both of non-hormonal antidepressant escitalopram (a selective serotonin reuptake inhibitor) and BNO 1055 essence (a medicinal product). In mild and moderate menopausal syndrome, it is recommended to use BNO essence, while severe cases should be treated with 10 mg escitalopram daily, and therapy efficacy should be assessed after 3 weeks of therapy. Key words: menopause, malignancies, menopausal syndrome, selective serotonin reuptake inhibitor, antidepressants, cimicifuga racemosa, BNO 1055.