The objective of the study is to evaluate the effect of menopausal hormone therapy on the parameters of the immune system. To do this, patients took blood to assess the immune status before the start of therapy and after 3 months. An additional task is to assess the content of blood sex hormones before the start of therapy and after 3 months.
A study of 60 perimenopausal and postmenopausal patients was included. The cohort was divided into groups depending on the treatment regimen. Group 1 (n=20) received transdermal menopausal hormone therapy (MHT). Group 2 (n=20) received oral MHT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
Dydrogesterone 10 mg + Estradiol 1 mg/Dydrogesterone 5 mg + Estradiol 1 mg
Estradiol 1,5 mg + Progesterone 200 mg/Estradiol 1,5 mg + Progesterone 100 mg
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Moscow, Russia
Evaluation of the severity of menopausal syndrome
The Green scale questionnaire was used initially and after 3 months against the background of menopausal hormone therapy. The questionnaire includes 21 questions from 0 to 3 points, where a lower score means a better result.
Time frame: 3 months
Changing the assessment of quality of life using the WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF)
The WHO Brief Questionnaire for Quality of Life (WHOQOL-BREF) was used at baseline and 3 months later. The questionnaire includes 26 questions, from 1 to 5 points, where a higher score means a better result.
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: the content cytotoxic T-lymphocytes (CD3+CD8+) in peripheral blood by flow cytometry in %. Literature reference values: 14,0-36,0%.
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of B-lymphocytes (CD3-CD19+HLA-DR+) in peripheral blood by flow cytometry in %. Literature reference values: 5,0-19,0%.
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of NK cells (CD3-CD56+CD16+) by flow cytometry in %. Literature reference values: 4,0-26,0%.
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of classical monocytes (CD14++CD16-) by flow cytometry in %. Literature reference values: 85,0-90,0%.
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Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of non-classical monocytes (CD14+CD16++) by flow cytometry in %. Literature reference values: 5,0-10,0%.
Time frame: 3 months
Evaluation of the effect of therapy on the parameters of the immune status
Determination of blood parameters of immune status: content of T-helper cells (CD3+CD4+) by flow cytometry in %. Literature reference values: 31,0-61,0%.
Time frame: 3 months