Introduction
Hormone therapy (HT) is used to improve climacteric symptoms and to achieve physical-psychosocial development. Many studies and opinions argue that the use of HT improves the health QOL, which means that the individual is in good health in terms of both physical and psychosexual functions. This article examines the effects of estradiol and norethindrone, specifically low-dose combined hormone therapy, on weight loss and quality of life (QOL) in menopausal women. The term low-dose HT refers to the lowest effective use dose of HT, which is a regimen containing lower amounts of oestrogen than the conventional dose. It will also discuss the potential benefits and risks associated with this treatment, including its impact on menopausal symptoms, cardiovascular health, and overall well-being.
Understanding Menopause and Hormone Therapy
Menopause is a natural biological process that marks the end of a woman's reproductive years, typically occurring in the late 40s or early 50s. The most common symptoms in menopausal women are vasomotor symptoms, and the main reason for this is menopause, which determines the QOL. This transition is characterized by a decline in estrogen production by the ovaries, leading to a variety of symptoms such as hot flashes, night sweats, vaginal dryness, sleep disturbances, and mood changes.
Hormone therapy (HT) is a treatment option that aims to alleviate these symptoms by supplementing the body with estrogen and/or progestin. Estrogen helps to regulate body temperature, vaginal lubrication, and mood, while progestin protects the uterus from the potential risks of estrogen-induced endometrial cancer.
The Role of Estradiol and Norethindrone
Estradiol is a form of estrogen that is identical to the estrogen produced by the ovaries. Norethindrone is a synthetic progestin that is commonly used in HT regimens. The continuous regimen of low-dose HT containing 1 mg 17β-oestradiol + 0.5 mg norethindrone acetate (E2 + NETA) was first introduced in 1990. Together, these hormones can help to alleviate menopausal symptoms and improve the quality of life for women experiencing menopause.
Low-Dose Hormone Therapy: An Overview
Low-dose HT refers to hormone therapy regimens that contain lower amounts of estrogen and progestin than conventional-dose HT. Lower doses of HT reduce the incidence of possible hormone-mediated side effects (such as chest pain and bleeding) and maintain positive treatment effects. The goal of low-dose HT is to provide effective symptom relief while minimizing the risk of side effects. Risks such as venous thromboembolism (VTE) and stroke are minimal in low-dose regimens. It is often considered a safer alternative to conventional-dose HT, particularly for women who are at higher risk of cardiovascular disease or other health complications.
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Estradiol and Norethindrone: Impact on Weight Loss
The relationship between estradiol, norethindrone, and weight loss is complex and not fully understood. While some women may experience weight gain or bloating as a side effect of HT, others may find that it has no effect on their weight.
Estrogen plays a role in regulating metabolism and body fat distribution. As estrogen levels decline during menopause, some women may experience a shift in body composition, with an increase in abdominal fat. Hormone therapy may help to counteract this effect by restoring estrogen levels and regulating metabolism.
However, it is important to note that HT is not a weight-loss solution. While it may help to prevent weight gain associated with menopause, it is unlikely to cause significant weight loss on its own. Maintaining a healthy lifestyle, including a balanced diet and regular exercise, is essential for managing weight during menopause.
Study on Low-Dose Estradiol and Norethindrone Acetate
To determine the effect of low-dose combined oestradiol and norethindrone acetate on menopausal symptoms and QOL and the frequency of early side effects in natural menopausal cases, a prospective cohort study was conducted. Forty-five natural menopause women admitted to the clinic during a 1-year period and diagnosed as menopause, who planned to have HT for menopausal symptoms, were enrolled in this prospective study. The study aimed to assess the impact of low-dose combined estradiol and norethindrone acetate on menopausal symptoms, quality of life, and the occurrence of early side effects in women experiencing natural menopause.
Methodology
Cases meeting the inclusion criteria were evaluated within the scope of this prospective cohort study. The results of routine tests (general physical examination, breast examination, pelvic exam, cervicovaginal smear, complete blood count, hormone levels [FSH, E2, TSH], liver-kidney function tests, transvaginal ultrasonography, mammography, bone mineral densitometer) were determined to be appropriate in terms of HT in each case. Five cubic centimetres of blood were taken in a heparinized biochemistry tube in the morning at around 08.00-09.00 after 8 hours of fasting in order to study the CRP in blood serum. On the same day, a vasomotor symptom severity rating was made according to the Blatt-Kupperman index (Table 1). Quality of life evaluation was done by the Menopause-Specific Quality of Life Questionnaire (MENQOL) (Table 2). Blood was drawn for basal CRP. The patients who were evaluated for the Blatt-Kupperman index and MENQOL were prescribed to take 3 months of hormone treatment, which included 1.03 mg of oestradiol hemihydrate and 0.5 mg of norethindrone acetate (Activelle®, 1 tablet daily, Novo Nordisk, İstanbul). The patients who completed the 3-month continuous hormone treatment were seen again (within 10 days). Five cubic centimetres of blood were taken again for study. All data were entered by coding in the SPSS 10.0 package program. Student’s t-test, χ2 test, and U Mann-Whitney test were used for comparison. According to our preliminary study result, it was assumed that the average Blatt-Kupperman menopause index (BKMI) value decreased from 29 to 15 with hormone therapy. The standard deviation was determined as 10.
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Results
According to these figures, the total BKMI decreased from 29.35 ±10.24 to 15.93 ±7.63 after 3 months of low-dose HT (p < 0.001). The Menopause-Specific Quality of Life Questionnaire total vasomotor, psychosocial, and physical symptom scores decreased statistically significantly after 3 months of low-dose hormone therapy. There was no statistically significant difference between the levels of white blood cells (6915 ±2444 vs. 7139 ±1869 numbers/ml, p = 0.535) before and after treatment in the study group. Similarly, there was no statistically significant change in serum CRP levels (0.3278 ±0.2164 vs.
The study found that low-dose combined estradiol and norethindrone acetate significantly reduced menopausal symptoms and improved quality of life in the participants. The Blatt-Kupperman menopause index and MENQOL scores were significantly decreased after 3 months of low-dose treatment. However, the study did not specifically assess weight loss as an outcome.
Side Effects
The only 8 cases during the 3-month low-dose HT (17.8%) treatment complained of vaginal bleeding for several days in a spotting style. No pathological findings were detected in the pelvic examination, transvaginal ultrasonography, and endometrial biopsy in these cases. Vaginal hysterectomy was performed in 1 case (2.2%) due to persistent bleeding after 3 months of treatment and additional symptoms and signs of pelvic organ prolapse. Also, in 1 case (2.2%) a cyst was detected in the breast in the 3rd month after the treatment.
Benefits of Low-Dose Estradiol and Norethindrone
In addition to alleviating menopausal symptoms, low-dose estradiol and norethindrone may offer several other benefits:
Cardiovascular Health
Hormone therapy creates a risk of cardiovascular disease by affecting the inflammation and haemostasis process. Results of studies regarding the effect of HT on the increase of C-reactive protein (CRP), which is an inflammatory marker that can be considered as a risk factor for cardiovascular disease, should be discussed. Hormone therapy affected the serum CRP concentration. Oral HT increased the level of CRP.
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Low-dose HT is associated with a lower risk of cardiovascular events compared to conventional-dose HT. Studies on the effect of low-dose HT on CRP have also been limited. The effect of low-dose continuous combined HT on the markers of vascular inflammation may be similar to that of other HT combinations. It may also have a positive impact on cholesterol levels and blood vessel function.
Bone Health
Estrogen plays a crucial role in maintaining bone density. Hormone therapy can help to prevent bone loss and reduce the risk of osteoporosis-related fractures in postmenopausal women.
Cognitive Function
Some studies suggest that HT may have a protective effect on cognitive function, reducing the risk of dementia and Alzheimer's disease.
Risks and Side Effects
While low-dose estradiol and norethindrone are generally considered safe, they are not without potential risks and side effects. These may include:
- Vaginal bleeding
- Breast tenderness
- Headaches
- Nausea
- Mood changes
It is also important to be aware of the potential long-term risks associated with HT, such as an increased risk of blood clots, stroke, and certain types of cancer.
Other Considerations
Individual Response
Response to treatment has been associated with dose to provide a minimally effective dose with different dose combinations. It's important to note that individual responses to hormone therapy can vary. Factors such as age, health status, and genetics can influence how a woman responds to treatment.
Alternative Therapies
Before starting HT, it is important to explore other treatment options for menopausal symptoms. Lifestyle changes, such as diet and exercise, can help to alleviate symptoms and improve overall health. Alternative therapies, such as acupuncture and herbal remedies, may also provide relief for some women.
The health management of the women in menopause
The health management of the women in menopause should not be limited to the treatment of biological changes; improving the QOL should be the main goal. Menopause causes different symptoms in people of the same or different cultures, and it has been reported that menopausal symptoms may be affected depending on cultural effects, physical causes, and individuals. Situations that negatively affect MENQOL are job status and having more children, and less education. Treatment is abandoned due to reasons such as vaginal bleeding, fear of breast and uterine cancer, tenderness in the breast, fatigue, and weight gain.
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