Menopause, a natural biological transition in a woman’s life, typically occurs between the ages of 45 and 55 and signifies the end of her reproductive years [1]. The physiological changes associated with menopause are primarily driven by a decline in ovarian function, which leads to a significant reduction in the production of the hormone’s estrogen and progesterone. These hormonal fluctuations result in various physical and emotional symptoms, ranging from hot flashes, night sweats, and mood swings to long-term consequences such as increased risks of osteoporosis and cardiovascular disease [2]. Hormonal therapy (HT), also referred to as hormone replacement therapy (HRT), has emerged as one of the most effective treatments to alleviate menopausal symptoms and address associated health risks. However, its role in women's health, particularly in terms of safety and long-term impact, has been the subject of extensive debate and research.The global discourse surrounding hormonal therapy for menopausal women is complex, shaped by evolving medical evidence, shifting public health recommendations, and the individualization of treatment approaches. Historically, HT was widely prescribed to menopausal women to manage symptoms and prevent chronic conditions such as heart disease and osteoporosis. Yet, major studies, such as the Women's Health Initiative (WHI) conducted in the early 2000s, raised concerns about the risks of HT, particularly its association with breast cancer, stroke, and blood clots [3]. These findings led to a significant decline in HT usage, with women and healthcare providers adopting more cautious approaches to hormone therapy.

However, subsequent analyses of the WHI data and additional studies have nuanced these initial concerns, suggesting that the risks and benefits of HT depend on factors such as the type of hormones used, the timing of initiation, and the individual health profiles of women [4]. As such, a more personalized approach to hormonal therapy has gained traction in recent years, with healthcare providers considering a woman's age, the severity of her symptoms, her risk factors for chronic diseases, and her personal preferences when determining the appropriateness of HT.This study investigates the role of hormonal therapy in menopause, focusing on its impact on women's health. It seeks to provide a comprehensive overview of the benefits and risks of HT, examine the latest clinical guidelines and recommendations, and explore the factors influencing the decision to pursue or avoid HT. By drawing on current research and clinical practice, this study aims to contribute to a deeper understanding of how hormonal therapy can be optimized to support the health and well-being of menopausal women.Menopause is marked by the cessation of menstruation, signifying the end of ovarian follicular activity. This process involves a gradual decline in the production of estrogen and progesterone, the two key hormones that regulate the menstrual cycle. Estrogen plays a vital role in maintaining bone density, regulating cholesterol levels, and supporting cardiovascular health. Progesterone, on the other hand, helps prepare the uterus for pregnancy and maintains early pregnancy. As the levels of these hormones decrease during menopause, women experience various symptoms, including vasomotor symptoms (hot flashes, night sweats), genitourinary syndrome (vaginal dryness, urinary incontinence), and mood disturbances [5].The hormonal changes of menopause also contribute to long-term health risks. Estrogen deficiency is strongly associated with a decline in bone mineral density, leading to an increased risk of osteoporosis and fractures [6]. Additionally, the decline in estrogen levels may lead to unfavorable changes in lipid profiles, potentially increasing the risk of cardiovascular disease (CVD), which is the leading cause of death among postmenopausal women. Given these health risks, the potential of HT to mitigate both short- and long-term consequences of menopause has become a focal point of research and clinical practice.

Hormonal therapy for menopause typically involves the administration of estrogen alone (in women who have had a hysterectomy) or a combination of estrogen and progestogen (in women with an intact uterus) to alleviate symptoms and protect against certain health conditions. Estrogen therapy (ET) is effective in reducing vasomotor symptoms, improving sleep quality, and enhancing quality of life [7]. It also plays a crucial role in preventing bone loss and reducing the risk of fractures. However, progestogen is added to the regimen to prevent the risk of endometrial hyperplasia and cancer, which can result from unopposed estrogen therapy [8].Despite its benefits, hormonal therapy is not without risks. The WHI study initially linked HT with an increased risk of breast cancer, heart disease, stroke, and venous thromboembolism. However, subsequent reanalysis revealed that these risks vary depending on the type of hormone, the dose, and the timing of therapy initiation. For instance, starting HT closer to the onset of menopause, rather than later, is associated with a more favorable risk-benefit ratio. Furthermore, transdermal estrogen and micronized progesterone have been associated with a lower risk of venous thromboembolism and stroke compared to oral preparations.

One of the key developments in understanding the safety of HT is the "timing hypothesis," which suggests that the effects of hormone therapy on cardiovascular health depend on the timing of initiation. According to this hypothesis, women who begin HT near the onset of menopause (within 10 years) are more likely to experience cardiovascular benefits, while those who start HT later in life may face increased cardiovascular risks [9]. This hypothesis has led to a more nuanced approach to prescribing HT, with clinicians now considering the "window of opportunity" for starting hormone therapy to maximize benefits and minimize risks.Individualized approaches to HT also take into account a woman’s health status, family history, and personal preferences. For example, women with a family history of breast cancer or who are at high risk for cardiovascular disease may opt for non-hormonal treatments for menopausal symptoms [10]. Conversely, for women with severe vasomotor symptoms or a high risk of osteoporosis, HT may offer significant benefits despite potential risks. The goal is to tailor treatment to the unique needs of each woman, balancing symptom relief with long-term health considerations.The evolving understanding of HT has led to updated clinical guidelines from various health organizations. The North American Menopause Society (NAMS) recommends that HT be considered for women with moderate to severe vasomotor symptoms and those at increased risk for osteoporosis who cannot tolerate or benefit from non-hormonal therapies [11]. The use of the lowest effective dose for the shortest duration necessary to achieve treatment goals is emphasized to minimize risks. Similarly, the International Menopause Society (IMS) supports the use of HT for symptom relief in women under 60 or within 10 years of menopause onset, provided they do not have contraindications such as a history of breast cancer or thromboembolic events [12].The role of hormonal therapy in managing menopause is multifaceted, offering both significant benefits and potential risks. While HT remains the most effective treatment for alleviating menopausal symptoms and preventing osteoporosis, its use must be carefully individualized, taking into account the timing of initiation, the type of hormones used, and the woman's health profile. As research continues to evolve, personalized approaches to HT are becoming the norm, allowing healthcare providers to offer women tailored treatments that address both their immediate symptoms and long-term health. Ultimately, the goal is to empower women to make informed decisions about their health during menopause, ensuring that hormonal therapy is used in a way that maximizes benefits while minimizing risks.

Aims and Objective

The aim of this study is to evaluate the effectiveness of hormonal therapy in alleviating menopausal symptoms and its impact on women's long-term health. The objective is to assess symptom relief, monitor potential side effects, and compare health outcomes between HT users and non-users, emphasizing cardiovascular and bone health.

Study Design

This prospective, observational study was conducted at Barasat Government Medical College & Hospital from January 2023 to June 2024, involving 108 menopausal women. The study assessed the impact of hormonal therapy (HT) on symptom relief and overall health outcomes. Patients were divided into two groups: HT users and non-users. Each participant underwent clinical assessments, including symptom evaluations and health markers such as bone density and cardiovascular health, over regular follow-up visits during the study period.

Inclusion Criteria

Women aged 45-60 who experienced natural menopause within the last five years were included. Eligible participants were those experiencing moderate to severe menopausal symptoms, such as vasomotor disturbances or mood fluctuations. Only patients who had not received previous hormone therapy and who provided informed consent were included. Additionally, participants needed to have a stable medical history, with no existing cardiovascular conditions or untreated chronic illnesses that could interfere with the study results.

Exclusion Criteria

Women with a history of breast or endometrial cancer, thromboembolic disorders, untreated cardiovascular diseases, or severe liver dysfunction were excluded from the study. Participants currently receiving hormone therapy or alternative treatments for menopause, such as phytoestrogens, were also excluded. Additionally, women with undiagnosed abnormal genital bleeding or those with a known allergy or contraindication to hormone therapy were ineligible to participate in the study to ensure accurate and safe results.

Data Collection

Data were collected through patient interviews, clinical examinations, and medical records at baseline and follow-up visits. Participants were evaluated for menopausal symptoms, bone density, cardiovascular risk markers, and overall health. Symptom severity was measured using standardized scales. Each patient’s HT regimen, dosage, and duration were recorded. Data were gathered every three months over the study period, with regular health assessments performed by clinicians to monitor for potential side effects and overall treatment effectiveness.

Data Analysis

The collected data were analyzed using SPSS version 26.0. Descriptive statistics were applied to summarize participant demographics, baseline characteristics, and health outcomes. Paired t-tests were used to compare pre- and post-treatment symptom severity in HT users, while independent t-tests assessed differences between HT and non-HT groups. Chi-square tests were employed to analyze categorical variables, such as side effects and health risks. Logistic regression models evaluated the association between HT use and long-term health outcomes, controlling for age and baseline health status. Results were considered statistically significant at a p-value of <0.05.

Ethical Approval

Ethical approval for the study was obtained from the Institutional Review Board (IRB) of Barasat Government Medical College & Hospital. All participants provided written informed consent before enrollment. Confidentiality was maintained by anonymizing patient data, and participation was voluntary, with the option to withdraw at any time without affecting treatment. The study adhered to the ethical principles outlined in the Declaration of Helsinki, ensuring that participants were fully informed about the study’s purpose, risks, and benefits.

This section presents the results of the study conducted on 108 menopausal women to evaluate the effects of hormonal therapy (HT) on menopausal symptoms and overall health outcomes. The following six tables summarize the key findings, including demographic characteristics, symptom relief, bone density improvement, cardiovascular health markers, side effects, and overall health outcomes.

Table 1: Demographic Characteristics of Study Population

This table shows that 33.3% of patients were aged 45-49, 42.6% were aged 50-55, and 24.1% were aged 56-60. Most of the patients were married (69.4%) and had completed high school (41.7%). The majority had a normal BMI (50.9%).

Figure 1: Symptom Relief Post-Hormonal Therapy

For HT users, 90.3% experienced reduced vasomotor symptoms, 80.6% reported reduced mood disturbances, 72.2% saw improved sleep quality, and 68.1% had relief from vaginal dryness.

Table 2: Bone Density Improvement

Among HT users, 41.7% experienced minor improvements in bone density (1-3% increase), while 27.8% saw significant improvement (>3%). A total of 30.6% of patients did not experience any improvement in bone density.

Table 3: Cardiovascular Health Markers

HT users experienced a 31.9% reduction in LDL levels, 33.3% had an increase in HDL levels, and 34.7% had a reduced risk of hypertension. These were all significantly higher compared to non-HT users.

Figure 2: Reported Side Effects of Hormonal Therapy

The most common side effects reported were headaches (15.3%), nausea (12.5%), weight gain (9.7%), and breast tenderness (8.3%).

Table 4: Overall Health Outcomes

HT users reported a significantly higher overall symptom improvement (90.3%) compared to non-users (52.8%). HT users also had a greater reduction in fracture risk (44.4%) and improved quality of life (66.7%) compared to non-HT users.

The findings of this study highlight the effects of hormonal therapy (HT) on menopausal symptoms, bone density, cardiovascular health, and overall well-being among 108 menopausal women, 72 of whom received HT [13,14]. The results align with many established studies, though they also reveal some distinctions that can be explained by cultural, geographic, and sample-related factors. This discussion explores how our results compare with previous research, examines potential reasons for any differences, and interprets the significance of these findings within the broader landscape of menopausal health management. Additionally, the practical implications of these findings and their relevance to clinical practice are analyzed.

Comparison with Other Studies

The efficacy of HT in reducing menopausal symptoms such as vasomotor disturbances, mood swings, and sleep disturbances is well-documented. In our study, 90.3% of HT users experienced relief from vasomotor symptoms (such as hot flashes and night sweats), and 80.6% reported improvements in mood disturbances. These results are consistent with prior studies, such as the North American Menopause Society’s (NAMS) reports, which indicate that HT provides relief from vasomotor symptoms in 80-90% of users [15]. Similarly, studies like the Women's Health Initiative (WHI) have also reported a high rate of symptom improvement with HT use.Our finding of 72.2% of patients experiencing improved sleep quality is also in line with earlier research, which suggests that HT improves sleep disturbances by regulating estrogen levels that influence sleep regulation and thermoregulation [16]. However, the slightly higher percentage of mood disturbance improvement in our study compared to WHI (which reported around 70%) may be attributed to the cultural and psychological support structures in the Indian context, where extended family systems and community networks play a role in emotional well-being. In this cultural context, HT might have synergistic effects when combined with social support, leading to greater mood improvements [17].

Bone Density Improvements

The role of HT in preventing osteoporosis and improving bone density has been well-established. In our study, 41.7% of patients showed minor bone density improvements, and 27.8% experienced significant improvements. This is in line with other studies, such as those by Kirazlıet al., which demonstrated that HT significantly increases bone mineral density and reduces the risk of fractures in postmenopausal women [18]. The slight difference in percentages across studies can be attributed to variations in baseline bone health, lifestyle factors such as physical activity and diet, and adherence to calcium and vitamin D supplements, which can influence the effectiveness of HT on bone health.Our study’s focus on a sample from India might also explain some differences, as the typical dietary intake of calcium and vitamin D in Indian populations is often lower than in Western countries, which could influence the baseline bone health of participants [19]. Furthermore, genetic factors and lifestyle differences, such as lower rates of physical exercise among postmenopausal women in India, may contribute to varied bone density responses compared to other populations studied in the United States or Europe.

A Complex Outcome

Cardiovascular health outcomes with HT have been a source of significant debate in the scientific community. Earlier studies, such as the WHI, raised concerns about an increased risk of cardiovascular disease (CVD) with HT use, especially when initiated later in life [20]. However, subsequent analyses, including our findings, suggest that HT may improve cardiovascular outcomes when started early in the menopausal transition.Our study showed that HT users experienced a 31.9% reduction in LDL levels and a 33.3% increase in HDL levels, indicating a favorable effect on cholesterol profiles. Additionally, 34.7% of HT users experienced a reduced risk of hypertension compared to 19.4% in non-users. These results support the "timing hypothesis," which proposes that HT offers cardiovascular benefits when initiated early in menopause, but may increase risks when started later in life. This hypothesis has been supported by several recent studies, which indicate that the window of opportunity for HT to provide cardiovascular protection is within the first 10 years of menopause or before age 60.The geographical context of our study may also play a role in the cardiovascular outcomes observed. Indian women, due to genetic predispositions and lifestyle factors, often have a different cardiovascular risk profile compared to Western women. For instance, research suggests that South Asian women have higher rates of insulin resistance and central obesity, which can influence cardiovascular outcomes [21]. These factors may explain why some studies from Western populations have reported different cardiovascular outcomes with HT compared to our findings.

Safety Considerations

The safety of HT, particularly concerning its side effects and long-term risks, has been a major focus of research. In our study, 15.3% of patients reported headaches, 12.5% experienced nausea, and 9.7% reported weight gain. These side effects are consistent with previous research, which has shown that mild side effects such as headaches, nausea, and breast tenderness are common but generally tolerable.However, the long-term risks of HT, particularly the potential increase in breast cancer risk, remain a concern. Although no cases of breast cancer were reported in our study, this may be due to the relatively short study duration of 18 months. Large-scale studies such as the WHI have shown that prolonged use of combined estrogen-progestin therapy is associated with a small but significant increase in breast cancer risk [22]. It is important to interpret our findings with caution, as the absence of long-term adverse effects in our study may not reflect the full risk profile of HT.Cultural and regional factors may also influence how side effects are reported and tolerated. For instance, Indian women may have different perceptions of weight gain or breast tenderness compared to women in Western countries, potentially leading to underreporting of certain side effects [23]. Furthermore, the availability of different formulations of HT in India, where oral formulations are more common than transdermal patches, could influence the type and severity of side effects experienced by patients.

Practical Significance and Clinical Implications

The practical significance of our study lies in its contribution to the ongoing discussion about the benefits and risks of HT. Our findings underscore the importance of individualized HT treatment, with careful consideration of when to initiate therapy and how to monitor patients for potential side effects. The high rates of symptom relief and improvements in bone density and cardiovascular health observed in our study support the continued use of HT for symptom management in early menopause [24]. However, the risk-benefit balance must be carefully considered for each patient, particularly in light of the potential long-term risks such as breast cancer.Our study also highlights the importance of considering regional and cultural differences when prescribing HT. For example, healthcare providers in India and other non-Western countries should be aware of the specific cardiovascular risk factors and cultural attitudes towards menopause that may influence HT use and outcomes. Additionally, the availability of different HT formulations in different regions should be taken into account, as some forms of HT, such as transdermal patches, may offer a more favorable safety profile compared to oral formulations [25].

Interpretation of Results

The findings of our study align well with existing literature on the benefits of HT for menopausal symptom relief, bone health, and cardiovascular outcomes. However, the nuanced differences observed, particularly in cardiovascular health outcomes and side effect profiles, highlight the need for more research in diverse populations. Most large-scale studies on HT have been conducted in Western populations, and our study provides valuable insight into how HT affects women in India, where genetic, dietary, and lifestyle factors may influence outcomes.One area where our study diverges slightly from existing literature is in the high rate of mood disturbance improvement (80.6%) observed among HT users. This may be explained by the cultural context of our study population, where family support structures and societal attitudes towards aging may mitigate some of the psychological effects of menopause. Previous research has suggested that women in collectivist cultures, such as India, may experience menopause differently from women in individualistic cultures, leading to variations in how mood disturbances are perceived and treated [26].

Limitations and Future Research

While our study provides valuable insights into the effects of HT in an Indian population, it is not without limitations. The relatively short duration of the study (18 months) means that long-term risks, such as breast cancer or thromboembolic events, could not be fully assessed. Future research should focus on longer-term follow-ups to better understand the long-term safety profile of HT in diverse populations.Additionally, our study did not control for lifestyle factors such as diet, exercise, and calcium/vitamin D intake, which are known to influence both bone and cardiovascular health. Further research is needed to explore how these factors interact with HT to affect health outcomes. Moreover, a larger sample size and inclusion of women from different regions of India would provide a more comprehensive understanding of how regional and cultural differences influence HT outcomes.

This study supports the effectiveness of hormonal therapy (HT) in relieving menopausal symptoms, improving bone density, and enhancing cardiovascular health when initiated early in menopause. While mild side effects were reported, the benefits significantly outweigh the risks in appropriately selected patients. Long-term monitoring is essential to mitigate potential risks, such as breast cancer, and further research is needed to explore HT's long-term safety, especially in diverse populations.

Recommendations

Initiate HT early in menopause for maximum cardiovascular and bone health benefits.

Personalize HT regimens based on individual risk profiles to minimize side effects.

Ensure regular follow-ups for long-term monitoring of breast cancer risk and other adverse effects.

Acknowledgment

The authors would like to express gratitude to the staff of Barasat Government Medical College & Hospital for their support and cooperation during data collection. Special thanks to all participants who consented to be part of this study. The authors also appreciate the guidance and expertise provided by the endocrinology and gynecology departments. This study was funded by the institutional research grant of Barasat Government Medical College.

Few Abbreviations

HT: Hormonal Therapy

LDL: Low-Density Lipoprotein

HDL: High-Density Lipoprotein

WHI: Women’s Health Initiative

CVD: Cardiovascular Disease

Article at a Glance

Study purpose

Investigate the impact of hormonal therapy on menopausal symptoms, bone density, and cardiovascular health.

Key findings

Significant relief from vasomotor symptoms, improved bone density, and favorable cardiovascular outcomes in HT users.

Newer findings

This study highlights the importance of early HT initiation and suggests cultural and geographic factors may influence outcomes. The study also emphasizes the safety of short-term HT use in Indian women.

Funding: No funding sources

Conflict of interest: None declared

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