COMPARATIVE ANALYSIS OF BIOIDENTICAL AND CONVENTIONAL HORMONE REPLACEMENT THERAPY IN MENOPAUSAL WOMEN: CLINICAL EFFICACY, SAFETY PROFILE, ECONOMIC IMPACT, AND CROSS-COUNTRY PERSPECTIVES Authors

Vollständiger Abstract

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Background: Menopause is a significant physiological transition characterized by declining ovarian hormone production and associated vasomotor, urogenital, psychological, and metabolic symptoms. Hormone Replacement Therapy (HRT) remains a cornerstone of menopausal symptom management; however, concerns regarding its long-term safety have increased interest in Bioidentical Hormone Replacement Therapy (BHRT). Differences in healthcare accessibility, socioeconomic conditions, and cultural attitudes further influence treatment selection worldwide. This study aimed to compare the efficacy, safety, economic burden, and utilization patterns of BHRT and conventional HRT among menopausal women across countries with diverse healthcare systems and Human Development Index (HDI) levels. Methods and Materials: A retrospective cross-sectional comparative study was conducted using clinical and economic data collected between 2019 and 2024 from menopausal women aged 46–52 years in India, the United States, Malaysia, Brazil, South Africa, and Switzerland. Women receiving either BHRT or conventional HRT for at least six months were included. Data regarding symptom severity, treatment outcomes, adverse events, hormone-related cancer risks, cardiovascular complications, treatment costs, and patient satisfaction were analyzed using descriptive and comparative statistical methods. Multivariate analyses were performed to evaluate associations between therapy type and clinical outcomes while adjusting for demographic and country-specific factors. Results: BHRT demonstrated superior symptom relief compared with conventional HRT, achieving greater reductions in hot flashes (80–90% vs. 50–70%), vaginal dryness (80–90% vs. 50–70%), night sweats (70–80% vs. 40–60%), and mood disturbances (70–80% vs. 40–60%). Lower incidences of breast, ovarian, and endometrial cancers were observed among BHRT users. Patient satisfaction and quality-of-life improvements were substantially higher in the BHRT group. However, BHRT costs were approximately 1.5–2 times greater than conventional HRT across all participating countries, limiting accessibility in low- and middle-income settings. High-HDI countries demonstrated greater utilization of personalized hormone therapies, whereas cost considerations strongly influenced treatment preferences in lower-HDI nations. Conclusion: BHRT appears to offer superior clinical efficacy, improved quality-of-life outcomes, and a more favorable safety profile than conventional HRT for menopausal symptom management. Nevertheless, its higher cost and limited accessibility remain significant barriers to widespread adoption. Treatment selection should be individualized, balancing symptom severity, safety considerations, patient preferences, and economic factors. Future longitudinal studies with standardized BHRT formulations are needed to establish definitive evidence regarding long-term efficacy, safety, and cost-effectiveness across diverse populations.