Gender-Specific Medicine is defined by the World Health Organization (WHO) as the in-depth study of the influence of biological (sex-determined) and socio-economic and cultural (gender-determined) differences on health status and disease occurrence in any individual.
A growing body of epidemiologic, clinical, and experimental data unequivocally points to the existence of substantial differences in the onset, progression, and clinical manifestations of diseases common to men and women, as well as in the response and adverse events associated with therapies, and even in lifestyles and response to nutrients. Inequalities in access to care, also related to gender, are a significant concern in the current health care landscape.
Biological differences and health impact
Biological differences between men and women significantly influence response to treatment and adverse drug reactions. In addition, access to care has significant gender-related inequalities. Women, for example, are more susceptible to disease, consume more medications, and face a higher risk of adverse reactions. Gender disparities are also manifested in the social sphere, where women are more exposed to violence and discrimination, affecting their overall health.
In addition, the clinical manifestations of diseases may vary between the sexes. Women may have different symptoms or different localizations than men for some common diseases, such as in myocardial infarction or colon neoplasms. In addition, differences in the immune system give women greater resistance to infection but greater susceptibility to autoimmune diseases, while men have a higher incidence of some diseases, such as cancer.
It is essential to consider these gender differences in clinical practice and drug research. Physiological parameters such as height, weight, and body composition vary between men and women, affecting the absorption, mechanism of action, and elimination of drugs. However, studies on response to therapies have been conducted mainly on male subjects, with dosages often based on standardized male models.
It is also important to take into account other factors, such as age and ethnicity, that influence response to therapy and effectiveness of medical devices. Therefore, it is critical to develop gender-sensitive treatment approaches and medical devices to ensure equitable and effective health care for all.
The priorities of a gender approach in medicine
Gender-Specific Medicine represents a necessary revolution in the medical-scientific approach, aimed at improving not only the understanding of gender differences but also the effectiveness of health interventions. Although the application of a gender approach should extend to all medical branches and specialties, certain areas emerge as priorities because their relevance has already been demonstrated by clinical evidence and research.
Among these areas, pharmacology and the use of medical devices are of particular importance. Gender differences in pharmacology are substantial and in part stem from biological variations between the sexes, such as hormonal fluctuations, differences in weight, body composition, and gastric acidity, which affect drug absorption, distribution, metabolism, and elimination. Women, compared with men, tend to consume more drugs, often in a polypharmacy regimen, and experience more adverse events. In addition, the efficacy of some drugs may vary by sex.
However, the presence of women in clinical trials is still limited, and most preclinical studies focus on male animal models. A similar situation can be found in medical device studies where adjustment for gender-related anatomic-functional differences is not yet fully integrated, despite its relevance in the health care setting.
Recent studies have shown correlations between risks and gender-related physiological characteristics in the use of medical devices, such as a higher risk of stroke related to body surface area in the use of Ventricular Assist Devices (VADs), or a higher incidence of wear and tissue reactions in “metal-on-metal” prosthesis implants in women. These findings underscore the importance of a gendered approach in clinical practice and medical research to ensure safe and effective therapeutic interventions and medical devices for both sexes.
The person at the center: the importance of a gender approach in health care
The multidimensional approach of Gender Medicine considers, first and foremost, the centrality of the sick person in the delivery of care. This approach assesses health not only in terms of biological and clinical characteristics, but also according to personal, cultural, and social factors that influence the individual’s experience.
The adoption of narrative in medicine, promoted by the Istituto Superiore di Sanità (ISS) guidelines, is an important strategy for acquiring narrative skills and developing new clinical and care models. The centrality of the patient, his or her active participation in the care pathway, and the protection of the care relationship are, in fact, fundamental to respond to emerging cultural and social needs in the health care setting.
Recently, the use of outcome indicators reported directly by patients, known as Patient Reported Outcomes (PROs), has shown promising results over traditional standardized metrics. These indicators should be integrated into clinical research, considering gender as a significant determinant of health.
Innovation in the health care setting is therefore manifested through modes and tools of dialogue, including digital ones, that actively involve patients. These innovative models offer opportunities to develop more effective and efficient health care systems.
To integrate these aspects into clinical practice, it is necessary to validate these models through targeted clinical research projects that consider gender differences. The use of sex- and gender-specific indicators can contribute to more personalized and precision medicine, improving diagnosis, prognosis, and response to treatments.
Therefore, to promote the culture of person-centered medicine, it is essential to adapt the training of healthcare personnel and conduct outreach and patient education activities.
