Original Title: Prise en charge des manifestations cliniques liées à la ménopause par l’hormonothérapie

Authors' objectives: Perimenopause and postmenopause are conditions that do not automatically require treatment, but many women experience clinical manifestations that affect their quality of life and could benefit from hormone therapy. It is against this backdrop that the Ministère de la Santé et des Services sociaux asked INESSS to develop a support tool for the management of the clinical manifestations of menopause using hormone replacement therapy and an information sheet for perimenopausal and postmenopausal women. The other available treatment options, such as lifestyle changes, stress reduction techniques, nonhormonal drugs and local measures, such as vaginal lubricants and moisturizers, are not discussed in this project.

Authors' results and conclusions: RESULTS (#1 SOCIOCULTURAL DIMENSION): The use of hormone therapy still seems to be limited by negative perceptions of the health risks that arose after the results of the Women’s Health Initiative (WHI) study were published in the early 2000s. However, considerable media coverage in Québec in 2021 and 2022 generated a lot of interest in hormone therapy labelled as “bioidentical” in the Québec population and led to efforts that resulted in expanded access to this type of treatment. (#2 POPULATIONAL DIMENSION): Based on the information found in the literature, the level of knowledge concerning menopause and hormone therapy and its acceptability and use seems to vary among women. The main reason for not using hormone therapy is the perception that menopause is a normal stage of reproductive life that does not require pharmacological treatment. Most of the women who answered the INESSS questionnaire felt that the benefits of hormone therapy outweigh the risks. They indicated that there is a need for information about menopause and hormone therapy. Most of the health professionals consulted seem to be of the view that hormone therapy mainly carries benefits and few risks. Furthermore, they reported that visit time, the lack of knowledge and training, and the fact that certain hormones are not covered are obstacles to prescribing hormone therapy. The information in the literature and that from the questionnaire-type consultations and from focus groups seems to differ with regard to the acceptability of hormone therapy, both by women and health professionals. This difference can be explained by the Québec media context and the existence of representation bias, since most of the people who participated in INESSS’s consultations had an interest in hormone therapy and were in favour of it. (#3 CLINICAL DIMENSION-BENEFITS AND RISKS OF HORMONE THERAPY ): The results of the systematic review of the literature indicate that, in general, hormone therapy, whether it is labelled as bioidentical or conventional, is effective in relieving the clinical manifestations of menopause, such as hot flashes, night sweats, sleep disturbances and clinical sexual manifestations. Furthermore, both labelled as bioidentical and conventional hormone therapy may reduce the risk of type 2 diabetes and fragility fracture. Based on the results of the systematic review of the literature, hormone therapy may carry certain health risks, but they vary according to the type of estrogen used (labelled as bioidentical or conventional), the route of administration (oral or transdermal), the age at initiation of the treatment, and the duration of use. (#3.1 CLINICAL DIMENSION-MANAGEMENT OF THE CLINICAL MANIFESTATIONS OF MENOPAUSE WITH HORMONE THERAPY): Perimenopause and postmenopause are physiological conditions that do not automatically require treatment, but a therapeutic approach, particularly with hormone therapy, may attenuate the clinical manifestations that affect the woman’s quality of life. The decision whether or not to initiate hormone therapy should take into account the severity of her clinical manifestations of menopause and their impact on her quality of life, her history and risk factors, her values and preferences regarding the importance of the benefits and risks of this therapy, and the other available treatment options (not covered here). The management of the clinical manifestations with hormone therapy requires adopting an individualized approach throughout the process of evaluating, initiating, monitoring, adjusting and reevaluating the therapy. To this end, providing objective, balanced information on the benefits and risks of hormone therapy is essential. (#4 ORGANIZATIONAL DIMENSION): The identified professional and organizational issues regarding the management of women with clinical manifestations of menopause are the difficulty accessing care, the differences between public practice and private practice, little interdisciplinary collaboration, insufficient professional training, and no coverage for certain hormones. (#5 ECONOMIC DIMENSION): With regard to systemic hormone therapy, the annual purchase cost of transdermal 17β-estradiol is twice as high as that of its oral form, and micronized progesterone is at least seven times more expensive as medroxyprogesterone acetate. The annual cost of hormone therapy preparations combining estrogens and progestogen varies, but it is lower than the cost of the other hormonal agents, i.e., bazedoxifene/conjugated estrogens and tibolone. Of the different locally acting options, vaginal creams are the most affordable, while vaginal tablets and the vaginal 17β-estradiol ring are two to three times more expensive. The cost of prasterone and ospemifene is much higher than that of vaginal estrogens. CONCLUSION: While not a substitute for clinical judgment, these items should assist primary care health professionals in the management of the clinical manifestations of menopause with hormone therapy and, ultimately, improve these women’s well-being and care. Practice improvement will depend mainly on the dissemination of the clinical tools stemming from this report and on the uptake of and adherence to the recommendations by the health professionals concerned.

Authors' methods: Three systematic reviews of studies in the scientific literature and one systematic review of publications containing information and clinical recommendations concerning hormone therapy in perimenopausal and postmenopausal women were carried out to document the clinical dimension. The objective of the systematic reviews of studies was to evaluate or determine, in perimenopausal and postmenopausal women, 1) the benefits and risks of hormone therapy; 2) if measuring the serum estradiol, estrone or progesterone level before or during hormone therapy can improve management compared to a prescription or an adjustment with no serum level measurement; 3) the association between the serum estradiol, estrone and progesterone levels and the clinical manifestations of menopause, depending on whether or not the woman is on hormone therapy. The objective of the systematic review of the publications containing information or clinical recommendations was to document 1) the aspects that should be considered when evaluating a woman who consults for clinical manifestations that might be due to perimenopause or postmenopause, and 2) the best practice approaches for initiating and monitoring hormone therapy. Narrative reviews were carried out to document the economic and populational dimensions. The economic dimension was documented by gathering the costs of the hormones available in Québec from the list of drugs covered by the public prescription drug insurance plan (Liste des médicaments) or from the private-insurer database (IQVIA-CDH), as the case may be. In addition, different perspectives were obtained in the context of this project, including those of key informers and members of the advisory committee, the monitoring committee, the Comité délibératif permanent – modes d’intervention en santé, perimenopausal and postmenopausal women, and other health professionals. Lastly, the overall quality of the resulting tools, their acceptability and their applicability were assessed by external reviewers specializing in the field of interest, and by future users who did not participate in the project.

Authors' identified further research: The advisability of updating the recommendations and the related tools will be determined in four years from their date of publication, or earlier, on the basis of the advances in scientific data, the evolution of clinical practice and any significant changes in the coverage criteria for hormone therapy in the public prescription drug insurance plan, and on the basis of the health and social services system’s needs.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/prise-en-charge-des-manifestations-cliniques-liees-a-la-menopause-par-lhormonotherapie.html

Year Published: 2024

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/prise-en-charge-des-manifestations-cliniques-liees-a-la-menopause-par-lhormonotherapie.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec