POESIT recommendations on management of body-identical hormones in menopausal symptoms

Abstract

Many women seek treatment to improve menopausal vasomotor symptoms (VMS). The selection of women most likely to benefit from menopause hormone therapy (MHT) is crucial in clinical practice. There is general agreement that women younger than 60 years or who initiate MHT within the first 10 years of menopause, with no contraindications, have greater benefits considering symptomatic relief and additional advantages. This group may have the advantage of protection from osteoporosis and from other chronic diseases that affect postmenopausal women, namely cardiovascular disease (CVD). Cumulating evidence supports MHT for symptomatic women. However, inadequate use according to the needs of symptomatic women led to a burden of suffering worldwide. In recent years, the emergent use of non-regulated body-identical hormones (non-rBHT) can expose patients to potential harms. These hormone preparations are not regulated through the same tests of safety, efficacy or dosing consistency as regulated-BHT (r-BHT). The POESIT (Portugal + Spain + Italy) recommendations highlight the use of 17β-estradiol (E2) and micronized progesterone (P4) as the real r-BHT. In addition, the group emphasizes as an example the data from the REPLENISH study with 1 mg E2/100 mg P4. The combination of the two hormones in one convenient pill showed a clear reduction or elimination of hot flashes and an improvement in sleep quality and, consequently, quality of life. At the same time, this combination has shown high rates of amenorrhea and no significant impact on lipid, glucose or coagulation parameters. Both the REPLENISH study and a real-life retrospective study pointed to the possibility of a lower risk of venous thromboembolism (VTE) with this formulation than with other combinations.

Keywords:

• Body-identical hormones
• menopause
• regulated
• non-regulated

Disclosure statement

R.E.N.: past financial relationships (lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Eli Lilly, Endoceutics, Exeltis, Novo Nordisk, Palatin Technologies, Pfizer, Procter & Gamble, Teva Women’s Health and Zambon; ongoing relationships with Abbott, Astellas, Bayer HealthCare, Besins Healthcare, Fidia, Gedeon Richter, HRA Pharma, Merck & Co, Organon, Shionogi, Theramex and Viatris; and serves as President Elect of the International Menopause Society.

A. Cano: advisories and educative activities for Abbott, Viatris, Theramex, Astellas and Itakfarmaco.

A. Cagnacci: lecturer and member of the Advisory Board for Theramex, Gedeon-Richter, Exeltis, Bayer, Italfarmaco and Shionogi.

C. Castelo-Branco: fees from Theramex and a grant from Shionogi.

M.J.C.: lecturer and member of the Advisory Board for Theramex, Gedeon-Richter, Exeltis, Bayer and Lifewell.

Additional information

Funding

This study project was funded by an unrestricted grant from Theramex.