Ospemifene and vulvovaginal atrophy: an update of the clinical profile for post-menopausal women.

INTRODUCTION: The demand for effective and safe treatments of genitourinary syndrome (GSM) in post-menopausal women (PMW) is growing. Published data on the efficacy and safety of ospemifene (OSP) prompt an updated literature review to enlighten possible improvements in the GSM treatment. AREA COVERED: We searched articles published in English from 2010 to 2023 through Medline (PubMed) and Embase databases with Boolean terms: OSP, PMW, GSM, endometrium, breast cancer, cardiometabolic syndrome, bone metabolism, adherence to treatment, and patient satisfaction. We selected randomized controlled trials (RCTs) and observational and cross-sectional studies and completed the search manually. EXPERT OPINION: Of the 157 retrieved records, 25 primary studies met the inclusion criteria (15 regarding efficacy and safety, two for additional effects, and four for adherence and satisfaction with the OSP treatment). Seven RCTs involved nearly 5,000 patients, 10 out of 18 prospective observational studies 563, and six retrospective analyses 356,439. Evidence of OSP treatment in PMW with GSM relies on RCTs and remarkable real-world data. The 25 primary studies showcased the high clinical response to symptoms, the favorable safety profile of OSP with very few adverse events, a neutral impact on the endometrium, breast, bone, and thrombosis, and the possible improvement of cardiovascular risk factors.

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy.

OBJECTIVES: To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments. STUDY DESIGN: Ongoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry. MAIN OUTCOME MEASURES: Severity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey. RESULTS: Overall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment. CONCLUSIONS: Moderate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.

Fractional CO2 laser for genitourinary syndrome of menopause in breast cancer survivors: clinical, immunological, and microbiological aspects.

The composition of vaginal microbiome in menopause and cancer survivor women changes dramatically leading to genitourinary syndrome of menopause (GSM) in up to 70% of patients. Recent reports suggest that laser therapy may be valuable as a not hormonal therapeutic modality. The aim of the present study was to evaluate the effects of fractional CO2 laser treatment on the vaginal secretory pathway of a large panel of immune mediators, usually implicated in tissue remodeling and inflammation, and on microbiome composition in postmenopausal breast cancer survivors. The Ion Torrent PGM platform and the Luminex Bio-Plex platform were used for microbiome and immune factor analysis. The significant reduction of clinical symptoms and the non-significant changes in vaginal microbiome support the efficacy and safety of laser treatment. Moreover, the high remodeling status in vaginal epithelium is demonstrated by the significant changes in inflammatory and modulatory cytokine patterns. Laser therapy can be used for the treatment of GSM symptoms and does not show any adverse effects. However, further studies will be needed to clarify its long-term efficacy and other effects.

Erratum to: Long-term reliability of fractioned CO2 laser as a treatment for vulvovaginal atrophy (VVA) symptoms.

In original publication, the Fig. 1 was incorrect. The correct figure has been given below.

Long-term reliability of fractioned CO2 laser as a treatment for vulvovaginal atrophy (VVA) symptoms.

PURPOSE: The aim of this study was to evaluate long-term effects of the fractional CO2 laser for the treatment of vulvovaginal atrophy (VVA) symptoms. METHODS: Women presenting with VVA symptoms and meeting inclusion criterion were enrolled to fractioned CO2 laser therapy. Patient's satisfaction was measured on five-point Likert scale at 4 weeks and 6, 12, 18, 24 months after treatment by interview and clinical examination for vaginal livability. RESULTS: 184 patients constituted the final study group: 128 women were spontaneous menopause and 56 were oncological menopause. 117 women were nulliparous and 36 had previous hysterectomy. 95.4% (172/184) of the patients declared that they were satisfied or very satisfied with the procedure at 4 weeks after treatment. At 6 months 92% (170/184) patients were satisfied; at 12 months 72% (118/162) were satisfied; at 18 months 63% (60/94) were satisfied; at 24 months 25% (4/16) of patients answered they were still satisfied. We observed a decline in patient's satisfaction between 18 and 24 months after laser therapy. Data showed that the time interval from onset of menopause was a statistically significant factor (p < 0.05) for treatment satisfaction in oncological group. CONCLUSION: Long-term data showed that the improvement of vaginal health may continue up to 24 months after fractional CO2 laser treatment although between 18 and 24 months benefits decline, and approximately 80% of women decide to start a new treatment cycle of laser applications.

Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors.

PURPOSE: The aim of this study was to evaluate the efficacy of fractional CO2 laser therapy in breast cancer survivors as a therapeutic method for vulvovaginal atrophy (VVA) dyspareunia. METHODS: 50 patients (mean age 53.3 years) underwent fractional microablative CO2 laser treatment for dyspareunia in oncological menopause (mean time of menopause 6.6 years). The Gloria Bachmann's Vaginal Health Index (VHI) score was chosen as system to evaluate the presence of VVA and its improvement after the treatment. Intensity of dyspareunia was evaluated using a visual analog scale (VAS). RESULTS: Data indicated a significant improvement in VVA dyspareunia (p < 1.86e-22) in breast cancer survivors who had undergone 3 sessions of vaginal fractional CO2 laser treatment. Moreover, VHI scores were significantly higher 30 days post-treatment (T4) (p < 0.0001). 76 % of patients were satisfied or very satisfied with the treatment results. The majority (52 %) of patients were satisfied after a long-term follow-up (mean time 11 months). No adverse events due to fractional CO2 laser treatment occurred. CONCLUSIONS: The treatment with fractionated CO2 laser appeared to be a feasible and effective treatment for VVA dyspareunia in breast cancer survivors with contraindications to hormonal treatments.

Management options of breast cancer related osteoporosis.

Breast cancer therapy after surgery has been improved in recent years. Adjuvant therapies like aromatase inhibitors are being extensively used among breast cancer survivors. This leaded to cancer related and iatrogenic osteoporosis. Management of these patients needs to be focused and differentiated from the standard age related osteoporosis in women. All guidelines consider mandatory to assess fracture risk periodically in all breast cancer survivors. Risk assessment diagnostic FRAX tool is the most used but it's not born specifically for cancer related osteoporosis. The therapeutic management of this kind of osteoporosis has been studied by different societies. Since breast cancer survivors are at risk of osteopenia and osteoporosis, counseling regarding modifiable risk factors is mandatory and advocated. The beginning of the treatment should be tailored in each patient.

Acupuncture and traditional Chinese medicine for hot flushes in menopause: a randomized trial.

OBJECTIVE: To evaluate the effect of acupuncture on hot flushes and other menopause-related symptoms used in an integrated system, including such therapeutic techniques as diet therapy and Tuina self-massage. DESIGN: Randomized trial. SETTING: Outpatient center. PARTICIPANTS: One hundred women in spontaneous menopause with at least three episodes of hot flushes daily were randomly allocated to two treatment groups (50 per group): Women in group A were given diet, self-massage training, and treatment with acupuncture, and women in group B (the control group) were given the same diet and self-massage training, but treatment with acupuncture started 6 weeks after they were enrolled into the study. INTERVENTION: Acupuncture treatments were scheduled twice weekly for 6 consecutive weeks. OUTCOME MEASURES: Mean change in frequency and/or intensity in menopause-related symptoms were estimated by questionnaire after treatment at week 4. RESULTS: Treatment with acupuncture significantly reduced the occurrence of hot flushes and sudden sweating (p<.001). Other symptoms (sleep disorders, tightness in the chest, irritability, bone pain, feeling depressed) significantly improved. CONCLUSIONS: Acupuncture in an integrated system that includes therapeutic techniques such as diet therapy and Tuina self-massage can be used to treat hot flushes and selected symptoms in postmenopausal women.

Prevention, diagnosis and treatment of osteoporosis following menopause induced due to oncological disease.

Owing to the improved effectiveness of the treatment protocols for oncological disease, in the last few years we have seen an increase in the number of women in iatrogenic menopause secondary to integrated oncological treatments or surgical, pharmacological or radiological therapies. Particularly if it is premature, menopause in these subjects, who are already strongly debilitated by the primary pathology, may have heavy physical and psychic repercussions on the quality of life.Particular attention must be paid to the prevention and treatment of osteoporosis, which is linked both to premature cessation of the reproductive capacity and to the treatments for the oncological disease, which may represent an additional risk for the development of premature, severe osteoporosis. Some oncological diseases involve therapies which affect bone metabolism. At the sametime, for example in breast cancer, some bone protective drugs like hormone replacement therapy are controindicated. The introduction for breast cancer of a new category of drugs, aromatase inhibitors, seems to be linked to an increase in bone fractures. Correct treatment of these subjects involves a multidisciplinary specialist approach which we believe can be created through a targeted menopause surgery, which would thus become the ideal place for the evaluation of problems linked to the treatment of cancer and the consequent early menopause.A targeted surgery like this allows us to create individual treatment paths with differentiated timing, and to address questions which are still unanswered, such as the risk of osteoporosis deriving from the effects of aromatase inhibitors on the bones, and the preventive effectiveness of the combination with bisphosphonates.