Global view of vasomotor symptoms and sleep disturbance in menopause: a systematic review.

Studies have shown racial/ethnic differences in the prevalence of vasomotor symptoms (VMS), sleep disturbance and VMS treatment in menopause. To assess the reproducibility of these differences, we systematically reviewed observational studies, published in 2000-2021, reporting the prevalence/incidence of VMS, sleep disturbance or treatment use in menopausal women stratified by race/ethnicity. We screened 3799 records from PubMed and Embase and included 27 papers (19 studies). No incidence data were found. Prevalence data varied widely, but some common patterns emerged. In all five studies comparing VMS between Black women and White, Hispanic and/or East Asian women, the prevalence was highest in Black women and lowest in East Asian women. The prevalence of sleep disturbance overall was compared among Black, White and East Asian women in two study populations, and was highest in White women in both papers. Sleep disturbance was more common than VMS in East Asian women. In all four studies comparing hormone therapy use between White women and Black and/or East Asian women, treatment use was more common in White women. These results highlight the need for individualized counseling and treatment, outreach to under-served minorities, and standardized definitions and outcome measures for VMS and sleep disturbance for future studies.

Swiss consensus on the role of DHEA in the management of genitourinary syndrome of menopause.

Genitourinary syndrome of menopause (GSM) has a significantly negative impact on affected women's lives. However, despite the increasing number of GSM treatment options (e.g. non-hormonal vaginal products, vaginal hormones [estrogens], dehydroepiandrosterone [DHEA; prasterone], vaginal laser therapy, oral ospemifene), many women remain untreated. The goal of the Swiss interdisciplinary GSM consensus meeting was to develop tools for GSM management in daily practice: a GSM management algorithm (personalized medicine); a communication tool for vaginal DHEA (drug facts box); and a communication tool for understanding regulatory authorities and the discrepancy between scientific data and package inserts. The acceptance and applicability of such tools will be further investigated.

Evaluation of a patient-centred, needs-based approach to support shared decision making in contraceptive counselling: the COCO study.

OBJECTIVES: The Contraceptive Counselling (COCO) study tested whether a structured approach to assessing patient needs and expectations improved method choice and satisfaction with the contraceptive decision-making process. METHODS: Physicians and women were invited to complete needs-based contraceptive counselling sessions using a structured questionnaire. Physicians recorded the individual responses online; women evaluated the process using an immediate post-consultation questionnaire and then via a structured online interview 6 months later. RESULTS: A total of 92 gynaecologists and 1176 women participated: 951 women completed the immediate post-consultation survey and 145 took part in the 6 month online evaluation. There was a substantial increase in satisfaction with the current contraceptive method: the number of women reporting they were 'very satisfied' with their contraceptive method increased by 30%. This applied to starters and switchers as well as to women continuing with their previous method. Women were highly satisfied with the structured approach; 95% rated the counselling as 'good' or 'very good' and 'comprehensive and detailed'. CONCLUSION: Using a structured approach to share information tailored to women's needs can help them choose from a broader range of methods and, in some cases, change to a method more suitable to their individual needs, and ultimately increase satisfaction with their choice.

Do radiation oncologists talk about sexual health and dysfunction with their cancer patients? Results of the igls-vienna-sexmed-survey.

BACKGROUND AND PURPOSE: The aim of this survey was to invite radiation oncologists to self-assess whether sexual health care and sexual dysfunction are an issue in daily routine. MATERIALS AND METHODS: At the annual congress of the Austrian Society of Radiation Oncology in 2017 doctors were asked about their care for sexual health in cancer patients by using questionnaires. No exclusion criteria were employed. Forty-one questionnaires were answered and statistically analysed so 44.5% of doctors participated. RESULTS: Only 4.9% of the participants self-assessed to routinely explore sexual health issues in 61-80% of their patients. Thirty-one point seven percent of the doctors suspected sexual problems in about half of their patients but did not raise the issue. The most common reason for not raising sexual issues by the patients was assumed by the doctors "other problems are more important" (73.2%), followed by "lack of time" (36.6%). Participants were also asked about additional medical qualifications: none of the physicians had training in sexual medicine. CONCLUSION: The main reason for not talking about sexual problems was the impression of the participating doctors that other problems were more important for the patients. Another reason for not bringing up the topic of sexual issues by the patients was assumed by the doctors: lack of time. As doctor shortage is a problem in the observed country other kind of networks and counselling possibilities should be evaluated. An interesting finding was that survey participants show a higher awareness for male sexual problems than for female issues.

Accelerating Progress in Sexual and Reproductive Health and Rights in Eastern Europe and Central Asia - Reflecting on ICPD 25 Nairobi Summit.

The International conference on population and development-25 in Nairobi (2019) has reaffirmed the UN and its member countries' commitment to develop focused strategies to provide comprehensive equitable sexual and reproductive health to every one. European Board and college of Obstetrics and Gynaecology(EBCOG) and the European Society of Contraception and Reproductive Health (ESCRH) commit to work with UNFPA EECA Region to deliver these objectives in Eastern Europe and Central Asia where progress as regards SRH targets has been sub-optimal.

Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials.

OBJECTIVES: Two identical 12-week, randomized, double-blind, placebo-controlled, multi-arm, parallel-group Phase III studies (Study P012, NCT00560833; Study P013, NCT00535288) evaluated the efficacy and safety of esmirtazapine, an investigational medicine, for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women. METHODS: Participants were randomized to placebo or esmirtazapine (2.25, 4.5, 9.0, or 18.0 mg). Co-primary efficacy endpoints (daily frequency and severity of moderate to severe VMS, both at weeks 4 and 12) were based on participative LogPad daily diaries. Adverse events (AEs) were recorded. RESULTS: In Studies P012 and P013, 942 and 946 participants were randomized, respectively. Compared with placebo, esmirtazapine significantly reduced the mean daily frequency by 1.4-2.2 moderate to severe VMS at weeks 4 and 12 (both ≥4.5 mg) and mean daily severity by 0.06-0.08 symptoms at weeks 4 (≥4.5 mg) and 12 (9.0 mg P012; 18.0 mg P013 only). Esmirtazapine was generally well tolerated with a more favorable safety profile at lower doses. Somnolence and fatigue were the most frequently reported AEs. CONCLUSIONS: Esmirtazapine reduced the frequency and severity of moderate to severe VMS associated with menopause and was generally well tolerated in the study population.

Overview of perimenopausal contraception.

The perimenopause is accompanied by important biological and psychosocial changes. The choice of contraceptive methods for women in the perimenopause, none of which is limited by age alone, will depend on the efficacy, safety, tolerability, and potential benefit of each method in relation to the biopsychosocial profile of the individual woman. Copper intrauterine devices are highly effective in the typical user and are a very safe method with, in general, good tolerability but are of limited use in women with heavy menstrual bleeding and subserous myomata. An additional benefit of copper intrauterine devices is protection against endometrial cancer. All progestogen-based methods share a favorable cardiovascular profile, making their use safe in most perimenopausal women. Long-acting implants and intrauterine systems are user independent and highly effective. Injectables and pills depend on user compliance. There is no evidence of a significant impact on breast cancer. Their impact on the endometrium can be either a negative side-effect (irregularity) or a benefit regarding reduction of heavy menstrual bleeding. Combined hormonal contraceptives have the highest cardiovascular risk. They can act as a promoting factor for breast cancer and cervical cancer, but they have the strongest potential regarding benefits (protection against endometrial and ovarian cancer, positive effect on bone mineral density, menstrual complaints, hyperandrogenic symptoms, hot flushes, and reduced risk regarding benign ovarian cysts and benign breast tumors).

Managing the risks of mood symptoms with LNG-IUS: a clinical perspective.

INTRODUCTION: Lack of awareness of reproductive hormone-related mood changes in the general population or limited acknowledgement of their existence by health care providers regularly contribute to fears or misconceptions about the link between hormonal contraception and potential mood changes. Recent media discussion linked the levonorgestrel intrauterine system (LNG-IUS 20 µg/d) to elevated cortisol levels and the possibility of panic attacks, anxiety, mood changes, sleep disturbance and restlessness. Efficacy of the LNG-IUS is based primarily on local effects but systemic effects, including a potential increase in mood symptoms, are a known risk and reflected in the product labelling for all LNG-IUS products. OBJECTIVE: There is a need to improve communication to the public and health care providers around potential risk of mood disorders in order to facilitate 'informed choice' amongst women considering an LNG-IUS as their contraceptive method and directly address the fears of women currently using an LNG-IUS. RESULTS: We propose a simple and brief, step-by-step process that can be embedded within current counselling that explores and clarifies the potential risk of developing mood symptoms prior to placement of LNG-IUS. It also addresses concerns from women using an LNG-IUS who either present with mood symptoms or are concerned about potential onset. CONCLUSION: Mood symptoms with use of LNG-IUS are uncommon; however, all women, including those who may experience an increased sensitivity to certain progestins, should be counselled appropriately to raise awareness of the potential risk within an informed discussion around effectiveness, benefits and possible adverse events.

Are there unmet needs in contraceptive counselling and choice? Findings of the European TANCO Study.

INTRODUCTION: Effective use of contraception requires women to make an informed choice about methods that match their individual needs and expectations. The European Thinking About Needs in Contraception (TANCO) study is a quantitative, online survey of healthcare provider and women's views on aspects of counselling around contraception and contraceptive use. METHODS: Healthcare providers and women attending their practices for contraceptive counselling were invited to complete online questionnaires. The women's survey explored knowledge and use of contraceptive methods, satisfaction with current method, and interest in receiving more information about all methods. Healthcare provider views were gathered in parallel. RESULTS: A total of 676 healthcare providers and 6027 women completed the online surveys in 11 countries. There was a high prevalence of contraceptive use and general satisfaction with current method across the countries. Fifty-five percent of women were using short-acting contraception (SAC) methods; 19% were using a long-acting reversible contraception (LARC) method. Sixty percent of women were interested in receiving more information about all methods; 73% of women said they would consider LARC if they received more comprehensive information. Healthcare providers tend to underestimate women's interest in receiving information on contraception in general and, more specifically, LARC methods. CONCLUSIONS: Despite high levels of use and satisfaction with current methods, women were interested in receiving more information about all contraceptive methods. Greater exploration of women's views on their needs and expectations of contraception could lead to increased knowledge, more effective discussions with healthcare providers and the greater likelihood of informed contraceptive choice.

ESC expert statement on the effects on mood of the natural cycle and progestin-only contraceptives.

Hormonal fluctuations during the natural cycle, as well as progestins used for hormonal contraception, can exert effects on mood especially in vulnerable women. Negative effects of levonorgestrel-releasing intrauterine contraception on mood are rare.

The use of cyproterone acetate/ethinyl estradiol in hyperandrogenic skin symptoms - a review.

INTRODUCTION: Hyperandrogenism affects approximately 10-20% of women of reproductive age. Hyperandrogenic skin symptoms such as hirsutism, acne, seborrhea and alopecia are associated with significant quality of life and psychological impairment. Women with abnormalities in androgen metabolism may have accompanying anovulation and/or polycystic ovary syndrome (PCOS), both of which have reproductive and metabolic implications if left untreated. Cyproterone acetate (CPA), combined with ethinylestradiol (EE), is indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age. OBJECTIVE: To review the data on the efficacy and safety of CPA 2 mg/EE 35 µg for the treatment of hyperandrogenic skin symptoms in women. METHODS: A non-systematic narrative review based on a literature search of the PubMed database. RESULTS: Seventy-eight studies were identified. The majority of sufficiently powered studies show a high efficacy of CPA 2 mg/EE 35 µg in the treatment of severe acne and hirsutism. Studies show that therapeutic response in women with hirsutism requires a long-term approach and that hyperandrogenic skin symptoms in patients with PCOS are efficiently treated. Additional benefits include cycle control and, in some women, improvement in mood and perception of body image. Safety and tolerability data are summarized by the pharmacovigilance risk assessment committee (PRAC) of the European Medicine's Agency's (EMA). CONCLUSIONS: This review provides a comprehensive overview about the efficacy of CPA 2 mg/EE 35 µg in the treatment of hyperandrogenic skin symptoms, thus allowing both health care professionals and women to balance the risks and benefits of treatment based on evidence.

Ultra-low dose - new approaches in menopausal hormone therapy.

Despite increasing life expectancy, the age of onset of natural menopause has not significantly changed in recent decades. Thus, women spend about one-third of their lives in an estrogen-deficient state if untreated. There is a need for appropriate treatment of acute symptoms and prevention of the sequelae of chronic estrogen deficiency. International guidelines call for the use of the lowest effective hormone dosage for vasomotor symptom relief, the major indication for menopausal hormone therapy (MHT). In 2011, an oral continuous combined ultra-low-dose MHT was approved in Switzerland. This publication was elaborated by eight national menopause specialists and intends to review the advantages and disadvantages of ultra-low-dose MHT after the first years of its general use in Switzerland. It concludes that, for many women, ultra-low-dose MHT may be sufficient to decrease vasomotor symptoms, but not necessarily to guarantee fracture prevention.

The quantitative and qualitative recovery of Campylobacter from raw poultry using USDA and Health Canada methods.

Harmonisation of methods between Canadian government agencies is essential to accurately assess and compare the prevalence and concentrations present on retail poultry intended for human consumption. The standard qualitative procedure used by Health Canada differs to that used by the USDA for both quantitative and qualitative methods. A comparison of three methods was performed on raw poultry samples obtained from an abattoir to determine if one method is superior to the others in isolating Campylobacter from chicken carcass rinses. The average percent of positive samples was 34.72% (95% CI, 29.2-40.2), 39.24% (95% CI, 33.6-44.9), 39.93% (95% CI, 34.3-45.6) for the direct plating US method and the US enrichment and Health Canada enrichment methods, respectively. Overall there were significant differences when comparing either of the enrichment methods to the direct plating method using the McNemars chi squared test. On comparison of weekly data (Fishers exact test) direct plating was only inferior to the enrichment methods on a single occasion. Direct plating is important for enumeration and establishing the concentration of Campylobacter present on raw poultry. However, enrichment methods are also vital to identify positive samples where concentrations are below the detection limit for direct plating.

The option of delayed reconstructive surgery following mastectomy for invasive breast cancer: why do so few patients embrace this offer?

BACKGROUND: Only a minority of patients who had undergone mastectomy for invasive breast cancer (BC) chose the option for delayed breast reconstruction (BR). We hypothesized that this might partly be (a) due to a lack of information, or (b) because many women cope well with their altered body. METHODS: A cross-sectional survey was completed by 101 early-stage BC survivors who had primary mastectomy. Twenty-six patients had delayed BR. The survey included measures to attitudes to BR and experiences/expectations about information related to BR. RESULTS: The percentage of patients who was informed regarding BR was high (97%). For 39.5% such information was not considered important, neither before mastectomy, nor during follow-up; advanced age was an important factor for the disinterest in information (odds ratio 1.81; 95% CI: 1.04-3.16; p = 0.033). For women without BR, the perception that mastectomy caused a serious damage to their body image changed over time to perceiving the operation as an acceptable alteration of the body (-1.10; 95% CI, -1.52, -0.64; p < 0.001); this process was similar to that in patients who had BR (paired t-test: -2.12; 95% CI, -2.82, -1.41; p > 0.001). From 63 patients who reported no intention to have a BR in the future, 28 (44.4%) responded with answers that showed a high satisfaction with their mastectomies without BR; 30 patients (47.6%) reported reasons, which might potentially be dispelled by information by an experienced reconstructive surgeon. CONCLUSIONS: We did not find any evidence that the low number of patients who chose delayed BR results from a lack of information regarding this procedure. The majority of patients overcome negative attitudes towards their mastectomy quickly and are uninterested in BR. Patients who are ambivalent must be identified; these women require particular attention and should receive intensive counseling.

Prenatal counseling--implications of the cultural background of pregnant women on information processing, emotional response and acceptance.

PURPOSE: Providing information about prenatal diagnosis (PND) that leads to an informed decision is ethically and psychologically challenging, especially in an intercultural context. The aim was to investigate cultural differences in information processing, test interpretation, evaluation of an established information leaflet, emotional response during screening and acceptance of PND. MATERIALS AND METHODS: This prospective study compared 30 pregnant Turkish immigrants with 30 women from Switzerland and countries within the European Union (EU). They completed a questionnaire prior to (T1) and after risk assessment between 11-14 weeks (T2) and after receiving the results (T3). The questionnaire focused on the perception of, experiences with and knowledge about the risk assessment and included the hospital anxiety and depression scale (HADS). χ(2) tests were used for dichotomous variables and Student's t-tests for scores on perception, experience, knowledge, depression and anxiety. Groups were compared over time by 2-factorial ANOVA. RESULTS: Regarding the 6 questions on knowledge, the rate of correct answers was between 32.2% and 62.5% at T1 and 35.1% and 75.0% at T2. The Turkish women's knowledge level was significantly lower. They rated the information leaflet as less helpful and found the counseling significantly more unsettling. The acceptance of PND was higher in Turkish women. CONCLUSION: Considering the information and knowledge deficits, informed consent was not given in every case, especially in Turkish women. Nevertheless, the acceptance of PND was good. Further studies will have to focus on counseling strategies that take into account the specific needs and expectations of pregnant women with different cultural backgrounds.

Pharmacological profile of estrogens in oral contraception.

The synthetic estrogen ethinylestradiol (EE)given by mouth is stable and yields satisfactory results in terms of ovulation inhibition and effects on the endometrium. It increases however the risk especially for venous thrombotic events and to a lesser degree also arterial thrombosis. Therefore research focused on diminuition of the EE dosage and the development of a different estrogen component in oral contraceptives, specifically an estrogen occurring during physiological processes in the female body. Two estrogens emerge: 17ß Estradiol is the most potent natural estrogen and it is the major estrogen secreted by the ovaries. Estetrol is a human sex steroid (15 alpha hydroxyestriol) which is only produced during pregnancy by the fetal liver. The pharmacolokinetic and pharmacodynamic properties of these estrogens are compared to those of EE (absorption, metabolization, bioavailability etc.) and the clinical profile is described as far it is known from a limited number of studies.

Safety, tolerability and pharmacokinetics of intravaginal pentamycin.

BACKGROUND/AIMS: Intravaginal pentamycin is a polyene macrolide with a broad spectrum of antimicrobial activity and is effective in various forms of infectious vaginitis. We evaluated the safety, tolerability and pharmacokinetics of escalating doses of this product. METHODS: Nineteen healthy volunteers were randomized to receive double blind one of five doses of intravaginal pentamycin (3, 10, 30, 60 or 100 mg) or the corresponding dose of pentamycin vehicle daily for 6 days. Patients with symptomatic vaginitis received a single dose of 60 (n = 6) or 100 mg (n = 6) of intravaginal pentamycin. Safety and tolerability parameters were monitored throughout the study. Plasma concentrations of pentamycin were measured daily in the healthy volunteers and on the day of drug application in the patients. RESULTS: The most frequently reported adverse events were mild or moderate vaginal discharge and mild symptoms of vaginal irritation (mainly pruritus or burning sensation), which also occurred in women who applied the vehicle. No patient with symptomatic vaginitis reported treatment-related adverse events. The plasma levels of pentamycin were below the quantification limit in all samples. CONCLUSION: Intravaginal pentamycin does not cause adverse reactions compared with vehicle and is not absorbed through the intact or the inflamed vagina.

Therapeutic options for postmenopausal female sexual dysfunction.

BACKGROUND: Female sexual dysfunction (FSD) is a multidimensional problem combining biological, psychological and interpersonal elements of multiple etiologies. Menopause-related sexual dysfunction may not be reversible without therapy. Hormonal deficiency does not usually decrease in severity over time. Many options are available for the successful treatment of postmenopausal FSD. OBJECTIVE: To review the pharmacological and non-pharmacological therapies available for postmenopausal FSD, focusing on practical recommendations for managing postmenopausal women with sexual complaints, through a literature review of the most relevant publications in this field. PSYCHOSOCIAL THERAPY: This type of therapy (basic counselling, physiotherapy and psychosexual intervention) is considered an adaptable step-by-step approach for diagnostic and therapeutic strategies, normally combined with biomedical interventions to provide optimal outcomes. PHARMACOLOGICAL THERAPY: For postmenopausal FSD, many interventional options are now available, including hormonal therapies such as estrogens, testosterone, combined estrogen/testosterone, tibolone and dehydroepiandrosterone. CONCLUSIONS: Menopause and its transition represent significant risk factors for the development of sexual dysfunction. FSD impacts greatly on a patient's quality of life. Consequently, it is receiving more attention thanks to the development of effective treatments. Non-pharmacological approaches should be used first, focusing on lifestyle and psychosexual therapy. If required, proven effective hormonal and non-hormonal therapeutic options are available.

Diabetes and female sexual health.

Sexual function in female diabetic patients is much less investigated than in males. Empirical studies do not show uniform results, but it appears that diabetic women experience more frequent sexual dysfunction in general than age-matched healthy controls, independent of the sociocultural environment. The most frequently cited dysfunctions are desire and arousal disorders, such as lubrication difficulties, while orgasmic capacity appears to be less affected. Direct pathophysiological effects on lubrication are proven, but the impact on mental arousal is unclear. The role of diabetic complications is controversial. The comorbidity with depression plays a major role. Individual coping with the disease and the quality of the relationship are also contributing factors. Patients should be encouraged to talk about their sexual problems, as both biomedical and psychosocial factors have to be explored. Therapeutic interventions include basic counseling, biomedical treatment of atrophy and lubrication difficulties, as well as treatment of comorbidities and/or sex therapy.