Efficacy and Tolerability of Low-dose Transdermal Estrogen (Oesclim®) in the Treatment of Menopausal Symptoms

Summary

Objective:To establish the proportion of symptomatic postmenopausal women who can be satisfactorily maintained on a low HRT dose of 25?μg/day 17-β-estradiol (Oesclim® 25 transdermal patches), after 8 weeks of treatment.

Study design and patients: This was a multicenter open label non-comparative trial. Treatment was initiated with 25?μg/day dosage, which could be increased to 50?μg/day if required after 8 weeks, according to clinical evaluation. Sequential treatment with an oral progestogen was also given for >12 days/month in all non-hysterectomized women. The primary criterion for evaluation of efficacy was the proportion of patients who remained on Oesclim® 25 after 8 weeks of treatment in comparison to patients requiring Oesclim® 50.

Results: Sixty-two patients were included in the study and 60 were treated. 88.3% of treated patients [CI: 78.7–94.9] fulfilled the primary criterion, remaining with the Oesclim® 25 dosage after 8 weeks of treatment. All clinical menopausal symptoms showed a decrease from baseline to the end of the study. The mean daily number of vasomotor symptoms decreased from

8.2 (±5.6) at baseline, for the entire treated population, to 1.0 (±2.2) and 1.0 (±1.2) at the end of the study in patients remaining with Oesclim® 25 and in those requiring Oesclim® 50, respectively. At the interim visit, patients in the Oesclim® 50 group had a higher number of symptoms than those maintained on Oesclim® 25. The global efficacy of the treatment was evaluated as very effective/effective by 93% of all patients and very good/good by investigators for 91% of their patients. Overall 91% of all patients evaluated the global tolerability as very well/well, while investigators rated it very good/good for 97% of their patients. The vast majority of all patients (93%) were very satisfied/satisfied with the trial treatment, and 90% of them were willing to continue the study drug.

Conclusion: Oesclim® low dose (25?μg) hormonal transdermal therapy was efficient in management of climacteric symptoms in this 16-week study. The good acceptance of the treatment was associated with its high efficiency and tolerability.     

Noninvasively measured radial pressure wave analysis provides insight into cardiovascular changes during pregnancy and menopause

ObjectivePregnancy and menopause are significant life events associated with major changes in female hormone levels and changes in cardiovascular health. The role of estrogen in influencing cardiovascular risk is an ongoing research topic. Many studies have provided evidence that radial pressure wave characteristics are an important indicator to consistently and independently predict cardiovascular events. The aim of this study was to investigate if radial pressure wave analysis provided statistical insights into the physiological variations due to pregnancy and menopause. Furthermore, the study investigated how these variations could serve as an indicator for cardiovascular risks. As the radial pulse measurement is non-invasive and speedy, it may be helpful in evaluating cardiovascular changes and risk during these transitions.Materials and methodA total of 702 randomly selected female subjects (90 pregnant and 97 post-menopausal), aged 20–59, enrolled in the study. The visit measured the subject's hemodynamic parameters including heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and radial pressure waves. SBP and DBP were evaluated by an automatic blood pressure monitor. Radial pressure wave data were continuously recorded for 12-s using a TD01C pulse measuring instrument. Spectrum analysis of the radial pressure wave was performed to evaluate the first five harmonic components (C1–C5).ResultsA comparison of pregnant women to non-pregnant women showed C3 and C5 were lower. Heart rate C2 and C4 were higher in pregnant women. A comparison of women pre-menopausal and post-menopausal showed no significant difference in SBP or DBP. Menopause significantly changed the C1 and C4 radial pressure wave harmonics. An increase in C1 and a decrease in C4 were observed.Conclusion and discussionThis study provided further clinical evidence to support the hemodynamic model that describes the cardiovascular changes and risks related to the harmonic components of the pulse spectrum. Beyond blood pressure, the effects of menopause on the radial pressure wave, especially on hemodynamic index C4, independent of age and BMI, may explain increased post-menopausal cardiovascular risk. This and past studies collectively suggest that radial pressure wave components may be an indicator of a female body's ability to supply oxygen and nutrients. Harmonic analysis of the radial pressure wave may provide additional insights into the underlying mechanism of the cardiovascular changes over the lifespan of a woman.     

The effect of ginseng on sexual dysfunction in menopausal women: A double-blind,randomized, controlled trial

ObjectivesSexual problems constitute a largely-overlooked problem for women during menopause. The present study was conducted to determine the effect of Ginseng on sexual function (primary outcome), quality of life and menopausal symptoms (secondary outcomes) in postmenopausal women with sexual dysfunction.DesignThis randomized controlled trial was conducted on 62 women who were randomly assigned to the intervention/control groups using block randomization.InterventionThe intervention group received 500 mg of Panax Ginseng and the control group received placebo twice daily for four weeks.Main outcome measuresStandard questionnaires including the Female Sexual Function Index (FSFI), the Menopause-Specific Quality of Life (MENQOL) and the Greene Menopausal Symptom Scale were completed before and four weeks after the intervention.ResultsThere were no statistically significant differences between the two groups in terms of demographic characteristics and the baseline scores of sexual function, quality of life and menopausal symptoms (P > 0.05). After the intervention, the mean total score of FSFI (Adjusted Mean Difference = 6.32, 95% CI = 3.48 to 9.16, P < 0.001) was significantly higher in the intervention group compared to the control group. The mean total score of quality of life (AMD=-20.79, 95% CI=-25.83 to -15.75, P < 0.001) and menopausal symptoms (AMD=-8.25, 95% CI=-10.55 to -5.95, P < 0.001) were significantly lower in the treatment group than the control group.ConclusionGinseng has significant effects in improving sexual function and quality of life and mitigating menopausal symptoms. As a multipotent plant, Ginseng can be a suitable alternative for conventional therapies to promote the health of menopausal women.     

Evaluation of the incorporation of an IOTA-ADNEX model in the discrimination of adnexal masses in our third-level hospital centre,taking into account the menopausal status of patients. Five years of experience

ObjectiveThe objectives were to estimate the performance of the IOTA-ADNEX model test after its incorporation into the ultrasound tests of our third-grade hospital gynecology service, as well as to assess whether its capacity of accuracy is modified when taking into account the patient's menopausal status.MethodsA cross-sectional study was conducted to clinically evaluate the diagnostic performance of the IOTA-ADNEX model test, which was performed between January 2016 and December 2021. The study included 573 women with an adnexal injury who underwent surgical excision within 180 days after ultrasound diagnosis and histological confirmation (gold standard). After the ultrasound exam, the injuries were classified using the ADNEX model. The study estimated the area under the receiver-operating-characteristics curve (AUC) of the ADNEX model for classifying between benign and malignant adnexal masses and compared the performance by menopausal state. Sensitivity and specificity were determined for different cut-off points.ResultsOut of the 573 women, 183 (31.9%) had a malignant tumor. The AUC of the ADNEX model for differentiating between benign and malignant adnexal masses at the time of ultrasound examination was 0.92 and the best malignancy threshold, detected by Youden index, was 22.5%. At this cut-off, the sensitivity of the ADNEX model was 91.8% and the specificity was 76.4%. However, it varies according to menopausal status: in the group of pre-menopausal patient, sensitivity was 86.1% (95% CI, 85.4%–86.8%) and specificity was 81.3% (95% CI, 85.4%–86.8%). In the postmenopausal group, sensitivity was 96.1% (95% CI, 95.6%–96.7%) and specificity was 68.5% (95% CI, 68.1%–68.8%).ConclusionsThe IOTA-ADNEX model is a reliable diagnostic tool to discard ovarian cancer. However, the accuracy of the test, at the same cut-off point, varies according to the menopausal state of the patient so it may be important to take it into account when taking decisions in clinical practice.     

转化生长因子-β3与纤维连接蛋白在子宫肌瘤及子宫肌层内的表达水平与生物学意义

目的:探讨转化生长因子(TGF)-β3与纤维连接蛋白(FN)在绝经或未绝经妇女子宫肌瘤及子宫肌层中表达的水平变化及其意义。方法:采用免疫组化法(SP)检测40例绝经后子宫肌瘤妇女(绝经组)、40例未绝经子宫肌瘤妇女(未绝经组)肌瘤组织及肌壁组织中的TGF-β3、FN的表达差异,同时将绝经组妇女根据肌瘤是否发生萎缩分为萎缩组(17例)、未萎缩组(23例)并进行上述指标的比较。结果:绝经组的肌瘤组织、肌壁组织中的TGF-β3表达评分分别为(3.11±0.78)分、(1.85±0.69)分均显著的低于未绝经妇女的(3.98±0.67)分、(2.31±0.82)分(P0.05);两组妇女肌瘤组织和肌壁组织中的FN表达评分差异不显著(P0.05)。子宫肌瘤萎缩和未萎缩患者的子宫肌瘤组织、肌壁组织中TGF-β3、FN表达在两组间差异均不显著(P0.05),萎缩组和未萎缩组的肌瘤组织TGF-β3表达分别为(2.90±0.65)分、(3.32±0.74)分均显著的高于本组肌壁组织中的(1.85±0.67)分、(2.25±0.61)分(P0.05);两组肌瘤和肌壁组织中的FN表达差异不显著(P0.05)。结论:TGF-β3表达可能与患者绝经前后的激素水平改变有关。     

Electromyographic evaluation of synergist muscles of the pelvic floor muscle depending on the pelvis setting in menopausal women: A prospective observational study

BackgroundPelvic floor muscle (PFM) training is recommended to increase their strength and endurance. Muscles which act synergistically with PFM are taken into consideration in the therapeutic management of weakened PFM.Research questionhow does electromyography activity of the synergists muscle to PFM change concerning pelvis position and does the greater bioelectric activity of synergist muscles affect PFM function?MethodsA prospective, observational study evaluating the surface electromyography (sEMG) activity of selected synergist muscles of the PFM depending on the orientation of the pelvis. One hundred thirty-one menopausal women registered for the study were screened for inclusion and exclusion criteria, and by the results, eighty-two participants were enrolled for measurements. The comparisons of results between the values obtained in different positions of the pelvis (anterior pelvic tilt – P1, posterior pelvic tilt – P2 and neutral pelvic tilt – P3) were performed using Kruskal–Wallis test. A multivariate linear regression analysis was used to assess relationships between the bioelectrical activity of PFM and activity of all tested muscles – rectus abdominis (RA), gluteus maximus (GM), and adductor magnus (AM).ResultsHigher RA, GM, AM bioelectrical activity was observed in the P2 as compared to P3 (during resting and functional PFM activity)(p < 0.05). Multivariate linear regression did not find the association between the bioelectrical activity of PFM and the activity of all synergist muscles in each position.SignificancesEMG activity of selected muscles acting synergistically with PFM differ depending on the pelvis position and is the highest in the posterior pelvic tilt. Greater activity of the synergists, resulting from the pelvic position, does not affect the myoelectric activity of PFM. It seems that muscles that act synergistically with PFM may not play such a significant role in the therapeutic management of PFM.