HRT misuse and the osteoporosis epidemic Gambacciani, M.
Climacteric : the journal of the International Menopause Society,
02/2012, Letnik:
15, Številka:
1
Journal Article
Recenzirano
A new study by Karim and colleagues has highlighted the intriguing issue of the consequences of cessation of long-term postmenopausal hormone use. While potential reductions in breast cancer risk and ...in the incidence of newly diagnosed breast cancer in the era after the Women's Health Initiative study have been heavily debated, the implications of withdrawal from hormone therapy for bone health and fracture risk have remained outside the main scope. This new study has now demonstrated that there is a very clear downside in skeletal outcome that should be considered while evaluating the pros and cons of discontinuing hormone therapy. During 532 686 person-years of observation and a follow-up period of 6.5 years, a 55% increased risk for hip fracture was observed in women who stopped hormone therapy. In view of the dramatic decline in the number of hormone users all around the world, this mini-review discusses the 'neglected' skeletal outcomes of such global trends.
Female urinary stress incontinence Cervigni, M.; Gambacciani, M.
Climacteric : the journal of the International Menopause Society,
01/2015, Letnik:
18, Številka:
sup1
Journal Article
Recenzirano
Urinary incontinence (UI) is more common than any other chronic disease, such as hypertension, depression or diabetes, with the prevalence estimated between 9 and 74%. Among the various forms of ...urinary incontinence, stress incontinence (SUI) is the most prevalent (50%), with urgency incontinence (UUI) representing 11% and mixed type (MUI) 36% (3% not classified). Nowadays, the restoration of urinary continence is one of the greatest challenges for the well-being and quality of life of women. The introduction of minimally invasive surgical procedures changed the anti-incontinence surgery, leading to similar, or even better results as traditional, invasive techniques. The development of the mid-urethral slings offers a viable alternative to surgical correction of SUI. These further developments of mini-sling procedures are appropriate for local anesthesia, less traumatic, 'tension-free' (to ensure continence without obstruction), simple, rapid and repeatable. The latest minimally invasive approaches can be performed in day surgery, with clear advantages compared to traditional procedures. A novel approach through the use of vaginal laser techniques could represent an additional opportunity, as a non-invasive, outpatient method to treat SUI.
Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) ...related to vaginal erbium laser (VEL™) treatment.
The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs.
The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies.
Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low.
A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared ...to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of −0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum HP) were given (−1.020 and −0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.
Effects of ospemifene on bone in postmenopausal women de Villiers, T. J.; Altomare, C.; Particco, M. ...
Climacteric : the journal of the International Menopause Society,
09/2019, Letnik:
22, Številka:
5
Journal Article
Recenzirano
Odprti dostop
Ospemifene is a selective estrogen-receptor modulator approved for treating menopause-related moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy (VVA), in the United ...States, and for treating menopause-related, symptomatic VVA in women not appropriate for local estrogen therapy in Europe. This review summarizes the effects of ospemifene on bone, including bone biomarker data from a phase 3 vaginal dryness study. Early-phase studies of postmenopausal women showed that ospemifene dose-dependently decreased bone turnover markers versus placebo, similar to raloxifene. A 12-week, phase 3 study of ospemifene 60 mg/day in postmenopausal women showed improvements in all VVA parameters and significantly greater decreases in seven of nine bone biomarkers versus placebo. Lower bone resorption markers with ospemifene were observed regardless of time since menopause (≤5 years or >5 years) or baseline bone mineral density (BMD) (normal n = 18, osteopenia n = 164, or osteoporosis n = 21). Biomarker studies (n = 565 who took ospemifene) therefore support a potential role for ospemifene in maintaining bone health (and possibly reducing fracture risk) in postmenopausal women taking it for VVA; however, caution is warranted because data are limited to biochemical markers, rather than fracture and BMD. Although studies show that bone turnover predicts BMD and fractures, any hypothesis about a bone-sparing effect of ospemifene needs testing in rigorous, long-term, phase 3 studies monitoring fractures and BMD.
This study aimed to compare the efficacy of concomitant application of an intraurethral (IU) + intravaginal (IV) non-ablative Erbium (Er):YAG laser with IV application in improving the symptoms of ...stress urinary incontinence (SUI) in women.
This observational retrospective cohort study included 122 patients with SUI, 60 women in the IU + IV laser arm and 62 in the IV laser arm. The primary outcome was the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form score at entry and at 3, 6 and 12 months from baseline.
Demographic characteristics were comparable in both arms. Significant improvement in SUI symptoms was seen 3 months after the intervention and was sustained until the end of month 12 in both arms. The women who had severe SUI symptoms initially showed greater improvement. A higher number of women who initially had mild to moderate SUI symptoms were dry after treatment. Patients treated with IU + IV Er:YAG laser showed significant improvement in SUI symptoms compared to IV laser only, especially at postmenopausal state (p = 0.003).
The Er:YAG laser appears to be an efficient treatment method for SUI. Concomitant application of an IU + IV Er:YAG laser is more effective in relieving SUI symptoms at postmenopausal state.
To test whether the erbium-doped yttrium aluminum garnet (Er:YAG) SMOOTH
laser treatment efficacy on stress urinary incontinence (SUI) in hysterectomized patients is non-inferior to its efficacy in ...non-hysterectomized patients.
In this real-world, retrospective cohort study performed in Turkey, Croatia and Italy, we enrolled a consecutive sample of 35 hysterectomized and 34 non-hysterectomized patients with SUI. We used the Er:YAG SMOOTH
laser (Fotona, Slovenia) with a wave length of 2940 nm. The primary outcome was median reduction of SUI symptoms measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-SF) with the non-inferiority margin defined as the minimum clinically important difference of ICIQ-SF (δ < 2.52 points).
In hysterectomized patients, the ICIQ-SF was reduced by 5 points (95% confidence interval 3-8;
< 0.001), a reduction of 45% (95% confidence interval 36-67%). After adjustment for baseline ICIQ-SF and five covariates, the reduction of symptoms in the hysterectomized group was not inferior to the reduction in the non-hysterectomized group.
The Er:YAG SMOOTH
laser treatment seems to improve the symptoms of SUI in hysterectomized women not clinically relevantly less than in non-hysterectomized women. It seems that the beneficial effect of Er:YAG SMOOTH
laser treatment for SUI in hysterectomized women is time-limited.
The VELA experience: a strategic format Grassiri, G.; Cervigni, M.; Bracco, G. L. ...
Climacteric : the journal of the International Menopause Society,
10/2020, Letnik:
23, Številka:
S1
Journal Article
The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH
) on sexual function in postmenopausal women suffering from the genitourinary syndrome ...of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth
, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (
= 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (
< 0.01 vs. corresponding basal values). Individual FSFI domain scores (
= 569) significantly (
< 0.001) increased after VEL-SMOOTH
treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (
< 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH
treatment may improve sexual function in postmenopausal women suffering from GSM.
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