-
BMC Women's Health Sep 2023To evaluate the effect of erbium-YAG laser on the number of vaginal lactobacilli in postmenopausal women. (Randomized Controlled Trial)
Randomized Controlled Trial
PRIMARY OBJECTIVE
To evaluate the effect of erbium-YAG laser on the number of vaginal lactobacilli in postmenopausal women.
SECONDARY OBJECTIVES
To evaluate the effect of erbium-YAG laser on vaginal atrophy symptoms and vaginal pH in postmenopausal women.
MATERIALS AND METHODS
A total of 44 postmenopausal women who met the inclusion criteria were randomized in the laser group (n = 22) and sham group (n = 22). Vaginal lactobacilli grading, vaginal pH, vaginal atrophy score, and vaginal atrophy symptoms were assessed before and after treatment with erbium-YAG laser for two consecutive times, with a four-week interval; the results were compared with the effects of the sham procedure. Any adverse events after the treatment were recorded.
RESULTS
A total of 44 women were included, and five were lost to follow-up. Compared with sham procedure, vaginal lactobacilli grading improved in the laser group (5/20 in the laser group and 1/19 in the sham group). However, the improvement did not reach statistical significance (adjusted odds ratio = 5.32, 95% CI = 0.5-56.21). Vaginal atrophy symptoms measured by the visual analog scale (VAS) and vaginal pH were improved in both groups without a statistically significant difference between the two groups. Vaginal "dryness" VAS and vaginal atrophy score after treatment were significantly lowered in the laser group compared with the sham group.
CONCLUSIONS
This study showed an improvement in vaginal lactobacilli grading after vaginal laser treatment. However, the difference in vaginal lactobacilli grading after treatment in both groups was not statistically significant.
Topics: Female; Humans; Lasers, Solid-State; Erbium; Postmenopause; Lactobacillaceae; Atrophy
PubMed: 37752478
DOI: 10.1186/s12905-023-02590-y -
Taiwanese Journal of Obstetrics &... Sep 2023To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and...
OBJECTIVE
To evaluate the efficacy of daily vaginal gel containing hyaluronic acid (HA) and Biosaccharide Gum-1 (BG-1) on vulvovaginal atrophy (VVA) and on sexual function and quality of life (QoL).
MATERIALS AND METHODS
One hundred-four postmenopausal women with VVA were enrolled in the nonrandomized comparison cohort study. Of them, 50 women on HA/BG-1 participated in the study group and 54 women on lubricants/moisturizers on-demand as a control group. The primary endpoint was the efficacy of the vaginal gel on VVA evaluated by the Vaginal Health Index (VHI) score. Secondary endpoints included sexual behavior by the self-administered female sexual function index (FSFI) questionnaire, and quality of life (QoL), by the Short Form-36 questionnaire (SF-36).
RESULTS
All symptoms of AVV improved after 12 weeks of treatment in women on HA/BG-1. The VMI, although improved at the 12-week follow-up compared to baseline, it connoted a low estrogenic stimulation value. Sexual function improved significantly in women on HA/BG-1. Moreover, women reported a significant improvement in the somatic aspects of QoL. No benefits were obtained by the women in the control group.
CONCLUSIONS
Treatment with HA/BG-1 could have used in postmenopausal women who complain of vaginal dryness. The amelioration of VVA-related signs could improve sexual function and QoL.
Topics: Humans; Female; Cohort Studies; Hyaluronic Acid; Postmenopause; Quality of Life; Vaginal Creams, Foams, and Jellies; Sexual Behavior
PubMed: 37678998
DOI: 10.1016/j.tjog.2023.07.011 -
Gynecological Endocrinology : the... Dec 2024Dienogest (DNG) improves endometriosis-associated pain (EAP) and patients' quality of life; however, the modern cornerstone of the management of endometriosis is the...
BACKGROUND
Dienogest (DNG) improves endometriosis-associated pain (EAP) and patients' quality of life; however, the modern cornerstone of the management of endometriosis is the long-term adherence of the patient to medical treatment.
OBJECTIVE
To evaluate DNG as a long-term treatment of endometriosis, focusing on patients' compliance and side effects, also correlating with different phenotypes of endometriosis.
METHODS
This was a cohort study on a group of patients with endometriosis ( = 114) undergoing long-term treatment with DNG. During the follow up visits (12, 24, and 36 months) patients were interviewed: an assessment of EAP was performed by using a visual analogue scale (VAS) and side effects were evaluated by using a specific questionnaire of 15 items.
RESULTS
At 12 months, 81% were continuing the DNG treatment, with a significant reduction of dysmenorrhea, dyspareunia, dyschezia, dysuria and chronic pelvic pain. Of the 19% that discontinued the treatment: 62% was due to spotting, reduced sexual drive, vaginal dryness, and mood disorders. The improvement of EAP was significant for all endometriosis phenotypes, especially in patients with the deep infiltrating type. At 36 months, 73% of patients were continuing the treatment, showing a significant reduction of EAP through the follow up, along with an increase of amenorrhea (from 77% at 12 months to 93% at 36 months). In a subgroup of 18 patients with gastrointestinal disorders, DNG was administered vaginally at the same dosage, showing similar results in terms of efficacy and tolerability.
CONCLUSIONS
DNG was an effective long-term treatment for all endometriosis phenotypes, with few side effects that caused the discontinuation of the treatment mainly during the first year. Thus, the course of 1-year treatment is a predictive indicator for long-term treatment adherence.
Topics: Female; Humans; Endometriosis; Treatment Outcome; Cohort Studies; Quality of Life; Pelvic Pain; Nandrolone
PubMed: 38579790
DOI: 10.1080/09513590.2024.2336121 -
Menopause (New York, N.Y.) Aug 2023Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA). (Meta-Analysis)
Meta-Analysis
Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis.
IMPORTANCE
Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA).
OBJECTIVE
The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe.
EVIDENCE REVIEW
Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses.
FINDINGS
A total of 44 controlled trials met the eligibility criteria ( N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment.
CONCLUSIONS AND RELEVANCE
Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.
Topics: Female; Humans; Dyspareunia; Vagina; Hyperplasia; Bayes Theorem; Network Meta-Analysis; Vulva; Atrophy; Tamoxifen; Selective Estrogen Receptor Modulators; Vaginal Diseases; Endometrial Neoplasms
PubMed: 37369079
DOI: 10.1097/GME.0000000000002211 -
Cureus Jul 2023Introduction Sexual dysfunction is rarely studied in Indonesian patients with breast cancer. We aimed to assess the prevalence of sexual dysfunction symptoms following...
Introduction Sexual dysfunction is rarely studied in Indonesian patients with breast cancer. We aimed to assess the prevalence of sexual dysfunction symptoms following chemotherapy, as well as the pattern and the associated factors. Methods This cross-sectional study included 135 female breast cancer patients receiving primary chemotherapy. The present study measured the prevalence of sexual dysfunction symptoms using an e-questionnaire containing Common Toxicity Criteria for Adverse Events (CTCAE) version 4 at different time points. Other data included sociodemography, clinicopathology, treatment, and other concurrent symptom characteristics. Bivariate and multivariate logistic regression tests were used to analyze any association among variables. Results In the whole panel, 86 (63.7%) of 135 cases experienced sexual dysfunction. The most common symptom was vaginal dryness (45.9%), followed by decreased libido (45.2%), dyspareunia (13.3%), delayed orgasm (11.1%), and anorgasmia (8.9%). When observed at five different time points, the frequency of symptoms increased during chemotherapy and persisted until six months after completing treatment. Chemotherapy duration of >120 days was associated with a higher probability of vaginal dryness (p=0.012) and decreased libido (p=0.033). Spouse age ≥55 years old and body mass index (BMI) ≥23 kg/m were associated with a reduced probability of decreased libido (p=0.033 and 0.025, respectively). The presence of comorbidity was associated with a reduced probability of delayed orgasm (p=0.034). Conclusions A significant proportion of patients with breast cancer had sexual dysfunction following chemotherapy. Vaginal dryness, decreased libido, and dyspareunia were the commonest symptoms observed. Duration of chemotherapy, spouse age, BMI, and comorbidity were associated with the risk of sexual dysfunction occurrence.
PubMed: 37449290
DOI: 10.7759/cureus.41744 -
Bioengineering (Basel, Switzerland) Oct 2023Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the...
INTRODUCTION
Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the definition of pelvic floor disorders (PFDs). Nonhormonal therapies, such as lubricants and moisturizers, are indicated as first-line treatments, while the "gold standard'' is represented by topical estrogen products; however, in cancer survivors hormonal treatment is not indicated. For this reason, energy-based therapeutic approaches-for instance, through laser technologies-may be employed as alternative options in this kind of patient; however, there are no studies evaluating the efficacy of a pure diode vaginal laser in the treatment of GSM. As a consequence, with our study, we aimed to evaluate outpatient nonablative diode laser treatment in sexually active women, with contraindications, no response, or refusal of local estrogenic therapy.
METHODS
This prospective study included patients with GSM, aged ≥ 18 years old, with contraindications, or refusal of local estrogen therapies. Women were evaluated via the use of their Vaginal Health Index (VHI) scores, which consists of five measures: elasticity, fluid volume, pH, epithelial integrity, and moisture. Moreover, the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) was measured using a 10 cm visual analog scale (VAS), where the left extreme of the scale (score = 0) indicated "absence of symptom" and the right indicated "symptom as bad as it could be" (score = 100). Sexual function was evaluated with the Female Sexual Function Index (FSFI-19) questionnaire. The treatment was performed using a Leonardo Dual diode laser (Biolitec Italia Srl, Milano, Italy). The laser treatment consisted of three sessions, one per month. One month after the third session, the VHI, symptom VAS, and FSFI-19 were re-evaluated. In addition, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected.
RESULTS
Our study enrolled a total of 26 consecutive patients. All patients were either in menopause or under treatment with gonadotropin-releasing hormone (GnRH). None of the patients reported adverse effects after laser treatment. In total, 19 (73.1%) patients referred improvements of their symptoms according to PGI-I scores. All domains of the FSFI-19 questionnaire, significantly improved after the diode laser treatment. The mean VHI score increased by 3.2 points, from 12.2 to 15.4 ( < 0.001). Additionally, we documented a significant improvement in symptoms affecting the VAS score, from 69.2 to 43.5 points ( < 0.001).
CONCLUSION
A diode vaginal laser is an effective and easily tolerated ambulatory procedure for vaginal functional restoration in the treatment of GSM and VVA.
PubMed: 37892888
DOI: 10.3390/bioengineering10101158 -
BMC Cancer Nov 2023Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where...
BACKGROUND
Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population.
METHODS
VagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH.
DISCUSSION
More randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT06007027 (registered 22 August, 2023).
PROTOCOL VERSION
Version 1, Date 13.11.2023.
Topics: Humans; Female; Breast Neoplasms; Cancer Survivors; Carbon Dioxide; Follow-Up Studies; Laser Therapy; Female Urogenital Diseases; Menopause; Vagina; Urogenital Neoplasms; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38031020
DOI: 10.1186/s12885-023-11656-x -
Breast Cancer Research and Treatment Oct 2023To analyze serum estradiol (E2) and estrone (E1) during letrozole treatment and their association to Quality of Life (QoL) and side-effects. (Clinical Trial)
Clinical Trial
Effects of letrozole on serum estradiol and estrone in postmenopausal breast cancer patients and tolerability of treatment: a prospective trial using a highly sensitive LC-MS/MS (liquid chromatography-tandem mass spectrometry) method for estrogen measurement.
PURPOSE
To analyze serum estradiol (E2) and estrone (E1) during letrozole treatment and their association to Quality of Life (QoL) and side-effects.
METHODS
Postmenopausal breast cancer patients starting adjuvant letrozole were eligible. Serum samples were taken at baseline, three, and 12 months. E2 and FSH were measured with routine chemiluminescent immunoassays. E2 and E1 were analyzed after trial completion with a highly sensitive liquid chromatography-tandem mass spectrometry method (LC-MS/MS) with lower limits of quantification (LLOQ) of 5 pmol/L. QoL was measured at baseline and at 12 months with the EORTC QLQ-C30 and QLQ-BR23 and the Women's Health questionnaires, and menopause-related symptoms with the modified Kupperman Index.
RESULTS
Of 100 screened patients 90 completed the trial. Baseline mean LC-MS/MS E2 and E1 were 12 pmol/L (range < 5-57) and 66 pmol/L (< 5-226), respectively. E2 levels measured by immunoassay and LC-MS/MS showed no correlation. E2 and E1 were completely suppressed by letrozole except for one occasion (E1 11 pmol/L at 3 months). Pain, side effects of systemic therapy, vasomotor symptoms, joint and muscle aches, and vaginal dryness increased during letrozole treatment. A high baseline E2 was significantly associated with increased aching joints and muscles, but not with the other side effects.
CONCLUSIONS
Letrozole supresses E2 and E1 completely below the LLOQ of the LC-MS/MS in postmenopausal women. High pre-treatment E2 levels were associated with more joint and muscle pain during letrozole. Automated immunoassays are unsuitable for E2 monitoring during letrozole therapy due to poor sensitivity.
Topics: Female; Humans; Breast Neoplasms; Chromatography, Liquid; Estradiol; Estrogens; Estrone; Letrozole; Postmenopause; Prospective Studies; Quality of Life; Tandem Mass Spectrometry
PubMed: 37491651
DOI: 10.1007/s10549-023-07054-3 -
Nutrients Aug 2023There is a longstanding interest in the relationship between diet and hot flash symptoms during midlife, especially in whether phytoestrogens ease menopausal symptoms....
There is a longstanding interest in the relationship between diet and hot flash symptoms during midlife, especially in whether phytoestrogens ease menopausal symptoms. The purpose of this study was to examine hot flashes, night sweats, trouble sleeping, and vaginal dryness in relation to the intake of foods rich in phytoestrogens among Bangladeshi women aged 35 to 59 years who were living either in Sylhet, Bangladesh ( = 157) or as migrants in London ( = 174). Consumption ranges for phytoestrogens were constructed from food frequencies. We hypothesized that diets rich in isoflavones, lignans, and coumestrol would be associated with lower symptom frequencies. However, adjusted logistic regression results showed that with each incremental increase in general phytoestrogen consumption (scale of 0 to 10), the likelihood of hot flashes increased by 1.4%. Each incremental increase in lignan consumption raised the likelihood of hot flashes by 1.6%. In contrast, the odds of vaginal dryness decreased by 2%, with each incremental increase in phytoestrogen and lignan consumption, and by 4%, with each incremental increase in isoflavone consumption. Night sweats and trouble sleeping were not associated with phytoestrogen intake in logistic regressions. Our findings add to the conflicting data on relationships between phytoestrogens and symptoms associated with menopause.
Topics: Humans; Female; Phytoestrogens; Bangladesh; London; Hot Flashes; Isoflavones; Lignans
PubMed: 37686708
DOI: 10.3390/nu15173676 -
Journal of Personalized Medicine Dec 2023In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and... (Review)
Review
In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO laser group upon the exclusion of specific studies. In conclusion, vaginal CO laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy.
PubMed: 38138921
DOI: 10.3390/jpm13121694