Short and long-term effect of polycarbophil vaginal gel on vaginal atrophy of peri- and post-menopausal women. The TRIPLE study.

OBJECTIVES: This TRIPLE study was aimed to evaluate the efficacy of polycarbophil vaginal gel (PCV) in treating symptoms of vaginal atrophy (VA) of peri- and post-menopausal women. MATERIALS AND METHODS: Sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA, were progressively enrolled and treated for 30 days with PCV. Those wishing to continue (n = 73) were treated for additional 180 days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100 mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30 days. In those continuing the treatment an evaluation was performed after additional 180 days. RESULTS: Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p < 0.056). After 30 days VHI increased (p < 0.001) of 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p < 0.001) of -24.4 ± 3.6, and -52.7 ± 2.6 (p < 0.001), VAS of irritation decreased (p<0.001) of -18.6 ± 4.4 and -47.8 ± 3.2, VAS of pain decreased (p < 0.001) of -26.2 ± 4.3 and -55.6 ± 3.1 and the GSS decreased (p < 0.001) of -3.9 ± 0.3, and -4.9 ± 0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p < 0.001)(p < 0.032 for GSS) in postmenopausal women, and after 30 days all outcomes were similar in the two groups of women. In comparison to baseline, after 210 days of treatment VHI increased of 7.7 ± 0.3 (p < 0.001), VAS of vaginal dryness decreased of -53.6 ± 1.9 (p < 0.001) VAS of irritation of -42.6 ± 1.4 (p < 0.001) VAS of pain of -46.7 ± 2.3 (p < 0.001) and the GSS of -6.5 ± 0.2 ± 0.2 (p < 0.001). All outcomes improved (p < 0.001) over the values observed after 30 days of treatment (p < 0.001). No side effect was reported. CONCLUSIONS: In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6 months further increases its efficacy.

Connecting salivary gland inflammation to specific symptoms in Sjögren's disease.

INTRODUCTION: The complex nature of Sjögren's Disease (SjD) necessitates a comprehensive and patient-centered approach in both diagnosis and management. This narrative review emphasizes the need for a holistic understanding of the connection between salivary gland inflammation and oral symptoms in SjD. AREAS COVERED: The intricate relationship between salivary gland inflammation and dry mouth is explored, highlighting the variability in associations reported in studies. The association of the severity of xerostomia and degree of inflammation is also discussed. The frequent presence of recurrent sialadenitis in SjD further accentuates the connection of compromised salivary gland function and inflammation. The review additionally discusses local inflammatory factors assessed through salivary gland biopsies which could potentially serve as predictors for lymphoma development in SjD. Insights into compromised quality of life and hypercoagulable state and their association with salivary gland inflammations are provided. Advancements in noninvasive imaging techniques, particularly salivary gland ultrasonography and Color Doppler ultrasound, offer promising avenues for noninvasive assessment of inflammation. EXPERT OPINION: There is a need for longitudinal studies to unravel the connections between salivary gland inflammation and oral symptoms. This will enhance management strategies and optimize treatment outcomes for Sjögren's Disease (SjD) patients.

Prevalence of dry eye disease in the low vision population at the University of Colorado

Purpose: To evaluate the prevalence of diagnosed dry eye syndrome, meibomian gland dysfunction, and blepharitis amongst the low vision population. Methods: A retrospective analysis was conducted on patients seen in the University of Colorado Low Vision Rehabilitation Service between the dates of 12/1/2017 and 12/1/2022. 74 ICD-10 codes were used to identify patients as having dry eye syndrome or not having dry eye syndrome. Data was further analyzed to determine the prevalence of blepharitis and meibomian gland dysfunction using 29 blepharitis and 9 meibomian gland dysfunction ICD-10 codes. Data were also analyzed to determine the age and sex of the patients with diagnosed dry eye syndrome. Results: The percentage of patients with a diagnosis of dry eye syndrome by an eyecare provider was 38.02 %. The prevalence of dry eye syndrome by age group was 3.57 % for 0–19 years, 14.35 % for 20–39 years, 29.07 % for 40–59 years, 43.79 % for 60–79 years, and 46.21 % for 80 and above. The prevalence of meibomian gland dysfunction and blepharitis was 11.90 % and 9.1 % respectively. Dry eye syndrome prevalence amongst males was 31.59 % and 42.47 % for females. Conclusion: This study demonstrates that dry eye syndrome in the low vision population is a significant co-morbidity occurring in over a third of patients in the University of Colorado Low Vision Rehabilitation Service. These findings are meaningful as ocular comfort should not be overlooked while managing complex visual needs. (AU)

Genitourinary syndrome of lactation: a new perspective on postpartum and lactation-related genitourinary symptoms.

BACKGROUND: The genitourinary syndrome of menopause (GSM) is a well-documented condition characterized by a range of genitourinary symptoms in peri- and postmenopausal women. As with GSM, postpartum lactating women experience reduced estrogen and androgen levels. However, there is limited research on the impact of symptoms during the postpartum breastfeeding period. OBJECTIVES: The aim was to review the literature for genitourinary health in the postpartum breastfeeding population and summarize key findings and potential treatments. METHODS: We performed a comprehensive literature review in PubMed, Google Scholar, and Scopus from inception of database to November 2023 using the following keywords individually and in combination: "physiology of postpartum" or "physiology of lactogenesis" or "vulvovaginal health" or "vaginal atrophy" or "vaginal dryness" or "dyspareunia" or "urinary incontinence" or "lactation" or "breastfeeding" or "vaginal estrogen." All identified articles published in English were considered. Relevant studies were extracted, evaluated, and analyzed. The work presented in this article represents a summative review of the identified literature. RESULTS: During lactation, high levels of prolactin inhibit estrogen and androgen secretion via negative feedback, which leads to an increased prevalence of vulvovaginal atrophy, vaginal dryness, dyspareunia, and urinary incontinence in lactating postpartum women. Despite these highly prevalent and potentially devastating symptoms, there is a lack of consistent screening at postpartum visits and no treatment guidelines available to health care providers. CONCLUSION: Postpartum breastfeeding women experience similar physiology and symptoms to the postmenopausal phase, as seen in GSM. We propose the introduction of a novel term to describe the genitourinary changes seen in postpartum breastfeeding individuals: genitourinary syndrome of lactation. The diagnostic use of genitourinary syndrome of lactation will equip health care providers with an all-encompassing term to bring awareness to the symptoms experienced by postpartum breastfeeding individuals and lead to improved screening and treatment for the high numbers of individuals experiencing these genitourinary changes.

Genome-Wide Identification and Expression Profile Analysis of the Phenylalanine Ammonia-Lyase Gene Family in Hevea brasiliensis.

The majority of the world's natural rubber comes from the rubber tree (Hevea brasiliensis). As a key enzyme for synthesizing phenylpropanoid compounds, phenylalanine ammonia-lyase (PAL) has a critical role in plant satisfactory growth and environmental adaptation. To clarify the characteristics of rubber tree PAL family genes, a genome-wide characterization of rubber tree PALs was conducted in this study. Eight PAL genes (HbPAL1-HbPAL8), which spread over chromosomes 3, 7, 8, 10, 12, 13, 14, 16, and 18, were found to be present in the genome of H. brasiliensis. Phylogenetic analysis classified HbPALs into groups I and II, and the group I HbPALs (HbPAL1-HbPAL6) displayed similar conserved motif compositions and gene architectures. Tissue expression patterns of HbPALs quantified by quantitative real-time PCR (qPCR) proved that distinct HbPALs exhibited varying tissue expression patterns. The HbPAL promoters contained a plethora of cis-acting elements that responded to hormones and stress, and the qPCR analysis demonstrated that abiotic stressors like cold, drought, salt, and H2O2-induced oxidative stress, as well as hormones like salicylic acid, abscisic acid, ethylene, and methyl jasmonate, controlled the expression of HbPALs. The majority of HbPALs were also regulated by powdery mildew, anthracnose, and Corynespora leaf fall disease infection. In addition, HbPAL1, HbPAL4, and HbPAL7 were significantly up-regulated in the bark of tapping panel dryness rubber trees relative to that of healthy trees. Our results provide a thorough comprehension of the characteristics of HbPAL genes and set the groundwork for further investigation of the biological functions of HbPALs in rubber trees.

The effects of saline water consumption on sperm parameters, testicular histopathology, hormonal and antioxidants concentrations in Barki Rams.

The study aimed to assess the effects of water salinity on the sperm parameters, levels of cortisol, LH, FSH, testosterone and antioxidants as well as the testes' histopathology in Barki rams. Fifteen healthy Barki rams (1-1.5 years) were divided into three equal depending on the type of drinking water for nine months. The rams in the tap water group (TW, water that contained 350 ppm of total dissolved salts (TDS). Males in the high saline water group (HSW) were permitted to consume high saline water with 8,934 ppm TDS, whereas those in the second group were permitted to have moderately saline water (MSW, 4,557 ppm TDS). High salt concentration in drinking water had adverse effect on sperm viability, morphology and sperm cell concertation. Nitric oxide and malondialdehyde concentrations in blood were significantly higher in the MSW and HSW groups than in TW. There was a significant decrease in glutathione concentration as well as superoxide dismutase activity in TDS and HSW. Cortisol was most highly concentrated in the HSW, next in the MSW, and least in TW. The testosterone, LH, and FSH concentrations in the HSW and MSW groups were significantly lower than in TW. As the salt concentration in drinking water increases, damage to testicular tissue. The MSW group demonstrating vacuolation of lining epithelial cells with pyknotic nuclei in the epididymis and necrosis and desquamation of spermatogenic cells in seminiferous tubules while HSW group displaying desquamated necrotic cells and giant cell formation in the epididymis, as well as damage to some of the seminiferous tubules and showed congestion, vacuolation of spermatogenic epithelium of seminiferous tubules, and desquamated necrotic spermatogenic epithelium. In conclusion, the salinity of the water has detrimental impacts on the sperm morphology, viability and concentration, hormones and antioxidant levels in Barki rams.

Mucoadhesive, antioxidant, and lubricant catechol-functionalized poly(phosphobetaine) as biomaterial nanotherapeutics for treating ocular dryness.

Dry eye disease (DED) is associated with ocular hyperosmolarity and inflammation. The marketed topical eye drops for DED treatment often lack bioavailability and precorneal residence time. In this study, we investigated catechol-functionalized polyzwitterion p(MPC-co-DMA), composed of 2-methacryloyloxyethyl phosphorylcholine (MPC) and dopamine methacrylamide (DMA) monomers, as potential topical nanotherapeutics for DED. The copolymers were synthesized via random free-radical copolymerization, producing different proportions of catecholic functionalization. All as-prepared polymer compositions displayed good ocular biocompatibility. At a feeding ratio of 1:1, p(MPC1-co-DMA1) can facilitate a robust mucoadhesion via Michael addition and/or Schiff base reaction, thus prolonging ocular residence time after 4 days of topical instillation. The hydration lubrication of MPC and radical-scavenging DMA endow the nano-agent to ease tear-film hyperosmolarity and corneal inflammation. A single dose of p(MPC1-co-DMA1) (1 mg/mL) after 4 days post-instillation can protect the cornea against reactive oxygen species, inhibiting cell apoptosis and the over-expression of pro-inflammatory factors (IL-6 and TNF-α). In clinical assessment, DED-induced rabbit eyes receiving p(MPC1-co-DMA1) could increase lacrimal fluid secretion by 5-fold higher than cyclosporine A. The catechol-functionalized polyzwitterion with enhanced lubricity, mucoadhesion, and anti-oxidation/anti-inflammation properties has shown high promise as a bioactive eye drop formulation for treating DED.

An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause.

OBJECTIVES: The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. STUDY DESIGN: Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. MAIN OUTCOME MEASURES: During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. RESULTS: A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. CONCLUSION: Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active. CLINICALTRIALS: gov identifier NCT05211505.

Immune Checkpoint Inhibitor-induced Sicca Syndrome.

The development of sicca in patients treated with immune checkpoint inhibitors (ICIs) is undoubtedly an underestimated complication, but one whose functional consequences and impact on quality of life are significant for patients. This update aims to review the frequency of this complication and different clinical pictures. The authors also propose a diagnostic and therapeutic approach to guide clinicians in daily practice.

Investigating the regional ecological environment stability and its feedback effect on interference using a novel vegetation resilience assessment model.

Vegetation resilience is critical for understanding the dynamic feedback effect of regional ecological environment stability against interferences. Thus, based on quantify the interferences of climate dryness and vegetation water deficit affecting vegetation growth function, incorporate mechanical Hooke's law to develop a vegetation resilience assessment model by quantitatively expressing vegetation growth function maintenance ability, to reveal the ecological environment stability and its feedback effect on interferences in the study area. The essential discoveries of the study are as follows: (1) with the increase of precipitation and the improvement of afforestation on soil erosion, the interferences intensity of climate dryness and vegetation water deficit in the ecological environment decreased by 5.88 % and 4.92 % respectively, the regional vegetation growth function loss was improved, especially in the southern region; (2) the decrease of vegetation growth function loss promoted the vegetation resilience level fluctuated from class II to class IV, with the average annual vegetation resilience increased by 7.02 %, reflecting that the regional ecological environment stability increased from difficult to rapid recovery after disturbance, and the benefit was especially noticeable in the eastern and southern forested areas; (3) the contribution rates of climate dryness and vegetation water deficit to the variation of vegetation resilience caused by vegetation restoration were -1.38 % and 4.73 %, respectively, and the prominent positive feedback effect of increasing vegetation resilience with decreasing vegetation water deficit degree in forest restoration area, indicating that the vegetation water deficit greatly impacts ecological environment stability in the study area, and forest restoration constantly improves regional ecological environment stability more than grassland restoration. This research has crucial guiding implications for supporting the sustainable development of regional ecological environments.

Oral health status, related behaviours and perceived stress in xerostomia, Sicca and Sjögren's syndromes patients - a cross-sectional study.

BACKGROUND: Mouth dryness increases the risk of some oral health-related conditions. Furthermore, it is unclear if patients with dry mouth engage in appropriate oral health-related behaviours. The study examined oral health, related behaviours, and perceived stress in dry-mouth patients and compared them to matched controls without mouth dryness. METHODS: Information about 182 dry-mouth patients and 302 age- and sex-matched subjects was retrieved. Three dry mouth groups: xerostomia, Sicca syndrome and Sjögren's syndrome, were formed based on patient self-reported and objectively assessed symptoms. The World Health Organization's Oral Health for Adults and Perceived Stress Scale (PSS-10) questionnaires inquired about sociodemographic characteristics, oral health-related behaviours, and self-perceived stress. Clinical oral health assessments included: caries experience measured as total numbers of decayed (DS), missing (MS), filled surfaces (FS), number of remaining teeth, erosive tooth wear and extent of periodontal pocketing. Data were analyzed using bivariate and multivariable tests. RESULTS: The dry-mouth participants had higher mean (SD) DMFS scores than their matched controls: xerostomia patients vs. controls: 74.6 (34.4) and 66.3 (35.4), Sicca syndrome patients vs. controls: 88.3 (34.0) and 70.1 (33.9), and Sjögren's syndrome patients vs. controls: 95.7 (31.5) and 74 (33.2). In comparison to controls, individuals with Sicca and patients with Sjögren's syndromes had lower mean (SD) number of remaining teeth, 15.9 (10.1) vs. 21.7 (8.4) and 13.8 (10.0) vs. 20.1 (9.2), and a lower mean (SD) extent of periodontal pocketing, 20.7 (28.6) vs. 41.1 (31.0), and 21.2 (24.1) vs. 34.8 (34.2), respectively. Xerostomia, Sicca syndrome and Sjögren's syndrome patients had higher odds of using fluoridated toothpaste; OR 1.8 (95%CI 1.1-2.9), OR 5.6 (95%CI 1.7-18.3) and OR 6.9 (95%CI 2.2-21.3), respectively. Participants with Sjögren's syndrome had lower odds of the last dental visit being within the last year; OR 0.2 (95%CI 0.1-0.8). CONCLUSIONS: Dry-mouth patients had higher caries experience and fewer teeth than comparison groups but a lower extent of periodontal pocketing. Even though more participants with dry mouth used fluoridated toothpastes, their oral health-related behaviours were not optimal.

An extended time-varying Budyko framework for quantifying the hydrological effect of vegetation restoration under climate variations at watershed scale.

The Budyko framework, widely used to quantify the watershed hydrological response to the watershed characteristics and climate variabilities, is continuously refined to overcome the disadvantages of steady state assumption. However, dynamic variations in vegetations and climate variables are not fully integrated including coverages and precipitation regimes of intensity, frequency, and duration. To address this, we developed an innovative approach for determining the parameter ω in the Budyko framework to quantify the hydrological effects of vegetation restoration in a mesoscale watershed located in northern China. We found that fractional vegetation coverage (FVC), heavy precipitation amount (95pTOT), and the number of precipitation days (R01mm) are significant variables for estimating ω to improve the predictive capability of the watershed response. This extended time-varying Budyko framework can rigorously capture the temporal variations and underlying mechanisms of interactions between vegetation dynamic and precipitation regime partitioning precipitation (P) to R. Under the Budyko-Fu framework, compared to constant ω (ω‾) or ω that only considers FVC (ωP) or precipitation regimes (ωFVC) for simulating R, using ω that integrated FVC and precipitation regimes (ωP-FVC) can improve Nash-Sutcliffe efficiency coefficient (NSE) by 24.81%, while reduced the root mean squared error (RMSE) and relative error (RE) by 64.08% and 65.77%, respectively. Although the increase in climatic dryness (PET/P) resulted in decreased R, the increase in FVC has also a significant contribution to this decrease due to vegetation restoration. We highlight that decrease precipitation intensity (95pTOT) and frequency (R01mm) amplified the hydrological effects of vegetation restoration, causing a 79.09∼100.31% increase in R compared to the independent impact of changes in FVC. We conclude that the extended time-varying Budyko framework by precipitation regime is more rigorous for quantifying the hydrological effects of ecological restoration under climate change and providing more reliable approach for adaptive watershed management.

Perception of Acceptance and Discrimination Among the LGBTQI + Community in their Churches and its Association with Spiritual Dryness: Findings from a Cross-Sectional Study in Germany.

Data from a cross-sectional survey with options for free text statements revealed that people who identify themselves as part of the LGBTQI+ community (n = 417) experienced both acceptance and discrimination by church members. Their negative experiences affected their relationship with God in terms of spiritual dryness and loss of faith. In regression analyses, the best predictors of life satisfaction and psychological well-being were self-acceptance and low spiritual dryness. This self-acceptance as a resource, mediated the link between spiritual dryness and life satisfaction. Nevertheless, 96% still wish for a church/faith community that welcomes all people-and accepts them as they are and feel.

Awareness and Hygiene Practices Among Contact Lens Wearers: A Population-Based Cross-Sectional Survey.

Background More than 150 million individuals worldwide wear contact lenses (CL) for therapeutic as well as cosmetic purposes. Researchers have linked failure to adhere to CL care instructions with outbreaks of serious eye infections. In the current study, we assess the consequences of inadequate cleanliness as well as awareness of and adherence to appropriate CL hygiene. Methods This is a cross-sectional descriptive study conducted in the Jazan region, southwest Saudi Arabia, during the period between October 2022 and April 2023. Results Out of a total of 718 participants, 391 (54.4%) were wearing CL. Of these, 318 (81.33%) CL wearers were female, while 73 (18.67%) were male. Among the CL wearers, 196 (50%) were aged 24 and younger. The overall knowledge was higher in females, with 320 (74.6%) having a high level of knowledge, compared to 195 (67.5%) males (p-value = 0.044). The level of knowledge was higher in those who had had an eye examination before using CL. Regarding practice, 202 (63.5%) females demonstrated better practices, while only 32 (43.8%) males did (p-value = 0.002). Variations in the adequacy of practice regarding CLs were identified according to the duration of CL use and the risk of suffering from eye dryness (p-values <0.05). Conclusions The participants' overall knowledge and practices were good. This should be encouraged by performing an eye examination before wearing CL and demonstrating good wearing habits in terms of hygiene behavior.

Study of Vulvovaginal Atrophy and Genitourinary Syndrome of Menopause and Its Impact on the Quality of Life of Postmenopausal Women in Central India.

Background Urogenital health is a necessary part of health for all women, especially in the postmenopausal age group. We suspected that the increased incidence of vulvovaginal atrophy (VVA) had some or other effects on the quality of life of older women. So, we aimed to study VVA/genitourinary syndrome of menopause (GSM) and its impact on the quality of life of postmenopausal women in Central India. Despite its significant prevalence and detrimental impact on women's health, VVA/GSM is underdiagnosed and undertreated. In view of the feminization of aging, VVA management is becoming increasingly crucial. This study contributes to postmenopausal women's understanding that keeping their urogenital and sexual longevity is a critical step toward healthy living and gender equality. Given its relationship with urogynecological conditions, this study will help to evaluate both subjectively and objectively the incidence of symptoms related to VVA and its effects on the quality of life of postmenopausal women. This will eventually help to understand the need to address this issue while making postmenopausal women health-related policies. Potential remedies to overcome the obstacles currently preventing patient-HCP interactions addressing sexual health include providing communication tools to facilitate the "uncomfortable" conversation, educating women, and providing enough training for healthcare professionals. Methods The current study was conducted at a rural tertiary healthcare center in Central India and is a cross-sectional study. The study population taken into consideration were all the postmenopausal women between the age group 45 and 75 years with at least one vulvovaginal symptom attending the Outpatient Department (OPD). The total study sample size was 100 women. Further study was conducted by interview method using a questionnaire by the principal investigator. Data was gathered with the help of a pretested questionnaire in the patient's language. Symptoms related to GSM were studied by the vaginal symptom Bothersomeness Scale. Further, a gynecological clinical examination for the confirmation of VVA was carried out, which included a gynecological physical examination. The Vaginal Health Index (VHI) was calculated for each female using the score scale. Assessment of the quality of life of postmenopausal females using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire was performed. Results The majority of females (34%) who presented with the symptoms were in the category of 55-60 years followed by 22% in the age group of 61-65 years. The most common symptoms experienced by females were vaginal dryness (77%) followed by vaginal discharge (74%). Our study confirmed that 79% of the total females included in the study have a VHI score of less than 15, i.e., they suffer from VVA, thus presenting our incidence at 79%. Conclusion According to the surveys discussed in this research, a significant portion of postmenopausal women have symptoms linked to VVA that have a negative impact on their quality of life, including their sexual relationships and self-esteem.

Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.

BACKGROUND: Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness. AIM: This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness. METHODS: A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended. RESULTS: Significant improvements were observed in the FSFI scores, indicating enhanced sexual function (p < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use (p < .001). CLINICAL IMPLICATIONS: This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD. STRENGTHS & LIMITATIONS: In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid. CONCLUSION: This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.

Varenicline solution nasal spray for dry eye disease in Chinese patients: a randomized phase 3 trial.

Background: Dry eye disease has a high prevalence and exerts a significant negative effect on quality of life. In China, there are currently no available nasal sprays to promote natural tear production in patients with dry eye disease. We therefore evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray versus vehicle in Chinese patients with dry eye disease. Methods: This was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 clinical trial conducted at ophthalmology departments in 20 hospitals across China (NCT05378945). Eligible patients had a diagnosis of dry eye disease based on patient symptoms, Eye Dryness Score (EDS), Schirmer's Test (with topical anesthesia) Score (STS), and corneal fluorescein staining (CFS) score. Participants were randomly assigned 1:1 using an Interactive Web Response System (IWRS) to receive OC-01 0.6 mg/mL twice daily (BID) or vehicle nasal spray. Participants, investigators, and sponsor were all masked to treatment assignment. The primary endpoint was the percentage of subjects in the intention-to-treat population achieving ≥10 mm improvement in STS from baseline at week 4. Findings: In total, 340 patients were randomized from 21 July 2022 to 04 April 2023, 78.8% were female. Patients in the OC-01 group (n = 176) had significantly higher achievement of ≥10 mm improvement in STS (35.8% [n = 63] versus 17.7% [n = 29], stratified odds ratio: 2.67, 95% CI: 1.570-4.533, p = 0.0002) and a significantly greater increase from baseline STS (least-squares mean difference [SE]: 3.87 [0.794], p < 0.0001) at week 4 versus the vehicle group (n = 164). In addition, OC-01 led to a numerically greater reduction in mean EDS from baseline at week 4 compared to the vehicle group (LS mean [SE] difference: -1.3 [2.20]; 95% CI: -5.64 to 2.99, p = 0.5467). The most common adverse event was mild, transient sneezing (78% of OC-01 administrations). No serious adverse events related to nasal administration occurred. Interpretation: OC-01 (varenicline solution) nasal spray BID has clinically meaningful efficacy for reducing the signs (as measured by STS) and may improve the symptoms (as measured by EDS) of dry eye disease, with an excellent safety and tolerability profile, in the Chinese population. Funding: Jixing Pharmaceutical Co. Ltd.

Bacterial Vaginosis (BV) and Vaginal Microbiome Disorders in Women Suffering from Polycystic Ovary Syndrome (PCOS).

Introduction: Polycystic ovary syndrome (PCOS) is a multifactorial, heterogeneous endocrine and metabolic disorder in women. Due to its association with the menstrual cycle and fertility disorders, the importance of this problem is emphasized especially in patients of reproductive age. Based on a number of analyses, the effect of PCOS on altering the diversity of the microbiome (e.g., intestinal or vaginal) is suggested. Vaginal dysbiosis can result in BV (bacterial vaginosis). The purpose of this study was to assess the prevalence of BV in patients with PCOS, as well as to determine the most reliable diagnostic factors. Material and Methods: Retrospective analysis of microbiological findings (2018-2022) of PCOS patients (n = 594) of reproductive age. The present analysis focused on the results of patients with PCOS (n = 380) and vaginal discharge with pH ≥ 4.4 and suspected BV. Biological material was a vaginal swab/vaginal secretion. The most commonly used routine methods for assessing BV were the Amsel analysis and the Nugent scoring system. Results: Patients with PCOS and vaginal fluid pH ≥ 4.4 and suspected BV (n = 380) accounted for 64% of all PCOS patients (n = 594). The relationship between pH and detection of "clue cells" showed significant dependency and increased with leukocytes. The pH measurement also showed dependency on high G. vaginalis counts. In addition, the elimination of lactic acid bacteria (LAB) in vaginal secretions was associated with an increase in the number of leukocytes with increasing pH values. A marked increase in G. vaginalis was found in more than half (56.8%) of PCOS women (n = 380) with suspected BV. No dependency was observed between the absence of LAB and the diagnosis of BV on a positive G. vaginalis culture. Of the n = 380 patients with PCOS, 191 (50%) had a Nugent score ≥ 7 positive for BV. No dependency was observed between the number of patients with Candida sp. in vaginal secretions and pH, BV (with clue cells), or elevated leukocyte levels. The LRM was adjusted and the statistical model represented by the following formula was obtained: log(p/(1 - p)) = -1.18 + 1.24 × Group4.6 + 1.08 × Group4.8 + 1.66 × Group5.4. Conclusions: Based on the present analysis, BV appears to be more common in patients with PCOS than in the non-PCOS population. Chronic inflammation in PCOS patients and abnormalities in the vaginal microbiome may predispose to the development of BV. In women with PCOS, BV may be one of the unrecognized causes of infertility or complications of pregnancy. Despite the potential link between PCOS and the development of BV, the extent to which this syndrome contributes to vaginal dysbiosis and reproductive complications requires further study.

Integrated physiology, transcriptome and proteome analyses highlight the potential roles of multiple hormone-mediated signaling pathways involved in tapping panel dryness in rubber tree.

Currently, one of the most serious threats to rubber tree is the tapping panel dryness (TPD) that greatly restricts natural rubber production. Over-tapping or excessive ethephon stimulation is regarded as the main cause of TPD occurrence. Although extensive studies have been carried out, the molecular mechanism underlying TPD remains puzzled. An attempt was made to compare the levels of endogenous hormones and the profiles of transcriptome and proteome between healthy and TPD trees. Results showed that most of endogenous hormones such as jasmonic acid (JA), 1-aminocyclopropanecarboxylic acid (ACC), indole-3-acetic acid (IAA), trans-zeatin (tZ) and salicylic acid (SA) in the barks were significantly altered in TPD-affected rubber trees. Accordingly, multiple hormone-mediated signaling pathways were changed. In total, 731 differentially expressed genes (DEGs) and 671 differentially expressed proteins (DEPs) were identified, of which 80 DEGs were identified as putative transcription factors (TFs). Further analysis revealed that 12 DEGs and five DEPs regulated plant hormone synthesis, and that 16 DEGs and six DEPs were involved in plant hormone signal transduction pathway. Nine DEGs and four DEPs participated in rubber biosynthesis and most DEGs and all the four DEPs were repressed in TPD trees. All these results highlight the potential roles of endogenous hormones, signaling pathways mediated by these hormones and rubber biosynthesis pathway in the defense response of rubber trees to TPD. The present study extends our understanding of the nature and mechanism underlying TPD and provides some candidate genes and proteins related to TPD for further research in the future.

Real­world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.

Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.