Mininvasive Cytoreduction Surgery plus HIPEC for Epithelial Ovarian Cancer: A Systematic Review.

Background and objectives: The Gold-Standard treatment for Advanced Epithelial Ovarian Cancer remains cytoreductive surgery followed by systemic chemotherapy. Surgery can be performed either by an open or minimally invasive approach (MIS), although the former remains the most widely used approach. Recently, Van Driel et al. proved that adding 100 mg/m2 of Cisplatin in Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Interval Debulking Surgery (IDS) gives a disease-free survival (DFS) advantage. Similarly, Gueli-Alletti et al. demonstrated how the MIS approach is feasible and safe in IDS. Moreover, Petrillo et al. reported pharmacokinetic profiles with a higher chemotherapy concentration in patients undergoing HIPEC after MIS compared with the open approach. Therefore, the following review investigates the oncological and clinical safety consequences of the association between MIS and HIPEC. Methods: Following the recommendations in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, we systematically searched the PubMed and Scopus databases in April 2022. Studies containing data about oncological and safety outcomes were included. We registered the Review to the PROSPERO site for meta-analysis with protocol number CRD42022329503. Results: Five studies fulfilled inclusion criteria. 42 patients were included in the review from three different Gynecological Oncological referral centers. The systematic review highlighted a Recurrence Rate ranging between 0 and 100%, with a 3-year Platinum-Free Survival between 10 and 70%. The most common HIPEC drug was Cisplatin, used at concentrations between 75 and 100 mg/m2 and at an average temperature of 42 °C, for 60 to 90 min. Only 1 Acute Kidney Insufficiency has been reported. Conclusions: The scarcity of clinical trials focusing on a direct comparison between MIS and the open approach followed by HIPEC in EOC treatment does not make it possible to identify an oncological advantage between these two techniques. However, the safety profiles shown are highly reassuring.

Vitamin D and Male Reproduction: Updated Evidence Based on Literature Review.

The purpose of this study was to clarify the vitamin D (VD) effect on male infertility. Our research was conducted using the following electronic databases: MEDLINE, Embase, Web of Science, Scopus, ClinicalTrials.gov, and Cochrane Library. Selection criteria included all published randomized controlled trials and non-randomized studies, focusing on vitamin D and male reproductive function. The results showed that the effects of VD on male reproduction has been investigated in three different topics: the molecular mechanism underlying VD effects on semen quality (SQ), the relationship between VD levels and SQ, and the effect of VD supplementation on SQ. Results supported the hypothesis of a relevant interrelation between concentrations of male VD and semen parameters, with particular reference to sperm motility; on the contrary, evidence on the effect of VD on male sex steroid hormone levels was inconclusive. The results of this review hold up the thesis that VD plays a role in male reproduction. Most of the data highlighted a positive effect on semen quality, particularly in sperm motility, both in fertile and infertile men. Additional dedicated studies are required to elucidate the still controversial aspects of this topic.

Safety of non-hormonal medications for managing hot flashes.

INTRODUCTION: Menopausal complaints are a critical aspect of women's lives. In particular vasomotor symptoms, such as hot flashes, may seriously impact quality of life and are considered the most bothersome complaint by patients. Although Menopausal Hormone Therapy (MHT) is considered the best option, women increasingly ask for a natural and more tailored treatment approach. AREAS COVERED: Nutraceutical compounds represent the most widespread alternative therapy for vasomotor symptoms, and their use is somewhat increasing. In this review, the authors analyzed the mechanism of action and the related safety of non-hormonal treatments, including new approaches and future aspects. EXPERT OPINION: MHT represents the traditional therapy for menopausal complaints, especially for severe and moderate symptoms; however, evidence has not defined a safety profile for all patients. To address this issue, nutraceuticals could represent a compelling and useful non-hormonal approach in selected patients.

The Medical Training Evaluation Questionnaire (MeTrE-Q): a multidimensional self-report instrument for assessing the quality of midwifery students' education.

This study aims to understand the factors that can hinder Italian midwifery students' educational process, what messages are given to students during their clinical practice, and how students interact with tutors and other professionals. Seven hundred and eighty Italian students of midwifery were asked to answer an Internet-based questionnaire regarding their own opinions concerning their theoretical-practical formative path. For male Italian students, satisfaction is lower than female students as well as for students from Southern than Northern Italy. Students are dissatisfied with the quality of their academic and practical training, particularly regarding recognising their professional role and their relationship with tutors. Based on these data, it is essential to design a formative path for midwives that considers students' opinions and the positive experiences of other countries.Impact StatementWhat is already known on this subject? Several studies underscore the poor preparation of students for learning in clinical settings. The current reality of the Italian academic path in most universities disregards midwifery students' expectations and formative needs.What do the results of this study add? For male Italian students, satisfaction is lower than for female students and students from Southern than Northern Italy. Students are dissatisfied with the quality of their academic and practical training, particularly regarding recognising their professional role and their relationship with tutors.What are the implications of these findings for clinical practice and/or further research? It is essential to design a formative path for midwives that considers students' opinions and other countries' positive experiences.

Non-hormonal Treatments For Menopausal Symptoms and Sleep Disturbances: A Comparison Between Purified Pollen Extracts and Soy Isoflavones.

BACKGROUND: Besides hot-flushes, sleep disturbances increase around menopause, impacting on the quality of life. When hormone replacement therapy is contraindicated, it is necessary to provide alternative treatments. OBJECTIVES: This study aimed to observe the effects of an herbal remedy from pollen extracts and soy isoflavones for menopausal complaints, particularly on sleep disorders. METHODS: A six-month prospective observational study was performed in women in natural menopause suffering from menopausal symptoms and sleep disturbances. Three groups were compared: 57 women receiving two tablets/ day containing herbal remedy from pollen extracts (group A), 60 women receiving one tablet/day containing isoflavones 60 mg (group B), 47 women not receiving any treatment (group C). At 3 (T3) and 6 months (T6), the daily number of hot-flushes, Kupperman index for menopausal symptoms, the Pittsburgh Sleep Quality Index (PSQI) test were assessed. RESULTS: Both groups A and B showed a significant improvement of hot flushes (p<0.001) and Kuppermann Index (p<0.001) from T0 to T3 and from T0 to T6. No significant differences between treatment groups were found at T3, while at T6 group A showed greater decrease of daily hot flashes and better improvement of Kupperman Index as compared to group B (respectively, -48.8% versus -18.4% and -24.4% versus -15.4%; p<0.001). Improvement of global sleep quality was more evident in the pollen treated group compared to isoflavones group at both three (-24.7% versus -9.3%, p<0.001) and six (-52.9% vs -4.0%; p<0.001) months, mainly for the scores related to subjective sleep quality, sleep latency and habitual sleep efficiency. CONCLUSION: Non-hormonal treatments can effectively be used in symptomatic menopausal women: among these, after six months of treatment, pollen extracts might achieve a better improvement of hot flushes, sleep disturbances and menopause-related symptoms than soy isoflavones. Herbal remedy from pollen extracts is mainly effective when the quality of sleep is the most disturbing complaint.

Vitamin D and Gestational Diabetes Mellitus: Is There a Link?

Gestational diabetes mellitus (GDM) is a very common condition among pregnant women worldwide with important metabolic implications on the mother and the offspring. Vitamin D status has been suggested to potentially play a role in GDM risk with no documented consequences for the offspring. The purpose of this article was to review currently available evidence on the relationship between vitamin D and GDM. Current evidence shows an association between vitamin D blood levels and risk of GDM, despite heterogeneity of results across studies limit the conclusions. Moreover, data from randomized controlled trials is scarce and resulting in null findings. Among the limitations to be noted, improving the standardization of dosages, the characteristics of individuals in the sample, and the appropriate outcome measurement could provide a more effective approach in understanding the relationship between vitamin D and GDM. In conclusions, despite observational studies may suggest that adequate vitamin D levels may decrease the risk of GDM compared to deficiency status, evidence from clinical trials is inadequate to draft any definitive conclusion regarding its supplementation. Future better designed randomized clinical trials taking into account a more integrated approach could provide clearer and definitive data on the outcomes of such a multifactorial condition.

A Nutraceutical Approach to Menopausal Complaints.

The menopausal transition, or perimenopause, is characterized by menstrual irregularities, vasomotor symptoms, sleep disturbances, mood symptoms, and urogenital tract atrophy. These changes can also affect the quality of life and one's self-esteem. Hormone replacement therapy (HRT) is considered the best option to achieve therapeutic relief of different menopausal symptoms but is usually restricted to moderate or severe symptoms. Moreover, many women refuse HRT for a variety of reasons concerning the fear of cancer and other adverse effects. According to these considerations, new topics are emerging: Dissatisfaction with drug costs and conventional healthcare, desire for personalized medicines, and the public perception that "natural is good". In this context, nonhormonal therapies are mostly evolving, and it is not unusual that women often request a "natural" approach for their symptoms. The aim of this study is to investigate nonhormonal therapies that have been identified to reduce the menopausal symptoms.

Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness.

The effectiveness for vasomotor symptoms and sleep disorders plus the long-term safety of a nutraceutical combination of agnus-castus and magnolia extracts combined with soy isoflavones (SI) and lactobacilli were assessed in postmenopausal women. A controlled study was carried out in menopausal women comparing this nutraceutical combination (ESP group) with a formulation containing isoflavones alone (C group) at the dosage recommended. The Kuppermann index, The Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36) were determined at baseline, three, six and 12 months. Endometrial thickness, mammary density and liver function were evaluated at baseline and after 12 months. One hundred and eighty women were enrolled in the study (100 in the ESP group and 80 in the C group). At the end of the treatment, mammary density, endometrial thickness, and hepatic function did not show substantial differences between groups. The Kuppermann index and particularly the tendency for hot flashes progressively and significantly decreased in frequency and severity during ESP versus C treatment. At the same time, a significant increase in sleep quality and psychophysical wellness parameters was observed in the ESP versus C groups. No adverse events were observed. Agnus-castus and magnolia, combined with SI + lactobacilli, can effectively and safely be used in symptomatic postmenopausal women, mainly when quality of sleep is the most disturbing complaint. The endometrium, mammary glands and liver function were unaffected after 12 months of treatment.

Endometrial, breast and liver safety of soy isoflavones plus Lactobacillus sporogenes in post-menopausal women.

OBJECTIVE: To assess the safety of a nutraceutical compound containing soy isoflavones and Lactobacillus sporogenes on endometrium, breast and liver function. SETTING: Outpatient Menopausal Clinic. STUDY DESIGN: 130 healthy postmenopausal women suffering from menopausal symptoms were randomized to receive soy isoflavones 60 mg and Lactobacillus sporogenes 1 billion spores (group E: 65 women) or calcium and vitamin D3 (group C: 65 women). Safety of the treatment was assessed at baseline and after 1 year taking into account endometrial thickness, mammographic density, serum levels of transaminases, γ-GT and bilirubin. Efficacy of the treatment was evaluated rating the score of menopausal symptoms at baseline and every 3 months. The statistical analysis was carried out with χ², Fisher exact's test and ANOVA. RESULTS: After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups, while menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D3. CONCLUSION: A 12 months treatment with a nutraceutical compound based on isoflavones and Lactobacillus sporogenes at the recommended doses is safe for endometrium, mammary glands and liver function in postmenopausal women.

Recombinant human FSH reduces sperm DNA fragmentation in men with idiopathic oligoasthenoteratozoospermia.

A prospective randomized controlled study was designed to evaluate the effects of recombinant human follicle-stimulating hormone (rFSH) treatment on sperm DNA fragmentation in men with idiopathic oligoasthenoteratozoospermia (iOAT). One hundred twenty-nine men with sperm count less than 10 × 10(6) spermatozoa/mL and forward motility <25% were included; normal serum levels of FSH, luteinizing hormone (LH), and testosterone, and no other causes of infertility were enrolled. The patients were randomized into 2 groups: 65 men were treated on alternate days for 90 days with injections of 150 IU rFSH, and 64 subjects received nonantioxidant vitamin supplements. Main outcome measures were serum levels of FSH, LH, testosterone, and inhibin B and DNA fragmentation index (DFI) at baseline and after 90 days. No significant differences were observed between the 2 groups with regard to sperm parameters and hormone values. The DFI was similar between the 2 groups at the time of the enrollment but reduced significantly (P < .05) after rFSH therapy in study group, whereas no significant variation occurred in the control group. In the subgroup of patients with high basal DFI values (>15%), rFSH treatment significantly increased DFI (P < .01), whereas no significant variation occurred after 90 days of vitamin supplements. We conclude that rFSH administration improves sperm DNA integrity in iOAT men with increased DFI values. The degree of sperm DFI might be useful to identify those iOAT patients in which rFSH treatment can be advantageous.

Effectiveness of the association micronized N-Palmitoylethanolamine (PEA)-transpolydatin in the treatment of chronic pelvic pain related to endometriosis after laparoscopic assessment: a pilot study.

OBJECTIVE: Aim of our study was to evaluate the effectiveness of the association between N-Palmitoylethanolamine and transpolydatin in the management of chronic pelvic pain related to EMS. STUDY DESIGN: This was a randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 61 subjects, submitted to a first line laparoscopic conservative surgery, who were randomized into 3 groups receiving: group A (n=21) the association N-Palmitoylethanolamine-transpolydatin 400 mg + 40 mg twice a day for 3 months; group B (n=20) the placebo for 3 months; group C (n=20) a single course of Celecoxib 200mg twice a day for 7 consecutive days. Assessments of the severity of pelvic endometriosis (pelvic pain, dysmenorrhoea and dyspareunia) were recorded before and after treatment on a questionnaire and a 10-point VAS. Differences between groups were verified with Kruskal-Wallis ANOVA for non-parametric multiple comparisons. RESULTS: A marked decrease in dysmenorrhoea, dyspareunia and pelvic pain was observed in all groups, and the association between N-Palmitoylethanolamine and transpolydatin resulted to be more effective than placebo (P<.001). Additionally, the treatment with Celecoxib resulted in a decrease in pelvic pain more effective either than the association N-Palmitoylethanolamine and transpolydatin or placebo. CONCLUSION: These preliminary results show that the association between micronized N-Palmitoylethanolamine and transpolydatin is effective in the management of pelvic pain related to endometriosis after laparoscopy. Additionally, this association seems to be safe, shows an optimal control of pain and can be used in patients who are unable to receive other therapies.

Long-term effects of oral and transdermal hormone replacement therapy on plasma homocysteine levels.

OBJECTIVE: To compare the long-term effects of oral and transdermal hormone replacement therapy (HRT) on serum homocysteine levels in postmenopausal women. DESIGN: An open, prospective, controlled study. Seventy-five healthy postmenopausal women were recruited as eligible for the study. Fifty women seeking HRT were randomized to receive continuous 17beta-estradiol, either by oral (2 mg daily; n = 25) or transdermal (50 microg daily; n = 25) administration, plus 10 mg dydrogesterone daily for 14 days of each 28-day cycle. Twenty-five women unwilling to receive hormone treatment received only calcium supplementation, representing the control group. Fasting blood samples were analyzed at baseline and then after 6, 12, and 24 months to determine plasma homocysteine levels. RESULTS: Fifty-nine women completed the study. After 6 months of therapy, homocysteine concentrations showed a statistically significant reduction in the treated groups versus both baseline and controls, and no further significant variations were found thereafter. The mean reduction in the homocysteine levels throughout the study was 13.6% in the oral and 8.9% in the transdermal group, respectively, without significant difference between the two routes of estradiol administration. Women with the highest baseline levels of homocysteine experienced the greatest reduction. No significant variations in homocysteine concentrations were found in the control group. CONCLUSIONS: Oral and transdermal estradiol sequentially combined with dydrogesterone shows comparable effectiveness in reducing plasma homocysteine levels in postmenopausal women. Women with the highest pretreatment concentrations of homocysteine benefit the most by the lowering effect of HRT.