Dietary Supplementation of Myo-Inositol, Cocoa Polyphenols, and Soy Isoflavones Improves Vasomotor Symptoms and Metabolic Profile in Menopausal Women with Metabolic Syndrome: A Retrospective Clinical Study.

Background and Objectives: Hormonal changes physiologically occurring in menopausal women may increase the risk of developing metabolic and vasomotor disturbances, which contribute to increase the risk of developing other concomitant pathologies, such as metabolic syndrome (MetS). Materials and Methods: Retrospective data from 200 menopausal women with MetS and vasomotor symptoms taking one sachet per day of the dietary supplement INOFOLIC® NRT (Farmares srl, Rome, Italy) were collected. Each sachet consisted of myo-Inositol (2000 mg), cocoa polyphenols (30 mg), and soy isoflavones (80 mg, of which 50 mg is genistin). Patients recorded their symptoms through a medical questionnaire at the beginning of the administration (T0) and after 6 months (T1). Results: We observed an improvement in both the frequency and the severity of hot flushes: increased percentage of 2-3 hot flushes (28 at T0 vs. 65% at T1, p value < 0.001) and decreased percentage of 4-9 hot flushes (54% at T0 vs. 18% at T1, p value < 0.001). Moreover, symptoms of depression improved after supplementation (87% at T0 vs. 56% at T1 of patients reported moderate depression symptoms, p value < 0.001). Regarding metabolic profile, women improved body mass index and waist circumference with a reduction in the percentage of overweight and obesity women (88% at T0 vs. 51% at T1, p value = 0.01; 14% at T0 vs. 9% at T1, p value = 0.04). In addition, the number of women suffering from non-insulin dependent diabetes reduced (26% at T0 vs. 16% at T1, p value = 0.04). Conclusions: These data corroborate previously observed beneficial effects of the oral administration of myo-Inositol, cocoa polyphenols, and soy isoflavones against menopausal symptoms in the study population. Considering the promising results of the present study, further prospective controlled clinical trials are needed to deeply understand and support the efficacy of these natural compounds for the management of menopausal symptoms.

Efficacy of a Novel Rigenase® and Polyhexanide (Fitostimoline® Septagel) Hydrogel Device for the Treatment of Vulvovaginitis Symptoms: Cross-Sectional Analysis of a National Survey and Prospective Observational Study.

Background and Objectives: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey gynecologists about their habits regarding the treatments of the pathology and to evaluate the efficacy of a novel vaginal hydrogel composed of wheat extracts and polyhexanide aimed at reducing vulvovaginitis symptomatology. Materials and Methods: A cross-sectional analysis of a national survey using 155 Italian gynecologists and a prospective, open-label, observational study were carried out in 75 outpatient clinics across Italy. Pre- and postmenopausal women with suspicion of vulvovaginitis due to at least four of the following symptoms (leucoxanthorrhea, bad odor from genitalia, vulvovaginal dryness, petechiae, burning, and pruritus) while waiting for microbiological swab analysis were included and treated with one hydrogel application every 3 days for 1 week. Primary endpoint was the complete resolution of symptomatology. Results: The pre-study survey reported that, for most clinicians, local or oral treatment (65.7% and 82.8%, respectively) with antibiotics or antifungals is used very often. Therefore, we proceeded to carry out an observational study. Overall, 615 (362 of fertile age and 253 in postmenopause) women were included in this study. At the 28th follow-up examination, complete resolution of symptomatology was achieved in 578/615 (94.1%; p < 0.001) within 12.72 ± 6.55 and 13.22 ± 6.33 days for those of fertile age and in postmenopause, respectively (p = 0.342). All of the evaluated symptoms were significantly reduced after treatment (p = 0.001) without differences according to the patient's menopausal status. A slightly significant reduction in Gardnerella Vaginalis (p = 0.040) and Candida Albicans (p = 0.049) was found after treatment. No patient reported side effects, adverse reactions, or discontinued therapy. Conclusions: This pilot study showed that a hydrogel based on Rigenase® (wheat extract) and polyhexanide could be a promising treatment for the relief of vulvovaginitis symptoms. However, these results are limited by the absence of a control group. Additional comparative and randomized controlled trials between the hydrogel and other non-antibiotic devices as well as local antibiotic therapy should be performed to increase the validity of the findings.

Late-onset fetal growth restriction management: a national survey.

BACKGROUND: Fetal growth restriction (FGR) is an obstetric condition that increases the risk of adverse neonatal outcomes. FGR antenatal care aims to decrease fetal morbidity and mortality through optimal fetal monitoring. However, no univocal strategies for late-onset FGR outpatient management are available, and this survey investigated gynaecologists' attitudes concerning outpatient frequency tests. METHODS: We mailed a survey to 429 Italian gynaecologists. The primary purpose was the ambulatory care of late-onset FGR without doppler alterations evaluation. The queries estimated the self-reported medical practice regarding cardiotocography (CTG) and obstetric ultrasound exams before hospitalization. Statistical analysis was performed with Stata 14.1 (Stata corp., College Station, TX, USA) for symmetrically distributed continuous variables, and the mean differences were analyzed using the t-test. Where appropriate, the proportions between the groups were evaluated using Fisher's exact or Chi-square test. P values <0.05 were considered statistically significant. RESULTS: 128 responses (29.8%) from the 429 SCCAL members were available for the survey. 39.9% of respondents had a late FGR standardized protocol. Regarding non-severe FGR with normal fetal doppler, 70.8% suggested a fetal doppler study after one week (92/128), 13.8% (18/128) and 6.9% (9/128) proposed the exam, respectively, two and three times for a week. 0.8% (1/128) of respondents had a daily doppler exam, 7.7% (10/128) did not answer, and 3.1% (4/128) repeated the ultrasound exam to time for a week. The antenatal CTG was offered: 70.8% (92/128) of gynaecologists recommended one weekly CTG, whereas 13.8% (18/128) suggested two. 6.9% (9/128) recommended three weekly tests and 0.8% a daily test. 7.7% (10/128) of gynaecologists did not respond. At least, we investigated the gynaecologist's recommendations for outpatient EFW evaluation: 59.4% (76/128) repeated EFW after two weeks, 31.3% (40/128) after one week. 3.9% (4/128) and 3.1 (4/128) recommended EFW after three weeks and twice a week. CONCLUSIONS: Gynaecologists recommend unnecessary cardiotocography and ultrasound Doppler exams for non-severe late-onset FGR with normal doppler. However, additional studies and comprehensive surveys are needed to support a standardized protocol and assess the feto-maternal outcomes impact.

Prevention and treatment of cystitis during menopause: efficacy of a nutraceutical containing D-mannose, inulin, cranberry, bearberry, Olea europaea, Orthosiphon and Lactobacillus acidophilus.

AIM OF THE STUDY: To evaluate the efficacy of a nutraceutical compound containing Uticlin® (D-mannose, cranberry, bearberry, Olea europaea), inulin, Orthosiphon and Lactobacillus acidophilus, in preventing recurrent urinary tract infections (UTIs) in menopausal women. MATERIAL AND METHODS: This was a prospective cohort study of menopausal women recruited with a history of recurrent UTIs in the previous twelve months and who intended to treat their bladder problem without the use of antibiotics and/or anti-inflammatories. Women were proposed the use of an oral nutraceutical compound. The drug was taken for ten days, every month. Women were assigned to two parallel cohorts: patients using (group 1) or not using (group 2) this nutraceutical compound. The primary objective of the study was to evaluate the number of women with less than two infective episodes in the 6-month follow-up and less than three episodes in the 12-month follow-up. The secondary endpoints were to evaluate the reduction of related symptoms at 12-month follow-up, according to the Visual Analog Scale (VAS). RESULTS: At 6 months of therapy, the reduction in the number of patients with ≥ 2 UTIs was statistically significant (p < 0.05) compared to baseline only in group 1. At 12 months, the number of patients who were disease-free was significantly higher (p < 0.05) in group 1 compared to group 2. Moreover, the improvement of related symptoms was statistically significant (p < 0.05) in group 1, as shown by the reduction in the VAS scale value. CONCLUSIONS: In menopausal women, the combination of D-mannose, inulin, cranberry, bearberry, Olea europaea, Orthosiphon and Lactobacillus acidophilus SGL 11 per os represents a useful therapy for recurrent UTIs in women wanting a natural approach.

Efficacy of food supplement Acidif plus® in the treatment of uncomplicated UTIs in women: a pilot observational study.

BACKGROUND: Urinary tract infections (UTIs) are among the most common bacterial infection diagnosed in women. The standard therapy is represented by short course of anti-microbial treatment to eradicate causative pathogens. However, due to antibiotic treatment, normal microbiota of the gastrointestinal tract is at risk of depletion and prolonged use of antibiotics can lead to the development of resistant strains. The aim of this pilot study was to assess the efficacy of Acidif plus®, a novel preparation containing L-Methionine, Boswellia serrata and Hibiscus sabdariffa, in the treatment of UTIs in women, in comparison with standard antibiotic treatment with fosfomycin. METHODS: We performed a pilot clinical study with 88 patients with uncomplicated UTIs treated in ambulatory care clinics. The subjects recruited in the study were divided into two groups: the treatment group included 57 patients with both symptomatic and asymptomatic uncomplicated, bacteriuria-positive UTIs, who were treated by oral administration of Acidif plus® two tablets per day (1 tablet in the morning and 1 tablet in the evening) for 7 days. The control group included 31 patients with both symptomatic and asymptomatic bacteriuria-positive uncomplicated UTIs, treated with fosfomycin for two consecutive days. Clinical improvement of symptoms and urine bacteriuria were evaluated as treatment outcomes. RESULTS: More than 50% of Acidif plus® treated patients were free of symptoms of UTIs at the end of the treatment regime. In addition, Acidif plus® treatment was effective in eliminating the bacterial infection in the post-treatment urine cultures in more than 85% of the patients. CONCLUSIONS: In this study Acidif plus® treatment in patients with uncomplicated UTIs was found to be non-inferior to the standard antibiotic therapy. In acute setting, Acidif plus® was shown to be even more effective in alleviating the symptoms than fosfomycin and in eliminating bacteria in urine cultures. It is therefore possible to propose Acidif plus® as a potential alternative option to reduce the problem of multi-drug resistance in urinary infections.

Effect of a Food Supplement Containing L-Methionine on Urinary Tract Infections in Pregnancy: A Prospective, Multicenter Observational Study.

OBJECTIVE: Adjuvants or alternatives to antibiotics in urinary tract infections (UTIs) during pregnancy seem advisable because of possible fetal stress. The present study assessed the effectiveness of a food supplement containing L-methionine and Hibiscus sabdariffa L. and Boswellia serrata Roxb. extracts as a treatment for symptomatic UTIs in pregnancy. DESIGN: Pregnant patients with symptomatic cystitis were screened for UTIs in three different clinical centers. Those unwilling to take antibiotics were offered two alternative treatments: (A) a 1-week treatment with the food supplement or (B) a week in which they were advised to increase their fluid consumption to more than 1.5 L daily. After 1 week, group B patients who still had positive urine cultures (UCs) or had no UC performed took the food supplement for an additional week. UCs were performed on all patients at the first visit (w0) and on most of them at 7 days (w1). Patients who were still positive at w1 or had no UC performed at w1 had UC performed 14 days (w2) thereafter. RESULTS: Of 264 pregnant women enrolled, 216 joined group A, while 48 joined group B. At w1, 70.0% of group A patients and 43.2% of those in group B had negative UCs (p = 0.003). The reduction of bacterial load was 42.2% ± 8.0% and 4.5% ± 9.2%, respectively (p < 0.0001). At w1, symptoms disappeared in 135 patients (62.5%) in group A and 22 patients (45.8%) in group B (p = 0.03). At w2, 30 of 32 group B patients who switched to taking the supplement for the second week had negative UCs, including 20 who had been positive at w1. At w2, all group A patients had negative UCs. No side effects were reported. CONCLUSIONS: The food supplement provided effective treatment and might be an adjuvant or alternative to antibiotic therapy of symptomatic UTI in pregnancy.