Background. Sleep complaints are common health issues in the general population. These conditions are associated with poorer physical and psychological activity, and they may have important social, economic, and personal consequences. In the last years, several food supplements with different plant extracts have been developed and are currently taken for improving sleep. Study Objectives. The aim of this study is to systematically review recent literature on oral plant extracts acting on sleep disorders distinguishing their action on the different symptoms of sleep complaints: difficulty in initiating or maintaining sleep, waking up too early, and quality of sleep. Methods. We searched the PubMed database up to 05/03/2020 based on data from randomized, double-blind, placebo-controlled trials, noncontrolled trials, and cohort studies conducted in children and adult subjects. The search words used contained the following terms: oral food supplement and sleep disorders and the like. The most studied compounds were further analyzed with a second search using the following terms: name of the compound and sleep disorders. We selected 7 emerging compounds and 38 relevant reports. Results. Although nutraceutical natural products have been used for sleep empirically, there is a scarcity of evidence on the efficacy of each product in clinical studies. Valerian and lavender were the most frequently studied plant extracts, and their use has been associated (with conflicting results) with anxiolytic effects and improvements in quality and duration of sleep. Conclusions. Sleep aids based on plant extracts are generally safe and well tolerated by the population. More high-quality research is needed to confirm the effectiveness of food supplements containing plant extracts in sleep complaints; in particular, it would be interesting to evaluate the association between plant extracts and sleep hygiene guidelines and to identify the optimal products to be used in a specific symptom of sleep complaint, giving more appropriate tools to the medical doctor.

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Background The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment. Objective This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV. Methods The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at least 2 episodes of RBV in the last 12 months. The trial includes 2 phases. In the first phase (according to an open-label noncontrolled design), the treatment involving PLGG is administered for 3 cycles and is followed by a 1-month period of follow-up without treatment. In the second phase, a 9-month follow-up period is envisaged. Thus, for each patient, a 10-month follow-up period without treatment is planned. The study involves 5 centers (2 in Italy and 3 in Romania). We calculated a sample size of 44 pairs to achieve a power of 80% and a 1-sided significance of 5% for detecting a difference of 0.25 between marginal proportions, in comparison with the mean recurrence rate of BV reported in the medical literature. We estimated a potential dropout rate of 20%, and thus, we decided to enroll 55 patients (1-group chi-square test). Results The study received ethics approval in 2016 in Romania and 1 year later in Italy. Recruitment started in September 2016. An interim analysis was performed in 2019, and full study analysis results are expected in July 2023. Conclusions The tested medical device involving PLGG could modify the mechanisms involved in the pathogenesis of BV and could improve microbiological parameters owing to the acidifying effect on vaginal pH. We believe that the findings of our study could be useful for other investigators who want to test different products against RBV using a standardized protocol and standardized procedures. Trial Registration ClinicalTrials.gov NCT02863536; https://clinicaltrials.gov/ct2/show/NCT02863536 International Registered Report Identifier (IRRID) RR1-10.2196/42787

14Several risk factors have been identified but the etiology and pathogenesis of Bacterial 15 vaginosis (BV) are still not completely understood, and the recurrence rate of BV remains 16 high despite adequate chemotherapy treatment. 17 The primary objective of the study was to assess the effectiveness of a new vaginal 18 medical device, which contains polycarbophil, 0.04 % lauryl glucoside, and glycerides 19 (Polybactum ® -Effik Italia), in reducing BV recurrence rate. 20 This was a multicenter, open label, not comparative study performed in Italy and Romania. 21 Female subjects over 18-years-old affected by recurrent BV were included. The latest 22 episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated 23 with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The 24 recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum ® 25 vaginal ovules, day 1-4-7, were started within the 12th and the 24th hr after the end of 26 metronidazole therapy and repeated monthly for 3 cycles. 27 The first 41 patients enrolled were evaluated for an interim analysis 6 months after the 28 study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The 29 recurrence rate was significantly reduced compared to previous published data (10.26% vs 30 40% p<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal 31 flora performed by phase contrast microscopy evidenced a significant improvement form 32 baseline (p=0.022) The Investigator global assessment of tolerability was excellent in 38 33 out of 39 cases. 34 IMPORTANCE 35 Bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing 36 age. In BV, Lactobacillus species, which are predominant in a healthy vaginal flora, are 37 replaced by anaerobes, mainly Gardnerella vaginalis. BV is responsible for more than 60% 38 of vulvovaginal infections and has been linked to serious, potentially life-threatening 39 3 conditions, including: pelvic inflammatory disease, postoperative infections, acquisition and 40transmission of the human immunodeficiency virus, preterm birth, and several adverse 41 pregnancy outcomes. Our research showed that 3 monthly cycles of Polybactum ® ovules 42 administered after one course of metronidazole vaginal therapy can reduce the rate of 43 Bacterial vaginosis recurrence and improve the vaginal milieu, favouring the growth of 44 vaginal lactobacillus species. Taken together our results confirm that Polibactum ® is a 45 safe and effective treatment to reduce BV recurrence rate after a first line therapy with 46 metronidazole. 47 48 49 Bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing 50 age (1). In BV, Lactobacillus species, which are predominant in a healthy vaginal flora, are 51 replaced by anaerobes, mainly Gardnerella vaginalis, but also Atopobium vaginae, 52 Mobiluncus mulieris, Prevotella bivia, and Fusobacterium nucleatum. 53 BV is responsible for more...

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