Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

BACKGROUND: Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. METHODS: Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. RESULTS: The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. CONCLUSIONS: In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.

Going Vegan for the Gain: A Cross-Sectional Study of Vegan Diets in Bodybuilders during Different Preparation Phases.

Numerous athletes compete at a high level without consuming animal products; although a well-planned vegan diet might be appropriate for all stages of the life cycle, a few elements need to be addressed to build a balanced plant-based diet for an athlete, particularly in bodybuilding, in which muscle growth should be maximised, as athletes are judged on their aesthetics. In this observational study, nutritional intakes were compared in a cohort of natural omnivorous and vegan bodybuilders, during two different phases of preparation. To this end, 18 male and female bodybuilders (8 vegans and 10 omnivores) completed a food diary for 5 days during the bulking and cutting phases of their preparation. A mixed-model analysis was used to compare macro- and micronutrient intakes between the groups in the two phases. Both vegans and omnivores behaved similarly regarding energy, carbohydrate, and fat intakes, but vegans decreased their protein intake during the cutting phase. Our results suggest that vegan bodybuilders may find difficulties in reaching protein needs while undergoing a caloric deficit, and they might benefit from nutritional professionals' assistance to bridge the gap between the assumed proteins and those needed to maintain muscle mass through better nutrition and supplementation planning.

A Practical Perspective on the Use of Botanicals During the COVID-19 Pandemic: From Proven to Potential Interactions.

In this review, we examined the top 10 nutraceutical products sold in Italian pharmacies and parapharmacies as well as hypermarkets and supermarkets; in the first, three product categories saw the greatest increase in sales (vitamins and minerals, immunostimulants, and sleep products) for the 12-month period between October 2019 and October 2020 (including first pandemic wave of SARS-CoV-2). We are investigating their respective formulas and isolating the botanicals that are used to make them. Many of these products have undergone preclinical and clinical studies. We performed a systematic literature search in the MEDLINE database using PubMed and Google Scholar from November 15, 2020 to December 15, 2020 (including studies carried out between 1980 and 2020). The search terms that were used included the complete name of the medicinal plant in English or Latin and the terms "cytochrome" or "drug interactions," crossing, respectively, the Latin name and English common names with "cytochrome" and "drug interactions." The search included in vitro and in vivo studies describing the effects of interaction between the plant (extract or botanical medicine) and human cytochromes. Despite their great complexity, there is decidedly limited clinical data on botanical medicine. In fact, of the 28 botanicals that were examined, only 2 (Citrus paradisi and Rhodiola rosea) show in vivo pharmacological interactions in human subjects. On the contrary, for the other botanicals, there is only weak evidence of dubious clinical significance or potential interactions shown in animal models or in vitro without clinical confirmation. This study provides a rational assessment of the most widely used products, including those used in self-medication, to simplify patient management during the COVID-19 health emergency.

Nutraceuticals and Herbal Food Supplements for Weight Loss: Is There a Prebiotic Role in the Mechanism of Action?

Numerous nutraceuticals and botanical food supplements are used with the intention of modulating body weight. A recent review examined the main food supplements used in weight loss, dividing them according to the main effects for which they were investigated. The direct or indirect effects exerted on the intestinal microbiota can also contribute to the effectiveness of these substances. The aim of this review is to evaluate whether any prebiotic effects, which could help to explain their efficacy or ineffectiveness, are documented in the recent literature for the main nutraceuticals and herbal food supplements used for weight loss management. Several prebiotic effects have been reported for various nutraceutical substances, which have shown activity on Bifidobacterium spp., Lactobacillus spp., Akkermansia muciniphila, Faecalibacterium prausnitzi, Roseburia spp., and the Firmicutes/Bacteroidetes ratio. Different prebiotics have beneficial effects on weight and the related metabolic profile, in some cases even acting on the microbiota with mechanisms that are completely independent from those nutraceuticals for which certain products are normally used. Further studies are necessary to clarify the different levels at which a nutraceutical substance can exert its action.

Role of a berberine-based nutritional supplement in reducing diarrhea in subjects with functional gastrointestinal disorders.

BACKGROUND: Berberine, an alkaloid obtained by extraction from Berberis spp., is a botanical that is widely used in the nutraceutical sector to control cholesterol and blood glucose levels. It is also a molecule that is effective in limiting diarrhea due to its multi-factorial properties, including its antimicrobial, gut eubiotic and antisecretive actions, and its ability to slow gut motility. In our routine clinical practice, we have suggested the use of a berberine-based nutraceutical, formulated with melatonin and depolymerized guar gum, to patients affected by functional diarrhea (FD) or by diarrhea-type irritable bowel syndrome (IBS-D). METHODS: We have therefore retrospectively analyzed the clinical effect of such a nutritional supplement in these two sub-groups of patients. RESULTS: Despite the highly pragmatic scheme of our study, our findings strongly confirm the antidiarrheal properties of berberine and recommend its use in some gut functional diseases characterized by frequent evacuation of mushy and/or watery stools. In fact, even after 30 days of treatment, the berberine-based nutritional supplement significantly reduces diarrheal events by 50-70%. After 90 days, this reduction improves to between 70 and 80%, with a reduction of more than 60% in the number of evacuations per week and with more than 50% of treated subjects demonstrating normalized, according to self-reported Bristol Stool Scale categorization, stool consistency. The product is well tolerated and adherence to the proposed therapy is good. Common side effects of the product are flatulence and meteorism, likely due to the "acarbose-like" berberine effects on gut α-glucosidase. CONCLUSIONS: Patients, especially those preferring "natural" therapy, can be successfully treated, when affected by a gut functional disease characterized by diarrhea, by berberine-based products.

Possible therapeutic role of a highly standardized mixture of active compounds derived from cultured Lentinula edodes mycelia (AHCC) in patients infected with 2019 novel coronavirus.

The outbreak of SARS-CoV-2 disease (COVID-19) is currently, March 2020, affecting more than 100,000 people worldwide and, according to the WHO (World Health Organization), a pandemic is shortly expected. The virus infects the lower respiratory tract and causes severe pneumonia and mortality in approximately 10% and 3-5%, respectively, of cases, mainly among the elderly and/or people affected by other diseases. AHCC is an α-glucan-based standardized mushroom extract that has been extensively investigated as an immunostimulant both in animals and/or in humans affected by West Nile virus, influenza virus, avian influenza virus, hepatitis C virus, papillomavirus, herpes virus, hepatitis B virus and HIV by promoting a regulated and protective immune response. Although the efficacy of AHCC has not yet been specifically evaluated with respect to SARS-CoV-2 disease, its action in promoting a protective response to a wide range of viral infections, and the current absence of effective vaccines, could support its use in the prevention of diseases provoked by human pathogenic coronavirus, including COVID-19.

Berberine and Dyslipidemia: Different Applications and Biopharmaceutical Formulations Without Statin-Like Molecules-A Meta-Analysis.

The aim of this study was to analyze the efficacy of berberine taken alone or in other formulations (with silymarin or other mixtures) on dyslipidemia through a systematic review of the literature and a meta-analysis. A systematic investigation was conducted on 19 studies that were selected based on inclusion and exclusion criteria. Both controlled trials (n = 12) and cross-sectional trials (n = 7) were included. The following formulations were examined: berberine used alone (n = 5), berberine combined with silymarin (n = 8), and other mixture containing berberine (n = 6). A meta-analysis was performed using a fixed-effects model and meta-regression. Total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides were considered. Moreover, possible associations of each parameter with age and the dose and duration of the treatment were analyzed. The data obtained showed a significant reduction in TC and LDL cholesterol for each formulation. A reduction in triglycerides was also observed for both TC and LDL but with a smaller impact. As regards HDL, a slight increase was observed, but it was not statistically significant. The formulation of berberine in association with silymarin was found to have the greatest impact on TC, LDL, HDL, and triglycerides. The greater efficacy of the formulation consisting of berberine associated with silymarin can probably be accounted for by the fact that the latter increases the bioavailability of berberine. However, it is necessary to carry out further clinical studies to better define the efficacy of the treatment and which patients show the best response.

A novel lecithin-based delivery form of Boswellic acids as complementary treatment of radiochemotherapy-induced cerebral edema in patients with glioblastoma multiforme: a longitudinal pilot experience.

BACKGROUND: Glioblastoma multiforme (GBM) is an extremely challenging neurological disease for which the development of more effective therapeutic options and of adjuvant/complementary treatment is needed. We investigated the effects of an innovative phytosome-based delivery form of boswellic acids extract (Monoselect AKBA™) on radiochemotherapy-induced cerebral edema in patients with primary GBM. METHODS: Patients with de novo GBM treated with surgery, radiotherapy and chemotherapy with temozolomide were enrolled in this longitudinal study and received boswellia-based product 4500 mg/die for a maximum of 34 weeks. Cerebral edema was assessed at 4, 12, 22 and 34 weeks post-surgery, together with steroids consumption and patients' psychological status. RESULTS: A total of 20 patients were included in the study. The percentage of patients with reduced edema was constant during the study, while the percentage of those with reduced or stable edema tended to increase over time. Of note, two patients achieved a considerable reduction in brain edema, which led to a more favorable and beneficial surgical resection. In addition, a good percentage of patients assumed a stable/reduced steroids dose or were dexamethasone free during the study. Lastly, patients' QoL and psychological state were maintained throughout the study. CONCLUSIONS: Complementary treatment with Monoselect AKBA™ might exert a beneficial effect in reducing radiochemotherapy-induced cerebral edema, thanks to the anti-inflammatory properties of the boswellia serrata extract. The reduction in brain edema might diminish dexamethasone assumption, thus minimizing steroids-induced side effects, and in few cases may allow a complete surgical excision of the tumor mass.