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.

An Edible Rechargeable Battery.

Edible electronics is a growing field that aims to produce digestible devices using only food ingredients and additives, thus addressing many of the shortcomings of ingestible electronic devices. Edible electronic devices will have major implications for gastrointestinal tract monitoring, therapeutics, as well as rapid food quality monitoring. Recent research has demonstrated the feasibility of edible circuits and sensors, but to realize fully edible electronic devices edible power sources are required, of which there have been very few examples. Drawing inspiration from living organisms, which use redox cofactors to power biochemical machines, a rechargeable edible battery formed from materials eaten in everyday life is developed. The battery is realized by immobilizing riboflavin and quercetin, common food ingredients and dietary supplements, on activated carbon, a widespread food additive. Riboflavin is used as the anode, while quercetin is used as the cathode. By encapsulating the electrodes in beeswax, a fully edible battery is fabricated capable of supplying power to small electronic devices. The proof-of-concept battery cell operated at 0.65 V, sustaining a current of 48 µA for 12 min. The presented proof-of-concept will open the doors to new edible electronic applications, enabling safer and easier medical diagnostics, treatments, and unexplored ways to monitor food quality.