Department of Maternal, Child Health and Urological Sciences, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.
Department of Science and Research, Velleja Research, Milan, Italy -
Minerva Obstet Gynecol. 2024 Aug;76(4):343-352. doi: 10.23736/S2724-606X.23.05409-X. Epub 2024 Feb 15.
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.
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.
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.
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.
尽管泌尿生殖系统绝经期综合征（GSM）的金标准治疗是基于使用局部或全身含雌激素的产品，但激素治疗的典型长期副作用，最重要的是，有乳腺癌和子宫内膜癌病史的患者的禁忌症，在某种程度上限制了其应用。由于透明质酸和一些高度纯化的植物提取物已明确显示出其抗炎和粘膜保护特性，我们在患有 GSM 的女性中测试了一种含有透明质酸钠凝胶的 II 类阴道医疗器械，以及一种含有纯化的来自花椒的烷基酰胺、积雪草中的三萜类化合物和罗望子中的高分子量多糖的粘膜粘附活性物质。
我们的单中心、开放标签、前瞻性和观察性研究在意大利罗马翁贝托一世综合医院妇产科进行，共纳入 50 名绝经后妇女。凝胶治疗持续 150 天，第 1-12 天每天一次，第 13-150 天每 48 小时一次。在基线和 12、57 和 150 天后进行临床评估。除了产品安全性外，我们研究的主要结果还包括：1）阴道健康（通过阴道健康指数评分[VHI]评估）；2）女性性困扰评分[FSDS]评估的性生活质量；3）报告有规律性生活的女性比例。
该产品安全，无特定不良事件报告。它显著改善了 VHI（57 天后约 5%，150 天后约 8%）、FSDS（57 天后约 7%，150 天后约 10%）和性生活（150 天后约 20%）。它还降低了干燥、性交痛、烧灼感、瘙痒和尿痛的发生率，150 天后分别约为 18%、14%、14%、27%和 11%。
在患有 GSM 的女性中，阴道内给予含有纯化植物活性物质的透明质酸钠凝胶可减轻性行为时的疼痛感觉，并增加有规律的性生活。
