Cesarone Maria R, Belcaro Gianni, Scipione Claudia, Scipione Valeria, Dugall Mark, Hu Shu, Cotellese Roberto, Feragalli Beatrice, Ledda Andrea
IRVINE3 Labs & Pap/Pea Screening Project and the International Irvine Network, Pescara, Italy.
IAAPS, International Agency for Pharma Standard Supplements, Chieti, Italy.
Minerva Ginecol. 2019 Dec;71(6):434-441. doi: 10.23736/S0026-4784.19.04466-6.
The aim of this pilot registry study was to use a standardized supplement (Lady Prelox®, Horphag Research) - including Pycnogenol®, l-arginine, L-citrulline and rose hip extract - to improve signs and symptoms associated with vaginal dryness in pre and post-menopausal healthy women. A group of women used only a standard management (SM) and a second group added Lady Prelox®.
Four groups of women were included in the study. 34 pre-menopausal and 38 post-menopausal women took Lady Prelox®, four tablets daily for 8 weeks and 33 pre-menopausal women and 35 post-menopausal women served as controls.
No safety problems were observed with the supplement that was well tolerated. The subgroups of controls and supplemented subjects were comparable in both the pre- and post-menopausal groups. Among pre-menopausal women, results of the female sexual function index (FSFI) were significantly improved with the supplement in comparison with the control subjects' group (P<0.05). The results of the FSFI questionnaire for post-menopausal women indicated a significant improvement at 8 weeks with Lady Prelox® (P<0.05) in comparison with controls. Preclinical items (vaginal dryness, pain/discomfort during intercourse, mucus, minimal infections, presence of candida and oxidative stress) were significantly improved (P<0.05) with Lady Prelox®) in comparison to minimal changes with the SM group. These measurements included all women.
The effects of the supplementation with Lady Prelox® on vaginal dryness were significant. The supplement was well accepted and revealed no side effects or tolerability problems. Further studies are evaluating the effects of Lady Prelox® on other aspects of the menopausal transition that may alter the quality of life of most women in advanced age. A gentle approach with suitable dietary supplementation, represents a promising option for addressing common challenges that women experience in such conditions.
这项初步注册研究的目的是使用一种标准化补充剂（乐美乐欣，贺发研究公司）——包括碧萝芷、L-精氨酸、L-瓜氨酸和玫瑰果提取物——来改善绝经前后健康女性与阴道干涩相关的体征和症状。一组女性仅采用标准管理方法（SM），另一组则添加乐美乐欣。
四组女性被纳入该研究。34名绝经前女性和38名绝经后女性服用乐美乐欣，每日四片，持续8周，33名绝经前女性和35名绝经后女性作为对照组。
该补充剂耐受性良好，未观察到安全问题。对照组和补充剂组的亚组在绝经前和绝经后组中具有可比性。在绝经前女性中，与对照组相比，补充剂使女性性功能指数（FSFI）结果有显著改善（P<0.05）。绝经后女性的FSFI问卷结果显示，与对照组相比，服用乐美乐欣8周时显著改善（P<0.05）。与SM组变化极小相比，乐美乐欣使临床前期项目（阴道干涩、性交时疼痛/不适、黏液、轻微感染、念珠菌存在和氧化应激）有显著改善（P<0.05）。这些测量涵盖了所有女性。
补充乐美乐欣对阴道干涩的效果显著。该补充剂被广泛接受，未显示出副作用或耐受性问题。进一步的研究正在评估乐美乐欣对绝经过渡其他方面的影响，这些方面可能会改变大多数老年女性的生活质量。采用温和的方法并适当补充饮食，是应对女性在这种情况下所面临常见挑战的一个有前景的选择。
