一种多成分膳食补充剂对性欲低下女性性功能的影响。
Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire.
作者信息
Palacios S, Soler E, Ramírez M, Lilue M, Khorsandi D, Losa F
机构信息
Gynaecology and Obstetrics Department, Palacios' Institute of Women's Health, C/Antonio Acuña 9, E-28009, Madrid, Spain.
Procare Health Iberia, Medical department, Barcelona, Spain.
出版信息
BMC Womens Health. 2019 Apr 30;19(1):58. doi: 10.1186/s12905-019-0755-9.
BACKGROUND
Studies have demonstrated that women with low desire and low excitement have negative feelings regarding their physical and emotional satisfaction, as well as their happiness. In this study, we evaluate the efficacy of Libicare® - a multi-ingredient food supplement - to improve sexual function in postmenopausal women.
METHODS
This was an exploratory, prospective, non-controlled, observational study. Postmenopausal women aged 45-65 with a risk of sexual dysfunction (Female Sexual Function Index (FSFI) < 25.83) were included during routine clinical visits and treated with 2 tablets of Libicare® daily for 2 months. Libicare® is an oral food supplement containing Trigonella foenum graecum, Turnera diffusa, Tribulus terrestris, and Ginkgo biloba dry extracts. Primary endpoint: change vs. baseline in FSFI score. Secondary endpoints: 1) changes in testosterone and serum steroid levels of free testosterone and sex hormone-binding globulin (SHBG) levels and 2) tolerability.
RESULTS
A total of 29 patients (mean age: 54.69 years) were included. FSFI mean (SD) score showed a significant increase: 20.15 (4.48) vs 25.03 (6.94), baseline vs final; p = 0.0011, paired t-test. Most patients (86.2%) increased their FSFI score. All FSFI domains, except dyspareunia, showed significant increases. The highest increase was observed in the desire domain (p = 0.0004). Testosterone and SHBG levels were assessed in 21 patients. A significant increase in testosterone level was observed: 0.41 (0.26) vs. 0.50 (0.34) pg/mL, baseline vs. final; p = 0.038, Wilcoxon test. 52.4% of patients increased their testosterone levels. Finally, a significant decrease was observed in SHBG level: 85 (32.9) vs. 73 (26.8) nmol/L, baseline vs. final; p = 0.0001; paired t-test. 95.2% of patients decreased their SHBG levels.
CONCLUSION
In this pilot study, a significant improvement in sexual function and related hormone levels was observed with Libicare®. Further studies must be conducted to confirm these exciting results.
TRIAL REGISTRATION
Current Controlled Trial ISRCTN12928573 . Date of registration: 28/March/2019. Retrospectively registered.
背景
研究表明，性欲低下和性唤起不足的女性在身体和情感满意度以及幸福感方面存在负面情绪。在本研究中，我们评估了一种多成分食品补充剂Libicare®改善绝经后女性性功能的疗效。
方法
这是一项探索性、前瞻性、非对照观察性研究。纳入年龄在45 - 65岁、有性功能障碍风险（女性性功能指数（FSFI）< 25.83）的绝经后女性，在常规临床就诊期间给予每日2片Libicare®，治疗2个月。Libicare®是一种口服食品补充剂，含有胡芦巴、白背三七、刺蒺藜和银杏叶干提取物。主要终点：FSFI评分相对于基线的变化。次要终点：1）睾酮、游离睾酮血清类固醇水平和性激素结合球蛋白（SHBG）水平的变化；2）耐受性。
结果
共纳入29例患者（平均年龄：54.69岁）。FSFI平均（标准差）评分有显著提高：基线时为20.15（4.48），最终为25.03（6.94）；p = 0.0011，配对t检验。大多数患者（86.2%）的FSFI评分有所提高。除性交困难外，所有FSFI领域均有显著提高。性欲领域提高最为明显（p = 0.0004）。对21例患者进行了睾酮和SHBG水平评估。观察到睾酮水平有显著提高：基线时为0.41（0.26）pg/mL，最终为0.50（0.34）pg/mL；p = 0.038，Wilcoxon检验。52.4%的患者睾酮水平升高。最后，观察到SHBG水平有显著下降：基线时为85（32.9）nmol/L，最终为73（26.8）nmol/L；p = 0.0001；配对t检验。95.2%的患者SHBG水平下降。
结论
在这项初步研究中，观察到Libicare®可使性功能和相关激素水平有显著改善。必须进行进一步研究以证实这些令人振奋的结果。
试验注册
当前受控试验ISRCTN12928573。注册日期：2019年3月28日。回顾性注册。
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