Suppr超能文献

洋甘菊阴道凝胶对绝经后女性性功能的影响:一项双盲随机对照试验

Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial.

作者信息

Bosak Zahra, Iravani Mina, Moghimipour Eskandar, Haghighizadeh Mohammad Hosein, Jelodarian Parivash

机构信息

Menopause Andropause Research Center, Midwifery Department, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Department of Midwifery, School of Nursing and Midwifery, Menopause Andropause Research Center, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

J Sex Med. 2022 Jun;19(6):983-994. doi: 10.1016/j.jsxm.2022.03.536. Epub 2022 Apr 7.

Abstract

BACKGROUND

Female sexual dysfunction (FSD) is a common complaint among postmenopausal women, which is largely because of the genitourinary syndrome in these women (GSM).

AIM

Considering the phytoestrogenic effects of chamomile, the present study was primarily aimed to investigate the effect of chamomile vaginal gel on the sexual function of postmenopausal women. The side effects of these drugs were evaluated as a secondary outcome of the study.

METHODS

This randomized double-blind clinical trial and placebo-controlled study was conducted on postmenopausal women with sexual dysfunction (FSFI ≤26.55). To this aim, 96 postmenopausal women were randomly assigned into three groups (n = 32 each) including women receiving (i) chamomile vaginal gel 5%, (ii) conjugated estrogen vaginal cream, and (iii) placebo vaginal gel, for 12 weeks (ie, every night in the first 2 weeks, and 2 nights per week in the next 10 weeks, each night 1 g was used). The sexual function was measured using female sexual function index (FSFI) before and after the intervention. Data analysis was performed by chi-square, one-way ANOVA, descriptive statistics, analysis of covariance (ANCOVA), and paired t test using SPSS software version 22. P < .05 was considered statistically significant.

OUTCOMES

The main study outcome measure was evaluate the effects of vaginal administration of chamomile gel in comparison with conjugated estrogen cream and placebo gel on postmenopausal FSD using the FSFI.

RESULTS

The findings showed that chamomile vaginal gel in compared to placebo vaginal gel caused a significant improvement in all six sexual function domains and the total FSFI score (effect size = +2.9 [95% CI, +2.1 to +3.6], P < .001). Also, there was no significant difference between the chamomile vaginal gel and conjugated estrogen vaginal cream groups in terms of the total score and all sub-domains of sexual function with the exception of orgasm (effect size = +0.13 [95% CI, -0.36 to +0.63], P = .02) and sexual satisfaction (effect size = 0 [95% CI, -0.49 to +0.49], P = .04). Two women in the chamomile group and one in the placebo group experienced a burning sensation (P = .345).

CLINICAL IMPLICATIONS

This treatment can be considered as a treatment option for postmenopausal women with sexual dysfunction who have contraindications to the use of hormone therapy.

STRENGTHS & LIMITATIONS: This study is the first study to investigate the effectiveness of chamomile vaginal gel on sexual function in postmenopausal women. However, in this study, treatment duration was 12 weeks and no follow up was performed beyond this time CONCLUSION: Based on the results of this study, the use of vaginal chamomile gel improved sexual function in postmenopausal women. Bosak Z, Iravani M, Moghimipour E, et al. Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial. J Sex Med 2022;19:983-994.

摘要

背景

女性性功能障碍(FSD)是绝经后女性的常见主诉,这主要是由于这些女性的泌尿生殖综合征(GSM)。

目的

考虑到洋甘菊的植物雌激素作用,本研究主要旨在探讨洋甘菊阴道凝胶对绝经后女性性功能的影响。这些药物的副作用作为研究的次要结果进行评估。

方法

本随机双盲临床试验和安慰剂对照研究针对患有性功能障碍(女性性功能指数[FSFI]≤26.55)的绝经后女性进行。为此,96名绝经后女性被随机分为三组(每组n = 32),包括接受(i)5%洋甘菊阴道凝胶、(ii)结合雌激素阴道乳膏和(iii)安慰剂阴道凝胶的女性,为期12周(即前2周每晚使用,接下来10周每周2晚,每晚使用1 g)。在干预前后使用女性性功能指数(FSFI)测量性功能。使用SPSS软件22版通过卡方检验、单因素方差分析、描述性统计、协方差分析(ANCOVA)和配对t检验进行数据分析。P <.05被认为具有统计学意义。

结果

主要研究结果指标是使用FSFI评估与结合雌激素乳膏和安慰剂凝胶相比,阴道给予洋甘菊凝胶对绝经后FSD的影响。

结果

研究结果表明,与安慰剂阴道凝胶相比,洋甘菊阴道凝胶在所有六个性功能领域和FSFI总分方面均有显著改善(效应大小= +2.9 [95% CI,+2.1至+3.6],P <.001)。此外,除性高潮(效应大小= +0.13 [95% CI,-0.36至+0.63],P =.02)和性满意度(效应大小= 0 [95% CI,-0.49至+0.49],P =.04)外,洋甘菊阴道凝胶组和结合雌激素阴道乳膏组在性功能总分和所有子领域方面无显著差异。洋甘菊组有两名女性和安慰剂组有一名女性出现烧灼感(P =.345)。

临床意义

对于有激素治疗禁忌证的绝经后性功能障碍女性,这种治疗可被视为一种治疗选择。

优点与局限性

本研究是第一项调查洋甘菊阴道凝胶对绝经后女性性功能有效性的研究。然而,在本研究中,治疗持续时间为12周,在此之后未进行随访。

结论

基于本研究结果,阴道使用洋甘菊凝胶可改善绝经后女性的性功能。博萨克Z、伊拉瓦尼M、莫吉姆普尔E等。洋甘菊阴道凝胶对绝经后女性性功能的影响:一项双盲随机对照试验。《性医学杂志》2022;19:983 - 994。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验