Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy in postmenopausal women: A 12-week randomised, placebo-controlled, multicentric study

IF 3.9 2区医学 Q2 GERIATRICS & GERONTOLOGY

Maturitas Pub Date : 2025-04-12 DOI:10.1016/j.maturitas.2025.108264

Fabienne Marchand Lamiraud , Hichem Bensmail , Carine Martin , Sofie Pelckmans , Firas Cha'ban , Aliette Siboni Frisch , Gulcan Deniz , Pascale Sabban Serfati , Brigitte Caubo , Brice Gurriet , Isabelle Petit Breuilh , Ann Inge Pastijn , Nicolas Berreni , Michel Cosson

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引用次数: 0

Abstract

Objective

To evaluate the efficacy and safety of a single injection session of cross-linked hyaluronic acid gel for vulvovaginal atrophy, versus placebo.

Design

Two-step study comprising a 12-week randomised, placebo-controlled, single-blind phase, followed by an open-label phase. Eligible postmenopausal women with vulvovaginal atrophy were randomised (2:1) to a single injection session of either hyaluronic acid or placebo. This is the report of the single-blind phase.

Main outcome measures

The primary outcome was the mean change in the severity score for the most bothersome symptom at 12 weeks compared with baseline. Secondary outcomes included differences in scores for individual vulvovaginal atrophy symptoms, score on the Female Sexual Function Index and vaginal pH.

Results

A total of 116 of the 117 patients in the randomised population contributed outcome data to the study (79 receiving hyaluronic acid and 37 placebo). Compared with baseline, the mean score for the severity of the most bothersome symptom was significantly reduced in the hyaluronic acid arm at 12 weeks (between-group difference [95 % confidence interval]: −0.58 [−1.01; −0.16], p = 0.008). Similarly, there were significant reductions in mean scores for dryness (−0.87 [−1.27; −0.47]; p < 0.001) and dyspareunia (−0.65 [−1.09; −0.21]; p = 0.004) and improvement in score on the Female Sexual Function Index (3.81 [0.91; 6.72]; p = 0.011) in the hyaluronic acid group. There were no differences in itching/irritation, pain or vaginal pH in either group. Hyaluronic acid treatment was well tolerated.

Conclusions

A single injection session of cross-linked hyaluronic acid is effective in reducing vulvovaginal symptoms and sexual dysfunction compared with placebo at 12 weeks, making it a suitable management option for moderate to severe vulvovaginal atrophy symptoms.

Trial registration

NCT 04219722 (https://clinicaltrials.gov/study/NCT04219722).

查看原文本刊更多论文

透明质酸注射治疗绝经后妇女外阴阴道萎缩症状：一项为期12周的随机、安慰剂对照、多中心研究

目的评价单次注射交联透明质酸凝胶治疗外阴阴道萎缩的疗效和安全性。该研究分为两步，包括一个12周的随机、安慰剂对照、单盲阶段，然后是一个开放标签阶段。符合条件的绝经后外阴阴道萎缩妇女随机（2:1）注射透明质酸或安慰剂。这是单盲阶段的报告。主要结局指标：主要结局是与基线相比，12周时最令人烦恼的症状严重程度评分的平均变化。次要结果包括个体外阴阴道萎缩症状评分、女性性功能指数评分和阴道ph评分的差异。结果在随机分组的117名患者中，共有116名患者为研究提供了结果数据（79名接受透明质酸治疗，37名接受安慰剂治疗）。与基线相比，透明质酸组在12周时最麻烦症状严重程度的平均评分显著降低(组间差异[95%置信区间]:- 0.58 [- 1.01；−0.16],p = 0.008)。同样，干燥的平均得分也显著降低(- 0.87 [- 1.27；−0.47);p & lt;0.001)和性交困难(- 0.65 [- 1.09；−0.21);p = 0.004)和女性性功能指数得分的改善(3.81 [0.91；6.72);P = 0.011)。两组在瘙痒/刺激、疼痛或阴道pH值方面没有差异。透明质酸治疗耐受性良好。结论与安慰剂相比，单次注射交联透明质酸可有效减轻12周外阴阴道症状和性功能障碍，是治疗中重度外阴阴道萎缩症状的合适选择。试验注册nct 04219722 （https://clinicaltrials.gov/study/NCT04219722）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Maturitas 医学-妇产科学

CiteScore

9.10

自引率

2.00%

发文量

142

审稿时长

40 days

期刊介绍： Maturitas is an international multidisciplinary peer reviewed scientific journal of midlife health and beyond publishing original research, reviews, consensus statements and guidelines, and mini-reviews. The journal provides a forum for all aspects of postreproductive health in both genders ranging from basic science to health and social care. Topic areas include:• Aging• Alternative and Complementary medicines• Arthritis and Bone Health• Cancer• Cardiovascular Health• Cognitive and Physical Functioning• Epidemiology, health and social care• Gynecology/ Reproductive Endocrinology• Nutrition/ Obesity Diabetes/ Metabolic Syndrome• Menopause, Ovarian Aging• Mental Health• Pharmacology• Sexuality• Quality of Life