Importance Nearly half of postmenopausal women report bothersome vulvovaginal symptoms, but few data support the efficacy of 2 commonly recommended treatments. Objective To compare the efficacy of a low-dose vaginal estradiol tablet and a vaginal moisturizer, each vs placebo, for treatment of moderate-to-severe postmenopausal vulvovaginal symptoms. Design, Setting, and Participants This 12-week multicenter randomized clinical trial enrolled postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration. Interventions Vaginal 10-&mgr;g estradiol tablet (daily for 2 weeks, then twice weekly) plus placebo gel (3 times a week) (n = 102) vs placebo tablet plus vaginal moisturizer (n = 100) vs dual placebo (n = 100). Main Outcomes and Measures The main outcome was decrease in severity (0-3) of most bothersome symptom (MBS) between enrollment and 12 weeks. Additional measures included a composite vaginal symptom score, Female Sexual Function Index (FSFI) score (2-36), modified Female Sexual Distress Score–Revised item 1, treatment satisfaction and meaningful benefit, Vaginal Maturation Index, and vaginal pH. Results The 302 women had a mean (SD) age of 61 (4) years and were primarily white (267 [88%]), college educated (200 [66%]), and sexually active (245 [81%]). Most women (294 [97%]) provided data for the primary analysis. The most commonly reported MBS was pain with vaginal penetration (182 [60%]), followed by vulvovaginal dryness (63 [21%]). Mean baseline MBS severity was similar between treatment groups: estradiol, 2.4 (95% CI, 2.3 to 2.6); moisturizer, 2.5 (95% CI, 2.3 to 2.6); placebo, 2.5 (95% CI, 2.4 to 2.6). All treatment groups had similar mean reductions in MBS severity over 12 weeks: estradiol, −1.4 (95% CI, −1.6 to −1.2); moisturizer, −1.2 (95% CI, −1.4 to −1.0); and placebo, −1.3 (95% CI, −1.5 to −1.1). No significant differences were seen between estradiol (P = .25) or moisturizer (P = .31) compared with placebo. Mean total FSFI improvement was similar between estradiol (5.4; 95% CI, 4.0 to 6.9) and placebo (4.5; 95% CI, 2.8 to 6.1) (P = .64), and between moisturizer (3.1; 95% CI, 1.7 to 4.5) and placebo (P = .17). Conclusions and Relevance Our results suggest that neither prescribed vaginal estradiol tablet nor over-the-counter vaginal moisturizer provides additional benefit over placebo vaginal tablet and gel in reducing postmenopausal vulvovaginal symptoms. Trial Registration clinicaltrials.gov Identifier: NCT02516202

中文翻译：

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阴道雌二醇或阴道保湿剂与安慰剂治疗绝经后外阴阴道症状的疗效

重要性 近一半的绝经后妇女报告出现令人烦恼的外阴阴道症状，但很少有数据支持两种常用推荐治疗方法的疗效。目的 比较低剂量阴道雌二醇片和阴道保湿剂（各自与安慰剂）对治疗中度至重度绝经后外阴阴道症状的疗效。设计、设置和参与者 这项为期 12 周的多中心随机临床试验招募了具有中度至重度外阴阴道瘙痒、疼痛、干燥、刺激或穿透疼痛症状的绝经后妇女。干预 阴道 10-&mgr;g 雌二醇片（每天 2 周，然后每周两次）加安慰剂凝胶（每周 3 次）（n = 102）vs 安慰剂片加阴道保湿剂（n = 100）vs 双安慰剂（n = 100）。主要结果和测量主要结果是在入组和 12 周之间最烦人的症状 (MBS) 的严重程度 (0-3) 降低。其他措施包括复合阴道症状评分、女性性功能指数 (FSFI) 评分 (2-36)、修正的女性性困扰评分——修正项目 1、治疗满意度和有意义的益处、阴道成熟指数和阴道 pH 值。结果 302 名女性的平均 (SD) 年龄为 61 (4) 岁，主要是白人 (267 [88%])、受过大学教育 (200 [66%]) 和性活跃 (245 [81%])。大多数女性 (294 [97%]) 为主要分析提供了数据。最常报告的 MBS 是阴道插入疼痛 (182 [60%])，其次是外阴阴道干燥 (63 [21%])。治疗组之间的平均基线 MBS 严重程度相似：雌二醇，2.4（95% CI，2.3 至 2.6）；保湿剂，2.5（95% CI，2.3 至 2.6）；安慰剂，2.5（95% CI，2.4 至 2.6）。所有治疗组在 12 周内 MBS 严重程度的平均降低程度相似：雌二醇，-1.4（95% CI，-1.6 至 -1.2）；保湿剂，-1.2（95% CI，-1.4 至 -1.0）；和安慰剂，-1.3（95% CI，-1.5 至 -1.1）。与安慰剂相比，雌二醇 (P = .25) 或保湿剂 (P = .31) 之间没有显着差异。雌二醇（5.4；95% CI，4.0 至 6.9）和安慰剂（4.5；95% CI，2.8 至 6.1）（P = .64）和保湿剂（3.1；95% CI，1.7）之间的平均总 FSFI 改善相似到 4.5）和安慰剂（P = .17）。结论和相关性我们的结果表明，在减少绝经后外阴阴道症状方面，处方阴道雌二醇片和非处方阴道保湿剂都没有比安慰剂阴道片和凝胶提供额外的好处。