BACKGROUND AND PURPOSE:

• RCTs have shown that vaginal estrogen creams and tablets, prasterone and ospemifene will provide relief from postmenopausal vaginal atrophy symptoms, but few studies have looked at sexual health and quality of life issues
• Diem et al. (Menopause 2018) compared the efficacy of vaginal estradiol tablets and vaginal moisturizer to treat menopause-related quality of life and mood in women with vulvovaginal symptoms

METHODS:

• Secondary data analysis of a 12-week, double-blind, placebo-controlled randomized trial (RCT)
• Previous primary results on sexual function and decrease in severity of most bothersome symptoms were recently reported in JAMA Int Med (see summary below in ‘Related ObG Topics’)
• Participants: Patients with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration
  • Age 45 to 70 years, at least 2 years since last menses, report of at least 1 moderate to severe symptom at least weekly within the past 30 days or
  • Pain with penetration at least once monthly
• Women were randomized to
  • 10 µg estradiol tablet plus placebo gel
  • vaginal moisturizer plus placebo tablet
  • dual placebo
• Tablets were daily for 2 weeks then twice weekly for remaining 10 weeks
• Vaginal gel was used every 3 days for 12 weeks
• The Menopause-Specific Quality of Life (MENQOL) questionnaire was used to assess changes in quality of life
• Evaluated specifically
  • Depressive symptoms as measured by Patient Health Questionnaire 8
  • Anxiety symptoms as measure by the Generalized Anxiety Disorder (GAD-7)

RESULTS:

• Vaginal estradiol resulted in a greater improvement in total MENQOL scores, compared to dual placebo
  • Mean difference between arms -0.3 at 12 weeks; 95% CI, -0.5, 0.0; P = 0.01
• A favorable group mean difference was observed for vaginal estradiol for MENQOL sexual function domain
  • -0.4 at 12 weeks; 95% CI -1.0, 0.1; P = 0.005
  • A favorable group mean difference for vaginal estrogen was not observed in any of the other domains
• Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores or any MENQOL domains
  • Mean difference 0.2 at 12 weeks; 95% CI -0.1, 0.4; P = 0.38
• Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire

CONCLUSION:

• Treatment with low-dose vaginal estradiol modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate-severe vulvovaginal symptoms
• Effect on MENQOL score was similar to low-dose oral 17-beta estradiol 0.5mg/day noted in a previous study
• The previous paper that reported on this study did not find a significant difference in sexual function using Female Sexual Function Index (FSFI) as the primary measuring tool
  • FSFI is much more detailed, while MENQOL asks three questions but focuses on whether a woman is bothered by a decrease in sexual deire, vaginal dryness during intercourse and avoiding intimacy
• The authors conclude that “multiple approaches to measuring sexual QOL are needed”

Learn More – Primary Sources:

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial.

Related ObG Topics:

What and When to Tell Patients About Lubricants?

Prasterone for Vulvovaginal Atrophy – What is it and How to Prescribe

Genitourinary Syndrome of Menopause: New Name, Old Problem

Vaginal Moisturizers vs Vaginal Estradiol for Postmenopausal Vulvovaginal Symptoms