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Vaginal Moisturizers vs Vaginal Estradiol for Postmenopausal Vulvovaginal Symptoms

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Describe the design of the Mitchell et al., study (JAMA Int Med, 2018) to determine if 12-week treatment with vaginal estradiol or vaginal moisturizer improves postmenopausal vulvovaginal symptoms
2. Discuss the results of this study as to the benefits of vaginal estradiol compared to moisturizers

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from May 7 2018 through May 7 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Pharmacy Education

Postgraduate Institute for Medicine designates this continuing education activity for 0.25 contact hour(s) (0.25 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number – JA4008162-9999-18-131-H04-P)

Type of Activity: Knowledge

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

BACKGROUND AND PURPOSE:

  • Vulvovaginal symptoms, including dryness and dyspareunia are common in postmenopausal women and are part of the Genitourinary Syndrome of Menopause (GSM)
  • Mitchel et al. (JAMA Int Med,  2018) compared the effectiveness of a low-dose vaginal estradiol tablet, a vaginal moisturizer, and placebo, as treatments for moderate-to-severe postmenopausal vulvovaginal symptoms

METHODS:

  • 12-week, randomized, multicenter clinical trial
  • 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 received either (1:1:1)
    • 10-µcg estradiol tablet (daily for 2 weeks, then twice weekly) plus placebo gel (3 times a week)
    • Placebo tablet plus vaginal moisturizer
    • Dual placebo
  • Moisturizer ingredients
    • Purified water, glycerin, mineral oil, polycarbophil, carbomer homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, and sodium hydroxide
      • Placebo gel ingredient was hydroxyethylcellulose gel
    • Primary outcome: Decrease in severity of most bothersome symptoms (MBS)
    • Secondary outcomes: Composite vaginal symptom score | Female Sexual Function Index (FSFI) score | modified Female Sexual Distress Score-Revised item 1 treatment satisfaction and meaningful benefit | Vaginal Maturation Index | vaginal pH

RESULTS:

  • Data was collected from 302 women; mean of 61 years
    • Primarily white, college educated, and sexually active
    • Tablet plus placebo moisturizer (n = 102)
    • Placebo plus moisturizer (n = 100)
    • Dual placebo (n = 100)
  • The most commonly reported MBS
    • Pain with vaginal penetration in 60%
    • Vulvovaginal dryness in 21%
  • All treatment groups had similar mean reductions in MBS severity over 12 weeks and no significant differences were seen between estradiol (P = .25) or moisturizer (P = .31) compared with placebo
    • Estradiol: −1.4 (95% CI, −1.6 to −1.2)
    • Moisturizer: −1.2 (95% CI, −1.4 to −1.0)
    • Placebo: −1.3 (95% CI, −1.5 to −1.1)
  • There was no statistical difference in mean total FSFI improvement between estradiol (P=.64) and moisturizer (P=.17) compared with placebo
    • Estradiol: 5.4; 95% CI, 4.0 to 6.9
    • Moisturizer: 3.1; 95% CI, 1.7 to 4.5
    • Placebo: 4.5; 95% CI, 2.8 to 6.1

CONCLUSION:

  • Neither prescribed vaginal estradiol tablet nor over-the-counter vaginal moisturizer reduced postmenopausal vulvovaginal symptoms compared to placebo
  • Estradiol tablets performed similarly to existing literature for vaginal estrogen, newly approved vaginal DHEA, and ospemifene, a selective estrogen receptor modulator
  • Placebo gel worked better than in previous studies, not linked to vaginal pH
    • Other factors beyond local vaginal environment may play a role
  • Authors suggest that

Our results suggest that most women can achieve greater than 50% reduction in symptom severity with regular, consistent use of a vaginal gel with lubricant properties and do not see added symptom improvement with vaginal estradiol.

Learn More – Primary Sources:

Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal SymptomsA Randomized Clinical Trial

 

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Related ObG Topics:

Genitourinary Syndrome of Menopause: New Name, Old Problem
What and When to Tell Patients About Lubricants?
Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option
Prasterone for Vulvovaginal Atrophy – What is it and How to Prescribe

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