Vaginal Moisturizers vs Vaginal Estradiol for Postmenopausal Vulvovaginal Symptoms
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
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, 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 Jan 25 2023, 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 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.
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
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
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
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
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.
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan