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Estrogen no better than vaginal lubricant for postmenopausal vaginal symptoms
Clinical Question
In women with postmenopausal vaginal symptoms, is local estrogen treatment better than vaginal lubricant or placebo?
Bottom line
Time for a rethink the idea that vaginal atrophy due to diminished estrogen is the cause of vaginal symptoms associated with menopause. Vaginal estradiol (Vagifem) is no more effective than a nonprescription vaginal lubricant (Replens Long-Lasting Vaginal Moisturizer) or placebo lubricant in the treatment of women with painful intercourse, vaginal dryness, or other symptoms usually associated with menopause. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (any)
Synopsis
This study evaluated the effect of a vaginal estradiol 10 mcg, a nonprescription vaginal lubricant, and matching placebo tablet and lubricant in 302 postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration. Estradiol was used daily for 2 weeks, then twice weekly; vaginal moisturizer was used every 3 days for 12 weeks. Results were analyzed using a modified intention-to-treat analysis, including women who returned for evaluation at 1 month and 3 months after beginning treatment, regardless of their continued use of treatment, At the beginning of the study women were asked to identify their most bothersome symptom, which was pain with vaginal penetration (60%) or vaginal dryness (21%) for most women; the main outcome measured was the effect of treatment on this outcome. Treatment with estradiol, lubricant, or placebo produced similar results, decreasing the average score (on a scale of 0 to 3) from 2.4 ("moderate" severity) at the beginning of treatment to 1.0 ("mild"). Half the women in each group, including the placebo group, had a clinically significant drop in scores with treatment. Sexual function, as measured by the Female Sexual Function Index, improved in all groups, with nearly half the women in all groups improving from "frequently" or "always" distressed about their sex life to "rarely" or "never" distressed about their sex life.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Comments
good poem
This is surprising. I think this information may help me reassure those women who prefer to avoid hormones and may save money for patients and health plans!
This is sad, to say that Vagifem is of little benefit. Maybe if it was used in a therapeutic dose range and not a homeopathic dose. Many postmenopausal women need to use it daily for several weeks, then use it every second day.
I have talked to many women who find that use of vaginal estriol compound does make their vaginal dryness better
HOLY MOLY!! Is this true???? I've been prescribing local HRT as a step up from vaginal lubricant for years! Now what?? Any alternatives if lubricant is not enough???
No distinction was drawn between naturally occurring menopause versus abrupt post-surgical menopause.
It would be nice to know what they used as a placebo, to recommend to woman.
If findings of this trial are replicable, we could see a reversal of medical decision making to use ERT as first line therapy for this condition
I don’t think low dose vagifem is effective either. It would be more interesting to compare Premarin cream to replens or Lubricant.
this may be a reflection that vaginal tablet estrogen is not a topical treatment, should study compare to an estrogen cream