Local oestrogen is recommended for urogenital symptoms in menopausal women.
The recommendation is strong because of large effect size on symptoms, absence of significant harms, and low cost. Treatment may also be beneficial for sexual function.
A Cochrane review [Abstract] 1 included 30 studies with a total of 6 235 patients. The overall quality of the studies was good. Outcome measures varied between the studies. Oestrogenic preparations in the form of creams, tablets and the oestradiol-releasing vaginal ring were all effective in relieving the symptoms of vaginal atrophy when compared to placebo and non-hormonal gel (table T1). There was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. There was no difference in adverse effects.
Outcome | Relative effect(95% CI) | Assumed risk - Placebo | Corresponding risk -Intervention (95% CI) | No of participants (trials) |
---|---|---|---|---|
Improvement in symptoms (participant-assessed),oestrogen tablets | OR 12.47 (9.81 to 15.84) | 294 / 1000 | 839 / 1000(803 to 868) | 1638(2) |
Improvement in symptoms (clinician-assessed), oestrogen tablets | OR 1.03 (0.70 to 1.52) | 697 / 1000 | 699 / 1000(612 to 774) | 528(3) |
Improvement in symptoms (participant-assessed), oestrogen cream | OR 4.10 (1.88 to 8.93) | 685 / 1000 | 899 / 1000(803 to 951) | 198(2) |
Improvement in symptoms (clinician-assessed), oestrogen cream | OR 3.29 (1.47 to 7.36) | 646 / 1000 | 857 / 1000(728 to 931) | 153(1) |
A systematic review 2 included 53 studies. Compared with placebo, all vaginal estrogens demonstrated superiority in objective endpoints and subjective endpoints of genitourinary syndrome. Some trials demonstrated superiority versus placebo in urogenital symptoms. No significant difference was observed between various dosages and dosage forms of vaginal estrogen products. Estrogen showed superiority over vaginal lubricants and moisturizers for the improvement of objective clinical endpoints of vulvovaginal atrophy but not for subjective endpoints.
Another systematic review 3 included 20 randomized controlled studies, 8 interventional studies, and 10 observational studies. Collectively, there was no increased risk of endometrial hyperplasia or cancer with low-dose vaginal estrogens. Rates of endometrial cancer and hyperplasia were 0.03% and 0.4%, respectively (20 RCT, n=2983). Overall, reports of endometrial hyperplasia were observed with various doses and durations and appeared sporadic, consistent with endometrial hyperplasia rates in the general population. The Women's Health Initiative Observational Study showed no association (1.3 cases/1000 women-years with vaginal estrogens versus 1.0/1000 women-years for nonuse).
The following decision support rules contain links to this evidence summary:
Primary/Secondary Keywords