#237 Verifying the value of vaginal estradiol tablets
CLINICAL QUESTION
Are vaginal estradiol tablets (Vagifem®) effective for genitourinary syndrome of menopause?
BOTTOM LINE
Vaginal estradiol tablets are likely no better than placebo vaginal gel for reducing “most bothersome symptom scores” (mainly dyspareunia). However, compared to placebo vaginal tablets, they reduce symptoms (example: treatment “success” at 12 months in 86% versus 41% placebo). A non-medicated vaginal gel may be reasonable first-line for dyspareunia.
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EVIDENCE
Six double-blind, placebo-controlled, randomized, controlled trials (RCTs). Most used 4-point outcome scale (range 0-3, lower better).1-4 Statistically significant unless indicated.
Versus placebo gel:
- 1 RCT (302 women). Most bothersome symptom score (pain with vaginal penetration in 60%). Final score at 12 weeks (baseline 2.5):
- 1.1 versus 1.2 (placebo), not statistically different.1
- "Meaningful benefit": 80% versus 65% (placebo).
- No difference: 11 other outcomes.
- Vaginal symptoms:
- Most bothersome symptom score (dyspareunia in 57%). Final score at 12 weeks (baseline ~2.3):
- 1 RCT (309 women): 1.1 versus 1.4 (placebo).2
- Composite vaginal symptom score (baseline ~2), final score:
- At 12 months (1612 women): 0.21 versus 1.15 (placebo).3
- At 12 weeks (230 women):4
- 25mcg dose 0.56 versus 1.1 (placebo).
- 10mcg dose not different from placebo.
- Percent without moderate-severe individual symptoms at 12 weeks (1 RCT, 164 women):5
- Dryness: 85% versus 72% (placebo).
- Itching/burning: 89% versus 74% (placebo), not statistically different.
- Dyspareunia: 92% versus 76% (placebo).
- Overall "success" at 12 months (1612 women):3 86% versus 41% (placebo), number needed to treat=3.
- Most bothersome symptom score (dyspareunia in 57%). Final score at 12 weeks (baseline ~2.3):
- Urinary incontinence:
- Percent without urinary symptoms:
- At 12 months (1612 women): 84% versus 64% (placebo).3
- “Change for the better”:
- At 12 weeks (164 women): 63% versus 32% placebo.5
- No difference frequency/nocturia at 12 weeks (110 women).6
- Cancer/endometrial thickening (unopposed estrogen), 2 industry-funded studies:7,8
- From 386 women with negative baseline investigations, 1 hyperplasia and 1 carcinoma.
- Similar to background rate.
- From 386 women with negative baseline investigations, 1 hyperplasia and 1 carcinoma.
- Percent without urinary symptoms:
- Systematic reviews combined different dosage forms and did not include all RCTs.9-12
- Some studies used 25mcg dose, not available in Canada.3-6
- Vaginal moisturizer no better than placebo gel.1
- More women satisfied with tablets than vaginal estrogen cream (85% versus 73%).13
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