#88 Hormone Therapy: Does Timing Make a Difference?
CLINICAL QUESTION
Is there evidence that starting combination oral hormone therapy (HT) closer to menopause result in reduced risk of harm or even possible benefit?
BOTTOM LINE
Evidence supporting the timing hypothesis of HT is not convincing. There is no consistent evidence of benefit with HT beyond symptomatic relief. Smaller but real risks are likely present even in those close to menopause.
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EVIDENCE
Randomized controlled trial (RCT):1 1006 women (mean age 52) randomized to HT or nothing x10 years
- Statistically significant reduction in composite outcome (death, hospitalization for heart failure, and myocardial infarction) in HT users
- Hazard ratio (HR) 0.48 (0.26-0.87)
- Limitations: Secondary analysis of an osteoporosis study with this outcome defined post-hoc; open-label design; included estrogen-only group; low event rate.
- Combination HT within 10 years of menopause had non-statistically significant:
- Reduced coronary heart disease (CHD): HR 0.88 (0.54-1.43)
- Increased stroke: HR 1.58 (0.81-3.05)
- Overall more harms than benefits (global index): HR 1.09 (0.87-1.37)
- Limitations: Subgroup analysis; >130 statistical tests, only 2 statistically significant (6-7 expected by chance alone).
- Subgroup analysis showed decreased mortality and CHD in HT users <10 years post-menopause, but not >10 years
- No evidence that risk of stroke or venous thromboembolism (VTE) lower if HT started <10 years of menopause
- Limitations: Risk reductions driven by above RCT1 and estrogen-only group of WHI (hysterectomy patients), which is not likely generalizable to patients without hysterectomy
- Older systematic review of 30 RCTs found similar effects on mortality for age <60 versus >60.5
- HT is effective for vasomotor and some urogenital symptoms in post-menopausal women.6
- Another Cochrane review7 of 23 RCTs (42,830 patients, mean >60 years) reported small statistically-significant increased risk for cardiovascular events, VTE, stroke, and breast cancer with HT.
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