Table 11

Summary of the evidence by key question

Key QuestionQuality of the evidenceConclusions
1. What is the comparative efficacy of different hormone therapy preparations for reducing symptoms of menopause?Fair: moderate to high drop-out rates.Placebo-controlled trials
Symptoms improve with estrogen +/− progesterone compared with placebo; low dose transdermal estrogen (1 trial) did not improve symptoms.
Other outcomes: estrogen effect on vaginal dryness was inconsistent; data on sleep disturbance and mood were sparse and conflicting; health-related quality of life improved in some studies but not in the WHI at 3-year follow-up.
2. What is the comparative efficacy of different hormone therapy preparations for preventing low bone density and fractures?Fair-goodFair: small numbers in most studies, recruited from clinics. The majority of studies were 1 or 2 years in duration. In placebo- controlled and head-to-head trials, estrogen regimens increased BMD or slowed rate of bone loss, but differences among estrogen preparations were not found. In both the CEE-only and the CEE- progesterone studies of the WHI, total fractures decreased and bone mineral density increased at over 5-year follow-up. There are no head-to-head trials with fracture outcomes.
3. What is the comparative safety of different hormone therapy preparations for short- term use (<5 years)?FairPlacebo-controlled trials
Estrogen preparations increased breast tenderness and vaginal bleeding. Endometrial hyperplasia did not occur in the few studies that examined this outcome.
4. What is the comparative safety of different hormone therapy preparations for long-term use (5 or more years)?Fair: based on data from WHI and HERS/HERS II; moderate to high drop-out rates.In the WHI, CEE/MPA increased CHD events in women without known CHD, but CHD mortality was not increased at 5.2-year follow- up. WHI, CEE-only and the HERS study did not find an increase in CHD events. Risk of stroke and venous thromboembolism were increased in the WHI with both CEE and CEE/MPA. Breast cancer was increased with CEE/MPA, but not in the HERS trial and not in the CEE-only study. The incidence of probable dementia increased with CEE/MPA usage, this effect was not seen with CEE only.

Small studies examining cognitive function found no differences between estrogen treatment and placebo.
5. Are there subgroups of patients for which one medication or preparation is more effective or associated with fewer adverse effects?Fair: based on data from WHI; moderate to high drop-out rates.In the WHI (CEE and CEE/MPA) study, the positive effect of treatment on symptoms was similar in women 50–54 compared to older women. Women with and without CHD at baseline had a similar increase in risk of CHD events in the WHI CEE/MPA study.

From: Summary

Cover of Drug Class Review: Hormone Therapy for Postmenopausal Women or Women in the Menopausal Transition Stage
Drug Class Review: Hormone Therapy for Postmenopausal Women or Women in the Menopausal Transition Stage: Final Report Update # 3 [Internet].
Nelson HD, Nygren P, Freeman M, et al.
Portland, (OR): Oregon Health & Science University; 2007 Oct.
Copyright © 2007, Oregon Health & Science University, Portland, Oregon.

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