In March 2007, the North American Menopause Society (NAMS) issued an updated evidence-based position statement on the risks and benefits of hormone therapy (HT) in peri- and post-menopausal women.1 This article will briefly review the major conclusions of that position statement and review three new reports from the Women’s Health Initiative (WHI) published after the NAMS position statement.2–4 The objective is to update clinicians on current recommendations on the use of HT and to assess, together with the preceding article in this supplement by Hodis, emerging data that will inform future recommendations.
TAKE-HOME POINTS FROM THE UPDATED NAMS POSITION STATEMENT
The 2007 NAMS position statement on HT was developed by 14 expert clinicians and researchers who used previous NAMS position statements on the topic from 2002, 2003, and 2004 as a basis. The experts then reviewed all relevant subsequent evidence from a comprehensive literature search to determine areas of consensus and nonconsensus. Twenty-four areas of consensus and two areas of nonconsensus were identified, which represented a clear increase in consensus relative to the prior NAMS position statements. Thirty-two areas were identified as requiring further research.
Key recommendations and observations from the 2007 NAMS position statement are cited below, in many cases verbatim or near verbatim to preserve the intent.1
Highlights of the NAMS position statement
NAMS proposes adoption of the following terminology:
- Estrogen therapy (ET) for use of unopposed estrogen
- Estrogen-progestogen therapy (EPT) for combined use of estrogen and progestogen
- Hormone therapy (HT) to include both ET and EPT
- Progestogen to include both progesterone and progestins.
Indications for HT
- Treatment of moderate to severe vasomotor symptoms
- Treatment of moderate to severe vulvovaginal symptoms. When ET is being used only for this symptom, NAMS recommends local (vaginal) delivery.
Use of a progestogen
- Because the primary purpose of progestogen use is to prevent the endometrial cancer associated with unopposed estrogen, only women with a uterus should take a progestogen along with estrogen.
- Lack of endometrial safety data prevents NAMS from recommending long-cycle progestogen (eg, 12 to 14 days every 3 to 6 months), progestogen intrauterine systems, or low-dose estrogen without progestogen.
- A progestogen is usually not necessary with use of low-dose vaginal estrogen.5 However, separate from the NAMS statement is a Cochrane review of the use of vaginally administered estrogens that recommends further investigation of long-term endometrial safety with use of vaginal estrogen beyond 6 months.6
Cardiac and cerebrovascular disease
- HT is not recommended for prevention of coronary heart disease (CHD) at any age, pending new data to the contrary.
- HT should not be used for prevention of stroke and should be discouraged in women who have an increased risk of stroke.
- HT increases the risk of venous thrombosis and venous thromboembolism (VTE).
- Both ET and EPT reduced the risk of incident diabetes mellitus requiring treatment (by 12% and 21%, respectively, relative to placebo in the WHI).
- Evidence is insufficient to recommend HT solely for the prevention of diabetes mellitus.
- EPT increased the risk of breast cancer in the WHI, but ET did not.
- Both ET and EPT increase breast cell proliferation, breast pain, and mammographic density. Diagnosis of cancer may be delayed.
- Both ET and EPT reduce the risk of postmenopausal fractures.
- HT is an option for reducing the risk of osteoporosis after the risks and benefits are weighed against those of other therapies.
Premature menopause and premature ovarian failure
- The absolute risks posed by ET and EPT may be lower in women with premature menopause or premature ovarian failure because of the lower incidence of CHD, stroke, and VTE in younger women. The risk-benefit ratio of HT is likely to be more favorable in this younger age group, but this has not yet been demonstrated.
Extended use of HT
- Extended use of HT may be considered in women who decide that menopausal symptom relief outweighs the risks of HT, particularly after an attempt to stop HT has failed.
- Extended use may be appropriate for women with vasomotor symptoms at high risk of osteoporosis-related fracture.
- Extended use may be considered for the prevention of further bone loss in women with established low bone mass when other therapies are contraindicated or are not well tolerated.
Caution on use of “bioidentical” hormones
- In the absence of further data, compounded “bioidentical” hormone preparations should be presumed to carry the known risks and benefits of HT.
- The lack of regulatory oversight with regard to purity and consistency of bioidenticals prompts caution in their use.
Areas of nonconsensus
The NAMS panel did not reach consensus on the best way to discontinue HT or on the relative safety of continuous versus sequential use of progestogen along with estrogen. Lack of data and conflicting data prevented consensus in these two areas.