Ten years ago the bottom dropped out of the use of estrogens and progestogens (EPT) for menopausal hot flashes and prevention of chronic disease. Gross exaggeration and misrepresentation of breast cancer findings in the WHI terrified women and sent them searching for alternatives.
Fortunately good research continued, and this week 2 major studies were reported. Both presented findings that should be truly reassuring to women, and highlight the need for major professional organizations to once again revisit their recommendations for use of hormones after menopause.
Let me first describe the studies and their findings, and then give you my read of where we now stand.
1. KRONOS EARLY PREVENTION STUDY (KEEPS) RANDOMIZED TRIAL
- 727 women average age 52.7, within 3 years of menopause
- Randomized prospective placebo-controlled study
- Duration 4 years
- Study medications: cyclic estradiol patch or conjugated equine estrogens (CEE) and micronized progesterone
- Primary endpoints – intima media thickness (IMT) and coronary artery calcium (CAC). Additional outcomes include quality of life (QOL) and cognition
- At this time we only have the preliminary reports presented to the media and at the October Annual Scientific Meeting of NAMS. The following is a brief summary of the study:
- Reduced symptoms on both hormone types
- Improved bone mineral density
- Significant improvement in sexual function (lubrication, decreased pain)
- Lipid markers favorable for oral except triglycerides
- IMT and CAC – no differences
- No statistical differences in breast cancer, endometrial cancer, MI, TIA, stroke or VTE but #’s small
- Cognition – no adverse or beneficial effects
- QOL – improvement on the Utian global QOL scale
2. DANISH OSTEOPOROSIS STUDY (DOPS)
Published in the British Medical Journal last week, this is a significant study because of its duration and that women, unlike in the WHI, were entered into the study on average at age 50 and around 3 months after menopause:
- 1006 women average age 50, recently postmenopause
- Randomized prospective controlled open-label study
- Duration 11 years with a further 6 years follow up
- Study medications: cyclic estradiol and norethisterone acetate
- Primary endpoints – mortality, heart failure, myocardial infarction
The results of 10 years continuous therapy showed the following results:
- Significant reduction in mortality, heart failure, and myocardial infarction
- No apparent increase in risk of cancer, venous thromboembolism, or stroke
- Previously this group had reported the major benefit of bone sparing and reduction in all fractures.
WHAT DOES THIS MEAN FOR WOMEN NOW?
The combination of the WHI results in women under age 60 and the KEEPS and DOPS study now present a uniform message. For women starting estrogen or estrogen-progestogen combinations within 10 years of menopause and having a clear indication for therapy, reassurance is the key word. The safety profile is good and the efficacy side is excellent.
In future columns I will address potential benefits and potential risks in detail.
In the interim, enjoy good news for once, and have a great week!
Wulf Utian MD PhD DSc, Author; CHANGE YOUR MENOPAUSE – Why one size does not fit all. https://www.amazon.com/Change-Your-Menopause-size-does/dp/0982845723/