Stopping Postmenopausal Hormones: What Women Experience
Abstract & Commentary
By Joseph E. Scherger, MD, MPH, Clinical Professor, University of California, San Diego
Dr. Scherger reports no financial relationship to this field of study.
Synopsis: When the Women’s Health Initiative (WHI) study was stopped, 9351 postmenopausal women stopped taking combined estrogen and progestin or placebo. The WHI investigators followed up on these women with a survey at 8 to 12 months after stopping the pills. More that half of the women taking the hormones developed vasomotor symptoms and, in about 21%, these symptoms were moderate to severe.
Source: Ockene JK, et al. Symptom experience after discontinuing use of estrogen plus progestin. JAMA. 2005;294: 183-193.
The Women’s Health Initiative (WHI) study dramatically changed the recommendations for postmenopausal women taking hormone replacement therapy (HRT). This 40-center, randomized, controlled trial trumped the many observational studies by demonstrating that HRT increases the risk of heart disease and some cancers instead of the opposite.1 The risk/benefit ratio tilted the other way seemingly overnight.
Many of these same investigators from Harvard and other leading study sites performed a follow-up survey on 8405 women who were taking either combined estrogen and progestin or placebo 8 to 12 months after stopping therapy. The total eligible N was 9351, so the response rate was excellent. It is important to remember that the WHI study women were older and generally in their 60s. The mean age of these women surveyed was 69.1 years. Moderate-to-severe vasomotor symptoms were reported in 21.2% of the women taking the hormones and in 4.8% of the women taking placebo. Some symptoms after stopping the pills were reported in 55.5% of women taking the hormones and in 21.3% of women taking the placebo. The reported vasomotor symptoms are impressive in both the women who were taking hormones and who were taking placebo.
Ockene and colleagues caution physicians that symptoms after stopping HRT are common and women should be advised of this and guided in therapy. They advise physicians to be versed in complementary and alternative treatments for postmenopausal vasomotor symptoms.2
Commentary
The popular press and Wyeth, maker of PREMARIN and PREMPRO, are jumping all over these findings. The Associated Press newspapers in mid July, 2005 reported on menopausal celebrities restarting their hormones.3 Cheryl Ladd, star of the 1970s TV series “Charlie’s Angels,” is declaring on TV ads that after months of horrible hot flashes and disrupted sleep, she resumed taking a hormone drug after consulting her physician. The ad is paid for by Wyeth and Ms. Ladd directs women to a web site, www.talkingtoyourdoctor.com, also sponsored by Wyeth.
There is general agreement that HRT should be given primarily to treat troublesome vasomotor symptoms. The lowest effective dose should be used for the shortest time needed to control symptoms. This leaves rooms for wide variation and interpretation of need. The demise of postmenopausal HRT, predicted by many, certainly seems premature. The WHI study was widely considered to be “the study to end all studies.” It now looks like WHI is only part of a never ending controversy.
What I find interesting in the report of this study and the accompanying editorial by Diana Petitti from Kaiser4 is the lack of any mention of hormone types.
The Wyeth products are conjugated equine estrogens and synthetic progestin. While quality research is lacking, there is a growing trend to using human identical hormones such as estradiol and progesterone. For other endocrine disorders such as diabetes mellitus and hypothyroidism, previous animal source hormones have been replaced by their human forms. Is this important for the complete effects of ovarian hormones on the body’s receptor sites? Are some of the negative effects of HRT due to the hormones chosen in the WHI study? The hypothesis certainly seems plausible.
The use of postmenopausal HRT will always be controversial since it includes personal and ethical issues involving normal aging, symptom control vs overall health risk, and control between patient and physician. Shared decision making between patient and physician is now the recommended approach to areas of treatment in which there is controversy and an uncertain risk and benefit analysis. Postmenopausal women should make their own informed decisions about HRT. Our job as physicians is to guide them with as little bias as possible, and direct our patients to good sources of information.
I was told early in my career that being a good physician, albeit the art of medicine, was in sometimes being a good chameleon. Our patients include women who accept the natural processes of menopause and are happy to adapt to normal body changes, women who want to preserve premenopausal youthful characteristics as long as possible, and those in between. Our patients include women who sail through menopause with little or symptoms and those who have severe changes, and those in between. Knowing and supporting our patients as individuals is nowhere in medicine more delicate and complex than in discussing and managing the menopausal transition and beyond.
References
1. Writing Group for the WHI. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002; 288:321-333.
2. Scherger J. Today’s Therapeutic Options for Hot Flashes. Internal Medicine Alert. 2004;26(3):17-18.
3. www.signonsandiego.com/uniontrib/20050718/news_1n18drugs.html.
4. Petitti DB. Some surprises, some answers, and more questions about hormone therapy: further findings from the Women’s Health Initiative. JAMA. 2005; 294:245-246.
When the Women’s Health Initiative (WHI) study was stopped, 9351 postmenopausal women stopped taking combined estrogen and progestin or placebo. The WHI investigators followed up on these women with a survey at 8 to 12 months after stopping the pills. More that half of the women taking the hormones developed vasomotor symptoms and, in about 21%, these symptoms were moderate to severe.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.