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The Journals of Gerontology Series A: Biological Sciences and Medical Sciences 60:460-462 (2005)
© 2005 The Gerontological Society of America

Use of Hormone Replacement Therapy by Postmenopausal Women After Publication of the Women's Health Initiative Trial

Jose Ness1, Wilbert S. Aronow2,, Erin Newkirk1 and Deanna McDanel1

1 Department of Medicine, University of Iowa School of Medicine, Iowa City.
2 Department of Medicine, Divisions of Cardiology and Geriatrics, New York Medical College, Valhalla.

Address correspondence to Wilbert S. Aronow, MD, Cardiology Division, New York Medical College, Macy Pavilion, Room 138, Valhalla, NY 10595. E-mail: wsaronow{at}aol.com


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 References
 
Background. After publication of the Women's Health Initiative (WHI) trial in July 2002, many physicians discontinued hormone replacement therapy (HRT) in most of their postmenopausal patients. However, little is known about the women who remain on HRT.

Methods. We performed a retrospective chart analysis of 1000 postmenopausal women seen at an internal medicine practice to establish the prevalence of continued HRT use after publication of the WHI trial, determine the reasons for its use, and establish the prevalence of conditions adversely affected by HRT.

Results. Of 1000 postmenopausal women, mean age 66 ± 9 years, 445 (45%) had used or still were on HRT (HRT users) at the time of the review. Of 445 HRT users, 159 (36%) were still on HRT, whereas 286 women (64%) had discontinued therapy. Of the latter, 181 women (63%) had stopped using HRT after the WHI publication, and 136 women (48%) reported the study as the direct cause of HRT cessation. Of the 159 women still on HRT, the main reasons for continued use were severe menopausal symptoms in 39 women (25%), osteoporosis or osteopenia in 31 women (20%), and patient preference in 20 women (13%). Of the 159 women still on HRT, 41 had atherosclerotic disease (26%), 7 had previous venous thromboembolic disease (4%), 8 had a history of breast cancer (5%), and 12 had a family history of breast cancer (8%).

Conclusions. Despite the widespread impact of the WHI trial results, many women still remained on HRT in an internal medicine practice for a variety of reasons and despite relative contraindications to its use.

THE publication of the Women's Health Initiative (WHI) trial results (1) in July, 2002 led to remarkable changes in physicians' and patients' attitudes toward hormone replacement therapy (HRT). Repercussions have been worldwide and characterized by a significant decline in the prescription and use of HRT (2–4).

HRT had been previously regarded as an intervention with great potential benefit in terms of cardiovascular disease prevention and osteoporosis treatment. The results of the Heart and Estrogen/Progestin Replacement Study (5) raised significant concerns regarding the efficacy and safety of HRT in women with coronary artery disease (CAD), but HRT retained its role among postmenopausal women without CAD. Publication of the WHI results led to a comprehensive re-evaluation of the role played by HRT in the management of older women, not only refuting the cardiovascular benefit of HRT, but also demonstrating an increased risk of cardiovascular events among HRT users (1,6,7). The increased risk of breast cancer and thromboembolic events associated with HRT was clearly confirmed (1,8), and no evidence of cognitive improvement was detected in a later analysis (9). In contrast, the beneficial impact of HRT on osteoporosis and fracture risk was shown (10), and HRT remains a very effective strategy for the successful management of postmenopausal symptoms (11).

Health care providers were then faced with the considerable challenge of advising their postmenopausal patients regarding HRT and its hazards. The ensuing discontinuation of therapy in large numbers of patients amidst the extensive media coverage brought about by the WHI study suggested decreasing numbers of HRT users (2–4).

However, despite the impact of the WHI trial results, there are still women using HRT. Little is known about the reasons behind their decision to continue on HRT and about the prevalence of conditions adversely affected by HRT in this group.


   METHODS
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 Abstract
 Methods
Results
 Discussion
 References
 
We performed a retrospective chart analysis of 1000 postmenopausal women (mean age 66 ± 9 years) seen consecutively at a large academic general internal medicine clinic between September, 2002 and February, 2003 to establish the prevalence of continued HRT use after publication of the WHI trial, determine the reasons for its use, and establish the prevalence of conditions adversely affected by HRT. HRT use was identified through a review of the women's present and past medication lists and included both use of estrogen alone and in combination with progestin. Whenever HRT was discontinued, a thorough review of the available data was undertaken to determine whether such a decision arose as a direct result of the WHI data. Furthermore, in the case of women still on HRT after the WHI publication, the reason for continuation of HRT was sought. Finally, the prevalence of the major conditions representing at least relative contraindications to HRT (CAD, atherothrombotic cerebrovascular disease, peripheral arterial disease, deep venous thrombosis and/or pulmonary embolism, personal history of breast cancer, and family history of a first-degree relative with breast cancer) was investigated. Chi-square tests were used for comparison of dichotomous variables among groups.


   RESULTS
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 Abstract
 Methods
 Results
Discussion
 References
 
Of the 1000 postmenopausal women, 941 (94%) were Caucasian. Of the 1000 women, 555 (56%) had never been on HRT, and 445 (45%) had been or still were on HRT (HRT users). Of the 445 HRT users, 159 (36%) were still on HRT at the time of the review, whereas 286 women (64%) had discontinued HRT. One hundred and fifty-two of 941 white women (16%) and 7 of 59 nonwhite women (12%) were still on HRT (p not significant). The mean age was 65 ± 9 years (range 50–85 years) in women on HRT and 66 ± 9 years (range 50–95 years) in women not on HRT (p not significant). Of 159 women still on HRT, 106 (67%) were on estrogen alone, and 53 women (33%) were on estrogen plus progestin.

Of the 286 women who had stopped HRT, 152 (53%) had been on estrogen plus progestin and 134 women (47%) were on estrogen alone. Of the 286 women who had stopped HRT, 181 women (63%) had discontinued HRT after publication of the WHI data, and 136 women (48%) had the study results as the major documented cause for HRT discontinuation. Table 1 lists the main causes for HRT discontinuation among the 286 women who had previously used HRT. There was no significant difference in any of these results between women >65 years and those ≤65 years. The mean duration of HRT use was 5 ± 5 years in women who stopped HRT and 5 ± 5 years in women who continued HRT (p not significant).


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  		Table 1. Main Reason for Discontinuation of Treatment Among 286 Previous Users of Hormone Replacement Therapy (HRT).

 
Table 2 lists the main documented reasons for persistent HRT. Table 3 compares the prevalence of conditions demonstrated to be adversely affected by HRT between women still on HRT and those not on HRT at the time of the review: Table 3 also lists levels of statistical significance.


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  		Table 2. Main Reason for Continued Therapy Among 159 Ongoing Users of Hormone Replacement Therapy (HRT).

 

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  		Table 3. Prevalence of Atherosclerotic Disease [Coronary Artery Disease (CAD), Stroke, or Peripheral Arterial Disease (PAD)], Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE), Personal History of Breast Cancer, and Family History of Breast Cancer Among Women Still Using and Not Using Hormone Replacement Therapy (HRT).

 

   DISCUSSION
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 Abstract
 Methods
 Results
 Discussion
References
 
The data reported initially by the Heart and Estrogen/Progestin Replacement Study and subsequently by WHI have encouraged health care providers to change the management of their postmenopausal patients. A review of the available literature confirms the lack of benefit associated with HRT in the prevention and treatment of atherosclerotic vascular disease and shows further proof of the harm linked to this therapy (1,6–9). The consequences of these studies may be recognized in our study. More than 60% of postmenopausal estrogen users in our study population had discontinued HRT, and more than half of these discontinuations were directly attributable to publication of the WHI trial. Seventy-five percent of the women who discontinued HRT after the WHI data were published did so as a direct result of a medical recommendation arising from that study. Furthermore, an additional 10% requested that therapy be stopped due to information received regarding the trial. Finally, a significant percentage of women still on HRT were actually on a downward taper with the eventual aim of stopping HRT. The duration of use of HRT was not a factor in the discontinuation of HRT.

Despite the widely publicized data indicating that there appear to be no cardiovascular benefits to HRT, many women still opted to remain on HRT. In our study, approximately 16% of all postmenopausal women were still on HRT (or 14%, if one excludes women on a downward taper). The reasons for such behavior merit investigation. HRT still represents the most effective therapeutic strategy for menopausal symptoms, aids in the management of osteoporosis (10), and has been shown to reduce the risk of colon cancer (1). In our sample of 1000 postmenopausal women, the leading cause of remaining on HRT was the desire to treat severe menopausal symptoms, followed by the need to treat osteoporosis/osteopenia and by patient preference. The latter category was used when patients requested to be kept on HRT, but the precise reasons were not documented in the charts. Approximately 8% of women still on HRT had failed an attempt at therapy discontinuation, with recurrence of menopausal symptoms.

Several trials have pointed to a relationship between improved quality of life after menopause and use of HRT (11–17). However, in a recent analysis of WHI quality-of-life data, no such relationship was identified (18).

In almost one fifth of the women still on HRT, no evidence of a discussion regarding HRT risks and benefits was found. This may reflect insufficient documentation or actual absence of the necessary conversation between provider and patient regarding HRT.

The prevalence of atherosclerotic disease was significantly lower in the group of women still on HRT. This could reflect an ongoing post-WHI selection process as physicians should be less likely to prescribe HRT in women with a history of CAD, cerebrovascular disease, or peripheral arterial disease. However, 26% of women still on HRT had a history of atherosclerotic disease and would be at a higher risk for cardiovascular complications. The prevalence of deep venous thrombosis or pulmonary embolism, personal history of breast cancer, and family history of breast cancer was also similar in patients on HRT and not on HRT.


   Footnotes
 
Decision Editor: John E. Morley, MB, BCh

Received December 10, 2003

Accepted January 14, 2004


   References
Top
 Abstract
 Methods
 Results
 Discussion
 References
 

  1. Writing Group for the Women's Health Initiative Investigators. 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.[Abstract/Free Full Text]
  2. Ettinger B, Grady D, Tosteson A, Pressman A, Macer J. Effect of the Women's Health Initiative on women's decisions to discontinue postmenopausal hormone therapy. Obstet Gynecol. 2003;102:1225-1232.[Abstract/Free Full Text]
  3. Lawton B, Rose S, McLeod D, Dowell A. Changes in use of hormone replacement therapy after the report from the Women's Health Initiative: cross sectional survey of users. BMJ. 2003;327:845-846.[Free Full Text]
  4. Austin PC, Mamdani MM, Tu K, Jaakkimainen L. Prescriptions for estrogen replacement therapy in Ontario before and after publication of the Women's Health Initiative study. JAMA. 2003;289:3241-3242.[Free Full Text]
  5. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280:605-613.[Abstract/Free Full Text]
  6. Manson JE, Hsia J, Johnson KC, et al. Women's Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003;349:523-534.[Abstract/Free Full Text]
  7. Wassertheil-Smoller S, Hendrix SL, Limacher M, et al. WHI Investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA. 2003;289:2673-2684.[Abstract/Free Full Text]
  8. Chlebowski RT, Hendrix SL, Langer RD, et al. WHI Investigators. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative randomized trial. JAMA. 2003;289:3243-3253.[Abstract/Free Full Text]
  9. Shumaker SA, Legault C, Rapp SR, et al. WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003;289:2651-2662.[Abstract/Free Full Text]
  10. Cauley JA, Robbins J, Chen Z, et al. Women's Health Initiative Investigators. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial. JAMA. 2003;290:1729-1738.[Abstract/Free Full Text]
  11. MacLennan A, Lester S, Moore V. Oral estrogen replacement therapy versus placebo for hot flushes: a systematic review. Climacteric. 2001;4:58-74.[Medline]
  12. Gelfand MM, Moreau M, Ayotte NJ, Hilditch JR, Wong BA, Lau CY. Clinical assessment and quality of life of postmenopausal women treated with a new intermittent progestogen combination hormone replacement therapy: a placebo-controlled study. Menopause. 2003;10:29-36.[Medline]
  13. Haines CJ, Yim SF, Chung TK, et al. A prospective, randomized, placebo-controlled study of the dose effect of oral oestradiol on menopausal symptoms, psychological well being, and quality of life in postmenopausal Chinese women. Maturitas. 2003;44:207-214.[Medline]
  14. Genazzani AR, Nicolucci A, Campagnoli C, et al. Progetto Donna Qualita della Vita Working Group. Assessment of the QoL in Italian menopausal women: comparison between HRT users and non-users. Maturitas. 2002;42:267-280.[Medline]
  15. Hall G, Pripp U, Schenck-Gustafsson K, Landgren BM. Long-term effects of hormone replacement therapy on symptoms of angina pectoris, quality of life and compliance in women with coronary artery disease. Maturitas. 1998;28:235-242.[Medline]
  16. Wilson DH, Taylor AW, MacLennan AH. Health status of hormone replacement therapy users and non-users as determined by the SF-36 quality-of-life dimension. Climacteric. 1998;1:50-54.[Medline]
  17. Zethraeus N, Johannesson M, Henriksson P, Strand RT. The impact of hormone replacement therapy on quality of life and willingness to pay. Br J Obstet Gynaecol. 1997;104:1191-1195.[Medline]
  18. Hays J, Ockene JK, Brunner RL, et al. Women's Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med. 2003;348:1839-1854.[Abstract/Free Full Text]



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