Changing use of hormone therapy among minority women since the Women's Health Initiative

OBJECTIVE: There has been a significant shift in the use of hormone therapy (HT) among nonminority women since the publication of results of the Women's Health Initiative (WHI). Little is known about how the WHI results affected minority populations. This survey measured patterns of HT use among inner city women after publication of the WHI results, identified factors involved in the decision to continue or discontinue HT, and characterized the symptom burden and the experience of women who attempted to discontinue HT. DESIGN: We conducted a cross-sectional survey of 101 English- and Spanish-speaking women in an inner city general internal medicine clinic from August 2003 to April 2004. All women had been taking HT at the time of the publication of the WHI results. The survey included questions on patient-reported experience with HT, symptoms of menopause, and use of alternative treatments. RESULTS: Overall, 101 of 142 (71%) eligible women agreed to participate. The mean age of participants was 60 years; 43% were African American and 46% were Hispanic. The mean duration of HT use was 9.6 years. Three quarters (74%) had heard about the WHI findings, and 87% had attempted to stop taking HT after their publication. The most common reason for attempting to stop HT was concern about an increased risk of cancer or a general increase in risk to health. Of those who stopped HT, the vast majority (85%) reported vasomotor symptoms, and 26% restarted HT, mostly to treat those symptoms. CONCLUSIONS: Nearly all minority women in this small sample attempted to stop HT use after the results of the WHI were published. Restarting HT for treatment of symptoms was common.     

Recent reversal of trends in hormone therapy use in a European population

OBJECTIVE: The impact of the Women's Health Initiative (WHI) randomized trial results published in July 2002 indicating that hormone therapy (HT) is potentially harmful for the heart and the mammary gland of naturally postmenopausal women was assessed for the first time in a European population. DESIGN: This study continuously monitored HT use from 1994 through 2003 in a population-based random sample of 5,758 women aged 35 to 74 years residing in Geneva (city and canton), Switzerland, yielding 1,938 naturally postmenopausal women with an intact uterus and 206 artificially postmenopausal women. Women in the former subgroup weighed substantially less than their WHI trial counterparts but were not otherwise at lower risk for cardiovascular disease. RESULTS: Among the naturally postmenopausal women with an intact uterus, current HT use increased from 29% to 46% (P < 0.0001) through July 2002 and then decreased abruptly to 31% in 2003. Current HT use remained stable (range, 38%-46%; trend P = 0.92) among the artificially postmenopausal women. CONCLUSIONS: Successive annual increases from 1994 through 2001 in the prevalence of current HT use by postmenopausal women living in Geneva were dramatically reversed to the level in 1994 just after the results of the WHI trial were published, but only for naturally postmenopausal women with an intact uterus. Approximately one in three of the latter women who stopped using HT may also have lost its beneficial effects on bone health.     

WHI and aftermath: looking beyond the figures

In contrast to the preliminary results of the WHI conjugated equine estrogen plus medroxyprogesterone acetate arm published 2 years ago, the final results from that arm as well as preliminary data from the conjugated equine estrogen-only arm showed that the panic over hormone treatment for menopausal women was unjustified. Moreover, the data for women younger than 60-years-old was even more reassuring. WHI was a study on elderly women starting hormones under the assumption that it may confer cardioprotection. The results of WHI should not be generalized and should not be a reason to withhold hormones in symptomatic perimenopausal or early post-menopausal women who could benefit from that therapy.     

Prior hormone therapy and breast cancer risk in the Women's Health Initiative randomized trial of estrogen plus progestin

OBJECTIVES: To assess the extent to which prior hormone therapy modifies the breast cancer risk found with estrogen plus progestin (E+P) in the Women's Health Initiative (WHI) randomized trial. METHODS: Subgroup analyses of prior hormone use on invasive breast cancer incidence in 16,608 postmenopausal women in the WHI randomized trial of E+P over an average 5.6 years of follow-up. RESULTS: Small but statistically significant differences were found between prior HT users and non-users for most breast cancer risk factors but Gail risk scores were similar. Duration of E+P use within the trial (mean 4.4 years, S.D. 2.0) did not vary by prior use. Among 4311 prior users, the adjusted hazard ratio (HR) for E+P versus placebo was 1.96 (95% confidence interval [CI]: 1.17-3.27), significantly different (p=0.03) from that among 12,297 never users (HR 1.02; 95% CI: 0.77-1.36). The interaction between study arm and follow-up time was significant overall (p=0.01) and among never users (p=0.02) but not among prior users (p=0.10). The cumulative incidence over time for the E+P and placebo groups appeared to cross after about 3 years in prior users, and after about 5 years in women with no prior use. No interaction was found with duration (p=0.08) or recency of prior use (p=0.17). Prior hormone use significantly increased the E+P hazard ratio for larger, more advanced tumors. CONCLUSION: A safe interval for combined hormone use could not be reliably defined with these data. However, the significant increase in breast cancer risk in the trial overall after only 5.6 years of follow-up, initially concentrated in women with prior hormone exposure, but with increasing risk over time in women without prior exposure, suggests that durations only slightly longer than those in the WHI trial are associated with increased risk of breast cancer. Longer-term exposure and follow-up data are needed.     

New evidence regarding hormone replacement therapies is urgently required transdermal postmenopausal hormone therapy differs from oral hormone therapy in risks and benefits

Controversies about the safety of different postmenopausal hormone therapies (HTs) started 30 years ago and reached a peak in 2003 after the publication of the results from the Women Health Initiative (WHI) trial and the Million Women Study (MWS) [Writing group for the women's health initiative investigations. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002;288:321-33; Million women study collaborators. Breast cancer and hormone-replacement therapy in the million women study. Lancet 2003;362:419-27]. The single HT formulation used in the WHI trial for non hysterectomized women-an association of oral conjugated equine estrogens (CEE-0.625 mg/day) and a synthetic progestin, medroxyprogesterone acetate (MPA-2.5 mg/day)-increases the risks of venous thromboembolism, cardiovascular disease, stroke and breast cancer. The MWS, an observational study, showed an increased breast cancer risk in users of estrogens combined with either medroxyprogesterone acetate (MPA), norethisterone, or norgestrel. It is unclear and questionable to what extent these results might be extrapolated to other HRT regimens, that differ in their doses, compositions and administration routes, and that were not assessed in the WHI trial and the MWS. Significant results were achieved with the publication of the WHI estrogen-only arm study [Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712] in which hormone therapy was reserved to women who had carried out hysterectomy. What emerged from this study will allow us to have some important argument to develop.     

The Women’s Health Initiative Conundrum

Summary The WHI has been designed to evaluate the metabolic risks and benefits of Estrogen/Progestagen Therapy (HT) or Estrogen Therapy (ET) in women in their later postmenopause. It has not been designed to study the effect of HT or ET on symptomatic peri- and early postmenopausal women. Furthermore, the selection criteria used in the WHI are not congruent with the profiles of women treated in daily medicine by HT/ET: women starting HT/ET in clinical routine are younger, less obese and healthier than the WHI population. Therefore, the results and the risk-benefit-conclusions of the WHI cannot be applied to normal symptomatic peri- and immediately postmenopausal women, and even less to women with early (40–50 years) or premature (40yrs.) menopause.     

Prevalence and correlates of hormonal therapy among Israeli women in the post-WHI era

OBJECTIVES: Following the results of recent randomized controlled trials on the risks and benefits of the long-term use of hormonal therapy (HT), practice guidelines regarding HT use have been revised. The aim of the study is to assess the prevalence and the correlates of HT use in Israel in 2003. METHODS: This is a cross-sectional study, conducted on a representative sample of the general population in Israel aged 21 years and over. The study questionnaire is based on the European Health Interview Survey (EUROHIS) project, aimed to develop uniform study tools, to enable international comparisons. The current module of the survey focused on women's health, and telephone interviews were conducted with 1396 women by trained interviewers in the year 2003. RESULTS: Out of a total of 1396 participants, 535 were defined as peri- or postmenopausal (38%). Of them, 9.9% were currently using HT (11.7% and 2.9% among the Jewish and Arab participants, respectively), and their mean age (S.D.) was 57.7 (6.5) years. Mean duration of HT use was 8.0 (5.5) years. Treatment of menopausal symptoms was the most common reason for HT use (69.2%). Significant correlates of HT use were age, being secular and having seen a gynecologist in the previous 12 months. CONCLUSIONS: Current HT use rates reported are lower than those reported 3 years ago for Israeli women. Awareness of both physicians and patients to the WHI results (2002), may have accounted for this trend, at least partially.     

Attitudes towards the menopause and hormone therapy over the turn of the century

Objective

To assess attitudes and beliefs about the menopausal transition in a population of peri- and postmenopausal women, and if these attitudes differed before and after publication of studies on risks and benefits with hormone therapy (HT).

Materials and methods

In 1999 and 2003 all women aged 53 and 54 years in the community of Linköping, Sweden, were sent a questionnaire about use of HT, menopausal status and attitudes regarding menopause and HT.

Results

Most women regarded menopause as a natural process characterized by both hormonal deficiency and aging and these views did not differ between 1999 and 2003. A majority of women thought that significant climacteric symptoms were a good reason to use HT, but not that women without symptoms should use HT. The fraction of women who supported HT use was, however, significantly lower in 2003 than in 1999. Most women agreed that menopause leads to increased freedom and that it is a relief not to have to think about contraception and pregnancies.

Conclusions

Most Swedish women had a mainly biological view on menopause but nevertheless they thought that only women with climacteric symptoms should use HT. Women's attitudes towards HT have changed after recent reports on risks from long-term use of HT whereas the attitudes towards the menopausal transition were stable. Other factors than attitudes towards menopause affect women's actual use of HT. Probably women's and health care provider's apprehension of the risk-benefit balance of HT use is one such factor.     

Changes in women's attitudes towards and use of hormone therapy after HERS and WHI

Objectives:To assess changes in women's attitudes towards risk and benefits of, and use of hormone treatment in the menopausal transition (HT) before and after Heart and Estrogen/Progestin Replacement Study (HERS) and the oestrogen and progestin trial of Women's Health Initiative (WHI).Methods:Postal questionnaires to all women 53 and 54 years of age in a Swedish community in 1999 (n = 1.760) and 2003 (n = 1.733). Data on sales of HT were collected from the database of the National Corporation of Swedish Pharmacies.Results:The fraction of women reporting current use of HT fell from 40.5 to 25.3% (p < 0.001, χ²-test) both by fewer women starting and more women discontinuing treatment. This corresponded to a decrease in dispensation of HT in Linköping and nationwide for the same age group. The fraction of women who had tried complementary treatment for climacteric discomfort, increased from 9.6 to 18.1% for natural remedies (p < 0.001, χ²-test).Women perceived HT as more risky and less beneficial in 2003 as compared with 1999 (both p < 0.001, χ²-test). The most frequent source of information about HT during the last year before the 2003 questionnaire were newspaper or magazines (43.8%) and television or radio (31.7%).Conclusions:The decreased use of HT in the community correlated with pronounced changes in the attitudes towards HT. Media were a more frequent source of information than health care personnel. This indicates that media reports about major clinical studies might have influenced the use of HT among women.     

Personal use of hormone therapy by postmenopausal women doctors and male doctors' wives in Italy after the publication of WHI trial

OBJECTIVE: To describe the prevalence of hormone replacement therapy (HT) use by postmenopausal women doctors and doctors' wives in Italy and to explore the relationship between their personal characteristics and HT use. DESIGN: A total of 500 women doctors and 500 men doctors answering on behalf of their female partners were interviewed by a specialised company in the first months of 2003. Questions were meant to explore medical, behavioural and professional characteristics, personal use of HT, reasons for or against HT use and side effects of HT. The distribution of doctors' specialisation (general practitioners (GPs), gynaecologists, medical oncologists) in the sample interviewed was the same as that of the Italian medical community. RESULTS: Overall, 37% of women doctors and 39% of doctors' wives had ever used HT after menopause, of which 64 and 58%, respectively, were current users. The median duration of HT in the past users was 2.7 years for women doctors and 3.7 for doctors' wives. There were wide differences of HT use according to the type of specialisation: gynaecologists were more willing to use HT (56-59%) than GPs (30-31%) or medical oncologists (16-30%).Vasomotor symptoms (68-69%), followed by the prevention of osteoporosis (28-39%), were the main reasons for commencing HT. The main reasons not to take or to stop HT were the absence or resolution of menopausal symptoms. Only 8% of women doctors and 4% doctors' wives stopped HT after the publication of the WHI data. CONCLUSIONS: In Italy, women doctors/doctors' wives personally use HT much more than postmenopausal general population.