Hormone therapy use and prescription durations of menopausal women in Taiwan: a 5 years' National Cohort study.

OBJECTIVES: To describe the prevalence and associated factors of hormone replacement therapy (HRT)-related utilization in a national representative fixed cohort in Taiwan. METHOD: The study population are women aged 40 years and over in Taiwan. Our data, provided by National Health Research Institutes, are the sampled registry information of 37,315 beneficiaries of National Health Insurance from 2000 to 2004. The dependent variables were HRT-related utilizations, including physician contact, HRT utilization rate/duration/patterns (new, prevalent and discontinue users). The independent variables were age, time, prior co-morbidities and prior utilization pattern. We used generalized estimating equation (GEE) model for repeated measurement analysis. RESULTS: The outpatient contact rates for menopause syndrome were low, though the HRT prescription rate among those who have contact were high. GEE shows that age, time, prior co-morbidities/HRT utilization patterns were significantly associated with all types of HRT-related utilizations, which all declined significantly following the publications of Women's Health Initiative (WHI) in 2002. The magnitudes of reduction, though similar in 2003-2004, were greater for physician contact and HRT durations than that of HRT prescription rate for those have contacts in 2002. Besides, the percentages of new (discontinue) users have already declined (increased) since 2001 although it had not declined until 2003 for the continued users. CONCLUSIONS: WHI publications have great impact on HRT-related utilizations. However, the response of the women was quicker and much drastic than that of the physicians in 2002. Besides, the efforts of the various women's associations before WHI might have some contribution to the declined (increased) of new (discontinued) users.

Economic impact of Tibolone compared with Continuous-Combined Hormone Replacement Therapy in the management of climacteric symptoms in postmenopausal women.

BACKGROUND: Deciding whether to treat postmenopausal women suffering from climacteric symptoms with Continuous Combined Hormone Replacement Therapy (CCHRT) has become increasingly difficult after the release of the Women's Health Initiative results. As a result, development of alternatives to CCHRT is required. Tibolone, which is a synthetic steroid that has estrogenic, progestogenic and androgenic properties, is reported to be a promising alternative. It has been used in Europe, in the same indication as CCHRT, for approximately 20 years but is not yet available in Canada. OBJECTIVE: We carried out a cost-utility analysis comparing a 3-year-treatment course with Tibolone 2.5mg and conjugated equine estrogens (CEE)/medroxyprogesterone acetate (MPA) (0.625 mg/2.5 mg) in the management of postmenopausal women with climacteric symptoms. METHODS: A Markov model, considering persistence, vaginal bleeding and climacteric symptoms, was elaborated to compare the different options in terms of cost and Quality Adjusted Life Years (QALYs), according to a public third-party payer perspective. RESULTS: Compared with CEE/MPA, Tibolone led to an increase in cost (dollars 485 for Tibolone versus dollars 232 for CEE/MPA) and a slight increase in QALYs (2.08 for Tibolone versus 2.05 for CEE/MPA). Consequently, the incremental cost per QALY gained ratio was dollars 9198. CONCLUSION: According to the results, Tibolone seems to be a cost-effective alternative to CEE/MPA. However, those results should be interpreted with caution insofar as the difference in terms of QALY is clinically difficult to value and taking into account the limited data on Tibolone's long-term innocuity.

Endometrial safety assessment of a specific and standardized soy extract according to international guidelines.

OBJECTIVE: To assess the effects of an oral soy isoflavone extract (Phytosoya) on endometrium (evaluated by biopsy and ultrasonography) in postmenopausal women treated for 12 months. DESIGN: A total of 395 postmenopausal women were included in this international prospective, open-label study. The women were treated for 12 months with a specific standardized soy isoflavone extract (total of 70 mg/d). Endometrial biopsy and transvaginal ultrasonography were performed before and after 12 months of treatment according to European guidelines. RESULTS: A total of 301 assessable biopsy specimens were obtained from women treated for 12 months; the results were 99.67% atrophic/inactive endometrium and 0.33% proliferative endometrium. No case of hyperplasia or carcinoma was diagnosed, demonstrating the endometrial safety of this extract (point estimate: 0.0; upper limit of 95% CI: 0.012). Endometrial thickness did not show any increase after 12 months of treatment (2.2 mm at inclusion and 2.12 mm at the end of the study). Only eight women reported some kind of bleeding as an adverse event during the study. CONCLUSIONS: These results of endometrial biopsy and endometrial thickness suggest that daily administration of 70 mg of a specific and standardized isoflavone extract for 12 months does not stimulate the endometrium.

Assessment of the variation in menopausal symptoms with age, education and working/non-working status in north-Indian sub population using menopause rating scale (MRS).

OBJECTIVE: To study the variation of the menopause rating scale (MRS) scores with age, working/non-working and educated/uneducated status in a cohort of north-Indian subpopulation and to look for the possible reasons for the incurred variations. MRS is a well-known and validated instrument for assessing the frequency and intensity of menopausal symptoms. METHOD: A menopause clinic was organized in collaboration with a primary care centre (under the guidance of a gynecologist). A random sample of 208 women aged 35-65 years participated in the study. The MRS scale, a self-administered standardized questionnaire was applied with additional patient related information (age at menopause, level of education, working/non-working and exercising or not). RESULTS: The results were evaluated for psychological (P), somatic (S), and urogenital (U) symptoms. The average age at which menopause set in, in the cohort was found to be 48.7+/-2.3 years (46.4-51 years). Based on the average age at the menopause, the cohort was divided into peri (35-45), menopausal/early menopause (46-51) and the postmenopausal (52-65) groups. A significantly higher % of perimenopausal women (36%) showed a P score of > or =7; while a higher % of postmenopausal showed S score and U score > or =7 (>40%; p< or =0.001). Working women seem to suffer more from psychological symptoms whereas non-working women showed a greater incidence of somatic symptoms. Educated women showed a lower incidence of psychological and somatic symptoms. CONCLUSIONS: Present study indicates that age, level of education and working/non-working status (in a group of women with same socio-cultural background) may also contribute to significant variations in menopausal symptoms.

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.

Quality of life assessment in a chemoprevention trial: fenretinide and oral or transdermal HRT.

BACKGROUND: Oral conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) relief menopause symptoms, but may increase breast cancer risk, while the effects of transdermal estradiol (E2) and MPA are less known. In previous studies, fenretinide decreased second breast malignancies in premenopausal but not in postmenopausal women, suggesting a hormone-sensitizing effect. We have evaluated the quality of life through a self-administered questionnaire during a randomized study of oral CEE or transdermal E2 and fenretinide or placebo. METHODS: A total of 226 postmenopausal women were randomly assigned to either CEE 0.625mg/day and placebo (n=55), or CEE and fenretinide 100mg/bid (n=56), or E2, 50microg/day and placebo (n=59), or E2 and fenretinide (n=56) for 12 months. Sequential MPA 10mg/day was added in all groups. Treatment effects were investigated using a validated questionnaire, the Menopause Quality of Life questionnaire (MENQOL). RESULTS: Oral CEE and transdermal E2 have a comparable activity in reducing menopausal symptoms (p=ns). Both routes ameliorate significantly the symptoms after 1 year of treatment (p<0.0001). Fenretinide does not modify the effects of hormonal replacement therapy. CONCLUSIONS: Oral CEE and transdermal E2 have similar effect on menopausal symptoms relief. The choice of the best estrogen replacement therapy (ERT) route should be decided based on a careful analysis of all the clinical aspects of every subject, considering that transdermal therapy may have a safer effect on the cardiovascular system.

A cost-effectiveness evaluation of two continuous-combined hormone therapies for the management of moderate-to-severe vasomotor symptoms.

OBJECTIVES: After the release of the results of the Women's Health Initiative, an emerging consensus suggests that continuous-combined hormone therapy (CCHT) should be limited to short-term management of moderate-to-severe vasomotor symptoms. This, in turn, raises the important question of the economic value, if any, of short-term CCHT for this indication. We conducted a cost-effectiveness analysis comparing a 1-year treatment course with 1 mg of norethindrone acetate/5 microg of ethinyl estradiol (1/5 NA/EE) or 0.625 mg/day of conjugated estrogens plus 2.5 mg of medroxyprogesterone (0.625/2.5 CEE/MPA) compared with no therapy for the management of moderate-to-severe vasomotor symptoms. DESIGN: A literature-based Markov model was developed to compare these three options' cost and quality-of-life (QOL) benefits. The impact of therapy on vasomotor symptoms and breakthrough bleeding/spotting on the direct costs of care and QOL were considered. RESULTS: Compared with no therapy, CCHTs resulted in net increases in quality-adjusted life-years (QALYs) gained (0.110 for 1/5 NA/NE v 0.104 for 0.625/2.5 CEE/MPA). Net costs (v no therapy) were $167 lower for 1/5 NA/NE compared with 0.625/2.5 CEE/MPA. Cost per QALY gained (compared with no therapy) were $6,200 and $8,200, respectively. Cost-effectiveness was most favorable for individuals with more severe symptoms who were less bothered by breakthrough bleeding/spotting. CONCLUSIONS: A short-term course of CCHT for the sole purpose of managing moderate-to-severe vasomotor symptoms is cost-effective. However, 1/5 NA/NE seemed to be more cost-effective than 0.625/2.5 CEE/MPA. These findings can be used to further refine the role of CCHT and to improve formulary decisions.

Clinical assessment and quality of life of postmenopausal women treated with a new intermittent progestogen combination hormone replacement therapy: a placebo-controlled study.

OBJECTIVE: The aim of this study was to evaluate the effects of a constant-estrogen, intermittent-progestogen hormone replacement regimen (Ortho-Prefest, Ortho-McNeil Pharmaceutical, Raritan, NJ, USA) on menopausal symptoms measured by the Kupperman Index and on quality of life measured by the Menopause Quality of Life-Intervention questionnaire. DESIGN: This was a randomized, double-blind, placebo-controlled multicenter study of 90 days' duration. Nonhysterectomized, postmenopausal women with vasomotor symptoms and at least 6 months' amenorrhea were eligible. On completion of the placebo-controlled portion of the study, participants could elect to receive active treatment for an additional 90 days. RESULTS: The study enrolled 119 participants, 59 and 60 in the Prefest and placebo groups, respectively. A marked reduction of menopausal symptoms, as measured by the Kupperman Index, was observed in the active treatment group compared with the placebo group after 45 days' treatment (mean reduction, 14.8 v 7.2 points, respectively), which was sustained to day 90 (16.8 v 7.8 points; < 0.001). Similarly, greater improvement in quality of life, as measured by the Menopause Quality of Life summary score, was also observed in the active treatment group for the same period (improvement of up to 1.6 points v 0.7 points; < 0.001). The adverse event profile was unremarkable. Of the 114 participants who received the active treatment, 6 withdrew because of adverse events. CONCLUSIONS: The constant-estrogen, intermittent-progestogen regimen was highly effective in relieving menopausal symptoms and in improving quality of life and was well received by the study participants.