Re: Short-interval follow-up mammography: are we doing the right thing?
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Breast Neoplasms↗
Biomedical subjects
Susan L Hendrix
Publications and source records attributed to Susan L Hendrix.
Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial.
CONTEXT: The Women's Health Initiative trial of combined estrogen plus progestin was stopped early when overall health risks, including invasive breast cancer, exceeded benefits. Outstanding issues not previously addressed include characteristics of breast cancers observed among women using hormones and whether diagnosis may be influenced by hormone effects on mammography. OBJECTIVE: To determine the relationship among estrogen plus progestin use, breast cancer characteristics, and mammography recommendations. DESIGN, SETTING, AND PARTICIPANTS: Following a comprehensive breast cancer risk assessment, 16 608 postmenopausal women aged 50 to 79 years with an intact uterus were randomly assigned to receive combined conjugated equine estrogens (0.625 mg/d) plus medroxyprogesterone acetate (2.5 mg/d) or placebo from 1993 to 1998 at 40 clinical centers. Screening mammography and clinical breast examinations were performed at baseline and yearly thereafter. MAIN OUTCOME MEASURES: Breast cancer number and characteristics, and frequency of abnormal mammograms by estrogen plus progestin exposure. RESULTS: In intent-to-treat analyses, estrogen plus progestin increased total (245 vs 185 cases; hazard ratio [HR], 1.24; weighted P<.001) and invasive (199 vs 150 cases; HR, 1.24; weighted P =.003) breast cancers compared with placebo. The invasive breast cancers diagnosed in the estrogen plus progestin group were similar in histology and grade but were larger (mean [SD], 1.7 cm [1.1] vs 1.5 cm [0.9], respectively; P =.04) and were at more advanced stage (regional/metastatic 25.4% vs 16.0%, respectively; P =.04) compared with those diagnosed in the placebo group. After 1 year, the percentage of women with abnormal mammograms was substantially greater in the estrogen plus progestin group (716 [9.4%] of 7656) compared with placebo group (398 [5.4%] of 7310; P<.001), a pattern which continued for the study duration. CONCLUSIONS: Relatively short-term combined estrogen plus progestin use increases incident breast cancers, which are diagnosed at a more advanced stage compared with placebo use, and also substantially increases the percentage of women with abnormal mammograms. These results suggest estrogen plus progestin may stimulate breast cancer growth and hinder breast cancer diagnosis.
Aged↗
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.
CONTEXT: Postmenopausal women have a greater risk than men of developing Alzheimer disease, but studies of the effects of estrogen therapy on Alzheimer disease have been inconsistent. On July 8, 2002, the study drugs, estrogen plus progestin, in the Women's Health Initiative (WHI) trial were discontinued because of certain increased health risks in women receiving combined hormone therapy. OBJECTIVE: To evaluate the effect of estrogen plus progestin on the incidence of dementia and mild cognitive impairment compared with placebo. DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Memory Study (WHIMS), a randomized, double-blind, placebo-controlled clinical trial, began enrolling participants from the Women's Health Initiative (WHI) estrogen plus progestin trial in May 1996. Of the 4894 eligible participants of the WHI study, 4532 (92.6%) postmenopausal women free of probable dementia, aged 65 years or older, and recruited from 39 of 40 WHI clinical centers were enrolled in the WHIMS. INTERVENTION: Participants received either 1 daily tablet of 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (n = 2229), or a matching placebo (n = 2303). MAIN OUTCOME MEASURES: Incidence of probable dementia (primary outcome) and mild cognitive impairment (secondary outcome) were identified through a structured clinical assessment. RESULTS: The mean (SD) time between the date of randomization into WHI and the last Modified Mini-Mental State Examination (3MSE) for all WHIMS participants was 4.05 (1.19) years. Overall, 61 women were diagnosed with probable dementia, 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21-3.48; 45 vs 22 per 10 000 person-years; P =.01). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74-1.55; 63 vs 59 cases per 10 000 person-years; P =.72). CONCLUSIONS: Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risks of estrogen plus progestin outweigh the benefits.
Aged↗
Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial.
CONTEXT: The Women's Health Initiative (WHI) trial of estrogen plus progestin was stopped early because of adverse effects, including an increased risk of stroke in the estrogen plus progestin group. OBJECTIVE: To assess the effect of estrogen plus progestin on ischemic and hemorrhagic stroke and in subgroups, and to determine whether the effect of estrogen plus progestin was modified by baseline levels of blood biomarkers. DESIGN: Multicenter double-blind, placebo-controlled, randomized clinical trial involving 16 608 women aged 50 through 79 years with an average follow-up of 5.6 years. Baseline levels of blood-based markers of inflammation, thrombosis, and lipid levels were measured in the first 140 centrally confirmed stroke cases and 513 controls. INTERVENTIONS: Participants received 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate (n = 8506) or placebo (n = 8102). MAIN OUTCOME MEASURES: Overall strokes and stroke subtype and severity were centrally adjudicated by stroke neurologists. RESULTS: One hundred fifty-one patients (1.8%) in the estrogen plus progestin and 107 (1.3%) in the placebo groups had strokes. Overall 79.8% of strokes were ischemic. For combined ischemic and hemorrhagic strokes, the intention-to-treat hazard ratio (HR) for estrogen plus progestin vs placebo was 1.31 (95% confidence interval [CI], 1.02-1.68); with adjustment for adherence, the HR was 1.50 (95% CI, 1.08-2.08). The HR for ischemic stroke was 1.44 (95% CI, 1.09-1.90) and for hemorrhagic stroke, 0.82 (95% CI, 0.43-1.56). Point estimates of the HRs indicate that excess risk of all stroke was apparent in all age groups, in all categories of baseline stroke risk, and in women with and without hypertension, prior history of cardiovascular disease, use of hormones, statins, or aspirin. Other risk factors for stroke, including smoking, blood pressure, diabetes, lower use of vitamin C supplements, blood-based biomarkers of inflammation, higher white blood cell count, and higher hematocrit levels did not modify the effect of estrogen plus progestin on stroke risk. CONCLUSIONS: Estrogen plus progestin increases the risk of ischemic stroke in generally healthy postmenopausal women. Excess risk for all strokes attributed to estrogen plus progestin appeared to be present in all subgroups of women examined.
Aged↗
Frequency and predictive value of a mammographic recommendation for short-interval follow-up.
BACKGROUND: A recommendation for short-interval follow-up of "probably benign finding" is associated with up to 11% of screening mammograms, but its predictive value for breast cancer is unclear. We examined the predictive values (i.e., the percentage of women with a diagnosis of breast cancer 2 years after a short-interval follow-up recommendation) and likelihood ratios (derived from the pretest and post-test odds of breast cancer in the Women's Health Initiative sample) for breast cancer that are associated with a recommendation for short-interval follow-up among postmenopausal women. METHODS: We performed a longitudinal analysis of a prospective cohort of 68 126 postmenopausal women (aged 50-79 years) who were participating in clinical trials as part of the Women's Health Initiative at 40 centers across the United States. Eligible participants had screening mammograms at baseline and at least 2 years of follow-up that included a repeat mammography. Outcomes measured were breast cancer events at 1 and 2 years after baseline and the results of subsequent mammograms. All P values were two-sided. RESULTS: A total of 2927 (5%) of the 58 408 eligible women had baseline mammograms that included recommendations for short-interval follow-up. The incidence of breast cancer for women with a short-interval follow-up recommendation was 1.0% at 2 years after the baseline mammogram compared with breast cancer incidences of 0.6% and 0.5% for women whose baseline mammograms were described as "benign" and "negative," respectively. Across the 40 participating centers, the prevalence of short-interval follow-up recommendations among baseline mammograms varied from 1.2% to 9.8% (P<.001), even when the analysis was adjusted for key variables in regression models. Centers reporting higher frequencies of such recommendations did not have lower positive predictive values for breast cancer than centers reporting lower frequencies. The likelihood ratio for breast cancer after a recommendation for short-interval follow-up on a subsequent mammogram was 2.20 (95% confidence interval = 1.65 to 2.86). CONCLUSION: Having a mammographic recommendation for short-interval follow-up was associated with a low positive predictive value for breast cancer among postmenopausal women during a 2-year follow-up. This result suggests that the current criteria for this recommendation-repeat mammography within 6 months-should be reconsidered.
Aged↗
Medroxyprogesterone acetate treatment of abnormal uterine bleeding: factors predicting satisfaction.
OBJECTIVE: This study was undertaken to identify the determinants of patient satisfaction with a cyclic regimen of medroxyprogesterone acetate (MPA) for abnormal uterine bleeding. STUDY DESIGN: A prospective cohort study of 413 premenopausal women were treated for 3 to 5 months with oral MPA 10 to 20 mg per day for 10 to 14 days per month. We assessed satisfaction with and willingness to continue MPA. Baseline characteristics hypothesized to predict treatment satisfaction were entered into logistic regression analysis. RESULTS: Sixty-five percent of subjects (271) completed at least 3 months of MPA, 79% (215) filled out a satisfaction survey, and 57% (123) expressed satisfaction with MPA. Satisfaction was predicted by age 35 years or older (odds ratio [OR] 2.67, CI 1.07-6.7), desire for uterine conservation (OR 1.36, CI 1.11-1.66), perceived importance of stopping bleeding (OR 0.69, CI 0.54-0.87), and tubal sterilization (OR 0.52, CI 0.28-0.96). Neither bleeding history nor parity predicted MPA satisfaction. CONCLUSION: These findings underscore the importance of considering patient age, fertility status, attitudes about uterine conservation, and desire for definitive resolution of bleeding when deciding whether to use MPA versus other treatments for abnormal uterine bleeding.
Adult↗
Endometritis does not predict reproductive morbidity after pelvic inflammatory disease.
OBJECTIVE: We investigated the association between endometritis and reproductive morbidity. STUDY DESIGN: Participants were 614 women in the PID Evaluation and Clinical Health (PEACH) Study with pelvic pain, pelvic organ tenderness, and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. We compared women with endometritis (>or=5 neutrophils or >or=2 plasma cells), Neisseria gonorrhoeae or Chlamydia trachomatis upper genital tract infection (UGTI) or both to women without endometritis/UGTI for outcomes of pregnancy, infertility, recurrent pelvic inflammatory disease (PID), and chronic pelvic pain (CPP), adjusting for age, race, education, PID history, and baseline infertility. RESULTS: Endometritis/UGTI was not associated with reduced pregnancy (odds ratio [OR] 0.8, 95% CI 0.6-1.2) or elevated infertility (OR 1.0, 95% CI 0.6-1.6), recurrent PID (OR 0.6, 95% CI 0.4-0.9), or CPP (OR 0.6, 95% CI 0.4-0.9). PEACH participants with and without endometritis/UGTI had higher age- and race-specific pregnancy rates than 1997 national rates. CONCLUSION: Among women with clinically suspected mild-to-moderate PID treated with standard antibiotics, endometritis/UGTI was not associated with reproductive morbidity.
Adolescent↗
Hormone therapy: evolving concepts.
OBJECTIVE: To review the medical literature published in 2002 regarding menopausal hormone therapy and its impact on clinical practice. METHODS: A literature search was performed using MEDLINE with the keywords of menopause, sex steroids, and hormone replacement therapy. Randomized clinical trials were reviewed. An evidence-based review is presented. RESULTS: Menopausal hormone therapy has undergone radical change since the publication of the Women's Health Initiative randomized prospective trial of combined estrogen plus progestin therapy for disease prevention. After a mean of 5.2 years of follow-up, the E + P versus placebo trial of 16,608 women was stopped because the health risks of taking E + P exceeded the benefits. An increase in breast cancer risk, coupled with an adverse trend in overall risk-benefit ratio, reached the preset stopping boundaries. In addition, there was an increased risk of nonfatal myocardial infarction, stroke, and pulmonary embolism. The decreased risks seen for osteoporotic fracture and colorectal cancer were outweighed by the above risks. The FDA has required mandatory label changes for all hormone products based on these findings. The Women's Health Initiative found that treatment with estrogen plus progestin for up to 5 years is not beneficial overall. There is early harm for coronary heart disease, continuing harm for stroke and venous thromboembolism, and increasing harm for breast cancer. This risk-benefit profile is not consistent with a viable intervention for primary prevention of chronic diseases in postmenopausal women. Menopausal hormone therapy should be reserved for women with moderate to severe vasomotor symptoms. CONCLUSIONS: In the past 20 years, menopause has become a household word, with much better understanding of its consequences. The growing numbers of menopausal women and clinical trials have coincided to draw increasing attention to the perimenopausal and menopausal years. Better studies of older therapies and the expanded number of new choices today, with more in development and evaluation, have complicated provider and patient choices but greatly improved the potential for effective intervention.
Aged↗
The Women's Health Initiative estrogen plus progestin trial: the study and how it changes our practice.
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Aged↗
Primary dysmenorrhea treatment with a desogestrel-containing low-dose oral contraceptive.
This randomized, double-blind, placebo-controlled exploratory study examined the efficacy and safety of a low-dose oral contraceptive (Mircette), desogestrel/ethinyl estradiol [DSG/EE] and ethinyl estradiol [EE]) in relieving the symptoms of dysmenorrhea. Twenty-three clinics in the United States enrolled 77 women (age < or =32 years) with primary dysmenorrhea documented for at least four consecutive cycles. Forty participants received DSG/EE&EE and 37 received placebo for four consecutive 28-day cycles. The intensity of menstrual-related distress was measured with the Menstrual Distress Questionnaire (MDQ). Patient diaries were used to assess number of school/work days missed as well as the use of rescue medication. Participants receiving DSG/EE&EE recorded reduced menstrual pain severity, lower total MDQ scores, and significantly less menstrual cramping. No significant change in bloating, anxiety, loneliness, weight gain, or acne was reported. The DSG/EE&EE formulation shows promise for the treatment of primary dysmenorrhea and was well tolerated by the participants in this study.
Adult↗
Effectiveness of inpatient and outpatient treatment strategies for women with pelvic inflammatory disease: results from the Pelvic Inflammatory Disease Evaluation and Clinical Health (PEACH) Randomized Trial.
OBJECTIVE: Pelvic inflammatory disease (PID) is a common and morbid intraperitoneal infection. Although most women with pelvic inflammatory disease are treated as outpatients, the effectiveness of this strategy remains unproven. STUDY DESIGN: We enrolled 831 women with clinical signs and symptoms of mild-to-moderate pelvic inflammatory disease into a multicenter randomized clinical trial of inpatient treatment initiated by intravenous cefoxitin and doxycycline versus outpatient treatment that consisted of a single intramuscular injection of cefoxitin and oral doxycycline. Long-term outcomes were pregnancy rate, time to pregnancy, recurrence of pelvic inflammatory disease, chronic pelvic pain, and ectopic pregnancy. RESULTS: Short-term clinical and microbiologic improvement were similar between women randomized to the inpatient and outpatient groups. After a mean follow-up period of 35 months, pregnancy rates were nearly equal (42.0% for outpatients and 41.7% for inpatients). There were also no statistically significant differences between outpatient and inpatient groups in the outcome of time to pregnancy or in the proportion of women with pelvic inflammatory disease recurrence, chronic pelvic pain, or ectopic pregnancy. CONCLUSION: Among women with mild-to-moderate pelvic inflammatory disease, there was no difference in reproductive outcomes between women randomized to inpatient treatment and those randomized to outpatient treatment.
Adolescent↗
Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity.
OBJECTIVE: The purpose of this study was to describe the prevalence of and correlates for pelvic organ prolapse. STUDY DESIGN: This was a cross-sectional analysis of women who enrolled in the Women's Health Initiative Hormone Replacement Therapy Clinical Trial (n = 27,342 women). Baseline questionnaires ascertained demographics and personal habits. A baseline pelvic examination assessed uterine prolapse, cystocele, and rectocele. Descriptive statistics and logistic regression models were used to investigate factors that were associated with pelvic organ prolapse. RESULTS: In the 16,616 women with a uterus, the rate of uterine prolapse was 14.2%; the rate of cystocele was 34.3%; and the rate of rectocele was 18.6%. For the 10,727 women who had undergone hysterectomy, the prevalence of cystocele was 32.9% and of rectocele was 18.3%. After controlling for age, body mass index, and other health/physical variables, African American women demonstrated the lowest risk for prolapse. Hispanic women had the highest risk for uterine prolapse. Parity and obesity were strongly associated with increased risk for uterine prolapse, cystocele, and rectocele. CONCLUSION: Pelvic organ prolapse is a common condition in older women. The risk for prolapse differs between ethnic groups, which suggests that the approaches to risk-factor modification and prevention may also differ. These data will help address the gynecologic needs of diverse populations.
Black or African American↗
Urinary incontinence and menopause: an evidence-based treatment approach.
OBJECTIVE: To review the evidence on risk factors, evaluation, diagnosis, and treatments in postmenopausal women with incontinence. DATA SOURCES: Articles on urinary incontinence were located by searching Medline and the Cochrane Database of Systematic Reviews in March 2000. RESULTS: Urinary incontinence is common with aging. The relationship between urinary incontinence and menopause is not well understood. There are 3 major types of urinary incontinence: stress, urge, and mixed. The diagnosis can often be established with a good history. For a long time estrogen was thought to be of benefit in the treatment of incontinence, however, there is now evidence it may exacerbate urinary incontinence. There are multiple new agents shown to be effective in the treatment of incontinence. Surgical approaches for the treatment of stress incontinence have not been studied in large clinical trials, however, open abdominal retropubic suspension seems to be better than anterior vaginal repair. CONCLUSIONS: As the aging population grows, urinary incontinence will become an increasing public health problem. Increasing awareness is needed by women and their providers to identify, evaluate, and apply evidence-based treatment approaches to urinary incontinence.
Evidence-Based Medicine↗
Radiographic measurements, bone mineral density, and the Singh Index in the proximal femur of white and black postmenopausal women.
BACKGROUND: Radiographic measurements, bone mineral density (BMD), and the Singh Index were examined to assess ethnic differences in the architecture and trabecular patterns in the proximal femur. METHODS: We measured height (cm), weight (kg), and the following radiographic variables in 326 white and black postmenopausal women participating in the Women's Health Initiative at the Clinical Center in Detroit, MI: neck breadth, inferior neck cortical thickness, head diameter, subtrochanteric breadth, and subtrochanteric medial and lateral cortical thicknesses. Bone densitometry was performed by dual-energy x-ray absorptiometry (Hologic QDR 1000 plus; Hologic Inc, Bedford, MA) at 5 regional sites in the proximal femur. The Singh Index was read by its originator. RESULTS AND CONCLUSIONS: There was no significant ethnic difference in mean age, height, or body mass index, but weight and BMD was higher in the black group at all regional sites. The inferior neck cortical thickness was significantly greater in the black group. The Singh Index was found to be grade VI (normal) in 87%, grade V in 9%, and grades II-IV in 4% of all subjects. Multiple regression models explained 35% to 60% of the variance in the regional BMDs; the Singh Index, weight, and subtrochanteric cortical thicknesses were significant contributors to all regional hip BMD models. Although there were ethnic differences in BMD, there were no ethnic differences in the distribution of the Singh Index scores.
Absorptiometry, Photon↗