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BackgroundThe efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.MethodsWe recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.ResultsHip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P

ContextObservational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial.ObjectiveTo evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.Design, setting, and participantsThe Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States.InterventionsParticipants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern.Main outcome measureInvasive colorectal cancer incidence.ResultsA total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.ConclusionIn this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up.Clinical trials registrationClinicalTrials.gov Identifier: NCT00000611.

ContextMultiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed.ObjectiveTo test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.Design, setting, and participantsRandomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years.InterventionIntensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials.Main outcome measuresFatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke).ResultsBy year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits.ConclusionsOver a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.Clinical trials registrationClinicalTrials.gov Identifier: NCT00000611.

Despite decades of use and considerable research, the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain.To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States.A randomized, double-blind, placebo-controlled disease prevention trial (the estrogen-alone component of the Women's Health Initiative [WHI]) conducted in 40 US clinical centers beginning in 1993. Enrolled were 10 739 postmenopausal women, aged 50-79 years, with prior hysterectomy, including 23% of minority race/ethnicity.Women were randomly assigned to receive either 0.625 mg/d of conjugated equine estrogen (CEE) or placebo.The primary outcome was coronary heart disease (CHD) incidence (nonfatal myocardial infarction or CHD death). Invasive breast cancer incidence was the primary safety outcome. A global index of risks and benefits, including these primary outcomes plus stroke, pulmonary embolism (PE), colorectal cancer, hip fracture, and deaths from other causes, was used for summarizing overall effects.In February 2004, after reviewing data through November 30, 2003, the National Institutes of Health (NIH) decided to end the intervention phase of the trial early. Estimated hazard ratios (HRs) (95% confidence intervals [CIs]) for CEE vs placebo for the major clinical outcomes available through February 29, 2004 (average follow-up 6.8 years), were: CHD, 0.91 (0.75-1.12) with 376 cases; breast cancer, 0.77 (0.59-1.01) with 218 cases; stroke, 1.39 (1.10-1.77) with 276 cases; PE, 1.34 (0.87-2.06) with 85 cases; colorectal cancer, 1.08 (0.75-1.55) with 119 cases; and hip fracture, 0.61 (0.41-0.91) with 102 cases. Corresponding results for composite outcomes were: total cardiovascular disease, 1.12 (1.01-1.24); total cancer, 0.93 (0.81-1.07); total fractures, 0.70 (0.63-0.79); total mortality, 1.04 (0.88-1.22), and the global index, 1.01 (0.91-1.12). For the outcomes significantly affected by CEE, there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years. The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years.The use of CEE increases the risk of stroke, decreases the risk of hip fracture, and does not affect CHD incidence in postmenopausal women with prior hysterectomy over an average of 6.8 years. A possible reduction in breast cancer risk requires further investigation. The burden of incident disease events was equivalent in the CEE and placebo groups, indicating no overall benefit. Thus, CEE should not be recommended for chronic disease prevention in postmenopausal women.

Objective To identify predictors of dietary change to and maintenance of a low-fat eating pattern (<20% energy from fat, [greater than or equal to] 5 servings fruits/vegetables daily, and [greater than or equal to] 6 servings grains daily) among a cohort of postmenopausal women. Candidate predictors included intrapersonal, in terpersonal, intervention program characteristics, and clinical center. Design Longitudinal study within the Women's Health Initiative Dietary Modification Trial. Dietary change was evaluated after 1 year of participation in the Women's Health Initiative Dietary Modification Trial, and dietary maintenance after 3 years. Subjects Postmenopausal women aged 50 to 79 years at baseline who were randomized to the intervention arm of the Women's Health Initiative Dietary Modification Trial (n=19,541). Statistical analysis Univariate and multivariate linear regression analysis was performed and associations evaluated between candidate predictors and each of the three dietary goals: percent energy from fat, fruit/vegetable servings, and grain servings. Results Year 1 (change) predictors of percent energy from fat (P<0.005) included being younger ([beta]=2.12; 70 to 79 years vs 50 to 59 years), more educated ([beta]=-.69; college vs high school), more optimistic ([beta]=-.07), attending more sessions ([beta]=-.69), and submitting more self-monitoring records ([beta]=-.74). At year 3 (maintenance), the predictors of percent energy from fat (P<0.005) included attending more sessions ([beta]=-.65) and submitting more self-monitoring scores ([beta]=-.71). The analytic model predicted 22% of the variance in fat intake at year I and 27% at year 3 (P<0.01). Conclusions The strongest predictors of dietary change and maintenance were attending intervention sessions and self-monitoring dietary intake. Novel was the finding that optimism predicted dietary change.

A study was conducted to determine the effects of conjugated equine estrogens (CEE) on breast cancers and mammographic findings. It was found that treatment with CEE alone does not increase breast cancer incidence in postmenopausal women with prior hysterectomy, however, treatment with CEE increases the frequency of mammography screening requiring short interval follow up.

Randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is examined. Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women, and the long latency associated with the development of colorectal cancer, along with seven year duration of trial may have contributed to this null finding.

Hormone replacement therapy (HRT) should not be prescribed for healthy postmenopausal women to reduce their risk of developing coronary heart disease, according to the final results of the Women's Health Initiative study. This study of 16,608 postmenopausal women found that HRT actually increased their risk of developing coronary heart disease, particularly during the first year of use. The study was even stopped early because of this increased risk among HRT users.

Postmenopausal women who take hormone replacement therapy may have twice the risk of developing dementia compared to other postmenopausal women, according to a study of 4,532 women. Hormone replacement therapy did not prevent mild intellectual deficits either. This study is part of the Women's Health Initiative study, which found that hormone replacement therapy may do more harm than good.

Objectives. Whether community-wide education changed cardiovascular risk factors and disease risk in Pawtucket, RI, relative to a comparison community was assessed. Methods. Random-sample, cross-sectional surveys were done of people aged 18 through 64 years at baseline, during, and after education. Baseline cohorts were reexamined. Pawtucket citizens of all ages participated in multilevel education, screening, and counseling programs. Results. The downward trend in smoking was slightly greater in the comparison city. Small, insignificant differences favored Pawtucket in blood cholesterol and blood pressure. In the cross-sectional surveys, body mass index increased significantly in the comparison community; a similar change was not seen in cohort surveys. Projected cardiovascular disease rates were significantly (16%) less in Pawtucket during the education program. This difference lessened to 8% posteducation. Conclusions. The hypothesis that projected cardiovascular disease risk can be altered by community-based education gains limited support from these data. Achieving cardiovascular risk reduction at the community level was feasible, but maintaining statistically significant differences between cities was not. Accelerating risk factor changes will likely require a sustained community effort with reinforcement from state, regional, and national policies and programs. (Am J Public Health. 1995; 85:777-785), Community programs in education about cardiovascular disease risk may have little long term impact on reducing risks factors. From 1984 to 1991, various Pawtucket, RI, community groups, grocery stores, and educational institutions ran a program to educate and change residents' behavior with regard to cardiovascular disease. Disease risk factors were assessed in a total of 15,261 people in Pawtucket and in a parallel control city without an education program. Participants were surveyed every 2 years from 1981 to 1993. Blood pressure and cholesterol levels dropped slightly more in Pawtucket than in the control city. Cigarette smoking decreased slightly more in the control city than in Pawtucket. Body mass index rose significantly more in the control city than in Pawtucket. The relative risk rate of cardiovascular disease in Pawtucket decreased by 20% during the program, but 3 years later the decrease was only 8%. People were receptive to the program, but it had a significant impact only when it was operating.

In the mid-1980s, the prospective payment system, under which diagnosis- related groups (DRGS) are used to reimburse hospitals for the care of Medicare patients, replaced the fee-for-service method of payment in some states. The resulting changes in financial incentives may have influenced the assignment of discharge diagnostic codes for coronary heart disease from lower to higher reimbursement codes. Altered discharge coding potentially could have a great effect. The mortality rate of ischemic heart disease, which has been declining for about 30 years, is a case in point. The ability to detect and track this significant trend during these years has been based on the assumption that the process of disease-labeling remained essentially unchanged. In this paper, the data cast doubt on the assumption for periods before and after the mid-1980s. The data are consistent with the hypothesis that the prospective reimbursement system has influenced the assignment of hospital discharge codes in a manner that would increase payment to hospitals. To reduce vagaries in healthcare statistics, along with the institution of any diagnosis-dependent reimbursement system, stable and reproducible criteria for the assignment of discharge codes must be developed.

BACKGROUND: The direct costs associated with menopausal and postmenopausal symptoms (hereafter "menopausal symptoms") may include the costs of physician and emergency department visits, medications, laboratory testing, and the management of side effects. However, much remains unknown about the costs related to menopausal symptoms, including how they compare with the costs of other diseases that are common among menopausal women. OBJECTIVE: To compare the economic burden of menopausal symptoms with other select prevalent chronic conditions among a nationally representative sample of US menopausal women aged 45 to 65 years. METHODS: Women aged 45 to 65 years who have not had a hysterectomy and who participated in the 2010-2012 Medical Expenditure Panel Survey Household Component were included in the analysis. We estimated the direct costs of care associated with the management of menopausal symptoms and compared them with the direct costs of care for other indications, including osteoporosis, influenza, disorders of lipid metabolism, essential hypertension, mood disorders, esophageal disorders, headache, osteoarthritis, urinary tract infections, asthma, glaucoma, anxiety disorder, diabetes, chronic obstructive pulmonary disease/bronchiectasis, and cataract. Regression analyses were used to estimate the differences in direct costs, which included total expenditures and charges for inpatient, outpatient, and emergency department visits. RESULTS: The annual perpatient direct cost of menopausal symptoms was $248 in 20102012 dollars. Based on the modeled costs, menopausal symptoms were associated with significantly higher annual costs than osteoporosis, disorders of lipid metabolism, and esophageal disorders; and these annual costs were comparable to those of influenza, asthma, anxiety disorder, essential hypertension, and headache. The direct costs associated with the management of menopausal symptoms were significantly lower than the direct costs associated with osteoarthritis, mood disorders, chronic obstructive pulmonary disease/ bronchiectasis, urinary tract infections, diabetes, glaucoma, and cataract. CONCLUSION: The direct costs of care for menopausal symptoms are substantial and are similar to or greater than the direct healthcare costs associated with a number of medical conditions often requiring medical attention in menopausal women. [ABSTRACT FROM AUTHOR]

Background/Purpose Little information exists on the comparative patient and economic burden of chronic widespread pain ( CWP) and fibromyalgia ( FM) in the United States. Methods This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use ( HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP ( CWP−), with CWP but without FM ( CWP+), and with confirmed FM were identified. Results Disease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP− to CWP+ to FM ( P = 0.0044, P < 0.0001, respectively). From CWP− to CWP+ to FM, there were reductions in health status ( EQ-5D, SF-12) and sleep outcomes ( MOS- SS, SSQ) (all P < 0.05). Pain severity, interference with function ( BPI- SF), and overall work impairment ( WPAI: SHP) increased from CWP− to CWP+ to FM (all P < 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP− subjects (32.8%; P < 0.0001). Significant differences in total direct and indirect costs across the three groups (both P < 0.0001) were observed, with highest costs among FM subjects. Conclusion Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs. [ABSTRACT FROM AUTHOR]