The cost-effectiveness of implementing a new guideline for cardiovascular risk management in primary care in the Netherlands.

BACKGROUND: A new Dutch guideline for cardiovascular disease management substantially extends the number of individuals for whom treatment with statins and/or antihypertensive agents is recommended. We estimated the cost-effectiveness of implementing the new guideline at the national level. METHODS: First, the number of currently untreated individuals who would become eligible for cholesterol-lowering or antihypertensive treatment under the new guideline was estimated using data from a recent population study. Cost-effectiveness of treating this group of patients was then assessed using a mathematical model. RESULTS: Implementing the guideline in the age category 30-69 years would lead to an additional 465,000 individuals requiring treatment. Over a period of 20 years, the cumulative incidence of acute myocardial infarction in the whole population would drop by 3.0%, that of stroke by 3.9%, and all-cause mortality would drop by 0.9%. The lifetime cost-effectiveness ratio was calculated to be 15,000 Euro per quality-adjusted life year gained. In the age categories 70-79 years and 80 years or above, an additional 600,000 and 450,000 persons, respectively, would need to be treated, resulting in corresponding reductions in cumulative incidences of 14 and 18% (acute myocardial infarction), 17 and 22% (stroke), and 1.2 and 0.6% (all-cause mortality) with cost-effectiveness ratios of 20,800 and 32,300 Euro, respectively, per quality-adjusted life year. CONCLUSION: Complete implementation of the new guideline would lead to a considerable increase in the number of individuals requiring treatment. This would be cost-effective up to the age of 70 years.

Soy protein containing isoflavones and mammographic density in a randomized controlled trial in postmenopausal women.

BACKGROUND: The relatively high dietary intake of soy in Asian countries has been hypothesized to, at least partly, explain the lower breast cancer incidence patterns in these countries compared with the Western world. The aim of the present study was to determine the effect of daily soy supplementation on mammographic density, one of the strongest known risk factors for breast cancer. METHODS: A double-blind, randomized, controlled trial was conducted to compare the effects of soy protein intake containing 99 mg isoflavones daily with intake of milk protein (placebo) for the duration of 1 year. Two hundred and two Dutch postmenopausal women ages 60 to 75 years were randomized. Mammographic density was assessed using a quantitative computer-assisted method on digitized mammograms. Equol producer status was assessed in plasma provided at the final visit (soy group) or after a 3-day challenge with soy after the trial was finished (placebo group). RESULTS: A total of 175 women completed the baseline visits and at least one follow-up visit and were included in the intention-to-treat analyses. For 126 women, both pre- and post-trial mammograms were available. Mammographic density decreased in both study arms, but the decrease did not differ significantly between intervention and placebo groups. Equol producer status did not modify the results. CONCLUSION: The results of this trial do not support the hypothesis that a diet high in soy protein among postmenopausal women decreases mammographic density.

Dietary phytoestrogen intake and cognitive function in older women.

BACKGROUND: Aging is associated with a decline in cognitive function; we explored the possible influence of dietary phytoestrogens on this decline. METHODS: We conducted a cross-sectional study in 301 Dutch women aged 60-75 years. Dietary isoflavone and lignan intake was assessed with a food-frequency questionnaire covering habitual diet in the year preceding enrolment. The endpoints were cognitive function measured in three domains: memory, processing capacity and speed, and executive function. Data were analyzed using linear regression models, after adjusting for confounders. RESULTS: No association between dietary isoflavone intake and cognitive function was found. High lignan intake was associated with a better performance in processing capacity and speed, and in executive function (p for trend over quartiles =.01 and.02, respectively). CONCLUSIONS: This finding calls for further research to elucidate the relatively underexplored role of lignans within the range of phytoestrogens.

Randomized controlled trial of the effects of soy protein containing isoflavones on vascular function in postmenopausal women.

BACKGROUND: The incidence of cardiovascular disease increases after menopause, possibly because of the decline in estrogen. Soy protein, a rich source of estrogen-like isoflavones, is hypothesized to improve vascular function. OBJECTIVE: The objective of this study was to investigate whether supplementation with soy protein, a rich source of estrogen-like isoflavones, improves vascular function. DESIGN: We performed a 12-mo double-blind randomized trial to compare the effects of soy protein containing 99 mg isoflavones/d (aglycone weights) with those of milk protein (placebo) on blood pressure and endothelial function in 202 postmenopausal women aged 60-75 y. RESULTS: Changes in endothelial function during the intervention were not significantly different between the soy and the placebo groups. After the intervention, systolic blood pressure increased in the soy group significantly more than it did in the placebo group; the difference in change was 4.3 mm Hg (95% CI: 0.3, 8.4 mm Hg; P = 0.04) for systolic blood pressure, but only 2.0 mm Hg (95% CI: -0.74, 4.71 mm Hg; P = 0.15) for diastolic blood pressure. In the soy group only, systolic and diastolic blood pressure decreased and endothelial function improved in the equol producers, whereas systolic and diastolic blood pressure increased and endothelial function deteriorated in the equol nonproducers. CONCLUSIONS: The results of this trial do not support the hypothesis that soy protein containing isoflavones have beneficial effects on vascular function in older postmenopausal women. Whether certain subgroups of women (eg, equol producers) do benefit from the intervention remains to be elucidated.

Dietary phytoestrogens and plasma lipids in Dutch postmenopausal women; a cross-sectional study.

OBJECTIVE: Isoflavone supplementation in high doses is associated with plasma lipid, glucose and insulin levels. Little is known about the effects of intake within the range of western diets on these endpoints. DESIGN: We conducted a population-based cross-sectional study in 301 women aged 60-75 years. METHODS: Dietary isoflavone and lignan intake was assessed with a food frequency questionnaire covering habitual diet during the year preceding enrollment. The outcome measures were total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Lp(a), fasting glucose and insulin levels. Data were analysed using linear regression and logistic regression models. In the analyses we adjusted for a wide range of potential confounders. RESULTS: High intake of isoflavones was associated with lower Lp(a) levels (tertile three versus tertile one: odds ratio 0.36, 95% CI 0.16; 0.80). No relation was found between blood levels and the other plasma lipids, glucose or insulin was found. CONCLUSION: The results of this study suggest that an effect of dietary phytoestrogen intake at low levels on plasma lipid levels is of limited magnitude. It is premature to advise postmenopausal women with low phytoestrogen intake to change their diet towards a phytoestrogen rich diet with the sole aim to prevent cardiovascular disease.

A randomized, placebo-controlled trial on the effects of soy protein containing isoflavones on quality of life in postmenopausal women.

OBJECTIVE: Postmenopausal estrogen decline is implicated in several age-related physical and psychological changes in women, including decreases in perceived quality of life (QoL). A number of trials with hormone therapy showed beneficial effects of the intervention on parameters of quality of life. However, because of known or suspected serious side-effects of conventional hormone therapy there is a need for alternatives. DESIGN: We conducted a double-blind randomized placebo-controlled trial with soy protein, containing 52 mg genistein, 41 mg daidzein, and 6 mg glycitein (aglycone weights), or milk protein (placebo) daily for 1 year. For this trial, we recruited 202 postmenopausal women aged 60 to 75 years. RESULTS: At baseline and at final visit, participants filled in the Short Form of 36 questions (SF-36), the Questionnaire on Life Satisfaction Modules (QLS(M)), and the Geriatric Depression Scale (GDS). For the placebo group scores on all dimensions of the SF-36 and the QLS(M) decreased during the intervention year, except for the dimension "role limitations caused by physical problems." The soy group showed increases on two dimensions of the SF-36 ("social functioning" and "role limitations caused by physical problems") and on one dimension of the QLS(M). There were however no statistically significant differences in changes of scores between the two intervention groups. For the GDS similarly, no significant differences were found between the groups. CONCLUSIONS: In conclusion, the findings in this randomized trial do not support the presence of a marked effect of soy protein substitution on quality of life (health status, life satisfaction, and depression) in elderly postmenopausal women.

Soy isoflavones, body composition, and physical performance.

OBJECTIVES: Physiologic changes, occurring during the process of aging, can have serious health consequences, such as increased risk of chronic disease and disability. Decline in estradiol levels after menopause is hypothesized to contribute to this risk. Thus, hormone therapy (HT) might prevent or delay those changes. However, HT has serious side effects and alternative approaches are needed. METHODS: We performed a 12-month double-blind randomized trial comparing soy protein containing 99mg isoflavones (aglycone weights) with milk protein (placebo) daily in 202 postmenopausal women aged 60-75 years. Endpoints were body composition, and physical performance. Randomization resulted in reasonable well-balanced groups, 153 (76%) women completed the trial. Compliance was good (plasma genistein levels 55 +/- 101 and 1259 +/- 1610 nmol/L for placebo and soy group, respectively). The changes in the endpoints during the intervention period among the two intervention groups were analyzed. RESULTS: Body mass index (BMI) and waist-to-hip ratio did not change during intervention. Handgrip strength at the final visit was slightly worse in the soy group compared to the placebo group (-0.45 kg (95% C.I.: -2.5, 1.6 kg; p = 0.7), but this difference was not statistically significant. Self-reported functional status, mobility and physical performance, all slightly improved during intervention but there were no differences between the groups. CONCLUSIONS: The results of the present trial do not support the view that soy isoflavones have favorable effects on body composition and physical performance in postmenopausal women.

Dietary phytoestrogens and vascular function in postmenopausal women: a cross-sectional study.

OBJECTIVE: To investigate the effects of low levels of intake of phytoestrogens in Western habitual diet on vascular function. DESIGN: A cross-sectional study. SETTING: A population-based study. PARTICIPANTS: A total of 301 postmenopausal women aged 60-75 years living in The Netherlands. DETERMINANT: Dietary phytoestrogen intake as assessed using a food frequency questionnaire covering the year prior to enrollment. MAIN OUTCOME MEASURES: Blood pressure, hypertension, endothelial function and ankle brachial index. RESULTS: The median isoflavone intake was 0.2 mg in the lowest tertile and 11.4 mg in the highest tertile. Median lignan intake was 0.8 and 2.2 mg, respectively. No associations were found for higher intake of isoflavones, systolic and diastolic blood pressures, ankle-arm blood pressure index, endothelial function or hypertension. For lignans no association was found for ankle-arm blood pressure index or endothelial function, but we did observe lower systolic and diastolic blood pressures and a lower prevalence of hypertension (systolic blood pressure difference T3-T1, -11.2 mmHg, 95% confidence interval = -17.8 to -4.5, P for trend = 0.001; diastolic blood pressure difference T3-T1, -3.6 mmHg, 95% confidence interval = -7.8 to 0.6, P for trend = 0,08; and prevalence of hypertension, odds ratio T3 versus T1 = 0.41, 95% confidence interval = 0.22-0.76, P for trend over tertiles = 0.004). CONCLUSION: The results of this study suggest a protective effect of dietary lignan intake on blood pressure and hypertension, even at low levels.

Design and baseline characteristics of a trial on health effects of soy protein with isoflavones in postmenopausal women.

This study is a double-blind, randomized, placebo-controlled trial to assess the effects of high amounts of phytoestrogens on bone mineral density, cardiovascular diseases, cognitive function, performance in activities of daily life and well being. Participants were healthy postmenopausal women, aged 60-75 years. Between March and September 2000, 202 women were recruited, and, after completion of the baseline measurements, randomized to either soy protein, containing 99 mg naturally occurring isoflavones or placebo (milk protein) daily for 1 year. Analysis of the endpoints will be based on the difference between baseline measurements and measurements at the end of the intervention period with group allocation as independent variable.

Effect of soy protein containing isoflavones on cognitive function, bone mineral density, and plasma lipids in postmenopausal women: a randomized controlled trial.

CONTEXT: Postmenopausal estrogen therapy has been posited to have some beneficial effects on aging processes, but its use has risks. Isoflavones, estrogenlike compounds naturally occurring in plant foods, might confer positive effects with fewer adverse effects. OBJECTIVE: To investigate whether soy protein with isoflavones improves cognitive function, bone mineral density, and plasma lipids in postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, placebo-controlled trial of 202 healthy postmenopausal women aged 60 to 75 years, recruited from a population-based sample in the Netherlands, conducted between April 2000 and September 2001. INTERVENTION: Participants were randomly assigned to receive 25.6 g of soy protein containing 99 mg of isoflavones (52 mg genistein, 41 mg daidzein, and 6 mg glycetein or total milk protein as a powder on a daily basis for 12 months. MAIN OUTCOME MEASURES: Cognitive function was assessed using the following instruments: dementia, Mini-Mental State Examination; memory, Rey Auditory Verbal Learning Test, immediate recall, delayed recall, and recognition, the Digit Span forward and reversed, and the Doors test; complex attention tasks, Digit Symbol Substitution and Trailmaking, A1, A2, and B; and verbal skills, Verbal Fluency A and N, animals and occupations, and the Boston Naming Task. Bone mineral density of the hip and lumbar spine was assessed using dual-energy x-ray absorptiometry scanning. Lipid assessment included lipoprotein(a), total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides. RESULTS: A total of 175 women completed the baseline and at least 1 postintervention analysis and were included in the modified intent-to-treat analysis. Adherence was good (median plasma genistein levels, 17.2 and 615.1 nmol/L for placebo and soy group, respectively). Cognitive function, bone mineral density, or plasma lipids did not differ significantly between the groups after a year. CONCLUSION: This double-blind randomized trial does not support the hypothesis that the use of soy protein supplement containing isoflavones improves cognitive function, bone mineral density, or plasma lipids in healthy postmenopausal women when started at the age of 60 years or later.

Veterans' access to and use of Medicare and Veterans Affairs health care.

OBJECTIVES: We examined the impact of access to care characteristics on health care use patterns among those veterans dually eligible for Medicare and Veterans Affairs (VA) services. METHODS: We used a retrospective, cross-sectional design to identify veterans who were eligible to use VA and Medicare health care in calendar year 1999. We analyzed national VA utilization and Medicare claims data. We used descriptive and multivariable generalized ordered logit analyses to examine how patient, geographic, and environmental factors affect the percent reliance on VA and Medicare inpatient and outpatient services. RESULTS: Of the 1.47 million veterans in our study population with outpatient use, 18% were VA-only users, 36% were Medicare-only users, and 46% were both VA and Medicare users. Among veterans with inpatient use, 24% were VA only, 69% were Medicare only, and 6% were both VA and Medicare users. Multivariable analysis revealed that veterans who were black or had a higher VA priority were most likely to rely on the VA. Patient with higher risk scores were most likely to rely on a combination of VA and Medicare health care. Patients who lived farther from VA hospitals were less likely to rely on VA health care, particularly for inpatient care. Patients living in urban areas with more health care resources were less likely to rely on VA health care. CONCLUSIONS: VA health care provides an important safety net for vulnerable populations. Targeted approaches that carefully consider the simultaneous impacts of VA and Medicare policy changes on minority and high-risk populations are essential to ensure veterans have access to needed health care.