Biomedical subjects

Robert Wallace

Publications and source records attributed to Robert Wallace.

At least 19 recordsLinked to original sources

PubMed2007

Risk factors for adverse drug events in older adults with mobility limitations in the community setting.

OBJECTIVES: To investigate risk factors for self-reported adverse drug events (ADEs) in a cohort of annually surveyed Iowa Medicare beneficiaries with mobility limitations. DESIGN: Prospective cohort study with baseline and two annual follow-up questionnaires. SETTING: Population-based sample of Iowa Medicare beneficiaries with mobility limitations. PARTICIPANTS: Members of the cohort with complete follow-up questionnaires and prescription dispensing data (N=689). MEASUREMENTS: The questionnaires asked about self-reported ADEs in the previous 12 months, sociodemographic data, smoking, alcohol use, number of mobility limitations, and history of chronic disease. Pharmacy dispensing records were the source of number and classes of prescription drug use. Linked Medicare claims provided additional comorbidity data. RESULTS: Of the 689 subjects, 151 (21.9%) reported an ADE, 83% of which resulted in physician contact and 56% of which resulted in discontinuing the medication. Number of different medications dispensed during the prior year was an independent predictor of a self-reported ADE. Neither age, extent of mobility limitation, nor number of chronic conditions was independently associated with reporting an ADE. CONCLUSION: Excess ADE risk observed with increasing mobility limitations is mediated through greater medication use.

Age Factors↗

PubMed2006

Is it time for a cardiovascular primary prevention trial in the elderly?

BACKGROUND AND PURPOSE: Statins have been shown conclusively to reduce the risk of cardiovascular events in subjects with clinical cardiovascular disease or diabetes aged 65 to 80 years of age. However, few data are available for primary prevention of cardiovascular disease in those aged > or =70 years. SUMMARY OF REVIEW: A moderate-dose statin was of little benefit in a population aged 70 to 82 years when given for 3 years in the setting of suboptimally treated blood pressure. More evidence supports the use of blood pressure-lowering medications, but few data are available regarding the appropriate blood pressure target and most effective agents in the elderly. Some evidence also suggests that the elderly could experience higher mortality with antihypertensive treatment. These findings, along with greater safety concerns and an increasing number of competing risks and medical conditions with advancing age, make it imperative to carefully evaluate the risk/benefit balance from treating hypercholesterolemia and hypertension in persons aged > or =70 years. CONCLUSIONS: We propose a 5-year 2x2 factorial trial of primary prevention in the elderly that will (1) evaluate whether statin therapy will reduce the risk of cardiovascular events when added to the treatment of hypertension to achieve a blood pressure <140/90 mm Hg in most patients and (2) determine the most appropriate blood pressure regimen for the prevention of cardiovascular and renal events.

Aged↗

PubMed2006

Association between alcohol intake and domain-specific cognitive function in older women.

Moderate levels of alcohol intake may be associated with better cognitive function; however, this relationship may vary between cognitive domains. Women, aged 65-80 years, enrolled in the Women's Health Initiative (WHI) randomized clinical trials of hormone therapy, underwent annual standardized testing for global cognitive function through the ancillary WHI Memory Study (average follow-up of 4.5 years) and domain-specific cognitive function through the WHI Study of Cognitive Aging (average follow-up of 1.7 years). Compared to nondrinkers, women reporting moderate levels of alcohol intake ( or=1 drink/day by 5.7% for verbal knowledge (p < 0.001) and by 5.7% for phonemic fluency (p = 0.004), compared to never-drinkers. Moderate levels of alcohol intake are associated with somewhat better cognition, which may be expressed most strongly in functions related to verbal knowledge and phonemic fluency. However, our observational study cannot rule out confounding associations with unmeasured factors.

Aged↗

PubMed2006

Elderly women diagnosed with nonspecific chest pain may be at increased cardiovascular risk.

BACKGROUND: Women are more likely than men to have nonspecific chest pain (NSCP) symptoms. The long-term outcomes in women discharged with a diagnosis of NSCP are unknown. METHODS: The Women's Health Initiative Observational Study enrolled postmenopausal women aged 50-79 years. After excluding those with prior cardiovascular disease (CVD), 83,622 women were studied. NSCP cases were defined as having an initial primary hospital discharge diagnosis of NSCP (ICD-9 codes 786.50, 786.51, 786.59) without a prior diagnosis of coronary heart disease (CHD). Risks of subsequent CHD events were estimated from Cox proportional hazard ratio (HR) models stratified by clinic and adjusted for baseline age, cardiovascular risk factors, and hormone use. RESULTS: Over an average of 8 years of follow-up, 11% (230 of 2,092) of women with NSCP experienced a cardiovascular event compared with 9.5% (7,724 of 81,530) who did not. Compared with women without a hospitalization for NSCP during follow-up, those with NSCP had a greater than 2-fold higher risk of a subsequent hospitalization for clinically diagnosed angina (HR 2.18, 95% CI 1.66-2.86) and at least a 1.5-fold higher risk of nonfatal myocardial infarction (MI) (HR 1.59, 1.10-2.31), revascularization (HR 1.67, 1.28-2.20), and congestive heart failure (HR 1.75, 1.27-2.41). Women with NSCP who subsequently experienced a CHD event were more likely to be over age 65 or to have cardiovascular risk factors. CONCLUSIONS: Older women discharged with a diagnosis of NSCP may be at increased risk of CHD morbidity. Further research is needed to replicate these findings in other populations.

Aged↗

PubMed2005

Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: results from the Women's Health Initiative Randomized Clinical Trial.

BACKGROUND: The Women's Health Initiative (WHI) clinical trial of conjugated equine estrogens (CEEs), involving 10,739 postmenopausal women with hysterectomy, aged 50 to 79 years, was stopped early owing to lack of overall health benefit and increased risk of stroke. Because CEE is still prescribed for treatment of menopausal symptoms and prevention of osteoporosis, it is important to understand the overall impact of this therapy on health-related quality of life (HRQOL). METHODS: All participants completed 6 specific measures of quality of life at baseline and 1 year, and a subsample (n = 1189) also completed the questions 3 years after randomization. Changes in scores were analyzed for treatment effect. RESULTS: Randomization to CEE was associated with a statistically significant but small reduction in sleep disturbance at year 1 compared with baseline (mean benefit, 0.4 points on a 20-point scale) and a statistically significant but small negative effect on social functioning (mean effect, -1.3 points on a 100-point scale). There were no significant improvements due to CEE in the areas of general health, physical functioning, pain, vitality, role functioning, mental health, depressive symptoms, cognitive function, or sexual satisfaction at year 1. A subgroup examined 3 years after baseline had no significant benefits for any HRQOL outcomes. Among women aged 50 to 54 years with moderate to severe vasomotor symptoms at baseline, CEE did not improve any of the HRQOL variables at year 1. CONCLUSION: In this trial of postmenopausal women with prior hysterectomy, oral CEE did not have a clinically meaningful effect on HRQOL.

Aged↗

PubMed2005

Iris and anterior chamber angle neovascularization after iodine 125 brachytherapy for uveal melanoma.

PURPOSE: Iris neovascularization (INV) and anterior chamber angle neovascularization after radiotherapy for uveal melanoma may lead to neovascular glaucoma and enucleation. However, neovascularization of the anterior ocular segment may respond favorably to treatment with panretinal photocoagulation. The purpose of this study was to evaluate the frequency, interval to development, and predisposing factors of anterior ocular segment neovascularization following iodine 125 (I125) brachytherapy for uveal melanoma. DESIGN: Retrospective, interventional, consecutive case series. PARTICIPANTS: Sixty-five patients (65 eyes), consecutively treated with I125 brachytherapy for uveal melanoma from 1995 through 2000 and followed up after radiation therapy for 24 months or more. METHODS: Clinical findings and ultrasonography characteristics as well as treatment parameters were analyzed. MAIN OUTCOME MEASURES: The frequency of INV was determined and the interval to development of INV as well as the predisposing factors were analyzed statistically. RESULTS: In 15 of 65 eyes (23%), INV was detected after I125 brachytherapy at a mean +/- standard deviation of 26.66+/-11.63 months (median, 24 months; range, 9-48 months). Risk factors displaying the stronger correlation with INV were greater maximal tumor height (P<0.01), greater tumor vascularity (P<0.01), and disinsertion of horizontal rectus muscles (P = 0.01). CONCLUSIONS: After I125 brachytherapy for choroidal melanoma, INV developed in 23% of eyes and was correlated with larger tumor size, greater tumor vascularity, and disinsertion of a horizontal rectus muscle.

Adult↗

PubMed2005

The effect of ultralow-dose transdermal estradiol on urinary incontinence in postmenopausal women.

OBJECTIVE: To estimate the effect of 2 years of treatment with ultralow-dose transdermal estradiol (E2) on incontinence in postmenopausal women. METHODS: Ultra Low Dose Transdermal estRogen Assessment (ULTRA) was a multicenter, randomized, double-blinded, placebo-controlled trial of unopposed ultralow-dose (0.014 mg/d) transdermal E2 for prevention of osteoporosis in 417 postmenopausal women aged 60 to 80 years. Frequency of incontinence episodes was assessed at baseline and after 4 months and 2 years of treatment using a self-reported questionnaire. We used an intention-to-treat analysis to compare change in incontinence frequency, improved (decreased 2 or more episodes per week), unchanged (increased or decreased no more than 1 episode per week), or worsened (increased 2 or more episodes per week) between the E2 and placebo groups among women with and without at least weekly incontinence at baseline. RESULTS: At baseline, the prevalence of at least weekly incontinence was similar between E2 and placebo groups (43%). After 2 years, there was no difference between groups in the proportions of women with incontinence at baseline whose incontinence improved, worsened, or was unchanged. The odds ratio for worsening incontinence in the E2 compared with placebo group was 1.35 (95% confidence interval 0.75-2.42. In women without incontinence at baseline, the odds of developing at least weekly incontinence after 2 years in the E2 compared with placebo group was not significant (odds ratio 1.2, 95% confidence interval 0.7-2.2). CONCLUSION: Two years of treatment with unopposed ultralow-dose transdermal E2 did not substantially change the frequency of incontinence symptoms or alter the risk of developing at least weekly incontinence. LEVEL OF EVIDENCE: I.

Administration, Cutaneous↗

PubMed2004

Effect of isoflavones on lipids and bone turnover markers in menopausal women.

OBJECTIVES: The purpose of this analysis was to compare the effects of two dietary supplements derived from red clover to placebo on lipids and bone turnover markers in symptomatic menopausal women. METHODS: The study was a 12-week randomized, double-blind, placebo-controlled trial. Two hundred and fifty-two menopausal women ages 45-60 years experiencing > or =35 hot flashes per week were randomly assigned to Promensil (82 mg total isoflavones), Rimostil (57.2 mg total isoflavones), or placebo. Primary outcome measures were mean absolute changes for HDL-cholesterol, serum osteocalcin, and urinary N-telopeptide. Secondary outcome measures were mean changes of total cholesterol, LDL-cholesterol, the ratio of HDL- to LDL-cholesterol, and triglycerides. RESULTS: Ninety-eight percent of participants completed the 12-week protocol. Women taking Rimostil or Promensil compared to those taking placebo had greater mean increases in HDL-cholesterol; however, this change was small in magnitude (<2 mg/dl) and did not reach significance. There was a significant decrease in triglyceride levels among women taking Rimostil (14.4 mg/dl, P = 0.02) or Promensil (10.9 mg/dl, P = 0.05) compared to those taking placebo. The decrease was primarily among women with elevated baseline triglyceride levels (P for interaction = 0.009). There were no differences in mean changes of total cholesterol, LDL-cholesterol, or the ratio of HDL- to LDL-cholesterol among treatment groups. There were no statistically significant differences among treatment groups for bone turnover markers. CONCLUSIONS: Compared with placebo, both of the supplements containing isoflavones decrease levels of triglycerides in symptomatic menopausal women; however, this effect is small in magnitude.

Bone and Bones↗

PubMed2004

Conjugated equine estrogens and global cognitive function in postmenopausal women: Women's Health Initiative Memory Study.

CONTEXT: The Women's Health Initiative Memory Study (WHIMS) previously reported that estrogen plus progestin therapy does not protect cognition among women aged 65 years or older. The effect of estrogen-alone therapy, also evaluated in WHIMS, on cognition has not been established for this population. OBJECTIVES: To determine whether conjugated equine estrogen (CEE) alters global cognitive function in older women and to compare its effect with CEE plus medroxyprogesterone acetate (CEE plus MPA). DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled ancillary study of the Women's Health Initiative (WHI), WHIMS evaluated the effect of CEE on incidence of probable dementia among community-dwelling women aged 65 to 79 years with prior hysterectomy from 39 US academic centers that started in June 1995. Of 3200 eligible women free of probable dementia enrolled in the WHI, 2947 (92.1%) were enrolled in WHIMS. Analyses were conducted on the 2808 women (95.3%) with a baseline and at least 1 follow-up measure of global cognitive function before the trial's termination on February 29, 2004. INTERVENTIONS: Participants received 1 daily tablet containing either 0.625 mg of CEE (n = 1387) or matching placebo (n = 1421). MAIN OUTCOME MEASURE: Global cognitive function measured annually with the Modified Mini-Mental State Examination (3MSE). RESULTS: During a mean follow-up of 5.4 years, mean (SE) 3MSE scores were 0.26 (0.13) units lower than among women assigned to CEE compared with placebo (P =.04). For pooled hormone therapy (CEE combined with CEE plus MPA), the mean (SE) decrease was 0.21 (0.08; P =.006). Removing women with dementia, mild cognitive impairment, or stroke from the analyses lessened these differences. The adverse effect of hormone therapy was more pronounced among women with lower cognitive function at baseline (all P<.01). For women assigned to CEE compared with placebo, the relative risk of having a 10-unit decrease in 3MSE scores (>2 SDs) was estimated to be 1.47 (95% confidence interval, 1.04-2.07). CONCLUSION: For women aged 65 years or older, hormone therapy had an adverse effect on cognition, which was greater among women with lower cognitive function at initiation of treatment.

Aged↗

PubMed2004

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial.

CONTEXT: Despite decades of use and considerable research, the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain. OBJECTIVE: To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: Women were randomly assigned to receive either 0.625 mg/d of conjugated equine estrogen (CEE) or placebo. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Aged↗

PubMed2004

Predictors of angina pectoris versus myocardial infarction from the Women's Health Initiative Observational Study.

Although risk factors for acute coronary syndromes have been extensively studied, characteristics distinguishing women who will develop unstable angina rather than acute myocardial infarction (MI) are less well understood. This analysis evaluates baseline demographic, physical, and medical characteristics as predictors of angina versus MI in the Women's Health Initiative Observational Study. During a prospective 4.5-year follow-up of 92,152 postmenopausal women, 1,527 hospitalizations for angina and 797 for MI were confirmed by centrally trained physician adjudicators. In a multivariate analysis of women with incident angina or MI, high cholesterol (odds ratio [OR] 0.62, 95% confidence interval [CI] 0.47 to 0.80; p = 0.0004) and prior coronary disease (OR 0.70, 95% CI 0.55 to 0.89; p = 0.004) independently predicted angina (referent), whereas current cigarette smoking (OR 1.60, 95% CI 1.13 to 2.26; p = 0.007) and diabetes mellitus (1.44, 95% CI 1.10 to 1.87; p = 0.007) predicted MI. Older age and hypertension were independently, but less strongly, predictive of MI. Aspirin or statin use, physical activity, body mass index, and educational levels were not independently associated with one or the other type of acute coronary syndrome. Thus, specific risk factors strongly and independently predicted whether women with an acute coronary syndrome would present with angina or with MI.

Aged↗

PubMed2004

Linear accelerator thalamotomy.

BACKGROUND: The capability of performing functional radiosurgery lesions in the brain using a dedicated linear accelerator (LINAC) have not yet been demonstrated. This study evaluates modern LINAC technology for the creation of a sharp, small and functionally eloquent lesion in the thalamus. METHODS: Three patients underwent thalamotomy using a dedicated linear accelerator to radiosurgery, 2 females and 1 male, ages were 52, 53, and 73 years. Two patients presented with unilateral poststroke central pain and 1 with unilateral upper extremity pain secondary to metastatic infiltration of the brachial plexus. Maximal doses varied from 150 to 200 Gy, delivered by a 5-mm diameter collimator and 5 to 8 noncoplanar arcs evenly distributed. RESULTS: All patients gained substantial relief of their pain. They were able to reduce their medications and improve their activity levels. The patient with end-stage metastatic disease died of his malignancy 2 weeks after the treatment. One patient presented with recurrence of the pain 4 months after the treatment. No clinical complications were noticed. CONCLUSIONS: A dedicated linear accelerator is able to perform a precise and circumscribed lesion in the thalamus for pain control. Moreover, it proved to be safe, because no complications were observed. For patients using chronic anticoagulant therapy or with severe disabilities caused by cardiac, pulmonary or malignant diseases, this technique represents an alternative of treatment to radiofrequency thalamotomy.

Aged↗

PubMed2004

Religious participation, interleukin-6, and mortality in older adults.

This study prospectively examined the relationship between religious attendance, interleukin-6 (IL-6) levels, and mortality rates in a community-based sample of 557 older adults. Attending religious services more than once weekly was a significant predictor of lower subsequent 12-year mortality and elevated IL-6 levels (> 3.19 pg/mL), with a mortality ratio of.32 (95% confidence interval [CI] = 0.15,0.72; p <.01) and an odds ratio for elevated IL-6 of.34 (95% CI = 0.16, 0.73, p <.01), compared with never attending religious services. Structural equation modeling indicated religious attendance was significantly related to lower mortality rates and IL-6 levels, and IL-6 levels mediated the prospective relationship between religious attendance and mortality. Results were independent of covariates including age, sex, health behaviors, chronic illness, social support, and depression. Findings are consistent with a role for IL-6 in processes mediating the relationship between religious attendance and mortality.

Activities of Daily Living↗

PubMed2004

Elders who delay medication because of cost: health insurance, demographic, health, and financial correlates.

PURPOSE: Prescription medication use is essential to the health and well-being of many elderly persons. However, the cost of medications may be prohibitive and contribute to noncompliance with medical recommendations. This study identifies community-dwelling elders who reported a delay in medication use because of prescription medication cost. DESIGN AND METHODS: This was a cross-sectional study of a nationwide sample of 6,535 elders participating in the Asset and Health Dynamics Among the Oldest Old (AHEAD) study. Participants reported if they had taken less medication than prescribed or if they had not filled prescriptions because of cost in the past 2 years. This response was then compared with the self-report of multiple variables, including demographic, health status, health insurance coverage, and financial variables. RESULTS: Elders who were most vulnerable to medication delay as a result of cost included those with Medicare coverage only, low income, high out-of-pocket prescription costs, and poor health as well as African American elders and those aged 65-80 years. IMPLICATIONS: This study provides important information about community-dwelling elders that reported a delay in medication use because of cost. As a Medicare prescription benefit has been passed, it will be important to monitor how these changes affect the elders identified at risk for medication delay.

Aged↗

PubMed2004

Effects of ultralow-dose transdermal estradiol on bone mineral density: a randomized clinical trial.

OBJECTIVE: Because small increments in levels of endogenous plasma estradiol are associated with higher postmenopausal bone mineral density, we investigated the safety and effectiveness in preventing bone loss of unopposed, very-low-dose transdermal estradiol for postmenopausal women. METHODS: This was a randomized, placebo-controlled, double-blind trial with 2-year follow-up at 9 United States clinical centers. The study population comprised 417 postmenopausal women, aged 60-80 years, with intact uterus and bone mineral density z scores of -2.0 or higher, who were randomly assigned to receive either unopposed transdermal estradiol at 0.014 mg/d (n = 208) or placebo (n = 209). All participants received calcium and vitamin D supplementation. Lumbar spine and total hip bone mineral density change was measured by dual-energy X-ray absorptiometry; endometrial hyperplasia incidence was assessed by endometrial biopsy. RESULTS: Median plasma estradiol level in the estradiol group increased from 4.8 pg/mL at baseline to 8.5 pg/mL at 1 year (P <.001 versus baseline) and to 8.6 pg/mL at 2 years (P <.001 versus baseline) and was unchanged in the placebo group. Lumbar spine bone mineral density increased 2.6% in the estradiol group and 0.6% in the placebo group (between-group difference 2.0%, P <.001). Mean total hip bone mineral density increased 0.4% in the estradiol group and decreased 0.8% in the placebo group (between-group difference 1.2%, P <.001). Osteocalcin levels and bone-specific alkaline phosphatase were lower in the estradiol group than the placebo group (P <.001 each). Endometrial hyperplasia developed in 1 woman in the estradiol group but in none of the placebo group (difference in 2-year rates 0.5%, 95% confidence interval 0-7.3%). CONCLUSION: Postmenopausal treatment with low-dose, unopposed estradiol increased bone mineral density and decreased markers of bone turnover without causing endometrial hyperplasia.

Administration, Cutaneous↗

PubMed2004

Can dementia be prevented? Brain aging in a population-based context.

As a consequence of global aging of the human population, the occurrence of cognitive impairment and dementia is rapidly becoming a significant burden for medical care and public health systems. By the year 2020, the WHO predicts there will be nearly 29 million demented people in both developed and developing countries. Primary and secondary prevention of dementia through individual and population-level interventions could reduce this imminent risk. Vascular risk factors such as type 2 diabetes, hypertension, dietary fat intake, high cholesterol, and obesity have emerged as important influences on the risk of both vascular and Alzheimer's dementia. Understanding the reasons for differences between populations in genetic vulnerability and environmental exposures may help to identify modifiable risk factors that may lead to effective prevention of vascular and Alzheimer's dementia.

Aged↗

PubMed2003

Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial.

CONTEXT: Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have increased interest in other therapies for menopausal symptoms. Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies for hot flashes, but there is a paucity of data supporting their efficacy. OBJECTIVE: To compare the efficacy and safety of 2 dietary supplements derived from red clover with placebo in symptomatic menopausal women. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week. The study was conducted between November 1999 and March 2001 at 3 US medical centers and included women who were recently postmenopausal (mean [SD], 3.3 [4.5] years since menopause) experiencing 8.1 hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week, or took medications affecting isoflavone absorption. INTERVENTION: After a 2-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day), or an identical placebo, and followed-up for 12 weeks. MAIN OUTCOME MEASURE: The primary outcome measure was the change in frequency of hot flashes measured by participant daily diaries. Secondary outcome measures included changes in quality of life and adverse events. RESULTS: Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil (5.1), Rimostil (5.4), and placebo (5.0) groups. In comparison with the placebo group, participants in the Promensil group (41%; 95% confidence interval [CI], 29%-51%; P =.03), but not in the Rimostil group (34%; 95% CI, 22%-46%; P =.74) reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the 3 groups. CONCLUSION: Although the study provides some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause.

Dietary Supplements↗

PubMed2003

Urinary incontinence and depression in middle-aged United States women.

OBJECTIVE: To determine the correlates of incontinence in middle-aged women and to test for an association between incontinence and depression. METHODS: This was a population-based cross-sectional study of 5701 women who were residents of the United States, aged 50-69 years, and participated in the third interview of the Health and Retirement Study. The primary outcome measure was self-reported urinary incontinence. Depression was ascertained based on criteria set by the Diagnostic and Statistical Manual of Mental Disorders, using a short form of the Composite International Diagnostic Interview. In addition, depressive symptoms were assessed using the revised Center for Epidemiologic Studies Depression Scale. Multivariable logistic regression models were constructed to determine the independent association between incontinence and depression, after adjusting for confounders. RESULTS: Approximately 16% reported either mild-moderate or severe incontinence. Depression, race, age, body mass index, medical comorbidities, and limited activities of daily living were associated with incontinence. After adjusting for medical morbidity, functional status, and demographic variables, women with severe and mild-moderate incontinence were 80% (odds ratio [OR] 1.82; 95% confidence interval [CI] 1.26, 2.63) and 40% (OR 1.41; 95% CI 1.06, 1.87) more likely, respectively, to have depression than continent women. The association did not hold for depressive symptoms measured by the revised Center for Epidemiologic Studies Depression Scale after adjusting for covariates. CONCLUSION: Depression and incontinence are associated in middle-aged women. The strength of the association depends on the instrument used to classify depression. This reinforces the need to screen patients presenting for treatment of urinary incontinence for depression.

Activities of Daily Living↗