Biomedical subjects

Eric Vittinghoff

Publications and source records attributed to Eric Vittinghoff.

At least 55 records · Page 3Linked to original sources

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↗

PubMed2005

Weight loss: a novel and effective treatment for urinary incontinence.

PURPOSE: We evaluated the effect of weight loss on urinary incontinence (UI) in overweight and obese women. MATERIALS AND METHODS: A randomized, controlled clinical trial was conducted among overweight and obese women experiencing at least 4 UI episodes per week. Women were randomly assigned to a 3-month liquid diet weight reduction program (24 in the immediate intervention group) or a wait-list delayed intervention group (24 in the wait-list control group). Participants in the wait-list control group began the weight reduction program in month 3 of the study. All women were followed for 6 months after completing the weight reduction program. Wilcoxon tests were used to compare intergroup differences in change in weekly UI episodes and quality of life scores. RESULTS: A total of 48 women were randomized and 40 were assessed 3 months after randomization. Median (with 25% to 75% interquartile range [IQR]) baseline age was 52 years (IQR 47 to 59), weight was 97 kg (IQR 87 to 106) and UI episodes were 21 weekly (IQR 11 to 33). Women in the immediate intervention group had a 16 kg (IQR 9 to 20) weight reduction compared with 0 kg (IQR -2 to 2) in the wait-list control group (p <0.0001). The immediate intervention group experienced a 60% reduction (IQR 30% to 89%) in weekly UI episodes compared with 15% (IQR -9% to 25%) in the wait-list control group (p <0.0005) and had greater improvement in quality of life scores. Stress (p =0.003) and urge (p =0.03) incontinent episodes decreased in the immediate intervention vs wait-list control group. Following the weight reduction program the wait-list control group experienced a similar median reduction in weekly UI episodes (71%). Among all 40 women mean weekly UI episodes decreased 54% (95% CI 40% to 69%) after weight reduction and the improvement was maintained for 6 months. CONCLUSIONS: Weight reduction is an effective treatment for overweight and obese women with UI. Weight loss of 5% to 10% has an efficacy similar to that of other nonsurgical treatments and should be considered a first line therapy for incontinence.

Adolescent↗

PubMed2005

Pulse pressure and cardiovascular events in postmenopausal women with coronary heart disease.

BACKGROUND: Pulse pressure (PP) has been shown to predict risk for cardiovascular events in men; however, this association has not been well established in women. Hormone replacement therapy may improve arterial compliance, but findings from cross-sectional and prospective studies report inconsistent results. We sought to examine the relationship between PP and risk for cardiovascular events, and to determine the effect of hormone therapy on PP in postmenopausal women with coronary heart disease (CHD). METHODS AND RESULTS: A total of 2,763 postmenopausal women (mean age, 66 +/- 7 years [+/- SD]) with CHD in the Heart and Estrogen/Progestin Replacement Study, a randomized, placebo-controlled, secondary CHD prevention trial of estrogen plus progestin, were followed up on average for 4.1 years. BP was measured at baseline and annually. Mean baseline PP was 62 +/- 16 mm Hg. There were 361 myocardial infarctions (MIs) or CHD deaths, 265 hospitalizations for congestive heart failure (CHF), and 215 strokes or transient ischemic attacks (TIAs). Women in the highest quartile of PP at baseline had a 47% increase in risk for MI or CHD death and more than a twofold increase in risk for stroke and TIA events or hospitalization for CHF (p < 0.01 for each outcome). After adjustment for other cardiovascular risk factors and mean arterial pressure, PP remained significantly associated with incident stroke or TIA events (odds ratio, 1.25; p = 0.02) and hospitalizations for CHF (odds ratio, 1.31; p < 0.01) but not with MI or CHD death. After adjustment for diastolic BP, systolic BP was similarly associated with stroke or TIA (odds ratio, 1.30; p < 0.01) and hospitalized CHF (odds ratio, 1.30; p < 0.01) and was also weakly associated with risk for MI and CHD death (odds ratio, 1.18; p = 0.02). Mean PP was 1- to 2-mm Hg higher in women randomized to hormone replacement therapy vs those receiving placebo (p < 0.01). CONCLUSIONS: PP had predictive value for CHF and stroke or TIA, but not MI or CHD death in this cohort of postmenopausal women with CHD. Use of hormone replacement therapy produced a small, statistically significant increase in PP. Further research is necessary to determine the clinical utility of PP as a potential therapeutic target.

Aged↗

PubMed2004

Age-Specific prevalence of anal human papillomavirus infection in HIV-negative sexually active men who have sex with men: the EXPLORE study.

BACKGROUND: In the United States, anal cancer in men who have sex with men (MSM) is more common than cervical cancer in women. Human papillomavirus (HPV) is causally linked to the development of anal and cervical cancer. In women, cervical HPV infection peaks early and decreases after the age of 30. Little is known about the age-specific prevalence of anal HPV infection in human immunodeficiency virus (HIV)-negative MSM. METHODS: We studied the prevalence and determinants of anal HPV infection in 1218 HIV-negative MSM, 18-89 years old, who were recruited from 4 US cities. We assessed anal HPV infection status by polymerase chain reaction. RESULTS: HPV DNA was found in the anal canal of 57% of study participants. The prevalence of anal HPV infection did not change with age or geographic location. Anal HPV infection was independently associated with receptive anal intercourse (odds ratio [OR], 2.0; P<.0001) during the preceding 6 months and with >5 sex partners during the preceding 6 months (OR, 1.5; P<.0001). CONCLUSIONS: Urban, HIV-negative MSM have a stable, high prevalence of anal HPV infection across all age groups. These results differ substantially from the epidemiologic profile of cervical HPV infection in women. This may reflect differences between these populations with respect to the number of new sex partners after the age of 30 and may explain the high incidence of anal cancer in MSM.

Adult↗

PubMed2004

Renal insufficiency as an independent predictor of mortality among women with heart failure.

OBJECTIVES: We sought to explore the association between renal insufficiency and mortality among women with heart failure (HF) and to evaluate this risk by the presence of preserved or depressed systolic function. BACKGROUND: Although HF is common in older women, little is known about their risk factors for mortality. METHODS: This prospective cohort study retrospectively analyzed data from the Heart and Estrogen/progestin Replacement Study (HERS). Of the 2,763 women in HERS, 702 had HF. Renal function was categorized as creatinine clearance (CrCl) >60 ml/min, 40 to 60 ml/min, and <40 ml/min. We used proportional hazards models to evaluate the association between renal insufficiency and mortality. RESULTS: Over a mean 5.8 years, 228 women with HF died (32%). Renal insufficiency was strongly associated with mortality, even after adjustment for co-morbid conditions, systolic function, and medications (adjusted hazard ratio [HR] 1.53, 95% confidence interval [CI] 1.09 to 2.16 for CrCl 40 to 60 ml/min; adjusted HR 2.40, 95% CI 1.60 to 3.62 for CrCl <40 ml/min). Preserved or depressed systolic function did not modify the association between renal insufficiency and mortality risk, but the use of angiotensin-converting enzyme (ACE) inhibitors did modify this risk (ACE users: adjusted HR = 0.9, 95% CI 0.6 to 1.6; ACE nonusers: adjusted HR 2.1, 95% CI 1.3 to 3.2; p = 0.02 for interaction). Compared with other risk factors for mortality, renal insufficiency had the highest population attributable risk (27%). CONCLUSIONS: Renal insufficiency was a major predictor of mortality among women with HF and preserved or depressed systolic function. This risk was attenuated by the use of ACE inhibitors.

Aged↗

PubMed2004

Predictors of heart failure among women with coronary disease.

BACKGROUND: Although heart failure is common among women with coronary disease, the risk factors for developing heart failure have not been well studied. We determined the risk factors for developing heart failure among postmenopausal women with established coronary disease. METHODS AND RESULTS: This is a prospective cohort study using data from the Heart and Estrogen/progestin Replacement Study (HERS), a randomized, blinded, placebo-controlled trial of 4.1 years' duration, and subsequent open-label observational follow-up for 2.7 years (HERS II), performed at 20 US clinical centers between 1993 and 2000. Of the 2763 postmenopausal women with established coronary disease in the HERS trial, we studied the 2391 women with no heart failure at baseline by self-report and physical examination. The primary outcome of this analysis was incident heart failure defined by hospital admission or death from heart failure. During the 6.3+/-1.4-year follow-up, 237 women (10%) developed heart failure. Nine predictors were identified: diabetes (defined as a self-reported history of diabetes on treatment), atrial fibrillation, myocardial infarction, creatinine clearance <40 mL/min, systolic blood pressure >120 mm Hg, current smoking, body mass index >35 kg/m2, left bundle-branch block, and left ventricular hypertrophy. Randomization to estrogen/progestin was not associated with heart failure (hazard ratio=1.0; 95% CI, 0.7 to 1.3). Diabetes was the strongest risk factor (adjusted hazard ratio=3.1; 95% CI, 2.3 to 4.2). Diabetic women with elevated body mass index or depressed creatinine clearance were at highest risk, with annual incidence rates of 7% and 13%, respectively. Among diabetic women, hyperglycemia was associated with heart failure risk (adjusted hazard ratio=3.0; 95% CI, 1.2 to 7.5 for fasting glucose >300 mg/dL compared with fasting glucose 80 to 150 mg/dL). CONCLUSIONS: We identified 9 predictors of heart failure in postmenopausal women with coronary disease. Diabetes was the strongest risk factor, particularly when poorly controlled or with concomitant renal insufficiency or obesity.

Black or African American↗

PubMed2004

The incidence of end-stage renal disease is increasing faster than the prevalence of chronic renal insufficiency.

BACKGROUND: The steady increase in end-stage renal disease (ESRD) incidence is a worldwide public health crisis. OBJECTIVE: To determine whether the increasing incidence of ESRD in the United States is preceded by increased prevalence of chronic renal insufficiency. DESIGN: Birth cohort analysis. SETTING: Nationally representative Second and Third National Health and Nutrition Examination Surveys (NHANES II [1976-1980] and III [1988-1994]) and nationally comprehensive U.S. Renal Data System registry. PATIENTS: Adults, 20 to 74 years of age, surveyed in NHANES II (midpoint, 1978) and NHANES III (midpoint, 1991), and adults, 25 to 79 years of age, who developed ESRD in 1983 and 1996. MEASUREMENTS: Prevalent chronic renal insufficiency (estimated glomerular filtration rate, 15 to 59 mL/min per 1.73 m2) and new ESRD cases. RESULTS: From 1978 to 1991, the number of adults age 20 to 74 years with chronic renal insufficiency increased from 2.6 to 3.9 million, an increase in prevalence from 1970 to 2460 per 100 000 persons. However, the increased incidence of ESRD was even greater during this period. For every 1000 adults with chronic renal insufficiency in 1978, 9 new cases of ESRD developed in 1983, but every 1000 adults with chronic renal insufficiency in 1991 produced 16 new cases of ESRD in 1996 (relative risk, 1.7 [95% CI, 1.1 to 2.7]). LIMITATIONS: We could not follow individual patients with chronic renal insufficiency for the development of ESRD, and we used estimated rather than measured glomerular filtration rate. CONCLUSIONS: During the period examined, growth in incident ESRD outpaced growth in prevalent chronic renal insufficiency, demonstrating that the ESRD epidemic in the United States is not merely a function of more cases of kidney disease. Future research should examine other potential contributors to ESRD growth, such as improved survival from nonrenal diseases and more liberal entry into treatment programs.

Adult↗

PubMed2004

Substance use and sexual risk: a participant- and episode-level analysis among a cohort of men who have sex with men.

Prior reports associating substance use with sexual risk behavior have generally used summary measures and have not adjusted for participants' background levels of substance use. In this 1999-2001 US study (the EXPLORE study), the authors determined whether substance use during sex was independently associated with sexual risk during recent sexual episodes, as reported by 4,295 human immunodeficiency virus-negative men who have sex with men. The main outcome measure was serodiscordant unprotected anal sex (SDUA). The influence of participant-level characteristics was examined by using repeated-measures logistic models. In assessing the influence of episode-level predictors on SDUA, the influence of participant-level characteristics, including 6-month substance use, was removed by using conditional logistic regression, in effect making each participant his own control. The authors also adjusted for partner characteristics. Eleven percent of participants reported heavy alcohol use, 37% used poppers, 19% sniffed cocaine, and 13% used amphetamines. In the participant-level analysis, use of poppers, amphetamines, and sniffed cocaine as well as heavy alcohol use in the prior 6 months were independently associated with SDUA. In the conditional analysis, consumption of > or = 6 alcoholic drinks or use of poppers, amphetamines, or sniffed cocaine just before or during sex was independently associated with SDUA. The authors concluded that programs aimed at preventing human immunodeficiency virus transmission should emphasize the influence of substance use during sex on increased risk behavior.

Adolescent↗

PubMed2004

Determinants of enrollment in a preventive HIV vaccine trial: hypothetical versus actual willingness and barriers to participation.

OBJECTIVE: To compare hypothetical and actual willingness to enroll in a preventive HIV vaccine trial and identify factors affecting enrollment. METHODS: Participants previously enrolled in an HIV vaccine preparedness study (VPS) in 8 US cities were invited to be screened for a phase 2 HIV vaccine trial. Demographic and risk characteristics of those enrolling, ineligible, and refusing enrollment were compared using the chi2 or Fisher exact test. Multivariable logistic models were used to identify independent predictors of refusal. RESULTS: Of 2531 high-risk HIV-uninfected former VPS participants contacted for the vaccine trial, 13% enrolled, 34% were ineligible, and 53% refused enrollment. Only 20% of those stating hypothetical willingness during the VPS actually enrolled in this vaccine trial. In multivariate analysis, refusal was higher among African Americans and lower in persons >40 years of age, those attending college, and those with > or =5 partners in the prior 6 months. All racial ethnic groups cited concerns about vaccine-induced seropositivity; African Americans also cited mistrust of government and safety concerns as barriers to enrollment. CONCLUSIONS: Steps can be taken to minimize potential social harms and to mobilize diverse communities to enroll in trials. Statements of hypothetical willingness to participate in future trials may overestimate true enrollment.

AIDS Vaccines↗

PubMed2004

Effect of hysterectomy vs medical treatment on health-related quality of life and sexual functioning: the medicine or surgery (Ms) randomized trial.

CONTEXT: Although a quarter of US women undergo elective hysterectomy before menopause, controlled trials that evaluate the benefits and harms are lacking. OBJECTIVE: To compare the effect of hysterectomy vs expanded medical treatment on health-related quality of life. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, randomized controlled trial (August 1997-December 2000) of 63 premenopausal women, aged 30 to 50 years, with abnormal uterine bleeding for a median of 4 years who were dissatisfied with medical treatments, including medroxyprogesterone acetate. The participants, who were patients at gynecology clinics and affiliated practices of 4 US academic medical centers, were followed up for 2 years. INTERVENTIONS: Participants were randomly assigned to undergo hysterectomy or expanded medical treatment with estrogen and/or progesterone and/or a prostaglandin synthetase inhibitor. The hysterectomy route and medical regimen were determined by the participating gynecologist. MAIN OUTCOME MEASURES: The primary outcome was mental health measured by the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36). Secondary outcomes included physical health measured by the Physical Component Summary (PCS), symptom resolution and satisfaction, body image, and sexual functioning, as well as other aspects of mental health and general health perceptions. RESULTS: At 6 months, women in the hysterectomy group had greater improvement in MCS scores than women in the medicine group (8 vs 2, P =.04). They also had greater improvement in symptom resolution (75 vs 29, P<.001), symptom satisfaction (44 vs 7, P<.001), interference with sex (41 vs 22, P =.003), sexual desire (21 vs 3, P =.01), health distress (33 vs 13, P =.009), sleep problems (13 vs 1, P =.03), overall health (12 vs 2, P =.006), and satisfaction with health (31 vs 14, P =.01). By the end of the study, 17 (53%) of the women in the medicine group had requested and received hysterectomy, and these women reported improvements in quality-of-life outcomes during the 2 years that were similar to those reported by women randomized to the hysterectomy group. Women who continued medical treatment also reported some improvements (P<.001 for within-group change in many outcomes), with the result that most differences between randomized groups at the end of the study were no longer statistically significant in the intention-to-treat analysis. CONCLUSIONS: Among women with abnormal uterine bleeding and dissatisfaction with medroxyprogesterone, hysterectomy was superior to expanded medical treatment for improving health-related quality-of-life after 6 months. With longer follow-up, half the women randomized to medicine elected to undergo hysterectomy, with similar and lasting quality-of-life improvements; those who continued medical treatment also reported some improvements.

Adult↗

PubMed2004

Modelling clustered survival data from multicentre clinical trials.

In randomized clinical trials, subjects are recruited at multiple study centres. Factors that vary across centres may exert a powerful independent influence on study outcomes. A common problem is how to incorporate these centre effects into the analysis of censored time-to-event data. We survey various methods and find substantial advantages in the gamma frailty model. This approach compares favourably with competing methods and appears minimally affected by violation of the assumption of a gamma-distributed frailty. Recent computational advances make use of the gamma frailty model a practical and appealing tool for addressing centre effects in the analysis of multicentre trials.

Humans↗

PubMed2004

Medicine or Surgery (Ms): a randomized clinical trial comparing hysterectomy and medical treatment in premenopausal women with abnormal uterine bleeding.

Hysterectomy may be overused as treatment for abnormal uterine bleeding due to benign causes in reproductive women. Medical therapies are an alternative, and there is a need for randomized trials comparing the outcomes of these approaches. Women of reproductive age who continued to have bothersome abnormal uterine bleeding after cyclic hormonal treatment with medroxyprogesterone acetate (MPA; 10-20 mg for 10-14 days/month) for 3-5 months were invited to participate in a randomized trial of hysterectomy versus other medical therapies. Participating gynecologists were free to choose the particular surgical (transabdominal or transvaginal) or medical (generally oral contraceptives and/or a prostaglandin synthetase inhibitor) approaches. Outcomes during 2 years of follow-up include quality of life (primary), sexual function, clinical effectiveness and cost. We screened 1557 women to find 413 who began 3-5 months of MPA; 215 completed this treatment, of whom 102 still had bothersome symptoms, and of these 38 consented to be randomized. Another 25 women with bothersome symptoms after a documented history of 3 months of cyclic MPA were also randomized, for a total of 63. The average age of randomized women was 41; 54% were African-American, and they reported uterine bleeding 12 days/month on average, heavy bleeding 6 days/month. Anemia (hematocrit<32) was present in 38% of African-Americans and 15% of Caucasians (p=0.05). Two thirds of the women had fibroids and 80% reported pelvic pain. Obesity was common (45% had a body mass index (BMI)>30), and associated with a longer duration of symptoms (12 vs. 4 years for BMI<25; p=0.02) and a greater prevalence of incontinence (44% vs. 16%; p=0.046). Although recruitment was difficult, we have completed enrollment in a randomized clinical trial comparing surgical and medical treatments for abnormal uterine bleeding.

Adult↗

PubMed2004

Creatinine levels and cardiovascular events in women with heart disease: do small changes matter?

BACKGROUND: Small changes in creatinine levels have been incrementally associated with increased risk for heart failure morbidity, but their association with cardiovascular events has not been evaluated in persons with established coronary heart disease (CHD). METHODS: This was an observational study from the Heart and Estrogen/Progestin Replacement Study (HERS) and the HERS-II follow-up study. Participants were 2,763 postmenopausal women with CHD who were followed up for a mean of 4.1 years during HERS and an additional 2.7 years during HERS-II. We evaluated the association of worsened renal function (creatinine level increase > or = 0.3 mg/dL [> or =26.5 micromol/L]) during HERS with CHD outcomes (nonfatal myocardial infarction and CHD death) that occurred during HERS-II. RESULTS: Only 194 participants (9%) had worsened renal function during HERS, and they were characterized by a greater prevalence of diabetes, lower high-density lipoprotein cholesterol and higher triglyceride levels, and increased rate of cardiovascular events during HERS (all P < 0.01). After adjustment for only baseline creatinine levels, worsened renal function was associated with HERS-II CHD events (relative hazard [RH], 1.54; 95% confidence interval [CI], 1.04 to 2.29). After adjustment for baseline characteristics, HERS cardiovascular events, and medication use, worsened renal function was no longer associated with CHD events (RH, 1.08; 95% CI, 0.70 to 1.67). However, baseline creatinine levels from HERS were remarkably strong predictors of HERS-II events. CONCLUSION: Although baseline renal function was among the strongest predictors of CHD events during 7 years of HERS follow-up, we found no significant association of worsened renal function with cardiovascular outcomes after adjustment for cardiovascular risk factors and interim events.

Aged↗

PubMed2004

Effect of raloxifene on urinary incontinence: a randomized controlled trial.

OBJECTIVE: To estimate the effect of 3 years of treatment with raloxifene on urinary incontinence in postmenopausal women. METHODS: We used measures of urinary incontinence severity, frequency, and type in the Multiple Outcomes of Raloxifene trial, a multicenter randomized, controlled trial of women who were at least 2 years postmenopausal with osteoporosis. At 10 U.S. sites of this trial, 963 women randomly assigned to raloxifene or placebo completed questionnaires about incontinence at baseline and 3 years later. We analyzed the odds of worsening severity and frequency of incontinence and type of incontinence after 3 years of treatment with raloxifene. RESULTS: The mean age of our subjects was 68.3 +/- 7 years. After 3 years of treatment, there was no significant difference between raloxifene and placebo groups in urinary incontinence severity (multivariable odds ratio [OR] 1.02; 95% [CI] 0.78, 1.34). The majority of the women (60%) had no change in urinary incontinence episodes from baseline to year 3. The odds of worsening urinary incontinence severity after 3 years of raloxifene treatment were 1.05 (95% CI 0.75, 1.48). Similarly, the odds of developing new onset incontinence were 0.95 (95% CI 0.59, 1.52). Finally, raloxifene did not effect the odds of having stress (OR 1.01; 95% CI 0.71, 1.43) or urge (OR 1.20; 95% CI 0.86, 1.68) incontinence after 3 years of use. CONCLUSION: In postmenopausal women with osteoporosis, 3 years of treatment with raloxifene had no effect on urinary incontinence. LEVEL OF EVIDENCE: I

Administration, Oral↗

PubMed2004

Hysterectomy versus expanded medical treatment for abnormal uterine bleeding: clinical outcomes in the medicine or surgery trial.

OBJECTIVE: To compare clinical outcomes after randomization to hysterectomy versus medical treatment in patients with chronic abnormal uterine bleeding refractory to medroxyprogesterone acetate. METHODS: We randomly assigned 63 premenopausal women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate treatment to receive either a hysterectomy or expanded medical treatment. Within each randomized group, the specific treatment approach was determined by patient and provider preference. The primary analysis compared changes in clinical outcomes at 6 and 24 months by using an intention-to-treat approach. Secondary as-treated analyses after adjustment for baseline covariates compared participants randomly assigned to medical treatment who continued the medical approach with those who crossed over to hysterectomy. RESULTS: The intention-to-treat analyses at 6 months revealed greater symptom improvement in the hysterectomy group than in the medicine group for pelvic pain (P <.01), urinary urgency (P =.03), incomplete bladder emptying (P =.03), breast pain (P =.02), and cessation of vaginal bleeding (87% versus 11%, P <.001). Seventeen of 32 women assigned to medicine (53%) eventually crossed over and received a hysterectomy, and by 24 months the statistically significant differences by intention-to-treat were limited to greater improvement in hot flushes (P <.01) and cessation of vaginal bleeding (P <.01). Within-group analyses at year 2 showed statistically significant improvements from baseline on most symptoms for women who had a hysterectomy, whether through randomization or crossover. Women remaining on medical treatments had statistically significant improvements in pelvic pain, pelvic/bladder pressure, and stress incontinence. In a nonrandomized comparison with women who remained on medical treatments through year 2, those crossing over to hysterectomy experienced greater improvements in bleeding (P <.01), pelvic pain (P <.01), low back pain (P =.02), breast pain (P =.01), urinary frequency (P =.01), and urgency (P =.02). However, they also experienced more days off from work or usual activities (P <.01) and more days spent in bed (P <.01) than those who remained on medicine. CONCLUSION: For patients with abnormal uterine bleeding refractory to medroxyprogesterone acetate, hysterectomy is superior to expanded efforts with oral medications for alleviating clinical symptoms but may lead to more days of restricted activity.

Adult↗

PubMed2004

Resource use for total and supracervical hysterectomies: results of a randomized trial.

OBJECTIVE: Hysterectomy is the most common major surgical procedure performed in the United States for nonobstetric reasons. Although most hysterectomies include removal of the cervix, the rate of supracervical procedures has increased in recent years. To provide evidence about the outcomes of both types of hysterectomy, we conducted a randomized clinical trial of total (TAH) or supracervical (SCH) hysterectomy (the "TOSH" trial). We report here an analysis of 24-month resource use by patients in this trial. METHODS: A randomized controlled trial was performed at 3 clinical centers to compare resources used by 120 patients who received a total or supracervical abdominal hysterectomy. Service use during a 24-month follow-up period was identified from medical and billing records and patient reports. Each service used was assigned a relative value, which was then converted into 2002 U.S. dollars. RESULTS: Overall resource use was similar in the 2 study groups in the first 12 months after randomization (TAH 5,870 US dollars; SCH 6,018 US dollars; 95% confidence interval for difference -960 US dollars, 1,255 US dollars; P <.79) and for the full 24 months (TAH 6,448 US dollars; SCH 7,479 US dollars; 95% confidence interval for difference -533 US dollars, 2,616 US dollars; P <.20). In exploratory multivariable analyses, resource use was significantly associated with baseline body mass index greater than or equal to 35 kg/m(2) (8,440 US dollars versus 6,398 US dollars, P =.02) and heavy bleeding (7,550 US dollars versus 5,368 US dollars, P =.02). CONCLUSION: We conclude that the use of medical care resources over a 24-month period is comparable for total and supracervical hysterectomy. The association of a woman's weight and bleeding pattern with subsequent resource use requires further investigation.

Adult↗

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

Renal insufficiency and the risk of lower extremity peripheral arterial disease: results from the Heart and Estrogen/Progestin Replacement Study (HERS).

Renal insufficiency is a risk factor for coronary heart disease and stroke, but whether it predicts lower extremity peripheral arterial disease (PAD) is unknown. The authors evaluated was the association of baseline renal insufficiency with future PAD events in the Heart and Estrogen/Progestin Replacement Study (HERS) and follow-up study (HERS II). A total of 2763 postmenopausal women with known coronary heart disease were enrolled in HERS and randomly assigned to receive hormone therapy with conjugated estrogens and medroxyprogesterone acetate or placebo and followed for up to 8 yr for clinical end points. The outcome was time from randomization to first occurrence of either a lower extremity amputation, revascularization (surgical or percutaneous), or lumbar sympathectomy during follow-up. Incident lower extremity PAD event rates among women with creatinine clearances > or =60, 30 to 59, and < 30 ml/min/1.73 m(2) were, respectively, 0.55%, 0.92%, and 2.73% per year. After multivariable proportional-hazard adjustment for potential confounders and other known risk factors for PAD, women with a creatinine clearance 30 to 59 ml/min/1.73 m(2) (hazard ratio [HR], 1.63; 95% confidence interval [CI], 1.04 to 2.54, P = 0.032) and <30 ml/min/1.73 m(2) (HR, 3.24; 95% CI, 1.20 to 8.78, P = 0.021) had a significantly increased risk of PAD compared with participants with a creatinine clearance > or =60 ml/min/1.73 m(2). Renal insufficiency was independently associated with future PAD events among postmenopausal women with coronary heart disease. Future studies should determine whether this association is present in other populations and investigate its potential mechanisms.

Aged↗