Self-rated health among women with coronary disease: depression is as important as recent cardiovascular events.

BACKGROUND: Prior studies have shown an association between depression and self-rated health among patients with coronary disease. However, the magnitude of the effect of depression on self-rated health compared with that of major clinical events is unknown. Our main objective was to clarify the association between depression and self-rated health using longitudinal data. METHODS: We performed a prospective cohort study of 2675 postmenopausal women with coronary disease. The primary predictor variable was a 4-state categorical depression variable based on the Burnam depression screen assessed at sequential visits. The outcome variable was self-rated overall health (excellent, very good, or good vs fair or poor). RESULTS: After adjustment for age, comorbidities, prior self-rated health, and interim events, women with depression at both current and prior annual visits had a >5-fold increased odds of fair/poor self-rated health (odds ratio [OR] 5.1, 95% CI 3.8-6.8). New depression was associated with a >2-fold increased odds of fair/poor self-rated health (OR 2.6, 95% CI 2.0-3.4). Having a history of depression at the preceding annual visit but not at the current visit was associated with a slight increased odds of fair/poor self-rated health (OR 1.3, 95% CI 1.0-1.7). The magnitude of the impact of persistent or new depression was comparable to that of recent angina, myocardial infarction, angioplasty, heart failure, or bypass surgery. CONCLUSIONS: Women with persistent or new depression are more likely to report fair/poor self-rated health. The magnitude of the impact of persistent or new depression is comparable to that of major cardiac events.

Sexual activity and function in postmenopausal women with heart disease.

OBJECTIVE: To examine the prevalence and correlates of sexual activity and function in postmenopausal women with heart disease. METHODS: We included baseline self-reported measures of sexual activity and the sexual problem scale from the Medical Outcomes Study in the Heart and Estrogen/Progestin Replacement Study (HERS), a study of 2,763 postmenopausal women, average age 67 years, with coronary disease and intact uteri. We used multivariable linear and logistic regression to identify independent correlates of sexual activity and dysfunction. RESULTS: Approximately 39% of the women in HERS were sexually active, and 65% of these reported at least 1 of 5 sexual problems (lack of interest, inability to relax, difficulty in arousal or in orgasm, and discomfort with sex). In multivariable analysis, factors independently associated with being sexually active included younger age, fewer years since menopause, being married, better self-reported health, higher parity, moderate alcohol use, not smoking, lack of chest discomfort, and not being depressed. Among the 1,091 women who were sexually active, lower sexual problem scores were associated with being unmarried, being better educated, having better self-reported health, and having higher body mass index. CONCLUSION: Many women with heart disease continue to engage in sexual activity into their 70s, and two thirds of these report discomfort and other sexual function problems. Physicians should be aware that postmenopausal patients are sexually active and address the problems these women experience. LEVEL OF EVIDENCE: II-2.

Sexual functioning after total compared with supracervical hysterectomy: a randomized trial.

OBJECTIVE: To compare sexual functioning and health-related quality-of-life outcomes of total abdominal hysterectomy (TAH) and supracervical hysterectomy (SCH) among women with symptomatic uterine leiomyomata or abnormal uterine bleeding refractory to hormonal management. METHODS: We randomly assigned 135 women scheduled to undergo abdominal hysterectomy in 4 U.S. clinical centers to either a total or supracervical procedure. The primary outcome was sexual functioning at 2 years, as assessed by the Medical Outcomes Study Sexual Problems Scale. Secondary outcomes included specific aspects of sexual functioning and health-related quality-of-life at 6 months and 2 years. RESULTS: Sexual problems improved dramatically in both randomized groups during the first 6 months and plateaued by 1 year. Health-related quality-of-life scores also improved in both groups. At 2 years, both groups reported few problems with sexual functioning (mean score on the Sexual Problems Scale for SCH group 82, TAH group 80, on a 0-to-100 scale with 100 indicating an absence of problems; difference = +2.95% confidence interval -8 to +11), and there were no significant differences between groups. CONCLUSION: Supracervical and total abdominal hysterectomy result in similar sexual functioning and health-related quality of life during 2 years of follow-up. This information can help guide physicians as they discuss surgical options with their patients.

Effect of estrogen plus progestin on progression of carotid atherosclerosis in postmenopausal women with heart disease: HERS B-mode substudy.

OBJECTIVE: The Heart and Estrogen/Progestin Replacement Study (HERS) found no overall effect of estrogen plus progestin (compared with placebo) on coronary event rates in 2763 postmenopausal women with established coronary disease (mean 4.1 years of follow-up). In addition to the events trial, a carotid ultrasound substudy was established in 1993 to be conducted concurrently to determine whether hormone therapy affects the progression of the underlying atherosclerotic process. METHODS AND RESULTS: Within the larger HERS, a subset of 362 participants underwent carotid B-mode ultrasound examinations at baseline and the end of follow-up. Progression of carotid atherosclerosis was measured as the temporal change in intimal-medial thickness (IMT). CONCLUSIONS: IMT progressed in the hormone treatment and placebo groups, although there was no statistical difference between the rates: IMT progressed 26 microm/y (95% CI 18 to 34 microm/y) in the hormone group and 31 microm/y (95% CI 21 to 40 microm/y) in the placebo group (P=0.44). There were also no significant treatment effects when the results were examined by carotid segment or were adjusted for covariates. These data support the American Heart Association recommendation that women with established coronary disease should not initiate hormone therapy with an expectation of atherosclerotic benefit.

Risk factors and secondary prevention in women with heart disease: the Heart and Estrogen/progestin Replacement Study.

BACKGROUND: Risk factors for coronary heart disease events have most commonly been evaluated in healthy men. OBJECTIVE: To assess risk factors, event rates, and use of secondary prevention treatments in women with preexisting coronary disease. DESIGN: A prospective cohort of clinical trial participants. SETTING: 20 U.S. clinical centers. PARTICIPANTS: 2763 postmenopausal women with known coronary disease in the Heart and Estrogen/progestin Replacement Study (HERS). MEASUREMENTS: Myocardial infarction or death from coronary heart disease. RESULTS: On multivariable analysis, the researchers found 11 risk factors: 6 noted by history (nonwhite ethnicity, lack of exercise, treated diabetes, angina, congestive heart failure, and more than one previous myocardial infarction) and 5 that were measured (blood pressure, low-density lipoprotein cholesterol level, high-density lipoprotein cholesterol level, lipoprotein(a) level, and creatinine clearance). The annual rate of coronary events was 1.3% (95% CI, 0.7% to 2.5%) in women with no risk factors and 8.7% (CI, 7.1% to 10.8%) in women with five or more risk factors (a sixfold increase). At entry into HERS, 83% of participants were receiving aspirin or other antiplatelet agents, 33% were receiving beta-blockers, 18% were receiving angiotensin-converting enzyme inhibitors, and 53% were receiving lipid-lowering drugs. Women with more risk factors were less likely to be taking aspirin (P < 0.001) and lipid-lowering drugs (P = 0.006). CONCLUSIONS: Women with coronary disease are at high risk for myocardial infarction or death from coronary heart disease even in the absence of other risk factors, and their risk increases up to sixfold when many risk factors are present. Established drugs for secondary prevention, including aspirin, beta-blockers, and lipid-lowering agents, are underused in these women, especially those at highest risk.

A randomized comparison of total or supracervical hysterectomy: surgical complications and clinical outcomes.

OBJECTIVE: To compare surgical complications and clinical outcomes after total versus supracervical abdominal hysterectomy for control of abnormal uterine bleeding, symptomatic uterine leiomyomata, or both. METHODS: We conducted a randomized intervention trial in four US clinical centers among 135 patients who had abdominal hysterectomy for symptomatic uterine leiomyomata, abnormal uterine bleeding refractory to hormonal treatment, or both. Patients were randomly assigned to receive a total or supracervical hysterectomy performed using the surgeon's customary technique. Using an intention-to-treat approach, we compared surgical complications and clinical outcomes for 2 years after randomization. RESULTS: Sixty-eight participants were assigned to supracervical hysterectomy (SCH) and 67 to total abdominal hysterectomy (TAH). Hysterectomy by either technique led to statistically significant reductions in most symptoms, including pelvic pain or pressure, back pain, urinary incontinence, and voiding dysfunction. Patients randomly assigned to (SCH) tended to have more hospital readmissions than those randomized to TAH, but this difference was not statistically significant. There were no statistically significant differences in the rate of complications, degree of symptom improvement, or activity limitation. Participants weighing more than 100 kg at study entry were twice as likely to be readmitted to the hospital during the 2-year follow-up period (relative risk [RR] 2.18, 95% confidence interval [CI] 1.06, 4.48, P=.034). CONCLUSION: We found no statistically significant differences between (SCH) and TAH in surgical complications and clinical outcomes during 2 years of follow-up.

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.

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.