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BackgroundCareful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin.MethodsWe invited 2,328 women, aged 45-70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses.ResultsAmong 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68-4.08), lack of symptom improvement (OR 4.21, CI 1.50-12.17), vaginal bleeding (OR 5.96, CI 1.44-24.6), and learning to cope with symptoms (OR 3.36, CI 2.21-5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26-0.61) and mood swings or depression (OR 0.63, CI 0.42-0.92).ConclusionsDoctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.

ObjectiveThe aim of this study was to identify provider characteristics associated with hormone therapy prescribing.MethodsThe study design is cross-sectional. In December 2005, we mailed surveys to providers practicing in two integrated healthcare delivery systems located in the northwestern and northeastern United States; 379 responded (74%) and 249 (49% of total) granted access to their automated data. Data included provider demographics, practice characteristics, and perceptions about hormone therapy. Provider-specific annual hormone therapy prescribing frequency was calculated as days supply of hormone therapy filled divided by the number of visits (among women aged 45-80 y). Factors associated with higher rates of hormone therapy prescribing were identified using bivariate and multivariate analyses.ResultsWe report results separately for primary care providers (internists and family practitioners) and obstetrician/gynecologists because significant correlates differed in these two groups. For both primary care providers and obstetrician/gynecologists, in multivariate analyses, hormone therapy prescribing varied by site (P < or = 0.002) and years at the healthcare organization (P < or = 0.01). For primary care providers only, higher hormone therapy prescribing was associated with reported expert knowledge of the hormone therapy trials (P < or = 0.001). For obstetrician/gynecologists, higher hormone therapy prescription was related to feeling well prepared to counsel women on hormone therapy (P < or = 0.007), believing that the risks of estrogen with progestogen had been exaggerated (P = 0.04), and seeing younger aged patients (P = 0.03).ConclusionsAfter the release of the Women's Health Initiative findings and practicing under similar clinical guidelines, hormone therapy prescribing is associated with providers' confidence, practice location, and time with a healthcare organization.

ObjectiveThe goal of this study was to assess whether menopausal symptoms were more common and/or more severe among women with depressive symptoms.MethodsA cross-sectional survey of 1358 women, ages 45-70, at two large integrated health plans (Seattle; Boston) was performed. Information on demographics, medical and reproductive history, medication use, menopausal experience and depressive symptoms (PHQ-8) were collected. Women taking HT were excluded. Logistic regression models adjusted for age and body mass index tested the associations between menopausal symptoms (hot flushes, night sweats, vaginal dryness and dyspareunia) and presence of moderate/severe depressive symptoms.Results770 women were included; 98 (12.7%) had moderate/severe depressive symptoms and 672 (87.3%) had no/mild depressive symptoms. Women with moderate/severe depressive symptoms were almost twice as likely to report recent vasomotor symptoms (hot flashes and or night sweats) vs. women with no/mild depressive symptoms (adjusted odds ratio (aOR) 1.67, 95%CI 1.04-2.68), and to report them as severe (aOR 1.63, 95%CI 0.95-2.83). A higher symptom burden was observed despite the fact that 20% of women with moderate/severe depressive symptoms (vs. 4.6% no/mild depressive symptoms) were using an SSRI or SNRI, medications known to improve vasomotor symptoms. The percentage of women with menopausal symptoms, and the percentage with severe vasomotor symptoms were linearly associated with the depressive symptom score.ConclusionsDepressive symptoms "amplified" the menopausal experience, or alternatively, severe vasomotor symptoms worsened depressive symptoms.

ObjectiveTo evaluate vaginal, endometrial, and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy (HT).DesignThis was a 1-year, randomized, double-blind, placebo-controlled trial of 351 women, ages 45 to 55, with two or more vasomotor symptoms per day. Women were randomly assigned to (1) black cohosh, (2) a multibotanical containing black cohosh, (3) the same multibotanical plus dietary soy counseling, (4) HT, or (5) placebo. Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month. Data on vaginal cytology and dryness were collected (at baseline and 3 and 12 mo). Daily menstrual diaries were maintained by 313 women with a uterus, and abnormal bleeding was evaluated. Serum estradiol, follicle-stimulating hormone, luteinizing hormone, and steroid hormone-binding globulin were assessed (baseline and 12 mo) among 133 postmenopausal women. Gynecologic outcomes of the five groups were compared.ResultsThe five groups did not vary in baseline vaginal cytology profiles, vaginal dryness, menstrual cyclicity, or hormone profiles. The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months (P < 0.05). Abnormal bleeding occurred in 53 of 313 (16.9%) women. There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups, whereas women in the HT group had a greater risk than those in the placebo group (P < 0.001). Among postmenopausal women, HT significantly decreased follicle-stimulating hormone and increased estradiol; none of the herbal interventions showed significant effects on any outcomes at any time point.ConclusionBlack cohosh, used alone or as part of a multibotanical product with or without soy dietary changes, had no effects on vaginal epithelium, endometrium, or reproductive hormones.

ObjectiveTo evaluate vaginal, endometrial, and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy (HT).DesignThis was a 1-year, randomized, double-blind, placebo-controlled trial of 351 women, ages 45 to 55, with two or more vasomotor symptoms per day. Women were randomly assigned to (1) black cohosh, (2) a multibotanical containing black cohosh, (3) the same multibotanical plus dietary soy counseling, (4) HT, or (5) placebo. Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month. Data on vaginal cytology and dryness were collected (at baseline and 3 and 12 mo). Daily menstrual diaries were maintained by 313 women with a uterus, and abnormal bleeding was evaluated. Serum estradiol, follicle-stimulating hormone, luteinizing hormone, and steroid hormone-binding globulin were assessed (baseline and 12 mo) among 133 postmenopausal women. Gynecologic outcomes of the five groups were compared.ResultsThe five groups did not vary in baseline vaginal cytology profiles, vaginal dryness, menstrual cyclicity, or hormone profiles. The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months (P < 0.05). Abnormal bleeding occurred in 53 of 313 (16.9%) women. There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups, whereas women in the HT group had a greater risk than those in the placebo group (P < 0.001). Among postmenopausal women, HT significantly decreased follicle-stimulating hormone and increased estradiol; none of the herbal interventions showed significant effects on any outcomes at any time point.ConclusionBlack cohosh, used alone or as part of a multibotanical product with or without soy dietary changes, had no effects on vaginal epithelium, endometrium, or reproductive hormones.

ObjectiveBlack cohosh (Actaea racemosa) is an herb commonly used to treat menopausal symptoms. Little is known about its effect on other physiologic parameters that could result in untoward events. This study examines the effect of black cohosh on lipids, fibrinogen, glucose and insulin.MethodsThree hundred and fifty-one, 45-55 years old, peri or post-menopausal women experiencing vasomotor symptoms participated in a 3-month, double blind trial with randomization to: (1) black cohosh (160 mg daily); (2) multibotanical including black cohosh (200 mg daily); (3) multibotanical plus soy diet counseling; (4) conjugated equine estrogen .625 mg, with or without medroxyprogesterone acetate 2.5mg daily, for women with or without a uterus, respectively; (5) placebo. Baseline and month 3 total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), triglyceride, insulin, glucose, and fibrinogen serum concentrations were measured in 310 women. Baseline information was also collected on medical history, demographic characteristics, and diet.ResultsThere were no statistically significant differences in the adjusted mean change from baseline to 3 months between the herbal groups and placebo in total cholesterol, LDL, HDL, triglycerides, glucose, and insulin. Adjusted fibrinogen levels appear to increase in the multibotanical treatment group in comparison with the other herbal groups and placebo overall (P = .02), but there was no statistically significant difference in the pairwise test against placebo (P = .11).ConclusionsBlack cohosh containing therapies had no demonstrable effects on lipids, glucose, insulin or fibrinogen.

BackgroundHerbal supplements are widely used for vasomotor symptoms.ObjectiveTo test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo.Design1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004.SettingGroup Health, Washington State.Participants351 women age 45 to 55 years with 2 or more vasomotor symptoms per day; 52% of the women were in menopausal transition and 48% were postmenopausal.MeasurementsRate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale.Interventions1) Black cohosh, 160 mg daily; 2) multibotanical with black cohosh, 200 mg daily, and 9 other ingredients; 3) multibotanical plus dietary soy counseling; 4) conjugated equine estrogen, 0.625 mg daily, with or without medroxyprogesterone acetate, 2.5 mg daily; or 5) placebo.ResultsVasomotor symptoms per day, symptom intensity, Wiklund Vasomotor Symptom Subscale score did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse with the multibotanical plus soy intervention than with placebo (P = 0.016). The difference in vasomotor symptoms per day between placebo and any of the herbal treatments at any time point was less than 1 symptom per day; for the average over all the follow-up time points, the difference was less than 0.55 symptom per day. The difference for hormone therapy versus placebo was -4.06 vasomotor symptoms per day for the average over all the follow-up time points (95% CI, -5.93 to -2.19 symptoms per day; P < 0.001).LimitationsThe trial did not simulate the whole-person approach used by naturopathic physicians. Differences between treatment groups smaller than 1.5 Vasomotor symptoms per day cannot be ruled out.ConclusionBlack cohosh used in isolation, or as part of a multibotanical regimen, shows little potential as an important therapy for relief of vasomotor symptoms.Clinical trials registration numberNCT00169299.

IntroductionThe purpose of this article is to examine the effectiveness of recruitment strategies used to recruit African-American older adults for a senior center-based health promotion trial with a 6-month exercise component.MethodsWe compared multiple strategies for recruiting participants from senior center members and other older adults residing in the surrounding predominantly African-American community. The phonathon, direct telephone recruitment by senior center leadership, is compared with traditional approaches.ResultsAll recruiting strategies combined yielded a total of 120 participants. Phonathons involving five or six senior center board members in two half-day sessions yielded 40 participants or 33% of all participants. Strategies categorized as printed media yielded 39 participants or 33% of all participants. Strategies categorized as word-of-mouth yielded 31 participants or 26% of all participants. Remaining approaches accounted for an additional 10 participants or 8% of all participants.ConclusionsOur results support employing a multifaceted recruitment approach and demonstrate the importance of strong linkages between the research team and community leaders in conducting health promotion research in minority communities. An innovative approach, the phonathon, may be a potentially important recruitment strategy.

PurposeAlthough coronary disease is the second most common cause of work and functional disability, little is known about the relative contributions of biomedical and psychosocial factors to this disability. This study was conducted to determine the associations of depression and anxiety with self-reported physical function and activity interference in patients with coronary artery disease.MethodsThis was a 1-year prospective cohort study of 198 HMO members who had elective cardiac catheterization for coronary artery disease in 1992. Measures included: severity of coronary artery stenosis from cardiac catheterization reports; anxiety and depression severity using interviewer-administered Hamilton Anxiety and Depression Rating Scales; and self-reported physical function and activity interference.ResultsAt the time of catheterization, patients' self-reported physical function differed significantly by number of main coronary vessels stenosed >70% (P

ObjectivesThe purpose of this study was to determine whether walking is associated with a reduced risk of cardiovascular disease hospitalization and death in community-dwelling older men and women.DesignA prospective study, with follow-up time of 4 to 5 years (average 4.2 years).SettingA western Washington health maintenance organization.ParticipantsMen and women aged 65 years and older from a random sample of HMO enrollees invited by mail to participate in a health promotion intervention trial (36% accepted the invitation and completed questionnaires). This report is based on 1645 older adults without severe disability and without history of heart disease. Vital status ascertainment was complete (100%), and only 2.6% did not complete the follow-up.MeasurementsReported frequency and duration of walking for exercise, work, errands, pleasure, and hiking in the 2 weeks before baseline were used to classify hours of walking per week. The two main outcomes were: (1) cardiovascular disease hospitalizations with a discharge diagnosis of coronary (ICD-9-CM 410-414) or other cardiovascular diseases (ICD-9-CM 390-409, 415-448) documented by computerized hospitalization records and (2) death. Numerous potential confounding factors were considered, including age, sex, treated high blood pressure, current estrogen use and chronic disease score (ascertained by computerized medical and pharmacy records), and ethnicity, education, income, physical function, self-rated health status, smoking, alcohol intake, and body mass index (ascertained by self-report on the mailed questionnaire).ResultsWalking more than 4 hours/week was associated significantly with a reduced risk of cardiovascular disease hospitalization in both sexes combined compared with walking less than 1 hour/week (age and sex-adjusted relative risk = 0.69; 95% confidence interval, 0.52-0.90). This association was not altered by adjustment for baseline cardiovascular risk factors and indicators of general health status. The association was present in all age groups, among those with and without physical limitations, and also among those who did and did not also participate in more vigorous physical activities. Walking more than 4 hours/week was also associated with a reduced risk of death (age and sex-adjusted relative risk = 0.73; 95% confidence interval, 0.48-1.10), however, this association was substantially diminished by adjustment for cardiovascular risk factors and measures of general health status.ConclusionsWalking more than 4 hours/week may reduce the risk of hospitalization for cardiovascular disease events. The association of walking more than 4 hours/week with reduced risk of death may be mediated by effects of walking on other risk factors. These findings provide much stronger evidence than previously available for advising older men and women to embark on or maintain a sustained program of walking to prevent cardiovascular disease events.

ObjectiveThis study examines the ability of commonly used self-reported health status measures to detect important changes in health (responsiveness) in older adults.DesignWe compared changes in health status measures over the year among subgroups of a cohort of seniors: those who experienced an intervening illness, hospitalization or increase in drug regimen, and those who didn't. Differences between the two groups in changes in the measures were quantitated using Guyatt's responsiveness statistic and receiver operating characteristic curves (ROC).SettingStaff model HMO.Participants1379 senior HMO enrollees who were participants in a health promotion trial and provided complete information at baseline and one year later.MeasurementsThe following self-reported health status measures were evaluated: restricted activity days, bed disability days, the Medical Outcomes Study physical function scale, self-evaluated health, and a positive affect scale.Main resultsAll measures except the positive affect scale were able to discriminate significantly between seniors who were or were not hospitalized and/or reported a major illness in the intervening year. The two disability days measures showed the best responsiveness for all indicators of worsening health and included 70%-80% of the area under the ROC curves for major illness defined by hospitalization or self-report.ConclusionsCommonly used, brief self-reported physical health status measures are responsive to intervening illness among relatively healthy seniors supporting their use in longitudinal geriatric research.

Objectives. This study examined whether pregnancy intention was associated with cigarette smoking, alcohol drinking, use of vitamins, and consumption of caffeinated drinks prior to pregnancy and in early pregnancy. Methods. Data from a telephone survey of 7174 pregnant women were analyzed. Results. In comparison with women whose pregnancies were intended, women with unintended pregnancies were more likely to report cigarette smoking and less likely to report daily vitamin use. Women with unintended pregnancies were also less likely to decrease consumption of caffeinated beverages or increase daily vitamin use. Conclusions. Pregnancy intention was associated with health behaviors, prior to pregnancy and in early pregnancy, that may influence pregnancy course and birth outcomes. (Am J Public Health. 1998; 88:663-666)

Background: Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). Methods: We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. Results: The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, -0.21 to 0.52, and p = 0.50, ES = 0.02, -0.34 to 0.39, respectively). Conclusion: Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. [ABSTRACT FROM AUTHOR]

Objective: To examine associations of women's characteristics with reports of provider advice to quit smoking and smoking cessation 1 year after a reproductive health visit., Study Design: Prospective survey., Methods: As part of a randomized smoking cessation trial, 432 women smokers completed telephone surveys 1 month and 1 year after their reproductive health visit. Most women were white (85%) with a mean age of 36 years., Results: Women more likely to report their provider advised them to quit smoking were white rather than another race (adjusted risk ratio, [RR] = 1.4, confidence interval [CI] = 1.14-1.64), employed versus unemployed (RR = 1.3, CI = 1.04-1.49), engaged in safer versus riskier sexual practices (RR = 1.3, CI = 1.09-1.54), were more rather than less ready to quit (RR = 1.3, Cl = 1.08-1.44), and saw family physicians versus gynecologists (RR = 1.3, CI = 1.12-1.41). Reported provider advice to quit smoking was not associated with subsequent cessation. Women were more likely to have quit smoking by the 1-year follow-up if at baseline they reported an annual Papanicolaou test in the prior 3 years (RR = 1.6, Cl = 1.02-2.26), were more rather than less ready to quit smoking (RR = 2.0, CI = 1.36-2.62), and were less rather than more dependent on nicotine (RR = 0.7, CI = 0.59-0.84)., Conclusions: Provider advice to quit is being directed to women who are most likely to quit and contributes little in explaining subsequent cessation. Providers may not be giving enough cessation advice to minority women, those not considering cessation, and those not prevention oriented. Interventions and system improvements are needed to increase providers' counseling of smokers who are unmotivated and from racial/ethnic minorities.