Biomedical subjects

Katherine M Newton

Publications and source records attributed to Katherine M Newton.

16 recordsLinked to original sources

PubMed2006

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial.

BACKGROUND: Herbal supplements are widely used for vasomotor symptoms. OBJECTIVE: To test the efficacy of 3 herbal regimens and hormone therapy for relief of vasomotor symptoms compared with placebo. DESIGN: 1-year randomized, double-blind, placebo-controlled trial conducted from May 2001 to September 2004. SETTING: Group Health, Washington State. PARTICIPANTS: 351 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. MEASUREMENTS: Rate and intensity of vasomotor symptoms (1 = mild to 3 = severe), and Wiklund Vasomotor Symptom Subscale. INTERVENTIONS: 1) 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. RESULTS: Vasomotor 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). LIMITATIONS: The 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. CONCLUSION: Black 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 NUMBER: NCT00169299.

Cimicifuga↗

PubMed2006

The incidence of repeat uterine surgery following myomectomy.

OBJECTIVE: To determine the incidence of subsequent leiomyoma surgery following myomectomy in a population-based cohort. METHODS: All women, ages 20-75 years, enrolled in a large HMO in Washington State, identified by CPT and ICD-9 codes as having a myomectomy between January 1, 1993, and December 31, 2002, were eligible for the study. The follow-up period was 0.1-11 years. Automated enrollment and inpatient, outpatient, pathology, and procedure data were linked. Age-adjusted hazard ratios (HR) and 95% confidence intervals (CI) using Cox proportional hazard models, age-specific Kaplan Meier estimates of cumulative risk, and incidence of uterine surgery after myomectomy were calculated. RESULTS: Among 628 eligible women, 127 (21.8%) had a second surgery, 95 (74.8%) of which were hysterectomies. The cumulative incidence of a second surgery was 23.5% at 5 years and 30% at 7 years. During 2766.5 woman-years of follow-up, the annual incidence of a subsequent myoma surgery was 4.6%. Compared with women aged 40-44, women >or=50 had a 50% decreased risk for subsequent surgery (HR = 0.5, 95% CI 0.3-0.9). CONCLUSIONS: The incidence of subsequent surgery for leiomyomas following myomectomy is high, almost 5% per year.

Adult↗

PubMed2005

The Herbal Alternatives for Menopause (HALT) Study: background and study design.

We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.

Cimicifuga↗

PubMed2005

Soy protein containing isoflavones does not decrease colorectal epithelial cell proliferation in a randomized controlled trial.

BACKGROUND: Soy isoflavones have numerous biological properties that suggest that they may protect against colorectal cancer. Colorectal epithelial cell proliferation has been used extensively as an intermediate endpoint biomarker for colorectal neoplasia. OBJECTIVE: We tested the hypothesis that supplementation with soy protein containing isoflavones decreases colorectal epithelial cell proliferation. DESIGN: A 12-mo randomized intervention was conducted in men and women aged 50-80 y with recently diagnosed adenomatous polyps. One hundred fifty participants were enrolled and randomly assigned to an active treatment group (58 g protein powder/d containing 83 mg isoflavones/d; +ISO) or a control group (ethanol-extracted soy-protein powder containing 3 mg isoflavones; -ISO). Biopsy specimens from the cecum, sigmoid colon, and rectum were collected at baseline and at the 12-mo follow-up. Ki-67 antibody immunohistostaining was used to detect cell proliferation. One hundred twenty-five participants completed the study, and proliferation was measured in the first 91 who completed the study. RESULTS: In the sigmoid colon, cell proliferation increased by 0.9 (95% CI: 0.09, 1.9) labeled nuclei per crypt more (11%) in the +ISO group than in the -ISO group over the 12-mo intervention, which was opposite the direction predicted. The number of labeled nuclei per 100 mum crypt height also increased more in the +ISO than in the -ISO group. In the cecum and sigmoid colon, but not in the rectum, the proliferation count increased as the serum genistein concentration increased. Proliferation distribution and crypt height were not changed by treatment at any site. CONCLUSIONS: Supplementation with soy protein containing isoflavones does not reduce colorectal epithelial cell proliferation or the average height of proliferating cells in the cecum, sigmoid colon, and rectum and increases cell proliferation measures in the sigmoid colon.

Adenomatous Polyps↗

PubMed2005

Changes in women's use of hormones after the Women's Health Initiative estrogen and progestin trial by race, education, and income.

BACKGROUND: We examined the impact of race, education, and household income on changes in rates of discontinuation and initiation of hormone therapy before and after release of the Women's Health Initiative estrogen plus progestin trial results. METHODS: We conducted an observational cohort study of 221 378 women aged 40-80 years enrolled in five health maintenance organizations to estimate the prevalence and rates of discontinuation and initiation of estrogen plus progestin and estrogen only between September 1, 1999, to June 31, 2002 (baseline), and December 31, 2002 (follow-up). We identified the census block group for each participant by geocoding her 2003 residential address. We categorized women into racial, education, and income groups based on the distribution of these characteristics in her community from year 2000 census data and the distributions of these characteristics within her HMO. RESULTS: There were significant differences in estrogen plus progestin and estrogen only prevalence by race, education level, and household income, and in estrogen plus progestin initiation by race and education level, but not by household income at follow-up. However, there were no differences by community race, education, or household income in change in the prevalence of either hormone therapy use at follow-up or in the rates of hormone therapy discontinuation or initiation from baseline to follow-up. CONCLUSIONS: Given the wide spread media attention to the Women's Health Initiative estrogen plus progestin trial results, our findings suggest comparable dissemination of this information across diverse socioeconomic groups.

Adult↗

PubMed2005

Health system responses to the Women's Health Initiative findings on estrogen and progestin: organizational response.

Recent randomized trials have indicated that the risks of hormone therapy for menopausal women may outweigh the benefits. The purpose of this study was to describe how health plans responded to the findings of the Women's Health Initiative (WHI) estrogen plus progestin trial. We surveyed five health plans affiliated with the HMO Research Network and the Cancer Research Network to document the response of each plan to the WHI in terms of patient and provider education and guidelines. Every health plan issued responses within 3 months of WHI's termination in a variety of formats. Recommendations were relatively consistent across the organizations. Given the documented changes in hormone therapy use in these five health plans in the post-WHI era, we conclude that attempts on the part of each organization to educate patients and providers about the implications of the WHI may have contributed to the observed changes in hormone therapy use.

Breast Neoplasms↗

PubMed2005

The impact of comorbidities on hormone use. After the 2000 release of the Women's Health Initiative.

OBJECTIVE: Determine the impact of fracture, coronary disease, and diabetes on changes in rates of discontinuation and initiation of estrogen therapy with (EPT) and without (ET) progestin, before (September 1, 1999 to June 30, 2002, baseline) versus 5 months after (follow-up) release of the Women's Health Initiative EPT trial results (WHI). DESIGN, SETTING, AND PARTICIPANTS: Observational cohort; 169,586 women 40 to 80 years old from 5 U.S. HMOs. METHODS: We used pharmacy data to identify ET and EPT users. A woman was a user any month she filled > or =1 estrogen prescription and in subsequent months based upon the number of pills/patches dispensed. We used inpatient and outpatient claims to identify fracture January 1, 1999 to June 30, 2002 and pharmacy data to identify disease-based groups of medications for diabetes and cardiovascular disease. MEASURES: EPT/ET prevalence, initiation, and discontinuation rates. RESULTS: Baseline to follow-up EPT and ET prevalence declined 45% and 22%, respectively, with no difference by comorbidity. Follow-up EPT initiation was half the baseline rate irrespective of comorbidity. Compared to baseline, follow-up EPT discontinuation rates increased among women with diabetes (relative risk [RR], 6.9; 95% confidence interval [CI], 5.6 to 8.4), cardiovascular disease (RR, 5.5; 95% CI, 4.9 to 6.2), fracture (RR, 3.8; 95% CI, 2.4 to 5.7), and no comorbidity (RR, 4.4; 95% CI, 3.9 to 4.9). The RRs for follow-up versus baseline EPT discontinuation were higher among women with diabetes (P<.01) and cardiovascular disease (P<.01) versus women without these comorbidities. ET discontinuation rates among these same groups were elevated 2- to 2.8-fold. CONCLUSIONS: Diabetes and cardiovascular disease were associated with higher EPT discontinuation rates post-WHI compared to women without comorbidity; comorbidity had little impact on changes in prevalence or initiation of ET/EPT after release of the WHI.

Adult↗

PubMed2004

Risk factors for coronary heart disease in women.

The increased focus on risk factors for CHD in women has greatly improved our understanding of this disease in women. The evidence against cigarette smoking, elevated serum cholesterol, and high blood pressure is strong, and sustained campaigns are underway to prevent and appropriately manage these conditions. The importance of adequate physical activity and weight control is well established, and research continues on other emerging risk factors. The focus of future research will be on clarifying the role of these factors, particularly for women and ethnic minorities.

Adult↗

PubMed2004

Indications for hormone therapy: the post-Women's Health Initiative era.

Information from the Women's Health Initiative (WHI) trial has given physicians valuable tools for counseling women aged 50 to 79 years about the short-term risks of hormone therapy (HT). Unanswered questions remain, particularly on the risks and benefits of discontinuing HT among long-term users. The decision to discontinue HT should be carefully considered, because stopping and re-starting after several months may "reset the clock" for risks associated with changes in hepatic protein synthesis. The current authors recommend low-dose transdermal hormonal formulations,but no large-scale randomized trials exist to confirm the veracity of this recommendation. It has been suggested that starting HT in the menopausal transition would alleviate the HT risks observed withWHI. Until additional data are available to counsel women in the menopausal transition, however, the conservative counseling approach is to apply those figures available from the WHI, particularly because women aged 50 to 59 years using estrogen-progestin therapy have an unfavorable risk-benefit ratio, similar to that seen in older women.

Aged↗

PubMed2004

Hormone therapy prescribing patterns in the United States.

OBJECTIVE: We sought to examine prescribing patterns (prevalence and rates of initiation and discontinuation) for estrogen plus progestin (hormone therapy [HT] and estrogen alone [ET]) in the United States in the 2 years before the published results of Women's Health Initiative's (WHI) HT trial's early termination and for 5 months after their release. METHODS: We conducted an observational cohort study of 169,586 women aged 40-80 years who were enrolled in 5 health maintenance organizations in the United States to estimate the prevalence of HT and ET and discontinuation and initiation rates between September 1, 1999, to June 31, 2002 (baseline), and December 31, 2002 (follow-up). We used automated pharmacy data to identify all oral and transdermal estrogen and progestin dispensed during the study period. RESULTS: The prevalence of HT declined 46% from baseline to follow-up (14.6% to 7.9%); ET use declined 28% during the same period (12.6% to 9.1%). The discontinuation of HT increased almost immediately, from 2.5% at baseline to 13.8% in October 2002. We saw an immediate decrease in HT and ET initiation rates, from 0.4% and 0.3% at baseline, respectively, to 0.2% for HT and ET at follow-up. CONCLUSION: The diffusion of the WHI HT trial results had an immediate impact on the discontinuation of HT and ET and is likely responsible for the 46% and 28% decline in the initiation of these respective therapies. Further exploration of why women continue to use HT and identification of methods for addressing reasons for continued use are indicated. LEVEL OF EVIDENCE: II-2.

Adult↗

PubMed2004

Quality of care for patients with type 2 diabetes mellitus in the Netherlands and the United States: a comparison of two quality improvement programs.

OBJECTIVE: To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. STUDY SETTING: Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. STUDY DESIGN: In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. DATA COLLECTION: Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. PRINCIPAL FINDINGS: In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. CONCLUSIONS: Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects.

Aged↗

PubMed2004

Soy isoflavones do not modulate prostate-specific antigen concentrations in older men in a randomized controlled trial.

Mortality rates for prostate cancer are low in Asia but high in the West. One explanation is the high level of soy consumption in Asia. Soy isoflavones reduce prostate tumor growth in many, but not all, animal models. Elevated levels of serum prostate-specific antigen (PSA) are a marker of prostate tumor growth. Our objective was to determine whether 12-month soy isoflavone supplementation would alter serum PSA concentrations in healthy, older men. The parent study was a double-blinded, parallel-arm, randomized trial in which participants were assigned to consume either a soy protein drink providing 83 mg/day isoflavones (+ISO) or a similar drink with isoflavones removed (-ISO). Participants in the parent study were 85% men. Of the 128 men enrolled in the trial, 112 completed. These men were later contacted for consent to allow their stored sera to be analyzed for PSA and 81 men consented. We measured PSA in serum collected at 0 and 12 months using a commercial radioimmunometric assay. Serum PSA concentrations increased in both groups over the 12-month intervention, but the changes were similar: Geometric mean PSA concentration increased 0.5% more in the +ISO group than in the -ISO group (P = 0.94; 95% confidence interval = -17.3 to 22.2). The proportion of participants having a serum PSA velocity greater than 1 ng/ml/year was similar in the +ISO and -ISO groups (17.6% versus 12.8%; P = 0.54). We found no evidence that a 12-month 83 mg/day isoflavone treatment alters serum PSA concentration or velocity in seemingly healthy men aged 50-80 years.

Aged↗

PubMed2003

Soy isoflavones do not modulate circulating insulin-like growth factor concentrations in an older population in an intervention trial.

Insulin-like growth factors (IGF) are essential for normal growth and maintenance of lean muscle mass; however, high insulin-like growth factor-I (IGF-I) and low IGF binding protein-3 (IGFBP-3) levels are also associated with several cancers. To test the hypothesis that long-term soy isoflavone supplementation decreases circulating IGF-I concentrations, we conducted a controlled, parallel-arm, double-blind intervention study with 150 participants (85% men), 50-80 y old. Participants were randomly assigned to consume a soy beverage powder daily for 12 mo. The active treatment group (+ISO) received soy protein containing 83 mg isoflavones, whereas the comparison group (-ISO) received soy protein containing 3 mg isoflavones. Serum IGF-I and IGFBP-3 were measured by ELISA. Mean change in serum IGF-I concentrations was similar in the two groups (+1.4 nmol/L in +ISO, +1.2 nmol/L in -ISO; P = 0.74, 95% confidence interval -1.1, +1.5 nmol/L for the 0.21 nmol/L difference between groups), indicating no effect of the isoflavone intervention. Similarly, the changes in IGFBP-3 and the IGF-I/IGFBP-3 ratio were similar in both groups, again showing no effect of +ISO treatment. A 12 mo, 83 mg/d soy isoflavone intervention did not modulate serum IGF in an older, mostly male population.

Aged↗

PubMed2003

Estrogen therapy and risk of cardiovascular events among women with type 2 diabetes.

OBJECTIVE: To evaluate the association between estrogen therapy and cardiovascular disease risk among women with type 2 diabetes. RESEARCH DESIGN AND METHODS: A retrospective, case-cohort study was conducted among 6017 women aged 45-80 years with type 2 diabetes from 1 January 1986 to 31 December 1992 at the Group Health Cooperative in Washington state. Cardiovascular outcomes, including nonfatal myocardial infarction (n = 215), coronary revascularization (n = 253), and cardiovascular deaths (n = 229), were ascertained through 31 December 1998. Use of estrogen and progestin was derived from automated pharmacy records and modeled as a time-dependent variable. Median follow-up was 6.8 years. Multivariable-adjusted relative risk (RR) and 95% CI were calculated using Cox proportional hazard models for case-cohort analyses. RESULTS: Current use of estrogen with (RR 0.43, 95% CI 0.22-0.85) or without (0.48, 0.30-0.78) progestin was associated with a decreased risk of cardiovascular events compared with never having used estrogen. Risk of cardiovascular events associated with a first episode of estrogen use (with or without progestin) of <25 months' duration (1.12, 0.49-2.54), first episode of use >or=25 months' duration (0.32, 0.06-1.70), and current use that was not the first episode of use (0.42, 0.42-0.67) indicated that recent initiation was not associated with an increase or decrease in risk. CONCLUSIONS: These results show an association of estrogen therapy, with or without progestin, with decreased risk of cardiovascular events among women with type 2 diabetes. This association should be further investigated in large randomized, controlled trials.

Adult↗

PubMed2002

Use of alternative therapies for menopause symptoms: results of a population-based survey.

OBJECTIVE: To describe self-reported prevalence of the use of alternative therapies for menopause symptoms and subject characteristics associated with their use. METHODS: A telephone survey of 886 women aged 45-65 years (87.2% response rate) was conducted at Group Health Cooperative in Washington state. Women were asked about eight alternative therapies and their use for menopause symptoms. RESULTS: The proportion of women who used each therapy was 76.1% for any therapy, 43.1% for stress management, 37.0% for over-the-counter alternative remedies, 31.6% for chiropractic, 29.5% for massage therapy, 22.9% for dietary soy, 10.4% for acupuncture, 9.4% for naturopath or homeopath, and 4.6% for herbalists. The proportion of women who used it to manage menopause symptoms was 22.1% for any therapy, 9.1% for stress management, 13.1% for over-the-counter alternative remedies, 0.9% for chiropractic, 2.6% for massage therapy, 7.4% for dietary soy, 0.6% for acupuncture, 2.0% for naturopath or homeopath, and 1.2% for herbalists. Among women who used these therapies, 89-100% found them to be somewhat or very helpful. A history of breast cancer was associated with a six-fold increase in use of dietary soy for menopause symptoms (odds ratio 6.23, 95% confidence limits 2.54, 15.28). Current users of hormone replacement therapy were half as likely to use alternative remedies or providers (odds ratio 0.48, 95% confidence limits 0.29, 0.77) as were never users. Sleep disturbances were associated with a four-fold increase in the use of body work, a three-fold increase in the use of stress management, and more than doubled the use of dietary soy products to manage menopause symptoms. CONCLUSION: The use of alternative therapies for menopause symptoms is common, and women who use them generally find them to be beneficial. Physicians should routinely ascertain perimenopausal women's use of alternative therapies.

Aged↗

PubMed2002

Gestational diabetes and the incidence of type 2 diabetes: a systematic review.

OBJECTIVE: To examine factors associated with variation in the risk for type 2 diabetes in women with prior gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: We conducted a systematic literature review of articles published between January 1965 and August 2001, in which subjects underwent testing for GDM and then testing for type 2 diabetes after delivery. We abstracted diagnostic criteria for GDM and type 2 diabetes, cumulative incidence of type 2 diabetes, and factors that predicted incidence of type 2 diabetes. RESULTS: A total of 28 studies were examined. After the index pregnancy, the cumulative incidence of diabetes ranged from 2.6% to over 70% in studies that examined women 6 weeks postpartum to 28 years postpartum. Differences in rates of progression between ethnic groups was reduced by adjustment for various lengths of follow-up and testing rates, so that women appeared to progress to type 2 diabetes at similar rates after a diagnosis of GDM. Cumulative incidence of type 2 diabetes increased markedly in the first 5 years after delivery and appeared to plateau after 10 years. An elevated fasting glucose level during pregnancy was the risk factor most commonly associated with future risk of type 2 diabetes. CONCLUSIONS: Conversion of GDM to type 2 diabetes varies with the length of follow-up and cohort retention. Adjustment for these differences reveals rapid increases in the cumulative incidence occurring in the first 5 years after delivery for different racial groups. Targeting women with elevated fasting glucose levels during pregnancy may prove to have the greatest effect for the effort required.

Delivery, Obstetric↗