Adherence in a 1-year whole foods eating pattern intervention with healthy postmenopausal women.

OBJECTIVE: To determine the degree of dietary adherence or change in eating patterns, and demographic, psychosocial and study characteristics associated with adherence, in the Comparing Healthy Options in Cooking and Eating (CHOICE) Study. DESIGN: Randomized controlled trial where women were randomized to one of three eating patterns: (i) Whole Foods, plant-based, macrobiotic-style (n 22); and Moderate Fat with (ii), and without (iii), 10 g of ground flaxseed added daily, which were combined (n 49). SETTING: A year-long intervention based on social cognitive theory, consisting of twenty-four class sessions involving hands-on cooking classes and behavioural sessions. Monthly 24 h food recalls were obtained and a psychosocial questionnaire was administered at baseline, 6 and 12 months. SUBJECTS: Healthy, free-living, postmenopausal women. RESULTS: A non-adherence score measuring all food servings out-of-compliance with eating pattern recommendations was specifically designed for the present study. Non-adherence scores decreased significantly (P < 0·05) in both groups to about 65 % during the adoption phase (first 4 months) and remained so during the 8-month maintenance period. Class attendance of the Moderate Fat group showed a trend towards significance as a predictor of adherence (P = 0·063). None of the other predictors (e.g. demographic and psychosocial factors) in a longitudinal regression model were significant. CONCLUSIONS: Postmenopausal women were able to adopt and maintain significant changes in their eating patterns, including those on a demanding, near-vegetarian eating plan, suggesting that behavioural interventions with a healthy free-living population can be effective. The non-adherence score developed for the study provides an example of a means for evaluating eating pattern adherence to a dietary intervention.

Miniature ambulatory skin conductance monitor and algorithm for investigating hot flash events.

A skin conductance monitoring system was developed and shown to reliably acquire and record hot flash events in both supervised laboratory and unsupervised ambulatory conditions. The 7.2 × 3.8 × 1.2 cm(3) monitor consists of a disposable adhesive patch supporting two hydrogel electrodes and a reusable, miniaturized, enclosed electronic circuit board that snaps onto the electrodes. The monitor measures and records the skin conductance for seven days without external wires or telemetry and has an event marker that the subject can press whenever a hot flash is experienced. The accuracy of the system was demonstrated by comparing the number of hot flashes detected by algorithms developed during this research with the number identified by experts in hot flash studies. Three methods of detecting hot flash events were evaluated, but only two were fully developed. The two that were developed were an artificial neural network and a matched filter technique with multiple kernels implemented as a sliding form of the Pearson product-moment correlation coefficient. Both algorithms were trained on a 'development' cohort of 17 women and then validated using a second similar 'validation' cohort of 20. All subjects were between the ages of 40 and 60 and self-reported ten or more hot flashes per day over a three day period. The matched filter was the most accurate with a mean sensitivity of 0.92 and a mean specificity of 0.90 using the data from the development cohort and a mean sensitivity of 0.92 and a mean specificity of 0.87 using the data from the validation cohort. The matched filter was the method implemented in our processing software.

Phytoestrogens for menopausal vasomotor symptoms.

BACKGROUND: Vasomotor symptoms, such as hot flushes and night sweats, are very common during the menopausal transition. Hormone therapy has traditionally been used as a highly effective treatment, but concerns about increased risk of some chronic diseases have markedly increased the interest of women in alternative treatments. Some of the most popular of these treatments are foods or supplements enriched with phytoestrogens-plant-derived chemicals that have estrogenic action. OBJECTIVES: To assess the efficacy, safety and acceptability of food products, extracts and dietary supplements containing high levels of phytoestrogens when compared with no treatment, placebo or hormone therapy for the amelioration of vasomotor menopausal symptoms (such as hot flushes and night sweats) in perimenopausal and postmenopausal women. SEARCH METHODS: Searches targeted the following electronic databases: the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of randomised trials (29 July 2013), the Cochrane Register of Controlled Trials (CENTRAL; 29 July 2013), MEDLINE (inception to 29 July 2013), EMBASE (inception to 29 July 2013), AMED (1985 to 29 July 2013), PsycINFO (inception to 29 July 2013) and CINAHL (inception to 29 July 2013). Attempts were made to access grey literature by sending letters to pharmaceutical companies and performing searches of ongoing trial registers. Reference lists of included trials were also searched. SELECTION CRITERIA: Studies were included if they were randomised, included perimenopausal or postmenopausal participants with vasomotor symptoms (hot flushes or night sweats), lasted at least 12 weeks and provided interventions such as foods or supplements with high levels of phytoestrogens (not combined with other herbal treatments). Trials that included women who had breast cancer or a history of breast cancer were excluded. DATA COLLECTION AND ANALYSIS: Selection of trials, extraction of data and assessment of quality were undertaken by at least two review authors. Most trials were too dissimilar for their results to be combined in a meta-analysis, so these findings are provided in narrative 'Summary of results' tables. Studies were grouped into broad categories: dietary soy, soy extracts, red clover extracts, genistein extracts and other types of phytoestrogens. Five trials used Promensil, a red clover extract; results of these trials were combined in a meta-analysis, and summary effect measures were calculated. MAIN RESULTS: A total of 43 randomised controlled trials (4,364 participants) were included in this review. Very few trials provided data suitable for inclusion in a meta-analysis. Among the five trials that yielded data assessing the daily frequency of hot flushes suitable for pooling, no significant difference overall was noted in the incidence of hot flushes between participants taking Promensil (a red clover extract) and those given placebo (mean difference (MD) -0.93, 95% confidence interval (CI) -1.95 to 0.10, I(2) = 31%). No evidence indicated a difference in percentage reduction in hot flushes in two trials between Promensil and placebo (MD 20.15, 95% CI -12.08 to 52.38, I(2) = 82%). Four trials that were not combined in meta-analyses suggested that extracts with high (> 30 mg/d) levels of genistein consistently reduced the frequency of hot flushes. Individual results from the remaining trials were compared in broad subgroups such as dietary soy, soy extracts and other types of phytoestrogens that could not be combined. Some of these trials found that phytoestrogen treatments alleviated the frequency and severity of hot flushes and night sweats when compared with placebo, but many trials were small and were determined to be at high risk of bias. A strong placebo effect was noted in most trials, with a reduction in frequency ranging from 1% to 59% with placebo. No indication suggested that discrepant results were due to the amount of isoflavone in the active treatment arm, the severity of vasomotor symptoms or trial quality factors. Also, no evidence indicated that these treatments caused oestrogenic stimulation of the endometrium or the vagina or other adverse effects when used for up to two years. AUTHORS' CONCLUSIONS: No conclusive evidence shows that phytoestrogen supplements effectively reduce the frequency or severity of hot flushes and night sweats in perimenopausal or postmenopausal women, although benefits derived from concentrates of genistein should be further investigated.

Stability of black cohosh triterpene glycosides and polyphenols: potential clinical relevance.

Concurrent to a clinical trial of black cohosh for menopausal hot flashes, the long-term stability of the black cohosh, over the duration of the clinical trial, was examined. Analytical results showed that the major constituents, both triterpene glycosides and polyphenols, were stable over the 3-year period of testing. These results indicate that a black cohosh product stored for several years in a controlled environment does not undergo significant changes in its major constituents. These results have implications not only for clinical research in natural products, but for basic science, as well as the dietary supplements industry.

Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This analysis was conducted to determine the efficacy of extracted or synthesized soybean isoflavones in the alleviation of hot flashes in perimenopausal and postmenopausal women. METHODS: PubMed and The Cochrane Controlled Clinical Trials Register Database were searched for relevant articles reporting double-blinded randomized controlled trials through December 14, 2010. References within identified articles, as well as peer-reviewed articles that had come to the attention of the authors through other means, were also examined for suitability. This systematic review and meta-analysis, which evaluated the effects of isoflavones on the frequency, severity, or composite score (frequency × severity) of hot flashes compared with placebo was conducted according to Cochrane Handbook guidelines. RESULTS: From 277 potentially relevant publications, 19 trials (reported in 20 articles) were included in the systematic review (13 included hot flash frequency; 10, severity; and 3, composite scores), and 17 trials were selected for meta-analyses to clarify the effect of soybean isoflavones on hot flash frequency (13 trials) and severity (9 trials). Meta-analysis revealed that ingestion of soy isoflavones (median, 54 mg; aglycone equivalents) for 6 weeks to 12 months significantly reduced the frequency (combined fixed-effect and random effects model) of hot flashes by 20.6% (95% CI, -28.38 to -12.86; P < 0.00001) compared with placebo (heterogeneity P = 0.0003, I = 67%; random effects model). Meta-analysis also revealed that isoflavones significantly reduced hot flash severity by 26.2% (95% CI: -42.23 to -10.15, P = 0.001) compared with placebo (heterogeneity, P < 0.00001, I = 86%; random effects model). Isoflavone supplements providing more than 18.8 mg of genistein (the median for all studies) were more than twice as potent at reducing hot flash frequency than lower genistein supplements. CONCLUSIONS: Soy isoflavone supplements, derived by extraction or chemical synthesis, are significantly more effective than placebo in reducing the frequency and severity of hot flashes. Additional studies are needed to further address the complex array of factors that may affect efficacy, such as dose, isoflavone form, baseline hot flash frequency, and treatment duration.

Phytochemical fingerprinting to thwart black cohosh adulteration: a 15 Actaea species analysis.

INTRODUCTION: The popular use of black cohosh products (Actaea racemosa L., syn. Cimicifuga racemosa L.) is growing as the demand for alternatives to estrogen therapy has increased. Critical to safe use is the assurance of unadulterated, high-quality products. Questions have been raised about the safety of black cohosh due to cases of liver toxicity in patients who reported taking it; subsequent evaluation found some products to be adulterated with other related herbal species. Correct plant species identification is a key first step for good manufacturing practices of safe black cohosh products. OBJECTIVES: To develop analytical methods which distinguish black cohosh from other species (American and Asian) of Actaea increasingly found as adulterants in commercially available black cohosh products. MATERIAL AND METHODS: Fifteen species of Actaea were collected from North America and Asia, and the phytochemical fingerprints of these samples were established using HPLC-PDA and LC-MS techniques. RESULTS: The HPLC and LC-MS fingerprints for polyphenols and triterpene glycosides revealed distinct patterns that make black cohosh clearly distinguishable from most other species of Actaea. Two marker compounds, cimifugin and cimiracemoside F, were found to be important to distinguish black cohosh from most Asian species of Actaea. Formononetin was not found from either Asian or American species of Actaea. CONCLUSIONS: Phytochemical fingerprinting is a practical, reliable method for authenticating black cohosh and distinguishing it from other species of Actaea increasingly found as adulterants in commercially available black cohosh products. This should facilitate the continued development of high-quality, unadulterated black cohosh products.

Gendered innovations: a new approach for nursing science.

Considerable sex and gender bias has been recognized within the field of medicine. Investigators have used sex and gender analysis to reevaluate studies and outcomes and generate new perspectives and new questions regarding differential diagnoses and treatments of men and women. Sex and gender analysis acts as an experimental control to provide critical scientific rigor; researchers who ignore it risk ignoring a possible source of error in past, current, and future science. In this article, the authors introduce some tools of sex and gender analysis and illustrate the concept of gendered innovations by demonstrating through examples how this type of analysis has profoundly enhanced human knowledge in health and disease. The authors also provide recommendations for incorporating the concepts of sex and gender analysis into nursing education and research.

Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment.

Hot flashes continue to be a troublesome problem for menopausal women the world over. After >50 y of research, we still do not understand the etiology and mechanism of hot flashes, nor do we know how estrogen, the major pharmaceutical treatment, works to reduce hot flashes. We are gaining insight into sociocultural complexities that may affect how and whether women report hot flashes. And we are becoming more sophisticated in our research tools (be it questionnaires, physiological monitors, or brain imaging techniques). New aspects of hot flash research, including neuroimaging and the study of genetic polymorphisms, when combined with increasingly nuanced ways of asking questions of culturally distinct populations, provide challenges but rich complexity from which a better understanding will emerge.

The importance of botellas and other plant mixtures in Dominican traditional medicine.

ETHNOPHARMACOLOGICAL RELEVANCE: Plant mixtures are understudied in ethnobotanical research. AIM OF THE STUDY: To investigate the importance of plant mixtures (remedies consisting of at least two plants) in Dominican traditional medicine. MATERIALS AND METHODS: A Spanish language questionnaire was administered to 174 Dominicans living in New York City (NYC) and 145 Dominicans living in the Dominican Republic (DR), including lay persons (who self-medicate with plants) and specialists (traditional healers). Plants were identified through specimens purchased in NYC botánica shops and Latino grocery shops, and from voucher collections. RESULTS: The percentage of mixtures as compared to single plants in plant use reports varied between 32 and 41%, depending on the geographic location (NYC or DR) and participant status (lay person or specialist). Respiratory conditions, reproductive health and genitourinary conditions were the main categories for which Dominicans use plant mixtures. Lay persons reported significantly more mixtures prepared as teas, mainly used in NYC to treat respiratory conditions. Specialists mentioned significantly more botellas (bottled herbal mixtures), used most frequently in the DR to treat reproductive health and genitourinary conditions. Cluster analysis demonstrated that different plant species are used to treat respiratory conditions as compared to reproductive health and genitourinary conditions. Interview participants believed that combining plants in mixtures increases their potency and versatility as medicines. CONCLUSIONS: The present study demonstrates the importance and complexity of plant mixtures in Dominican traditional medicine and the variation in its practices influenced by migration from the DR to NYC, shedding new light on the foundations of a particular ethnomedical system.

Actein activates stress- and statin-associated responses and is bioavailable in Sprague-Dawley rats.

The purpose of this study was to assess in rats the pharmacological parameters and effects on gene expression in the liver of the triterpene glycoside actein. Actein, an active component from the herb black cohosh, has been shown to inhibit the proliferation of human breast cancer cells. To conduct our assessment, we determined the molecular effects of actein on livers from Sprague-Dawley rats treated with actein at 35.7 mg/kg for 6 and 24 h. Chemogenomic analyses indicated that actein elicited stress and statin-associated responses in the liver; actein altered expression of cholesterol and fatty acid biosynthetic genes, p53 pathway genes, CCND1 and ID3. Real-time RT-PCR validated that actein induced three time-dependent patterns of gene expression in the liver: (i) a decrease followed by a significant increase of HMGCS1, HMGCR, HSD17B7, NQO1, S100A9; (ii) a progressive increase of BZRP and CYP7A1 and (iii) a significant increase followed by a decrease of CCND1 and ID3. Consistent with actein's statin- and stress-associated responses, actein reduced free fatty acid and cholesterol content in the liver by 0.6-fold at 24 h and inhibited the growth of human HepG2 liver cancer cells. To determine the bioavailability of actein, we collected serum samples for pharmacokinetic analysis at various times up to 24 h. The serum level of actein peaked at 2.4 microg/mL at 6 h. Actein's ability to alter pathways involved in lipid disorders and carcinogenesis may make it a new agent for preventing and treating these major disorders.

Costus spicatus tea failed to improve diabetic progression in C57BLKS/J db/db mice, a model of type 2 diabetes mellitus.

AIM OF THE STUDY: Costus spicatus Sw. (Costaceae) is a prominent medicinal herb used by Dominicans in the Dominican Republic and the United States for the treatment of diabetes, a growing epidemic in the Hispanic community. An ethnobotanical survey of the Dominican community in New York City revealed the popular use of a tea from the insulina plant to treat hyperglycemia. Insulina was identified as Costus spicatus. We tested the ability of a tea made from the leaves of Costus spicatus to alter glucose homeostasis in C57BLKS/J (KS) db/db mice, a model of obesity-induced hyperglycemia with progressive beta cell depletion. MATERIALS AND METHODS: From 6 to 16 weeks of age, Experimental and Control animals (n=6/5) were given ad lib access to Costus spicatus tea or water, respectively. RESULTS: Weight gain and progression of hyperglycemia and insulinopenia between the Experimental and Control groups were statistically indistinguishable. There was no difference between groups in average fed or fasting glucose and insulin concentrations. Intraperitoneal (IP) insulin tolerance testing after the 10-week study period showed that Costus spicatus tea consumption did not alter insulin sensitivity. CONCLUSIONS: These data suggest that at the dose given, tea made from Costus spicatus leaves had no efficacy in the treatment of obesity-induced hyperglycemia. More investigation is needed to more fully explore dosages and the possible utility and biological activity of this common Dominican herbal remedy for the treatment of type 2 diabetes mellitus.

Disclosure of complementary and alternative medicine to conventional medical providers: variation by race/ethnicity and type of CAM.

BACKGROUND: Complementary and alternative medicine (CAM) is often used alongside conventional medical care, yet fewer than half of patients disclose CAM use to medical doctors. CAM disclosure is particularly low among racial/ethnic minorities, but reasons for differences, such as type of CAM used or quality of conventional healthcare, have not been explored. OBJECTIVE: We tested the hypotheses that disclosure of CAM use to medical doctors is higher for provider-based CAM and among non-Hispanic whites, and that access to and quality of conventional medical care account for racial/ethnic differences in CAM disclosure. METHODS: Bivariate and multiple variable analyses of the 2002 National Health Interview Survey and 2001 Health Care Quality Survey were performed. RESULTS: Disclosure of CAM use to medical providers was higher for provider-based than self-care CAM. Disclosure of any CAM was associated with access to and quality of conventional care and higher among non-Latino whites relative to minorities. Having a regular doctor and quality patient-provider relationship mitigated racial/ethnic differences in CAM disclosure. CONCLUSION: Insufficient disclosure of CAM use to conventional providers, particularly for self-care practices and among minority populations, represents a serious challenge in medical encounter communications. Efforts to improve disclosure of CAM use should be aimed at improving consistency of care and patient-physician communication across racial/ethnic groups.

Health practices and vaginal microbicide acceptability among urban black women.

BACKGROUND: Intravaginal topical microbicides are being investigated for prevention of HIV transmission. Use of vaginal microbicides will constitute a new type of practice, occurring in the context of other vaginal practices related to contraception, hygiene, and self-care, which are affected by cultural norms and personal beliefs. Given the high rate of HIV infection among black women, research on practices and decision making relevant to microbicide acceptability is needed in this population. METHODS: Twenty-three black women in New York City, aged 25-64, completed in-person semistructured interviews and self-administered questionnaires. Quantitative analyses examined vaginal practices and willingness to use microbicides. Qualitative analyses explored underlying decision-making processes involved in choices regarding vaginal practices and general healthcare. RESULTS: Willingness to use vaginal products for HIV prevention was high, especially among more educated women. Safety was a major concern, and women were cautious about using vaginal products. Whereas some viewed synthetic products as having potentially harmful side effects, others perceived natural products as risky because of insufficient testing. Choices about vaginal practices were affected by assessments of risk and efficacy, prior experience, cultural background, and general approach to healthcare. CONCLUSIONS: The majority of women in the sample expressed willingness to use a vaginal product for HIV prevention. Decision-making processes regarding vaginal practices were complex and were affected by social, cultural, and personal factors. Although specific preferences may vary, attitudes toward using a vaginal product are likely to be positive when side effects are minimal and the product is considered safe.

Stability evaluation of selected polyphenols and triterpene glycosides in black cohosh.

Black cohosh ( Actaea racemosa L., syn. Cimicifuga racemosa L.) is rich in both triterpene glycosides and polyphenols, which have various biological activities that may be important to its medical use. To evaluate the stability of the polyphenolic constituents and triterpene glycosides of black cohosh, experiments were conducted using three sample types: plant material, extracts of black cohosh, and encapsulated commercial extract. The samples were stored at various temperatures and humidity conditions. Three triterpene glycosides and six major polyphenols in black cohosh were quantitatively measured with an HPLC-PDA method at 0, 3, 6, and 9 weeks. The triterpene glycosides were stable at the tested conditions, whereas the polyphenols were stable only at room temperature and low humidity and not stable at higher temperature and/or humidity due to hydrolysis and/or oxidation. The rate of compound decomposition depended upon the chemical structure of the individual polyphenols. Polyphenols in the extracts decomposed more readily than those in plant material.

Medical pluralism among American women: results of a national survey.

BACKGROUND: Medical pluralism can be defined as the employment of more than one medical system or the use of both conventional and complementary and alternative medicine (CAM) for health and illness. American women use a variety of health services and practices for women's health conditions, yet no national study has specifically characterized women's medical pluralism. Our objective was to describe medical pluralism among American women. METHODS: A nationally representative telephone survey of 808 women >or=18 years of age was conducted in 2001. Cross-sectional observations of the use of 11 CAM domains and the use of an additional domain--spirituality, religion, or prayer for health--during the past year are reported. Women's health conditions, treatments used, reasons for use, and disclosure to conventional physicians are described, along with predictors of CAM use. RESULTS: Over half (53%) of respondents used CAM for health conditions, especially for those involving chronic pain. The majority of women disclosed such practices at clinical encounters with conventional providers. Biologically based CAM therapies, such as nutritional supplements and herbs, were commonly used with prescription and over-the-counter (OTC) pharmaceuticals for health conditions. CONCLUSIONS: Medical pluralism is common among women and should be accepted as a cultural norm. Although disclosure rates of CAM use to conventional providers were higher than in previous population-based studies, disclosure should be increased, especially for women who are pregnant and those with heart disease and cancer. The health risks and benefits of polypharmacy should be addressed at multiple levels of the public health system.