Soy Protein Supplements Do Not Reduce Plaque in Arteries of Postmenopausal WomenSoy protein supplements containing isoflavones do not significantly reduce the progression of atherosclerosis (build-up of plaque in the arteries) in postmenopausal women, according to a recent study published in the journal Stroke. However, a subgroup analysis of this study showed that soy supplements may benefit women who had experienced menopause within the last 5 years. Isoflavones are compounds similar to the female hormone estrogen and act like estrogen in some tissues. Previous epidemiological and laboratory research has suggested that isoflavones extracted from soybeans may have cardioprotective effects and may be a safe therapeutic alternative to hormone therapy for postmenopausal women. Researchers randomly assigned 350 healthy postmenopausal women to receive either isoflavone-rich soy protein (25 g/day containing 91 mg aglyconisoflavone equivalents) or placebo for 2.7 years. The researchers monitored participants (e.g., dietary intake, adverse events) every month for the first 6 months and then every other month for the remainder of the trial. Once every 6 months the researchers conducted laboratory tests (e.g., ultrasound of carotid arteries, serum lipids) and administered lifestyle and medical questionnaires.The researchers observed that compared with the placebo group, the progression rate of atherosclerosis was reduced on average by 16 percent in the soy protein supplement group, but this effect was not statistically significant. In a subgroup analysis, the researchers found that among the women who had experienced menopause within the past 5 years, the participants in the supplement group had on average a 68 percent lower progression rate of atherosclerosis than the placebo group. The supplements had no effect on the women who were more than 5 years beyond menopause. Additionally, the researchers observed no serious adverse events from the soy protein supplements for the duration of the trial.The researchers concluded that further study is needed to determine whether a beneficial treatment effect of isoflavone-rich soy protein supplements may be limited to women who begin taking supplements within 5 years of menopause. Similarly, early postmenopausal women who start hormone therapy soon after menopause have been shown to experience reduced cardiovascular disease, whereas women who start hormone therapy later in menopause do not reap cardiovascular benefits. They also noted that the soy protein supplements had a similar beneficial effect as hormone therapy with respect to the increase in circulating high-density lipoprotein (HDL) or “good” cholesterol. More research is needed to explore these results.
A diet high in monounsaturated fatty acids may be associated with less cognitive decline in older healthy women, according to a study published in the Journal of the American Geriatrics Society. Previous research has linked cognitive decline with cardiovascular disease, and certain types of dietary fatty acids (saturated and trans) are a known risk factor for cardiovascular disease. However, in this study, no association was found between cognitive decline and saturated or trans fatty acids. Monounsaturated fats are found in olive and canola oils, and saturated fats are found in coconut and palm oils as well as in butter, cheese, milk, and fatty meats. Trans fats are found in some margarines, commercial baked goods, and other foods made with or fried in partially hydrogenated oil.Researchers analyzed the dietary intake of 482 women aged 60 and older from a food frequency questionnaire, and assessed their cognitive function—memory, vision, executive function, language, and attention—upon enrollment and again after 3 years. The study is part of a larger observational study that examined associations between dietary and lifestyle factors and cognitive function in older women without dementia.The researchers found that a higher intake of dietary monounsaturated fatty acids was associated with less cognitive decline over a 3-year period. Further, after testing for associations between monounsaturated fatty acids and individual components of cognitive function, the researchers found that greater intake of monounsaturated fatty acids was associated with less decline in visual-spatial ability and memory after adjusting for other factors (i.e., age, education, reading ability). In addition, higher intakes of saturated fatty acids, trans-fatty acids, and dietary cholesterol were not associated with cognitive decline after adjusting for other factors.The researchers noted that monounsaturated fatty acids have anti-inflammatory effects and suggested that these effects may provide one explanation for their protection against cognitive decline (as chronic inflammation appears to be one contributor to Alzheimer’s disease). Limitations of this observational analysis include the small sample size and the use of a study population consisting primarily of healthy, educated Caucasian women, which the researchers noted may limit the generalizability of findings to other populations.
Drinking cranberry juice is no better than placebo for preventing the recurrence of urinary tract infections (UTIs), according to researchers at the University of Michigan. The study, supported by NCCAM and published in Clinical Infectious Diseases, was conducted among college-aged women, since they have the highest incidence of UTIs annually.Participants (319 women with an average age of 21 years) had symptoms of an acute UTI. They were randomly assigned to drink either 8 ounces of cranberry juice cocktail (27 percent cranberry juice) or non-cranberry juice (placebo) twice a day for 6 months. Upon enrollment in the study, and at 3- and 6-month visits, participants provided urine specimens for analysis and completed questionnaires regarding symptoms of UTIs and other conditions, behavioral and risk factors associated with UTIs, diet, and medical history. Participants also completed online questionnaires at 1, 2, 4, and 5 months.Although the recurrence rate of UTIs among participants was lower than the researchers expected (16.9 percent instead of 30 percent), results of the study showed that drinking 8 ounces of cranberry juice cocktail twice a day offered no better protection against the risk of recurring UTIs compared with placebo. Contrary to the researchers' expectations, the cranberry group had a slightly higher recurrence rate (19 percent vs. 15 percent) of UTIs.The researchers noted that the findings from this study differ from previous studies in similar populations in which cranberry juice was shown to significantly reduce the recurrences of UTIs. However, they added that these previous studies were not adequately powered (i.e., unable to reliably detect a clinically significant effect if one exists).
Research supported in part by NCCAM, suggests that the herbs black cohosh (Cimicifugaracemosa) and red clover (Trifolium pretense) are no better than placebo in treating the hot flashes and night sweats that often accompany menopause. The findings were published in the journal Menopause.Researchers from the University of Illinois at Chicago College of Medicine and Northwestern University Feinberg School of Medicine tested the herbs in women experiencing at least 35 episodes of hot flashes and night sweats per week. Although conventional menopausal hormone therapy can effectively manage these symptoms, health concerns related to such care have increased interest in alternative treatments.During the year-long investigation, 89 women were randomly assigned to take daily doses of black cohosh (128 mg), red clover (398 mg), placebo, or menopausal hormone therapy. As researchers expected, the most significant effects were seen in the women who took menopausal hormone therapy—the average number of symptoms they experienced per week fell by 94 percent. Women given placebo experienced a symptom decline of 63 percent (much higher than expected). Those who took red clover showed a decline of 57 percent—similar to placebo—while women who took black cohosh reduced the number of symptoms they experienced by only 34 percent. Symptom intensity among all groups was similar—however, at 6 and 9 months, women receiving black cohosh reported higher symptom intensity than women receiving placebo.Placebo, black cohosh, and red clover produced similar rates of adverse effects, such as gastrointestinal symptoms, nausea, vomiting, or fatigue. Previous research suggested that black cohosh could damage the liver and red clover could affect the blood's ability to clot. Neither adverse effect was apparent during this study.
Wang C, Schmid CH, Rones R, et al. A randomized trial of tai chi for fibromyalgia. New England Journal of Medicine. 2010;363(8):743–754.Yeh GY, Kaptchuk TJ, Shmerling RH. Prescribing tai chi for fibromyalgia—are we there yet? New England Journal of Medicine. 2010;363(8):783–784.People with fibromyalgia may benefit from practicing tai chi, according to a study published in the New England Journal of Medicine. Fibromyalgia is a disorder characterized by muscle pain, fatigue, and other symptoms. People with fibromyalgia have chronic widespread pain, as well as "tender points" on areas of the body, which hurt when slight pressure is applied. Although exercise appears to be an important part of fibromyalgia treatment, many people with fibromyalgia need medication to control symptoms and are unable to maintain muscle strength, flexibility, and overall fitness.Researchers, funded in part by NCCAM, evaluated the physical and psychological benefits of tai chi (which combines meditation, slow movements, deep breathing, and relaxation) in 66 people with fibromyalgia. The participants were assigned to one of two groups: an attention control group that received wellness education and practiced stretching exercises, or a tai chi group that received instruction in tai chi principles and techniques and practiced 10 forms of Yang‑style tai chi. Both groups met in 1‑hour sessions twice a week for 12 weeks and also practiced daily at home. Tai chi participants used an instructional DVD to continue practice for 12 more weeks. Compared with the attention control group, the tai chi group had a significantly greater decrease in total score on the Fibromyalgia Impact Questionnaire at 12 weeks. In addition, the tai chi group demonstrated greater improvement in sleep quality, mood, and quality of life. Improvements were still present at 24 weeks. No adverse events were reported.The researchers concluded that these findings support previous research indicating benefits of tai chi for musculoskeletal pain, depression, and quality of life. The underlying mechanisms are unknown, and the researchers noted that larger, longer term studies are needed to evaluate the potential benefits of tai chi for patients with fibromyalgia.
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Complementary Medicine inWomen’s HealthWomens Health 2012: The 20th Annual CongressMarch 16, 2012Josephine P. Briggs, M.D.Director, National Center for Complementary andAlternative MedicineNational Institutes of Health
DISCLOSUREI HAVE NO FINANCIAL INTERESTS ORCONFLICTS OF INTEREST TO DISCLOSE
What is Complementary Medicine? A group of diverse medical and health care interventions, practices, products, or disciplines that are not generally considered part of conventional medicine Boundaries are Gray Moving Cultural
N at ur % of Adult Population al pr 10 15 20 0 5 od D uc ee ts p br ea th in g M ed ita tio C n hi ro pr ac 38.8 million tic Therapies: 2007 M as sa ge 16 million Yo Sp ga ec iaBarnes et al., 2008 ld ie ts R Adult Use of Selected CAM el ax at io n Im ag A er y cu p un ct ur e
% of those adults who used CAM Ba 0 5 10 15 20 ck pa Ne in ck pa Jo in i nt p ai n Ar th rit 14.3 million Conditions: 2007 is 5 million An xi et Ch ol y es te ro lBarnes et al., 2008 Co O ld s th er m Adult Use of CAM for Selected us He c ad ac he In so 1.8 million m ni a
Adult Use of Selected CAM Therapies:2002 vs. 2007 2002 2007 *** % of Adult Population 10 5 0 Barnes et al. 2004, 2008
Reasons for CAM Use: 2007 87% Treatment 76% Wellness 42% Wellness 54% Treatment% using therapy for given 100% 90% Other Reasons 80% 70% reason 60% 50% Treatment AND 40% Wellness/Prevention 30% 20% 10% 0% Treatment only Wellness/Prevent only Stussman, 2010
NHIS CAM Survey: Use and Costs, 2007 CAM use in U.S.: Overall Use by Gender 40% of adults Women Men Average 12% of children 43% 34% 40% CAM spending in U.S.: $34 billion out-of-pocket 1% of total health care expenditures 10% of total out-of-pocket costs Across all demographics Women > men West >Midwest >Northeast >South Greater use in people with higher education levels
The Range of Research Questions How does Can it be What are the How well does it it work? studied in specific work in real world people? effects? settings? Outcomes Basic Translational Efficacy and Science Research Studies Effectiveness Research
Hierarchy of Evidence Guidelines Systematic reviews Rigorous human studies Basic biological understanding
Research SpotlightIsoflavone soy protein supplementation and atherosclerosis progression in healthy postmenopausal women: a randomized controlled trial.Hodis HN, Mack WJ, Kono N, et al. Isoflavone soy protein supplementation and atherosclerosis progression in healthypostmenopausal women: a randomized controlled trial. Stroke. 2011;42(11):3168–3175.
Research SpotlightNaqvi AZ, Harty B, Mukamal KJ, et al. Monounsaturated, Trans, and Saturated Fatty Acids and Cognitive Decline in Women. J ofthe American Geriatrics Society. 2011;59(5):837-843.
Research SpotlightBarbosa-Cesnik C, Brown MB, Buxton M, et al. Cranberry juice fails to prevent recurrent urinary tract infection: results from arandomized placebo-controlled trial. Clinical Infectious Diseases. 2011;52(1):23–30.
Research SpotlightGeller SE, Shulman LP, van Breemen RB, et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms:a randomized controlled trial. Menopause. 2009;16(6):1156–1166.
Beyond Drugs:How alternativetreatments can easepainMarch 7, 2011
Journal of Manipulative and Physiological Therapeutics
Menopause Research In 2002, the Womens Health Initiative raised concerns about long-term safety of menopausal hormone therapy. One reason that many women are turning to complementary therapies. In 2005, NIH State-of-the-Science conference on the management of menopause-related symptoms determined that more research is needed to clearly define the natural history of menopause, associated symptoms, and effectiveness and safety of treatments for bothersome symptoms.
NCCAM Menopause ResearchNCCAM supports a number of studies on complementary healthpractices for menopausal symptoms, such as: A trans-NIH initiative to improve scientific measures of hot flashes Research to identify natural plant-based compounds as promising alternatives to traditional menopausal hormone therapy Safety and efficacy and mechanisms of action of black cohosh, red clover, soy supplements, and other botanicals Mind and body therapies like yoga, meditation, hypnotherapy, and acupuncture for reducing hot flashes.