The effect of soy protein with or without isoflavones relative to milk protein on plasma lipids in hypercholesterolemic postmenopausal women.

BACKGROUND: Clinical trial data and the results of a meta-analysis suggest a hypocholesterolemic effect of soy protein. The effect may be partially attributable to the isoflavones in soy. Few studies have examined the separate effects of soy protein and isoflavones. OBJECTIVE: The objective of this study was to determine the effect of soy protein and isoflavones on plasma lipid concentrations in postmenopausal, moderately hypercholesterolemic women. DESIGN: This was a randomized, double-blind, placebo-controlled clinical trial with 3 treatment groups. After a 4-wk run-in phase during which the women consumed a milk protein supplement, the subjects were randomly assigned to 12 wk of dietary protein supplementation (42 g/d) with either a milk protein (Milk group) or 1 of 2 soy proteins containing either trace amounts of isoflavones (Soy- group) or 80 mg aglycone isoflavones (Soy+ group). RESULTS: LDL-cholesterol concentrations decreased more in the Soy+ group (n = 31) than in the Soy- group (n = 33) (0.38 compared with 0.09 mmol/L; P = 0.005), but neither of these changes was significantly different from the 0.26-mmol/L decrease observed in the Milk group (n = 30). The results for total cholesterol were similar to those for LDL cholesterol. There were no significant differences in HDL-cholesterol or triacylglycerol concentrations between the 3 groups. CONCLUSIONS: The difference in total- and LDL-cholesterol lowering between the 2 soy-protein supplements suggests an effect attributable to the isoflavone-containing fraction. However, the unexpected LDL-cholesterol lowering observed in the Milk group, and the fact that there was no significant difference between either soy group and the Milk group, suggests that changes may have been due to other factors related to participation in the study.

Methodologic issues in measuring physical activity and physical fitness when evaluating the role of dietary supplements for physically active people.

Physical activity and physical fitness are complex entities comprising numerous diverse components that present a challenge in terms of accurate, reliable measurement. Physical activity can be classified by its mechanical (static or dynamic) or metabolic (aerobic or anaerobic) characteristics and its intensity (absolute or relative to the person's capacity). Habitual physical activity can be assessed by using a variety of questionnaires, diaries, or logs and by monitoring body movement or physiologic responses. Selection of a measurement method depends on the purpose of the evaluation, the nature of the study population, and the resources available. The various components of physical fitness can be assessed accurately in the laboratory and, in many cases, in the field by using a composite of performance tests. Most coaches and high-level athletes would accept as very beneficial a dietary supplement that would increase performance in a competitive event by even 3%; for example, lowering a runner's time of 3 min, 43 s in the 1500 m by 6.7 s. To establish that such small changes are caused by the dietary supplement requires carefully conducted research that involves randomized, placebo-controlled, double-blind studies designed to maximize statistical power. Statistical power can be increased by enlarging sample size, selecting tests with high reliability, selecting a potent but safe supplement, and maximizing adherence. Failure to design studies with adequate statistical power will produce results that are unreliable and will increase the likelihood that a true effect will be missed.

Complementary and alternative medicine use among elderly persons: one-year analysis of a Blue Shield Medicare supplement.

BACKGROUND: Large scale surveys in the United States and abroad suggest that 35-60% of adults have used some form of complementary/alternative medicine (CAM). However, no studies to date have focused on predictors and patterns of CAM use among elderly persons. METHODS: The population surveyed were Californians enrolled in a Medicare risk product that offers coverage for acupuncture and chiropractic care. Surveys were mailed to 1597 members in 1997 and responses received by 728 (51% response rate). Health risk assessment data were also obtained at baseline and 12-15 months following enrollment in the plan. Multiple logistic regression analyses were carried out to examine predictors of CAM use. RESULTS: Forty-one percent of seniors reported use of CAM. Herbs (24%), chiropractic (20%), massage (15%), and acupuncture (14%) were the most frequently cited therapies. CAM users tended to be younger, more educated, report either arthritis and/or depression/anxiety, not be hypertensive, engage in exercise, practice meditation, and make more frequent physician visits. Use of CAM was not associated with any observed changes in health status. Respondents also expressed considerable interest in receiving third-party coverage for CAM. Although 80% reported that they had received substantial benefit from their use of CAM, the majority (58%) did not discuss the use of these therapies with their medical doctor. CONCLUSIONS: Findings suggest that there is significant interest in and use of complementary/alternative medicine among elderly persons. These results suggest the importance of further research into the use and potential efficacy of these therapies within the senior population.

A review of mind/body therapies in the treatment of musculoskeletal disorders with implications for the elderly.

BACKGROUND: A comprehensive, but not systematic, review of the research on complementary and alternative treatments, specifically mind/body techniques, on musculoskeletal disease was conducted at Stanford University. The goals of the review were to establish a comprehensive literature review and provide a rationale for future research carrying the theme of "successful aging." METHODS: Computerized searches were conducted using MEDLINE, PsychInfo, Stanford Library, Dissertation Abstracts, Lexus-Nexus, the Internet as well as interviews conducted with practitioners and the elderly. Mind/body practices evaluated were: social support, cognitive-behavioral therapy, meditation, the placebo effect, imagery, visualization, spiritual/energy healing, music therapy, hypnosis, yoga, tai chi, and qigong. Studies published after 1990 were the priority, but when more recent literature was scarce, other controlled studies were included. RESULTS: Mind/body techniques were found to be efficacious primarily as complementary treatments for musculoskeletal disease and related disorders. Studies provided evidence for treatment efficacy but most apparent was the need for further controlled research. CONCLUSIONS: Reviewers found a dearth of randomized controlled research conducted in the US. There is a lack of studies with which to determine appropriate dosage and understand the mechanisms by which many of the practices work. Anecdotal evidence, some controlled research, clinical observation, as well as the cost effectiveness and lack of side effects of the mind/body treatments make further investigation a high priority.

Current trends in the integration and reimbursement of complementary and alternative medicine by managed care organizations (MCOs) and insurance providers: 1998 update and cohort analysis.

OBJECTIVES: To assess the status of managed care and insurance coverage of complementary and alternative medicine (CAM) and the integration of such services into conventional medicine. METHODS: A literature review and information search was conducted to determine which insurers had special policies for CAM. Telephone interviews were conducted with a definitive sample of 9 out of 10 new MCOs or insurers identified in 1998 and a cohort of eight MCOs and insurers who responded both to the original survey in 1997 and again in 1998 to determine trends. RESULTS: This study constitutes the results of the second year of a 3-year ongoing survey. For 1998, 10 MCOs and insurance carriers initiated CAM coverage. Survey results are analyzed for these 10 new providers as well as the results of a cohort of eight insurers surveyed in both 1997 and 1998 to determine current trends. A majority of the insurers interviewed offer some coverage for the following: nutrition counseling, biofeedback, psychotherapy, acupuncture, preventive medicine, chiropractic, osteopathy, and physical therapy. All new MCOs and insurers said that market demand was their primary motivation for covering CAM. Factors determining whether insurers would offer coverage for additional therapies included potential cost-effectiveness, consumer interest, demonstrable clinical efficacy, and state mandates. Among the most common obstacles listed to incorporating CAM into mainstream health care were lack of research on efficacy, economics, ignorance about CAM, provider competition and division, and lack of standards of practice. CONCLUSIONS: Consumer demand for CAM is motivating more MCOs and insurance companies to assess the benefits of incorporating CAM. Outcomes studies for both conventional and CAM therapies are needed to help create a health care system based upon treatments that work, whether they are conventional, complementary, or alternative.

A review of the incorporation of complementary and alternative medicine by mainstream physicians.

BACKGROUND: Studies suggest that between 30% and 50% of the adult population in industrialized nations use some form of complementary and/or alternative medicine (CAM) to prevent or treat a variety of health-related problems. METHOD: A comprehensive literature search identified 25 surveys conducted between 1982 and 1995 that examined the practices and beliefs of conventional physicians with regard to 5 of the more prominent CAM therapies: acupuncture, chiropractic, homeopathy, herbal medicine, and massage. Six studies were excluded owing to their methodological limitations. RESULTS: Across surveys, acupuncture had the highest rate of physician referral (43%) among the 5 CAM therapies, followed by chiropractic (40%) and massage (21%). Rates of CAM practice by conventional physicians varied from a low of 9% for homeopathy to a high of 19% for chiropractic and massage therapy. Approximately half of the surveyed physicians believed in the efficacy of acupuncture (51%), chiropractic (53%), and massage (48%), while fewer believed in the value of homeopathy (26%) and herbal approaches (13%). CONCLUSIONS: This review suggests that large numbers of physicians are either referring to or practicing some of the more prominent and well-known forms of CAM and that many physicians believe that these therapies are useful or efficacious. These data vary considerably across surveys, most likely because of regional differences and sampling methods, suggesting the need for more rigorous surveys using national, representative samples. Finally, outcomes studies are needed so that physicians can make decisions about the use of CAM based on scientific evidence of efficacy rather than on regional economics and cultural norms.

A review of mind-body therapies in the treatment of cardiovascular disease. Part 1: Implications for the elderly.

BACKGROUND: A review of research on complementary and alternative treatments, specifically mind-body techniques, was conducted at Stanford University. The goals of the review were to establish a comprehensive literature review and to provide a rationale for future research concerning successful aging. METHODS: Computerized searches were conducted using MEDLINE, PsychInfo, Stanford Library, Dissertation Abstracts, Lexus-Nexus, the Internet, and interviews conducted with practitioners. All studies since 1990 that examined mind-body treatments of cardiovascular disorders in the elderly were included. Mind-body practices evaluated were social support, cognitive-behavioral treatment, meditation, the placebo effect, hope, faith, imagery, spiritual healing, music therapy, hypnosis, yoga, t'ai chi, qigong and aikido. Studies conducted after 1990 were a priority, but when more recent literature was scarce, other studies using randomized, controlled trials were included. RESULTS: Mind-body techniques were found to be efficacious primarily as complementary and sometimes as stand-alone alternative treatments for cardiovascular disease-related conditions. Studies provided evidence for treatment efficacy, but the need for further controlled research was evident. CONCLUSIONS: Reviewers found only a handful of randomized, controlled research studies conducted in the United States. As a result, there is a lack of replicated studies with which to determine appropriate treatment dosage and the mechanisms by which many of the practices work. Compelling anecdotal evidence, the presence of some controlled research, overall cost effectiveness, and the lack of side effects resulting from mind-body treatments make further investigation a high priority.

Current trends in the integration and reimbursement of complementary and alternative medicine by managed care, insurance carriers, and hospital providers.

OBJECTIVES: To assess the status of managed care and insurance coverage of complementary and alternative medicine (CAM) and the integration of such services offered by hospitals. METHODS: A literature review and information search was conducted to determine which insurers had special policies for CAM and which hospitals were offering CAM. Telephone interviews were conducted with a definitive sample of 18 insurers and a representative subsample of seven hospitals. RESULTS: A majority of the insurers interviewed offered some coverage for the following: nutrition counseling, biofeedback, psychotherapy, acupuncture, preventive medicine, chiropractic, osteopathy, and physical therapy. Twelve insurers said that market demand was their primary motivation for covering CAM. Factors determining whether insurers would offer coverage for additional therapies included potential cost-effectiveness based on consumer interest, demonstrable clinical efficacy, and state mandates. Some hospitals are also responding to consumer interest in CAM, although hospitals can only offer CAM therapies for which local, licensed practitioners are available. Among the most common obstacles listed to incorporating CAM into mainstream health care were lack of research on efficacy, economics, ignorance about CAM, provider competition and division, and lack of standards of practice. CONCLUSIONS: Consumer demand for CAM is motivating more insurers and hospitals to assess the benefits of incorporating CAM. Outcomes studies for both allopathic and CAM therapies are needed to help create a health care system based upon treatments that work, whether they are mainstream, complementary, or alternative.

Role of water-soluble dietary fiber in the management of elevated plasma cholesterol in healthy subjects.

Guidelines for the use of water-soluble dietary fibers (WSDF) in the dietary management of elevated plasma cholesterol are not well-established. Consequently, 4 studies were conducted to explore the plasma lipid-lowering effects of a variety of WSDF. Studies were randomized, double-blind, placebo-controlled trials involving healthy men and women (plasma cholesterol greater than 5.17 mmol/liter; greater than 200 mg/dl). Study duration ranged from 4 to 12 weeks. The WSDF acacia gum yields a low viscosity, palatable beverage when mixed in water. However, despite its WSDF classification, acacia gum consumed for 4 weeks as the sole WSDF source (15 g of WSDF/day) or primary source in a WSDF mixture (17.2 g of WSDF/day; 56% derived from acacia gum) did not produce a significant lipid-lowering effect versus placebo. When 15 g of WSDF/day consisting of psyllium hust, pectin, and guar and locust bean gums (medium viscosity) was consumed for 4 weeks, significant reductions in cholesterol resulted (total cholesterol 8.3%, low-density lipoprotein cholesterol 12.4%; p less than 0.001) that were comparable to changes achieved with 10 g of WSDF/day from high-viscosity guar gum. The magnitude of the lipid-lowering effect was related to intake of WSDF ranging from 5 to 15 g/day (low-density lipoprotein cholesterol +0.8% [placebo], -5.6% [5 g/day], -6.8% [10 g/day], -14.9% [15 g/day]; p less than 0.01 for trend). The effects of WSDF on plasma lipids were similar for men and women. A diet rich in selected WSDF may be a useful adjunct to the dietary management of elevated plasma cholesterol.