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CAMPS Research projects

Completed Research

Complementary and Alternative Therapies for Menopausal Symptoms

This project evaluated women's decision-making concerning menopausal symptom management, particularly around the use of alternative therapies to estrogens and perceived role of the physician in these treatment decisions following the July 2002 publication of the Women Health Initiative findings. With many women now hesitant to use estrogens, complementary and alternative medicine (CAM) therapies, such as black cohosh, are being considered. However, data are limited regarding how menopause-age women evaluate these options and make treatment decisions.  This study analyzed data from a nationally representative survey using a sample of 750 women (aged 40-65).  The online survey addresses frequency and severity of symptoms, sources of information related to treatment options, attitudes and behaviors regarding traditional and alternative approaches, trends in symptom treatment, and the level of physician involvement in their decision-making.  The project also developed materials to facilitate improved physician-patient discussions about the range of treatments available for menopausal symptoms.

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Tai Chi Versus Western Exercise In Older Women and Men
Working Title of Study: Wellness Interventions for Self-Enrichment (WISE)

The major objective of this study is to evaluate the effects of a one year program of "Tai Chi Exercise" versus a standard program of "Western Exercise" consisting of endurance, strength, and flexibility training in community-living women and men age 70 years and older. The primary endpoints of the study are changes in physical functioning associated with a lower risk of falling, psychological status and health-related quality of life as measured by standard self-report questionnaires, and autonomic tone as measured by heart rate variability and baroreflex sensitivity. Women and men living in the communities of Menlo Park, Palo Alto, Mountain View, and Sunnyvale, CA who are ambulatory and without life threatening diseases will be recruited, perform a baseline evaluation, and if found eligible, will be randomized to one of three groups: Tai Chi Exercise, Western Exercise, or no-exercise 'attention' control. A total of 180 subjects will be randomized with a target of 150 subjects completing the one year study. The two treatment conditions will consist of class and at-home sessions. Throughout the year, classes of 45-minutes will be held twice a week. On all days that classes are not held, subjects will be instructed to perform their assigned exercise program for 20-30 minutes. Follow-up evaluations will be performed at three, six and twelve months, with primary outcomes being assessed at twelve months. The results of this research will provide the first direct comparison of Tai Chi versus Western Exercise in this high priority target population and will help identify interventions for maintaining independence and enhancing quality of life in older persons.

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Successful Aging: A Proposed Intervention to Elicit and Sustain Optimal Health for Individuals Age 55-85
Working Title of Study: Successful Aging Growth Experience (SAGE)

"SAGE" is a three (3) year intervention program to elicit and sustain optimal health and longevity through a comprehensive lifestyle program for a multiethnic group of ?90 adults who are between the ages of 55 - 85 years. It involves the development and dissemination of a program to promote healthy lifestyles that will reduce disability and disease among older adults through a program that is:

    1. Community based and will interact with the community organizations;
    2. A program where participants will be directly involved in the actual design; and,
    3. One where the program components include the regular practice of meditation; emphasis on a plant-based diet, moderate Eastern and Western exercise, social support, community service, and, appropriate use of both conventional and alternative medicine.

For the program, each of the three groups of 30 adults will begin as a leader led group and transition to a completely, peer leadership, community based model over the 12 months of the project. Among the dependent variables to be measured at baseline and periodic intervals are cognitive function, psychosocial variables, and basic physical assessments. This "SAGE" multifactorial intervention to elicit and sustain "successful aging" is the first program of its type and can serve as a prototype for other similar programs to address the needs of the growing elderly population. Once such a program is demonstrated to be effective, it can provide the evidence necessary to influence insurance companies and MEDICARE to include such programs in their health plans for older adults.

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The Effect of a Commercial Supplement Containing Ginkgo Biloba (GB), Centella Asiatica (Gotu Kola) Docosahexanenoic acid (DHA) On Cognitive Function, Quality of Life, Platelet Function, and Gait and Balance In Older Adults
Working Title of Study: Ginkgo’s Effect on Memory (GEM)

Reduction in cognitive function is a widespread problem among persons over 65 years of age. A significant amount of research has been conducted in Europe which has demonstrated positive effects with GB containing supplements on cognitive dysfunction, however the majority of the studies have involved patients with dementia including various degrees of Alzheimer's disease. Additionally, some research has shown potential benefits of Gotu Kola (GK) and DHA in affecting factors related to cognitive function. To date, only one randomized clinical trial involving GB has been reported in the US. Since for many cognitive function declines slowly with age, it is important to determine if widely available commercial supplements touted to improve cognitive function can improve, prevent, or delay cognitive function in older adults.

Purpose: This randomized double blinded clinical trial examined the effect of a commercial supplement containing GB, GK, and DHA on cognitive function in 70 male and female participants 65-85 years old without dementia. Ninety participants were randomized to one of two treatment arms 1) GB/GK/DHA supplement and 2) placebo.

Primary hypothesis: The change in cognitive function from baseline to 16 weeks will be significantly greater in the GB/GK/DHA treatment group compared to the placebo group. Cognitive function will be based on the sum score from a battery of standardized tests. Secondary outcomes will include quality of life measures, platelet function, and gait and balance.

Methods: Participants with evidence of dementia (based on the mini-mental screen) or depression (based on the geriatric depression scale) were excluded. Also, those on anticoagulant therapy, psychoactive medications, or those taking antioxidant supplements were excluded from study participation. Cognitive function, quality of life, platelet function and gait and balance were evaluated at baseline and 16 weeks. The battery of tests will include validated measures of cognition, concentration, verbal and non-verbal memory, and language ability. Quality of life will be measured using an SF-36. Platelet function will be assessed using an FDA-approved technique. To account for potential dietary factors associated with selected outcomes, nutrition behavior was monitored and a multi-vitamin, multi-mineral was taken by both study arms.

Relevance: This pilot study will determine if this widely available supplement (GB/GK/DHA) positively effects cognitive function, quality of life and selected blood parameters associated with improved blood flow in elderly individuals with mild to modest cognitive dysfunction. If the findings are significant, it will provide increased justification for individuals experiencing cognitive decline for using this product or a similar product. Also, these data will provide a basis for a larger long-term study that will focus on identifying the biological mechanisms responsible for improvements.

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The Effect of a Garlic Preparation on Plasma Lipid Levels in Moderately Hypercholesterolemic Adults.

Garlic supplements are the most consumed herbal products in the United States. The most common health claim made for these products is that of cholesterol lowering. However, this claim has not been supported by recent clinical studies. Concern has been raised that the negligible effects reported in these recent studies has a lot to do with the types of garlic preparations used, and the possibility that the active ingredient found in fresh garlic - a molecule named allicin - is lost during, or due to, the manufacturing procedures of many commercial preparations. To date, the type of garlic preparation used in these clinical trials has predominantly been dried garlic powders. A few clinical trials have reported beneficial lipid effects using an aged garlic extract, and only a small number of weak and inconclusive uncontrolled trials have used fresh garlic. New commercial garlic formulations have been designed to enhance the yield of bioavailable allicin. A rigorous trial directly comparing different types of garlic preparations for their effects on cardiovascular benefits is the crucial need that this study seeks to address.

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The Effect of Soy Protein with or without Isoflavones Relative to Milk Protein on Plasma Lipids in Hypercholesterolemic Postmenopausal Women.
Working Title of Study: Phytoestrogen and Cholesterol Study (PACS)

Clinical trial data and a meta-analysis support a hypocholesterolemic effect of soy protein. It has been suggested the effect may be partially attributable to the isoflavones present 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 among postmenopausal, moderately hypercholesterolemic women.

Design: This was a randomized, double-blind, placebo-controlled clinical trial consisting of three treatment groups. After a four-week run-in taking a milk protein supplement (MILK-pre), women were randomized to 12-weeks of dietary protein supplementation (42 g/day) composed of either milk protein (MILK), or one of two soy proteins containing either trace amounts (SOY—), or 80 mg aglycone isoflavones (SOY+).

Results: DL-cholesterol (LDL-C) concentrations decreased more in the SOY+ group (n=31) relative to the SOY— group (n=33), —14 mg/dL vs. —3 mg/dL, p=0.02, but neither of these were significantly different than the —11 mg/dL decrease observed in the MILK group (n=30). There were no significant differences in total- or HDL-cholesterol or triacylglycerol concentrations between any of the three groups.

Conclusion: The difference in LDL-C lowering between the two soy protein supplements suggests an effect attributable to the isoflavone-containing fraction. However, the unexpected LDL-C concentration lowering observed in the milk protein group, and no significant difference between either soy group and the milk protein group, suggest a possible alternate interpretation that changes were due to other factors related to study participation.

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A Controlled Pilot Study of Stress Management Training of Elderly Patients with Congestive Heart Failure

To evaluate the effect of stress management training on quality of life, functional capacity and heart rate variability in elderly patients with NYHA class I-III CHF.

Background: While substantial research exists on stress management training for patients with coronary heart disease, there is little data on the value of psychosocial training on patients with CHF.

Methods: Thirty-three multi ethnic patients (mean age=66 +/- 9 years) were assigned through incomplete randomization to one of two treatment groups or a wait listed control group. The fourteen participants who completed the treatment attended eight training sessions during a ten-week period. The training consisted of 75-minute sessions adapted from the Freeze- frame stress management program developed by the Institute of HeartMath. Subjects were assessed at baseline and again at the completion of the training. Depression, stress management, optimism, anxiety, emotional distress and functional capacity were evaluated as well as heart rate variability.

Results: A significant improvement (p< .05) was noted in the patients assigned to treatment vs. the control group in perceived stress, emotional distress, six minute walk and depression and positive trends were noted in each of the other psychosocial and functional capacity measures. The 24-hour heart rate variability showed no significant changes in autonomic tone.

Conclusions: CHF patients made willing study participants and their emotional coping and functional capacity were enhanced. Given the incompleteness of CHF medical management, and the exploding interest in complementary medical intervention, it seems imperative that further work in psychosocial treatment be undertaken.

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Current Trends in the Integration and Reimbursement of Complementary and Alternative Medicine by Managed Care, Insurance Carriers, and Hospital Providers

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: literature review and information research 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.

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.

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This document was last modified: January 13, 2004.
Copyright © 2004, Stanford University School of Medicine. All rights reserved
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