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.
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.
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:
Community based and will interact with the community organizations;
A program where participants will be directly involved in the
actual design; and,
- One where
the program components include the regular practice of meditation;
emphasis on a plant-based diet,
and Western exercise, social support, community service,
and, appropriate use of both conventional and alternative
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
the 12 months
the project. Among the dependent variables to
be measured at baseline and periodic intervals are
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
and MEDICARE to include such programs in their
health plans for older adults.
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: Ginkgos 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
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
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
flow in elderly individuals with
mild to modest cognitive dysfunction. If the findings are
significant, it will provide increased justification for
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.
The Effect of a Garlic Preparation on Plasma Lipid Levels in
Moderately Hypercholesterolemic Adults.
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.
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.
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+).
(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
The difference in LDL-C lowering between the two soy protein supplements
suggests an effect attributable to
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
that changes were due to other factors related to study
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.
While substantial research exists on stress management training
with coronary heart disease, there is little
data on the value of psychosocial training on patients with CHF.
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
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.
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
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
CHF patients made willing study participants and their emotional
coping and functional capacity were enhanced.
the incompleteness of CHF medical management, and the exploding
in complementary medical intervention,
it seems imperative that further work in psychosocial treatment
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.
review and information research was conducted to determine which
insurers had special
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:
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.
Consumer demand for CAM is motivating more insurers and hospitals
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,