the National Institute of Diabetes and Digestive and Kid-
ney Diseases—This is a Phase III, double-blind
placebo-controlled, randomized clinical trial of the
effect of 160 mg (taken twice daily) of saw pal-
metto extract on symptoms, objective parameters
of disease severity, and quality of life in men with
moderate-to-severe BPH. The primary outcome
measurement is the American Urological Associa-
tion Symptom Index score; the secondary outcome
measures are peak urinary flow rate, post-void
residual urine volume, and BPH Impact Index.
WOMEN’S HEALTH
Study of Women’s Health Across the Nation
(SWAN) (Ellen B. Gold, MD, University of Cali-
fornia, Davis) Cofunded with the National Institute on
Aging and the National Institute of Nursing—A multi-
site study to describe and contrast menopausal
transition in relation to ethnicity, SWAN aims to
contribute substantive new knowledge on the
menopause transition through its prospective
design,multiethnic/racial composition, representa-
tiveness of defined populations, and comprehen-
sive measurement and power. A major goal of the
project is to collect and analyze data on demo-
graphics, health and social characteristics, race/eth-
nicity, reproductive history, pre-existing illness,
physical activity (includes activity limitations),
health practices (includes diet, smoking, use of
over-the-counter medications, use of CAM treat-
ments) as potential predictor variables and to
describe the multiethnic community-based samples
of mid-life women.
Acupuncture Treatment of Depression Dur-
ing Pregnancy (Rachel Manber, MD, Stanford
University) Cofunded with the Agency for Healthcare
Research and Quality—The primary study objective
of this Phase II trial is to determine if the efficacy
of acute (short-term) acupuncture treatment for
depression during pregnancy or postpartum is sub-
stantial enough to warrant a large-scale clinical trial.
Since it is known that the mother’s psychological
state affects the infant’s health, the trial will also
assess the effect of treatment on infant well-being.
RESEARCH CENTERS
NCCAM supports a number of centers. CAM Spe-
cialized Centers provide focal points for initiating
and maintaining state-of-the-art multidisciplinary
CAM research, developing core research
resources, careers of new CAM investigators, and
expanding the research base through collabora-
tive research with scientists and clinicians. Botan-
ical Centers, cofunded with the NIH Office of
Dietary Supplements, the Office of Research on
Women’s Health, and the National Institute of
General Medical Sciences, foster multidisciplinary
research to identify potential health benefits and
develop a systematic evaluation of the safety and
effectiveness of botanicals available as dietary
supplements.SPECIALIZED RESEARCH CENTERS
Pediatric Center for Complementary/Alter-
native Medicine(Fayez Ghishan, MD, University
of Arizona)—The goal of this Center is to study
integrative approaches in pediatrics. Three Phase II
trials investigate the role of alternative approaches
to treating very common pediatric problems for
which there are no good conventional medical
therapies. Included are randomized, controlled tri-
als in children to evaluate:- Craniosacral osteopathic manipulation and
botanical treatment of recurrent otitis; - Relaxation/guided imagery and chamomile tea
as therapeutic modalities to treat functional
abdominal pain; and - The use of self-hypnosis, acupuncture, and
osteopathic manipulation on muscle tension in
children with spastic cerebral palsy.
Center for Addiction and Alternative Med-
icine Research (Thomas Kiresuk, PhD, Min-
neapolis Medical Research Foundation)—This
Center will focus on the utilization, applicability,
and effectiveness of selected CAM modalities in the
treatment of addictive, health and psychological
complications of substance abuse. The Center is
studying:- Herbal treatment of hepatitis C in methadone
maintained patients (Phase I clinical trial);and - Electroacupuncture examined for its effects and
mechanisms of action.
Appendix V 235