Washington University Medical Center)-The major
specific aim of this pilot study is to demonstrate
that using a “single blind-mute “methodology, true
and sham acupuncture can be administered in a
standardized and unbiased fashion. The condition
to be studied is carpal tunnel syndrome (CTS), a
common,well-delineated syndrome causing hand
pain with characteristic clinical and objective elec-
trodiagnostic findings. Other aims of this study are:
(1)to identify and standardize the most appropriate
sham acupuncture points for CTS, (2)to develop a
manual that standardizes the administration of true
and sham acupuncture that can be used at any
study site performing a randomized clinical trial
(RCT), (3)to demonstrate that patient recruitment
for and retention in an RCT of acupuncture for CTS
is sufficient to justify a full-scale RCT, (4)to deter-
mine, in a small Phase II RCT, whether true
acupuncture provides meaningful benefit for pain
in CTS compared to sham acupuncture and
whether the frequency of administration of
acupuncture influences the outcome.
Usual Care vs. Choice of Alternative Ther-
apy for Low Back Pain (David M. Eisenberg,
MD, Beth Israel Deaconess Medical Center)—
Patients with uncomplicated acute low-back pain
will be randomized in this Phase III trial to either
usual care or choice of expanded benefits (chiro-
practic,acupuncture, or massage therapy). It is
hypothesized that patients offered their choice of
expanded benefits will experience a more rapid
improvement in symptoms, a faster return to base-
line functional status, a decrease in utilization of
conventional medical services, and will be more
satisfied with their care.
NEUROLOGICAL DISORDERS
Ginkgo biloba Prevention Trial in Older
Individuals (Steven DeKosky, MD, University of
Pittsburgh)—Cofunded with the National Heart, Lung,
and Blood Institute, the National Institute on Aging, and
the National Institute of Neurological Disorders and
Stroke—This is a multicenter, randomized, double-
blind, placebo-controlled Phase III trial to determine
the effect of 240mg/day of Ginkgo bilobain decreas-
ing the incidence of dementia, in general, and
Alzheimer’s disease, specifically. The subjects will be
aged 75 years and older. Secondary outcomes,
including changes in cognitive function, incidence of
cardiovascular disease and total mortality, will also
be measured.
Melatonin for Sleep Disorders in Parkin-
son‘s Disease (Glenna Dowling, RN, PhD, Uni-
versity of California, San Francisco) Cofunded with
the National Institute of Nursing Research—The pur-
pose of this Phase III, multisite, double-blind study
is to compare the effects of melatonin given at two
different doses (5mg and 50mg)and placebo on
nocturnal sleep. The clinical design, a placebo-con-
trolled, double crossover trial, will also allow for
assessment of any adverse events associated with
melatonin related to its safety and tolerance. This
research may lead to the development of safer,
more physiologic therapies for treating sleep distur-
bances in patients with Parkinson‘s Disease.
Neurobiology of Acupuncture Analgesia
(Ji-Sheng Han, MD, Beijing Medical University)—
This study is examining the effects of elec-
troacupuncture on gene and protein expression in
a rat model by exploring the regulation of the
endogenous opioid system in the nervous system.
Neuroprotective Agents from Oriental
Medicines (Tae H.Oh, PhD, University of Mary-
land)—These studies are designed to elucidate and
establish the mechanism(s)of neuroprotection
demonstrated by isolates of oriental medicines
(Panax ginseng, Cynanchum wilfordii, Scrophularia
buergeriana). Specifically, this project investigate
whether Rg3 (a gingenoside fraction prepared from
Panax ginseng) and MCA (a p-methoxy-trans_cin-
namic acid prepared from Scrophulara buergeriana)
exert neuroprotective activities by inhibiting Ca++
influx by determining their effects on Ca++ influx in
vitro; whether Rg3, cynandione A and MCA exert
neuroprotective activity by inhibiting neuronal
apopotosis by assessing their effects on apoptosis and
its markers in vitroand in vivo; and whether neoline
ameliorates deficits in short-term memory by influ-
encing central cholinergic transmission in the brain.
In addition, the study addresses issues involved in
drug delivery across the blood brain barrier.UROLOGICAL
Saw Palmetto Extract in Benign Prostatic
Hyperplasia (BPH) (Andrew Avins, MD, Veter-
ans Medical Center, San Francisco) Cofunded with234 The Encyclopedia of Complementary and Alternative Medicine