domized controlled, single-blinded, Phase II trial
investigating whether transcendental meditation will
reduce cardiac events in patients with coronary heart
disease. The control groups will participate in a cardi-
ology education program. The primary outcome is
arterial vasomotor dysfunction (brachial artery reac-
tivity) and the secondary outcome is autonomic ner-
vous system imbalances (heart rate variability).
DENTAL DISORDERS
Acupuncture for Dental Pain: Testing a Model
(Lixing Lao, DDS, PhD, University of Maryland)—
This double-blind, randomized controlled trial tests
the hypothesis that acupuncture can produce bet-
ter analgesic effects than control procedures on
postoperative dental pain caused by extraction of a
partially impacted third molar model. The first pilot
phase will develop and validate two sham proce-
dures to test the efficacy of acupuncture. The Phase
II trial will test the efficacy and safety of real
acupuncture compared to the sham model devel-
oped in the Phase I study.
DIGESTIVE DISORDERS
Acupuncture and Moxa For Chronic Diarrhea
in HIV Patients (Joyce K. Anastasi, RN, PhD,
LAc, Columbia University Health Sciences)—This
study is designed to assess the efficacy of two alter-
native medicine treatments for chronic diarrhea
associated with HIV. It is a randomized, controlled,
blinded Phase III clinical trial in which parallel
groups are studied under the intent-to-treat princi-
ple. True acupuncture, moxibustion, and combina-
tion therapy, in which specific meridian points are
stimulated according to protocol, will be compared
to each other and with the control group. End-
points will include diarrhea frequency and stool
consistency.
GENERAL MEDICAL SCIENCES
Biomechanical Effect of Acupuncture Needling
(Helene M. Langevin, MD, University of Vermont)—
This investigation will lead to quantification of nee-
dle grasp by measuring the peak force required to
pull out acupuncture needles inserted at acupunc-
ture points and control points in 80 normal human
volunteers. Needling operations will be carried out by
a computer-controlled device, eliminating potential
investigator bias. All needling parameters will be con-
sistent with clinical practice. The investigators will
also study varying dwell times after insertion and dif-
ferent types of needle manipulation. They will corre-
late the force required to withdraw the needle with
the depth of its insertion into muscle and subcuta-
neous tissue, which will allow determination of
which tissue is most responsible for needle grasp.
Complementary and Alternative Medicine
Data Archive (Eric L. Lang, PhD, Sociometrics
Corporation)—The goal of this project is to facili-
tate access to, and statistical analysis of, outstand-
ing scientific data sets and documentation on CAM
through the creation of an international CAM Data
Archive.
Melatonin and Cerebral Blood Flow
Autoregulation (Mohan Viswanathan, PhD,
Children’s Research Institute)—The present project
will attempt to define the physiological role of
melatonin receptors in cerebral blood flow. The
study will focus on functional studies and signal
transduction mechanisms of melatonin receptors in
the cerebral arteries and pharmacological charac-
terization of melatonin binding sites.
Nonpharmacologic Analgesia for Invasive
Procedures (Elvira Lang, MD, Beth Israel Dea-
coness Medical Center)—It is proposed that the use
of nonpharmacologic analgesia (a combination of
relaxation training, hypnosis and guided imagery)
during invasive radiologic procedures will reduce
the need for intravenous drugs, improve patient
safety, and prove cost effective. To test these
hypotheses, the relative performance of nonphar-
macologic analgesia will be compared to standard
care in a randomized, Phase III trial.LIVER DISEASE
Herbal Remedies and the Treatment of Liver
Disease (Mark Zern, MD, Thomas Jefferson Uni-
versity)—The objective of this study is to investi-
gate the effectiveness of a number of herbal
remedies, employing a rigorous scientific approach,
to determine the relative effectiveness of these
agents and the mechanisms by which they may be
inhibiting liver injury and fibrosis. Both in vitro
models of liver cell injury and rat models of liver
injury and fibrosis will be employed.232 The Encyclopedia of Complementary and Alternative Medicine