Current
Research
Many alternative
therapies have not been thoroughly tested. Most plant extracts and compounds,
for example, are not regulated as drugs and are therefore less likely
to be thoroughly investigated before reaching the marketplace. On the
other hand, some advocates of CAM treatments are skeptical that medical
science is capable of giving alternative therapies a fair trial.
This Center
challenges itself to help bridge the gap between CAM treatment and research.
Our current research will serve practitioners of both CAM and conventional
medicines, as well as patient populations, by subjecting promising CAM
treatment methods to rigorous scientific scrutiny.
l3AR:
Botanical Compound for Treatment of Hepatitis C Symptoms.
Hepatitis
C (HCV) has emerged as a major public health issue in the United States,
with recent studies suggesting that HCV will be the major cause of cirrhosis
and liver cancer in the next century. Although its incidence is not limited
to persons with a history of intravenous drug use, they comprise the largest
known risk group: Greater tahn 90 percent of long term
IV drug users will eventually test positive for the virus, and even short
term experimentation with IV drug use presents a substantial risk of infection.
Currently
approved therapy for HCV includes recombinant interferons and ribavirin,
but some patients can experience unpleasant side effects, not all patients
are good candidates for the treatments, and only a minority of patients
receiving them experience sustained remission of the disease.
Led
by Jeffrey Albrecht, MD, CAAMR researchers are conducting a randomized,
placebo-controlled preliminary human trial of a botanical compound called
3AR for the treatment of HCV symptoms. Researchers monitor participants'
quality of life, HCV symptomology, and their blood chemistry for changes
in liver function and viral load.
Classified
as an Investigational New Drug by the Food and Drug Administration, 3AR
is formulated with bupleurum and 9 other traditional Chinese medicinal
herb extracts chosen for their widespread use in treatment of hepatitis
and liver disorders and their reported mutual amplification, immune system
fortification, lack of toxicity, and circulation-improving properties.
In
Asia, herbal remedies have been the mainstay of treatment for liver-related
illnesses for centuries, with formulations appearing as far back as 205
AD. The experience of Uli Beyendorff, Dipl. Ac., C.H., at the Hennepin
Faculty Associates Alternative Medicine Clinic suggests 3AR may relieve
HCV symptoms and bring about some improvements in laboratory measures
of liver function. No serious side effects for any of the herbs in 3AR
have been noted based on research or clinical observations.
Plant
Derivatives for the Treatment of Alcohol Abuse.
Dr.
Milton Bullock will lead CAAMR's preliminary human trial of a compound
of plant extracts used historically in Chinese herbal medicine to treat
alcohol intoxication. Pre-clinical trials have established a dose dependent
reduction in alcohol consumption with no noted harmful side effects. Toxicity
studies in 1999 confirmed the formula's safety, and human trials are set
to begin in May 2000.
The preliminary
human trial is designed to:
- Determine
the effects of a placebo compared with the experimental compound in
terms of alcohol use, craving, health status, psychological status,
and treatment drop-out rates
- Identify
the relationship of non-specific and placebo factors to treatment outcome
- Describe
any effects on treatment outcome associated with gender
- Assess
patient compliance with the treatment regimen
- Determine
treatment outcome effect sizes and relapse rates associated with a placebo
and the experimental compound
- Note
any possible adverse effects of the treatments
The compound
is comprised of six Chinese herb extracts, the major ingredient of which
is pueraria lobata, or kudzu. (This is the vine whose uncontrollable growth,
following its introduction from Asia in 1876, has made it a legend in
the southeastern U.S.) Used to treat a variety of afflictions, an extract
of the kudzu root was acknowledged by practitioners of Chinese medicine
as a treatment for alcoholism more than 400 years ago, and it may have
been used to treat inebriation as early as 600 AD.
Electroacupuncture
Effects on Mechanisms Mediating Opiate Withdrawal.
Electroacupuncture
(EA), the augmentation of acupuncture with low-level electrical current,
has been used since the 1970s to treat the effects of opiate withdrawal.
Its efficacy, however, appears to vary between individuals and may be
marginal at best. The goal of a study mounted by James Valentine, Ph.D.
at CAAMR is to determine whether EA will alleviate the physical and motivational
effects of opiate withdrawal by affecting the brain mechanisms which have
been demonstrated to mediate withdrawal.
Experiments
have shown that naloxone, an opioid antagonist (which preemptively binds
with opioid receptor sites in the brain, blocking opioids from binding
to them), causes the swift onset of physical withdrawal symptoms when
administered in cases of active opiate addiction. In preclinical studies,
electroacupuncture, given before naloxone, has been associated with a
lower incidence of naloxone-induced physical withdrawal symptoms. The
project focuses on the following processes:
- Determining
the effect of EA treatment on opioid withdrawal symptoms and regional
brain activity. Studies have already helped identify which parts of
the brain respond to a medication commonly used to treat opiate withdrawal.
Researchers will test whether EA can prevent naloxone's activation of
brain regions that are associated with physical withdrawal symptoms.
- Comparing
specific brain locations (since EA may only affect some of the brain
structures involved in withdrawal) in order to rate each for the level
of withdrawal-related activity suppression associated with EA and sham
(false) EA.
- Determining
the effects of EA treatment on extracellular levels of neurotransmitters
in specific brain regions during opiate withdrawal. Studies have shown
that norepinephrine, dopamine and glutamate activities increase during
opiate withdrawal. It is known that drugs which block the activation
of these systems can reduce or prevent many withdrawal symptoms.
These three
initial studies will serve practitioners of both CAM and conventional
medicines, as well as patient populations, by subjecting promising CAM
treatment methods to rigorous scientific scrutiny. Although they are widely
sold and consumed, most plant extracts and compounds are not regulated
as drugs and are therefore less likely to be thoroughly investigated before
reaching the marketplace. The electroacupuncture project concretely approaches
a treatment whose mechanisms of action have yet to be fully demonstrated
and explained. For researchers at the CAAMR, the possibility of finding
effective new treatments for addictions is balanced by the need to document
those that are ineffective or potentially unsafe.
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