Articles
Acupuncture
What
is it? One of the oldest healing methods known, acupuncture is
based on the ancient Chinese belief that there are patterns of
energy (Qi) flowing throughout the body. Disease occurs if this
flow is blocked or disrupted. When thin needles are inserted into
the body at specific points, each linked to a particular organ
network, the energy flow supposedly can be restored.
Is
it effective? A 1997 National Institute of Health (NIH) consensus
development conference reported evidence that acupuncture is effective
for nausea after surgery or chemotherapy and probably during pregnancy.
It may also be helpful as an adjunct treatment for other conditions,
including headaches, asthma, stroke rehabilitation, and fibromyalgia.
A
comparison of detoxification programs in Boston found that people
who chose to enter outpatient acupuncture programs were less likely
to re-enter detox than those in residential programs. In a trial
of acupuncture as a treatment for chronic pain completed by Finland’s
National Health Service, 65 percent of patients either stopped
taking painkilling drugs or reduced their dosage.
Western
doctors as a rule dismiss the concept of Qi. Instead, researchers
surmise the needles prompt the release of natural pain killers
called endorphins, or hormones that stimulate the immune system.
Today many doctors regard acupuncture as practical in mainstream.
The NIH panel declared, "There’s sufficient evidence
in acupuncture’s value to expand its use into conventional
medicine."
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Translated
from Korean News, Atlanta - July 1999
Patient**
recovers right before surgical intervention by
the use of the constitutional 5-element acupuncture technique.
Staff doctors amazed by superiority of Eastern medicine over modern
medicine.
Knowledge
of the superiority of Eastern medicine spreads throughout the
Korean community as a patient suffering from acute gastrointestinal
infection is cured right before going into the operating room.
On
July 22nd, Eastern therapy doctor, Sung Ho Kim, surprised staff
doctors by the use of the constitutional 5 element technique on
a patient (age 23) who showed vast improvement in his condition
overnight. The patient was scheduled to have surgery at G.B. hospital
that day. This treatment method saved the patient from a lifetime
of handicap had surgery been performed.
The
patient was admitted through the emergency room due to prolonged
severe diarrhea along with a temperature of over 100 degrees which
he suffered from for 16 days due to the infection. Consequential
examinations showed that the patient had approximately 10 inches
of an internal infected area from his rectum to his intestines.
He showed some improvement after the administration of antibiotics.
However, after eating Jell-O, the infection spread throughout
the intestines resulting in intense pain. The hospital decided
that surgery would be performed if the patient's condition did
not improve after 48 hours of treatment with antibiotics. After
the 48 hours, there was no improvement, the pain became even more
excruciating, and therefore, it was decided to operate.
The
patient's father remembered that Dr. Sung Ho Kim, whom he had
met while on vacation, had told him to contact him in the event
that the treatments at the hospital failed. His father requested
a 1-day postponement of surgery. The internist and the 2 surgical
specialists advised against the delay, citing that the intestines
could potentially burst during that time. Due to the severity
of the pain, even the patient insisted on immediate surgery. However,
the hospital had to concede to the wishes of the father and wrote
on the medical charts, "surgery postponed due to parental
intervention" with the contingency that surgery would be
allowed if there was no improvement in the patient's condition
after 24 hours.
At
approximately 1 p.m. that day, the patient fell comfortably asleep
after taking the first mixture of the herbal medicine prepared
by Dr. Kim. Around 6 p.m. he took another dose of the medicine
and then was given acupuncture therapy the next morning about
7 a.m.
After
this point, the patient's condition was so much improved that
the staff doctor examining him for surgical preparations expressed
amazement that Dr. Sung Ho Kim's Eastern medicine therapy had
resulted in incredible improvement overnight.
From
the 24th to the 30th, the patient took the herbal medicine 3 times
a day and had acupuncture two days from the start of therapy.
On the 29th, he was released from the hospital with just a few
warnings. At that time, Dr. Kim used a total of 4 needles on the
patient's wrist, ankle, knee and the ear area. The needles used
are very thin which are inserted less than a centimeter into the
skin and patients hardly feel a prick.
The
amazement among the doctors is understandable since the tiny needles
inserted into totally non-related areas resulted in a critically
ill patient to be able to forgo surgery altogether.
If
surgery had been performed, as recommended by the hospital doctors,
the patient's entire intestine would have been removed and then
reconnected directly to the rectum after the initial wound had
healed. This would have resulted in a dramatic reduction of the
functionality of the gastrointestinal tract; and the patient not
only would have been reduced to the inconvenience of constantly
go to the bathroom, but also would be in a lot of pain during
bowel movement.
Dr.
Sung Ho Kim explains that "modern medicine's method of treatment
is based on finding the problem area as determined by the specialist
and treating only the affected area. However, Eastern medicine
finds the source of the problem and treats the original root cause
of the sickness and that is the difference between Eastern and
Western medicine."
Dr.
Sung Ho Kim emphasizes the importance of wisely determining the
best treatment method between Eastern and Western medicine depending
on the patient's illness. "Those who ignore Eastern treatment
methods and listen only to the Western doctors will ultimately
compromise their health. On the other hand, Eastern medicine is
not a miracle cure for all physical problems and Dr. Kim himself
has experienced occasions when he referred his patients to other
hospitals. Therefore, a wise choice should be made in determining
the best treatment method on an individual case-by-case basis."
Dr. Kim also explains that "the physiology of the human body
can be thought of as a small-scale universe. Diagnosis and treatment
is performed as if making space travel by the use of the constitutional
5 element technique." Dr. Kim further delineates that "modern
medicine considers the Eastern method of treatment as non-scientific.
However, this is due to a lack of understanding by the modern
scientific community of the profound and spiritual aspect of Eastern
medicine."
He
explains that modern medicine considers all gastrointestinal infections
to be the same. However, Eastern medicine considers the relationship
of other surrounding organs, liver, etc. and acupuncture is effective
by creating balance and harmony between the person's entire physiology
and its relation to the particular organ.
Modern
medicine is effective during the acute or partial stage of the
illness, however, in the terminal stage of illness, Eastern medicine
can be more effective by treating the entire physiological system
in relation to each of the different areas of the body. This particular
instance is a good example of such a case.
Dr.
Sung Ho Kim has 36 years of experience in the art of Eastern medicine
and became widely known to the American community through a special
program on prime time Channel 2 WSB TV action news where Dr. Kim
was introduced. Dr. Kim's schedule is fully booked by the many
American patients who seek his expertise.
He
is especially known for his treatment of urinary incontinence
for female patients and prostate problems for male patients and
is thought to be the foremost acupuncture specialist in those
areas.
The
patient's father visited Dr. Kim's office after completion of
his son's treatment. The patient is not only well, but also recovering
at an incredible rate. The patient's father intended to bring
the patient to this meeting, but came alone since the patient
went swimming instead.
**Names
deleted from original article to preserve privacy of the patient
and his family
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Reprinted
from US NEWS & WORLD REPORT, May 13, 1996
NOD
TO AN ANCIENT ART
The
FDA has OK'd Acupuncture Needles - and They Could Help You
Western
medicine just leaned to the East. In a tentative bow to centuries
of Chinese teachings, the Food and Drug Administration has decreed
that acupuncture needles are as respectable a medical tool as
a syringe or a scalpel. The March ruling stopped short of suggesting
that acupuncture works for specific ailments; FDA officials said
they needed more proof. But that may come soon. As research proceeds
at many U.S. medical centers, the evidence is piling up that people
with a variety of problems - from asthma and arthritis to migraines
and strokes - can truly be helped by the ancient healing art.
For
now, patients who find acupuncture beneficial will be left to
wonder why. Most mainstream researchers in Western countries roll
their eyes at the traditional Chinese belief that manipulating
needles at certain points on the body stimulates the flow of Qi
("chee"), or natural healing energy. Many believe instead
that the answer lies in the placebo response. You expect to feel
better, so you do. But Bruce Pomeranz, a neurophysiologist at
the University of Toronto who has spent 20 years studying acupuncture,
is convinced he has found a rational explanation of the mechanism
at work (Page 80). "There is overwhelming evidence from animal
studies that acupuncture reduces pain by triggering the release
of endorphins [natural morphinelike chemicals] and other substances
by the nervous system, he says. According to Pameranz's "neural
theory," acupuncture also stimulates the nervous system to
release ACTH (for adrenocorticotropic hormone), a chemical that
aids in fighting inflammiation; prostaglandins, which are thought
to help wounds heal faster; and other substances that may promote
nerve regeneration.
No
side effects. Science or art, acupuncture relieved Clevelander
Michele Schmidt's pain. When migraines struck with a vengeance
early in her pregnancy, Schmidt, 30, couldn't take her usual medication
for fear of side effects. So she turned to acupuncturists at the
prestigious Cleveland Clinic. "During the third treatment,
I could actually feel the endorphins kicking in, bringing peace,"
she says. Schmidt's migraines are gone, but if they return she
plans to stick with acupuncture even after her child is born rather
than go back to her migraine medicine. Indeed, Austrian researchers
have observed dramatic improvement in chronic migraine sufferers
who have gone under the needle for regular preventive treatments.
Last fall, in the scholarly journal Headache, the researchers
noted that 18 of 26 patients reported a third fewer painful attacks
after needle treatments; for 15, the improvement last three years.
EAST MEETS WEST. University of Maryland medical students can add
acupuncture to their arsenal. Lixing Lao, an assistant professor,
shows how needles can help treat back pain.
Over 12 million Americans have turned to
acupuncture and many more may try —
especially if its leap toward the mainstream
inspires insurers to cover treatments.
It may
be the cocktail of pain-killing endorphins and anti-inflamatory
substances that explains why some patients with arthritis find
relief. In last June's issue of the journal Osteoarthritis and
Cartilage, doctors at the University of Maryland School of Medicine
reported that 12 patients with painful and inflamed osteoarthritic
knees improved after acupuncture; now, a larger study comparing
acupuncture with standard arthritis medications is underway. If
acupuncture does indeed combat inflammation, asthmatics, too,
may have good reason to seek the treatment. Linda Stalvey says
quarterly treatments have allowed her to cut down on her asthma
medication.
Weapon
against stroke? The research is still scanty, but many scientists
now think even stroke patients might benefit. So far, the only
hard evidence of nerve regeneration by acupuncture has been seen
in animals, but a recent study in Neurology showed provocative
results with people. Swedish researchers looked at 78 stroke patients
with paralysis, all of whom received physical therapy and half
of whom also received acupuncture treatments twice a week for
10 weeks. A year after their therapy ended, the acupuncture patients
scored significantly higher on tests measuring such things as
balance, mobility and quality of life.
More
than 12 million Americans have already turned to acupuncture,
and the FDA nod may entice many more to try it — particularly
if, as practitioners hope, its leap toward the mainstream inspires
insurers to cover treatments. In most states, people who go under
the needle are treated by a medical doctor; about half the states
allow non-M.D. acupuncturists to practice. Only six states mandate
that insurers cover acupuncture. And the beacons that the industry
typically follows — Medicare and Medicaid — have no
plans now to stop being stingy; the FDA's measured move wasn't
endorsement enough. Sometimes insurers will pay the bills if a
doctor deems treatments necessary. But it may take some needling.
by Doug Podolsky
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F.D.A.
RECLASSIFIES
ACUPUNCTURE NEEDLES
National
Acupuncture Foundation
P.O.
Box 2271, Gig Harbor, WA 98325-4271
EXECUTIVE
SUMMARY
On
March 29, 1996, the U.S. Food and Drug Administration (FDA) issued
Reclassification order, Docket No. 94P-0443, Acupuncture Needles
for the Practice of Acupuncture ("Order"). The FDA's
Order reclassifies acupuncture needles for the practice of acupuncture
and substantially equivalent devices into class II, under the
generic name: acupuncture needles.
The
FDA's Order responded to the National Acupuncture Foundation ("NAF"),
a not-for-profit 501(c)(3) organization conducting research and
education in the field of Acupuncture and Oriental Medicine, and
a coalition of organizations and individuals representing the
United States acupuncture community,who on November 3, 1994 petitioned
the FDA to have acupuncture needles reclassified from a class
III to a class II medical device.
The
FDA's Order stated that acupuncture needles intended for use in
the practice of acupuncture by qualified practitioners as determined
by the States could be safely reclassified from a class III medical
device ("investigational") to a class II medical device
("implementation of special controls required").
The
special controls required are compliance with 1) Labeling provisions
for single use only and a prescription statement (restriction
to use by or on order of qualified practitioners as determined
by the States); 2) device material biocompatibility, and 3) device
sterility.
Under
certain situations, before they can be legally marketed, acupuncture
needles must be the subject of a cleared premarket notification
[510(k)] submission to the FDA.
The
petitions, as originally submitted, included five separate 513
(f) Medical Device Reclassification Petitions for the reclassification
of acupuncture needles for five specific medical indications.
The
five medical indications included: Acute and Chronic Pain; Antiemesis;
Substance Abuse; Paralysis Due to Central Nervous System Damage;
and Pulmonary Disease.
The
FDA's Order reclassifies acupuncture needles for general use in
the practice of acupuncture; however, the Order does not reclassify
acupuncture needles for any of the petitioned medical indications,
and any labeling reference to a specific disease, condition, or
therapeutic benefit requires a cleared premarket notification
[510(k)] submission that includes valid scientific evidence in
the form of well-controlled prospective clinical studies.
In
petitioning to reclassify acupuncture needles from a class III
medical device to a class II medical device, petitioners presented
to the FDA a large body of scientific evidence demonstrating the
efficacy and safety of acupuncture. Reclassification of acupuncture
needles as a class II medical device will allow for a broader
and less restricted use of acupuncture needles. This action by
the National Acupuncture Foundation and its co-petitioners is
part of an ongoing effort by the acupuncture community to promote
the use of acupuncture, and to educate and inform the public on
the availability and benefits of acupuncture as a medical treatment.
END
NOTES:
1.
This Executive Summary is for general information purposes only,
and is not intended as a legal analysis or a legal opinion of
the FDA Order. If any individual or organization requires such
information regarding the FDA Order, they should obtain legal
counsel for a detailed review of their specific fact situation.
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NATIONAL
INSTITUTE OF HEALTH CONSENSUS STATEMENT
ACUPUNCTURE
November 3-5, 1997 Revised Draft 11/5/97
This statement will be published as:
Acupuncture. NIH Consensus Statement 1997 November
NIH
Consensus
Statement
1997 November 3-5; 15(5): in press. For making bibliographic reference
to consensus statement no. 107 in the electronic from displayed
here, it is recommended that the following format be used: NIH
Concensus Statement Online 1997 November 3-5 [cited year, month,
day]; 15(5): in press.
NIH
Consensus Statements are prepared by a non-advocate, non-Federal
panel of experts, based on (1) presentations by investigators
working in areas relevant to the consensus questions during a
2-day public session; (2) questions and statements from conference
attendees during open discussion periods that are part of the
public session; and (3) closed deliberations by the panel during
the remainder of the second day and morning of the third. This
statement is an independent report of the consensus panel and
is not a policy statement of the NIH of the Federal Government.
Contents
Introduction
1.
What is the efficacy of acupuncture, compared with placebo or
sham acupuncture, in the conditions for which sufficient data
are available to evaluate?
2.
What is the place of acupuncture in the treatment of various conditions
for which sufficient data are available, in comparison with or
in combination with other interventions (including no intervention)?
3.
What is known about the biological effects of acupuncture that
helps us understand how it works?
4.
What issues need to be addressed so that acupuncture may be appropriately
incorporated into today's health care system?
5.
What are the directions for future research?
Conclusions
and Recommendations
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Introduction
Acupuncture
is a component of the health care system of China that can be
traced back for at least 2,500 years. The general theory of acupuncture
is based on the premise that there are patterns of energy flow
(Qi) through the body that are essential for health. Disruptions
of this flow are believed to be responsible for disease. The acupuncturist
can correct imbalances of flow at identifiable points close to
the skin. The practice of acupuncture to treat identifiable pathophysiological
conditions in American medicine was rare until the visit of President
Nixon to China in 1972. Since that time, there has been an explosion
of interest in the United States and Europe in the application
of the technique of acupuncture to Western medicine.
Acupuncture
describes a family of procedures involving stimulation of anatomical
locations on the skin by a variety of techniques. The most studied
mechanism of stimulation of acupuncture points employs penetration
of the skin by thin, solid, metallic needles, which are manipulated
manually or by electrical stimulation. The majority of comments
in this report are based on data that came from such studies.
Stimulation of these areas by moxibustion, pressure, heat, and
lasers is used in acupuncture practice, but due to the paucity
of studies, these techniques are more difficult to evaluate. Thus,
there are a variety of approaches to diagnosis and treatment in
American acupuncture that incorporate medical traditions from
China, Japan, Korea, and other countries.
Acupuncture
has been used by millions of American patients and performed by
thousands of physicians, dentists, acupuncturists, and other practitioners
for relief or prevention of pain and for a variety of health conditions.
After reviewing the existing body of knowledge, the U.S. Food
and Drug Administration recently removed acupuncture needles from
the category of "experimental medical devices" and now
regulates them just as it does other devices, such as surgical
scalpels and hypodermic syringes, under good manufacturing practices
and single-use standards of sterility.
Over
the years, the National Institutes of Health (NIH) has funded
a variety of research projects on acupuncture, including studies
on the mechanisms by which acupuncture may have its effects, as
well as clinical trials and other studies. There is also a considerable
body of international literature on the risks and benefits of
acupuncture, and the World Health Organization lists a variety
of medical conditions that may benefit from the use of acupuncture
or moxibustion. Such applications include prevention and treatment
of nausea and vomiting; treatment of pain and addictions to alcohol,
tobacco, and other drugs; treatment of pulmonary problems such
as asthma and bronchitis; and rehabilitation from neurological
damage such as that caused by stroke.
To
address important issues regarding acupuncture, the NIH Office
of Alternative Medicine and the NIH Office of Medical Applications
of Research organized a 2 1/2 day conference to evaluate the scientific
and medical data on the uses, risks, and benefits of acupuncture
procedures for a variety of conditions. Cosponsors of the conference
were the National Cancer Institute, the National Heart, Lung,
and Blood Institute, the National Institute of Allergy and Infectious
Diseases, the National Institute of Arthritis and Musculoskeletal
and Skin Diseases, the National Institute of Dental Research,
the National Institute on Drug Abuse, and the Office of Research
on Women's Health of the NIH. The conference brought together
national and international experts in the fields of acupuncture,
pain, psychology, psychiatry, physical medicine and rehabilitation,
drug abuse, family practice, internal medicine, health policy,
epidemiology, statistics, physiology, and biophysics, as well
as representatives from the public.
After
1 1/2 days of available presentations and audience discussion,
an independent, non-Federal consensus panel weighed the scientific
evidence and wrote a draft statement that was presented to the
audience on the third day. The consensus statement addressed the
following key questions:
What
is the efficacy of acupuncture, compared with placebo or sham
acupuncture, in the conditions for which sufficient data are available
to evaluate?
What is the place of acupuncture in the treatment of various conditions
for which sufficient data are available, in comparison with or
in combination with other interventions (including no intervention)?
What is known about the biological effects of acupuncture that
helps us understand how it works?
What issues need to be addressed so that acupuncture may be appropriately
incorporated into today's health care system?
What are the directions for future research?
The primary sponsors of this meeting were the National Genome
Research Institute and the NIH Office of Medical Applications
of Research. The conference was cosponsored by the National Institute
of Diabetes and Digestive and Kidney Diseases; the National Heart,
Lung, and Blood Institute; The National Institute of Child Health
and Human Development; the NIH Office of Rare Diseases; the National
Institute of Mental Health; the National Institute of Nursing
Research; the NIH Office of Research on Women's Health; the Agency
for Health Care Policy and Research; and the Centers for Disease
Control and Prevention.
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___________________________________________________
1.
What is the efficacy of acupuncture, compared with placebo or
sham acupuncture,
in the conditions for which sufficient data are available to evaluate?
Acupuncture
is a complex intervention that may vary for different patients
with similar chief complaints. The number and length of treatments
and the specific points used may vary among individuals and during
the course of treatment. Given this reality, it is perhaps encouraging
that there exist a number of studies of sufficient quality to
assess the efficacy of acupuncture for certain conditions.
According
to contemporary research standards, there is a paucity of high-quality
research assessing the efficacy of acupuncture compared with placebo
or sham acupuncture. The vast majority of papers studying acupuncture
in the biomedical literature consist of case reports, case series,
or intervention studies with designs inadequate to assess efficacy.
This
discussion of efficacy refers to needle acupuncture (manual or
electroacupuncture) because the published research is primarily
on needle acupuncture and often does not encompass the full breadth
of acupuncture techniques and practices. The controlled trials
usually have only involved adults and did not involve long-term
(i.e., years) acupuncture treatment.
Efficacy
of a treatment assesses the differential effect of a treatment
when compared with placebo of another treatment modality using
a double-blind controlled trial and a rigidly defined protocol.
Papers should describe enrollment procedures, eligibility criteria,
description of the clinical characteristics of the subjects, methods
for diagnosis, and a description of the protocol (i.e., randomization
method, specific definition of treatment, and control conditions,
including length of treatment, and number of acupuncture sessions).
Optimal trials should also use standardized outcomes and appropriate
statistical analysis. This assessment of efficacy focuses on high-quality
trials comparing acupuncture with sham acupuncture or placebo.
Response
Rate
As
with other interventions, some individuals are poor responders
to specific acupuncture protocols. Both animal and human laboratory
and clinical experience suggest that the majority of subjects
respond to acupuncture, with a minority not responding. Some of
the clinical research outcomes, however, suggest that a larger
percentage may not respond. The reason for this paradox is unclear
and may reflect the current state of the research.
Efficacy
for Specific Disorders
There
is clear evidence that needle acupuncture is efficacious for adult
post-operative and chemotherapy nausea and vomiting and probably
for the nausea of pregnancy.
Much
of the research is on various pain problems. There is evidence
of efficacy for postoperative dental pain. There are reasonable
studies (although sometimes only single studies) showing relief
of pain with acupuncture on diverse pain conditions such as menstrual
cramps, tennis elbow, and fibromyalgia. This suggests that acupuncture
may have a more general effect on pain. However, there are also
studies that do not find efficacy for acupuncture in pain.
There
is evidence that acupuncture does not demonstrate efficacy for
cessation of smoking and may not be efficacious for some other
conditions. While many other conditions have received some attention
in the literature and, in fact, the research suggests some exciting
potential areas for the use of acupuncture, the quality or quantity
of the research evidence is not sufficient to provide firm evidence
of efficacy at this time.
Sham
Acupuncture
A
commonly used control group is sham acupuncture, using techniques
that are not intended to stimulate known acupuncture points. However,
there is disagreement on correct needle placement. Also, particularly
in the studies on pain, sham acupuncture often seems to have either
intermediate effects between the placebo and Oreal' acupuncture
points or effects similar to those of the Oreal acupuncture points.
Placement of a needle in any position elicits a biological response
that complicates the interpretation of studies involving sham
acupuncture. Thus, there is substantial controversy over the use
of sham acupuncture as control groups. This may be less of a problem
in studies not involving pain.
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2.
What is the place of acupuncture in the treatment of various conditions
for which sufficient data are available, in comparison with or
in combination with other interventions (including no intervention)?
Assessing
the usefulness of a medical intervention in practice differs from
assessing formal efficacy. In conventional practice, clinicians
make decisions based on the characteristics of the patient, clinical
experience, potential for harm, and information from colleagues
and the medical literature. In addition, when more than one treatment
is possible, the clinician may make the choice taking into account
the patient's preferences. While it is often thought that there
is substantial research evidence to support conventional medical
practices; this is frequently not that case.
This
does not mean that these treatments are ineffective. The data
in support of acupuncture are as strong as those for many accepted
Western medical therapies. One of the advantages of acupuncture
is that the incidence of adverse effects is substantially lower
than that of many drugs or other accepted medical procedures used
for the same conditions. As an example, musculoskeletal conditions,
such as fibromyalgia, myofascial pain, and "tennis elbow,"
or epicondylitis, are conditions for which acupuncture may be
beneficial. These painful conditions are often treated with, among
other things, anti-inflammatory medications (aspirin, ibuprofen,
etc.) or with steroid injections. Both medical interventions have
a potential for deleterious side effects, but are still widely
used, and are considered acceptable treatment. The evidence supporting
these therapies is no better than that for acupuncture.
In
addition, ample clinical experience, supported by some research
data, suggests that acupuncture may be a reasonable option for
a number of clinical conditions. Examples are postoperative pain
and myofascial and low back pain. Examples of disorders for which
the research evidence is less convincing but for which there are
some positive clinical reports include addiction, stroke rehabilitation,
carpal tunnel syndrome, osteoarthritis, and headache. Acupuncture
treatment for many conditions such as asthma, addiction, or smoking
cessation should be part of a comprehensive management program.
Many
other conditions have been treated by acupuncture; the World Health
Organization, for example, has listed more than 40 problems for
which the technique may be indicated.
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3.
What is known about the biological effects of acupuncture
that helps us understand how it works?
Many
studies in animals and humans have demonstrated that acupuncture
can cause multiple biological responses. These responses can occur
locally, i.e., at or close to the site of application,or at a
distance, mediated mainly by sensory neurons to many structures
within the central nervous system. This can lead to activation
of pathways affecting various physiological systems in the brain
as well as in the periphery. A focus of attention has been the
role of endogenous opioids in acupuncture analgesia. Considerable
evidence supports the claim that opioid peptides are released
during acupuncture and that the analgesic effects of acupuncture
are at least partially explained by their actions. That opioid
antagonists such as naloxone reverse the analgesic effects of
acupuncture further strengthens this hypothesis. Stimulation by
acupuncture may also activate the hypothalamus and the pituitary
gland, resulting in a broad spectrum of systemic effects. Alteration
in the secretion of neurotransmitters and neurohormones and changes
in the regulation of blood flow, both centrally and peripherally,
have been documented. There is also evidence that there are alterations
in immune functions produced by acupuncture. Which of these and
other physiological changes mediate clinical effects is at present
unclear.
Despite
considerable efforts to understand the anatomy and physiology
of the "acupuncture points," the definition and characterization
of these points remains controversial. Even more elusive is the
scientific basis of some of the key traditional Eastern medical
concepts such as the circulation of Qi, the meridian system, and
the five phases theory, which are difficult to reconcile with
contemporary biomedical information but continue to play an important
role in the evaluation of patients and the formulation of treatment
in acupuncture.
Some
of the biological effects of acupuncture have also been observed
when "sham" acupuncture points are stimulated, highlighting
the importance of defining appropriate control groups in assessing
biological changes purported to be due to acupuncture. Such findings
raise questions regarding the specificity of these biological
changes. In addition, similar biological alterations including
the release of endogenous opioids and changes in blood pressure
have been observed after painful stimuli, vigorous exercise, and/or
relaxation training; it is at present unclear to what extent acupuncture
shares similar biological mechanisms.
It
should be noted also that for any therapeutic intervention, including
acupuncture, the so-called "non-specific" effects account
for a substantial proportion of its effectiveness, and thus should
not be casually discounted. Many factors may profoundly determine
therapeutic outcome including the quality of the relationship
between the clinician and the patient, the degree of trust, the
expectations of the patient, the compatibility of the backgrounds
and belief systems of the clinician and the patient, as well as
a myriad of factors that together define the therapeutic milieu.
Although
much remains unknown regarding the mechanism(s) that might mediate
the therapeutic effect of acupuncture, the panel is encouraged
that a number of significant acupuncture-related biological changes
can be identified and carefully delineated. Further research in
this direction not only is important for elucidating the phenomena
associated with acupuncture, but also has the potential for exploring
new pathways in human physiology not previously examined in a
systematic manner.
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4.
What issues need to be addressed so that acupuncture may be appropriately
incorporated into today's health care system?
The
integration of acupuncture into today's health care system will
be facilitated by a better understanding among providers of the
language and practices of both the Eastern and Western health
care communities. Acupuncture focuses on a holistic, energy-based
approach to the patient rather than a disease-oriented diagnostic
and treatment model.
An
important factor for the integration of acupuncture into the health
care system is the training and credentialing of acupuncture practitioners
by the appropriate state agencies. This is necessary to allow
the public and other health practitioners to identify qualified
acupuncture practitioners. The acupuncture educational community
has made substantial progress in this area and is encouraged to
continue along this path. Educational standards have been established
for training of physician and non-physician acupuncturists. Many
acupuncture educational programs are accredited by an agency that
is recognized by the U.S. Department of Education. A national
credentialing agency exists that is recognized by some of the
major professional acupuncture organizations and provides examinations
for entry-level competency in the field.
A
majority of States provide licensure or registration for acupuncture
practitioners. Because some acupuncture practitioners have limited
English proficiency, credentialing and licensing examinations
should be provided in languages other than English where necessary.
There is variation in the titles that are conferred through these
processes, and the requirements to obtain licensure vary widely.
The scope of practice allowed under these State requirements varies
as well. While States have the individual prerogative to set standards
for licensing professions, harmonization in these areas will provide
greater confidence in the qualifications of acupuncture practitioners.
For example, not all States recognize the same credentialing examination,
thus making reciprocity difficult.
The
occurrence of adverse events in the practice of acupuncture has
been documented to be extremely low. However, these events have
occurred in rare occasions, some of which are life threatening
(e.g., pneumothorax). Therefore, appropriate safeguards for the
protection of patients and consumers need to be in place. Patients
should be fully informed of their treatment options, expected
prognosis, relative risk, and safety practices to minimize these
risks prior to their receipt of acupuncture. this information
must be provided in a manner that is linguistically and culturally
appropriate to the patient. Use of acupuncture needles should
always follow FDA regulations, including use of sterile, single-use
needles. It is noted that these practices are already being done
by many acupuncture practitioners; however, these practices should
be uniform. Recourse for patient grievance and professional censure
are provided through credentialing and licensing procedures and
are available through appropriate State jurisdictions.
It
has been reported that more than 1 million Americans currently
receive acupuncture each year. Continued access to qualified acupuncture
professionals for appropriate conditions should be ensured. Because
many individuals seek health care treatment from both acupuncturists
and physicians, communication between these providers should be
strengthened and improved. If a patient is under the care of an
acupuncturist and a physician, both practitioners should be informed.
Care should be taken so that important medical problems are not
overlooked. Patients and providers have a responsibility to facilitate
this communication.
There
is evidence that some patients have limited access to acupuncture
services because of inability to pay. Insurance companies can
decrease or remove financial barriers to access depending on their
willingness to provide coverage for appropriate acupuncture services.
An increasing number of insurance companies are either considering
this possibility or now provide coverage for acupuncture services.
Where there are State health insurance plans, and for populations
served by Medicare and Medicaid, expansion of coverage to include
appropriate acupuncture services would also help remove financial
barriers to access.
As
acupuncture is incorporated into today's health care system, and
further research clarifies the role of acupuncture for various
health conditions, it is expected that dissemination of this information
to health care practitioners, insurance providers, policymakers,
and the general public will lead to more informed decisions in
regard to the appropriate use of acupuncture.
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5.
What are the directions for future research?
The
incorporation of any new clinical intervention into accepted practice
faces more scrutiny now than ever before. The demands of evidence-based
medicine, outcomes research, managed care systems of health care
delivery, and a plethora of therapeutic choices makes the acceptance
of new treatments an arduous process. The difficulties are accentuated
when the treatment is based on theories unfamiliar to Western
medicine and its practitioners. It is important, therefore, that
the evaluation of acupuncture for the treatment of specific conditions
be carried out carefully, using designs which can withstand rigorous
scrutiny. In order to further the evaluation of the role of acupuncture
in the management of various conditions, the following general
areas for future research are suggested.
What
are the demographics and patterns of use of acupuncture in the
U.S. and other countries?
There
is currently limited information on basic questions such as who
uses acupuncture, for what indications is acupuncture most commonly
sought, what variations in experience and techniques used exist
among acupuncture practitioners, and whether there are differences
in these patterns by geography or ethnic group. Descriptive epidemiologic
studies can provide insight into these and other questions. This
information can in turn be used to guide future research and to
identify areas of greatest public health concern.
Can
the efficacy of acupuncture for various conditions for which it
is used or for which it shows promise be demonstrated?
Relatively
few high-quality, randomized, controlled trials have ben published
on the effects of acupuncture. Such studies should be designed
in a rigorous manner to allow evaluation of the effectiveness
of acupuncture. Such studies should include experienced acupuncture
practitioners in order to design and deliver appropriate interventions.
Emphasis should be placed on studies that examine acupuncture
as used in clinical practice, and that respect the theoretical
basis for acupuncture therapy.
Although
randomized controlled trails provide a strong basis for inferring
causality, other study designs such as used in clinical epidemiology
or outcomes research can also provide important insights regarding
in the usefulness of acupuncture for various conditions. There
have been few such studies in the acupuncture literature.
Do
different theoretical bases for acupuncture result in different
treatment outcomes?
Competing
theoretical orientations (e.g., Chinese, Japanese, French) currently
exist that might predict divergent therapeutic approaches (e.g.,
the use of different acupuncture points). Research projects should
be designed to assess the relative merit of these divergent approaches,
as well to compare these systems with treatment programs using
fixed acupuncture points.
In
order to fully access the efficacy of acupuncture, studies should
be designed to examine not only fixed acupuncture points, but
also the Eastern medical systems that provide the foundation for
acupuncture therapy, including the choice of points. In addition
to assessing the effect of acupuncture in context, this would
also provide the opportunity to determine if Eastern medical theories
predict more effective acupuncture points, as well as to examine
the relative utility of competing systems (e.g., Chinese vs. Japanese
vs. French) for such purposes.
What
areas of public policy research can provide guidance for the integration
of acupuncture into today's health care system?
The
incorporation of acupuncture as a treatment raises numerous questions
of public policy. These include issues of access, cost-effectiveness,
reimbursement by state, federal, and private payors, and training,
licensure, and accreditation. These public policy issues must
be founded on quality epidemiologic and demographic data and effectiveness
research.
Can
further insight into the biological basis for acupuncture be gained?
Mechanisms
which provide a Western scientific explanation for some of the
effects of acupuncture are beginning to emerge. This is encouraging,
and may provide novel insights into neural, endocrine and other
physiological processes. Research should be supported to provide
a better understanding of the mechanisms involved, and such research
may lead to improvements in treatment.
Does
an organized energetic system exist in the human body that has
clinical applications?
Although
biochemical and physiologic studies have provided insight into
some of the biologic effects of acupuncture, acupuncture practice
is based on a very different model of energy balance. This theory
may provide new insights to medical research that may further
elucidate the basis for acupuncture.
How
do the approaches and answers to these questions differ among
populations that have used acupuncture as a part of its healing
tradition for centuries, compared to populations that have only
recently begun to incorporate acupuncture into health care?
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Conclusion
and Recommendations
Acupuncture
as a therapeutic intervention is widely practiced in the United
States. There have been many studies of its potential usefulness.
However, many of these studies provide equivocal results because
of design, sample size, and other factors. The issue is further
complicated by inherent difficulties in the use of appropriate
controls, such as placebo and sham acupuncture groups.
However,
promising results have emerged, for example, efficacy of acupuncture
in adult post-operative and chemotherapy nausea and vomiting and
in post-operative dental pain. There are other situations such
as addiction, stroke rehabilitation, headache, menstrual cramps,
tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low
back pain, carpal tunnel syndrome, and asthma where acupuncture
may be useful as an adjunct treatment or an acceptable alternative
of be included in a comprehensive management program. Further
research is likely to uncover additional areas where acupuncture
interventions will be useful.
Findings
from basic research have begun to elucidate the mechanisms of
action of acupuncture, including the release of opioids and other
peptides in the central nervous system and the periphery and changes
in neuroendocrine function. Although much needs to be accomplished,
the emergence of plausible mechanisms for the therapeutic effects
of acupuncture is encouraging.
The
introduction of acupuncture into the choice of treatment modalities
that are readily available to the public is in its early stages.
Issues of training, licensure, and reimbursement remain to be
clarified. There is sufficient evidence, however, of acupuncture's
value to expand its use into conventional medicine and to encourage
further studies of its physiology and clinical value.
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Consensus
Development Panel
David J. Ramsay, D.M., D. Phil.
Panel and Conference Chairperson
President
University of Maryland, Baltimo
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