NIH Consensus on Acupuncture
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. Acupuncture may 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.
There are a variety of approaches to diagnosis and treatment
in American acupuncture that incorporate medical traditions
from China, Japan, Korea, and other countries. 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 because of the paucity
of studies, these techniques are more difficult to evaluate.
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 produce 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:
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 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
can be appropriately incorporated into today's health care system?
What are the directions for future research?
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 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 involved only 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 or 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 analyses.
This assessment of efficacy focuses on high-quality trials comparing
acupuncture with sham acupuncture or placebo.
Response Rate.
As with other types of 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 postoperative 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.
Although 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 'real' acupuncture points or effects similar to
those of the 'real' 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
in control groups. This may be less of a problem in studies
not involving pain.
2. What Is the Place
of Acupuncture in the Treatment of Various Conditions for Which
Sufficient Data Are Available, in Comparison 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 the 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 treatments. 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 trials include addiction, stroke
rehabilitation, carpal tunnel syndrome, osteoarthritis, and
headache. Acupuncture treatment for many conditions such as
asthma or addiction 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 for which the technique may be indicated.
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 of 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 remain 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 other related theories, 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.
4. What Issues Need
To Be Addressed So That Acupuncture Can 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 for nonphysician
practitioners and provides examinations for entry-level competency
in the field. A nationally recognized examination for physician
acupuncturists has been established.
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, consistency
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 on 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 before 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 to ensure
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 or 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.
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 make 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 that 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 United States 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 are there 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
been 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 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 trials provide a strong basis
for inferring causality, other study designs such as those used
in clinical epidemiology or outcomes research can also provide
important insights regarding 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 (i.e., the use of different acupuncture points).
Research projects should be designed to assess the relative
merit of these divergent approaches and to compare these systems
with treatment programs using fixed acupuncture points.
In order to fully assess 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 whether
Eastern medical theories predict more effective acupuncture
points.
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
payers, 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 that 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 That Has Clinical Applications
Exist in the Human Body?
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 might or might not provide new insights to medical
research, but it deserves further attention because of its potential
for elucidating the basis for acupuncture.
How Do the Approaches and Answers to These Questions Differ
Among Populations That Have Used Acupuncture as a Part of Their
Healing Tradition for Centuries, Compared With Populations That
Have Only Recently Begun to Incorporate Acupuncture Into Health
Care?
Conclusions
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 postoperative 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
for which acupuncture may be useful as an adjunct treatment
or an acceptable alternative or 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 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 its potential
value to conventional medicine to encourage further studies.
There is sufficient evidence of acupuncture's value to expand
its use into conventional medicine and to encourage further
studies of its physiology and clinical value.
