NIH Consensus Statement: Volume 15, Number 5 November 3-5, 1997
NIH Consensus Statement: Volume 15, Number 5 November 3-5, 1997
NIH Consensus Statement: Volume 15, Number 5 November 3-5, 1997
Acupuncture
NATIONAL INSTITUTES OF HEALTH
Office of the Director
Reference Information
For making bibliographic reference to this consensus state
ment, it is recommended that the following format be used,
with or without source abbreviations, but without authorship
attribution:
Acupuncture. NIH Consens Statement 1997 Nov 3-5; 15(5): 1-34.
Acupuncture
Disclosure Statement
All of the panelists who participated in this conference and
contributed to the writing of this consensus statement were
identified as having no financial or scientific conflict of interest,
and all signed conflict of interest forms attesting to this fact.
Unlike the expert speakers who present scientific data at the
conference, the individuals invited to participate on NIH
consensus panels are selected specifically because they
are not professionally identified with advocacy positions
with respect to the conference topic or with research that
could be used to answer any of the conference questions.
Abstract
Objective
The objective of this NIH Consensus Statement is to inform
the biomedical research and clinical practice communities of
the results of the NIH Consensus Development Conference
on Acupuncture. The statement provides state-of-the-art
information regarding the appropriate use of acupuncture,
and presents the conclusions and recommendations of the
consensus panel regarding these issues. In addition, the
statement identifies those areas of study that deserve further
investigation. Upon completion, the reader should possess
a clear working clinical knowledge of the state-of-the-art
regarding this topic. The target audience of physicians
for this statement includes, but is not limited to, family
practitioners, medical acupuncturists, psychiatrists, and
specialists in pain medicine.
Participants
A non-Federal, nonadvocate, 12-member panel represent
ing the fields of acupuncture, pain, psychology, psychiatry,
physical medicine and rehabilitation, drug abuse, family
practice, internal medicine, health policy, epidemiology,
statistics, physiology, biophysics, and the public. In addition,
25 experts from these same fields presented data to the
panel and a conference audience of 1,200.
Evidence
The literature was searched through Medline, and an exten
sive bibliography of references was provided to the panel and
the conference audience. Experts prepared abstracts with
relevant citations from the literature. Scientific evidence was
given precedence over clinical anecdotal experience.
Consensus Process
The panel, answering predefined questions, developed their
conclusions based on the scientific evidence presented in
open forum and the scientific literature. The panel composed
a draft statement, which was read in its entirety and circulated
to the experts and the audience for comment. Thereafter, the
panel resolved conflicting recommendations and released
a revised statement at the end of the conference. The panel
finalized the revisions within a few weeks after the conference.
The draft statement was made available on the World Wide
Web immediately following its release at the conference and
was updated with the panels final revisions.
Conclusions
Acupuncture as a therapeutic intervention is widely practiced
in the United States. While there have been many studies of its
potential usefulness, 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 placebos and sham acupunc
ture groups. However, promising results have emerged, for
example, showing efficacy of acupuncture in adult postopera
tive and chemotherapy nausea and vomiting and in postopera
tive 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, in which acupunc
ture 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.
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. 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 diag
nosis and treatment in American acupuncture that incor
porate medical traditions from China, Japan, Korea, and
other countries. The most studied mechanism of stimula
tion of acupuncture points employs penetration of the skin
by thin, solid, metallic needles, which are manipulated manu
ally 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 acupunc
ture needles from the category of experimental medical
devices and now regulates them just as it does other
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 sug
gest 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.
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 acu
puncture 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 interpre
tation of studies involving sham acupuncture. Thus, there
is substantial controversy over the use of sham acupunc
ture in control groups. This may be less of a problem in
studies not involving pain.
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.
10
11
12
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14
15
16
17
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Conclusions
Acupuncture as a therapeutic intervention is widely prac
ticed 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 chemo
therapy 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 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 treat
ment 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 acupunctures value to expand
its use into conventional medicine and to encourage further
studies of its physiology and clinical value.
19
Consensus
Development Panel
David J. Ramsay, D.M., D.Phil.
Panel and Conference
Chairperson
President
University of Maryland, Baltimore
Baltimore, Maryland
Marjorie A. Bowman, M.D., M.P.A.
Professor and Chair
Department of Family Practice
and Community Medicine
University of Pennsylvania
Health System
Philadelphia, Pennsylvania
Philip E. Greenman, D.O., F.A.A.O.
Associate Dean
College of Osteopathic Medicine
Michigan State University
East Lansing, Michigan
Stephen P. Jiang, A.C.S.W.
Executive Director
Association of Asian Pacific
Community Health
Organizations
Oakland, California
20
Speakers
Abass Alavi, M.D.
The Role of Physiologic
Imaging in the Investigation
of the Effects of Pain and
Acupuncture on Regional
Cerebral Function
Professor of Radiology
Chief, Division of Nuclear
Medicine
Hospital of the University
of Pennsylvania
Philadelphia, Pennsylvania
Brian M. Berman, M.D.
Overview of Clinical Trials
on Acupuncture for Pain
Associate Professor of
Family Medicine
Director
Center for Complementary
Medicine
University of Maryland
School of Medicine
Baltimore, Maryland
Stephen Birch, Lic.Ac., Ph.D.
Overview of the Efficacy
of Acupuncture in the
Treatment of Headache
and Face and Neck Pain
Anglo-Dutch Institute for
Oriental Medicine
The Netherlands
Hannah V. Bradford, M.Ac.
Late-Breaking Data and Other
News From the Clinical
Research Symposium (CRS)
on Acupuncture at NIH
Acupuncturist
Society for Acupuncture
Research
Bethesda, Maryland
21
22
23
Planning
Committee
Alan I. Trachtenberg, M.D., M.P.H.
Planning Committee Chairperson
Medical Officer
Office of Science Policy and
Communication
National Institute on Drug Abuse
National Institutes of Health
Rockville, Maryland
Brian M. Berman, M.D.
Associate Professor of
Family Medicine
Director
Center for Complementary
Medicine
University of Maryland
School of Medicine
Baltimore, Maryland
Hannah V. Bradford, M.Ac.
Acupuncturist
Society for Acupuncture
Research
Bethesda, Maryland
Elsa Bray
Program Analyst
Office of Medical Applications
of Research
National Institutes of Health
Bethesda, Maryland
Patricia Bryant, Ph.D.
Director
Behavior, Pain, Oral Function,
and Epidemiology Program
Division of Extramural Research
National Institute of Dental
Research
National Institutes of Health
Bethesda, Maryland
24
25
26
Lead
Organizations
Supporting
Organizations
27
Bibliography
The speakers listed above identified the following key references
in developing their presentations for the consensus conference.
A more complete bibliography prepared by the National Library
of Medicine at NIH, along with the references below, was provided
to the consensus panel for its consideration. The full NLM bibliography
is available at the following Web site: http://www.nlm.nih.gov/pubs/
cbm/acupuncture.html.
Addictions
Bullock MD, Umen AJ, Culliton PD, Olander RT. Acupuncture
treatment of alcoholic recidivism: a pilot study. Clin Exp Res
1987;11:292-5.
Bullock ML, Culliton PD, Olander RT. Controlled trial of acupuncture
for severe recidivist alcoholism. Lancet 1989;1:1435-9.
Clavel-Chapelon F, Paoletti C, Banhamou S. Smoking cessation
rates 4 years after treatment by nicotine gum and acupuncture.
Prev Med 1997 Jan-Feb;26(1):25-8.
He D, Berg JE, Hostmark AT. Effects of acupuncture on smoking
cessation or reduction for motivated smokers. Prev Med 1997;
26(2):208-14.
Konefal J, Duncan R, Clemence C. Comparison of three levels of
auricular acupuncture in an outpatient substance abuse treatment
program. Altern Med J 1995;2(5):8-17.
Margolin A, Avants SK, Chang P, Kosten TR. Acupuncture for the
treatment of cocaine dependence in methadone-maintained patients.
Am J Addict 1993;2:194-201.
White AR, Rampes H. Acupuncture in smoking cessation. In: Cochrane
Database of Systematic Reviews [database on CDROM]. Oxford:
Update Software; 1997 [updated 1996 Nov 24]. [9p.]. (The Cochrane
Library; 1997 no. 2).
Gastroenterology
Cahn AM, Carayon P, Hill C, Flamant R. Acupuncture in gastroscopy.
Lancet 1978;1(8057):182-3.
Chang FY, Chey WY, Ouyang A. Effect of transcutaneous nerve
stimulation on esophageal function in normal subjectsevidence
for a somatovisceral reflex. Amer J Chinese Med 1996;24(2):185-92.
Jin HO, Zhou L, Lee KY, Chang TM, Chey WY. Inhibition of acid
secretion by electrical acupuncture is mediated via J-endorphin and
somatostatin. Am J Physiol 1996;271(34):G524-G530.
29
General Pain
Chen XH, Han JS. All three types of opioid receptors in the spinal
cord are important for 2/15 Hz electroacupuncture analgesia. Eur J
Pharmacol 1992;211:203-10.
Patel M, Gutzwiller F, et al. A meta-analysis of acupuncture for
chronic pain. Int J Epidemiol 1989;18:900-6.
Portnoy RK. Drug therapy for neuropathic pain. Drug Ther 1993;23:41-5.
Shlay JC et al. The efficacy of a standardized acupuncture regimen
compared to placebo as a treatment of pain caused by peripheral
neuropathy in HIV-infected patients. CPCRA protocol 022. 1994.
Tang NM, Dong HW, Wang XM, Tsui ZC, Han JS. Cholecystokinin
antisense RNA increases the analgesic effect induced by EA or low
dose morphine: conversion of low responder rats into high responders.
Pain 1997;71:71-80.
Ter Riet G, Kleijnen J, Knipschild P. Acupuncture and chronic pain:
a criteria based meta-analysis. J Clin Epidemiol 1990;43:1191-9.
Zhu CB, Li XY, Zhu YH, Xu SF. Binding sites of mu receptor increased
when acupuncture analgesia was enhanced by droperidol: an auto
radiographic study. Acta Pharmacologica Sinica 1995;16(4):289-384.
30
Immunology
Cheng XD, Wu GC, Jiang JW, Du LN, Cao XD. Dynamic observation
on regulation of spleen lymphocyte proliferation from the traumatized
rats in vitro of continued electroacupuncture. Chinese Journal of
Immunology 1997;13:68-70.
Du LN, Jiang JW, Wu GC, Cao XD. Effect of orphanin FQ on the
immune function of traumatic rats. Chinese Journal of Immunology.
In press.
ZhangY, Du LN, Wu GC, Cao XD. Electroacupuncture (EA) induced
attenuation of immunosuppression appearing after epidural or intra
thecal injection of morphine in patients and rats. Acupunct Electrother
Res Int J 1996; 21:177-86.
Miscellaneous
Medical Devices; Reclassification of acupuncture needles for the
practice of acupuncture. Federal Register 1996;61(236):64616-7.
NIH Technology Assessment Workshop on Alternative Medicine;
Acupuncture. J Alt Complement Med 1996; 2(1).
Bullock ML, Pheley AM, Kiresuk TJ, Lenz SK, Culliton PD. Character
istics and complaints of patients seeking therapy at a hospital-based
alternative medicine clinic. J Altern Compl Med 1997;3(1):31-7.
Cassidy C. A survey of six acupuncture clinics: demographic and
satisfaction data. Proceedings of the Third Symposium of the Society
for Acupuncture Research. Georgetown University Medical Center.
1995 September 16-17:1-27.
Diehl DL, Kaplan G, Coulter I, Glik D, Hurwitz EL. Use of acupuncture
by American physicians. J Altn Compl Med 1997;3(2):119-26.
31
Musculoskeletal
Naeser MA, Hahn KK, Lieberman B. Real vs sham laser acupuncture
and microamps TENS to treat carpal tunnel syndrome and worksite
wrist pain: pilot study. Lasers in Surgery and Medicine 1996;Suppl 8:7.
Neurology
Asagai Y, Kanai H, Miura Y, Ohshiro T. Application of low reactivelevel laser therapy (LLLT) in the functional training of cerebral palsy
patients. Laser Therapy 1994;6:195-202.
Han JS, Wang Q. Mobilization of specific neuropeptides by peripheral
stimulation of identified frequencies. News Physiol Sci 1992:176-80.
32
Han JS, Chen XH, Sun SL, Xu XJ, Yuan Y, Yan SC, et al. Effect
of low- and high-frequency TENS on met-enkephalin-Arg-Phe and
dynorphin A immunoreactivity in human lumbar CSF. Pain 1991;
47:295-8.
Johansson K, Lindgren I, Widner H, Wiklung I, Johansson BB.
Can sensory stimulation improve the functional outcome in stroke
patients? Neurology 1993;43:2189-92.
Naeser MA. Acupuncture in the treatment of paralysis due to central
nervous system damage. J Alt Comple Med 1996;2(1):211-48.
Naeser MA, Alexander MP, Stlassny-Eder D, Galler V, Bachman D.
Acupuncture in the treatment of paralysis in chronic and acute stroke
patients: improvement correlated with specific CT scan lesion sites.
Acupunct Electrother Res 1994;19:227-49.
Simpson DM, Wolfe DE. Neuromuscular complications of HIV infection
and its treatment. AIDS 1991;5:917-26.
Reproductive Medicine
Yang QY, Ping SM, Yu J. Central opioid and dopamine activities
in PCOS during induction of ovulation with electro-acupuncture.
J Reprod Med (in Chinese) 1992;1(1):6-19.
Yang SP, He LF, Yu J. Changes in densities of hypothalamic opioid
receptor during cupric acetate induced preovulatory LH surge in rabbit.
Acta Physiol Sinica (in Chinese) 1997;49(3):354-8.
Yang SP, Yu J, He LF. Release of GnRH from the MBH induced
by electroacupuncture in conscious female rabbits. Acupunct
Electrother Res 1994;19:9-27.
Yu J, Zheng HM, Ping SM. Changes in serum FSH, LH and ovarian
follicular growth during electroacupuncture for induction of ovulation.
Chin J Integrated Tradit Western Med 1995;1(1):13-6.
Research Methods
Birch S, Hammerschlag R. Acupuncture efficacy: a compendium
of controlled clinical trials. Tarrytown (NY): Nat Acad Acu & Oriental
Med; 1996.
Hammerschlag R, Morris MM. Clinical trials comparing acupuncture
to biomedical standard care: a criteria-based evaluation. Compl Ther
Med. In press 1997.
Kaptchuk TJ. Intentional ignorance: a history of blind assessment
in medicine. Bull Hist Med. In press 1998.
33
Singh BB, Berman BM. Research issues for clinical designs. Compl
Therap Med 1997;5:3-7.
Vincent CA. Credibility assessment in trials of acupuncture. Compl
Med Res 1990;4:8-11.
Vincent CA, Lewith G. Placebo controls for acupuncture studies.
J Roy Soc Med 1995;88:199-202.
Vincent CA, Richardson PH. The evaluation of therapeutic
acupuncture: concepts and methods. Pain 1986;24:1-13.
Side Effects
Lao L. Safety issues in acupuncture. J Altern Comp Med 1996;2:27-31.
Norheim AJ, Fnneb V. Acupuncture adverse effects are more
than occasional case reports: results from questionnaires among
1135 randomly selected doctors and 197 acupuncturists. Compl
Therap Med 1996;4:8-13.
34
Acupuncture
A Continuing Medical Education Activity Sponsored by the
National Institutes of Health/Foundation for Advanced
Education in the Sciences
OBJECTIVE
The objective of this NIH Consensus Statement is to inform the biomedical research
and clinical practice communities of the results of the NIH Consensus Development
Conference on Acupuncture. The statement provides state-of-the-art information
regarding the appropriate use of acupuncture, and presents the conclusions and recom
mendations of the consensus panel regarding these issues. In addition, the statement
identifies those areas of study that deserve further investigation. Upon completing this
educational activity, the reader should possess a clear working clinical knowledge of
the state-of-the-art regarding this topic.
ACCREDITATION
The National Institutes of Health/Foundation for Advanced Education in the Sciences is
accredited by the Accreditation Council for Continuing Medical Education to sponsor
continuing medical education for physicians.
The National Institutes of Health/Foundation for Advanced Education in the Sciences
designates this continuing medical education activity for 1 credit hour in Category I
of the Physicians Recognition Award of the American Medical Association. Each
physician should claim only those hours of credit that he/she actually spent in the
educational activity.
EXPIRATION
This form must be completed and postmarked by November 5, 2000, for eligibility
to receive continuing medical education credit for this continuing medical education
activity. The expiration date for this test may be extended beyond November 5, 2000.
Beginning November 6, 2000, please check the NIH Consensus Development Program
web site (http://consensus.nih.gov) or call the NIH Office of Medical Applications
of Research at 301-496-1144 for information regarding an extended expiration date
for this continuing medical education activity.
INSTRUCTIONS
The consensus statement contains the correct answers to the following 10 questions.
Select your answer(s) to each question and write the corresponding letter(s) in the
answer space provided. Mail the completed test by the expiration date shown above
to CME Program, Office of Medical Applications of Research, National Institutes of
Health, Building 31, Room 1B03, 31 Center Drive MSC 2082, Bethesda, MD 20892
2082. You will receive notification of your test results within 2 to 3 weeks. If you
have successfully completed the test (7 or more correct answers), you will receive
a certificate for 1 hour of continuing education credit along with your test results. The
estimated time to complete this educational activity is 1 hour. Photocopies of this form
are acceptable. There is no fee for participating in this continuing education activity.
ANSWER(S): _________________________________________________
2. There is clear evidence that acupuncture is effective in the treatment of:
(You must indicate all that are true.)
a. nausea and vomiting following surgery
c. smoking cessation
b. nausea and vomiting associated
d. fibromyalgia
with chemotherapy
e. pregnancy-related nausea
ANSWER(S): _________________________________________________
3. Research has shown that sham acupuncture, the placement of acupuncture needles in
positions other than known acupuncture points, elicits no biological response and is
an effective control group mechanism for studies involving pain.
a. true
b. false
ANSWER: ____________________________________________________
4. The incidence of adverse effects of acupuncture is substantially lower than that of many
drugs or other accepted medical procedures used for the same conditions.
a. true
b. false
ANSWER: ____________________________________________________
5. Many studies in animals and humans have demonstrated that acupuncture can cause
multiple biological responses, which usually occur:
a. close to the site of application
b. at a distance from the site of application
c. either locally or distant to the site of application
ANSWER: ____________________________________________________
6. Mechanisms of action that may be activated by stimulation from acupuncture
include: (You must indicate all that are true.)
a. the release of endogenous opioid peptides, which may play a role in the analgesic
effects of acupuncture.
b. an increase in adrenal gland activity leading to increased corticosteroid and
catecholemine secretions
ANSWER(S): _________________________________________________
d. the quality of the relationship between the clinician and the patient
ANSWER(S): _______________________________________________
8. An important factor for the integration of acupuncture into the health care
system is:
a. the need to develop educational standards for physician and nonphysician
acupuncturists
b. the need to establish a national credentialing agency for nonphysician
in the field
ANSWER: __________________________________________________
9. Licensure or registration for acupuncture practitioners is provided by
all states and the requirements to obtain licensure vary only slightly
from state to state.
a. true
b. false
ANSWER: __________________________________________________
10. Which of the following safeguards should be observed to prevent the
rare occurrence of any adverse effects of acupuncture?
(You must indicate all that are true.)
a. Use of acupuncture needles should follow FDA regulations, including the
use of sterile, single-use needles.
b. Patients should receive their first acupuncture treatment only from a physican
trained in acupuncture.
c. Patients should be fully informed of their treatment options, expected
ANSWER(S): _______________________________________________
Your response to the following four questions is optional and will have no effect on
the grading results of this test.
To what extent did this CME activity meet the stated objectives?
a. not at all
c. somewhat
e. completely
b. very little
d. considerably
ANSWER: _____________________________________________________
To what extent will participation in this CME activity enhance your professional
effectiveness?
a. not at all
c. somewhat
e. completely
b. very little
d. considerably
f. does not apply
ANSWER: _____________________________________________________
Do you have additional comments you think would enhance the utility or impact
of this NIH Consensus Statement?
Are there new topics you would like to have covered in a similar or related NIH
Consensus Development Conference or Statement?
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