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adverse
events
OVERVIEW: ADVERSE
EVENTS OF ACUPUNCTURE
James
K. Rotchford, MD
ABSTRACT
Acupuncture
and adverse event are defined herein, followed by a review of problems
associated with accurately determining the incidence of acupuncture's
adverse events. The adverse events of acupuncture stated in the English-language
literature, as well as suggestions on avoiding these adverse events
from a clinical perspective, follow.
KEY WORDS
Acupuncture,
Adverse Events, Adverse Effects, Side Effects, Overview
INTRODUCTION
The
ancient Greeks gave Western medicine an important maxim: primum non
nocere, "first do no harm." This maxim needs reassessing. If we
are honest, we acknowledge that rare is the intervention that carries
no risk of harming the patient. On the other hand, we have a duty to
ensure that the possible benefits of any intervention clearly outweigh
its risks. Additionally, informed consent is an appropriate and standard
expectation in modem medicine; with the scanty data currently available,
informed consent related to acupuncture is compromised. Further research
into the possible adverse events associated with acupuncture will improve
our ability to provide better informed consent. Exploring issues related
to reducing and researching the risks are fundamental to serious research
regarding clinical applications for acupuncture.
Definition of Acupuncture
Many
of the reviews and case studies of adverse events of acupuncture fail
to clearly define their use of the term acupuncture. One definition
might be derived through the etymology of the word from the Latin roots
acus (needle) and punctura (to puncture), implying that
acupuncture is simply puncturing with needles. Another definition of
acupuncture is "a model of medicine that promotes health through altering
Qi flow within the body, and whose theories date from ancient
Chinese times " Webster's dictionary defines acupuncture as originally
a Chinese practice of puncturing the body (as with needles) to cure
disease or relieve pain.
According
to a 1997 National Institutes of Health Consensus Conference on acupuncture,
"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."1
Definitions
of acupuncture vary significantly. For the purpose of this discussion
and research prerequisites, a very explicit definition is indicated.
Thus, the definition of acupuncture is proposed:
Acupuncture is considered a therapeutic
and/or preventive surgical procedure, and defined as the insertion
of at least 1 thin, solid, metallic needle into the body. To meet
the specific definition of acupuncture, the needles can be manipulated
or stimulated only manually. The primary intent of needling is the
stimulating of acupuncture point(s) as commonly defined in textbooks
of acupuncture.2,3
To be more
explicit regarding the elements generating risk, the term acupuncture
is limited to the use of needles. It is best to consider electrical
stimulation, moxibustion, laser therapy, plum blossom therapy, cupping,
etc, as separate procedures that are associated with their own unique
risks. The paucity of data on these procedures, along with their inherent
differences from "needling," also warrants their separate consideration.
The intent to stimulate acupuncture points as a criteria for acupuncture
is included. The common technique of dry needling trigger points should
remain a separate procedure vis-a-vis definitions and risk assessment.
Until data can be gathered to show otherwise, the risks and prerequisite
skills associated with established Western medical procedures are best
considered different from those of actually performing acupuncture.
Perhaps this is true despite the common acceptance that when dealing
with musculoskeletal complaints, a majority of "active" acupuncture
points are also trigger points.
Definition of Adverse Event
A simple
definition, used in the medical literature on adverse events in the
hospital setting, is: "An adverse event is an injury or untoward event
due to treatment, including failure to treat." Medical personnel generally
know what this means in the hospital setting. For acupuncturists and
researchers alike, there has been controversy regarding what constitutes
an adverse event. Recent reviews and surveys, along with editorials
and letters to the editor, have underscored some of these controversies.4-8
In response
to MacPherson, along with White's opinion, to differentiate "healing
reactions" from other acupuncture events, 6,7
Yamashita notes that "we should be consistent with those of adverse
drug reactions."8 Further discussion
followed about events that should be considered practitioner negligence
or malpractice, and which simply are patient reactions. In her letter,
White wrote of delayed diagnosis/therapy as an adverse event! She recounts
the case in which a person died from asthma because of a failure to
receive "standard" allopathic care in a timely fashion. This example
reflects an indirect adverse event of acupuncture, rather than a direct
one. Should it, therefore, be listed as an adverse event of acupuncture?
The definition offered above includes delayed treatment as an adverse
event, and is consistent with the list of adverse events following.
As long as there are differences in intent with regard to acupuncture
and differences in the interpretation
of acupuncture events, a resolution of this controversy is unlikely.
Cultural and intracultural differences with regard to standards of care
also further complicate what is considered "adverse" in terms of care.
Furthermore, it is problematic to define a priori what events constitute
negligence or malpractice. These types of judgments are inevitably contextual/
legal, and rather than facilitating research in this area, might actually
impede it and interfere with appropriate "system" preventive measures.9
It is difficult enough to accurately assess and evaluate the incidence
of events attributable to acupuncture.
Problems Determining the Incidence of
Acupuncture-Related Events
Under-reporting
Acupuncture
is a surgical procedure and thus, clearly not entirely safe. It is,
nonetheless, commonly considered to be relatively safe compared with
Western medications and procedures.10,11
Acupuncture literature supports this notion; malpractice premiums are
consistent with relatively low risk.12
The majority of state legislatures have permitted non-physician health
care professionals to be licensed as acupuncturists.13
However, some believe that underreporting of adverse events is rampant,
even in hospital settings.14
Perhaps under-reporting of pneumothorax following acupuncture is an
example.
The medical literature suggests that the incidence
of pneumothorax is rare and/or is only associated with incompetency.4,5,15
Yet there have been at least 2 cases in the author's practice of 15
years, and reports of at least 3 other cases in patients or their immediate
family members. This reflects higher incidences than reported in the
literature, but does not necessarily reflect incompetency. In the aforementioned
2 cases, the patients had chronic serious lung disease, and their tissues
were compromised by prolonged cortisone use. In addition, electrical
acupuncture was used.
If no attempt is made to define comorbidity
or other risk factors that might act as significant confounding variables,
the expected incidence of pneumothorax secondary to acupuncture is impossible
to assess accurately. Furthermore, pneumothorax can be easily missed
diagnostically. Physicians and non-physician health care professionals
may be unaware that shoulder pain might be the only symptom. Perhaps
non-physician clinicians are not adequately trained to either suspect
or to adequately make the diagnosis. Suspicions of under-reporting of
pneumothorax associated with acupuncture are perhaps justified.
Another reason to expect under-reporting comes
from the work of Lucian Leape, MD, an established authority in hospital
adverse events and unwarranted surgical procedures.9,16-23
There is abundant evidence that most
adverse events are not reported, as high as 95%. 1 can think of no
obvious reason why that should be different for acupuncture complications
or errors. So you do have to do some on-hands data collection, and
the better you do that, the more you will find alone (i.e., we found
more with the nurse visit and daily review than with just retrospective
review of hospital charts alone) [personal communication, 1997].
In addition,
if one looks at studies in which the population studied, techniques
used, and/or location of points needled are not "typical," the ability
to generalize the findings are significantly compromised. The recent
report of 65,482 treatments in Japan' for which no pneumothorax was
reported is an example. In this report, the fact that adverse events
were noted by students, and were reported only through
self-report of the practitioners, further compromises the validity of
the findings.
Based on
current available data, under-reporting is a significant issue and limits
our ability to accurately predict the incidence of adverse events related
to acupuncture.
Over-reporting
Paradoxically, over-reporting is also
a problem. The frequency of infection in Western nations is most likely
exaggerated by the literature, and may be based on the degree of Western
standard training in sterile technique and use of sterile needles. Perhaps
a selection bias in the English medical literature toward reporting
adverse effects of alternative forms of therapy, rather than their benefits,
is prevalent.
Another cause of possible inflation of acupuncture
adverse events has to do with baseline incidence of certain medical
events. Again, let us look at pneumothorax as an example. The incidence
of pneumothorax has been estimated to be as high as 18.0 cases per 100,000
population per year. The risk can be 7 times greater in smokers.24
If this is true, then the odds of having spontaneous pneumothorax may
be as high as what some literature reports as being associated with
acupuncture. This would be especially true in a high-risk group such
as tall male smokers. One can easily see the possibility of a case of
spontaneous pneumothorax being inaccurately attributed to acupuncture.
Overview of the Literature
Several
formal reviews of adverse effects of acupuncture have been reported
in the literature.4,25-28
Recent editorials and letters are testimony to controversies/difficulties
in the area of reporting acupuncture adverse events.6-8,29
A recent report from Japan reported that of a total of 55,291 acupuncture
treatments, 64 adverse events were reported, including I I types of
events .5
The list
of adverse events reported in the literature and/or personally observed
includes:
Acute bacterial endocarditis from auricular
acupuncture
Aggravation of symptom(s)
Asthma attack
Behcet's cedilla syndrome
Bleeding
Blue macules of localized argyria
Bum injury (caused by thermotherapy, including moxibustion)
Cardiac tamponade
Cellulitis
Compartmental syndrome
Contact dermatitis
Convulsion
Coughing
Death
Deep venous thrombosis
Delayed conventional diagnosis/therapy
Discomfort, general, during or after treatment
Dizziness
Drowsiness
Ecchymosis without pain
Ecchymosis with pain Fall from treatment table
Feeling faint
Forgotten needles
Glenohumeral pyoarthrosis
Granuloma
Hemothorax
Hematoma
Hepatitis B
Hepatitis C
HIV infection
Hypotension, transient
Interactions with drugs
Itching and/or redness, during treatment
and/or afterward
Malaise
Multiple lymphocytoma cutis of the ears
Myelitis
Nausea, during treatment and/or afterward
Nerve injury-peripheral
Pain in the puncture region, during insertion, removal, or afterward
Pain at distant location, during insertion, removal, or afterward
Perichondritis of the ear
Peripheral nerve injury
Perspiration
Pneumothorax
Prurigo pigmentosa
Pseudoaneurysm
Psoas abscess
Reduced bowel movements
Renal injury and calculus formation from retained needles
Retained needles
Return of old complaints
Sepsis
Spinal injury
Spinal cord injury
Spinal arachnoiditis
Subarachnoid hemorrhage
Suppression of a demand cardiac pacemaker (electrical acupuncture)
Syncope
Vomiting
Serious Adverse Events
In the English-language literature, 5 fatalities
(case reports) have been published: 2 with cardiac tamponade,30,31
2 cases of staphylococcal septicemia,32
and 1 asthmatic death.33
This list is most likely incomplete. The question
remains: Does the frequency of reports in the literature correspond
to the true incidence of the events? The article by Rosted28
is a good review of the frequency of specific adverse events reported
in the literature.
Common events
associated with acupuncture are drowsiness, pain with insertion and
manipulation, minor bruising, and a temporary aggravation of the symptom.
Hepatitis and pneurnothorax are the most commonly reported serious adverse
events. "Serious" events associated with acupuncture are rare. (In the
author's opinion, a serious complication [pneumothorax, hepatitis, delayed
diagnosis, cardiac tamponade, etc.] of acupuncture occurs in about 1
in 5,000 cases. This estimate is based on personal experience of approximately
30,000 treatments over a 15-year period, plus the review of the current
literature on adverse events in acupuncture.)
Based on
current standards of practice in surgery and anesthesiology, these rare
events need not be discussed with patients a priori. Nonetheless, it
remains the responsibility of practitioners to prevent and recognize
these events when they do occur. Prompt and appropriate treatment can
then follow.
Clinical Strategies for Reducing Adverse
Events
Given
the current literature on adverse events related to acupuncture, along
with personal experience and observations, clinical recommendations
generally self-evident for the medical physician with some background
in acupuncture include the following:
- Use appropriate sterile technique.
- Over the sternum, angulate the needle
to avoid passing through congenital
foramens overlying the heart.
- If the patient has a significant risk
factor for infection, i.e., advanced
age, diabetes, immunosuppressive therapy, artificial joints,
heart murmurs, prosthetic valves, active cancer, etc., avoid
using implanted needles. Generally, implanted needles imply
greater risk to the patient.
- Based on personal experience and stories
from patients, if cellulitis occurs
in the context of acupuncture, take appropriate cultures and consider
immediate parenteral antibiotics.
- If a patient is taking anticoagulants,
consider superficial needling and in all cases, apply firm pressure
after removing a needle. (The author believes that electrical acupuncture
in this context implies greater risk to the patient.)
- To avoid pneumothorax, consider patients
at greater risk to be smokers, tall males, patients with emphysema,
patients who are or have been taking corticosteroids, patients with
active cancer, and patients who are emaciated for any reason. (Any
point overlying pleura can be risky but especially LR 14, GB 21, 23,
25, and SP 21 are vulnerable. Electrical stimulation of these points
implies greater risk.)
- Be cautious and hesitant to assume that
acupuncture is the only therapy indicated for your patients. Physicians
are legally held to higher standards than lay acupuncturists with
regard to missed conventional diagnoses and/or therapeutic options.
- Elderly and new patients are preferably
supine during acupuncture treatments.
- Significant insomnia predating acupuncture
generally is associated with significantly more discomfort and pain
during and after an acupuncture session.
- Be alert for metal allergy.
- Warn patients, especially after the
first treatment, to be more cautious in driving. A half-hour recovery
period for new patients would be considered prudent.
- Be vigilant and informed about possible
adverse events.
- Facilitate a systematic approach toward
reducing barriers that interfere with improving patient care and safety.9
(This author would be interested in
hearing the results of a study in which the hypothesis was that practitioners
who actively prayed for their patients had patients who experienced
fewer adverse events.)
CONCLUSION
Informing
the reader of possible complications of acupuncture and
how to prevent them is the intent of this article. Factors that are
essential for further progress in
the research of acupuncture are emphasized.
Clear definition of terms is mandatory.
REFERENCES
1. NIH Consensus
Statement. Acupuncture. Bethesda, Md: National Institutes of
Health; 1997.
2. O'Connor J, Bensky D, eds trans. Acupuncture:
A Comprehensive Text. Seattle, Wash: Eastland Press; 1981:67-75.
3. Helms JM. Acupuncture Energetics: A Clinical
Approach for Physicians. Berkeley, Calif: Medical Acupuncture Publishers;
1995.
4. MacPherson H. Fatal and adverse events from acupuncture:
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5. Yamashita H, Tsukayama H, Tanno Y, Nishijo K.
Adverse events in acupuncture and moxibustion treatment: a six-year
survey at a national clinic in Japan. J Altern Complement Med.
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6. MacPherson H. How safe is acupuncture? developing
the evidence on risk. J Altern Complement Med. 1999;5:223-224.
7. White A. Letter to the editor. J Altern Complement
Med. 1999;5:1-2.
8. Yamashita H. Letter to the editor. J Altern
Complement Med. 1999;5:2.
9. Leape LL. A systems analysis approach to medical
error. J Eval Clin Pract. 1997;3:213-222.
10. Safety and Regulation of Acupuncture Needles
and Other Devices. Bethesda, Md: National Institutes of Health;
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11. American Medical Association. Proceedings of
the House of Delegates. 1981.
12. Studdert DM, Eisenberg DM, Miller FH, et al.
Medical malpractice implications of alternative medicine. JAMA.
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13. Acupuncture Licensure, Training, and Certification
in the United States. Bethesda, Md: National Institutes of Health;
1997.
14. Bates DW, Leape LL, Petrycki S. Incidence and
preventability of adverse drug events in hospitalized adults. J Gen
Intern Med. 1993;8: 289-294.
15. Rampes H. Adverse reactions to acupuncture.
In: Filshie J, White A, eds. Medical Acupuncture: A Western Scientific
Approach. Edinburgh, Scotland: Churchill Livingstone; 1998:361-374.
16. Leape LL. Preventing adverse drug events.
Am J Health Syst Pharm. 1995;52:379-382.
17. Leape LL. Unnecessary surgery. Annu Rev Public
Health. 1992;13: 363-383.
18. Leape LL. Out of the darkness: hospitals begin
to take mistakes seriously. Health Syst Rev. 1996;29:21-24.
19. Johnson WG, Brennan TA, Newhouse JP, et al.
The economic consequences of medical injuries: implications for a no-fault
insurance plan. JAMA. 1992;267:2487-2492.
20. Leape LL, Woods DD, Hatlie MJ, Kizer KW, Schroeder
SA, Lundberg GD. Promoting patient safety by preventing medical error.
JAMA. 1998;280:1444-1447.
21. Leape LL, Bates DW, Cullen DJ, et al. Systems
analysis of adverse drug events. JAMA. 1995;274:35-43.
22. Leape LL, Lawthers AG, Brennan TA, Johnson WG.
Preventing medical injury. QRB Qual Rev Bull. 1993; 19:144-149.
23. Brennan TA, Leape LL, Laird NM, Localio AR,
Hiatt HH. Incidence of adverse events and negligent care in hospitalized
patients. Trans Assoc Am Physicians. 1990; 103:137-144.
24. Fraser R, Pare J. Diagnosis of Diseases of
the Chest. 2nd ed. Philadelphia, Pa: WB Saunders; 1977.
25. Ernst E, White A. Life-threatening adverse reactions
after acupuncture? a systematic review. Pain. 1997;71:123-126.
26. Ernst E. The risks of acupuncture. Int J
Risk Saf Med. 1995;6:179-186.
27. Rampes H, James R. Complications of acupuncture.
Acupuncture Med. 1995;8:26-31.
28. Rosted P. Literature survey of reported adverse
effects associated with acupuncture treatment. Am J Acupuncture.
1996;24:27-34.
29. Ernst E, White A. Acupuncture: safety first
[editorial]. BMJ. 1997;314:1362.
30. Schiff AF. A fatality due to acupuncture. Med
Times. 1965;93:630-631.
31. Halvorsen TB, Anda SS, Naess AB, Levang OW.
Fatal cardiac tamponade after acupuncture through congenital sternal
foramen [letter]. Lancet. 1995;345:1175.
32. Pierik MG. Fatal Staphylococcal septicemia following
acupuncture: report of two cases. R I Med J. 1982;65:251-253.
33. Ogata M, Kitamura 0, Kubo S, Nakasono 1. An asthmatic
death while under Chinese acupuncture and moxibustion treatment. Am
J Forensic Med Pathol. 1992;13:338-341.
AUTHOR INFORMATION
Dr James K. Rotchford is in private practice
in Port Townsend, Washington. Rotchford is a founding member of the
American Academy of Medical Acupuncture (AAMA), and is President of
the Medical Acupuncture Research Foundation (MARF). He acts as Web Dragon
Master for the AAMA home page (www.medicalacupuncture.org).
Dr James K. Rotchford, MD,
MPH
1334 Lawrence St
Port Townsend, WA 98368
Phone: 360-385-4843 - Fax: 360-379-1441
E-mail: kimber@olympus.net
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