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Is Acupuncture Safe?
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This article is a September 2002 revision
and update of one portion of "Challenging
the Skeptics," from December 2001, a comprehensive
answer to skeptics' concerns with acupuncture. |
Acupuncture is much safer than most western medical treatments.
To support that statement, I will cite such phenomenally credible
sources as:
- The National Institutes of Health (NIH)
- The Journal of the American Medical Association
(JAMA) - several places
- The Food and Drug Administration (FDA)'s Center
for Drug Evaluation and Research (CDER)
- The British Medical Journal (BMJ)
- The American Society of Health-System Pharmacists
- 7 peer-reviewed medical journals found on the
National Library of Medicine's MedLine
- Studies of data from malpractice claims
- Retrospective studies (from America and the
U.K.) of more than 100,000 acupuncture treatments
First I will discuss issues of acupuncture safety.
Then, I will bring out some issues in western
medicine safety... just to give you a sense of the comparison
between the two...
The National Institutes of Health Consensus
Statement on Acupuncture
In 1997, the National Institutes of Health issued a consensus
statement on acupuncture which said, among other things:
"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."
- National
Institutes of Health Consensus Statement on Acupuncture, 1997
Did you get that? They said that aspirin, anti-inflammatories,
and steroids have not been supported by scientific evidence any
better than acupuncture.
The Safety of Acupuncture in terms of Malpractice
Insurance Claims
"In an analysis of data from malpractice insurers from 1990
through 1996, Studdert and colleagues18 found that claims against
chiropractors, massage therapists, and acupuncturists generally
occurred less frequently and usually involved less severe injury
than claims against medical doctors." - Phil
B. Fontanarosa, MD; George D. Lundberg, MD - JAMA 1998
Retrospective Studies of Acupuncture Treatment
Safety
The Frequency and Types of Adverse Events in 55,291 Acupuncture
Treatments
(see
table)
99.8% of acupuncture is performed with no significant minor
adverse events; "During these 5 years, a total of 76 acupuncturists
(13 preceptors and 63 interns) participated in the study, and
the total number of acupuncture treatments was 55291. A total
of 64 adverse events were reported and included 11 types of events...
The most frequent adverse event was failure to remove needles
after treatment; no sequelae (problems) occurred after removal
of the needles. The second most common adverse event was dizziness,
discomfort, or perspiration probably due to transient hypotension
(low blood pressure) associated with the acupuncture treatment....
We may, therefore, reasonably conclude that serious adverse
events in acupuncture treatment are uncommon in the practice of
adequately trained acupuncturists... ." - Hitoshi
Yamashita, Bac, Hiroshi Tsukayama, BA, Yasuo Tanno, MD, PhD, Kazushi
Nishijo, PhD, JAMA
Two September 2001 Studies of safety of acupuncture in British
Medical Journal
Discusses the details of just 43 minor adverse events in 34,407
acupuncture treatments; and only 91 minor events in another 31,822
acupuncture treatments. If combined with the other study above,
that equals a total of 121,520 treatments with 198 minor
adverse events (only 0.16% incidence), and no pnemuothoraxes
(collapsing of the lung- this was concluded to be "extremely rare").
- The
British Medical Journal (BMJ) 2001
Yet another patient follow-up survey is underway in the United
Kingdom - read about it here.
What's the worst that can happen from acupuncture - and did
it?
The most serious adverse events possible with acupuncture are
pneumothorax (collapsing the lung due to puncture) and
septicemia (systemic infection of the blood by bacteria);
"Instruction is given by both lectures and practical training
and includes information about anatomically risky depth of insertion
and use of aseptic procedure for puncturing... Most important,
no serious events such as pneumothorax, spinal lesion,
or infection were reported." - JAMA
November 1998
...Zero out of 55,291! But even just one would have meant
only a 0.002% chance of these occurring.
The Safety of Acupuncture compared with
that of Biomedicine:
Antibiotic overuse leads to resistant super-bacteria
"The prevalence of antibiotic-resistant bacteria in Taiwan
is due to the heavy use of antimicrobial agents in both animal
husbandry and clinical practice over the past decades" -
Int
J Antimicrob Agents 2001 Sep) as well as intestinal flora
imbalance (diarrhea, vaginal candidiasis)
"Antibiotic use is a short-term risk factor for symptomatic
vulvovaginal candidiasis, either as a first episode or in the
form of recurrence. Increasing duration of antibiotic use is
directly related with an increased prevalence of Candida vaginal
infection. " - Am
J Obstet Gynecol 1999 Jan
"The spectrum of diarrheal disease associated with antibiotic
therapy ranges from antibiotic associated diarrhea and colitis,
to the more severe pseudomembranous colitis, which is always associated
with Clostridium difficile (CD)." - Acta
Gastroenterol Latinoam 1996
The FDA approves unsafe drugs if they are
effective enough
"No drug product is "perfectly" safe. Every single drug that
affects the body will have some side effects. Since the FDA
considers both the benefits and risks of all medications before
approval, side effects are generally not serious. For every
drug FDA approves, the benefits are balanced against its risks.
In addition, FDA makes sure the labeling (package insert) outlines
the benefits and risks reported in the tested population. You
and your health-care provider should decide together if the benefits
outweigh the risks for YOU. Talking about your medicines with
your health-care provider is just as important and good for your
health as a complete check-up and taking your medicine as directed."
-
Frequently asked questions from the Center for Drug Evaluation
and Research (CDER) at the FDA
"The benefit-risk ratio weighs the benefits provided
by a drug, versus risks or safety problems that may be associated
with use of the drug. No drug can be considered to be totally
safe. Drugs that are associated with more significant safety problems
are expected to have sufficiently greater benefits to justify
the increased risk." - Questions
and Answers from CDER's
Over-the-Counter Drug Products Public Hearing (FDA)
What does benefit-risk mean to us? From a discussion of
tamoxifen (a breast cancer drug): "there are categories that,
from my perspective, clearly fall out where the benefits unequivocally
outweigh the risks... I think physicians very frequently discuss
risk-benefit ratios for all sorts of treatments, and it ultimately
comes down to a decision between the patient and the doctor."
- Questions
and Answers from CDER's
Over-the-Counter Drug Products Public Hearing (FDA)
ADR's (adverse drug reactions):
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen
"Gastrointestinal (GI) Adverse Drug Reactions (ADRs) from
the +NSAIDs are a major cause of morbidity and mortality
in arthritic patients taking these drugs... Clearly, the need
to develop newer NSAIDs with lower risks of ulcers and bleeding
as well as symptomatic ADRs is still representing a major challenge."
- J
Physiol Paris 2001
High dosage Steroid use (e.g. in Asthma or COPD)
"High dose of inhaled steroids may lead to adrenocortical
suppression and hence estrogen deficiency in postmenopausal women"
- J
Allergy Clin Immunol 1989 Feb
"the daily dose, but not the duration, of inhaled steroid
therapy may adversely affect bone density" (osteoporosis)
-
J Allergy Clin Immunol 1995 Aug
"The potential risks of antiasthmatic inhaled steroid
therapy are essentially dose-related and include oropharyngeal
complications such as
- thrush and dysphonia, and
- systemic complications such as
- hyperactivity
- behavioural change
- hypothalamic-pituitary-adrenal axis suppression
- facial and weight changes characteristic of hypercortisonism
- cataracts
- increased intraocular pressure
- dermal atrophy causing steroid purpura
- retarded growth in children and
- osteoporosis.
- A few cases of fracture or acute adrenocortical insufficiency
have been reported." - Can
Respir J 1998
This last article is subtitled "First do no harm"
after the Hippocratic Oath taken by most MD's.
Drug Misadventures: "Still, we know from
studies published to date that drug misadventures account for:
So in summary...
It's clear that no medicine is totally safe. Except perhaps prayer!
Hopefully the comparison above is telling- the risks of most western
medical interventions are greater than in acupuncture.
Letter to the Editor about
this Topic
Dear Brian,
I've just finished reading your article - Medical
Acupuncture vs Licensed Acupuncture: What is the Difference?
- and realised that some of your claims regarding the 'safety'
of acupuncture may need to be revised. I don't know the 'retrospective'
studies you are quoting the figures regarding safety, but I am
aware that all large studies on acupuncture and safety (eg McPherson,
Norheim etc) are flawed. For example, the type of acupuncture
procedure being carried out is never stated. In terms of practice,
if 50, 000 treatments were undertaken on leg points how many of
these treatments would then be associated with pnuemothorax -
the most common type of mechanical injury? None!
In terms of serious adverse events, there are numerous cases
of pnuemothorax, at leat two cases of angina associated with electroacupuncture,
one case of cardiogenic shock from puncture of the left ventricle,
several cases of spinal cord puncture and at least one death associated
from this, death due to systemic bacterial infection, hepatitis
B transmission when standard precautions have broken down. Further,
many countries/states don't have transparent mechanisms for adverse
events to be reported, so the true rate is difficult to determine.
Your argument should be that acupuncture, while not associated
with as many adverse events and serious complications as 'western'
medicine, still has the potential risk of doing serious harm to
the patient. The point of your argument however, should rest upon
the educational qualifications of the practitioner. Level of competency
and education would translate to lower risk of potential harm
to the health and safety of patients. Therefore, you can continue
with your case about the high level of training that acupuncturists
undertake compared to short weekend courses that other health
professionals opt for (MD, DO, DC etc).
Hope this is helpful.
Take care.
Sean Walsh
Bachelor of Health Science (Acupuncture)
University of Technology, Sydney.
Sean,
Thanks for your thoughtful response.
I must agree that these studies may not be specific enough to
draw certain conclusions... e.g. the % rate of pneumothoraxes
since we don't know in how many treatments points near the lungs
were needled.
But we do see in those retrospectives that there weren't any
of those types of events... So that's still zero percent, no matter
what number you're dividing zero into. And it's unthinkable that
a good percentage of those treatments didn't use points for which
there are pneumothorax cautions. We can't quantify it exactly,
but it still implies good training and real safety.
We do need mechanisms for reporting acupuncture and herbal adverse
events, you're right.
B
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