Is Acupuncture Safe? by Brian Benjamin Carter Brian is the founder of the Pulse of Oriental Medicine. He teaches at the Pacific College of Oriental Medicine and maintains a private acupuncture and herbal practice in San Diego, California, and is the author of Powerful Body, Peaceful Mind: How to Heal Yourself with Foods, Herbs, and Acupressure.

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:

• 8-10% of admissions of patients to hospitals
• 25% of admissions to hospitals by persons age 65 years of age or older
• 10-15% of visits to emergency rooms in some urban settings
• 4.5 drug order errors per 1000 drug orders in hospitals
• Significant decreases in the quality of life (due to inappropriate prescribing, e.g., of hypnotics for the elderly)
• 2 in 1000 deaths in hospitals, and Deterioration or destruction of specific organs." - "Toward defining and applying a higher standard of quality for medication use in the United States" from the American Society of Health-System Pharmacists

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

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