http://bmj.com/cgi/content/full/323/7311/486
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Papers
The York acupuncture safety study: prospective survey of 34 000
treatments by traditional acupuncturists
Hugh MacPherson
a See Editorial by Vincent and p 485 Foundation for
Traditional Chinese Medicine, York YO24 4EY, b Medical Care
Research Unit, University of Sheffield, Sheffield S1 4DA, c Sheffield
Health Economics Group, School of Health and Related Research, University of
Sheffield
Correspondence to: H MacPherson hugh@ftcm.org.uk
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Participants,
methods, and results |
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The study involved a prospective postal audit of treatments undertaken
during a four week period in 2000. All 1848 professional acupuncturists
who were members of the British Acupuncture Council and were
practising in the United Kingdom were invited to record details of
adverse events and mild transient reactions after treatment. Standardised
self report forms were used. Participating practitioners also
provided information on themselves, including age, sex, length of
training, and years of practice. To have a 95% probability that no
serious event occurs in n treatments, a survey sample size
needs to be three times n.4 On this
basis, a sample of 30 000 treatments was sought. Piloting
indicated that a four week period was needed.
A total of 574 practitioners participated, 31% of the total population.
The mean age of participants was 44.8 years (range 23-79 years),
65% were female, and 62% had been practising acupuncture for more
than five years. Information on sex, training college, and length of
practice was available from the British Acupuncture Council's
database. Participants were sufficiently representative of the population
of practitioners for a re-weighting of the primary data to be
unnecessary. Participating practitioners reported on 34 407
treatments.
Practitioners were asked to give details of any adverse events they
considered to be "significant," including any event that was
"unusual, novel, dangerous, significantly inconvenient, or requiring
further information." There were no reports of serious adverse
events, defined as events requiring hospital admission, leading to
permanent disability, or resulting in death (95% confidence interval
0 to 1.1 per 10 000 treatments). Practitioners did, however,
report 43 minor adverse events, a rate of 1.3 (0.9 to 1.7)
per 1000 treatments. The most common events were severe nausea
and fainting (table). Three avoidable events
two
patients had needles left in, and one patient had moxibustion burns
to the skinwere
caused by practitioners' errors.
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Participating practitioners recorded 10 920 mild transient reactions occurring
in 5136 treatments, 15% (14.6% to 15.3%) of the 34 407
total. Some local reactions at the site of needling were reportedmild
bruising in 587 (1.7%) cases, pain in 422 (1.2%) cases,
and bleeding in 126 (0.4%) cases. Patients experienced an
aggravation of existing symptoms after 966 (2.8%) treatments, 830 (86%)
of which were followed by an improvement, possibly indicating a
positive "healing crisis." The most commonly reported mild transient
reactions were "feeling relaxed" in 4098 (11.9%) cases and
"feeling energised" in 2267 (6.6%) cases, symptoms
that often indicate an encouraging response to treatment.3
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Comment |
In this prospective survey, no serious adverse events were reported after
34 407 acupuncture treatments. This is consistent, with 95%
confidence, with an underlying serious adverse event rate of between
0 and 1.1 per 10 000 treatments. This conclusion was based
on data collected over a four week period by one in three of the
members of the British Acupuncture Council. Even given the potential
bias of self reporting, this is important evidence on public health
and safety as professional acupuncturists deliver approximately two
million treatments per year in the United Kingdom. Comparison of
this adverse event rate for acupuncture with those of drugs
routinely prescribed in primary care suggests that acupuncture is a
relatively safe form of treatment.5 Further
research measuring patients' experience of adverse events is merited.
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Acknowledgments |
Contributors: HMacP initiated the project, coordinated the study, and is the
guarantor. KT and MF contributed to the study design, interpretation of
results, and drafting of the manuscript. SW analysed the data and assisted with
the interpretation of results. The study was adapted from a survey design
developed by Adrian White and colleagues. Alan Bensoussan, Stephen Birch, Alan
Breen, Roy Carr-Hill, and Adrian White provided valuable comments on a draft
protocol.
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Footnotes |
Funding: The study was supported by a grant from the British Acupuncture
Council.
Competing interests: None declared.
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References |
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1. |
British Medical Association Board of Science and
Education. Acupuncture: efficacy, safety and practice. London: Harwood
Academic Publishers, 2000. |
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2. |
House of Lords. Complementary and alternative medicine.
London: Stationery Office, 2000. (Report of the Select Committee on Science
and Technology.) |
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3. |
MacPherson H. How safe is acupuncture? Developing the
evidence on risk. J Alternative Complementary Med 1999; 5: 223-224 |
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4. |
Eypasch E, Lefering R, Kum CK, Toidl H. Probability of
adverse events that have not yet occurred: a statistical reminder. BMJ
1995; 311: 619-620 |
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5. |
Tranmer MR, Moore RA, Reynolds DJM, McQuay HJ.
Quantitative estimation of rare adverse events, which follow a biological
progression: a new model applied to chronic NSAID use. Pain 2000; 85:
169-182 |
(Accepted 23 May 2001)
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Related editorials in BMJ:
The safety of acupuncture.
Charles Vincent
BMJ 2001 323: 467-468.
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