http://bmj.com/cgi/content/full/323/7311/485
|
|||||||
|
|
Papers
Adverse events following acupuncture: prospective survey of 32 000
consultations with doctors and physiotherapists
Adrian White
a See Editorial by Vincent and p 486 Department of
Complementary Medicine, School of Postgraduate Medicine and Health Sciences,
University of Exeter EX2 4NT, b Pain Clinic, Colchester District
General Hospital, Colchester CO4 5JL, c Faculty of Science,
University of Central Lancashire, Preston PR1 2HE
Correspondence to: A White a.r.white@ex.ac.uk
|
|
Participants,
methods, and results |
|
|
Volunteer acupuncture practitioners were recruited through journals
circulated to members of the British Medical Acupuncture Society and
the Acupuncture Association of Chartered Physiotherapists (approximately
2750 members).2
A prospective survey was undertaken using forms for intensive event
monitoring that had been piloted previously.3 Minor
adverse events were defined as "any ill-effect, no matter how
small, that is unintended and non-therapeutic, even if not
unexpected." These events were reported every month, along with
the total number of consultations. Minor or serious events that were
considered to be "significant"
"unusual,
novel, dangerous, significantly inconvenient, or requiring further
information"were
reported on separate forms when they occurred. Anonymous reporting was
accepted. A sample size of 30 000 consultations was necessary to
identify with 95% confidence any adverse event with a frequency of
1 in 10 000 consultations.4
Estimates of incidences per 10 000 population were calculated with the
acupuncturist (not the consultation) as the primary sampling unit.
Since the data were skewed, with extreme values present, confidence
intervals corrected for bias were calculated using bootstrapping
procedure "bs" on estimates from the function "svyratio"
in intercooled Stata version 6.0 with 10 000 replications.
Data were collected from June 1998 to February 2000 from
78 acupuncturists, 13 of whom chose to remain anonymous. The average
age of the acupuncturists was 47 (range 27-71) years, 61% were doctors
and 39% physiotherapists, and 71% had practised for five years or
more. In all, 31 822 (median 318, range 5-1911) consultations were
included.
Altogether, 43 "significant" events were reported (table),
giving a rate of 14 per 10 000 (95% confidence interval 8/10 000
to 20/10 000). In addition, 48 apparently similar events were
reported on the monthly forms, presumably due to different interpretations
of "significant". All adverse events had cleared within one
week, except for one incident of pain that lasted two weeks and one
of sensory symptoms that lasted several weeks. According to accepted
criteria,3
none (0/10 000 to 1.2/10 000) of these events was serious.
|
A total of 2135 minor events was reported, giving an incidence of
671 per 10 000 (42/10 000 to 1013/10 000) consultations.
The most common events were bleeding (310 (160 to 590) per 10
000 consultations) and needling pain (110 (49-247) per 10 000
consultations). Aggravation of symptoms occurred in 96 (43-178)
per 10 000 consultations; in 70% of these cases, there was a
subsequent improvement in the presenting complaint. The highest
rates reported by individual acupuncturists, expressed as a
percentage of consultations, were 53% for bleeding, 24% for pain,
and 11% for aggravation of symptoms.
|
|
Comment |
Doctors and physiotherapists who performed acupuncture reported no serious
adverse events and 671 minor adverse events per 10 000
acupuncture consultations. These rates are classified as minimal5; however,
14 per 10 000 of these minor events were reported as
significant. These event rates are per consultation, and they do not
give the risk per individual patient.
Demographic data suggest that the acupuncturist volunteers were reasonably
representative of the members of the two societies, but
over-reporting and under-reporting are inherently possible in such
studies. High individual rates may be due to a low personal threshold
for reporting, or they may indicate the need for further training of
the acupuncturist. Some avoidable adverse events occurred, and
acupuncturists might consider modifying their practice to reduce the
incidence of such events.
|
|
Acknowledgments |
We thank members of the British Medical
Acupuncture Society and the Acupuncture Association of Chartered
Physiotherapists for collecting data, Mike Fitter and Hugh
MacPherson for advice in designing the questionnaire, and Val
Hopwood for help in recruiting volunteers.
Contributors: EE, SH, and AW planned the study, which was supervised by AW.
The data were collected by members of the British Medical Acupuncture Society
and the Acupuncture Association of Chartered Physiotherapists. The results were
collated by AW, and AH performed the statistical analysis. The final report was
written by AW, SH, AH, and EE. AW and EE will act as guarantors.
|
|
Footnotes |
Funding: The posts of AW and EE are funded by the Maurice Laing Foundation.
Competing interests: AW has received fees for lecturing at scientific and
educational meetings arranged by the British Medical Acupuncture
Society and the Acupuncture Association of Chartered Physiotherapists.
SH has received fees for lecturing and for acting as editor of the
professional journal of the British Medical Acupuncture Society, Acupuncture
in Medicine.
|
|
References |
|
|
|
1. |
Ernst E, White A. Life-threatening adverse reactions after
acupuncture? A systematic review. Pain 1997; 71: 123-126 |
|
2. |
White AR, Hayhoe S, Ernst E. Survey of adverse events
following acupuncture. Acupunct Med 1997; 15: 67-70 |
|
3. |
Edwards RI, Aronson JK. Adverse drug reactions:
definitions, diagnosis, and management. Lancet 2000; 356: 1255-1259 |
|
4. |
Eypasch E, Lefering R, Kum CK, Troidl H. Probability of
adverse events that have not yet occurred: a statistical reminder. BMJ
1995; 311: 619-620 |
|
5. |
British Medical Association Ethics. Medical ethics
today. Its practice and philosophy. London: BMA Professional Division
Publications, 1993. |
(Accepted 17 May 2001)
|
|||||||
|
|
Related editorials in BMJ:
The safety of acupuncture.
Charles Vincent
BMJ 2001 323: 467-468.
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.