Acupuncture safety: what patients report on adverse events

1
Acupuncture safety what patients report on
adverse events

• Hugh MacPherson
• Foundation for Traditional Chinese Medicine
• York, UK.

2
The 2001 safety survey

• York acupuncture safety study prospective
  survey of 34,000 treatments by traditional
  acupuncturists
• Published BMJ 2001323486-7

3
2001 safety surveysample size

• 574 (31) British Acupuncture Council
  practitioners participated
• Almost all patients self-funded
• Adverse events reported over a one month period,
  covered 34,407 treatments

4
2001 safety survey results

• No serious adverse events
• 43 significant minor adverse events, a rate of 12
  per 10,000 treatments
• 10,920 mild transient reactions (1 in 3
  treatments)

5
2001 safety survey BMJ editorial

• Acupuncture is safe in the hands of competent
  practitioners
• Charles Vincent BMJ 2001323467-8

6
But what do patients say?

• .the one source of experience that remains
  largely ignored .
• Patients have a key role to play in
  identifying adverse events ..

Vincent Coulter QSHC 2002 11 76-80
7
What about delayed conventional diagnosis?

• Since acupuncture is used as a complete medical
  system, . a sinister underlying cause. (may be)
  missed
• Ernst E. 2001 Desktop Guide to Complementary
  Alternative Medicine

8
What about delayed conventional treatment?

• With depressing regularity we hear of.delayed
  access to potentially life-saving conventional
  treatment.
• Ernst E. 2001 Desktop Guide to Complementary
  Alternative Medicine

9
What about acupuncturists advising a change to
prescribed medication?

• (Practitioners) . have the unfortunate habit of
  doing this.
• Ernst E. 2001 Desktop Guide to Complementary
  Alternative Medicine

10
Aims of new survey to..

• Find out from patients their experience of
  adverse events
• Identify adverse events associated with
• Delayed conventional diagnosis or treatment
• Advice from acupuncturists about prescribed
  medication

11
What we planned to doa prospective patient
survey

• All 1955 practitioners of the British
• Acupuncture Council invited
• Identify up to 60 consecutive patients each
• Patients sign consent forms and send to centre
• Three month questionnaires sent direct to
  patients from centre
• Target of 30,000 consultations

12
Patient consent form

• Demographic data (age, sex)
• First time acupuncture?
• Treatment self-funded?
• Contact with General Practitioner?
• Experience of acupuncturist
• Any short-term reactions?

13
Three month questionnaire

• Checklist of significant adverse events
  (derived from previous surveys)
• Details about nature, severity, duration and
  outcome

14
Three month questionnaire

• Was the adverse event serious?
• Hospitalisation?
• Permanent disability?
• Life-threatening?
• Over the three months
• Number of treatments
• Contact with General Practitioner

15
Survey results

• 638 BAcC practitioners participated (33)
• 9,408 patients consented
• 6,348 three-month questionnaires received (67)
• reports covered 30,196 treatments

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About the patients

• 76 female 24 male
• 52 years average age
• 4 acupuncture paid by state
• 11 not had acupuncture before

17
Main conditions being treated
18
Pathway to acupuncture
19

Serious adverse events over three months

• Three events occurred
• Hospital admission 1
• patient, with advanced breast and secondary
  cancer, severe pain (8244)
• Life threatening 2
• patient became severely ill, experience was
  cathartic (3265)
• patient, two days after treatment, fell asleep at
  the wheel and crashed her car (5721)
• Permanent disability 0

20
Commonest significant events
Patients n 6348 No. events 1044
21
Did your acupuncturist advise you to reduce or
stop taking medication prescribed by your doctor?

• 196 (3) patients reported yes of whom 6
  patients reported adverse consequences
• - hydrocortisone skin cream (4704)
• - antidepressant Seroxat (7122)
• - antidepressant Seroxat (7248)
• - antidepressant Setraline (8851)
• - hormone replacement therapy (8995)
• - medication unknown (9355)

22
Did your acupuncturist advise you to consult
your GP or hospital specialist?

• 660 (10) reported yes
• 5527 (87) patients reported no, of whom 2
  patients report adverse consequences
• - 1 patient cost of ineffective
  acupuncture for jaw pain, subsequent tooth
  extraction (3611)
• - 1 patient prolonged urinary tract
  infection, subsequent antibiotics (6348)

23
Absolute risk

24
Relative risk

25
Would you be willing to have acupuncture again?

• 40 (0.6) of all 6348 patients
• had an adverse event
• and
• wouldnt want to have acupuncture again

26
Patients short-term reactions to acupuncture
(n9408)
27
Comparison of the two surveys

28
Comparison of serious events

29
Comparison of numbers of significant adverse
events

30
Comparison of frequency of short-term reactions

31
Limitations of the survey

• Not all practitioners participated
• Self-reporting by patients
• Sample too small for rare events
• No assessment of risk-benefit

32
Conclusions

• Serious adverse event rate is very low
• Low risk of indirectly caused adverse events
• Patients outside state health system are not at
  higher risk
• Despite adverse events, almost all willing to
  continue with acupuncture

33
Acknowledgements

•  
• 9,408 Patients
• 638 Practitioners

• Research Team
•  
• Hugh MacPherson
• Tony Scullion
• Kate Thomas
• Stephen Walters