Strategies for acupuncture research

1
Strategies for acupuncture research

• Hugh MacPherson
• Research Director
• Foundation for Traditional Chinese Medicine
• York
• Senior Research Fellow
• Department of Health Sciences
• University of York

2
Strategies for the clinical evaluation of
acupuncture

• Acupuncture as a simple intervention
• Route maps to evidence .
• Acupuncture as a complex intervention - a whole
  system approach

3
Problems with acupuncture research so far

• Mostly built on assumption that acupuncture is a
  simple intervention
• Inexperienced acupuncturists
• Inadequate acupuncture
• Over-emphasis on internal validity
• Compounded by poor reporting of the acupuncture
  trials

4
Route maps to evidence




Drug model
mechanism



-
month follow
-
up


efficacy
Responses

146 (92)



12
-
month follow
-
up

effectiveness

Responses

147 (92)

safety
24
-
month follow
-
up


Responses

123 (77)


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Acupuncture as a simple intervention

• Is there a single active ingredient? If so can it
  be isolated?
• Or if multiple active ingredients, can we divide
  up the intervention and measure each active
  ingredient separately?
• If so, then easier to attribute acupuncture to
  outcome - showing cause and effect (internal
  validity)

6
Bandolier 1999
7
Internal validity of low back pain trials
Cochrane/van Tulder 1999
Internal validity score out of 9
Garvey et al 7
Duplan et al 6
Mendelson et al 5
Edelist et al 4
Gunn et al 4
MacDonald et al 4
Lehmann et al 3
Lopacz Gralewski 3
Thomas Lundberg 3
Von Menke et al 3
Coan et al 2
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Coan et al 1980 paperAim to evaluate the
impact of acupuncture for low back pain

• Mode of therapy acupuncture was performed
  according to the classical Oriental meridian
  theory of promoting healing by stimulating the
  energy flow in the body.

9
Internal validity of low back pain trials
Cochrane/van Tulder 1999
Internal validity score out of 9
Garvey et al 7
Duplan et al 6
Mendelson et al 5
Edelist et al 4
Gunn et al 4
MacDonald et al 4
Lehmann et al 3
Lopacz Gralewski 3
Thomas Lundberg 3
Von Menke et al 3
Coan et al 2
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Garvey et al 1989 paperAim to evaluate impact
of a single steroid injection for low back pain
Improved
Lidocaine 40
Lidocaine plus steroid 45
Single dry needle (acupuncture) 61
Vapocoolant spray with acupressure 67
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Balancing internal and external validity

• Internal validity
• The degree to which the design establishes
  cause-and-effect between treatment and observed
  outcome, i.e. attribution
• External validity
• The degree to which the design and intervention
  can be generalised, i.e. real world applicability

12
Route maps to evidence




Drug model
CAM model
safety
mechanism



effectiveness
-
month follow
-
up


efficacy
Responses

146 (92)



12 month follow-up
efficacy
12
-
month follow
-
up

effectiveness

Responses

68 (85)
Responses

147 (92)

safety
mechanism
24
-
month follow
-
up

24
-
month follow
-
up

Responses

123 (77)
Responses

59 (73)


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Acupuncture as a complex intervention 1

• Medical Research Council
• the greater the difficulty in . defining
  precisely what are the active ingredients . the
  greater the likelihood you are dealing with a
  complex intervention.1
• 1 MRC A framework for the development and
  evaluation of RTCs for complex interventions, 2000

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Acupuncture as a complex intervention 2

• Reducing a complex intervention from its whole to
  its parts will result in an
• irretrievable loss1
• 1 MRC 2000

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Whole system research key features1

• treatment individualization,
• multiple components,
• patient-practitioner interaction,
• importance of therapeutic setting,
• patient-determined outcome values
• 1 Ritenbaugh C, Verhoef M, Fleishman S, Boon H,
  Leis A. Whole systems research a discipline for
  studying complementary and alternative medicine.
  Altern Ther Health Med. 2003 9(4)32-6.

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Whole system research challenges and
opportunities

• defining scope of treatment
• impact of practitioner
• active patient participation
• synergy between components
• long-term follow up
• optimising internal and external validity

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Strategic directions .

• Acupuncture as a complex intervention
• Evaluation of acupuncture as a whole system