Transcript Complementary and Alternative Medicine (CAM)

Strategies for
acupuncture research
Hugh MacPherson
Research Director
Foundation for Traditional Chinese Medicine
York
Senior Research Fellow
Department of Health Sciences
University of York
1
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
2
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
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Route maps to evidence …
Drug model
mechanism
- month follow -up
efficacy
Responses = 146 (92%)
12- month follow -up
effectiveness
Responses = 147 (92%)
24- month
follow -up
safety
Responses = 123 (77%)
4
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)
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Bandolier 1999
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Internal validity of low back
pain trials – Cochrane/van Tulder 1999
Internal validity score out of 9
Garvey et al
7
Duplan et al
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Mendelson et al
5
Edelist et al
4
Gunn et al
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MacDonald et al
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Lehmann et al
3
Lopacz & Gralewski
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Thomas & Lundberg
3
Von Menke et al
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Coan et al
2
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Coan et al 1980 paper:
Aim: 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”.
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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 paper:
Aim: 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 causeand-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
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Route maps to evidence …
Drug model
CAM model
mechanism
safety
- month follow -up
efficacy
Responses = 146 (92%)
effectiveness
12- month follow -up
effectiveness
Responses = 147 (92%)
12 – month
follow-up
efficacy
24- month
follow -up
safety
Responses = 123 (77%)
Responses = 68 (85%)
24- mechanism
month follow -up
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 loss”1
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
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