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Complementary and Alternative Medicine _CAM_

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Complementary and Alternative Medicine _CAM_ Powered By Docstoc
					     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

                                       3
    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)

                                         5
Bandolier 1999   6
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                   7
   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”.



                                         8
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                   9
   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%


                                             10
    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



                                                      11
    Route maps to evidence …
   Drug model              CAM model
   mechanism                  safety



 - month follow -up
      efficacy            effectiveness
Responses = 146 (92%)




12- month follow -up      12 – month follow-up
                               efficacy
   effectiveness         Responses = 68 (85%)
Responses = 147 (92%)



 24- month follow -up
       safety                month follow -up
                         24- mechanism
 Responses = 123 (77%)   Responses = 59 (73%)

                                                 12
 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
    RCTs for complex interventions, 2000

                                                             13
    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


                                           14
     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.

                                                             15
  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


                                        16
  Strategic directions ….


Acupuncture as a complex intervention

Evaluation of acupuncture as a whole
system




                                        17