Acupuncture research: strategies for developing the evidence without distorting the medicine

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Acupuncture researchstrategies for developing
the evidence without distorting the medicine

• Hugh MacPherson
• Senior Research Fellow
• Department of Health Sciences
• hm18_at_york.ac.uk

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Effectiveness gaps in primary care

• Based on survey of GP perceptions (n78)
• Musculoskeletal 95
• Depression 45
• Eczema 36
• Chronic pain 32
• Irritable bowel 32
• Fisher 2004

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Reasons for consulting acupuncturists

• Based on survey of GP perceptions (n78)
• Musculoskeletal 95
• Depression 45
• Eczema 36
• Chronic pain 32
• Irritable bowel 32
• Fisher 2004

MacPherson et al 2006
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BUT ..

• How do we translate the results we see in the
  clinic into evidence!!!!

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Route maps to evidence




Drug model
Mechanism - physiological



-
month follow
-
up


Efficacy RCT with placebo
Responses

146 (92)



12
-
month follow
-
up

Effectiveness comparative RCT

Responses

147 (92)

RCT randomised controlled trial
Safety pharmacovigilance
24
-
month follow
-
up


Responses

123 (77)


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Why use the RCT?

• Key reasons are
• Control for natural history of the disease
  (people tend to recover anyway)
• Attribute change to intervention (minimise bias)
• Maximising the internal validity

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RCTs are good in theory, but where .

• Narrow understanding of acupuncture
• defined as simple intervention
• acupuncture as needling only
• individualisation compromised
• (may underestimate acupuncture effect)
• Use of physiologically active sham controls
• (may overestimate the placebo effect)

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Internal validity of low back pain trials
Cochrane/van Tulder 1999
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Garvey et al 1989 paperAim to evaluate impact
of a single steroid injection for low back pain
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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.

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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 (or ecological validity)
• The degree to which the design and intervention
  can be generalised, i.e. real world applicability

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Comparing pragmatic and explanatory RCT
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Route maps to evidence




Drug model
CAM model
Safety
Mechanism



Effectiveness of package of care
-
month follow
-
up


Efficacy
Responses

146 (92)



12 month follow-up
Efficacy of components
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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Alternative frameworks for building an evidence
base

• Acupuncture as a complex intervention - a
  package of care
• Acupuncture as a whole system

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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 RCTs 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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Taking acupuncture as it is practised in routine
care,we set out to test the hypothesis that.

• . primary care patients with persistent low
  back pain, when given access to an acupuncture
  service, gain more relief from pain than those
  offered usual management only, for equal or less
  cost.

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Interviews with acupuncturists a qualitative
sub-study

• Six acupuncturists
• One hour interviews
• Topic guide
• Analysed using Framework
• A priori themes
• Emergent themes

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Key therapeutic components beyond needling that
are characteristic of acupuncture

• Building a therapeutic relationship
• Establishing rapport.
• Facilitating two-way communication
• Individualising of treatment
• Matching treatment to diagnosis
• Facilitating patients active involvement in
  self-management of their healthcare.

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The role of advice/support on self-care as a
specific component of acupuncture

• Identifying categories of self-care advice from
  the diagnosis
• Providing explanations based on theory
• Facilitating patient active engagement
• Supporting sustained long-term change

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Example from an interview with a practitioner

• When talking about advice. much involves
  discussion of aetiological factors and
  precipitating factors, helping the patient
  discover their own patterns so that they can be
  empowered to introduce necessary changes into
  their lives. This kind of change is likely to be
  long lasting as it is self motivated and has
  meaning.

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SF-36 Bodily Pain score adjusted for baseline
Diff 8 pts P 0.032
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SF-36 Bodily Pain score adjusted for baseline
Diff 8 pts P 0.032
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Worry about back pain at 24 months (compared to
baseline)
Diff. between groups Plt0.001
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NHS and total social costs (mean cost/patient at
24 months)

• Estimated cost per QALY gained 4,241
• Taking 20,000 as the NICE threshold,

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Acupuncture for IBS

• IBS is not well treated in primary care
• Many patient consult for acupuncture
• The evidence base is weak

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Acupuncture for IBS a pilot study

• 30 Patients recruited from primary care
• 20 receive usual GP care
• 10 receive acupuncture plus usual GP care
• Acupuncture consists of up to 10 sessions
• 4 Five Element practitioners (9 patients)
• 1 TCM practitioner ( 1 patient)

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IBS trial acupuncture plus usual GP care vs.
usual GP care alone
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The context of routine acupuncture

• a complex intervention - a package of healthcare
• needling is only one component of acupuncture
• active impact of practitioner
• patient participation
• individualised care
• self-care advice - a long term approach
• indivisibility of specific and non-specific
  effects
• interactions - synergy

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Strategies for appropriate evaluation

• the importance of pragmatic RCT designs
• defining the scope of treatment
• the need to consider both external and internal
  validity
• the need for longer-term outcomes
• the impact of cost-effectiveness
• the role of qualitative research