Acupuncture and the RCT: Developing the evidence for acupuncture, without losing key characteristics of the medicine

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Acupuncture and the RCTDeveloping the evidence
for acupuncture, without losing key
characteristics of the medicine

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

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Complementary and Alternative Medicine CAM

• Three quarters of the population think CAM should
  be available on the NHS
• 90 of the population access CAM outside the NHS
• Source Foundation for Integrated Health

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Numbers of practitioners

• 50,000 CAM practitioners
• 10,000 acupuncture practitioners - approx
• 2500 doctors (BMAS)
• 2500 physios (AACP)
• 2500 acupuncturists (BAcC)
• 2500 Chinese shop practitioners (unregulated)
• House of Lords Report

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Style of acupuncture practised in the UK by BAcC
members

• TCM 67
• Five Element 57
• Eight Principle 28
• Japanese 7
• Other 9
• Dont know 4
• White E 2000

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Underlying principles of acupuncture

• Diagnosis of imbalance
• Catalyst for change
• Leads to self-healing
• Goal of longer-term impact

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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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Why use the randomised controlled trial (RCT) for
evidence of effectiveness?

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

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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)

safety
24
-
month follow
-
up


Responses

123 (77)


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Comparing pragmatic and explanatory RCT
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The trade of between 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

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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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Health Technology Assessment Call for proposals
1997

• Does acupuncture have long term effectiveness in
  the management of pain in primary care?

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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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Treatments received during first three months
from recruitment
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SF-36 Bodily Pain score adjusted for baseline
Diff 5 pts P 0.129
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SF-36 Bodily Pain score adjusted for baseline
Diff 6 pts P 0.111
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SF-36 Bodily Pain score adjusted for baseline
Diff 8 pts P 0.032
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At randomisationDo you believe that
acupuncture can help your low back pain?
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At randomisationDo you believe that
acupuncture can help your low back pain?
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Worry about back pain at 24 months (compared to
baseline)
Diff. between groups Plt0.001
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Clinical summary

• Primary outcome
• Better pain scores (clinical and statistical
  significance at 24 months)
• Secondary outcomes
• Trend in favour of acupuncture some statistical
  significance
• Cost-effectiveness .. ?

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NHS and total social costs (mean cost/patient at
24 months)
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Cost utility over 24 months

• Estimated cost per QALY gained 4,241
• Taking 20,000 as the NICE threshold, then
  acupuncture for low back pain appears highly
  cost-effective.

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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 features of an acupuncture consultation (for
acupuncturists)

• 1. Building a therapeutic relationship
• 2. Individualising of treatment
• 3. Facilitating patients active involvement.

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1. The therapeutic relationship

• 1.1 Establishing rapport.
• One acupuncturist talked about trying to really
  meet the patient where they are
• 1.2 Facilitating two-way communication.
• (I) would try to make sure that Im open to the
  big picture all of the time
• 1.3 Utilising explanations
• (using) words they make a lot of sense to people
  and cycles the basic nature of the Chinese
  medical model

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2. The importance of individualising

• 2.1 Diagnostic processes
• glean you know what their orientations in life
  is in a sense and feel whether its basically
  healthy within the terms of the Chinese model.
  
• 2.2 Matching treatment to the diagnosis
• in terms of building a good relationship .
  the whole needling process is quite important if
  it is pitched at the right level.

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3. Facilitating patients active involvement.

• 3.1 Engaging with patients attitudes
• variability in the extent to which patients were
  willing to take responsibility for getting
  better.
• 3.2 Helping patients become actively involved
• The goal of more long-lasting treatment was
  identified as important by most of the
  practitioners.
• One practitioner talked about always trying to be
  open to the big picture all of the time, so
  there's room for it, at least in my
  consciousness, and I really listen, I really
  listen to what they are saying.

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Emergent meta themes

• a whole system approach to healthcare
• a complex intervention
• individualised care
• indivisibility of specific and non-specific
  effects (sometimes called context effects)
• a long term approach

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Conclusions

• It is possible to conduct a pragmatic RCT of
  individualised acupuncture in primary care.
• A short course of acupuncture confers long-term
  clinical and cost benefits
• Results are unlikely to be due to belief
• The acupuncturists were able to provide the key
  characteristics of treatment

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Acknowledgements re back pain trial

• NCCHTA
• Patients
• Acupuncturists
•  
• Patient representative
• David Laverick
• Advisory Board
• Trevor Sheldon (chair)
• Sally Bell?Syer

• Research Team
•  
• Kate Thomas (PI)
• Lucy Thorpe
• Mark Roman
• Julie Ratcliffe
• John Brazier
• Mike Fitter
• Mike Campbell
• Ann Morgan
• Liz Oswald
• Helen Wilkinson
• Jon Nicholl