Transcript School of Medicine PP

Complementary and
integrative Medicine;
The Research Agenda
George Lewith – Professor of Health Research
www.cam-research-group.co.uk
School for Primary Care Research
What is CAM?
• A complex whole system intervention, but so is much
of conventional medicine
• Individualised and prioritises patient-centred needs
• Involves mind body, hands on and medication based
therapies, e.g.
– Acupuncture/massage
– Nutritionals, herbals and homeopathics
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• Uses unique and unconventional conceptual
frameworks to diagnose and attribute disease
causation (TCM)
• Using the pharmaceutical model may lead to
inappropriate research designs;
– Placebo for spiritual healing
– Placebos for acupuncture
– Undervaluing the unique power of the CAM
consultation
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How much do we really know?
BMJ Clinical Evidence
http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp
• Commonly used
interventions supported
by good evidence from
2500 treatments.
Beneficial 15
Likely to be beneficial 22
Trade off benefits and harm 7
Unlikely to be beneficial 5
Ineffective or harmful 4
Unknown effectiveness 47
• “The figures suggest that
the research community
has a large task ahead and
that most decisions about
treatments still rest on the
individual judgments of
clinicians and patients.”
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Patient use is widespread in chronic illness
• Arthritis 70%
• IBS 50%
• Inflammatory bowel disease 30%
• Fibromyalgia 90%
And managing chronic illness medically is expensive
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Practitioners’
“mindlines”
Patient’s
view
Gabbay & Le May BMJ 329, 2004
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Conventional pharmaceutical
development
Screening of chemical substances
Suggested models
for CAM research
Biological mechanisms
Biological mechanisms
Phase I trials
Phase II trials
Phase III trials
Component efficacy
Comparative effectiveness
Safety status
Context, paradigms,
philosophical understanding,
and utilization
Clinical practice
Clinical practice
Fonnebo et al, BMC Medical Research Methodology, 2007
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The relationship between the research question and the
corresponding study design (Witt 2009)
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RAWLINS 2008. NICE
• Decisions about the use of therapeutic interventions,
whether for individuals or entire healthcare systems,
should be based on the totality of the available
evidence. The notion that evidence can be reliably or
usefully placed in ‘hierarchies’ is illusory. Decision
makers need to exercise judgement about whether
(and when) evidence gathered from experimental or
observational sources is fit for purpose.
• Recommends more complex observational studies and
Bayesian analysis.
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The challenges of investigating
complementary medicine
(Kings Fund Report 2008)
• The context of the intervention
• The importance of a person centred not a disease centred
approach
• The complex relationship between cause and effect
• Understanding the non specific (placebo) effects and therapy
specific effects
• Being both pragmatic and rigorous about our research
endeavours
• Creating consensus around an open minded and patient (public )
centred research strategy
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The context of the intervention
Availability of treatment and belief may affect
our research
• Equipoise may influence outcomes from RCT’s
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Context and equipoise
(Kaptchuck, White & Lewith for Acupuncture)
Kaptchuck et al
White & Lewith
Condition
IBS >200
OA hip/knee >200
Intervention
RA vs SN
RA vs SN
Factor
Dose of ‘practitioner’ and empathy in the
consultation
Significant
Insignificant
Outcome
Confounders
Consent and belief destroy equipoise
and confound outcome
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A person centred approach?
• RA treated with homeopathy (RCT)
• Patients randomised to consultation (± homeopathy)
vs non consultation (± homeopathy)
• Homeopathic consultations produce a significant
change in EULAR
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“I’d like to go and see someone that was going
to deal with actually being ill, because that’s
what he [the homeopath] did, he …kind of took
the illness thing into perspective”
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Do we understand how it works?
• Acupuncture for addiction, pain and nausea may
invoke different physiological mechanisms needing
different types of trials.
• Homeopathy may work differently in acute and
chronic illness.
• Healing may all be about hope and expectation.
• Mind body therapies may simply allow us to reframe
chronic illness.
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What exactly should we evaluate?
Developing model validity (best Practice for Chinese
Herbal Medicines)
• Individualised or patented herbal preparations?
• Systematically review papers for TCM diagnosis and
herbal frequency of use
• Develop an expert consensus around the herbs, their
preparation dosage and treatment duration
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Improvement in outcome measures at
3 months from baseline in the acupuncture
in routine care trials
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Being both pragmatic and rigorous
about our research designs
The ATEAM trail evaluated dose and cost effectiveness
of Alexander Technique for back pain (BMJ 2008)
• Using qualitative methods to understand the patients
needs and perspective
• Pragmatic and comparative randomised trial to
evaluate risk, cost and clinical benefit
• Determining how beliefs impact treatment outcome
and managing this process
• Determining cost effectiveness
• Understanding the process (mechanism)
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RCT Design
No Exercise
Exercise
Control
Group1
Group5
Massage
Group2
Group6
6AT
Group3
Group7
24AT
Group4
Group8
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Creating consensus around an open,
involved and patient centred (public)
research strategy
• Defining the public health questions
• Maximising (ethically) the safe and non specific
effects of treatment
• Interpreting evidence thoughtfully
• Not assuming the absence of evidence is negative
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12 months individual groups function
Control: 9.2
24AT 45%***;
m
as
sa
ge
EP
+6
A
T
EP
+2
4A
T
e
EP
+
Ex
er
ci
s
24
A
T
T
6A
M
as
sa
ge
2
1
0
-1
Differenc -2
-3
e
-4
Roland
-5
score
E 18%*/-; E+M 26%*; E+6AT 32%** E+24AT 46%**
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Some thoughts
• CAM interventions are complex whole systems.
• Are they different to good conventional practice?
• Practitioners like me are often taught dogma so make
inappropriate assumptions about efficacy. I suspect this
often happens for all medical interventions
• Evaluating widely available treatments requires a
different strategy to new pharmaceuticals.
• Great care is needed in defining the research question.
• We have the technology to do this but do we have the
understanding?
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School for Primary Care Research
www.cam-research-group.co.uk
www.nspcr.ac.uk/index.cfm
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