Research strategies for building a relevant evidence base for CAM

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Research strategies for building a relevant
evidence base for CAM
Hugh MacPherson
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Complementary medicine kills (1997)
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A total of five fatalities are documented in the
literature (Schiff 1965 Pierik 1982 Ogata et al
1992 Halvorsen et al 1995).
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BMJ VOLUME 2001 323 486-487.
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2001 safety survey BMJ editorial

• Acupuncture is safe in the hands of competent
  practitioners
• Charles Vincent BMJ 2001323467-8

BMJ VOLUME 2001 323 485-486.
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Since acupuncture is used as a complete medical
system, . a sinister underlying cause. (may be)
missed
With depressing regularity we hear of.delayed
access to potentially life-saving conventional
treatment.
(Practitioners) . have the unfortunate habit of
doing this (changing prescribed medication).
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Since acupuncture is used as a complete medical
system, . a sinister underlying cause. (may be)
missed
With depressing regularity we hear of.delayed
access to potentially life-saving conventional
treatment.
(Practitioners) . have the unfortunate habit of
doing this (changing prescribed medication).
8
Since acupuncture is used as a complete medical
system, . a sinister underlying cause. (may be)
missed
With depressing regularity we hear of.delayed
access to potentially life-saving conventional
treatment.
(Practitioners) . have the unfortunate habit of
doing this (changing prescribed medication).
9
Since acupuncture is used as a complete medical
system, . a sinister underlying cause. (may be)
missed
With depressing regularity we hear of.delayed
access to potentially life-saving conventional
treatment.
(Practitioners) . have the unfortunate habit of
doing this (changing prescribed medication).
10
Data collection in the two surveys

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Did your acupuncturist advise you to consult
your GP or a hospital specialist?

• 660 (10) reported yes
• 5527 (87) patients reported no, of whom
• 2 patients report adverse consequences
• - 1 patient cost of ineffective
  acupuncture for jaw pain, subsequent tooth
  extraction (3611)
• - 1 patient prolonged urinary tract
  infection, subsequent antibiotics (6348)

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Did your acupuncturist advise you to reduce or
stop taking medication prescribed by your doctor?

• 196 (3) patients reported yes of whom 6
  patients reported adverse consequences
• - hydrocortisone skin cream (4704)
• - antidepressant Seroxat (7122)
• - antidepressant Seroxat (7248)
• - antidepressant Setraline (8851)
• - hormone replacement therapy (8995)
• - medication unknown (9355)

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Would you be willing to have acupuncture again?

• 40
• 40 (0.6) of all 6348 patients
• had an adverse event
• and
• reported said that they would not want to
  have acupuncture again

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Main conditions treated by acupunture
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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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How much do we really know about conventional
treatments?Source BMJ Clinical Evidence
http//clinicalevidence.com/ceweb/about/systemati
c_reviews.jsp

• Based on evidence from 2500 treatments.
• 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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Explanatory vs pragmatic attitudes
Schwartz D, Lellouch J. Explanatory and pragmatic
attitudes in therapeutic trials. 1967
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Acupuncture for low back painSF-36 Pain scores
n241
Diff 5 pts P0.06
Diff 6 pts P0.06
Diff 8 pts P0.003
Thomas et al BMJ 2006
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Acupuncture for chronic headacheheadache scores
n401
Diff 3.9 pts P0.001
Diff 4.6 pts P0.0002
Vickers et al BMJ 2004
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Economic outcomes for acupuncture
NICE threshold 20,000 - 30,000 per QALY
gained
1 Wonderling et al BMJ 20042 Ratcliffe et al BMJ
2006
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IBS Symptom Severity Score (SSS) score at 3
months vs. IBS SSS score at baseline
Reynolds et al. Acupuncture in Medicine 2008.
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Pilot study acupuncture vs counselling vs usual
GP care alone
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How to research CAM in practice Model 1?

• Medical model
• CAM as simple intervention to replace drug
• Leaves existing GP-patient relationship same
• Efficacy and mechanism of CAM important

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Dominant model for establishing evidence (i.e.
for a new drug)
Screening
Mechanism
Efficacy - Phase I to III trials
Effectiveness Phase IV (longer term)
Safety in routine use
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How to research CAM in practice Model 2?

• CAM model
• CAM as a complex individualised intervention
• Treatment outcomes depend on specific processes
  e.g. patient-practitioner relationship
• Overall clinical and cost effectiveness important

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MRC model for evaluation of complex interventions
(2000)
MRC 2000
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New drug(product development)
CAM practice (in widespread use)
Screening
Utilisation
Mechanism
Safety
Efficacy
Effectiveness overall
Effectiveness
Component efficacy
Safety
Mechanism
Fonnebo et al. BMC Med Res Methodol. 2007
11(7)7.
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Challenges ahead

• Is acupuncture/CAM just a placebo?
• Can we influence research agenda towards a more
  clinically relevant context?
• How best to build research capacity in the field?

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GERAC Randomized Trials
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Standardised mean differences between sham
acupuncture and no treatment in pain
Sham acupuncture
Inert placebo
Hrobjartsson A, Götzsche P. NEJM
20013441594-1602
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Towards more and better research .

• Involving practitioners in research
• Collaborating with supportive academics
• Promoting research that is relevant to practice
• Building research capacity in the field