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PC2/2009/Oct/CAM ToT V5 - 1
Complementary and Alternative Medicine
(CAM)
Trick or Treatment?Edzard Ernst
Complementary MedicinePeninsula Medical School
Universities of Exeter & Plymouth, UKEmail: [email protected]
Website: www.pms.ac.uk/compmed
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Background
• Large proportions of the general population use CAM
• For patient populations, the figures are much higher
• In the UK we spend ~ £1.6 billion on CAM each year (>90% out of our own pocket)
• Even the most fundamental questions remain unanswered
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Trick or Treatment?
- How can we find out?
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• Plausibility
• The test of time
• Ask the patient
• Do the research
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Plausibility
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• Acupuncture
• Chiropractic
• Homeopathy
• Reflexology
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Yin Yang
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Daniel David Palmer
“95 % of all diseases are caused by subluxations”
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“like cures like”
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Reflexology foot map
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1) Some implausibilities turned out to be true (and some plausibilities to be false)
2) A theory can be wrong but the treatment might still be effective
But …
… implausible does not always mean false!
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So …
… implausibility can be an indicator but not a proof
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The test of time:
“What has been around for hundreds of years must be OK”
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“Experience is the name we give to our mistakes”
(Oscar Wilde)
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Ask the patient
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Hierarchy of evidence: the patient’s perspective
Verhoef M. 11th Annual Symposium on Complementary Healthcare
Gutfeelings
Trial and error
Anecdotal evidence
Popular press
Scientific evidence
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Problem: the complexity of the therapeutic response
TreatmentTreatment
PTR
Pain Pain
intensityintensity
(PTR = (PTR = perceived therapeutic response)therapeutic response)TimeTime
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Assumption: PTR was caused by the treatment
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Assumption: PTR was caused by the treatment
…a somewhat naïve idea
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The perceived therapeutic effect
Specific effect of therapy
True placebo-effect
Clinician-patientinteraction
Natural history
Regression towards themean
Social desirability
Concomittent therapies
Other context effects
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Do the research
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“Let us take.. 200 or 500 poor people that have fever… Let us divide them into two halves, let us cast lots… I will cure them without bloodletting… but you do as ye know… We shall see how many funerals we both shall have.”
The man who first suggested a controlled clinical trial
Jan Babtist van Helmont 1662
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… 147 years later…
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Sample:
Method:
Result:
366 soldiers with various conditions
Alternating allocation to 3 groups.
A)Treated by Hamilton without blood letting
B) Treated by Anderson without bloodletting
C) Treated with bloodletting.
Death rates A) 4B) 2C) 35
Hamilton’s trial of bloodletting (1809)
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Scurvy in the 18th century• Killed many 100 thousand sailors• Cause was unknown• Many treatments had been tried:
- blood letting- mercury- saltwater- vinegar- sulphuric acid- hydrochloric acid- Moselle Wine- burying patient in sand- hard labour
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The first controlled clinical trial
Date: 20 May 1747
Primary investigator: Dr. James Lind
Condition: scurvy (purid gums, lassitude with weakness of their knees)
Design:
N=12
2 sailors: a quart of cider2 sailors: 3x25 drops of elixir of vitriol2 sailors: 3x2 spoonful of vinegar 2 sailors: ½ pint of seawater2 sailors: paste of garlic, mustard, radish root and gum myrrh2 sailors: 2 oranges and a lemon
Treatment period: 6 days
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Acupuncture for knee osteoarthritis
Design:
Sample:
Intervention:
Primary outcome measure:
Main results:
RCT, sham-controlled
570 patients
A) Regular acupuncture or B) sham-acupuncture or C) education
Pain
A Improved pain significantly better than B
Berman B, et al. Ann Intern Med 2004; 141: 901
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Imagine a body of evidence (e.g. 100 RCTs)
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50 suggest efficacy
50 fail to suggest efficacy
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suggest efficacy
fail to suggest efficacy
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Such an approach is called a “ Systematic
Review”
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Two conditions are evidence-based
•Some forms of pain
•Nausea/ vomiting
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“95 % of all diseases are caused by displaced
vertabrae, the remainder by subluxations of other joints”
DD Palmer
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Chiropractic: non-spinal conditions
“…chiropractic spinal manipulation cannot be considered an effective treatment”
42Hypertension
“There is no evidence to suggest that chiropractic is effective…”
89CTS
“…there is insufficient evidence…”?Fibromyalgia
“No evidence”?Otitis
“No evidence to support the use of chiropractic SM”57Asthma
“…no convincing evidence…”63Infant Colic
“There is no evidence that SM is effective”63Dymenorrhoea
Conclusion of systematic reviews%Condition
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Chiropractic: non-spinal conditions (SRs)
“…chiropractic spinal manipulation cannot be considered an effective treatment”
42Hypertension
“There is no evidence to suggest that chiropractic is effective…”
89CTS
“…there is insufficient evidence…”?Fibromyalgia
“No evidence”?Otitis
“No evidence to support the use of chiropractic SM”57Asthma
“…no convincing evidence…”63Infant Colic
“There is no evidence that SM is effective”63Dymenorrhoea
Conclusion of systematic reviews%Condition
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American Chiropractic AssociationBritish Chiropractic AssociationCanadian Chiropractic AssociationChiropractic Patients Association (US)International Chiropractors Association
Organisations promoting chiropractic for asthma (Oct-Nov 2008)
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Risks of chiropractic spinal manipulation
~ 50% mild to moderate adverse effects (not disputed)
+Several hundred cases of
severe complications (hotly disputed)
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harm
benefit
More good than harm?
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•Like cures like
•Less is more
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The homeopathic dose
0
10
20
30
40
50
60
70
80
90
100
D0 D1 D2 D3 D4
“potency”
%
%
%
%
%
%
%
%
%
%
concentration
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The results… do not suggest that homeopathic arnica has an advantage
over placebo
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The results… do not suggest that homeopathic arnica has an advantage
over placebo
Later confirmed by two independent systematic reviews of all 8 RCTs on
the subject
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But this is not individualised homeopathy!
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…no evidence that adjunctive homeopathic
remedies… are superior to placebo…
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…but this is just one of many RCTs…
(remember: distrust the “cherry pickers”)
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…the best evidence… does not warrant positive
recommendations for its [homeopathy’s] use in
clinical practice.
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Harm?
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Google searches: swine
flu/homeopathy
0
9
26
50
0
10
20
30
40
50
60
18/04/2009
19/04/2009
20/04/2009
21/04/2009
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25/04/2009
26/04/2009
27/04/2009
28/04/2009
29/04/2009
30/04/2009
01/05/2009
02/05/2009
Thousand hits
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harm
bene
fit
More
good th
an h
arm
?
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So far so good?
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St John’s wort
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“…Hypericum is a safe and effective symptomatic
treatment for…depression.”
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“…Hypericum is a safe and effective symptomatic
treatment for…depression.”
Meanwhile: ~ 40 RCTs
~12 systematic reviews
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SJW – organ transplantation
Ernst Arch Surgery 2002, 137: 316
Design:
Sample:
Results:
systematic review
76 case reports of SJW-cyclosporine interactions after organ transplant
•no doubt about causality•several life-threatening situations•high costs
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Reflexology foot map
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Reflexology
Ernst MJA 2009, 191: 263
Design:
Sample:
Results:
Conclusion
systematic review
18 Randomised clinical trials
•Trials were in 13 different areas•Independent replications were rare•Methodological quality was mostly poor•5 studies were positive, 1 were negative
“The best evidence… does not demonstrate… that reflexology is an effective treatment for any medical condition.”
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Massage therapy for cancer palliation
Ernst Support Care Cancer 2009
Design:
Sample:
Results:
systematic review
14 RCTs
Massage therapy improves the following symptoms•Pain•Nausea•Anxiety•Depression•Anger•Stress•fatigue
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Conclusion