is the use of sham acupuncture valid as a placebo-control in randomized controlled clinical trials?...
TRANSCRIPT
Is the use of sham acupuncture valid as a
placebo-control in randomized controlled clinical trials?
Iréne Lund, Jan Näslund, Thomas LundebergDepartment of Physiology and Pharmacology, Karolinska Institutet,
Stockholm, SwedenFoundation for Acupuncture and Alternative Biological Treatment
Methods, Sabbatsbergs Hospital, Stockholm, Sweden
An evidence based challenge• Randomized, placebo-controlled clinical trials are recommended for
evaluation of a treatment’s efficacy with the goal of separating the specific effects (verum) from the non-specific ones (placebo).
• In order to be able to carry out placebo-controlled randomized trials with acupuncture, a sham acupuncture needle was introduced.
• Clinical studies have reported that both verum acupuncture and sham/minimal acupuncture induce a significant alleviation of migraine headache, low back pain and knee osteoarthritis pain.
• Minimal and sham acupuncture sets up activity in afferent nerve fibers, as verum acupuncture does, and induces a modulation of the activity in many of the same brain structures as verum acupuncture.
Percentage responder rates migraine
The portion of patients (%) reporting decreased frequency of days with migraine headache
0
10
20
30
40
50
60
70
80
90
100
Acupu
nctu
re
Min
imal
acupu
ncture
Wai
ting l
ist
Flunar
izin
5mg
Flunar
izin
10m
g
Propa
nolol
Propa
nolol
Placeb
o tab
let
Acupu
nctu
re
Met
opro
lol
Acupu
nctu
re
Min
imal
acupu
ncture
Standar
d Med
icatio
n
%
Linde 2005 [58],n=302
Diener 2002 [56],n=808
van Der Kuy 2002 [57],n=2013
Streng 2006 [60],n=114
Diener 2006 [59],n=960
The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.
Percentage responder ratesknee osteoarthritic pain
Portion of patients (%) reporting decreased knee osteoarthritis pain and increased function
0
10
20
30
40
50
60
70
80
90
100
Acupu
nctu
re
Min
imal
acupu
ncture
Wai
ting l
ist
Acupu
nctu
re
Min
imal
acupu
ncture
Standar
d trea
tmen
t
Acupu
nctu
re
Standar
d trea
tmen
t
%
Witt 2005 [64],n=294
Scharf 2006 [65],n=1007
Witt 2006 [66],n=712
The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.
Percentage responder rates low back pain
The portion of patients (%) reporting decreased low back pain and increased funktion
0
10
20
30
40
50
60
70
80
90
100
Acupu
nctu
re
Min
imal
acupu
ncture
Wai
ting l
ist
Acupu
nctu
re
Min
imal
acupu
ncture
Standar
d trea
tmen
t
Acupu
nctu
re
Standar
d trea
tmen
t
%
Brinkhaus 2006 [61],n=298
Haake 2007 [63],n=1162
Witt 2006 [62],n=3093
The figures are modified after a power point presentation of Dr M. Cummings and with the permission of Dr K. Linde.
Conclusion
• Acupuncture is not a standardized treatment and there is no verum acupuncture.
• Sham acupuncture is not inert and should therefore not be used as a placebo-control in RCTs for the test of efficacy, i.e. the present research paradigm (verum vs sham acupuncture) may be questioned as not valid. Instead of reducing bias it introduces a bias against the findings of the tested treatment.
• The use of observational research design is a way to evaluate the clinical effectiveness of acupuncture effects.