I thank Mr Rose for his gracious apology and am glad that my previous
response has helped him focus. In turn, I offer my own apology for
imposing on his time to reply at length and with appeals to ‘authority’.
Old habits unfortunately, die hard.
Mr Rose’s complaint that supporters of CAM ‘continually wail’ not
enough research has been done is somewhat egregious, as many of them are
actually hard at work, uncomplainingly investigating CAM, and in a
research environment that is generally less well financed than most. The
only wailing to be heard is from various contributors to this and earlier
threads demanding a halt to further CAM research because of the
presumption that in many cases, ‘it shouldn’t work, therefore it cannot
work’.
This is especially so with homeopathy, and it might interest Mr Rose
to know that far from being ‘researched almost literally to death’, it is
actually very much alive. Not only is there growing evidence of
homeopathy’s therapeutic [1] and cost effectiveness [2, 3] (e.g., in the
treatment of long-term chronic conditions such as fibromyalgia), but over
500 clinical studies of homeopathy and over 1000 trials in biological and
physical systems have been performed world-wide of which around 60% show
evidence of efficacy [4]. Concerning RCTs - a technique by the way, which
was first pioneered by homeopaths as far back as the 1830’s [5] - of 134
published, 59 (44%) were positive (i.e., showed an effect beyond placebo);
67 (50%) were either inconclusive or showed a small positive effect; while
8 (6%) were negative. Of 23 systemic reviews published 10 have shown an
overall positive effect for homeopathy; 8 were inconclusive and 5 showed
little or no evidence of efficacy [6].
The odds here are generally in favour of homeopathy’s efficacy, but
perhaps Mr Rose was correct when in an earlier response, he pointed out
that RCTs have their limitations; an observation made rather more
forcefully by Smith and Pell in the conclusion to their paper on the use
of parachutes to prevent death by falling: ‘As with many interventions
intended to prevent ill health, the effectiveness of parachutes has not
been subjected to rigorous evaluation by using randomised controlled
trials. Advocates of EBM have criticised the adoption of interventions
evaluated by using only observational data. We think that everyone might
benefit if the most radical protagonists of EBM organised and participated
in a double blind, randomised, placebo controlled, crossover trial of the
parachute [7].
The points Mr Rose makes about Sackett’s statement suggest our
differences here could well hinge on how one interprets ‘….following the
trail to the next best external evidence and working from there’. This
depends on the emphasis placed on the statement’s previous clause ‘if no
RCT has been carried out for our patient’s predicament….’ [8]. Mr Rose
chooses to emphasise RCTs, but what about the phrase ‘our patient’s
predicament’? For what Sackett in a recondite way is saying (and which has
been pointed out previously in this thread) is that doctors, therapies,
even RCTs and Evidence-based Medicine (EBM) exist for the benefit of
patients and not the other way around.
No doubt Mr Rose would agree with this and might even think that I am
unnecessarily splitting hairs. But as Sackett was implying, the RCT was
originally intended as part of an evidence package within EBM that could
include patient-reported, and clinician observed evidence [9]. The
elevation of the RCT to an exclusively worshipped ‘golden calf’ of
evidence goes against the first part of what Sackett was saying and that
Mr Rose left out, ‘Evidence-based medicine is not restricted to randomised
trials and meta- analyses. It involves tracking down the best external
evidence with which to answer our clinical questions.....’, something that
chimes with the thrust of Sir Michael Rawlins’ Harveian oration [10].
So, we should ask ourselves: are we trying to answer clinical
questions for the benefit of our patient’s predicament, or are we serving
a scientific (perhaps even scientistic? [11]) ‘ideal’ of what some think
medicine ought to be? From this perspective, one can perhaps detect a note
of compassion in Sackett’s original formulation of EBM that now seems
sadly lacking in those who insist RCTs are the only acceptable form of
evidence of efficacy.
Finally, I agree wholeheartedly with Mr Rose that we should not
follow the dictats of charismatic individuals, nor are authorities to whom
one might appeal necessarily 100% correct. Dr Noel B Thomas’s quote from
Marcia Angell, the ex-editor of the New England Journal of Medicine about
her lack of belief in published clinical research provides a sobering
reminder of that [12]. And as the Enlightenment empirical philosopher John
Locke pointed out 320 years earlier, ‘For where is the man that has
uncontestable evidence of the truth of all that he holds, or of the
falsehood of all he condemns; or can say that he has examined to the
bottom all his own or other men’s opinions? The necessity of believing
without knowledge, nay often upon very slight grounds, in this fleeting
state of action and blindness we are in should make us more busy and
careful to inform ourselves than to restrain others….There is reason to
think that if men better instructed themselves, they would be less
imposing on others’ [13]; a suggestion that perhaps those who might wish
to ‘enforce’ RCTs on medicine [14] as the sole arbiter of a modality’s
efficacy – something which could ultimately deny patients their right of
therapeutic choice within the NHS - might usefully meditate upon.
References
1. Relton C, Smith C, Raw J, et al. Healthcare provided by a homeopath as
an adjunct to usual care for Fibromyalgia (FMS): results of a pilot
randomised controlled trial. Homeopathy. 2009, 98(2):77-82:
2. Witt CM,
Lüdtke R, Baur R, Willich SN. Homeopathic treatment of patients with
chronic low back pain – a prospective observational study with 2 years
follow-up. Clinical Journal of Pain 2009;25(4):334-9:
3. Witt CM, Lüdtke
R, Willich SN. Homeopathic treatment of patients with psoriasis – a
prospective observational study with 2 years follow-up. Journal of the
European Academy of Dermatology and Venereology 2009;23(5):538-43:
4. van
Wijk R, Albrecht H. Proving and therapeutic experiments in the HomBRex
basic homeopathy research database. Homeopathy 2007;96:252–257:
5.
Kaptchuk T (2004). Early use of blind assessment in a homoeopathic
scientific experiment. The James Lind Library, www.jameslindlibrary.org:
7. Smith GCS and
Pell JP. Parachute use to prevent death and major trauma related to
gravitational challenge: systematic review of RCTs. BMJ 2003;327:1459-
1451:
8. Sackett, DL., Rosenberg WMC, Muir Gray JA, et al. (1996) Evidence
based medicine: what it is and what it isn't. BMJ 1996; 312 (7023): 71-2.:
9. McKibbon, KA, Wilczynski N, Hayward RS, et al. The medical literature
as a resource for evidence based care. Working paper from the Health
Information Research Unit, McMaster University, Ontario, Canada, 1995:
10.
Rawlins M. De Testimonio: On the evidence for decisions about the use of
therapeutic interventions.The Harveian Oration, delivered before the Royal
College of Physicians of London, 16th October 2008, ISBN 978-1-86016-3470:
11. Okasha S. Philosophy of science: a very short introduction. Oxford
University Press, 2002, pp13-17:
12. Angell, M. ,The New York Review of
Books, Volume LV1, Number 1; January 15th, 2009:
13. Locke J. Essay
concerning human understanding, edited with an introduction by Nidditch
PH, Oxford University Press (paperback) 1979:
14. Holmes D, Murray SJ,
Perron A, Rail G. Deconstructing the evidence- based discourse in health
sciences: Truth, power, and fascism. International Journal of Evidence
Based Healthcare 2006;4:180.
Rapid Response:
Re: Misuse of scientific authorities
I thank Mr Rose for his gracious apology and am glad that my previous
response has helped him focus. In turn, I offer my own apology for
imposing on his time to reply at length and with appeals to ‘authority’.
Old habits unfortunately, die hard.
Mr Rose’s complaint that supporters of CAM ‘continually wail’ not
enough research has been done is somewhat egregious, as many of them are
actually hard at work, uncomplainingly investigating CAM, and in a
research environment that is generally less well financed than most. The
only wailing to be heard is from various contributors to this and earlier
threads demanding a halt to further CAM research because of the
presumption that in many cases, ‘it shouldn’t work, therefore it cannot
work’.
This is especially so with homeopathy, and it might interest Mr Rose
to know that far from being ‘researched almost literally to death’, it is
actually very much alive. Not only is there growing evidence of
homeopathy’s therapeutic [1] and cost effectiveness [2, 3] (e.g., in the
treatment of long-term chronic conditions such as fibromyalgia), but over
500 clinical studies of homeopathy and over 1000 trials in biological and
physical systems have been performed world-wide of which around 60% show
evidence of efficacy [4]. Concerning RCTs - a technique by the way, which
was first pioneered by homeopaths as far back as the 1830’s [5] - of 134
published, 59 (44%) were positive (i.e., showed an effect beyond placebo);
67 (50%) were either inconclusive or showed a small positive effect; while
8 (6%) were negative. Of 23 systemic reviews published 10 have shown an
overall positive effect for homeopathy; 8 were inconclusive and 5 showed
little or no evidence of efficacy [6].
The odds here are generally in favour of homeopathy’s efficacy, but
perhaps Mr Rose was correct when in an earlier response, he pointed out
that RCTs have their limitations; an observation made rather more
forcefully by Smith and Pell in the conclusion to their paper on the use
of parachutes to prevent death by falling: ‘As with many interventions
intended to prevent ill health, the effectiveness of parachutes has not
been subjected to rigorous evaluation by using randomised controlled
trials. Advocates of EBM have criticised the adoption of interventions
evaluated by using only observational data. We think that everyone might
benefit if the most radical protagonists of EBM organised and participated
in a double blind, randomised, placebo controlled, crossover trial of the
parachute [7].
The points Mr Rose makes about Sackett’s statement suggest our
differences here could well hinge on how one interprets ‘….following the
trail to the next best external evidence and working from there’. This
depends on the emphasis placed on the statement’s previous clause ‘if no
RCT has been carried out for our patient’s predicament….’ [8]. Mr Rose
chooses to emphasise RCTs, but what about the phrase ‘our patient’s
predicament’? For what Sackett in a recondite way is saying (and which has
been pointed out previously in this thread) is that doctors, therapies,
even RCTs and Evidence-based Medicine (EBM) exist for the benefit of
patients and not the other way around.
No doubt Mr Rose would agree with this and might even think that I am
unnecessarily splitting hairs. But as Sackett was implying, the RCT was
originally intended as part of an evidence package within EBM that could
include patient-reported, and clinician observed evidence [9]. The
elevation of the RCT to an exclusively worshipped ‘golden calf’ of
evidence goes against the first part of what Sackett was saying and that
Mr Rose left out, ‘Evidence-based medicine is not restricted to randomised
trials and meta- analyses. It involves tracking down the best external
evidence with which to answer our clinical questions.....’, something that
chimes with the thrust of Sir Michael Rawlins’ Harveian oration [10].
So, we should ask ourselves: are we trying to answer clinical
questions for the benefit of our patient’s predicament, or are we serving
a scientific (perhaps even scientistic? [11]) ‘ideal’ of what some think
medicine ought to be? From this perspective, one can perhaps detect a note
of compassion in Sackett’s original formulation of EBM that now seems
sadly lacking in those who insist RCTs are the only acceptable form of
evidence of efficacy.
Finally, I agree wholeheartedly with Mr Rose that we should not
follow the dictats of charismatic individuals, nor are authorities to whom
one might appeal necessarily 100% correct. Dr Noel B Thomas’s quote from
Marcia Angell, the ex-editor of the New England Journal of Medicine about
her lack of belief in published clinical research provides a sobering
reminder of that [12]. And as the Enlightenment empirical philosopher John
Locke pointed out 320 years earlier, ‘For where is the man that has
uncontestable evidence of the truth of all that he holds, or of the
falsehood of all he condemns; or can say that he has examined to the
bottom all his own or other men’s opinions? The necessity of believing
without knowledge, nay often upon very slight grounds, in this fleeting
state of action and blindness we are in should make us more busy and
careful to inform ourselves than to restrain others….There is reason to
think that if men better instructed themselves, they would be less
imposing on others’ [13]; a suggestion that perhaps those who might wish
to ‘enforce’ RCTs on medicine [14] as the sole arbiter of a modality’s
efficacy – something which could ultimately deny patients their right of
therapeutic choice within the NHS - might usefully meditate upon.
References
1. Relton C, Smith C, Raw J, et al. Healthcare provided by a homeopath as
an adjunct to usual care for Fibromyalgia (FMS): results of a pilot
randomised controlled trial. Homeopathy. 2009, 98(2):77-82:
2. Witt CM,
Lüdtke R, Baur R, Willich SN. Homeopathic treatment of patients with
chronic low back pain – a prospective observational study with 2 years
follow-up. Clinical Journal of Pain 2009;25(4):334-9:
3. Witt CM, Lüdtke
R, Willich SN. Homeopathic treatment of patients with psoriasis – a
prospective observational study with 2 years follow-up. Journal of the
European Academy of Dermatology and Venereology 2009;23(5):538-43:
4. van
Wijk R, Albrecht H. Proving and therapeutic experiments in the HomBRex
basic homeopathy research database. Homeopathy 2007;96:252–257:
5.
Kaptchuk T (2004). Early use of blind assessment in a homoeopathic
scientific experiment. The James Lind Library, www.jameslindlibrary.org:
6. See, www.anhcampaign.org/practitioners/homeopathy:
7. Smith GCS and
Pell JP. Parachute use to prevent death and major trauma related to
gravitational challenge: systematic review of RCTs. BMJ 2003;327:1459-
1451:
8. Sackett, DL., Rosenberg WMC, Muir Gray JA, et al. (1996) Evidence
based medicine: what it is and what it isn't. BMJ 1996; 312 (7023): 71-2.:
9. McKibbon, KA, Wilczynski N, Hayward RS, et al. The medical literature
as a resource for evidence based care. Working paper from the Health
Information Research Unit, McMaster University, Ontario, Canada, 1995:
10.
Rawlins M. De Testimonio: On the evidence for decisions about the use of
therapeutic interventions.The Harveian Oration, delivered before the Royal
College of Physicians of London, 16th October 2008, ISBN 978-1-86016-3470:
11. Okasha S. Philosophy of science: a very short introduction. Oxford
University Press, 2002, pp13-17:
12. Angell, M. ,The New York Review of
Books, Volume LV1, Number 1; January 15th, 2009:
13. Locke J. Essay
concerning human understanding, edited with an introduction by Nidditch
PH, Oxford University Press (paperback) 1979:
14. Holmes D, Murray SJ,
Perron A, Rail G. Deconstructing the evidence- based discourse in health
sciences: Truth, power, and fascism. International Journal of Evidence
Based Healthcare 2006;4:180.
Competing interests:
None declared
Competing interests: No competing interests