Chiropractic for paediatric conditions: substantial evidence?
BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b2766 (Published 09 July 2009) Cite this as: BMJ 2009;339:b2766
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I must admit to being confused. Apparently chiropracters do not claim
to "treat" illnesses like asthma and colic (only to "help" them), yet they
see no contradiction in calling their interventions "treatments". This is
something that any layman would infer as indicating active treatment or
cure.
Perhaps it is time there was legislation in place to prevent the
proponents of all alternative medicines and quack remedies from implying
their therapies can treat or cure patients, if only to prevent them
retreating behind weasel words of legal double speak by bleating: "But I
only ever said they could 'help'..." when challenged for the evidence, and
resorting to suing anyone who does challenge them.
Competing interests:
I am a believer in evidence-based medicine.
Competing interests: No competing interests
There is a fine line between sensible business promotion and over-
selling ineffective treatments or actively encouraging unnecessary
consultations. I believe most therapists in the UK private sector –
chiropractors, osteopaths and non-NHS physiotherapists – practise
ethically.
However, medico-economic ethics are relatively easier to maintain in
state funded health care than in private practice. If physiotherapy was
largely a private sector service across the UK, the same temptations that
face any private practitioner to oversell their services would apply
equally to physiotherapists.
My point was that the legal action against Simon Singh could be
interpreted – rightly or wrongly – as protecting the financial interests
of private practitioners who just happen to be chiropractors.
Competing interests:
None declared
Competing interests: No competing interests
Richard Brown has patently read Professor Ernst's commentary (1) on
the
evidence-base for chiropractic treatment of paediatric non-spinal
conditions.
I think many observers would probably agree it is now germane for Mr
Brown
to answer some simple questions with short, pertinent answers.
1. Why did the BCA's "plethora" of evidence not include the well-
conducted
trials (2, 3, 4) identified by Professor Ernst? I can think of only two
answers,
so would ask Mr Brown to select one of these binary options: were they
unaware of these trials or were they aware of them but withheld mention of
them in their "plethora"?
Suing for libel was not the only option available to the BCA, but Mr
Brown has
made
public statements on more than one occasion justifying the BCA's resort to
a
libel suit against Dr Singh.
2. Why did they not choose to publish a rebuttal at
the time, given the opportunity reportedly offered by The Guardian? (5) Why
has
Mr Brown again made no mention of that opportunity?
1. Ernst E. Chiropractic for paediatric conditions: substantial
evidence?
BMJ 2009; 339: b2766
2. Balon J, Aker PD, Crowther ER, Danielson C, Cox PG, O’Shaughnessy
D. A comparison of active and simulated chiropractic manipulation as
adjunctive treatment for childhood asthma. N Engl J Med 1998;339:1013-20.
3. Nielsen NH, Bronfort G, Bendix T, Madsen F, Weeke B. Chronic
asthma and chiropractic spinal manipulation: a randomized clinical trial.
Clin
Exper Allergy 1995;25:80-8.
4. Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised
controlled trial of infantile colic treated with chiropractic spinal
manipulation.
Arch Dis Child 2001;84:138-41
5. Simon Singh "BCA v Singh The Story So Far 3 June 2009". http://www.senseaboutscience.org.uk/index.php/site/project/340
Competing interests:
None declared
Competing interests: No competing interests
The vice president of the BCA regrets that I “deconstructed a single
sentence of [his] paper and selectively overlooked the main thrust of the
article”. What I did was to analyse the evidence he had provided. It would
have been fun to deconstruct the rest of his article – but would he have
sued me for libel?
And by the way, contrary to what Brown states the “competing
interests” of my article[1] do mention that I publish the book “Trick or
Treatment” with Simon Singh – but thanks for the plug anyway.
References
(1) Ernst E. Chiropractic for paediatric conditions: substantial
evidence? BMJ 2009; 339:b2766.
Competing interests:
None declared
Competing interests: No competing interests
Richard Brown complains that the current discussion about the
evidence for chiropractice has included the use of the term quackery to
describe chiropractice. The Wikipedia entry on Qauckery includes this
interesting definition,
"To avoid semantic problems, quackery could be broadly defined as
"anything involving overpromotion in the field of health." This definition
would include questionable ideas as well as questionable products and
services, regardless of the sincerity of their promoters. In line with
this definition, the word "fraud" would be reserved only for situations in
which deliberate deception is involved."
I would agree that the use of the word is commonly derogatory and
should not be part of scholarly discussion. Nevertheless, the burden of
disease on vulnerable people has always meant that health is an area wide
open to false claims of efficacy - whatever the underlying intention.
The flip side of this therefore is that scholarly discussion in a
prestigious medical journal should include evidence of efficacy, which
seems to be the point in question with regards to the claims of the BCA.
Competing interests:
Chairman of HealthWatch
Competing interests: No competing interests
Richard A Brown says in his Rapid response (1) that "..it seems
ironic that Ernst characterises it [chiropractic] as potentially lethal
based on single case reports when he summarily dismisses any potential of
benefit demonstrated by a similar level of evidence". This statement
betrays a common misunderstanding about the standard of scientific
evidence required for healthcare interventions, be they drugs, surgical
operations, or chiropractic.
A scientific approach regards a treatment to be ineffective and
unsafe until there is good evidence that it is effective and good evidence
that the risks are low. There is an asymmetry in the types of evidence
regarded as acceptable for showing effectiveness and safety. This
asymmetry is reasonable and necessary.
Effectiveness, unless the outcomes are truly dramatic and noticable
soon after the intervention, should be demonstrated in a randomized
controlled trial (RCT) (with patients, their healthcare professionals, and
assessors of outcomes blinded as far as possible).
The evidence requirements are different for safety. Safety is
assessed by the rates of adverse events. Serious adverse events are
usually rare. If they were common, they would be easily measured and would
outweigh any benefit of the treatment. RCTs (and other clinical trials)
are seldom large enough to detect the signal of rare serious adverse
events above the noise of more common random events. So, for drugs,
surgical operations, and chiropractic, evidence for rare serious adverse
events has often to come from case reports and uncontrolled observational
studies. This is why the UK monitors for adverse drug events with the
"yellow card" scheme and the "black triangle" post-marketing surveillance
scheme.
Ernst was thus being scientific and not being impartial when he took
case reports as evidence on the hazards of chiropractic.
(1) Brown RA. Criticism of Chiropractors: No Competing Interests? BMJ
Rapid Responses. 2009 July 13. Accessed at
http://www.bmj.com/cgi/eletters/339/jul08_4/b2766
Competing interests:
None declared
Competing interests: No competing interests
In his commentary (1), Edzard Ernst has deconstructed a single
sentence of my paper (2) and has selectively overlooked the main thrust of
the article. While the article focused on matters related to a range of
issues, not least of which were the defamatory statements made of the
British Chiropractic Association (BCA) by Simon Singh, Ernst devoted the
entirety of his response to a dissection of evidence put forward by the
BCA in response to Singh’s assertion that there was ‘not a jot’ of
evidence existing in relation to chiropractors being able to help (not
treat, or cure) various childhood conditions. Regarding competing
interests, he omits to mention that he, with Simon Singh, co-authored a
book on alternative medicine (3). Fiona Godlee, in her editorial (4),
describes Ernst’s analysis as ‘a demolition’ and supports calls to keep
the libel laws out of science.
The BCA does not contest the need for further research. It is quite
proper that responsible health professionals should seek to improve their
knowledge by undertaking rigorous trials to test hypotheses and clinical
experience. Contrary to Ernst’s assertion that the evidence denying
benefit is strong, the reality is that there is a paucity of comprehensive
clinical trials in this area and further quality research is needed. There
is clearly, however, more evidence than ‘not a jot’ and it was quite wrong
of Singh to label the treatments promoted by the BCA as ‘bogus’.
The case has clearly ignited fierce debate, and a number of
correspondents have allowed emotion and bias to cloud the pursuit of
scholarly debate, dismissing chiropractic as quackery (5) and caricaturing
the profession as deserving of unprofessional language (6). Surely such
vitriol is not the way to advance debate in the pages of a prestigious
medical journal?
Amongst the responses, a physiotherapist has sought to elevate the
status of his profession at the expense of chiropractic by alleging that
‘[chiropractic’s] business model has always been profit-based’, whilst his
own has been based on public service (7). Such regrettable and misinformed
comments do little to advance the debate and the lack of references for
his allegations is telling.
Some have called for forceful manipulation of the neck to be made
illegal, after having observed a rheumatological colleague undertaking the
procedure (8). I do not know, of course, what level of training this
colleague had received, but in like manner I could call for extraction of
wisdom teeth to be outlawed based on having observed a physiotherapist
performing the procedure. The safety of chiropractic techniques,
particularly spinal manipulation, should rightly be subjected to scrutiny,
yet it seems ironic that Ernst characterises it as potentially lethal
based on single case reports when he summarily dismisses any potential of
benefit demonstrated by a similar level of evidence. There is no doubt
that, as with any medical intervention, manipulation of the spine may
result in adverse events, some of which may be serious. However, to
portray chiropractors as reckless and dangerous is wholly misleading and
ignores both the quality of undergraduate training present throughout
Europe and the lauded regulation of the chiropractic profession in the UK
(9).
Readers should not forget that the BCA resorted to legal action only
after requests to correct libellous statements were refused. While it has
been criticised for its stance, at no time prior to publicising his
article did Singh approach the BCA to question its claims; he simply
commenced the debate in The Guardian and in so doing defamed the BCA and
its reputation.
The BCA has no difficulty in accepting the proposal that views and
suggestions about the perceived efficacy of healthcare interventions
should be permitted in quality peer-reviewed journals. It supports high
quality research which objectively informs and evolves the evidence base
and would exhort chiropractors to modify their practices where conclusive
evidence demonstrates ineffectiveness or a real risk of serious adverse
events.
Greenhalgh (10) and Thornton (11) summarise the position well in
urging authors to be professional and scholarly. Had Singh expressed his
argument thus, rather than accusing the BCA of dishonestly promoting bogus
treatments for which there was no evidence whatsoever, it is almost
certain that this action would never have taken place.
1. Ernst E. Chiropractic for paediatric conditions: substantial
evidence? BMJ 2009; 339: b2766
2. Brown R. Chiropractic: clarifying the issues. BMJ 2009; 338: b2782
3. Singh S, Ernst E. Trick or Treatment? Alternative Medicine on Trial
(2008) Bantam Press
4. Godlee F. Keep libel laws out of science. BMJ 2009; 339:b2783
5. Gøtzsche PC. Quackery, chiropractic and alternative medicine. BMJ Rapid
Responses 2009 14 July. Accessed at
www.bmj.com/cgi/eletters/339/jul08_4b2766
6. Colquhoun D. Unprofessional language is appropriate when dealing with
unprofessional people. BMJ Rapid Responses. 2009 July 15. Accessed at
www.bmj.com/cgi/eletters/339/jul08_4b2783
7. Bartley R. Business Models. BMJ Rapid Responses 2009 July 15.
www.bmj.com/cgi/eletters/339/jul08_4b2783
8. Gøtzsche PC. Quackery, chiropractic and alternative medicine. BMJ Rapid
Responses 2009 14 July. Accessed at
www.bmj.com/cgi/eletters/339/jul08_4b2766
9. Council for Healthcare Regulatory Excellence (2009) Performance Review
of Health Professional Regulatory Bodies 2008/09.
10. Greenhalgh T. But was it libel? BMJ Rapid Responses. 2009 July 13.
Accessed at www.bmj.com/cgi/eletters/339/jul08_4/b2783
11. Thornton H. Choosing our words carefully. BMJ Rapid Responses 2009
July 13: www.bmj.com/cgi/eletters/339/jul08_4/b2783
Competing interests:
Vice President, British Chiropractic Association
Competing interests: No competing interests
Prof Garrow suspects Bolton’s comments to be a hoax, and I spotted
several other funny remarks amongst the comments. White seems to think
that the evolution of the evidence-base of chiropractic might follow that
of acupuncture. Why? Just because two treatments are not plausible, they
will not necessarily develop along similar paths!
White also points out that “it is still open to judgement whether the
evidence amounts to substantial evidence of lack of effectiveness” of
chiropractic. Is this a hoax too? On a theoretical level, it is not
normally possible to employ science for proving a negative. On a practical
level, responsible clinicians are guided by positive proof and do not wait
until “substantial evidence of lack of effectiveness” tells them not to
use this or that therapy. In other words, until we have good evidence that
a treatment works, we should be very cautious recommending it.
Finally we have Lewith raising the subject of safety of chiropractic.
His remarks are funny because safety is neither at the heart of the libel
case, nor is it a central theme of the BCA’s evidence[1], nor of my
analysis of that evidence.[2]
But safety is certainly a subject that must be uncomfortable to the
chiropractic profession. Chiropractors cannot dispute that about half of
all their patients suffer transient adverse effects after spinal
manipulation. This is demonstrated by a mountain of their own data.[3]
These adverse effects are usually mild to moderate, but often serious
enough to notably reduce the patient’s quality of life for one or two
days. If this were the full story, a risk-benefit analysis of chiropractic
for the disputed conditions would already turn out to be negative. But
there is more! Well over one hundred very serious complications, mostly
vascular accidents after neck manipulation, are on record.[4]Chiropractors
dispute that the association is causal by nature.[5] Yet the totality of
the evidence seems to indicate otherwise.[6] The most generous
interpretation of this evidence cannot lead to any decree of certainty
that spinal manipulation is not the cause of vascular accidents, strokes
and deaths. Applying the precautionary principle, one should therefore not
recommend chiropractic but warn patients not to use this form of therapy.
References
(1) Brown R. Chiropractors: clarifying the issues. BMJ 2009;
339(b2782).
(2) Ernst E. Chiropractic for paediatric conditions: substantial evidence?
BMJ 2009; 339:b2766.
(3) Ernst E. Prospective investigations into the safety of spinal
manipulation. J Pain Sympt Managem 2001; 21:238-242.
(4) Di Fabio RP. Manipulation of the cervical spine: risks and benefits.
Physical Ther 1999; 79:50-65.
(5) Cassidy JD, Boyle E, Côté P, He Y, Hogg-Johnson S, Silver FL et al.
Risk of verebrobasilar stroke and chiropractic care. Spine 2008;
33(45):S176-S183.
(6) Gouveia LO, Castanho P, Ferreira JJ. Safety of chiropractic
interventions: A systematic review. Spine 2009; 34:E405-E413.
Competing interests:
None declared
Competing interests: No competing interests
I read the response headed "substantial evidence?" several times
while trying to decide if it is a joke. Bolton asks how much more time
and effort is needed to substantiate the treatments of chiropractors,
since at present the evidence of efficacy is weak. Her reply is that "of
course" much, much more research is needed.
She declares that she has no competing interests, but her job is
director of an institution researching chiropractic.
I think this interest has biased her judgement.
An unbiased person might conclude that the situation does not need
more research into chiropractic teatments for childhood conditions, since
we already know from many trials that chiropractic is not effective for
these conditions. Even the most generous critic might say that if Bolton
wants to do more of this research she is the person who should do it, and
try to show that it is effective. But she insists that in the absence of
good RCT evidence we must be guided by "the clinician's expertise and
experience and also the views and wishes of the patient."
The reason that I still suspect that the response is a hoax is the
way in which she condemns the attitude of those who want evidence of
efficacy before they will endorse the treatment. Her final sentence is
this:
To do so is a dogmatic and self-serving perspective that has no place
in an inclusive and modern day understanding evidence-based clinical care.
Doesn't that brilliantly describe the situation in which she has
landed herself?
Competing interests:
Preference for treatments that have been shown to be effective by good RCTs.
Competing interests: No competing interests
Reply to Brown 22 July 2009
Mr. Brown writes "Contrary to Ernst’s assertion that the evidence
denying benefit is strong, the reality is that there is a paucity of
comprehensive clinical trials ... There is clearly, however, more evidence
than ‘not a jot’ [of evidence supporting certain applications of
chiropractic.]"
The "evidence" provided by chiros was so feeble that anyone
knowledgeable about evaluating clinical evidence must conclude that it
does not amount to "a jot." For example, there are four papers concerning
the treatment of colic, three are execrable in terms of experiment design
and cannot be construed as favorable to the practice. The fourth is large
and well-designed, and it is negative. By the way, when did the BCA's
famous "plethora" of evidence become a "paucity"?
Mr. Brown also writes "Some have called for forceful manipulation of
the neck to be made illegal, after having observed a rheumatological
colleague undertaking the procedure ..."
No, there is much more evidence than that for 'chiropractors' causing
strokes.(1, 2) While strokes seem to be rare, it is unknown how many
victims are uncounted because they left the chiropractor's office and
died, or left (and survived) without anyone making the connection. It is
only in recent years that neurologists learned to ask stroke victims about
recent chiropractic treatment.
Furthermore, there is no reliable evidence that the "forceful
manipulation" is more beneficial than more conservative treatment. Thus,
the risk/benefit calculation results in a very large number (division by
zero) mitigating against the chiropractic procedure.
Mr. Brown, when you are in a hole, stop digging.
1. http://www.ptjournal.org/cgi/content/full/79/1/50
2. http://stroke.ahajournals.org/cgi/content/full/32/5/1054
Competing interests:
Preference for science-based treatments
Competing interests: No competing interests