Chiropractic: A Pain in The Neck

Cast your minds back if you will to May 2009 when I wrote my very first blog post: Bogus science and bogus law about the fact that the British Chiropractic Association had declared war on science and reason in general, and Simon Singh in particular, by suing him (in person rather than the paper that published his article) for the following:

The British Chiropractic Association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying, even though there is not a jot of evidence. This organisation is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments. ref

You can find almost everything you might wish to read on this sorry saga (and then some more ;-) ) here and here (thank you to @Blue_Wode for these links).

I don't want to spoil the ending too much, but Simon won eventually when the BCA caved in.

Anyway, to come back to the point of this post .....

When the BCA declared war on a fellow scientist and rationalist, some of us decided to fight back. With the help of @Simon_Perry's IT skills we were able to generate (and then post) the paper letters required to report every Chiropractor in the country who was making bogus claims (rather a lot of them as it turned out) to local Trading Standards offices. We then set about reporting the same miscreants to the General Chiropractic Council ("GCC") which is the official regulator for the "profession".

My first email went as follows:

Dear Sir/Madam

I note that your CoP contains the following entry:

"C1.6 Chiropractors may publicise their practices or permit another person to do so consistent with the law and the guidance issued by the Advertising Standards Authority."

As you may be aware, the ASA recently declared in a ruling against Chiropractors "Dr Carl Irwin and Associates" (ref) that

"We considered that, whilst some of the studies indicated that further research was worth pursuing, in particular in relation to the chiropractic relief of colic, we had not seen robust clinical evidence to support the claim that chiropractic could treat IBS, colic and learning difficulties.

On these points the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and Beauty Products and Therapies)."

It has come to my attention that ***the chiropractic practice I complained about*** make the following claim on their website:

"Birth and early infancy can sometimes be a very difficult and traumatic time for both mother and baby. After the baby's head has engaged, usually during the eighth month of pregnancy, there can be a lot of stress on its head and back as it continues to move within the womb. This stress can increase further during the birth process, particularly if it is prolonged or involves breech presentation or forceps delivery. As the child grows up, and starts to walk, climb and run, the inevitable falls and bumps can affect the still-developing bones of the spine and skull. Once at school, the child carries heavy bags, sits on badly-designed chairs and participates in a variety of sporting activities.
These stresses and injuries can result in the tightening of muscles in the neck or back, so causing the bones of the spine to lose their normal motion or position. This can irritate or put stress onto the nerve roots that branch off the spinal cord to the organs and tissues of the body. In babies and young children this may lead to symptoms including:
* asthma
* colic
* hyperactivity
* bedwetting
instead of treating the symptoms with drugs, or assuming that the child will 'grow out of it', the chiropractor will gently adjust a child's spine to remove the nerve stress and return his/her body to healthy healing."

Unsurprisingly, the cited Danish research is not regarded as "robust clinical evidence" by the ASA - it would seem to fall well short of the standards applied in conventional medical research.

The claim concerning "colic" would seem to be in breach of the ASA Code. While this is not an advertisement in the sense defined by the ASA, ***the chiropractic practice I complained about*** are publicizing their practice and would, therefore, appear to be in breach of your code.

Please could you inform me whether you consider ***the chiropractic practice I complained about***'s claims to be appropriate and whether you intend to take action against this company.

Yours faithfully

Dr* M A Ward

*non-clinical

I initially received the following response:

Dear Mr [sic] Ward

Your email of 4 June has been brought to my attention because it refers to the recent ASA adjudication against a chiropractor – Carl Irwin. I thought you might be interested to see that the GCC’s patient information leaflet (copy attached) includes the following statements

Chiropractors mainly treat
• back, neck and shoulder problems
• joint, posture and muscle problems
• leg pain and sciatica
• sports injuries
You may also see an improvement in some types of
• asthma
• headaches, including migraine; and
• infant colic

It’s important to emphasise that the GCC doesn’t claim that chiropractors 'treat' asthma, headaches (including migraine) and infant colic. It is possible that chiropractic care may help to alleviate the symptoms of some of these conditions. Chiropractors are trained in differential diagnosis and should refer any patient for appropriate care from another health professional when necessary. It is important that, where appropriate, there is good co-management of patient care. But the statement about the possibility of improvement has been included on the basis of the currently available evidence.

I'm not sure what level of detail to go into but as you may know there are a number of ways of measuring, or rating, evidence levels. One relevant example is Brønfort G. Efficacy of Manual Therapies of the Spine, Amsterdam: Thesis Publishers, 1997. This study rates the levels of evidence available at the time and provides a measuring tool to do it - I've cut and pasted the 'ratings table' below for your information. If there's anything that's unclear please do get back to me.

The available evidence of the efficacy of the chiropractic contribution to the management of some types of asthma, migraine headache and infant colic is inconclusive (i.e. level D in the measuring tool used by Brønfort).

Further, with regard to some types of asthma:
• Brønfort concluded in 1997 that there is moderate evidence (Level B) that SMT is a non-efficacious therapy for chronic to moderately severe asthma in adults. There was insufficient data (Level D) to draw conclusions about the efficacy of spinal manipulative therapy (SMT) for other respiratory diseases (including childhood asthma)
• In 2001, Brønfort et al ( see c. below) concluded that after three months of combining chiropractic SMT with optimal medical management for childhood asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. The observed improvements were thought unlikely to be as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily.

So although some clinical trials had positive results there is insufficient data to make strong statements about efficacy. There is a higher level of available evidence (i.e. level B) with regard to some types of headache (such as tension-type and cervicogenic headache) and there appears to be a clinical advantage, of both SMT and exercises, both of which chiropractors use, compared to placebo and at least equivalence with commonly used therapies.

Other studies which appear to echo the evidence levels outlined in the paragraphs above are:
a. Nielsen NH, Brønfort G, Bendix T. et al 1995. Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial. Clin Exp Allergy Jan;25(1):80-8
b. Balon J, Aker PD et al 1998. A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma. NEJM 339 (15): 1013-1020
c. Brønfort G , Evans RL, Kubic P, Filkin P 2001. Chronic pediatric asthma and chiropractic spinal manipulation: a prospective clinical series and randomized pilot study. JMPT 24(6):369-77
d. Brønfort G, Nilsson N, Haas M, Evans RL, Goldsmith CH, Assendelft WJJ, Bouter LM. Non-invasive physical treatments for chronic/recurrent headache. Cochrane Database of Systematic Reviews 2004, Issue 3 Art. No.: CD001878. DOI: 10.1002/14651858.CD001878.pub2
e. Wiberg JMM, Nordsteen J, Nilsson N. 1999. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomised controlled clinical trial with a blinded observer, JMPT 22 (8): 517-22.
This isn’t an exhaustive list but I do hope that this level of detail is helpful.
Please don't hesitate to contact me if you have any questions.
Yours sincerely
***name redacted***
Chief Executive & Registrar

Levels of evidence (one definition of evidence ratings – there are others – but this one was used by Brønfort)
A Strong evidence of efficacy or inefficacy Must include two or more randomised clinical trials (RCTs) with a validity score of > 50 as well as clinically important and statistically significant results
B Moderate evidence of efficacy or inefficacy Must include one RCT with a validity score of > 50 as well as clinically important and statistically significant results
C Limited evidence of efficacy or inefficacy Must include one RCT with a validity score of 21-49 as well as clinically important and statistically significant results; or
Must include two or more RCTs with a validity score of > 20 as well as clinically important and statistically significant results
D Inconclusive evidence of efficacy or inefficacy Minimal standards for classification as limited evidence were not met or the evidence was conflicting

Levels of evidence which do not form the basis for efficacy determination
a. One RCT with a validity score of > 20 and absence of statistically significant results
b. Non-randomised comparative studies between current patients who did receive the experimental intervention and other patients (e.g. historical controls) who did not or who received another form of therapy and where otherwise incomparable
c. Clinical case series without controls. These studies provide information about the outcome of a treatment, and if promising, may form the basis for other studies that can address efficacy. These studies may contain useful clinical information, although they constitute the lowest level of evidence since favourable treatment responses are often based on biased interpretation by the clinicians that provide the therapy and collect the data.

I got straight back:

Dear Ms ***name redacted***

Thank you for your email, but I do not feel that you have addressed the complaint I raised.

To summarize:

the GCC’s CoP states that chiropractors “may publicise their practices or permit another person to do so consistent with the law and the guidance issued by the Advertising Standards Authority.”

The ASA have made it clear that it is not acceptable for chiropractors to claim that they can treat infant colic – a judgement which you appear to endorse in your email to me.

***the chiropractic practice I complained about*** claim that they can treat infant colic.

I suggest, therefore, that ***the chiropractic practice I complained about*** would seem to be in breach of your CoP and I am requesting that, in view of this, you take action against them.

Yours sincerely

Dr M A Ward

I then received this:

Dear Dr Ward,

Thank you for your email of 4 June 2009. With regard to the final sentence of your email, the Investigating Committee of the General Chiropractic Council investigates complaints relating to the fitness to practise of individual chiropractors, rather than complaints against companies or organisations. In this respect please contact us if you wish to make a complaint about a chiropractor or wish to receive a copy of our complaint information pack.

As your email refers in part to a ruling made by the ASA against a chiropractor, I have referred your email to the Chief Executive & Registrar, ***name redacted***, who will provide a separate response to your email.

Yours sincerely


***name redacted***
Specialist Officer (Regulation)
General Chiropractic Council

I received a very polite phone call later from the Chief Executive & Registrar during which we both essentially restated what we had both said earlier.

I resubmitted my complaint naming the individuals practising at the firm:

Dear Ms ***name redacted***

I should like to resubmit my complaint to you this time naming Dr ***name redacted*** and Dr ***name redacted*** of ***the chiropractic practice I complained about*** as the individual chiropractors responsible for making the claims that would appear to breach the ASA guidelines.

I look forward to hearing from you.

Yours sincerely

Dr Ward

Over the next year I received about a dozen packages of paper from the GCC - often recorded delivery - but containing nothing of any substance - well apart from trees that would have been better left standing.

The other day I finally received the two adjudications I had been waiting for (both the same so I'll only post one):

Act 1994 (“the Act”)
and
The General Chiropractic Council (Professional Conduct Committee) Rules 2000 (“the Rules”)
and
The consideration of an allegation by the Professional Conduct Committee
NOTICE OF FINDING BY
THE PROFESSIONAL CONDUCT COMMITTEE OF THE GENERAL CHIROPRACTIC COUNCIL
Name of Respondent: ***name redacted***
Address of Respondent: ***address redacted***
Registration Number of Respondent: 00927
In the week commencing 18 April 2011, the Professional Conduct Committee (“the Committee”) of the General Chiropractic Council (“the GCC”) met to consider the following Allegation against you, referred to it by the Investigating Committee in accordance with Section 20(12)(b)(ii) of the Chiropractors Act 1994 (“the Act”):
THE ALLEGATION:
That being a registered chiropractor you are guilty of unacceptable
professional conduct.
_____________________________________________________

PARTICULARS OF THE ALLEGATION:
That, whilst a registered chiropractor:
1. On or about 10 June 2009 and for an unknown period prior to that date, you practised at ***address redacted*** (“the practice”).
FOUND PROVED
2. On or about 10 June 2009 and for an unknown period prior to that date, you caused or permitted the website ***name redacted***, which advertised the practice to contain the statements highlighted in the website extract in Schedules 1-2.
FOUND PROVED
3. The statements highlighted in the website extract in Schedule 1 were not supported by high or moderate positive evidence from randomised controlled trials.
FOUND NOT PROVED [sic]
4. The statements highlighted in the website extract in Schedule 1 were potentially misleading.
FOUND NOT PROVED [sic]
5. The statements highlighted in the website extract in Schedule 2 had the potential to put pressure on members of the public viewing the website to seek chiropractic care for pregnant women, and babies and children.
FOUND NOT PROVED [sic]
In accordance with the provisions of Rule 18(1) (a) of the General Chiropractic Council (Professional Conduct Committee) Rules 2000 (“the Rules”), notice is hereby given of the decision of the Committee.
DECISION
In accordance with Rule 3(1) of the General Chiropractic Council (Professional Conduct Committee) Rules 2000, the Professional Conduct Committee had previously determined not to hold a public hearing to deal with the Allegation as notified to (“the Respondent”) on 25 June 2010.
The Respondent agreed to waive her right to attend and accepted that, if the Committee found the Allegations proved, it could impose a sanction of Admonishment at the meeting without considering any further written or oral representations from her.
The Respondent has made submissions in written form, that the Allegation brought by the GCC should be stayed on four separate grounds that, individually and cumulatively, amount to an abuse of the process. However the Respondent has indicated that she formally reserves her position. The Committee’s understanding is that she is content for this meeting to proceed without considering the abuse of process arguments.
The Committee therefore decided to proceed and considered the Allegation on the basis of documentary evidence with neither party present.
The Committee considered all of the documentary evidence provided by the Respondent and by the GCC. It has borne in mind that the burden of proof on facts is on the GCC and that the standard of proof is the civil standard, which is the balance of probabilities. This Committee has decided to receive in evidence under Rule 17, a copy of the Bronfort et al report on the effectiveness of manual therapies: the UK evidence report (“the Report”).
This Committee has taken account of the decision of the Professional Conduct Committee made on 17 November 2010 in relation to the status and scope of the Report. It agrees with that Committee that the Report is an academic report and not an expert report.
This Committee regarded the Report as a comprehensive statement of those conditions for which randomised controlled trial (RCT) evidence for the efficacy of manual therapy exists, subject to the limitations set out in the Report. The Report provides a summary of the scientific evidence regarding the effectiveness of ‘manual treatment’ in relation to a number of conditions.
The Committee considered each of the Particulars of the Allegations and in doing so it was mindful of the provisions of C1.6 of the Code of Practice (effective from 8 December 2005).
Particular 1
On or about 10 June 2009 and for an unknown period prior to that date, you practised at ***address redacted*** (“the practice”).
This Particular was admitted and the Committee found it proved.
Particular 2
On or about 10 June 2009 and for an unknown period prior to that date, you caused or permitted the website ***name redacted***, which advertised the practice to contain the statements highlighted in the website extract in Schedules 1-2.
The Respondent admitted “permitting” the website to contain the statements highlighted in Schedules 1 – 2 and the Committee found the Particular proved on that basis.
Particular 3
The statements highlighted in the website extract in Schedule 1 were not supported by high or moderate positive evidence from randomised controlled trials.
The GCC advised the Committee that it was not pursuing Particulars in respect of infant colic, asthma, sciatica, tension headaches, menstrual pain and digestive disorders. The GCC submitted that it recognised that patient information leaflets published by the GCC in the past made reference to these conditions. It accepted that chiropractors may have relied on information published by the GCC, as their regulator, about these conditions in preparing their websites. The Committee accepted the GCC’s submission that it would have been reasonable for chiropractors to have relied on the GCC’s leaflets in relation to claims made on their websites in respect of these conditions. [sic]

In relation to the outstanding matters, the Committee considered the submission made by the GCC that “there is not high or moderate positive evidence from RCTs to support such statements. The Respondent has not, in responding to the allegations against her, produced any RCTs showing that there is high or moderate evidence to support the statements in question.”
The Committee reminded itself that the burden of proving the Particulars rests with the GCC and the Respondent does not have to prove any fact.
In reaching its decision in relation to this particular the Committee has taken into account:
1. That the purpose of the Bronfort report was to “provide a summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions”. However the report acknowledges that a number of other non-invasive physical treatments and patient education were identified. Further, the Committee accepts that chiropractic is not limited to manual therapy and that chiropractors may and do utilise a package of care that can include a range of interventions, advice and information. The GCC submissions do not address whether or not high or moderate positive evidence from RCTs exists for non-manual therapies. [sic]
2. That there were limitations to the Bronfort Report in that “Search restrictions were human subjects, English language, peer-reviewed and indexed journals, and publications before October 2009”. The Committee accepts, as does the Report, that it is possible that there are RCTs undertaken and reported in other languages. The Committee has received no evidence from the GCC of the absence of RCTs in other languages regarding manual therapy. [sic]
3. That some of the statements highlighted by the GCC were general in nature, such as statements about the usual practice of the Respondent, the types of patient normally treated or generic headings and labels used to delineate sections of the website.
In order to find Particular 3 proved, the Committee had to be satisfied that the highlighted statements were not supported by high or moderate positive evidence from RCTs.
In relation to general statements, such as “Chiropractic treatment” the Committee observed that RCT evidence is inapplicable. Such statements are incapable of being verified by RCTs and hence Particular 3 cannot be found proved in relation to a general statement of this kind. [sic]
The Committee noted that the GCC had highlighted a number of more specific statements that did represent claims about the effect of chiropractic care on named conditions or symptoms. Such statements are, in principle, capable of being verified by RCT evidence.
However, where the statements refer to (or could be taken to refer to) the effect of nonmanual as well as manual therapy, the Committee was unable to determine whether or not that they were supported by RCT evidence. This is because the evidence submitted by the GCC relates only to the effect of manual therapies (the Bronfort Report, see paragraph 1).
In the present case, the Committee concluded that all of the specific statements highlighted by the GCC could be seen as relating to the effects of a package of manual and non-manual interventions. Accordingly the effectiveness of the care package could not be assessed solely by means of the Bronfort Report, and the Committee could not be satisfied that the GCC had proved its case in relation to these statements.
The Committee found Particular 3 not proved.

Particular 4
The statements highlighted in the website extract in Schedule 1 were potentially misleading.
In relation to this Particular, which alleged that statements were “potentially” misleading, the Committee was of the opinion that the word “potentially” added nothing material to an allegation that statements were “misleading”. The Committee considered that a statement can be misleading whether or not someone has actually been misled by it.
The Committee reminded itself of the responsibilities of chiropractors to comply with section C1.6 of the Code or Practice (effective from December 2005) which states that: “If chiropractors, or others on their behalf, do publicise, the information must be factual and verifiable. The information must not be misleading or inaccurate in any way.” The Committee is mindful that the Respondent had an obligation to comply with this requirement.
The Committee also notes that at the time of the complaint in June 2009 the GCC had not issued its advertising guidance providing more specific clarification for the profession as to the basis on which they could make claims about their services. This guidance was not issued until March 2010. The Committee accepts the Respondent’s submission that RCTs were not the only acceptable form of evidence for making advertised claims at the relevant time.
Furthermore, the Committee recognises and accepts that at the relevant time chiropractors relied on information provided during their training and issued by professional associations and the GCC.
The GCC submitted that the statements were misleading in that they were not verifiable by reference to the material considered by, and the conclusions reached by, the Bronfort Report and that they were not appropriately qualified or limited as to the effectiveness of the treatment being advertised. The GCC has not put forward any limitations that should have been expressed, other than by reference to the Bronfort Report. The Committee does not accept that lack of support from the Bronfort report automatically makes a statement misleading. The Committee has already concluded that (i) the Bronfort Report does not exclude the possibility of non-manual therapies that might constitute effective treatment for the conditions referred to in these statements and (ii) there may be other evidence that would justify the statements. [sic]
Although the Committee did not consider that the failure to meet the Bronfort RCT criteria was sufficient to demonstrate that a statement was misleading, the Committee did examine the relevant statements to determine whether they could be regarded as misleading on other grounds.
The Committee found no such misleading statements and has concluded that Particular 4 has not been proved.

Particular 5
The statements highlighted in the website extract in Schedule 2 had the potential to put pressure on members of the public viewing the website to seek chiropractic care for pregnant women, and babies and children.
The Committee noted the word ‘potential’ in the allegation. The specific wording of C1.6 of the Code of Practice states that the information must not “put pressure on people to use chiropractic”. In this case, the people referred to were members of the public viewing the website. It concluded that there could be a breach of the Code of Practice even if only a section of the public might be pressurised. The Committee considered that a website that had the potential to put pressure on certain members of the public would be in breach of the Code of Practice whether or not there was evidence that anyone had actually been pressurised.
Reading the statements in context, the Committee concluded that they were informative statements and did not have the potential to put pressure on members of the public viewing the website to seek chiropractic care for children by arousing ill founded fear for their future health. [sic]
The Committee, therefore, found Particular 5 not proved.
UNACCEPTABLE PROFESSIONAL CONDUCT
The Committee considered whether the Allegation of Unacceptable Professional Conduct was well founded by reason of its findings in relation to the Particulars found proved. The Committee decided that Particulars 1 and 2 could not amount to Unacceptable Professional Conduct as they were merely factual Particulars.
Therefore the Committee found that the Allegation of Unacceptable Professional Conduct is not well founded.
That concludes the matter.
Chair of the Professional Conduct Committee
In accordance with provision of Rule 18(1)(a) of the General Chiropractic Council (Professional Conduct Committee) Rules 2000, we must remind you of your right of appeal under Section 31 of the Chiropractors Act 1994, as amended by Section 34 of the National Health Service Reform and Health Care Provisions Act 2002, to the High Court of Justice in England and Wales against this decision of the Committee. Any such appeal must be made before the end of the period of 28 days, beginning with the date upon which this notice is served upon you.
Please note that the decision of this Committee is a relevant decision for the purposes of Section 29 of the National Health Service Reform and Health Care Professions Act 2002.
As of 1 January 2009, the Council for Healthcare Regulatory Excellence has a period of 40 days, in addition to any appeal period provided to the chiropractor, in which to lodge an appeal.
Signed: Dated: 05 May 2011
***name redacted***
Specialist Officer (Regulation)
On behalf of the Professional Conduct Committee

Explanatory Notes:
1. The Allegation: This section contains the full allegation as drafted by the Investigating Committee and as considered by the Professional Conduct Committee.
2. The Decision: This section contains the findings of fact reached by the Professional Conduct Committee on the allegation and the reasons therefore. In particularly complex cases the reasons may be given separately from the findings of fact for purposes of clarity.

[my emphases and "sic"s]

So to summarize: The two chiropractors I complained about were claiming on their website that that they could treat infant colic by "adjusting" a child's spine. As Simon Singh has noted, there is not a jot of evidence to support such claims and the Advertising Standards Authority would not (and did not) allow such claims to be made in adverts or (since 2011 March 1) on websites).

(NB This is not to say, of course, that there is no evidence whatsoever (what little the BCA could come up with is demolished here thank you Alan @zeno001 for link). There is, after all, some evidence for unicorns, but none of it is credible or stands up to scientific scrutiny. It's just the same with chiropractic claims about colic - though I can quite believe that the chiropractors I complained about honestly believe this nonsense, and perhaps in unicorns as well.)

The "Professional Conduct Committee" seem to accept that neither they nor the GCC nor the chiropractors concerned are aware of any evidence that any "therapies" provided at this practice can treat infant colic but console themselves by noting that there may be some evidence somewhere (perhaps in another language) of which none of these parties are aware. The PCC also notes that the GCC was, at the time in question, itself making the same bogus claims as the "professionals" it purports to regulate.

This is risible!

In short, the claim that chiropractic is a "regulated profession" would seem to be entirely as bogus as the claims (now removed from almost every chiropractic website in the land) that chiropractic can treat infant colic.

(Oh and I never did get an answer to my question as to whether the chiropractors were, in publicizing their practice in a way that was inconsistent with the guidance issued by the Advertising Standards Authority, in breach of the GCC CoP.)