A general record of my ongoing battle with all forms of nonsense.

Friday 31 July 2009

Please sign the letter to Trading Standards

UPDATE: We've now got 500 signatories and I'm preparing the letter to send off. Thank you for all your support.

If you've visited this blog for the first time, here's a lightning-speed explanation: the evidence suggests that Chiropractic doesn't work as a treatment for colic, I made several complaints to trading standards about Chiropractors who were making this claim. Most trading standards offices have taken action, a few chiropractors are holding out. This last letter is to get those last few businesses to stop making unscientific claims about important issues of health. It will be mail-merged the details and claims made by approx 50 chiropractors.

While the names of signatories will of course need to be printed on the letters to Trading Standards, they will otherwise be kept private.

The full text is below.

To Whom it May Concern,

We are writing to complain about [company name]. While it is up to you to establish whether this company is breaking the law, we wish to bring a possible infringement of The Consumer Protection from Unfair Trading Regulations 2008 to your attention.

This company makes the following claims on their web site [web site url to be inserted here]:

[copied & pasted claim]

This text clearly implies that the company in question is willing to use chiropractic to treat infant colic. There is no reliable evidence to support the belief that colic is caused by a problem with the spine, nor that chiropractic is effective in treating it. In addition, there is reliable evidence from a controlled trial that clearly shows chiropractic to be no more effective than placebo.

Below are listed the studies typically cited by chiropractors to show that chiropractic is an effective treatment for colic. We have included an explanation of the trial and the conclusion that can be drawn from it. The final study in the list is generally ignored by chiropractors making this claim; however, it clearly shows the treatment to be ineffective.

1. Klougart N, Nilsson N and Jacobsen J (1989) Infantile Colic Treated by Chiropractors: A Prospective Study of 316 Cases, J Manip Physiol Ther,12:281-288.

This study tracked 316 children with symptoms of colic during chiropractic treatment and showed that there was improvement in 94% of cases.

However, this study failed to provide any evidence for or against the efficacy of chiropractic in the treatment of colic for the following reason: all children with colic improve over time.

If all children improve from colic anyway, then showing that they improve after a certain treatment is unhelpful unless there is a control group not receiving treatment with which to compare them. This study contained no such group.
This is irrelevant.

It is irrelevant because it cannot demonstrate that treatment improves recovery from the condition.

2. Mercer, C. and Nook, B. in the Proceedings of the 5th Biennial Congress of the World Federation of Chiropractic (1999)This doesn't seem to have been published, so was not peer reviewed. As it seems to be almost impossible to get hold of the paper, there is very little that can be said.

From the summary provided by the BCA, however, it appears that this was a simple observational study like the one above with no control group.
This is irrelevant.

It is irrelevant because it cannot demonstrate that treatment improves recovery from the condition.
3. Wiberg J, Nordsteen J, Nilsson N. The short term effect of spinal manipulation in the treatment of infantile colic. A randomised controlled trial with a blinded observer. J Manipulative Physiol Ther (1999) 22:517-522.This study was a randomised controlled trial comparing chiropractic with dimethicone in the treatment of colic.

Without blinding between the two groups, it is likely that the placebo effect could play a major part in the outcome. The placebo effect is likely to be more pronounced with the chiropractic treatment as it is a more dramatic intervention.

In addition, the system of measurement (asking parents to record crying hours) adds another potential bias. The parents who were keeping the diaries were were not blinded.

Wiberg and Nilsson appear to concede this point themselves here: http://adc.bmj.com/cgi/eletters/84/2/138#124
This is inconclusive at best due to the lack of blinding, with the effects shown likely to be due to placebo and bias in record keeping.
4. Hayden & Mullinger (2006) Complementary Therapies in Clinical Practice (2006) 12, 83–90.This study did not investigate chiropractic, but cranial osteopathy.

Even so, this was a preliminary trial. Preliminary trials are of too small a scale to reach a conclusion. They are used only to see if it might be worth performing a proper trial.
This is irrelevant.

It is irrelevant because it does not study chiropractic.
5. Hipperson AJ (2004) Clinical Chiropractic 11, 122 – 129.This was merely a report of two case studies. This is irrelevant for the same reason as Klougart N, Nilsson N and Jacobsen J, but with only two subjects.This is irrelevant.

It is irrelevant for the same reason as the first study.
6. Browning M. Miller, J. Clinical Chiropractic (2008) 11, 122—129 This study compared two different forms of chiropractic in the treatment of colic. Maybe they both work, maybe neither work. This study did not attempt to answer that question.This is irrelevant.

It is irrelevant because it did not test if the treatment worked. It merely compared two different types of chiropractic treatment. This outcome would be expected if neither method worked.
7. Leach RA (2002) J Manip Physiol Ther, 25, 58 -62. Simply another two case studies as Hipperson AJ (2004) above.This is irrelevant.

It is irrelevant for the same reason as the first study.
8. Miller J (2007) Clinical Chiropractic 10, 139—146 Cry babies: A framework for chiropractic care.This is not a study at all, we are not sure why it has been quoted by the BCA.This is irrelevant, as it is not a study of any kind.
9. Nilsson N. 1985 Eur J Chiropr 33, 264 – 255 Infantile colic and chiropractic.This is merely a survey of parents who have had their child gone through chiropractic treatment for colic. No parents who did not take their children to chiropractors were questioned, making this study even more poorly designed than Klougart N, Nilsson N and Jacobsen J.This is irrelevant.

It is irrelevant for the same reason as the first study.
10. Olafsdottir E, Forshei S, Fluge G, Markestad T (2001) Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. AIMS: To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic. METHODS: One hundred infants with typical colicky pain were recruited to a randomised, blinded, placebo controlled clinical trial. RESULTS: Nine infants were excluded because inclusion criteria were not met, and five dropped out, leaving 86 who completed the study. There was no significant effect of chiropractic spinal manipulation. Thirty two of 46 infants in the treatment group (69.9%), and 24 of 40 in the control group (60.0%), showed some degree of improvement. CONCLUSION: Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic. This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic.

This is the only properly conducted trial comparing chiropractic against placebo for the treatment of colic. The conclusion is that it simply does not work.
This is highly relevant, and clearly shows that chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic.

Part 2, Section 5 of the regulations list misleading actions as below. You can see from the text below that a trader is in breach if they present information in a way that is misleading even if it is factually accurate. For instance, a trader presenting a testimonial from a client promoting efficacy or even just stating "some parents have found chiropractic useful in treating colic" or a trader citing a poorly conducted trial as evidence without informing the potential customer of a well conducted trial showing the opposite outcome is therefore performing a misleading action under the regulations.
Misleading actions
5.—(1) A commercial practice is a misleading action if it satisfies the conditions in either paragraph (2) or paragraph (3).
(2) A commercial practice satisfies the conditions of this paragraph—
(a)if it contains false information and is therefore untruthful in relation to any of the matters in paragraph (4) or if it or its overall presentation in any way deceives or is likely to deceive the average consumer in relation to any of the matters in that paragraph, even if the information is factually correct; and
(b)it causes or is likely to cause the average consumer to take a transactional decision he would not have taken otherwise.

According to The Consumer Protection from Unfair Trading Regulations 2008, the onus of evidence relating to any factual claim is on the company making the claim. So it is not a requirement that a prosecutor proves that the claims are factually incorrect, rather it is a requirement that the company must be able to show that their claims are backed by adequate evidence. Section 27 of the regulations state:

(1) This section applies where an application for an enforcement order or for an interim enforcement order is made in respect of a Community infringement involving a contravention of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market.
(2) For the purposes of considering the application the court may require the person named in the application to provide evidence as to the accuracy of any factual claim made as part of a commercial practice of that person if, taking into account the legitimate interests of that person and any other party to the proceedings, it appears appropriate in the circumstances.
(3) If, having been required under subsection (2) to provide evidence as to the accuracy of a factual claim, a person—
(a) fails to provide such evidence, or
(b) provides evidence as to the accuracy of the factual claim that the court considers inadequate,
the court may consider that the factual claim is inaccurate

As an enforcement authority, you also have the right to demand any documentation, such as their evidence for the claim, from the company. Section 21 (b) states "if he has reasonable cause to suspect that a breach of these Regulations has been committed, he may, for the purpose of ascertaining whether it has been committed, require any trader to produce any documents relating to his business and may take copies of, or of any entry in, any such document;"

So, to summarise the points above:
  • The consumer protection regulations cover the overall impression given by the trader and the trader may be in breech even if the actual claims are factually accurate.
  • The consumer protection regulations require the trader to provide evidence for any claims they make, rather than the prosecutor needing to prove those claims to be false.
  • The evidence we have found from chiropractic organisations so far appears not to be relevant to the question of efficacy in all but one study. In the one study where it is relevant it appears to be inconclusive, with a complete lack of blinding.
  • The only properly conducted trial of the use of chiropractic in treating colic shows this treatment to be no more effective than placebo.
  • While prosecution can proceed solely on the grounds that the company provides no evidence, or inadequate evidence; your position is much stronger: the best evidence available clearly shows this treatment to be ineffective.

We have only checked the claims on this company's web site. They may also be making similar claims in leaflets within their practice, or their advice to their customers. We hope you will be able to visit the practice to ensure compliance with the law.

While we have focused on colic for the purposes of this letter, we have also found some practices also claiming to treat children for sleeping and feeding problems, ear infections, asthma and prolonged crying. The evidence for chiropractic's efficacy for these treatments is similar to that for colic above. We sincerely hope you will take similar action against any such claims.

Yours faithfully,

[list of names, titles etc]


Andy said...

3. Wilbery J, Nordsteen J, Nilsson N. The

I think you mean "Wiberg".

Nick Gibbins said...

"a trader is in breech" should read "a trader is in breach".

Andy said...

Also, I think it is incorrect to say the Wiberg et al study showed equal outcomes for dimethicone and chiro.

The conclusion, as I recall, was that chiro performed better and that was without counting numerous dropouts from worsening symptoms in the dimethicone group.

However, after Olafsdottir et al showed negative results, Wiberg and Nilsson appeared to concede, here, that non-blinding might be one reason for their own positive result.

Simon said...

Thanks for the corrections, keep them coming if you spot any more. I'll fix spelling errors in the doc, but I'll have to add in notes for any more serious changes because over 230 people have signed the doc as is.

Won't get this done until Monday as I'm currently away camping for the weekend.

Unknown said...

Point of grammar, your summary of study 8 states that one study is more irrelevant than another, I don't think that's possible. All irrelevant studies must by definition be equaly irrelevant in that they all possess a quantity of relevance which is exactly zero.

Simon said...

I've made those few corrections, thanks to all those who commented.

Dr. Brian Blood said...

In addition, the system of measurement (asking parents to record crying hours) adds another potential bias. The parents who were keeping the diaries were were not blinded.

from reference 3.

comment: Too many weres