Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
Back pain
Of all types of alternative medicine, acupuncture is the one that has received the most approval from regular medicine. The benefit of that is that it’s been tested more thoroughly than most others. The result is now clear. It doesn’t work. See the evidence in Acupuncture is a theatrical placebo.
This blog has documented many cases of misreported tests of acupuncture, often from people have a financial interests in selling it. Perhaps the most egregious spin came from the University of Exeter. It was published in a normal journal, and endorsed by the journal’s editor, despite showing clearly that acupuncture didn’t even have much placebo effect.
Acupuncture got a boost in 2009 from, of all unlikely sources, the National Institute for Health and Care Excellence (NICE). The judgements of NICE and the benefit / cost ratio of treatments are usually very good. But the guidance group that they assembled to judge treatments for low back pain was atypically incompetent when it came to assessment of evidence. They recommended acupuncture as one option. At the time I posted “NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself“. That was soon followed by two more posts:
NICE fiasco, part 2. Rawlins should withdraw guidance and start again“,
and
“The NICE fiasco, Part 3. Too many vested interests, not enough honesty“.
At the time, NICE was being run by Michael Rawlins, an old friend. No doubt he was unaware of the bad guidance until it was too late and he felt obliged to defend it.
Although the 2008 guidance referred only to low back pain, it gave an opening for acupuncturists to penetrate the NHS. Like all quacks, they are experts at bait and switch. The penetration of quackery was exacerbated by the privatisation of physiotherapy services to organisations like Connect Physical Health which have little regard for evidence, but a good eye for sales. If you think that’s an exaggeration, read "Connect Physical Health sells quackery to NHS".
When David Haslam took over the reins at NICE, I was optimistic that the question would be revisited (it turned out that he was aware of this blog). I was not disappointed. This time the guidance group had much more critical members.
The new draft guidance on low back pain was released on 24 March 2016. The final guidance will not appear until September 2016, but last time the final version didn’t differ much from the draft.
Despite modern imaging methods, it still isn’t possible to pinpoint the precise cause of low back pain (LBP) so diagnoses are lumped together as non-specific low back pain (NSLBP).
The summary guidance is explicit.
“1.2.8 Do not offer acupuncture for managing non-specific low back 7 pain with or without sciatica.”
The evidence is summarised section 13.6 of the main report (page 493).There is a long list of other proposed treatments that are not recommended.
Because low back pain is so common, and so difficult to treat, many treatments have been proposed. Many of them, including acupuncture, have proved to be clutching at straws. It’s to the great credit of the new guidance group that they have resisted that temptation.
Among the other "do not offer" treatments are
- imaging (except in specialist setting)
- belts or corsets
- foot orthotics
- acupuncture
- ultrasound
- TENS or PENS
- opioids (for acute or chronic LBP)
- antidepressants (SSRI and others)
- anticonvulsants
- spinal injections
- spinal fusion for NSLBP (except as part of a randomised controlled trial)
- disc replacement
At first sight, the new guidance looks like an excellent clear-out of the myths that surround the treatment of low back pain.
The positive recommendations that are made are all for things that have modest effects (at best). For example “Consider a group exercise programme”, and “Consider manipulation, mobilisation”. The use of there word “consider”, rather than “offer” seems to be NICE-speak -an implicit suggestion that it doesn’t work very well. My only criticism of the report is that it doesn’t say sufficiently bluntly that non-specific low back pain is largely an unsolved problem. Most of what’s seen is probably a result of that most deceptive phenomenon, regression to the mean.
One pain specialist put it to me thus. “Think of the billions spent on back pain research over the years in order to reach the conclusion that nothing much works – shameful really.” Well perhaps not shameful: it isn’t for want of trying. It’s just a very difficult problem. But pretending that there are solutions doesn’t help anyone.
Follow-up
In July 2008 I wrote an editorial in the New Zealand Medical Journal (NZMJ), at the request of its editor.
The title was Dr Who? deception by chiropractors. It was not very flattering and it resulted in a letter from lawyers representing the New Zealand Chiropractic Association. Luckily the editor of the NZMJ, Frank Frizelle, is a man of principle, and the legal action was averted. It also resulted in some interesting discussions with disillusioned chiropractors that confirmed one’s worst fears. Not to mention revealing the internecine warfare between one chiropractor and another.
This all occurred before the British Chiropractic Association sued Simon Singh for defamation. The strength of the reaction to that foolhardy action now has chiropractors wondering if they can survive at all. The baselessness of most of their claims has been exposed as never before. No wonder they are running scared. The whole basis of their business is imploding.
Needless to say chiropractors were very cross indeed. Then in February 2009 I had a polite email from a New Zealand chiropractor, David Owen, asking for help to find one of the references in the editorial. I’d quoted Preston Long as saying
"Long (2004)7 said “the public should be informed that chiropractic manipulation is the number one reason for people suffering stroke under the age of 45.”
And I’d given the reference as
7. Long PH. Stroke and spinal manipulation. J Quality Health Care. 2004;3:8–10
I’d found the quotation, and the reference, in Ernst’s 2005 article, The value of Chiropractic, but at the time I couldn’t find the Journal of Quality Healthcare. I did find the same article on the web. At least the article had the same title, the same author and the same quotation. But after finding, and reading, the article, I neglected to change the reference from J Quality Health Care to http://skepticreport.com/sr/?p=88. I should have done so and for that I apologise.
When I asked Ernst about the Journal of Quality Healthcare, he couldn’t find his copy of the Journal either, but he and his secretary embarked on a hunt for it, and eventually it was found.
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It turns out that Journal of Quality Healthcare shut down in 2004, without leaving a trace on the web, or even in the British Library. It was replaced by a different journal, Patient Safety and Quality Healthcare (PSQH) A reprint was obtained from them. It is indeed the same as the web version that I’d read, and it highlighted the quotation in question. The reprint of the original article, which proved so hard to find, can be downloaded here. |
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The full quotation is this
"Sixty-two clinical neurologists from across Canada, all certified members of the Royal College of Physicians and Surgeons, issued a warning to the Canadian public, which was reported by Brad Stewart, MD. The warning was entitled Canadian Neurologists Warn Against Neck Manipulation. The final conclusion was that endless non-scientific claims are being made as to the uses of neck manipulation(Stewart, 2003). They need to be stopped. The public should be informed that chiropractic manipulation is the number one reason for people suffering stroke under the age of 45."
I have often condemned the practice of citing papers without reading them (it is, of course, distressingly common), so I feel bad about this, though I had in fact read the paper in question in its web version. I’m writing about it because I feel one should be open about mistakes, even small ones.
I’m also writing about it because one small section of the magic medicine community seems to think they have nailed me because of it. David Owen, the New Zealand chiropractor, wrote to the editor of the NZMJ, thus.
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The quote [in question] is the public should be informed that chiropractic manipulation is the number one reason for people suffering stroke under the age of 45. Long PH. Stroke and Manipulation. J Quality Health Care. 2004:3:8-10 This quote actually comes from the following blog article http://www.skepticreport.com/medicalquackery/strokespinal.htm [DC the URL is now http://skepticreport.com/sr/?p=88] I have attached all my personal communications with Colquhoun. They demonstrate this is not a citation error. Prof Colquhoun believes the origin of the quote doesn’t matter because Long was quoting from a Canadian Neurologists’ report (this is also incorrect). As you can see he fails to provide any evidence at all to support the existance [sic] of the “J Quality Health Care.” Colquhoun ‘s belief that my forwarding this complaint is me “resorting to threats” is the final nail in the coffin. If he had any leg to stand on where is the threat? This may seem pedantic but it surely reflects a serious ethical breach. Is it acceptable to make up a reference to try and slip any unsupported statement into a “scientific” argument and thereby give it some degree of credibility? Incidentally, at the end of the article, conflicts of interest are listed as none. As Colquhoun is a Professor of Pharmacology and much of his research funding no doubt comes from the pharmaceutical industry how can he have no conflict of interest with therapies that do not advocate the use of drugs and compete directly against the billions spent on pain medications each year? If I may quote Colquhoun himself in his defence of his article (Journal of the New Zealand Medical Association, 05-September-2008, Vol 121 No 1281) I’ll admit, though, that perhaps ‘intellect’ is not what’s deficient in this case, but rather honesty. David Owen |
Financial interests
Well, here is a threat: I’m exposed as a shill of Big Pharma. ". . . much of his funding no doubt comes from the pharmaceutical industry". I can’t count how many times this accusation has been thrown at me by advocates of magic medicine. Oddly enough none of them has actually taken the trouble to find out where my research funding has come from. None of them even knows enough about the business to realise the extreme improbability that the Pharmaceutical Industry would be interested in funding basic work on the stochastic properties of single molecules. They fund only clinicians who can help to improve their profits,
The matter of funding is already on record, but I’ll repeat it now. The media ‘nutritional therapist’, Patrick Holford, said, in the British Medical Journal
“I notice that Professor David Colquhoun has so far not felt it relevant to mention his own competing interests and financial involvements with the pharmaceutical industry “
To which my reply was
” Oh dear, Patrick Holford really should check before saying things like “I notice that Professor David Colquhoun has so far not felt it relevant to mention his own competing interests and financial involvements with the pharmaceutical industry”. Unlike Holford, when I said “no competing interests”, I meant it. My research has never been funded by the drug industry, but always by the Medical Research Council or by the Wellcome Trust. Neither have I accepted hospitality or travel to conferences from them. That is because I would never want to run the risk of judgements being clouded by money. The only time I have ever taken money from industry is in the form of modest fees that I got for giving a series of lectures on the basic mathematical principles of drug-receptor interaction, a few years ago.”
I spend a lot of my spare time, and a bit of my own money, in an attempt to bring some sense into the arguments. The alternative medicine gurus make their livings (in some cases large fortunes) out of their wares.
So who has the vested interest?
Does chiropractic actually cause stroke?
As in the case of drugs and diet, it is remarkably difficult to be sure about causality. A patient suffers a vertebral artery dissection shortly after visiting a chiropractor, but did the neck manipulation cause the stroke? Or did it precipitate the stroke in somebody predisposed to one? Or is the timing just coincidence and the stroke would have happened anyway? There has been a lot of discussion about this and a forthcoming analysis will tackle the problem of causality head-on,
My assessment at the moment, for what it’s worth, is that there are some pretty good reasons to suspect that neck manipulation can be dangerous, but it seems that serious damage is rare.
In a sense, it really doesn’t matter much anyway, because it is now apparent that chiropractic is pretty well discredited without having to resort to arguments about rare (though serious) effects. There is real doubt about whether it is even any good for back pain (see Cochrane review), and good reason to think that the very common claims of chiropractors to be able to cure infant colic, asthma and so on are entirely, ahem, bogus. (See also Steven Novella, ebm-first, and innumerable other recent analyses.)
Chiropractic is entirely discredited, whether or not it may occasionally kill people.
Complaint sent to UCL
I had an enquiry about this problem also from my old friend George Lewith. I told him what had happened. Soon after this, a complaint was sent to Tim Perry and Jason Clarke, UCL’s Director and Deputy Director of Academic Services. The letter came not from Lewith or Owen, but from Lionel Milgom. Milgrom is well known in the magic medicine community for writing papers about how homeopathy can be “explained” by quantum entanglement. Unfortunately for him, his papers have been read by some real physicists and they are no more than rather pretentious metaphors. See, for example, Danny Chrastina’s analysis, and shpalman, here. Not to mention Lewis, AP Gaylard and Orac.
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Dear Mr Perry and Mr Clark, I would like to bring to your attention an editorial (below) that appeared in the most recent issue of the New Zealand Medical Journal. In it, one of your Emeritus Professors, David Colquhoun, is accused of a serious ethical breach, and I quote – “Is it acceptable to make up a reference to try and slip any unsupported statement into a “scientific” argument and thereby give it some degree of credibility?” Professor Colquhoun is well-known for writing extensively and publicly excoriating many forms of complementary and alternative medicine, particularly with regard to the alleged unscientific nature and unethical behaviour of its practitioners. Professor Colquhoun is also a voluble champion for keeping the libel laws out of science. While such activities are doubtlessly in accord with the venerable Benthamite liberal traditions of UCL, I am quite certain hypocrisy is not. And though Professor Colquhoun has owned up to his error, as the NZMJ’s editor implies, it leaves a question mark over his credibility. As custodians of the college’s academic quality therefore, you might care to consider the possible damage to UCL’s reputation of perceived professorial cant; emeritus or otherwise. Yours Sincerely Dr Lionel R Milgrom |
So, as we have seen, the quotation was correct, the reference was correct, and I’d read the article from which it came I made a mistake in citing the original paper rather than the web version of the same paper..
I leave it to the reader to judge whether this constitutes a "serious ethical breach", whether I’d slipped in an "unsupported statement", and whether it constitutes "hypocrisy"
Follow-up
It so happens that no sooner was this posted than there appeared Part 2 of the devastating refutation of Lionel Milgrom’s attempt to defend homeopathy, written by AP Gaylard. Thanks to Mojo (comment #2) for pointing this out.
Peter Dixon is a chiropractor. He is chair of the General Chiropractic Council (GCC). He was also a member of the hotly-disputed NICE low back pain guidance group that endorsed (you guessed it) the use of chiropractic, a decision that has led to enormous criticism of the standards of the National Institute of health and Clinical Excellence (NICE).
As a consequence largely of the decision of the British Chiropractic Association (BCA) to sue Simon Singh for defamation, there has been an unprecedented interest taken in the claims made by chiropractors in general.
Peter Dixon has a problem because something like 600 individual complaints about unjustified health claims have been sent to the GCC. Even when a web site does not claim to be able to benefit things like asthma and colic, a phone call may reveal that claims are made in private (one of the many complaints to the GCC concerns such behaviour by two practices belonging to, ahem, Peter Dixon Associates).
The crucial question is, as always, one of evidence. The BCA claim to have a plethora of evidence for their claims, but they have been strangely reluctant to produce it. In fact evidence is cited on the “Your first visit” page on Dixon’s site.
At the bottom we see “How effective is Chiropractic?”.
That sounds very impressive indeed: . ” . . . patients who received chiropractic treatment improved by 70% more than those given hospital out-patient.”
But hang on. If we look at the paper, Meade et al., 1990 [download reprint], we see that Figure 2 looks like this.
Several things jump out. First, the Oswestry disability index scale runs for 0 to 100, but scores are plotted only from 0 to 35, so the size of the effects are exaggerated. Second, there are no error bars on the points. Third there is essentially no advantage for chiropractic at all when all patients are taken together (top graph). Fourth, and most important, the patients who were followed up for two years (bottom graph) seem to show a slight advantage for chiropractic but on average, the effect is 7 percent (on the 100 point scale, NOT 70 percent as claimed on the web site of Peter Dixon Associates.
What sort of mistake was made?
The abstract of the paper itself says “A benefit of about 7% points on the Oswestry scale was seen at two years.” How did this become “improved by 70% more”?
It could have been simple a typographical error, but that seems unlikely, Who’d boast about a 7% improvement?
Perhaps it is a question of relative versus absolute change. The Figure does not show the actual scores on the 100 point scale, but rather the change in score, relative to a questionnaire given just before starting treatment. If we look at the lower part of the Figure, restricted to those patients who stayed with the trail for 2 years (by this time 28% of the patients had dropped out), we see that there is a reduction in score (improvement) of about 10 points on the 100 point scale with hospital treatment (not a very impressive response). The improvement with those sent to private chiropractic clinics was about seven points bigger. So a change from 10 to 17 is a 70 percent change. What’s wrong with that?
What’s wrong is that it is highly misleading, as relative changes often are. Imagine that the hospital number had been 7 points and the chiropractic number had been 14 (both out of 100). That would mean that both treatments had provided very modest benefits to the patients. Would it then be fair to describe the chiropractic patients as have improved by 100 percent more than the hospital patients, when in fact neither got much benefit? Of course it would not. To present the results in this way would be highly deceptive.
Put another way, a 70% increase in a trivial effect is still pretty trivial.
That isn’t all either. The paper has been analysed in some detail on the ebm-first site. The seven point difference on a 100 point scale, though it may be real, is too small to be ‘clinically significant’ In other words the patient would scarcely notice such a small change. Another problem lies in the nature of the comparison. Patients were, quite properly, allocated at random to chiropractic or to to hospital treatment. BUT the comparion was very from blind. one group was treated in hospital. The other group was sent to private chiropractic clinics. The trivial 7 point difference could easily be as much to do with the thickness of the carpets rather than any effect of spinal manipulation.
What this paper really tells you is that neither treatment is very effective and that there is little to choose between them.
It is really most unfortunate that the chairman of the GCC should show himself to be so careless about evidence at a time when the evidence for the claims of chiropractors is under inspection as never before. It does not add to their case for criticising Simon Singh and it does not add to one’s confidence in the judgement of the NICE guidance group.
Follow-up
The Pain Society revolt. A letter has been sent from several distinguished members of the British Pain Society to its President and Council.
“We, the undersigned, call upon the President of the British Pain Society to issue a statement to NICE and to the press condemning outright the conclusions of the recent UK National Institute for Health and Clinical Excellence (NICE) guidelines . . .”
The sigificance of this letter is that the present president of the British Pain Society is Professor Paul Watson who was a member of the NICE guidance group that produced the recommendations which have engendered such criticism. He was clinical advisor to the guidance group. There is a video of Paul Watson talking about back pain, that seems to me to illustrate very well the problem with the guidance. He says it is a huge problem (everyone knows that) and that something must be done, but he doesn’t say what. There is no admission that, in very many cases, nobody knows what to do. It is exactly this sort of hubris that that makes the NICE report so bad,
One caustic comment on the letter says
“We are led by a physiotherapist! A Professor who cannot even interpret straight forward evidence when it is presented to him on a plate.
Who’s going to be the next BPS President? A Hospital Porter?”
The first post was NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself.
That was followed by NICE fiasco, part 2. Rawlins should withdraw guidance and start again.
Since then, something of a maelstrom has engulfed NICE, so it’s time for an update.
It isn’t only those who are appalled that NHS should endorse voodoo medicine on the basis of very slim evidence who are asking NICE to rethink their guidance on low back pain. Pain specialists are up in arms too, and have even started a blog, ‘Not Nearly as NICE as you think …‘, to express their views. Equally adverse opinions are being expressed in the Britsh Medical Journal. A letter there is signed by over 50 specialists in pain medicine. It ends thus
“Because of these new guidelines patients will continue to experience unnecessary pain and suffering and their rights to appropriately individually tailored treatment have been removed on the basis of a flawed analysis of available evidence. We believe the guidelines do not reflect best practice, remove patient choice and are not in our patients’ best interests.”
In a contribution headed “NICE misguidance”. Dr Michel Vagg ends
It seems to me that this guideline has been used as a propaganda vehicle to allow cherry-picked evidence to be enshrined as doctrine. This is an abuse of the guideline development process . . . ”
I have to say, though, that it seems to me that some of these people are promoting their own interests as much as chiropractors and acupuncturists. The evidence that spinal injections produce worthwhile benefits seems to be as thin as the evidence that chiropractic and acupuncture produce worthwhile benefits. But no doubt the injections are good for the budgets of PCTs or private practice doctors.. Could it perhaps be the case that some of the clinicians’ anger is being generated by doctors who are rushing to defend their own favourite ineffective treatment?
Why, oh why, can’t either NICE or the pain consultants bring themselves to state the obvious, that nothing works very well. The only thing that can be said for most of the regular treatments is that although they may not be much more effective than acupuncture or chiropractic, at least they don’t come with the intellectually-offensive hokum that accompanies the latter. Very sensible attempts have been made to identify the cause of low back pain [reviewed here], Occasionally they succeed. Mostly they don’t.
One clinician’s letter deserves special attention because it goes into the evidence, and the costs, in some detail. Its conclusions are very different from those in the NICE guidance.
The letter, a Review of NICE guidance, is from Dr C.J.D. Wells [download the whole letter]. He is a pain relief consultant from Liverpool.
Let’s look at some highlights.
Wells points out the absurdity of the cost estimates
“In the pricing section, they estimate that this will require an increase of facilities so that 3,500 patients can be treated instead of 1,000 at present (again see comments on pricing). This is not many treatments for the 20 million sufferers, of whom we can estimate that at least 2 million will have significant long-term disability and psychological distress”
And that is without even costing all the secondary costs of miseducating a new generation of students in fables about “Qi”, meridians, energy flow, subluxations and innate intelligence.
“The abysmal ignorance of the committee is reflected in the poor overall advice. So if you have a committee with special interests in Exercise, Manipulation, PMP’s, and Surgery, and you call an expert on Acupuncture, you get advice to use Exercise, Manipulation, Acupuncture, PMP’s and Surgery. Amazing.”
Another pain consutant, Charles Guaci, says in a comment in the Daily Mail.
I am a Pain Consultant of 30 years experience, have published two books (one translated into different languages).
NICE never asked me for my opinion.
This is the most ridicuculous pseudo-scientific document I have ever seen.
The panel consisted of a surgeon, psychologist, osteopath, acupuncturist a physiotherapist and an academic; not one pain consultant! The conclusions are simply a means of increasing the employment of their friends!
All evidence submitted to NICE was ignored.
It is almost certain than unless NICE rethink their ideas that Pain Consultants will be seeking a judicial review as well as full disclosure of how the panel arrived at their bizarre findings under the Freedom of information act.
Patients should realise that they are being taken for a ride.
Despite the outcry from opponents of magic medicine and from pain specialists, the assessment by the normally excellent NHS Choices site was disappointing. It made no mention at all of the secondary consequences of recommending CAM and described the assertions of the guidance group quite uncritically.
The reputation of NICE
NICE has been criticised before, though usually unjustly. In the past I have often supported them. For example. when NICE said that treatment of dementia with anticholinesterase drugs like galantamine was ineffective, there was a great outcry, but NICE were quite right. There is little or no rationale for such treatments, and more importantly, very little evidence that they work. But patients, especially when they are desperate, have greater faith in drug treatments than most pharmacologists, They want to clutch at straws. A bit like the NICE guidance committee, faced with a bunch of treatments most of which are almost ineffective, clutched at the straws of acupuncture and chiropractic. But this time it isn’t only the patients who are cross. It is most of the medical and scientific world too.
One interpretation of these bizarre events is that they represent a case of medical/scientific arrogance. Ben Goldacre wrote of another aspect of the same problem thus week, in Dodgy academic PR [download the paper on which this is based].
The first job of a scientist is to say openly when the answer to a question is not known. But scientists are under constant pressure to exaggerate the importance of their results. Last year we published an article which I feel may, if verified, turn out to be the second most important that I have ever been an author on. Because it happened to be published in Nature (not because of its quality), a press release was written (by an arts graduate!). It took some argument to prevent the distorted and exaggerated account being imposed on the public. This is typical of the sort of thing reported in Goldacre’s column. I reported a similar case a while ago, Why honey isn’t a wonder cough cure: more academic spin.
If NICE does not reconsider this guidance, it is hard to see how it can be taken seriously in the future. I hope that when NICE’s director, Professor Sir Michael Rawlins, returns from his trips abroad, he will find time to look at the case himself.
Indirectly, then, it can be argued that NICE’s bizarre guidance is just another manifestation of the management of science being passed from the hands of scientists into the hands of administrators and spin experts. It is yet another example of DC’s rule
Never trust anyone who uses the word ‘stakeholder’
Some bone-headed bureaucrat decides that any charlatan or quack is a ‘stakeholder’ in the provision of NHS care and gives them a quite disproportionate say in how taxpayers’ money is spent. The bureaucrats are so busy following processes and procedures, ticking boxes, and so deficient in scientific education, that they failed to notice that they’ve been caught out by the old trick of used car salesmen, bait and switch.
The consequences
The expected consequences have already started to materialise. The Prince of Wales’ Foundation for Magic Medicine is jubilant about having been endorsed by NICE. And I’m told that “The chiropractors have now just written letters to all health boards in Scotland asking for contracts for their services to deal with back pain”.
There could hardly have been a worse time for NICE to endorse chiropractic. We are in the middle of a storm about free speech because of the disgraceful action of the British Chiropractic Associaton in suing one of our best science writers, Simon Singh, for defamation because he had the temerity to express an opinion, Of course, even if the BCA wins in court, it will be the overall loser, because chiropractic claims are now being scrutinised as never before (just look at what they told me).
Follow-up
A much-cited paper. The paper that is most often cited by chiropractors who claim to be able to cure colic by spinal manipulation is 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 is not easy to get hold of but Steve Vogel has sent me s scanned copy which you can download here. As evidence it is about as useless as the infamous Spence study so beloved of homeopaths. There was no control group at all. It simply follows 316 babies and found that most of them eventually got better. Well, they do, don’t they? It is a sign of the pathetic standard of reaearch in chiropractic that anyone should think this paper worth mentioning at all.
June 6 2009. More flak for NICE from the Royal College of Anaesthetists, and more adverse comment in the BMJ. And of course the blogs. for example, “If this is “evidence based medicine” I want my old job back“.
“Acupuncture on the NHS: a dangerous precedent”: a good analysis at counterknowledge.com.
June 6 2009, Comment sent to the BMJ. The comment was submitted, as below, early on Friday 5th June. The BMJ said it was a “sensitive issue” and for the next five days lawyers pondered over it.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors find it so hard to find evidence for their practices that, when one of our finest science writers, Simon Singh, asked to see the evidence they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against this iniquitous persecution.
Of course I’m sure this bizarre decision has nothing to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. Nevertheless, I am curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that they could probably treat infantile colic and asthma. Such claims have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments work very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, when asked to produce evidence, resort to legal intimidation.
Eventually, on Wednesday 10 June the comment appeared in the BMJ, and it wasn’t greatly changed. Nevertheless if is yet another example of legal chill. This is the final version.
Underwood and Littlejohns describe their guidance as being a “landmark”. I can only agree with that description. It is the first time that NICE has ever endorsed alternative medicine in the face of all the evidence. The guidance group could hardly have picked a worse moment to endorse chiropractic. Chiropractors are so sensitive about criticisms of their practices that, when one of our finest science writers, Simon Singh, queried the evidence-base for their therapeutic claims they sued him for defamation. I suggest that the guidance group should look at the formidable list of people who are supporting Singh, after his brave decision to appeal against an illiberal court ruling in this iniquitous persecution.
One wonders whether this bizarre decision by NICE has anything to do with the presence on the guidance group of Peter Dixon, chair of the General Chiropractic Council. I am also curious to know why it is that when I telephoned two of the practices belonging to Peter Dixon Associates, I was told that chiropractic could be effective in the treatment of infantile colic and asthma. Similar claims about treating colic have just been condemned by the Advertising Standards Authority.
The low back pain guidance stands a good chance of destroying NICE’s previously excellent reputation for dispassionate assessment of benefits and costs. Yes, that is indeed a landmark of sorts.
If NICE is ever to recover its reputation, I think that it will have to start again. Next time it will have to admit openly that none of the treatments works very well in most cases. And it will have to recognise properly the disastrous cultural consequences of giving endorsement to people who, instead of engaging in scientific debate, resort to legal intimidation.
Bait and switch. Oh dear, oh dear. Just look at this. British Chiropractic Association tell their members to hide their sins from prying eyes.
Excellent round-up of the recent outburst of writing about “chiroquacktic” (Tut, tut, is there no respect?).
Dr Crippen writes “NICE recommends a cure for all known disease” [Ed some exaggeration, surely]
Two days ago I wrote NICE falls for Bait and Switch by acupuncturists and chiropractors: it has let down the public and itself
Now the official ‘guidance’ is out, and it is indeed quite as bad as the draft.
The relevant bits now read thus.
- Offer one of the following treatment options, taking into account patient preference: an exercise programme, a course of manual therapy or a course of acupuncture. Consider offering another of these options if the chosen treatment does not result in satisfactory improvement.
- Consider offering a structured exercise programme tailored to the person:
- This should comprise of up to a maximum of 8 sessions over a period of up to 12 weeks.
- Offer a group supervised exercise programme, in a group of up to 10 people.
- A one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person.
- Consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks
- Consider offering a course of acupuncture needling comprising up to a maximum of 10 sessions over a period of up to 12 weeks.
The summary guidance still doesn’t mention chiropractic explicitly, just a coy reference to “spinal manipulation”. At a time when the British Chiropractic Association is busy trying to suppress free speech via the law courts, I guess it isn’t surprising that they don’t like to use the word.
The bias in the recommendations is perhaps not surprising because the guidance development group had a heavy representation from alternative medicine advocates, and of people with a record of what, is, in my view, excessive tolerance of mumbo-jumbo.
Royal College of General Practitioners (RCGP) played a large part in writing the guidance. That is an organisation thar has steadfastly refused to make any sort of sensible statement of policy about magic medicine. It isn’t long since I was told by a senior person at the RCGP that there was nothing odd about neuro-linguistic programming. That does not bode well.
Professor Martin Underwood, Professor of Primary Care Research Warwick Medical School, University of Warwick. Underwood chaired the guidance development group. Martin Underwood is also a GP in Coventry See also the British Osteopathic Association. Underwood was lead author of the BEAM trial (download reprint). It is well worth reading the comments on this trial too. It was a randomised trial (though not, of course, blind).
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Our main aim was to estimate, for patients consulting their general practitioner with back pain, the effectiveness of adding the following to best care in general practice: a class based exercise programme (“back to fitness”), a package of treatment by a spinal manipulator (chiropractor, osteopath, or physiotherapist), or manipulation followed by exercise Conclusions |
In other words, none of them worked very well. The paper failed to distinguish between manipulation by physiotherapists, chiropractors and osteopaths and so missed a valuable chance to find out whether there is an advantage to employing people from alternative medicine (the very problem that this NICE guidance should have dealt with)
Steve Vogel, another member of the guidance development group, is an osteopath. Osteopathy has cast off its shady origins better than chiropractic, but it remains a largely evidence-free zone, and is still usually classified as alternative medicine.
Peter Dixon DC FCC FBCA is chairman of the General Chiropractic Council and founder of Peter Dixon Associates. They run six chiropractic clinics. The claims made by these clinics on their web site are mostly related to musculo-skeletal conditions (not, all spine-related however). But they also include
“Chiropractic is also suitable for relieving the symptoms of stress, and optimizing the way the body works is one of the best ways of enhancing health and wellbeing.”
I wonder how they could justify that claim? Then we get
A chiropractor is always willing to discuss individual conditions or answer questions in order to assess whether chiropractic may be of benefit.
Thanks for the invitation. I accepted it. After the first two phone calls, I had learned all I needed.
The first of Peter Dixon’s clinics that I called, was asked about my son who was suffeiing from perpetual colic. I asked for advice. I was put through to the chiropractor. Here are some extracts from the conversation.
“I think now it’s termed irritable baby syndrome. . . . . We’ve found chiropractic is very effective for colic . . . . £50 up to 3/4 hour which would involve taking a case history, examining the baby, with regard to seeing how the joints in the spine work because often colic is down to, er um, faulty movement patterns in the spine. We deal with an awful lot of things to do with the frame -how the spine moves -and it’s often problems with the way that the bones of the spine move in infants and babies that is the underlying cause in colicky symptoms. . . usually on the whole, I’ve shot myself in the foot by saying this in the past, if there are -um when I say back problems they’re usually temporary issues -when they are there the response for most babies is quite quick . . . it depends on how it’s related to what’s gone on in the birth process -there is usually some traumatic cause and it usually sets up a problem in the upper neck or the mid-back and that will drive those colic symptoms. . . . Yes it’s quite a straightforward thing we just check the baby’s spine and see if it’s problem we can deal with or not.”
Yes, I think you just shot yourself in the foot again. I have no idea in what fraction of cases a chiropractor would fail to claim that it was a case that they could deal with. At least that possibility was envisaged. But when I asked where he’d refer me to in such case I was told it might be a result of bottle feeding -“what they consume”. So I expect it would have been sent to some sort of “nutritional therapist” who would have used one of their usual battery of unreliable tests for food allergies.
I tried a second clinic in Peter Dixon’s empire and asked if chiropractic could help with asthma.”It can do, depending on what type of asthma you have". After some questions I was asked
“Do you have any general aches and pains otherwise, any tension .problems round the rib cage or thoracic spine . . . There are two things we’d look as chiropractors as to whether we could help or not and that would include the tension round the rib cage -in any type of asthma you’ll become tight round the rib cage and merely by keeping that area loose you’d help to stop the asthma from becoming quite as bad. And the second part is we’d look at the neck area with you to see if there is any restriction there -which houses the nerve supply to the lungs which can be indicated in some asthma cases also.”
I was invited to come for a free screen, so I asked if it usually worked quickly, “It depends what the problem is but you’d need a course I suspect”. £45 for the first appointment then £28 per session. “In most cases you’d need to look at a six to eight session course”.
Would anyone with experience of crying babies or of asthma like to comment on these proposed treatments? They are not my idea of evidence-based treatments and I find it quite surprising that someone who sponsors them is thought appropriate to write guidance for NICE.
This sort of ‘sting’ always makes me feel a bit uneasy, but it seems to be the only way to find out what actually goes on. And what goes on has all the appearance of classic bait and switch. You go in for your backache, and before you know where you are you are being sold a course of treatment to stop your baby crying.
Media follow-up after the NICE announcement
Sadly, I heard that the Today programme (my favourite news programme) was pretty wet. if only their science reporting was as good as their politics reporting.
The 27th May was certainly pretty busy for me, Apart from a couple of local paper interviews, this is what happened,
Sky News TV. Richard Suchet and two cameraman came to UCL and filmed a lot of stuff out of which a 20 second clip was used. And then they grumble that they don’t make money.
BBC TV 6 o’clock News. Similar, but at least only two people this time. Both TV stations spent ages showing pictures of people having needles pushed into them and very little time discussing the problems. A pathetically bad attempt at science reporting. Radio, on the whole, did much better
BBC Three Counties Radio (09.20) Host Ronnie Barbour, The daytime talk shows may be appalling to some of us, but the hosts did a far better job of airing the problems than TV [download the mp3].
Radio 5 Live Victoria Derbyshire [download the mp3]
BBC Radio Sheffield (12.05) was the best talk show by far. First speaker was Steve Vogel, the osteopath from the guidance development group. Although invited by the rather sensible host, Rony, to respond to the idea that a secondary consequence of the guidance would be to introduce hocus-pocus, he steadfastly refused to answer the question. At the end a rather sensible GP summed up the view from the coalface. [play the mp3]
Radio 4 PM programme This excellent early evening news programme is run by Eddie Mair. It was the best interview yet. The other side was put by Martin Underwood, chair of the guidance development group [play the mp3]
Underwood said “the evidence shows that it [acupuncture] works”. I disagree. The evidence shows that acupuncture, in a non-blind comparison with no acupuncture shows a small, variable additional effect that doesn’t last and is of marginal clinical significance, That is not what I call “works”. Underwood then indulges in the subgroup analysis fallacy by asserting that a few people get a large benefit from acupuncture. Or perhaps a few people just happen to get better that day. I was not convinced.
More 4 News TV 20.20 was an interview, with the other side being put by my old friend, George Lewith.
During the introduction, an acupuncturist. Lisa Sherman, ‘explained’ acupuncture in the usual sort of utterly meaningless words that illustrate perfectly the problem.
George Lewith said that “we don’t have a good pretend form of acupuncture”. “We don’t have a good placebo and we can demonstrate that acupuncture is literally twice as effective as conventional care”. The first is simply nonsense: huge efforts have gone into developing good controls in acupuncture studies (see, for example, Barker Bausell’s book, Snake Oil Science). And I hope that George will send the references for his “twice as effective” claim. It seems to me to be nothing short of preposterous.
My conclusions
So what went wrong?
One problem could be regarded as medical arrogance. The fact is that the problem of low back pain has not been solved, either by drugs or anything else. It is a failure of medicine (and of pharmacology). That should be the premise of all discussions, and it smacks of arrogance not to tell people straight out. Of course there are some cases when causes can be identified, and perhaps remedied, usually by surgery, but these are the exceptions not the rule.
One consequence of the inability of medicine to help much is that patients get desperate, and willing to try anything. And of course if they happen to have a remission, that is attributed to the treatment, however preposterous that treatment may have been. Conditions like back pain that come and go unpredictable are a gift for quacks.
Another consequence, for researchers rather than patients, is to clutch at straws. Even small and inconsistent effects are seized on as ‘successes’. This phenomenon seems to be part of the reason for the NICE guidance. Another reason is, almost certainly, the grinding of axes by some of the people who wrote it.
What should be done now?
Professor Sir Michael Rawlins is a sensible chap. He cares about evidence, But it does seem that in this case, he might have taken his eye off the ball, for once. In my opinion, he should restore the reputation of NICE by withdrawing this guidance and starting again.
Follow-up
An interesting document has come my way. It shows the responses of the guidance group to the consultation on the draft guidance. Many people made comments not unlike mone, but they were all brushed aside in a way that looks to me rather partisan. The document appears to have vanished from NICE’s web site, but you can download it here.
Friday 29th May. The Times prints a letter from two consultants in pain medicine, Joan Hestor and Stephen Ward. It says, inter alia
“As experienced pain specialists we feel that NICE has lost its way in publishing these guidelines.”
“We are saddened that NICE has chosen to ignore our important role and promote seemingly unworkable and for the most part clinically ineffective treatments”
Friday 29th May. NICE has had a good reputation in the USA for its important, and usually high-quality, attempts to assess what works and what doesn’t. That makes it all the sadder to see it condemned already from the USA for its latest effort. The excellent Yale neurologist, Steven Novella, has written about it on his Neurologica blog.
Friday 29th May. A correspondent points out that the costings of the guidance can be found on the NICE web site. Table 1 has a strong air of make-believe.
The Daily Mail (29 May 2009). Their article quotes serious criticisms of NICE.
Dr Ron Cooper, past chairman of the group and a consultant pain specialist in Northern Ireland, said: ‘I have never known so many pain medicine specialists to be so furious. More patients will end up having more expensive surgery, which is unnecessary, risky and has worse results.
‘NICE made it difficult for us to submit evidence to a committee on which there was not one experienced pain physician.
‘The guidelines will make us the laughing stock of Europe, Australia and the U.S. where pain specialists will continue to have full access to a wide range of treatments.’
Chirowatch suspended. 30 May 2009. The invaluable chiro-watch site, http://www.chirowatch.com, run by Dr Canadian physician, Dr Tom Polevoy, has been “suspended”. In fact the whole of his domain, healthwatcher.net, has been disabled. It seems that this was the result of a legal threat to his ISP, not by chiropractors this time, but by William O’Neill of the Canadian Cancer Research Group, which is far from being what the respectable-sounding title suggests, according to Dr Stephen Barrett. The site will be back soon, I’m told. Meanwhile you can read the suspended page here, and the only result of their hamfisted bullying will be to vastly increase the number of people who read it. You can read lots more at Quackwatch’s chirobase and at ebm-first.
A new blog, Not as NICE as you think appeared on May 30th. It is written by a pain physician, Stephen Ward. and is devoted to pointing out the serious problems raised by NICE’s guidance. It starts with the (very critical) World Institute of Pain Press Release.
British Medical Journal has more flak for the NICE guidelines
And the BMJ has published a letter signed by 50 consultants in pain medicine, NICE guidelines on low back pain are flawed.(this will probably appear as a letter in the print edition of the BMJ).
First the MHRA lets down the public by allowing deceptive labelling of sugar pills (see here, and this this blog). Now it is the turn of NICE to betray its own principles.
The National Institute for Health and Clinical Excellence (NICE) describes its job thus
“NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.”
Its Guidance document on Low Back Pain will be published on Wednesday 27 May 2009, but the newspapers have already started to comment, presumably on the assumption that it will have changed little from the Draft Guidance of September 2008. These comments may have to be changed as soon as the final version becomes available.
The draft guidance, though mostly sensible, has two recommendations that I believe to be wrong and dangerous. The recommendations include (page 7) these three.
- Consider offering a course of manual therapy including spinal manipulation of up to 9 sessions over up to 12 weeks.
- Consider offering a course of acupuncture needling comprising up to 10 sessions over a period of up to 12 weeks.
- Consider offering a structured exercise programme tailored to the individual.
All three of this options are accompanied by a footnote that reads thus.
“A choice of any of these therapies may be offered, taking into account patient preference.”
On the face if it, this might seem quite reasonable. All three choices seem to be about as effective (or ineffective) as each other, so why not let patients choose between them?
Actually there are very good reasons, but NICE does not seem to have thought about them. In the past I have had a high opinion of NICE but it seems that even they are now getting bogged down in the morass of political correctness and officialdom that is the curse of the Department of Health. It is yet another example of DC’s rule number one.
Never trust anyone who uses the word ‘stakeholder’.
They do use it, often.
So what is so wrong?
For a start, I take it that the reference to “spinal manipulation” in the first recommendation is a rather cowardly allusion to chiropractic. Why not say so, if that’s whar you mean? Chiropractic is mentioned in the rest of the report but the word doesn’t seem to occur in the recommendations. Is NICE perhaps nervous that it would reduce the credibility of the report if the word chiropractic were said out loud?
Well, they have a point, I suppose. It would.
That aside, here’s what’s wrong.
The Evidence
I take as my premise that the evidence says that no manipulative therapy has any great advantage over the others. They are all more or less equally effective. Perhaps I should say, more or less equally ineffective, because anyone who claims to have the answer to low back pain is clearly deluded (and I should know: nobody has fixed mine yet). So for effectiveness there are no good grounds to choose between exercise, physiotherapy, acupuncture or chiropractic. There is, though, an enormous cultural difference. Acupuncture and chiropractic are firmly in the realm of alternative medicine. They both invoke all sorts of new-age nonsense for which there isn’t the slightest good evidence. That may not poison your body, but it certainly poisons your mind.
Acupuncturists talk about about “Qi”, “meridians”, “energy flows”. The fact that “sham” and “real” acupuncture consistently come out indistinguishable is surely all the evidence one needs to dismiss such nonsense. Indeed there is a small group of medical acupuncturists who do dismiss it. Most don’t. As always in irrational subjects, acupuncture is riven by internecine strife between groups who differ in the extent of their mystical tendencies,
Chiropractors talk of “subluxations”, an entirely imaginary phenomenon (but a cause of much unnecessary exposure to X-rays). Many talk of quasi-religious things like “innate energy”. And Chiropractic is even more riven by competing factions than acupuncture. See, for example, Chiropractic wars Part 3: internecine conflict.
The bait and switch trick
This is the basic trick used by ‘alternative therapists’ to gain respectability.
There is a superb essay on it by the excellent Yale neurologist Steven Novella: The Bait and Switch of Unscientific Medicine. The trick is to offer some limited and reasonable treatment (like back manipulation for low back pain). This, it seems, is sufficient to satisfy NICE. But then, once you are in the showroom, you can be exposed to all sorts of other nonsense about “subluxations” or “Qi”. Still worse, you will also be exposed to the claims of many chiropractors and acupuncturists to be able to cure all manner of conditions other than back pain. But don’t even dare to suggest that manipulation of the spine is not a cure for colic or asthma or you may find yourself sued for defamation. The shameful legal action of the British Chiropractic Association against Simon Singh (follow it here) led to an addition to DC’s Patients’ Guide to Magic Medicine.
(In the face of such tragic behaviour, one has to be able to laugh).
Libel: A very expensive remedy, to be used only when you have no evidence. Appeals to alternative practitioners because truth is irrelevant.
NICE seems to have fallen for the bait and switch trick, hook line and sinker.
The neglected consequences
Once again, we see the consequences of paying insufficient attention to the Dilemmas of Alternative Medicine.
The lying dilemma
If acupuncture is recommended we will have acupuncturists telling patients about utterly imaginary things like “Qi” and “meridians”. And we will have chiropractors telling them about subluxations and innate energy. It is my opinion that these things are simply make-believe (and that is also the view of a minority of acupuncturist and chiropractors). That means that you have to decide whether the supposed benefits of the manipulation are sufficient to counterbalance the deception of patients.
Some people might think that it was worth it (though not me). What is unforgivable is not to consider even the question. The NICE guidance says not a word about this dilemma. Why not?
The training dilemma
The training dilemma is even more serious. Once some form of alternative medicine has successfully worked the Bait and Switch trick and gained a toehold in the NHS, there will be an army of box-ticking HR zombies employed to ensure that they have been properly trained in “subluxations” or “Qi”. There will be quangos set up to issue National Occupational Standards in “subluxations” or “Qi”. Skills for Health will issue “competences” in “subluxations” or “Qi” (actually they already do). There will be courses set up to teach about “subluxations” or “Qi”, some even in ‘universities’ (there already are).
The respectability problem
But worst of all, it will become possible for aupuncturists and chiropractors to claim that they now have official government endorsement from a prestigious evidence-based organisation like NICE for “subluxations” or “Qi”. Of course this isn’t true. In fact the words “subluxations” or “Qi” are not even mentioned in the draft report. That is the root of the problem. They should have been. But omitting stuff like that is how the Bait and Switch trick works.
Alternative medicine advocates crave, above all, respectability and acceptance. It is sad that NICE seems to have given them more credibility and acceptance without having considered properly the secondary consequences of doing so,
How did this failure of NICE happen?
It seems to have been a combination of political correctness, failure to consider secondary consequences, and excessive influence of the people who stand to make money from the acceptance of alternative medicine.
Take, for example, the opinion of the British Pain Society. This organisation encompasses not just doctors. It
includes “doctors, nurses, physiotherapists, scientists, psychologists, occupational therapists and other healthcare professionals actively engaged in the diagnosis and treatment of pain and in pain research for the benefit of patients”. Nevertheless, their response to the draft guidelines pointed out that the manipulative therapies as a whole were over-represented.
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Manipulation The guidelines assess 9 large groups of interventions of which manual therapies are only one part. The full GDG members panel of 13 individuals included two proponents of spinal manipulation/mobilisation (P Dixon and S Vogel). In addition, the chair of the panel (M Underwood) is the lead author of the UKBEAM trial on which the positive recommendation for |
It seems that the Pain Society were quite right.
LBC 97.3 Breakfast Show (25 May 2009) had a quick discussion on acupuncture (play mp3 file). After I had my say, the other side was put by Rosey Grandage. She has (among other jobs) a private acupuncture practice so she is not quite as unbiassed as me). As usual, she misrepresents the evidence by failing to distinguish between blind and non-blind studies. She also misrepresented what I said by implying that I was advocating drugs. That was not my point and I did not mention drugs (they, like all treatments, have pretty limited effectiveness, and they have side effects too). She said “there is very good evidence to show they (‘Qi’ and ‘meridians’] exist”. That is simply untrue.
There can’t be a better demonstration of the consequences of falling for bait and switch than the defence mounted by Rosey Grandage. NICE may not mention “Qi” and “meridians”; but the people they want to allow into the NHS have no such compunctions.
I first came across Rosey Grandage when I discovered her contribution to the Open University/BBC course K221. That has been dealt with elsewhere. A lot more information about acupuncture has appeared since then. She doesn’t seem to have noticed it. Has she not seen the Nordic Cochrane Centre report? Nor read Barker Bausell, or Singh & Ernst? Has she any interest in evidence that might reduce her income? Probably not.
Where to find out more
An excellent review of chiropractic can be found at the Layscience site. It was written by the indefatigable ‘Blue Wode’ who has provided enormous amounts of information at the admirable ebm-first site (I am authorised to reveal that ‘Blue Wode’ is the author of that site). There you will also find much fascinating information about both acupuncture and about chiropractic.
I’m grateful to ‘Blue Wode’ for some of the references used here.