I’ll try sending the link to the ASA and see what they say.

what completed and reported trial? on that site there is a whole bunch of mostly rubbish, and then a few bits taken from the published oxford-durham study. I’ve summarised this paper elsewhere at least twice:

“Richardson, A.J. and Montgomery, P., The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics, 2005. 115(5): p. 1360-6.

“Kids with Developmental Coordination Disorder, no significant differences between placebo and fish oil groups for motor skills, but improvements for the fish oil group in reading and spelling (P= 0.04 and <0.01) and CTRS-L global scale (P<0.05) and some subscale improvements (P<0.05) for the fish oil group. 117 subjects, 6% dropped out.”

this was performed by two researchers from oxford university, but with some research assistance from durham council as the study was done on durham children (although if you read it eg portwoods name is nowhere on the paper): however ownership of this paper seems to have been rather grandly adopted by the Durham fish oil posse, in ways that create rather more confusion. for example, there is no citation to the published paper, so no way of knowing what is published, where, by who, etc. so i can absolutely understand why you might find it a bit confusing, i think that anyone going there trying to make sense of it would be as rightly confused as you were. i would say this confusing lack of clarity is the dominant theme in the presentation by durham of their research.

what about the rest of the “studies” on the site, with all the graphs? well, durham also claim to have many other randomised controlled trials, as we know, none of which are published, or even available to read in any public form that i can see, and this weeks column describes the bizarre difficulties i had in getting the most basic info out of durham.

so, the other two studies on that durhamtrial.org site are frankly a bit of a joke. neither have placebo controls (that’s becoming a bit of a standard Durham research strategy by the looks of things) and they are reported so badly that for eg the secondary school study there are no stats, and they don’t even tell you how many children were in it!

there’s not a lot you can do with that kind of “science”. it’s cargo cult stuff: looks like science on the outside, all thos nice graphs, but on closer inspection…. i mean, dude, it doesn’t even tell you how many kids were in the study! how much further do you go with a site like that in trying to find useful data?

Well, “we have to keep them calm and make them compliant”……… Yeah, ready for fingerprinting at school, ready for their national ID cattle tag. Well programmed duped ‘droids ready to serve the State and it’s intrusive database.

Stir in the “paedo-hysteria” and no-one will let the wheezing, pasty, allergic, obese little muffins more than a foot from their front doors without a CRB checked adult. So they sit at home watching the box and playing “safe” games or in an “organized” event. No freedom, no risk, no adventure, everywhere an adult “just in case”, that is the REAL child abuse.

And meanwhile when they get away from us for a few minutes, they go over the top in what they do. Drigs, sovenys, fags, booze, graffiti, train surfing… sex, anything that give some excitement. And meanwhile the official kiddie-fiddlers, the “responsible CRB checked Pc adults” keep nausing it all up.

So carry on with the Omega-3, the Folic Acid, MMR, “Healthy bloody jamie bleeding Oliver Eating”, Lots of water, no salt, no crisps, no fizz, no chocolate and worst of all no Macdonalds. Loads of energy free salads, fruit and other sundry “healthy” by energy and nutrition free food, it will make no difference, because once our backs are turned, kids will stick two fingers up at the well-meaning kiddie-mind-f++kers and do exactly what they want.

The State will throw their hands up in horror and propose a new “initiative” or “crackdown”, The Archbishop of canterbury will blame cartoon network instead of his boring the arses off of his congregations and the whole merrygoround will continue as adults, terrified of doing anything without “guidance” sign up to the whole ghastly agenda. Who’d be a child in 2006????

I suspect if you asked Alex Richardson, aka Evidence-biased, how convinced she is about the findings in her published trial AND WHAT THEY IMPLY, it would depend what you asked and how.

I would assume she is convinced that the findings – fish oil supplements help certain problems in kids with developmental coordination disorder – are real, within statistical caveats described in the paper, and with some reservations about possible confounding effects (also mentioned).

But as for the wider implications, how about this for a guess :

“Are you convinced enough to say we should now run a bigger multi-centre DBPC trial of kids w different kinds of developmental difficulties to nail down if the supplements help?”

(and by implication with a view to using the supplements more widely IF THEY ARE SHOWN TO WORK) NB DBPC =Double-blind placebo-controlled

Ans I guess YES (from her published writings – there is some positive trial evidence for ADHD and dyslexia)

“Are you convinced enough to say we should view it as a done deal and give the supplement to any kid with developmental problems?”

Ans I am pretty sure NO

“Are you convinced enough to say we should now run some proper trials on kids who don’t have identifiable developmental problems?”

Ans I guess YES

“Are you convinced enough to say we should view it as a done deal for it helping ALL kids and give it to the lot of them?” (What Durham are actually going to do)

NO NO NO – because a study on the 5-8% of kids with specific identifiable developmental problems does not really tell you what you would expect in normal children – hence the need for a properly constituted study, not a PR stunt.

Sorry, this is really just re-phrasing what I wrote above, and apologies to AR for taking her name in vain.

The point is about what precisely the trials do, and don’t show. They say nothing about normal kids, and SHOW nothing about (e.g.) “slighly slower readers” (not tested) – although you might want to go on and study the latter group.

‘Now I am not so interested in the TV. I just like reading books. The best place in all the world is the library. I absolutely love it.’

By including this quote they are suggesting that fish oil changes kids’ tastes like this. This goes far beyond any claims yet made.

And they are giving these brain-changers out to thousands of kids in an uncontrolled study – sorry, initiative.

What fun.

- No evidence of ethics committee approval so far (I wrote to Durham Council to ask. Got a reply but not one which addressed my questions, which included “what ethics committee approved this initiative”). I’m guessing this was not ever sent for ethics approval. Presumably if it had been turned down they wouldn’t have gone ahead but I can’t imagine any ethics committee allowing it to go ahead. I hear that you don’t HAVE to have approval for nutritional supplements experiments, but it’s obvious that a trial on children should be checked over, regardless of the letter of the law.

- No possibility of the “trial”/”initiative” actually showing anything useful.

Never mind though eh? Get the kids to swallow untested pills of uncertain effect and watch the money rolling in.

i took a quick look at the front page of that link… bit busy here to go through the trials themselves but i like this paragraph from the front page.

“With current research revealing that fatty acid deficiencies may be a factor connecting these learning difficulties, it was possible that for some pupils an improved diet would lead to improvements elsewhere: however overturning the high-carbohydrate heavily- processed diets that children typically consume was going to be a momentous task.”

So we have learning difficulties as the target group and the next bit is pure Jamie Oliver.

Also they are going to review the results of this non trial trial on the basis of “expected results”. Who set’s the expectations?

So they will be looking at the spread of grades in examinations… which if i remember new’s articles correctly are trending upwards all the time (exams getting easier?)

Are they going to compare this result spread with other schools in the same area who are not participating?

Also the degree of hype around this trial will affect the students who are part of it. They have also been told (no doubt) by the respectable men in white coats that this pill will help them concentrate and retain info. The very act of this may induce the desired results.

The bottom line is that without proper scientific methods being applied this “trial” is actually a “farce” who’s sole measurable result will be to establish the amount of free media time and column inches they gain from it.

But it cost’s them money to donate the product i hear you cry…. true it does, but let’s face it, the “street value” of this product is much greater than the cost to the company of manufacture and delivering it to the schools.

So for the 1 million £ worth of product they are donating i would be surprised to see more than £100,000 of costs. How many column inches and prime time minutes would that buy them compared to what they are getting from the hype!

Or am i just being cynical again?

As he points out, there’s just not enough evidence to go on yet, unless you look at the bigger picture (which I’ve tried to do in most of my reviews over the years… )

But if anyone wants a copy of my 2006 review as cited in #34 and can’t get it directly from the journal, please could I ask that you request this via the website at http://www.fabresearch.org rather than using my University email address? The widespread availability of the latter means that it’s usually overloaded not just with spam (I thought you didn’t display email addresses on this site, Ben?) but with seemingly endless enquiries about the latest ‘Durham trials…’ and/or desperate parents wanting to know: ‘Will supplements help my child…?’
It all gets a bit tiring after a while…

Profnick – I’d also been hoping that someone else might answer your question #8. This issue did come up at least obliquely in earlier threads, but FYI, one of the several trials alluded to on durhamtrials.org certainly has been published – see http://www.fabresearch.org/view_item.aspx?item_id=805
Sorry I can’t help you on the others, but they had nothing to do with me.

Prof Nick

Unfortunately to analyse the published studies PROPERLY case by case one would have to be expert in analysing human clinical trials on behavioural problems in kids (how kids selected, how assessed, how data analysed, etc). Even as a grizzled biomedical scientist I’m not expert enough for this, although some people reading this may be. So I have to fall back on the expert and systematic reviewers who write the reviews and meta-analyses in this area.

For instance:

Richardson AJ

Int Rev Psychiatry. 2006 Apr;18(2):155-72
.
Department of Physiology, Human Anatomy and Genetics, University of Oxford, UK. alex.richardson@physiol.ox.ac.uk

Omega-3 fatty acids are dietary essentials, and are critical to brain development and function. Increasing evidence suggests that a relative lack of omega-3 may contribute to many psychiatric and neurodevelopmental disorders. This review focuses on the possible role of omega-3 in attention-deficit/hyperactivity disorder (ADHD) and related childhood developmental disorders, evaluating the existing evidence from both research and clinical perspectives. Theory and experimental evidence support a role for omega-3 in ADHD, dyslexia, developmental coordination disorder (DCD) and autism. Results from controlled treatment trials are mixed, but the few studies in this area have involved different populations and treatment formulations. Dietary supplementation with fish oils (providing EPA and DHA) appears to alleviate ADHD-related symptoms in at least some children, and one study of DCD children also found benefits for academic achievement. Larger trials are now needed to confirm these findings, and to establish the specificity and durability of any treatment effects as well as optimal formulations and dosages. Omega-3 is not supported by current evidence as a primary treatment for ADHD or related conditions, but further research in this area is clearly warranted. Given their relative safety and general health benefits, omega-3 fatty acids offer a promising complementary approach to standard treatments

…plus others.

Coming from someone with a research interest in FA supplements and their effecst on the brain, this is pretty cautious stuff. Note the sentence “Omega-3 is not supported by current evidence as a primary treatment for ADHD or related conditions”

As I read the summaries of this and other reviews, the verdict is:

“For specific DEFICITS like ADHD: some promising, though not startling, evidence for benefit, but trials too small or ill-designed to be confident – more bigger ones needed”

“For normal children, little or no evidence at all, so no argument for giving it to loads of them” (this is what the Food Standards Authority seems to have said).

Equazen can hardly not be aware of these verdicts, and similar ones which no doubt come from their own paid consultant experts.

So the obvious thing for them to do doing would be to run:

“Larger trials… to confirm these findings, and to establish the specificity and durability of any treatment effects as well as optimal formulations and dosages.”

This is what they are spinning (or allow the media to spin) that they are doing in Durham.

In fact they are not doing anything of the kind, as Matt Kelliher has now admitted.

So I think we are justified in terming it a media operation, which will not get anyone any nearer to knowing whether the supplements have any effect, but will probably help Equazen sell the stuff.

As Alex Richardson says at the end “further research is warranted”. But this isn’t research – it’s a PR stunt.