Losing it.

Losing your marbles is a quaint English phrase for dementia. Losing the rag is a quaint English phrase for getting unexpectedly angry. I had the one about the other last week.

Alzheimer's Disease AD is a terrible disease because it blats the mind long before the heart, kidneys or lungs fail and death occurs. In Irish society we haven't decided how to deal with this mens nulla in corpore sano dilemma. Which is rather ostrich because there are 55,000 citizens with AD of which about 10% are Institutionalised. Those 5,000 residents are in nursing homes because the state is paying €1,300 a week, on top if which  the nursing home is garnering an average of €20/wk extra for haircuts, entertainment and a retainer for the local doctor. The annual bill is €70,000 each or about €350,million paid every year through the nose of me-the-taxpayer.  Meanwhile back at the castle home, rather than A Home, the 50,000 are being cared for by their families. Often the carer is the spouse who has kept more marbles; but in other cases it is a daughter, less often a son or a more distant relative. How does The Man support these unacknowledged givers, who are saving the state €70K a year? The Man coughs up a Carer's Allowance of €214/week or just over €11,000/year. This is only buttons more than the Supplementary Welfare Allowance SWA of €196/week which you can claim if you have no source of income. You can see that we are incentivised to leave our demented or otherwise troublesome parents into A&E and walk away. It's a wonder and a tribute to family feeling that more people don't do this.

It therefore raises hopes when someone claims to have found a remedy for Alzheimer's which is readily accessible over the counter. It's also nice when it turns out that the participants were drawn from County Waterford and two of the investigators work in Waterford IT and Waterford University Hospital: you want the local team to win big. Indeed, the article went up on Facebook and was picked up by two members of the family for internal broadcast. But my ould crap detector sounded alarms when it turned out that the study was based on Macushield and ended with this:
On this particular successful trial, there were 25 patients and 15 controls used. The next trial will see 120 patients with mild to moderate Alzheimer’s given the nutritional formula. Dr Howard added: “It would be negligent for us to ignore these results until the next study reports back, which will take several years.”
That sounds worryingly unscientific: if there were two old buffers both with Alzheimer's Disease AD and one was given Macushield and the other sunflower oil and the former's disease progression was slower would you believe the difference was driven by Macushield or any aspect of the many differences in the caring regime: more Bingo; more aerobic exercise; better sleep; more skyping the grandchilder; less daytime TV; regular singing; weekly head-and-shoulder massage and so on. Would you be more convinced if the sample was 2 vs 2 or 5 vs 5?  "Convinced" as in would you re-mortgage your house to invest in the company which had that good a result on a sample of 25 patients and 15 controls?

Macushield does not work for macular degeneration.
I know Macushield of old (Dietary carotenoids: Lutein 10mg, Zeaxanthin 2mg, Meso-Zeaxanthin 10mg) because it used to be part of Pat the Salt's daily drug-bundle when he could get it on prescription at €2 for 30 tabs. Pat's eyesight is pretty good for 93 but the pills weren't doing any harm and 6c/day was affordable. Heck I'd offer to pay that much for him myself. Then the National Centre of Pharmacoeconomics (NCPE) published a report in May 2015 to say that there was no good evidence that Macushield did what it says on the tin and the HSE quickly responded ". . . therefore does not recommend that products containing these preparations be reimbursed under any community drug scheme . . . Supplementation, if desired, should be obtained by purchasing products over the counter. These products are not licensed medicines and are classed as food supplements." As an optional dietary supplement the price jumped to nearer €0.60/day and I said it would be better for Pat to give him a glass of cheap red wine before bed than to give him a worthless 'medicine'. Nobody listened, especially went the family optician ignored the scientific evidence, including the NCPE and a Cochrane Review, and announced ex cathedra optica that Macushield was Grand Altogether.  It's like vitamin C: authority figure asserts something to be true against all the evidence.

I hunted up the original study Phospholipid oxidation and carotenoid supplementation in Alzheimer’s disease patients to scope the basis for "Trial participants were “overwhelmingly” identified to have positive outcomes". And the conclusion is just not true! Indeed it says quite clearly in the paper "Carotenoid supplementation using 10 mg meso-zeaxanthin;10 mg lutein; 2 mg zeaxanthin did not have any effect on cognitive performance in either group (Fig. 3a and b)"  If you scan the text looking for statistical significance you can find it

MMSE, Mini Mental State Examination; Semantic fluency score, (categorical verbal fluency) score was obtained from the number of animals named by the subject in 1 min; Phonemic fluency score, (word fluency) score was generated by the total number of words produced for each of the letters F, A, and S, in 1 min.  But that's not news: that's almost a definition of AD: you can't remember the names of animals or words beginning with S. Heck, if you asked me, a professional biologist, to name animals until a buzzer went off at the end of a minute I'd probably be no better than Pat the Salt, who left school at 14 and has 30 years on me. I'll show you what a non-significant result looks like (Fig. 3a and b):

You won't be able to read the small print so it's Control group on placebo; Control group on carotenoid; AD group on placebo; AD group on carotenoid; for each category the score is calculated at baseline 0-C-P etc. and after 6 months of treatment 6-C-P etc. This shows that the Controls on the Left are more with it on the memory-front than the Demented on the Right - no news here.  But that 6 months of MacuShield (that will be €108, please) will have No Effect on your cognitive function [or on your eyesight, or in any sense except on your wallet]. The study is even more woefully under-powered than I thought. The 25 ADs are divided in 2 groups for the 6 month Macuwuwu vs sunflower-oil study and controls likewise: 8 vs 8. Is it that difficult to find undemented people in their 70s and 80s in Co Waterford? They should have talked to me, we could have doubled the sample at the Tramore Heritage Group.