Not throwing the baby out with the bathwater
I was going through a elderly lady’s medications recently when I came across a very pharmaceutical looking bottle labelled ICAPS. Hmm, never heard of that, I thought. I thumbed my BNF – nothing in there. By this stage, I was suspecting the worst. The patient told me it was for their eyes, for Age-Related Macular Degeneration (ARMD). If I stopped Joe Public on the street and asked him the reason he was most likely to lose his eyesight in old age then he would probably opt for cataracts. There are some pretty nifty hi-techy type treatments for that. There is next to chuff all for ARMD (though there is a bit more on offer for the ‘wet’ type) and that doesn’t tend to attract headlines.
If you are going to lose your eyesight then it is most likely to be ARMD that does for you:
This is a condition where the central portion of the retina deteriorates with age resulting in central vision loss.
Normal vision and AMRD compared:
What about this ICAPS stuff then?
I googled it and looked up the website. Eeek, a food supplement. Not only that but the front page has an endorsement by a media doctor. I feared the worse. I could see it all unfolding before me – the exploitation of vulnerable elderly people who were going blind with useless ‘natural’ remedies. I braced myself for an onslaught of pseudo-science. ICAPs has got zinc, vitamins A, C and E, and the carotenoids, lutein and zeaxanthin. It has also got some vitamin B2, selenium, copper and manganese thrown in for good measure.
Well, rather than a knee-jerk reaction I thought I had better take a look at the available evidence. The Cochrane Database is always a good place to start.
There is a Cochrane review of the benefit of antioxidants (carotenoids, vitamins C and E) and minerals (selenium and zinc). Here is the last line of the authors’ conclusion:
There is no evidence to date that the general population should take antioxidant vitamin and mineral supplementation to prevent or delay the onset of AMD. [my italics]
However, there is another review – the same authors looked at whether the antioxidant vitamins and minerals could delay the progression of established AMD. They state:
The review of trials found that supplementation with antioxidants and zinc may be of modest benefit in people with AMD.
But as they point out:
The evidence as to the effectiveness of antioxidant vitamin and mineral supplementation in halting the progression of AMD comes mainly from one large trial in the USA. The generalisability of these findings to other populations with different nutritional status is not known. Further large, well-conducted randomised controlled trials in other populations are required. Long-term harm from supplementation cannot be ruled out. Beta-carotene has been found to increase the risk of lung cancer in smokers; vitamin E has been associated with an increased risk of heart failure in people with vascular disease or diabetes.
And I should highlight that ICAPS has 1000% of the Vitamin E RDA according to their own info. However, to give them their due they do warn off smokers in the small print.
What do Bandolier reckon?
Antioxidants for macular degeneration - this looked solely at the large USA trial – AREDS which was in the Archives of Ophthalmology. Bandolier was pretty darn effusive compared with the more measured tones of the Cochrane review.
This is a terrific trial. It was large and well conducted, and in an important disease area. It showed that the combination of antioxidants plus zinc was worthwhile in people with extant macular degeneration to prevent or slow further advancement in some of them.
The approximate NNT to prevent a single AMD event in 5 years was 13. I think I could safely say that was a modest effect at best.
There is also this rather brilliant little summary of the epidemiology and some of the treatment options around ARMD in 2004.
My first instinct was one of scepticism but on second glance the evidence is starting to look favourable. There is clearly more work to be done but it looks like nutritional supplementation for ARMD can perhaps move off the snake oil shelf and into the evidence-based cupboard. In particular, it would be nice to be reassured with some big trials that there are not significant side-effects or little sub-groups copping it. We all know there is no such thing as a free lunch.
I thought this supplement looked like a duck and walked like a duck. But in the end it perhaps doesn’t quack as much as I first thought.
The following comment was in the post before this – it looks to have gone walkies so I have copied it into its proper home.
Submitted on 2008/12/04 at 9:40pm
Absolutely
And what is worse, the buggers who make this stuff have been handing out freebies in eye clinics
http://nhsblogdoc.blogspot.com/2007/06/crippen-diaries-2007-24.html
John
nhsblogdoc@gmail.com
Dr John Crippen
http://nhsblogdoc.blogspot.com/
“ICaps helps to protect the eye by reducing oxidative stress and absorbing damaging blue light.”!?!
So, do we prescribe ICAPS or ask the elderly to chew on raw Kale? Or both?
£10.55 for 60 tabs (2 tabs daily) from my nearest chemist (I’ve just asked them). I can see them for £8.55 online.
Interestingly my computer system (System One) will let me prescribe it although I have not done so yet.
Until I can learn to like kale (I am working on it), I think a combination of good diet and supplements may be the best option.
Leslie Degner, RN, BSN
http://www.webrn-maculardegeneration.com
I know, I know – the website doesn’t inspire confidence from the health professional viewpoint. Dr Crippen drew attention to that (link above) last year.
I am fairly sure the patient I saw was being prescribed – rather than a jazzy little box they came in a bog-standard pill pot. If they work with acceptable side-effects (and are cost-effective) then why not prescribe them?
Giving them out free strikes me as a rather seedy marketing ploy.
The AREDS study is worth reading, Oct 2001 American Journal of Ophthalmology.
4000 patients with impecable double masking and photo assessment of progression, supervised by the Wilmer eye institute, probably the best eye dept in the USA.
Interestingly it was a trial of hypersupplementation, with deliberately 5 x RDa doses, and the patients already had higher serum vitamins than the USA average. They were not malnourished.
The study is being rerun as AREDS 2 to assess the role of Leuteins etc. The formulation used in AREDS was “ocuvite preservision” marketed as preservision in the UK.
I share your scepticism about a lot of food supplements but for once there is substantial evidence for the use of these in ARMD. The number needed to treat is not out of order compared with a lot of other interventions such as mild systemic hypertension, and may well beat Lucentis in cost effectiveness.
If this was another drug then there would be much less controversery, but supplements do have the whiff of quakery.
As people continue to live longer, the incidence of eye disease such as macular degeneration is on the rise. These types of debilitating eye diseases rob people of vision, and can result in individuals losing their independence.
It is believed that the visual system requires up to 25% of the nutrients we take into our bodies in order to stay healthy. Impaired circulation and/or poor absorption of nutrients can significantly contribute to eye disease.
There is a great deal of peer review research now showing the vision can be preserved through a proper diet and specific nutritional supplementation.
Essential nutrients include lutein, zeaxanthin, omega-3 fatty acids, taurine, gingko biloba, lycopene, vitamin A, E, zinc, copper, selenium for example, that can help both prevent the onset of eye disease such as macular degeneration as well as help preserve vision for those with macular degeneration.
For more information and specific research studies by eye condition on nutrition and vision, go to http://www.naturaleyecare.com
Thanks fox in sox. I guess one of the issues with supplements is that because they aren’t subject to the same regulations it is a bit of a job sorting the wheat from the chaff. This certainly looks more wheatish.
I do agree that the NNT is comparable with many accepted interventions. Presumably if this had the weight of Big Pharma behind it we would be groaning under a pile of trials and assorted evidence.
Michael – any conflicts of interest you would like to declare? I have left your post up in the interests of keeping an open forum and others may wish to explore the claims further.
It IS “Big Pharma”, Euan. I-Caps are made by Alcon Laboratories – “the world’s largest eye-care company” as it says on the I-caps website, 2006 revenue US $ 5 Billion, approx 7000 US Employees and approx the same outside the US. Not all that different in size to the largest biotechs, like Genentech. And last I heard, Novartis were buying 25% of Alcon for US $ 11 Billion, with a view to taking over the whole company.
There may be reasons why there aren’t more large-scale trials of the supplements, but lack of dosh seems highly unlikely to be one of them.
Very interesting. Maybe I am being naive but why is this so relatively low key in the medical world? One would have expected this to be getting rammed down GPs’ throats or directly to patients.
Could it be that this is a nice little niche and it is more profitable to keep it that way? Who knows.
That is a very interesting question.
There could be reasons for a PharmaCo NOT to push a “nutritional solution” with a big high-profile campaign. One obvious one is that, since the individual ingredients are presumably all licensed for human consumption as “food supplements”, it would be easy for any vitamin company to concoct an imitation version and flog it as a dietary supplement. Sort of a “super-version” of the OTC vs branded argument. So the company might be better sticking to a discreet pitch just to the medical profession, backed by trial evidence but consciously low key.
This is an interesting angle on the argument you often hear on the Alt.Medicine circuit that “PharmaCos won’t research natural and nutritional remedies because they can’t make any money out of them”. One obvious reason being that any remedy of this kind they did come up with would instantly be copied and flogged by hundreds of other people as a “nutritional supplement”. I am no great friend of the PharmaCos, but they are on a bit of a hiding to nothing with this kind of thing.
A well-known example of this is the search for drugs derived from resveratrol, of which SRT1720 is the best-known example. It will take a long time to get SRT1720 through all the trials, if it makes it at all. Meanwhile, sales of resveratrol supplements are rocketing. The Pharmas with resveratrol derivatives in the works derivatives must surely have wondered about simply marketing the compounds as “nutritional wonder supplements”, which would just require safety tests and no need to demonstrate any kind of efficacy.