Allergy Relievers: Red Light Nonsense

Its just about coming into allergy season again, so today I am turning my attention to a product I’ve seen for sale in a few pharmacies I’ve locumed at of late: The Allergy Reliever Device. These things are sold under some pharmacy chain’s own names, or under brand names like Kinetik.

It’s yet another medical device. These things seem to be hitting the pharmacy shelves more and more often these days, giving them a level of respectability which personally I don’t think they deserve. At least this device makes it clear that it is a device though, unlike things like Prevalin which pretend to be real medicine.

According to Kinetik, it uses “red light therapy to suppress the cells that release histamine, thereby relieving the symptoms of hayfever and allergic rhinitis.”

So, essentially shoving some Christmas tree lights up your nose then. Well I must admit that’s a new one on me. It’s pretty hard to sniff out (geddit?) the theory behind this one too.  The manufacturers of these things don’t give any explanation as to why red light would suppress mast cells, and several Google searches later I’m none the wiser. I have managed to dig out one published paper in rats, where the authors seem to be suggesting that red light changes the redox state of cells, which might cause some changes within the cell. Even these others say that they’re not quite sure what’s happening though, and that further investigation is required.

Armed with a few unsuccessful Google Searches, I delved into the medical literature. I tried every which way I could think of to search for evidence that this thing works, but ended up drawing a total blank. I think this may well be the least successful search for evidence I’ve done so far, and that’s saying something. Even the manufacturers can’t be bothered with listing any sources instead they go wild with the clipart, giving us a Generic Smiley White Coated Person and Happy Photostock Chef alongside some very random recipes and general lifestyle advice.

And it looks like this thing really isn't very pleasant or practical to use. You're supposed to shove the probes up your schnozz as far as you comfortably can, then keep them there for three minutes. Not the most dignified of poses. And you're supposed to do this three or four times a day. That's a lot of inconvenience. Seems like prime Use Once Then Put In A Dark Cupboard territory for me, especially since taking a one a day antihistamine tablet is no hassle at all. 

In short, I wouldn’t waste your money. There’s no basis to these things, and it saddens me that they are not only being sold in pharmacies, but are being sold under pharmacy brand names. The more we associated our profession with such nonsense, the less trustworthy we become to other healthcare professionals and patients alike.

Hxxx

"I do my own research"

Something that I see a lot in on-line debates about alternative medicine is phrases like “I did my own research” or “people should be allowed to do their own research and make their own decisions”

However, I don’t think that the vast majority of people are able to do their own research. Now, that’s probably a pretty unpopular opinion. It’s patronising, paternalistic, and it flies in the face of patient choice. Who am I to question the intelligence and abilities of other people? Why do I think I'm so clever compared to anyone else out there? Allow me to explain myself.

I've been a pharmacist for a very long time now. From uni, through pre-reg, to my own revision at work, I've been taught critical appraisal skills. Yet to this day, it’s something that I actually find really hard work. It’s a skill that requires continual honing, and every time I use it I feel like I am fighting with my brain.

Even in the last two weeks, I've been revisiting my critical appraisal skills to make sure they are up to date. I've done some in-house work, three on-line courses, and a one to one training session. Yet I still find myself sat here at my desk for several hours, if not days, looking over the same study with a furrowed brow, desperately trying to make the numbers and statistics tell me their story.

There’s hazard ratios, odds ratios, confidence intervals, numbers needed to treat, event rates, absolute risks and other confuddling terms to deal with. I naturally struggle with numbers at the best of times; like most people, I much prefer narratives. That means that I have to constantly argue with myself to keep looking at the results page, rather than just flicking to the discussion. Becasue if I did that, I'd be relying on what the authors, with all of their possible biases and agendas, say their numbers say. Then, when I eventually manage to squeeze the swimming mass of figures into some sort of order in my head, I find out that these numbers aren't the full story, and I need to dig even deeper into other analyses of the same figures to find out what’s really going on.*  

A quick and very simplistic visualisation of all the layers of interpretation that might lead to information found on your common or garden health information website. That's a whole lot of bias. 

I am truly terrible at MS paint, but you get the idea. 

What a typical EMBASE search looks like. This is for a new drug with few synonyms so its a fairly straightforward one. Others can have forty odd lines of searches. 

It’s not a pleasant task by any stretch of the imagination. It really does feel like a mental marathon. I often question whether I am even up to the task- I can end up feeling stupid, and confused. But in order to really figure out whether or not a drug works I need to strip away all the levels of other peoples’ interpretation and start from scratch, with the cold, hard, impersonal numbers. That way I can build my own narrative, uninfluenced by what the study’s authors or sponsors want me to think, by what newspapers want me to believe, by what campaigners want me to know. The only way to know the truth is to start right at the bottom, in a dark dank pit of statistics, then to slowly start building yourself a ladder until you emerge, blinking, into the pleasant knowledge that you've worked out what on earth is going on.

This sort of raw data is not only extremely hard to deal with once it’s in front of you, but its also pretty difficult to come by. Finding it in the first place includes searching multiple medical databases- and these things aren't just a quick free text search like you would do on Google. Constructing a search can in itself take an hour or so, and then you have to trawl through the results to decide which are relevant to what you are specifically looking for. For me, most of the time, a question is structured like this:

What is the evidence that [drug/ group of drugs] works for [disease] in [patient group]?

                                                        

So, in my poorly drawn Venn diagram below, I need to find those holy grail papers that reside in the pink area:

Some of these papers might be pay-walled, so it’ll take me a week or so to get my hands on them. Some of them might initially look promising, but once you start to dig down into the figures you see that there might actually be problems with how they were undertaken or reported, or they might turn out to not quite fit in some way- perhaps the dose they used in the trial is different to the licensed dose in the UK, or the people enrolled into the trial don’t quite fit the population you want to know about, or perhaps the trial just didn't recruit enough people so any results from it are invalidated.

I've been doing this job for years, and I really do still struggle with all of this stuff. That’s not because I'm poor at my job, or because I'm stupid, or because I haven’t put the effort in to understand it. It’s because, when it comes down to it, this stuff is really bloody hard. It’s time-consuming, boring, and unintuitive.

People might well feel like they've done their own research. They might spend several hours digging about on the internet and feel empowered by any decisions that they make. But what they don’t realise is that what they've been researching isn't just the information- it’s the information with many, many layers of interpretation (and therefore bias) added. For a choice to be truly informed, you need to go right back to the start, to those terrifying tables of numbers and statistics. That’s simply not realistic for the majority of people.

Far better, then, to learn how to decide on whose interpretation you’re going to rely on. Will it be those that take the media reports at face value, or who have an agenda or a product to sell you? Or will you go with those that have years of training in how to pull apart complicated data and disseminate it in understandable ways?

Hxxx

*I thought I’d give you a quick real life example here, but I thought it best to asterisk it because I've probably bored you enough already. I'm currently looking at a drug called edoxaban and its use in reducing the risk of stroke in patients with atrial fibrillation. It’s the newest in a series of  novel oral anticoagulant drug- they’re supposedly like warfarin, but less faffy. So I find and look at the main trial, and spend days unpicking the stats. It looks like both strengths used in the trial are no worse than warfarin, and the higher dose might even be a little better. Great, right?

Well, that’s not quite the end of the story. Because it turns out- and this isn't reported in the trial at all, but instead is contained in the FDA’s briefing document- that in people with fully working kidneys, edoxaban is actually worse than plain old warfarin. In people whose kidney’s aren't quite at full capacity though, it might work better than warfarin. So the overall trial results are kind of skewed, and if we didn't dig deeper, we might have been giving a whole group of people a more expensive drug with worse outcomes than warfarin.

it's Thyme to Bronchostop this nonsense

I’m sorry, I just could not resist that headline.

Whilst working a locum shift the other week, I noticed a couple of new products had leapt their way to the pharmacy shelves. “Bronchostop”. Sounds interesting, I thought, until I moved a bit closer and noticed that they are, in actual fact, a herbal cough remedy, and my vague excitement was replaced with a bit of my soul dying. Then I saw the price tag, and the anger kicked in.

Brought to us by our old friends at Omega Pharma, Bronchostop syrup contains thyme extract and marshmallow root, whilst the lozenges just contain thyme extract. Omega claim that it “relieves any type of cough”, and that it “takes the hassle out of choosing a solution”. Well, I must say, I’m pleased to hear that, because I find one of the main stressors in my life is choosing which cough remedy to use. I mean, it’s just so complicated to decide if you have a dry or a chesty cough, then realise that it makes no difference anyway as most cough medicines don't work, so you then just by a cheapo honey and lemon thing to make yourself feel placebo-ey better. 

So, given that the great all-consuming cough medicine dilemma of my life has now been sorted out by Omega, I can spend some quality time looking up the evidence to see if it works.

It turns out that there are some preliminary trials which suggest thyme might improve cough symptoms. However, these all use specific cough syrups with different combinations of ingredients compared to Bronchostop, so they’re not very helpful. Because the product is being sold as a traditional herbal remedy, the manufacturers don’t need to bother collecting any evidence that it works before it goes on sale- their claims are based entirely on “traditional use”, which means nothing at all scientifically.

One attempt at a clinical trial compared thyme syrup with a “real” expectorant, bromhexine, and found no difference over a five day period. There are a number of problems with this though- firstly, bromhexine isn’t commonly used in cough medicines. Secondly, there’s little to no good evidence that expectorants work anyway, so we’re comparing something that may or may not work with something that doesn’t.

Worryingly, the websitewww.bronchostop.co.uk contains absolutely no safety information whatsoever. It doesn’t tell you who can’t use it, who needs to be careful using it, or what any of the side effects might be.

What side effects could it possibly have, you’re wondering. After all, its just a herb. We eat it, so it can’t be that bad, right? Well, sort of. The amounts used in food tend to be a lot lower than when it is used as a herbal medicine.

On the whole, thyme is well tolerated, but occasional gastrointestinal effects can occur. Uncommonly, and more seriously, people can have allergic reactions to it. It can interact with drugs, including those that thin the blood, those used in Parkinson’s disease, those with anticholinergic or cholinergic effects, oestrogens (research suggests it may decrease the effects of HRT, but theoretically also the contraceptive pill), and non-steroidal anti-inflammatory drugs. It may cause problems in people with bleeding disorders, who are undergoing surgery, or who have hormone sensitive cancers. We have no idea of the effects that medicinal amounts of thyme can have in pregnant or lactating women.

It seems to me, however, that its main adverse effect will be on your bank balance. This stuff is £8.99 for a 200ml bottle or £4.99 for 20 pastilles- that’s a whole lot more than simple linctus, which is about £1.50 and which will probably do just as good a job.

Hxxx

Coldzyme: a result of real science being left out in the cold

There’s no getting away from it, folks. Its sniffle season. For the next 6 months or so, the sounds of sneezes, coughs, and millions of noses being blown will echo throughout the nation.

We all know by now that the common cold is a virus. We all know that there is no cure. We also all know that, although you feel like crawling into a small dark warm cave and dying at the time, its usually much better after a few days, and it goes away of its own accord. Cold and flu remedies do nothing to actually get rid of your cold- they are there to make you feel better during it, although many of them are actually irrational combinations of products in shiny boxes with a redonkulously high price.

It is often said that if someone did come up with a cure for the common cold, they would be millionaires. I was, therefore, surprised to read this week in Chemist + Druggist magazine that indeed, the first ever product to not only treat the symptoms but to act on the virus itself was winging its way to pharmacy shelves as we speak. Really? Because blimey charlie, if that's the case, then this product should be Big News. 

Image source: http://www.sourcewire.com/news/84612/by-cod-now-your-plate-of-fish-chips-could-stop

The product is ColdZyme, a mouth spray that costs £8.99 for 20mLs. Seems a pretty fair price to pay for a product which claims to cure the most prominent infectious disease in the western hemisphere. It seems odd, though, that instead of this marvellous scientific breakthrough being plastered all over the media and medical literature, the article announcing it is tucked away quietly in a barely read corner of a trade journal.

What is this breakthrough, miracle product that will powerfully break down viruses? Well, an enzyme called trypsin. An enzyme that already merrily and plentifully kicks about in your digestive system, breaking down proteins. An enzyme which, for the purposes of this product, is inexplicable being derived from cod (which has meant that I have had to resist the urge to refer to it as somewhat fishy.) An enzyme which should be stored at temperatures of between -20 and -80 degrees Celsius, to prevent autolysis. Now, I've seen some fancy medicine packaging in my time, but never a simple mouth spray bottle that can manage such cold chain storage feats. So, if trypsin really is present in this product, then it seems fairly likely that its going to be inactive, unless the manufacturers have found a way of warping room temperature. Or you happen to be in Winnipeg in the middle of winter.

Medicine vs. Medical Device

The manufacturers make some really very extraordinary claims on their website, including one textbook example of special pleading. Their product, they state, isn’t a medicine. It’s a medical device, because it has no systemic effect. They then of course go on to helpfully tell us about the systemic effect it has:

“The medicines currently on the market only treat the various symptoms of a cold. ColdZyme treats the cause of the symptoms – the virus itself – and thus works both preventively against the common cold and shortens the duration of illness if you have already been infected.”

Right. So in the same breath, they are claiming that the product only forms a barrier, no more. But then they are also claiming that this barrier affects the ability of the virus to produce illness if you are already infected- viruses which are already through that barrier and inside your body. Come on, Enzymatica, you can’t have it both ways.

The Evidence

All these claims are backed up by evidence, right? Well, there is a tiny trial performed on only 46 people, which isn’t published anywhere. I can’t say whether or not it is a well designed trial, because I can’t see it in full, so to be honest, we pretty much have to just discount it. What we can do, however, if have a look to see if there is any other decent published information looking at the effect of trypsin on the cold virus. So I turned to the medical databases Medline and Embase, to trawl through the published medical literature. 

I did find one experiment which looked at the trypsin sensitivity of several human rhinovirus serotypes(1). And this appears to have found that viruses are only really susceptible to trypsin when there have been exposed to low pH, followed by neutralization- something which wont have happened to your common or garden cold viruses. I couldn’t find much else suggestive of a clinically significant antivirus action of trypsin.

The practicalities

This isn’t a simple, one-off- couple of sprays and away flies your cold sort of product. You have to use it every two hours, as well as after you brush your teeth and before you go to bed, and you have to continue this “until your symptoms are relieved”. That’s one hell of a regime. I have difficulty remembering to use medicines twice daily, never mind every two hours. I’ve never used this product, but I’d imagine that if it really does leave a “barrier” coating in your mouth, its a pretty unpleasant sensation. I can’t imagine many people sticking closely to these dosage instructions, and if the mechanism of action is as the manufacturer’s claim, skipping doses would cause the product to fail (if, indeed, it works in the first place)

We are also directed to “Start using ColdZyme^® as soon as possible when you detect symptoms of a cold.”. Now, those of use who suffer with cold sores who have ever used aciclovir cream will know that this is often easier said than done- you probably haven’t got the stuff in the house, or at work, and by the time you’ve managed to get your hands on some, its already too late- your cold sore is out loud and proud, and using the drug will be pointless. Its likely that the very same thing will apply here. And remember that the incubation period for a cold is about 2 days- so the virus will already be cosily settled into your body before you even know about it. Its therefore completely ludicrous that this product claims to be able to reduce the length of a cold simply by forming a barrier.  

I know it can be used as a cold preventative, but how many people who feel completely fine are going to remember to use the product every two hours, every day, for the entirely of the cold season?

To Summarise

So, do I think there is scientific evidence to back up the extraordinary claims being made by ColdZyme? I might do when hell freezes over. Or at least when some decent trials are published, which might take just as long.  Do I think that this product should be sold through pharmacies? Absolutely not- this isn’t, if you ask me, real medicine. This is pure pseudoscience, trying its best to fool you into buying real medicine. Do I think lots of people will buy this, use it once or twice, then leave it to languish in their bathroom cabinet? Absolutely.

Here’s the problem though: this stuff will appear on the shelves of pharmacies all over. The pharmacists wont have a clue what this stuff is, and because they are really busy and probably quite tired at the end of each day, they wont be able to do the sort of evidence review I have managed to squeeze into a quiet moment. So they’ll get asked about it, and they’ll sell it. Some people will buy it and will feel better after a few days, and will think that the spray has made them better, forgetting that colds are self-limiting anyway. A customer might come back in the pharmacy one day, and say something like “hey, that new-fangled spray got rid of my cold!”, and the pharmacy staff will end up making recommendations on the basis of customer feedback and anecdotes, rather than on the basis of rational, scientific evidence. In my eyes, this really is a shame, and by selling this sort of nonsense, we really are cheapening our profession, and we're causing our customers to waste their money. 

If patients ask me about it, when I’m working behind the counter, I’ll tell them something along the lines of: “there’s no evidence or logical way that it works. It seems to be a bit of an expensive gimmick, with no decent basis to it. You’ll feel horrible with your cold, but it will start to go away of its own accord, I promise. In the meantime, you’d be much better off looking after yourself, having plenty of fluids and rest, and taking paracetamol according to the packet.”

Hxxx

A Miracle Migraine Machine?

Cefaly. No, it's not a village in Wales, nor is it a type of cheese (actually, it might be for all I know, but nevermind.) It is instead a new all singing, all dancing miracle cure for migraines, according to its manufacturers anyway. So, in our usual fashion, let's take a look at the evidence and see what on earth it is, and whether it is worth spending money on.



It's a medical headband device that you wear on your noggin, around your forehead. This means that you can easily pretend to be the Empress from the Never Ending Story. The downside is that you'll have to pay somewhere in the region of £250 to do so, plus electrodes and batteries. So, for that amount of money, you want to know that what you're getting is going to provide you with a bit more than simply cosplaying as a child-like film character.



It is essentially a TENS machine, which applies an electric current to the middle of the forehead via self adhesive electrodes. Anyone who has ever used one of those godawful Slendertone thingies on their stomach is probably right now recoiling in horror at the idea of having to endure such torture right between their eyes- I know I am. But first I suppose we need to see if it works- after all, migraines are horrible things which can massively impact on the quality of life of sufferers. Those who are desperate may be quite happy to have their foreheads electrocuted.



Its been approved by the FDA, which is nice. What isn't quite so nice is the fact that this approval is based on one trial- the one and only trial in existence, despite what the manufacturers would have you believe.



This trial included 67 patients who suffered at least 2 migraine attacks per month. Although small, this trial is well designed, with an identical sham stimulator being used as a comparison to the test product. After three months of daily 20 minute usage, the mean number of migraine days in users of Cefaly was significantly reduced (6.94vs 4.88, p=0.023), but were not significantly changed in the sham group. But here's the thing: the difference between groups was not significant (p=0.054).



There was significantly higher percentage of responders (defined as ≥ 50% reduction in no of migraine days per month) in the Cefaly group compared to the sham group (38.24% vs 12.12%, p=0.023).



There was no significant difference in severity of migraine.



Although some of the results in this trial are encouraging, it is limited by its very small size. It is worth noting that the authors and manufacturers claim that this trial proves that the product is effective at preventing migraine, despite the lack of a significant between-group difference in the primary outcome of migraine days.



Other papers have been published in the literature regarding this product, and the manufacturers try their best on their website to make them look like they are real trials. However, these range from letters, conference abstracts, experiments in healthy adults, and case studies- not robust clinical trials.



An uncontrolled survey of 2313 Cefaly rental users found that roughly just over half of patients were satisfied with the treatment and would be willing to buy the device. The rest of the patients stopped therapy- that's a pretty high number of people. There are a number of methodological and confounding problems with this study, so the conclusions drawn from it should be considered unreliable.


Being a rental user is one thing- at least they were able to try it out before taking the plunge and handing over a rather large wad of cash. In the UK, though, it seems that the rental option isn't readily available. £250 is an awful lot of money to spend on a product, especially when, for roughly half of its purchasers, its going to be used a couple of times then lie in a cupboard, forlorn and forgotten about.



Let's have a think about compliance. To get the best results, you are supposed to use it for 20 minutes per day. Now, initially that might not sound like too big a deal, but if you work, have a social life, go to the gym, or spend every waking minute building a house in Minecraft, finding 20 minutes a day for something that could be, in most cases, painful, is probably pretty unappealing, and impractical. I can't see too many people who will be able to religiously use this product exactly as intended in the long term. I'm guessing that in most cases its going to go the way of that bit of exercise equipment that you bought 5 years ago and that you've used twice and now only trip over on occasion.



So to summarise: there is a little bit of encouraging data, though it's not as compelling as the manufacturers would like us to think. It's extremely expensive, impractical, and probably pretty unpleasant to use. Its an interesting device, but one that I am placing firmly in the "Yet to be convinced by larger trials" pile.



Hxxx

Evidence-Based Ambridge

Ahh. Sunday mornings. They can mean only one thing: bacon.
Okay, two things: bacon and tea
Whoops, no let's make that three things: bacon, tea, and The Archers omnibus. 

So welcome to the first instalment of an occasional series (probably so occasional that this is the only one), in which I critically examine the treatment choices of the fictional residents of Ambridge. 

In today's omnibus, Hell-on's child falls over. There is much hysterical panic, and much bewailing the fact that she wasn't watching him properly. Apparently its hard to look after a child and gaze lovingly off into the distance in the direction of Rob Titchener's house. Who knew. 

But never fear, Hell-on's mother, Pat (who doesn't appear to have noticed that her husband has been kidnapped and replaced by an interloper), is on hand to reassure her that she has done her best with the arnica. 

Arguably, I'd say arnica is one of the most accepted forms of woo in the UK. Arnica cream is a standard item in many pharmacies, and I would say that many people know that it is supposed to be useful for bruises. I wonder just how many first aid boxes have a tube of arnica languishing in them, but I reckon it is quite a few.

Its also a poster boy for the sort of confusion that reigns between the public perception of homeopathy and herbal medicine. herbal arnica cream often sits side by side homeopathic versions with no explanation of the difference. 

Even Nelson's seem rather confused about which modality to use, with both herbal and homeopathic arnica sitting in their "Arnicare" range of products. I can't quite get my head around this to be honest. Imagine going into an off-license and seeing two bottles of Smirnoff, one of which contains vodka and one of which contains water, though the only difference on the label is that one says Smirnoff Vodka 30C. Hmm.

Does the distinction matter? Yes, I think it does. I think its pure, outright deception to sell a homeopathic product to someone expecting a herbal medicine. One has arnica in, one doesn't. 

Anyway, all of this is by the by. Obviously there is no evidence that homeopathic arnica works for bruising. It's homeopathy. It has nothing in it. 

And as for herbal arnica? there's also no evidence that it works, although there is a little bit of prior plausibility, in that some of the chemicals in the arnica plant have an anti-inflammatory and anti-platelet action. There is, however, no information on how clinically significant these actions are, and whether rubbing a bit of cream into an area would get these potentially useful chemicals to the right place in any meaningful amounts.
Let's not forget that bruises are self-limiting. They go away of their own accord (and probably at the same pace), regardless of whether or not you rub some gunk into them. herbal arnica isn't risk free: the cream can cause  contact itchiness, dry skin, and rash. Orally, arnica can be pretty nasty stuff, even causing coma and death in extreme cases. 

So, my evidence-based advice to Helen would be: kiss it better, and leave it be. Henry is a small child, and falling over is pretty common in that age group. Don't apply an ineffective treatment which could rarely lead to side effects, and save your money. 

What Zombies Don't Tell You

Today it is Hallowe'en. And in honour of one of the scariest, most horrific things to have happened today (the release of What The Doctors Don't Tell You's clearly illegal and highly dangerous Cancer Special), here is the fruits of my lunch hour's labour:

You're welcome, world.

Enjoy Hallowe'en.

Hxxx

Disclaimer: The advice given in this publication  is not intended to replace that of Randy. Before following any of the advice given, please check with him first.

PS: Randy is an obscure reference to the We're Alive podcast. If you're a Behemoth zombie, you're probably already riddled with tumours anyway.

PPS: Brains probably don't cure cancer. But then neither will any of the other nonsense that What The Doctors Don't Tell You are peddling. 

Postscript: Homeopathic Harms 3.1: C's Story

Imagine you're twelve years old.

You're on the cusp of adolescence, a time where you start to move away from the comfort and protection of your family and begin to forge your own way in life. Friendships become increasingly important, and you're in a constant process of trying to make new ones, maintaining old ones, and falling out with others. The world seems confusing, terrifying, and wonderful in varying measures, and you spend a lot of your time watching those around you and drinking in how they act, what works and what doesn't, deciding how to act yourself to fit in and be accepted. This is the time when, though the ground is constantly shifting beneath your feet. you start to put down little social foundations and try to make sense of the world.


There is a wealth of evidence that suggests many benefits of connecting with people of your own age during adolescence. At such a crucial, tumultuous time of life, being socially isolated from your peers can have long lasting and harmful effects.


What's this got to do with homeopathy?

I've written before about how poor advice from homeopaths can potentially cause a lot of damage, and through our Homeopathic Harms series of blog posts, Nancy (of the Evidence Based Skepticism blog) and I have hopefully managed to convey to you an idea of how it can sometimes be the seemingly innocuous and difficult to quantify harms that can be most worrying.

I received an e-mail the other day that I have since been thinking a lot about and which I wanted to share with you. Its a real-life example of just how much harm poor advice from a homeopath can cause. The chap who sent me the email has very kindly allowed me to share his story with you, but of course I am going to respect his anonymity and refer to him as C.

C's story

C. had delayed puberty. Now this is something that is fairly common, happening in about 3% of cases, and which can be caused by a number of factors, but the most common type is Constitutional delay in growth and puberty (CDGP). This is basically a technical way of saying 'Just one of those things, which might be caused a whole load of stuff or possibly just chance.'

Conventional medicine would manage CDGP by... well, usually just by waiting, really. Monitoring, and reassurance are often all that is required. Otherwise, short courses of sex hormones should be enough to do the trick. If the delay in puberty is caused by something, then ideally the underlying cause would be appropriately treated. You can see some good, reliable guidance on management here.

Note, by the way, that the definition of delayed puberty according to patient.co.uk specifies '...in boys beyond 14 years old'.  Now, I have no way of saying what the definition of delayed puberty was at the time that we join C's story, but his experiences began when he was 12- well below the point where we would diagnose delayed puberty nowadays.

C's mother consulted a homeopath. He was given some homeopathic pills, which on account of just being made out of sugar, had no beneficial effects, but also no harmful effects. However, the homeopath also appears to have given C's mum some advice, the goal of which seems to have been isolating him from his peers between the ages

C was:

• not allowed to stay at school for lunchtime, but instead had to go home.
• not allowed to stay at school after the school day had finished.
• not allowed to cross the local footbridge over the motorway, which cut him off from the majority of his peers.
• not allowed to go down the street of the one classmate who lived on his side of the motorway.
• allowed and encouraged to socialise with one boy who was two years his junior.

The first question is why. Why on earth would a homeopath give such advice? We can only speculate that the homeopath in question thought- apropos of nothing- that since C was a late developer he should be kept away from people his own age and instead only socialise with younger children. I've had a look around some homeopathic websites on the internet, and found nothing that looks similar to this sort of advice. [I did, however, find this website, which amused me no end due to its impressive reference list. No, really, go and look at the link and scroll to the bottom, if you want a good laugh]. In fact, I couldn't find anything at all suggesting that enforced social isolation is good for anyone or for treating anything, really.

C's case would appear to be one of a homeopath acting outside of their competence and providing bizarre and very harmful advice. In C's case, homeopathic treatment was certainly not safe, although this had nothing to do with the sugar pills themselves.

The result of this set of rules on C were, in his own words:

"a boy who was immature, shy and lacking in self-confidence. When it came to puberty I had significant mental health problems (starting with OCD due to high levels of anxiety) which have had an impact throughout my life....I didn't regain a sense of normality (in terms of socialising properly) until the age of 25-26."

Limitations

C's story is, of course, merely one anecdote, and as good skeptics we of course have to realise the limitations of it. There's nothing to say that, if C hadn't have followed these rules, he wouldn't have gone on to develop any mental health problems, and indeed delayed puberty itself is not without an increased risk of psychological problems.

Given our very human need to fit in, it may be the case that children with delayed puberty have a preference for younger friends, as they stand out less. This is entirely understandable, but in C's case it is clear that his situation was enforced upon him.

 But given the established link between social isolation in adolescence with mental health issues, I think we can pretty safely say that this is a case where at the very least homeopathy worsened his situation. His quality of life was undoubtedly affected when he had to obey the rules.

Thankyou to C

Many, many thanks to C for sharing his story with me. I think its so important to hear these stories, as they might help to raise awareness of the less obvious, nebulous harms that can arise from treatment by unregulated, alternative practitioners. Unfortunately, its really difficult to quantify these sorts of harms into cold hard evidence, and that's why I, and many others like me, keep banging on as loudly as we can about them. If you have any examples of potential harm caused by homeopathy, it goes without saying that I would love to hear from you.


H xxx

Nelsons- suggesting kids need mood stabilisers from 2 years+

You know of Rescue Remedy, right? You probably had an aunt who would constantly swig a drop for her nerves, or might have even taken some before a driving test or exam.

Rescue Remedy has become a pretty well known brand- so well known, in fact, that most people don't bother finding out whats in it, or what principles its based on. You wouldn't want to know the recipe of Coca-Cola before you take a refreshing swig- you'd just assume that because its a well known brand, its probably going to work.

Rescue Remedy is, however, a whole load of woo nonsense. Sorry, but there's no other way of putting it. Some dude called Edward Bach decided- apropos of nothing- a good few years ago that some flowers, if left out in the sun and dissolved in alcohol,  will be able to balance physical and emotional distress. This is interesting, really, given that its taken the entire fields of neuroscience, psychiatry, and psychology many, many years to get to a point where there are still a vast amount of unknowns regarding mood disorders.

Science is getting there- slowly- when it comes to understanding things like depression. It's a vastly complicated subject. There's no perfect cure-all drug out there for treating such things- mainly because we don't yet understand it that well yet. So forgive me if I am skeptical that some random guy years ago has just randomly (without any basis in science) decided that, for example, mustard flower:

 "is the remedy for deep gloom and depression that descends for no apparent reason out of a clear blue sky. People in this state often list all the reasons they have to feel happy and contented, but still everything looks black and hopeless to them. The remedy helps to dispel the clouds so that we can once again appreciate the joy and peace in our lives."

Rescue Remedy is a blend of some of Dr Bach's made up flower remedies, diluted in brandy. You're supposed to reach for it in times of anxiety, as a soother. Funnily enough, brandy, being alcohol and all, it might make you feel a little bit better, but similarly to homeopathic remedies, they are dilutes such that very little or no levels of active ingredient are likely to remain. So even if Dr Bach were right about the flowers (despite evidence and science suggesting otherwise), there wouldnt be enough flower-stuff in a drop of it anyway to make a difference.

I can't quite get away from the fact that this is a cynical product which Dr Bach made up in an attempt to target wealthy women ("ooh! pretty flowers!") in the days where women were considered "hysterical" and many were labelled as having "problems with their nerves" based entirely on their sex.

Anyway, why am I on about Nelsons, and why am I on about children? Well, because the Bach Rescue Remedy brand- in all of its many, varying, and just-as-cynically money-grabbing-as-Big-Pharma- forms- is sold via Nelson's homeopathic brand. That's Nelson's who the FDA discovered weren't putting magic woo water in all of their magic woo water pills, but were happy enough to put particles of glass in there. That's Nelson's who are all "ooh, we care about you and your healthcare unlike those big meanie pharmaceutical companies who only care about money" all the time.

Well, I happened to stumble across this product of theirs today. Rescue Remedy Gummy Stars- aimed at children from 2 years and onwards. According to Nelsons:

"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. RESCUE® Gummy stars - The latest addition to the RESCUE brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains four drops of RESCUE, the famous soothing combination of five flower essences."

What's wrong with that? The fact the Nelsons are attempting to medicalise a perfectly normal part of childhood purely for their profit, that's what. Being nervous on your first day of school is entirely normal, especially for a little one. What they need to do is to develop normal coping mechanisms to deal with their anxiety. What they don't need to feel is that their anxiety is abnormal and something which only a medicine can fix.

When encountering the world of complementary or alternative medicine, I often like to stop for a moment and replace the names of the companies with those of Big Pharma. It gives a good indication of whether or not there really is a difference in practices between the two camps, and whether people's reactions would be different

"The first day back at school is a big day so parents should have a secret weapon against tiny tears on standby in the school run bag. PROZAC® Gummy stars - The latest addition to the PROZAC brand come in fun star shapes to help turn a frown upside down at the school gates and each Gummy Star contains 10mg of PROZAC, the famous soothing antidepressant fluoxetine."

Icky, right?

Hxxx

Water in a can now available on prescription. No, really.

No, its not a homeopathic sort of magic water this time, but instead Magicool.

Yep, remember when there were cheesy adverts on the TV all the time advertising this breakthrough, world's first spray? The website for Magicool even goes so far as to call it "heaven-sent". What in it? Well, water it would seem. I can't find any of the other ingredients listed on the website, save for a rambling explanation of how they still manage to get away with putting fragrance into it whilst claiming that it is an "unscented" product. Presumably it will have some sort of propellant in it too.

The theory is simple, and to be honest pretty good. When its warm, water on your skin evaporates, drawing out the heat. You feel cooler. So that's good. But its fairly impractical to keep having a cold shower every two seconds if you're at work or out and about, so Magicool is a nice portable option. Fine so far.

However, Magicool have decided to go one step further, and start making medical claims with their Magicool Plus range. They're classed as medical devices (sound familiar?) so don't need to go through the rigorous clinical trials that licensed medical lotions or potions have to. But they're now apparently available on prescription, so there must be some evidence that they work, right?

The Magicool website is frankly appalling. But what I'm looking for is a plausible mechanism of action for why their products work, and some good evidence that they do work. Let's have a lookie, shall we?

Kinetic pulses? anaesthetizing? vital deep cell hydration? adjusting pH? Despite its claims to be unscented, I am smelling pseudoscience at work. And what is with the text speak?! I've had emails from Nigerian princes asking for my bank details so that they can send me millions of pounds that are better written than this supposedly medical resource.

The evidence section appears to be a badly scraped together list of links from places like Trip Advisor and Yahoo Answers, where people have vaguely mentioned in passing that the product worked. But, dear readers, as we know by now, testimonials and reviews certainly do not constitute robust medical evidence, especially when lots of them are merely spam adverts posted on forums etc, as they are here. Again, there's no indication of what the ingredients actually are, so I have no idea whether or not there is even any plausibility in the claims above and beyond the fact that it might make you feel a little bit cooler.

So, if the manufacturer's aren't being forthcoming with any evidence, let's turn to the medical literature. This is made difficult, of course, by fact that I have no idea what is in it, other than water. Searching for the brand name brings up nothing at all, so it would appear that there is a grand total of no evidence whatsoever that this stuff actually works more than ordinary Magicool, or a shower, or standing next to a fan. The manufacturers are claiming that the product has "maximum therapeutic efficacy" on the basis of thin air.


According to Chemist and Druggist, the availability on prescription is coinciding with a large advertising campaign. This means two things:We'll have to sit through more daft adverts filled with smug thin people on holiday cooling themselves down despite not even looking remotely hot (where's the red face and frizzy hair, eh?!) and that some patients will inevitably rock up to their doctors and demand it on prescription.

The cost price to the NHS is £5.77. That doesn't seem like its going to break the bank, but I don't care how small an amount it is, frankly. There is a finite pot of money in the NHS, and we need to use every single penny of it wisely. If £5.77 is being spent on water in a can, that £5.77 can no longer be used to pay for something life saving.

Hxxx

The friendly and respectful homeopath.

I dont want to have to write this post, but it has been bothering me and I find myself thinking about it a fair bit. So, here it goes, and apologies for yet more homeopathy bashing.

I've written before about how i'm sure that a homeopathic consultation is probably quite nice. Spending an hour with someone who really listens to you, as opposed to a 10 minute curt conversation with a harried GP must feel lovely. And of course, homeopaths play on this contrast between holistic care and a more conventional symptom-based approach. They like to portray themselves as caring, benign folk who really care about your health and your rights as a patient.

I'm sure many of them really do care, although by definition misguidedly. Unfortunately, though, there are some who like to portray themselves as caring, but who in actual fact can be so utterly disrespectful it can make your jaw drop and cause you to still be thinking about it after a month has passed.

If you've ever said anything skeptical about homeopathy on Twitter, you will probably have encountered I'm-Not-Really-A-Doctor Nancy Malik. I don't mean this to be an as hominem attack, but goodness does she make it hard to refer to her without resorting to one.

I can't actually really remember the specifics of this conversation, but it involved a couple of us skeptic types questioning something posted by @urbanhealing. The conversation was going in the usual way, namely requests for evidence were being met with all sort of batshit crazy quantum bollocks. When that tactic didnt work, @urbanhealing had resorted to insinuating that we skeptics are stupid. In jumped Nancy Malik, with this bombshell, which took my breath away.

You can see my incredulous response to her, which was met with silence, even despite a couple of follow up tweets.

Motor neurone disease is an absolutely devastating disease, which has huge effects on its sufferers, as well as those around them. When my ex-husband's friends mother was diagnosed with it, the shockwaves and devastation of it were clear to see, even from a distance. It's no laughing matter, and it is certainly not something to fling about as an insult to people who reasonably question you.

Motor neurone deficiency means many things, but it does not mean you're stupid, which is the insinuation in the context of this conversation. It is a rare, severely debilitating disease which impacts on both morbidity and mortality but not IQ, and it is utterly disgraceful and disgusting to say so.

Probably the most famous sufferer of motor neurone disease is of course Stephen Hawking. So what on earth is she thinking using it as an insult to the intelligence of skeptics?!

I don't have motor neurone disease, and nor does anyone who I know directly. But that does not stop me from feeling rather sick and insulted by what Nancy Malik has said. Anyone with a little bit of empathy, heart and respect for other people would probably feel the same as me, I would imagine.

This is not indicative of a caring, holistic practice, but instead is cynical, unthinking and brutally insensitive. And its made all the worse by the constant portrayal of homeopathy as more caring than conventional medicine.

Oh, and of course it goes without saying that I will be more than happy to hear exactly what Nancy Malik meant with her tweet, and I will of course welcome an apology from her for the offence she has caused.

Hxxx

Making Clinical Trials Sexy

If you're buying a new TV, how do you go about it? My guess is that you probably have a look around the shops or internet, find a model you like, then get online to find some reviews of it and decide whether or not to buy based on what you've read. You may well scroll down to the reviews if you're buying something on Amazon, before you click the "Buy" button. If you book a holiday, you're probably straight on Trip Advisor to see what other people- humans just like yourself- have got to say about the hotel.

It is perfectly reasonable behaviour. We understand and respond to the personal experiences of other people- its part of our nature, stitched into our being. Each review is a little story, and humans love stories, especially when they are about other humans.

Its therefore a hugely unfortunate problem that, when it comes to healthcare, stories just aren't good enough. When peoples' lives are hanging in the balance, reviews and testimonials just aren't up to scratch. Here's why:

I have guttate psoriasis. Imagine I go on holiday (alas this is merely a pipedream this year, thanks to what feels like millions of large unexpected bills that seem to keep turning up in my life) and lo and behold, when I return, my psoriasis has cleared up. I conclude that it is definitely the sunshine that has cured it, and proceed to proclaim that I have found the ultimate 100% effective cure for psoriasis.

Is it reasonable that I have come to that conclusion, based only on my own experience? No, not at all. Why have I focused on the sunshine aspect alone? Maybe a week spent relaxing is what has actually cured it. Maybe its because I've changed my diet on holiday and have been eating lots of lovely fresh fruit and vegetables and fish?  Maybe it is because there is a magic ingredient in Sangria which miraculously beats rogue skin cells into submission. What if chlorine in swimming pool water is my skin superhero? Maybe-just maybe- its because guttate psoriasis can be self-limiting, and it has just faded away of its own accord. With just my experience to go on, there is no way I will ever be able to know what it is that has made my condition improve.

What I would need to do to be able to decide is to scale things up. Get as many people as possible with guttate psoriasis, and divide them into at least two groups- one exposed to sunlight, one not. I'd have to try to control the peoples' behaviour as best as I could for the other factors like diet, chlorine exposure, sangria intake, stress etc. Whilst I could never completely control for everything, if the group exposed to sunshine experience a significantly better improvement in their psoriasis, then I could say with more certainty that it is the sunshine that did it rather than anything else.

This is the beauty and elegance of a clinical trial. They are simply the best, slickest, most reliable way we have of teasing out whether a treatment actually does make a difference. They're like an anthology of stories, carefully selected and analysed by researchers in a bid to start finding an answer to a treatment question. Whilst they're not 100% perfect, they're certainly the best sort of information we have at the moment on which to base any decisions about which treatment to choose for which disease, and for which patient.

This is, however, very easy to forget when you actually have to read one. I do not have a mathematically inclined brain, and when faced with tables full of numbers, p values, confidence intervals, hazard ratios, relative and absolute risks etc, my grey matter is usually to be found quivering and wimpering in the corner of my skull. I have to really try hard to focus on the stats and results when reading a clinical trial- its a constant fight to wrench my thoughts back onto the page, when they keep merrily skipping away to think about kittens or bunnies or *that* picture of a minipig wearing red wellies. And I say this as a geeky pharmacist who has undertaken a decent amount of training in how to read a clinical trial. What hope then, does an individual patient or regular joe have of understanding trial data?

A quick glance at pretty much any website selling an 'alternative medicine' and you'll notice there is usually a "Testimonials" page on there. Many other types of healthcare sites also use testimonials to prove their treatment works. They're easy to read, often full of personality, and can really seem to speak to you as a reader. They may seem convincing, but as you've (hopefully) seen from my example above, they simply can't be used to decide if a product works or not. A glossy celebrity story endorsing a product in a magazine is infinitely more sexy than ten pages full of stats and graphs in a medical journal.

Testimonials and reviews are, at first glance, more attractive and more seductive than the more dowdy clinical trial. So what can we do to help the clinical trial apply a bit of lippy, spray some perfume on itself, and don its heels to get out on the town and make people weak at the knees? My short answer is I don't know. Campaigns like International Clinical Trials Day help of course, but at the moment it feels like we're swimming against the tide somewhat. My ultimate dream would be a primetime TV series, fronted by a hunky Brian Cox type. If he can make physics sexy enough to be at the forefront of our entertainment, surely there is some way that we can do the same for one of the best inventions in healthcare? I'd like to get to a place were it's second nature for everyone, whether they be a patients, pharmacist, healthcare professional or general geek, instinctively bypasses testimonials to look for clinical trial evidence instead.

Do you have any ideas? Have you had any really good experiences of explaining clinical trials to patients? Are there any techniques we can use to simplify the stats and make trials more accessible to all? My friend Nancy had a great idea of including a Plain English summary as part of an abstract for every trial. Is there anything else we could do? Let me know, however outlandish your idea, either by commenting, tweeting me (@SparkleWildfire), or dropping me an e-mail at my new shiny sparkly e-mail address healthydoseofskepticism@gmail.com

Hxxx

Dermalex: a superficial skin miracle?

I've written before about the guttate psoriasis which suddenly appeared at the start of this year and the impact it has had on my life.

I'm pleased to report that, after 9 weeks of phototherapy, it is much better. It has virtually gone on my top half, but the plaques on my legs are still stubbornly visible, although much better. The fact that it hasn't gone away entirely yet means its probably not going to clear up. Without wanting to sound over-dramatic, it actually feels like quite a bit to deal with- I've never had any long-term health conditions before, and although I've become slightly more confident, I'm still really conscious and nervous of having to expose any affected skin.

A while ago, my Mum rang me. "There's this new product out that says its for psoriasis, shall I buy you it so you can try it and see if it works?". To be honest, it was tempting, but when she told me the price £29.99 for just 150g, I declined. Skin diseases really can have an enormous impact on your life, and leave you desperate to try anything to find that one miracle that will get rid of it once and for all. Since then, I've seen it prominently displayed in quite a few pharmacies, hailed on shelf-edges as a 'breakthrough in psoriasis treatment'. So the big question is, is there any evidence that it works?

The product is Dermalex, and it is made by Omega Pharma. If their name sounds familiar to you, that may be because they also produce Prevalin, the overpriced, overcomplicated, under-evidenced Vaseline substitute for hayfever. This leaves me with a slight prickling of my skepticism, but lets keep an open mind for now.

This poor chap obviously has some practical joker friends who like to write words of skin conditions in his sun tan lotion when he is sleeping in the sun.

How is it supposed to work? Well, the fact that the website itself titles this section "How its works?" (sic) begins to worry me slightly. I know this blog is liberally sprinkled with typos and spelling errors, but at least I have the courtesy of being shameful about it. In a professional website selling a quality medicinal product, I don't think spelling errors are acceptable, and there are a few dotted around the whole website. Nowhere on the website does it actually tell you what is in the product. Its said to:

"Reduce Psoriasis symptoms by: Normalising skin cell production and Acceleration of the recovery of the skin barrier 

and

Fortify the skin barrier through: The creation of a protective shield on the skin by means of Alumino silicates against outside to inside insults (bacterial superantigens & toxins) through the non-intact skin barrier.
Providing a barrier to water loss"

This is helpfully illustrated by a diagram of the skin, which has labels that don't correspond to any numbers at all- either they're deliberately trying to make it look all science-like and confusing, to make the patient think "this is too complicated for me, so it must work", or its just sloppy oversight. Either way is bad enough.

Some labels on those numbers would be nice. Unless there really are little blue circles with random number in them floating about in the layers of our skin.

We can pretty much entirely discount the claims for "fortifying the skin barrier". All this means is moisturing the skin, and a plain old (cheaper) emollient will do just as good a job at that. Once again, this seems to be Omega Pharma reinventing the Vaseline-greased wheel. As for the former claims, well, I need to see some evidence to corroborate them and decide if they are reasonable or not. So let's have a little lookie, shall we?

Having had a bit of a dig about on the website, I could see no clinical evidence. So of course I emailled the manufacturers, and got back a curt response after several days telling me to look at this page for references. So, here it is, the grand total of the evidence that Dermalex Psoriasis works:

"PASI based clinical efficacy study of Dermalex Psoriasis cream for the treatment of Psoriasis Vulgaris symptoms in a mono application therapy, Józsefváros Health Center, Budapest, Hungary; Open Label Clinical Study into the overall efficacy of Dermalex Psoriasis Cream, 2008, Dermatology and Psoriasis Clinics Laudau and Kandel, Germany"

For some reason, Omega Pharma seem to want to throw away the usual format of referencing- the one that is accepted and good enough for use in the rest of the medical profession. These references do not give me enough information to find the original studies, so what use are they? I've emailled them back to ask for standard reference formats, including where the studies are published, and have been greeted with a loud silence. I've tried googling the titles, and this brings up nothing, suggesting that they haven't even been published.

Why isn't the evidence published anywhere? How many patients were involved? What are the study designs? What were the results, and the statistical analysis of the results? Without answers to any of these questions, all I can do is discount this as evidence at the moment. 

Of course I didn't just leave my research there, in the hands of the manufacturers. I've also had a look myself at the medical literature. And could I find anything at all for whether Dermalex works for psoriasis? Not a sausage. 

You're supposed to apply this stuff  three times a day. 150 grams will not last you long at that rate. That makes this a whoppingly expensive product. The national minimum wage in the UK is £6.31, meaning one pack would be equivalent to just under 5 hours work. I simply don't think that a couple of unpublished trials that may or may not say it works is a good enough reason to justify the expense. They're either being deliberately evasive about the evidence, or remarkably blase with people's hard earned cash.  

They say beauty is only skin deep. It would seem that the evidence that Dermalex is even more shallow than that.

Hxxx

Update: I was contacted by the manufacturers of Dermalex, who promised to provide me with the references I asked for above. Here is the response I've gotten, with my response to the points they have raised below. .

Thank you for your enquiry regarding Dermalex.

As you may be aware, the Dermalex range contains a number of different products to treat the following conditions; atopic eczema, contact eczema, psoriasis, rosacea, atopic eczema for babies and children. Please rest assured that all Omega Pharma products have been produced under strict guidelines and regulations.

A range of proprietary studies have been conducted across the Dermalex product portfolio and as medical devices, these products have undergone statutory trials to ensure they meet the safety and efficacy standards required by regulatory bodies to demonstrate an impact on skin pathologies.

Medical devices are designed, engineered and formulated, in compliance with the UNI EN ISO 14971:2009 and 13485 guidelines. This means that each step of development and marketing has been strictly regulated to ensure the safety and efficacy of the products.  All testing is carried out by medical device status certified organizations, which include leading dermatology research centres. In addition, all studies were conducted by practicing clinicians. Please note that these studies include varying number of participants and study designs.

The research behind the Dermalex range is ongoing - we are working towards publishing data on the product range this year to ensure we are able to communicate the efficacy and safety of these products to healthcare professionals. We are working closely with the University of Amsterdam and are looking to publish the first set of results in the International Journal of Contact Eczema. We will also be presenting this data at the upcoming conference on ‘impaired skin barrier in the pathogenesis of atopic and contact dermatitis’ in Amsterdam in June.

To date, we have conducted six trials across the product portfolio involving nearly 200 patients. The products have also been used in in Belgium, France, The Netherlands, UK, Italy, Portugal, Austria, Switzerland, Ukraine, Czech Republic, Slovakia, Turkey and Australia, among nearly 3 million sufferers.

All Dermalex products are well tolerated and have been clinically proven to work. In summary, the trials showed:

·         Dermalex Contact Eczema produces symptom improvement comparable to prescription drug treatments

·         Dermalex Atopic Eczema (Babies & Children and Adult formulations) effectively relieves both objective and subjective symptoms of contact or atopic eczema

·         Dermalex Psoriasis is effective against objective and subjective symptoms of psoriasis

·         Dermalex Rosacea & Couperose is effective against objective and subjective symptoms of rosacea

We hope that this information is useful and thank you for taking the time to contact us."

Firstly: I was aware that Dermalex is being sold as a medical device, but only because of those telltale words "Clinically proven!" and based on knowledge of Omega Pharma's other product, Prevalin. the fact it is classed as a medical device (and therefore not subject to the rigorous clinical testing of a real medicine) is even less prominent on the Dermalex website than it is on the Prevalin website. 

The rest of the e-mail appears to be a lengthy way of saying "We don't have any trials published yet, and no, you can't have any results in order to make up your own mind whether or not it works, you'll just have to take our word for it.". 

What's particularly interesting is that the International Journal of Contact Eczema doesn't appear to actually exist, as nothing at all is coming up for it on a Google search.

They say they have conducted six trials, which initially sounds reasonable. But this is across the product range, which includes at least four products and also children's versions. 200 people over six trials is not a lot- if shared equally that is only 33 patients per trial, and assuming they're placebo controlled, that would only mean that 16 patients per trial are actually exposed to the product- nowhere near enough to claim clinical significance of any results. Stating that the product has been used in other countries is meaningless, unless it is backed up by good, robust clinical trials. Its a logical fallacy- an appeal to popularity. Just being used doesn't mean it works- people might just try it once, or use it on the basis of advertising alone, but the product could still be ineffective.

So here's my main problem. How do Dermalex justify charging such an enormous price for a product before they have proven its efficacy. If good quality research had been undertaken prior to marketing, and robust results said that it worked, then that's one thing. But charging people £29.99 for "We think it might work, but we don't know yet because we're still doing research now, and the trials we've done so far that haven't been published yet in a non-existent journal are too small to decide" is, to my mind, entirely unjustified.