clinical evidence

Is SoreFix a sore loser?

Cold sores truly are the devil's work. The pesky little blighters make a habit of cropping up at the worst moment, crushing your self confidence within a mere matter of hours. 

Given that cancelling everything and holing yourself up in a darkened room until it has gone away tends not to be all that practical for most of us, It's no surprise that folk are desperate for something that really works, and fast. I've already written about several other new cold sore products on this here blog, neither of which are the miracle cures they're marketed as. 

Enter Sorefix, a product selling itself as a new all-round product to both treat and prevent cold sores. Interestingly, the manufacturers claim that it even works after the cold sore has come out, which if true would make it a really useful product. 

In case you are too late to prevent a cold sore, SoreFix relieves symptoms such as itching, burning and the blisters on or around the lips and it speeds up the healing process. So prevent feeling embarrassed and choose SoreFix!
— http://www.sorefix.com/sorefix-cold-sore/

Medicine vs Medical Device? 

Once again, this product isn't a medicine. It seems that nearly every new OTC product these days is actually a medical device masquerading as a medicine, and this is no exception. It might look like a medicine, it might be sold in pharmacies, and the manufacturers might even make claims that make it sound like a medicine, but nay, it is in fact a medical device. Essentially, this means that the need for good quality, robust evidence of efficacy before marketing is virtually non-existent. Le sigh.

The evidence   

Usually, the first step in finding evidence for how a product works is to find out what is actually in the product. This is proving quite difficult for Sorefix, as all I can find is some vague statements about "two zinc salts". hmph. Ah well, I shall have to make do with what I can. What i am particularly interested in is the claim that Sorefix can reduce healing times for a cold sore once it is already out. 

The manufacturers themselves don't bother with providing any cursory clinical trial data. This is unusual, and sort of  refreshing in a way; at least they aren't trying to palm off some nonsense animal studies as irrefutable evidence. It does, however, leave me with even less of a start than I normally would have for these sorts of posts. 

A quick Google search found nothing whatsoever, so I delved into the medical literature in a Medline and Embase search to see if there is any studies looking at the effects of zinc on cold sores. As I can't find which exact zinc salts are in the product, I just did a search for zinc. I found a grand total of three results, none of which were relevant. 

I did manage to find some information about the topical use of zinc in a trusted database. It seems that there is some, very limited data which suggests that some specific zinc-containing products, none of which are Sorefix, may reduce the duration of symptoms by a grand total of 1.5 days, and that's only if used within 24 hours of onset. There is also some evidence that zinc isn't effective for recurrent infections, which is probably going to be pretty much everyone. 

So it seems that I can find nothing at all to back up any of the manufacturers claims at this point. I've contacted them to see if they have any further information, and it'll be really interesting to see if I ever get anything back. 

Safety

Safety-wise, it's very difficult to comment on without knowing what exactly is actually in it. The manufacturers say you shouldn't use it if you are very sensitive to any of the ingredients, though of course they don't tell you what they are. Helpful much :S

The practicalities

The key with cold sore treatments is that you need to start using them before they appear, and you need to use them regularly. Despite what the manufacturers seem to be saying, it would appear that this product is no different. It doesn't contain an antiviral, but the limited amount of evidence looking at the effects of zinc for cold sores suggest that it needs to used every two hours in order to have an effect. That's a lot of applications per day, and I think it's unlikely that most people will be able to keep up with it for any reasonable amount of time. It's worth noting that, because cold sores can worsen quickly, this probably does include overnight too.

I really like the idea of having something to use for prevention, but its hard to remember to apply something at the best of times.  Its even harder if you haven't got a throbbing mass of evil reminding you of its presence constantly.  Given the lack of evidence for prevention, there is no specific guidance on how often you are supposed to use it in order to prevent a cold sore, but I suspect its going to have to be very regularly. 

The cost

It costs £7.47 for a jar or tub of this stuff. Although that's quite similar to other new products for cold sores, it's waaay more expensive than generic aciclovir or plain old vaseline. 

So, is it worth a shot? 

At this time, no. I can't see anything to suggest it's any better than existing treatments. I'll be interested to see if I get anything back from the manufacturers, but I can't see any reason why this product would work, and there is certainly no evidence to back up their claims.

Unfortunately, when it comes to cold sores, time is the best healer, especially once they are out and proud.  If it hurts, then use painkillers like paracetamol or ibuprofen. If its still at the tingling stage, go for topical aciclovir, but make sure you get a cheap generic version rather than Zoivirax: its exactly the same stuff. It's not going to make much difference once its already taken hold though, and at this point you're better off just using something like vaseline to keep it as supple as possible. 

Hxxx

 

Is Herpatch Mouth Ulcer Gel worth a shot?

Mouth ulcers can be very unpleasant little blighters. They’re often really painful and can be rather distracting, especially when eating. And, if you ask me, anything that makes eating difficult makes life more miserable. They tend to be self-limiting, but for those most painful moments, there aren’t that many treatment options available over the counter. There’s a new product available in Boots currently called Herpatch mouth ulcer gel, so I thought I’d cast an eye over it to see whether it’s worth spending your hard earned cash on.

What's in a name? Mainly confusion in this case

Its actually been quite hard to find manufacturer’s information on this product due to some brand name issues. It would seem that the Herpatch range is being marketed elsewhere in Europe as two products for cold sores, a preventer and a treatment “serum”. The same manufacturers also market a product called Aphtgel, which is for mouth ulcers.

It seems that in the UK, however, the picture is less clear. From what I’ve managed to cobble together, only two products are being marketed, and they’re both doing so under the Herpatch brand. There is a mouth ulcer gel, which appears to be the same as Aphtgel, as well as the cold sore preventer product. The serum doesn’t appear to be available over here yet. The brand name makes little sense for the mouth ulcer product- there’s no patches, it has nothing to do with herpes, and it ends up sounding gender specific, which is nonsense.

What is it?

Aphtgel Remesense is based on Sylphar’s film forming technology. Upon application, it will form a transparent, thin muco-adhesive film on the mouth ulcer. This film will protect and isolate the injured mouth area affected by the ulcer.
— http://www.sylphar.com/sites/default/files/productfiles/111085Aphtgel_Psheet_UK00.pdf

This actually seems like a very reasonable mode of action. Forming a cover over the ulcer may in theory reduce pain, as well as reducing the likelihood that a secondary bacterial infection can creep in and make itself comfortable. It’s also useful to cover over an ulcer whilst it heals, but its obviously very difficult to stick a plaster in your gob, so a product like this certainly does have an important role, at least in theory. It’s not a new concept, but refreshingly it also doesn’t seem to be marketed as such. A product called Orabase used to do a similar sort of job, though its no longer available.

The main active ingredient is hyaluronic acid, which is naturally abundant in skin and cartilage, along with a few other bits and pieces like xanthan gum and cellulose. Basically, it contains a collection of gloopy, sticky stuff that probably won’t dissolve immediately when in contact with saliva. 

Medicine vs Medical Device?

As with many new Over the Counter products, Herpatch gel isn’t actually a medicine. Instead, it is classed as a medical device- a fact that is fairly difficult to deduce unless you do a fair bit of poking about on the manufacturer’s website. This means that the product doesn’t have to go through the rigorous testing that a medicine would, and it shouldn’t have any direct pharmacological effect- in this case it forms a physical barrier, but isn’t absorbed greatly and doesn’t produce any other effects on the body.

Does it work? 

Wonders will never cease, but it seems that there is actually some half-decent evidence that this product works. There are some actual, real life trials for gingivitis, periodontitis, and a similar product is already licensed for chemotherapy-induced mucositis. There’s not much evidence, admittedly, but the published stuff seems to suggest a decent effect size. It’s worth noting that most trials and evidence include people with recurrent or more severe ulcers, which might skew the results somewhat- most of the folk buying it over the counter will be using it for the occasional ulcer rather than for a more serious, recurrent problem.

Is it safe? 

Evidence seems to suggest that topical hyaluronic acid is well tolerated and there aren’t really any safety concerns that I can see think of with this product. One problem could be indirect harm caused by lengthy self-treatment of an ongoing problem. If an ulcer persists for more than 3 weeks, there’s a possibility that it could be something more suspicious.

The practicalities

Using the product might be a bit onerous. The aforementioned Orabase used to be a claggy, gritty paste which felt pretty unpleasant in your mouth. Being a gel, I’d imagine that Herpatch might feel a bit better, but there’s still a possibility that it might feel weird. You’re supposed to wait for 30 minutes before eating and drinking and avoid rubbing the area with your tongue. That seems… unlikely. We’ve all got that little masochistic streak in us that means you can’t quite leave it alone. I’m therefore not sure how long the barrier will stay in place for.

The cost.

This product isn’t cheap, coming in at £7 a pack. That seems pretty steep to me, especially for something that is self-limiting and will probably resolve in two or three days.

To summarise

Not a medicine as such, but a product that has some prior plausibility and some evidence suggesting it may work. Pretty pricey, but I guess if you’re going out for an important curry or something, you might decide it’s worthwhile. There aren’t that many other options available that aren’t hokum or placebos, so I’d actually-for once- be fairly happy to recommend this product to some patients over the counter.

 

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.

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

An allergy reliever display spotted on a Tesco pharmacy counter by @TheWholeT00th. 

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.  If I find it so hard, then how on earth is someone without any medical background or critical appraisal training supposed to do any of it? 

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. Because 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.

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.

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:

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

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.

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.

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. Even the FDA findings are borderline- some of what they describe doesn't reach statistical significance.

When real science gets left out in the Coldzyme

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. 

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.

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 

What I love about pictures like this is that it's always perfectly made-up women in them. As if anyone can be arsed to think about makeup when they're vomiting everywhere and their head feels like its being crushed. 


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
 

A comparison between medical and homeopathic information sources

Recently, I’ve been delving back into the world of homeopathy, and all of the nonsense that it entails.

Part of my research and preparation has been consulting homeopathic texts- materia medica and repertories that are still in use by modern homeopaths.

One thing that I have been repeatedly struck by is the stark differences in the quality of these information sources compared to those used in modern medicine. Let’s take a look at some of those differences.

Up To Date?

Part of my day job’s role is resource management. This means that I need to make sure that all of the resources that we use and have access to are present and up to date. Whenever I use a book as part of my work, I document which edition I have used. If I use a website, I make sure to include when it was last updated. When we get a new book in the office, I find the old copy and cover it in stickers saying “Out of date- do not use”.

I don’t do these things because I am weird, or because I enjoy it. I do it to ensure that I give the most accurate, up to date information so that the patient gets the best care. What we know about medicines is constantly evolving- new medicines, new safety information, and new evidence is emerging daily. What might have been correct to the best of our knowledge last year may now have been subsumed by more recent experiments, and so the information sources I use change accordingly. So, for example, I can reach for a copy of the British National Formulary from 2005, and find information that recommends sibutramine as a weight loss aid in certain patients. However, if I look at the current version, I won’t see it in there, as it has since been withdrawn for safety reasons. If I were to have used the 2005 copy to advise a patient, I might have given them the wrong advice, in the context of what we know today.

How up to date is the information used by homeopaths? According to The Homeopathic Pharmacy (Kayne, S. 2nd Edition, published in 2006 by Elsevier Churchill Livingstone, page 192- I did warn you about the documentation): ‘The most well known are Boericke’s Materia Medica with repertory and Kent’s Repertory of the Homeopathic Materia Medica’. Sadly, the author of this book doesn’t see fit to bother telling us when these were published. Neither does the online version of it, although there is a bit of a hint in that the “Preface to the ninth edition” on there is signed off by William Boericke in 1927.

Nineteen Twenty Seven. Medicine and healthcare is a pretty fast-paced industry, with new innovations and information coming out at an overwhelming rate. So much has happened in medicine since 1927 that there is no way that anyone should accept health care advice based on something written from that time. I know I certainly wouldn’t be too happy if my GP gave me health advice from a dusty tome, or if I went to the dentist’s to find them using equipment from the 1920’s.

Maybe Kent’s Repertory will be more up to date? A Quick look at the website gives us no clues. This time, the preface contains no date at all. The closest thing that we have to a publishing date is the fact that the website is copyright 1998, and appears to have been formatted by a default-font loving child in the early nineties.

Political Correctness

Over the years, medical terminology has changed and evolved along with society and scientific discoveries, and rightly so. In some cases, words that used to be considered as perfectly legitimate scientific terminology (such as ‘Mongol’, or ‘Mongoloid Idiocy’, used to describe a person with Down syndrome) are now considered downright offensive. Even whole swathes of what is now considered normal society (such as gay people) were once declared as illnesses- and of course we know better by now, or at least we should do, and if you don’t- grow the hell up, will you. We generally don’t refer to people as “hysterical”, or “insane” anymore, as we know a lot more about such conditions, so are able to categorise people more helpfully and professionally.

As a result, we healthcare professionals are very aware of how crucial the use of clear, concise, professional communication is, including the information in our resources. No self-respecting modern medical text would ever dream of using out-dated, offensive terms, and if it did, there would be an outcry.

Let’s have a look at the sort of thing that Boericke’s Repertory wants to help us to treat. There are things like “Brain-Fag”, “Cretinism”, “Masturbatic dementia”, “Fears of syphilis”, “hysteria”, “insanity”, “weak memory from sexual abuse”, “Haughty”, “Stupid”, and many others. These were just taken from the “Mind” section, but there are many other examples in the other sections too. These terms are just too outdated and are wholly inappropriate to be used in today’s society.

Having looked through various other Materia Medica entries too, I’ve found statements that are sexist, bigoted, and occasionally racist. Nice eh? You don’t find that sort of thing in an up-to-date copy of Martindale: The Complete Drug Reference.

Clarity

Good, modern medical resources are all about clarity. They need to be- after all if someone gives the wrong medical advice because they have interpreted something incorrectly, patients could be at risk.

Jargon is sometimes necessary, but nowadays medical jargon tends to use standardized, accepted terminology which keeps the risks of misinterpretation to a minimum.

Homeopathic repertories and material medica, on the other hand, are full of vague, odd terms which are massively open to interpretation. What, pray tell, is a “voluptuous, tingling female genitalia” when it is at home? (and I wonder whether Ann Summers offers free delivery on such a thing?). What does “expectoration, taste, herbaceous” mean clinically? How is one supposed to diagnose “Taedium vitae”? When would you class a person as “Obscene, amative”, and when would they be considered as merely “gay, frolicsome, hilarious”?

In Conclusion

Our health is arguably the most important asset that we have. Why would we entrust it to sources which are terribly out of date, inaccurate, and in some cases, offensive?

Homeopaths like to paint themselves as a caring, human alternative to the more business-like, clinical world of real health-care professionals. But when this alternative categorises people as being “stupid”, or “cretinous”, and is happy to use criminally out of date resources which can risk peoples’ health, I wonder just how caring and ethical it really can be.  

I've said this before, and I'll say it again: why would you continue to use an abacus when calculators exist, and are proven to have a better record at getting the right answer?

 

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.  

Blowing a raspberry

Imagine there is a door in front of you. There is a person standing next to the door:

"Hey there, pudgy, do you want to be thin and beautiful without having to do any exercise at all? All you have to do is hand me some cash and step through that door there."

This person goes on to explain that if you step through the magic door, you will step out of the other side with a perfect, slim figure. You won't need to change your diet or do any exercise. You just need to walk through the door. They show you some glossy before and after pictures. There are pictures of beautiful, smiling people holding out the waistbands of their old elasticated tracksuit bottoms, so you can see just how much more skinny they are now.

There is a slight rumble from behind the door. You ask what is behind it.

"Oh, we don't know. But honestly, it'll work." 
"But is it safe?" you ask. 

"Oh yes, its perfectly safe" is the reply. "All you need to do is go through that door, and you will definitely lose all of that stubborn weight and absolutely nothing bad will happen to you whatsoever. Now if you'll just hand me your money there, that'll be great."   

Sounds great, right? You excitedly take a step towards the door.

But before you step through the door, you take a moment to consider what might be behind it.  You don't know, and the person telling you to go through the door doesn't know what's in there either. No one has studied what's behind the door. There are no photos and  no videos of what's in there. All you have is this person's word that it is safe, and it will work. 

Broadly speaking, there are three possibilities of what's behind the door:

  1. Nothing. Its just a room. You go through the door, and nothing happens. You don't lose any weight, but you have lost your money. 
  2.  It works. You step through the door and emerge as a smiling, happy, beautiful, skinnier you. You quickly run home to find some horrible grey tracksuit so you can smugly show everyone how marvellous you are now you're skinny.
  3.  Something harmful is in there. Maybe there is a big pile of dog poo right behind the door, and you are destined to step in it, which will be mildly unpleasant for you. Or the door could be perched on top of a cliff, below which is a mesh of razor blades that will cut you into little pieces. Worse than that, perhaps Piers Morgan is through there.

Do you step through the door? 

Now, I really do want to lose weight. But I also don't like being deceived, and I really don't like being harmed. I also really don't like Piers Morgan. 

All of which brings me nicely on to this season's most fashionable weight- loss aid, Raspberry ketone. Its the chemical contained in raspberries that makes them smell nice. Its widely used as a flavouring and fragrance agent in foods, which begs the question: if its so effective, why don't we already lose weight when we eat food that it is in?

You've probably heard about it already. By which I mean that you've probably seen someone on Twitter tweeting about how they lost 3000 kg using raspberry ketone, along with a handy link to a website where you can buy it. You've also then probably seen the follow up tweets, that go something along the lines of "Urgh, my account has been hacked. I've changed my password now, sorry."

And there's the first warning sign. People who make real medicines which work don't tend to need to resort to hacking people's social media accounts in a desperate bid to get people to buy their wares. You don't see Pfizer or Glaxo, for all their faults, hacking into random peoples' accounts and mass tweeting "My cancer is in remission thanks to Drug X. Buy it here!!!!". Its not a particularly ethical way to sell healthcare products.

Putting all of that aside, is there any evidence that raspberry ketones work as a weight loss aid?

In short: no, except for 18 mice and a difference of about 5 grams at most. Which also means there is no evidence that it is safe. There are no human studies out there at all. All of this hype about it is based on the fact that its chemical structure looks a bit like two other chemicals (capsaicin and synephrine) which might have some effects on weight loss.

That's a bit of a stretch. Human bodies are complicated things, and we can't always predict how they will react to medicines. Even when we theoretically think that something might work for good, plausible reasons, there's no guarantee that it will (COX-2 inhibitors come to mind as an example). Marketing raspberry ketone as a foolproof weight loss aid just because it looks a bit like some other chemicals is like finding a random key on a street and expecting it to work without fail on your front door, just because it looks a bit similar to your front door key. 

If you were to decide to take raspberry ketone, you would essentially be walking through that door. You might lose a bit of weight, or you might not. You might be harmed, or you might not. There's just no way of knowing right now.

Hxxx


Stick a label on this...

Since before I began my career in pharmacy, there has been a drive to get pharmacists "out of the dispensary", in a bid to better utilise their medicines expertise with patients. This sounds great- we have unique clinical knowledge and skills that we have always wanted to use more to make sure medicines are used effectively, safely and efficiently.

For a patient to use a medicine effectively, they need to actually have it in their possession. There is no getting away from the fact that dispensing prescriptions remains a large part of the community pharmacy business model (leaving aside concerns about the contract and reimbursement etc for now). However, dispensing remains the frumpy friend of the drop dead gorgeous, charismatic clinical side of pharmacy. It seems that these days it is seen as repetitive drudgery: the smartie counting and label sticking that we hear so much about. It is, in short, a waste of pharmacists' time, and is something the profession as a whole seems to unquestioningly want to leave behind.

I believe, however, that it is pharmacy's unique selling point. Its only through dispensing that a prescriber's directions are translated into reality. We can prescribe and advise on the most efficient use of medicines imaginable, but if the patient doesn't physically have the right medicines and know how to use them, all of that is pointless.

Yes, there are ways to reduce the pharmacist's input in the dispensing process. There are robots, accredited checking technicians etc. But a prescription still needs to be clinically checked- and that requires the unique skills, knowledge, and abilities that only pharmacists have.

But lets say we step away from dispensing and move in a purely clinical direction. We sit in a room and do reviews of patient's medicines, answer queries, prescribe medicines, monitor and screen patients. Does this sound familiar to you? It sounds to me like the sort of thing a GP does. So, why do pharmacists exist? What do they add to the healthcare picture? Doubtless such pharmacists would be useful, but the profession would become more nebulous, the edges of our role more diluted and less defined.

In my eyes it is our practicality, our ability to supply essential medicines in a safe and effective way to patients that defines us as a separate profession. That, to me, doesn't have to just mean sticking labels on boxes, and doesn't mean that the profession has to be at a standstill. I just think that we need to stop putting ourselves down and accept and be proud of our role in supply. For years we have been declaring ourselves as able to provide new and more clinical services- and we can. But we need to make sure that we define and build on our niche to give us the solid foundations we need to start branching out.

We pharmacists are an interface. Our role is as go-between, and a bloody important role it is. We are go-between a patient and their GP or their consultant, or whoever. Or, we are a go-between the patient and complex medicines information- we can, crucially, convert difficult to understand evidence into patient friendly terms. We can explain what they read in the paper or on the internet, what the directions of a reducing dose are, help them to navigate through the overwhelming choice of medicines over the counter. We are a go-between the drug manufacturing plants and the patient's bathroom cabinet. And the thing that underpins this role is our accessibility. And the reason we are so accessible is because- wait for it- we dispense prescriptions.

If you ask me (not that anyone will), we need to stop thinking of dispensing as the poor relation and see it for just how useful it is.

Hxxx


 

Does XLS Medical Fat Binder weigh up?

Oh Omega Pharma. Once again you provide me with some juicy blog fodder.

XLS-Medical Fat Binder has been on my radar for some time, but I haven't really gotten round to writing a blog post on it or taking a proper look at the evidence. However, prompted by a bit of real-life work I've just been doing, I've been doing some digging.

So what is it? Well, it contains something called litramine, which appears to be a cactus extract. It supposedly binds onto dietary fat and stops it being absorbed. Sounds suspiciously similar in action to orlistat, a licensed medicine. However, XLS- Medical Fat Binder is instead marketed as a medical device.

Here's what the company have to say on the matter:


  
"What is a medical device and how does it differ from traditional medicine? 
  • A medical device is designed to work on or inside the body - either temporarily or permanently. Its main aim is to prevent, diagnose, monitor or treat diseases. 
  • The key difference compared to traditional medicines is that medical devices work mechanically as opposed to pharmacologically. So it works alongside or with your body rather than affecting the chemistry of the human cells."

 

I think what they've missed out here is this: "If we sell this product as a medical device we just need to fill in a form and send it to the MHRA rather than actually having to bother proving that it works so YAY LETS JUST DO THAT!!." It would seem pretty bizarre that orlistat, which is also not absorbed from the GI tract and which also prevents absorption of fat from the diet is regulated as a medicine whereas this product isn't. 

What of the evidence? Well, Omega Pharma once again provide us with a list of the most vague references ever seen, making it virtually impossible to find anything to back up the results they are shouting about. As references go, just writing: "In vivo, 2-armed, randomised, placebo-controlled, double-blind study, conducted in Germany, 2009" is, as someone so succinctly put it on Twitter, the equivalent of saying "This one time, at Band Camp...". These studies don't appear to be published in any peer-reviewed medical journals, so there is no way to verify the results from them. Oh dear.

Of course, not one to rely on the manufacturers alone, I performed a literature review to see if there was anything else out there. And there is: all of one study. And to be honest, the results are promising. Whilst there is a link to this bit of evidence on the XLS Medical website, its hidden away in the tiniest of tiny footnotes, which seems a bit odd really, given it seems to show that Litramine actually works. The trial appears well desgined (double-blind, randomized, placebo-controlled), and whilst not massive (n=123), it isn't as tiny as the usual sort of guff that can be purported as evidence. Patients who used Litramine lost an average of 3.8kg (+/- 1.8) compared to 1.4kg (+/- 2.6) in the placebo group (p<0.001), which actually seems rather encouraging. 

Hang on though, let's not all jump for joy and throw away the salad leaves just yet. Patients in the trial had a hypocaloric diet plan and exercise regimes. The trial only lasted for 12 weeks, so is pretty short- term. and of course its still quite small, and the results would need to be replicated in further, larger, well-designed trials before we could know for sure.

And here's the big problem with it. the study medication is described as:

"Litramine IQP G-002AS is a natural fiber complex derived from Opuntia ficus-indica, enriched with additional soluble fiber from Acacia spp.IQPG-002AS is standardized for its lipophilic activity and has been shown to reduce the dietary fat absorption through GI fat binding." 

- Grube B, Chong P, Lau K, and Orzechoski H. A Natural fiber complex reduces body weight in the overwieght and obese: A double blind, randomised placebo controlled study. Obesity 2013. 21: 58-64

 

The study participants were given 500mg tablets three times a day. However I can't see anywhere on the XLS-Medical website that actually tells me how much litramine is in the tablets- it could be 5mg or 500mg. . So whether or not we can apply these promising results to XLS-Medical, we simply can't say.  

 

And wahoosa are these things are expensive. £39.99 for a months supply? That's six and a half hour's work at minimum wage.

 

Hxxx

Is Gareth Bale worth more than eradicating malaria?

Many moons ago, in what now feels like a different life, I went on a trip to London. The date was October 12th, 2009, and I was armed with a long pole, a dispensing basket I had nicked from work, and a mosquito net.

I had an hour. An hour, to do whatever I wanted, in Central London. Its not particularly unusual to have an hour to kill in the capital, but it just so happened that I would be spending this hour atop the Fourth Plinth in a moonlit Trafalgar Square. I had been lucky enough to have been selected to take part in Anthony Gormley's One & Other artwork. I decided, after much deliberation, to represent the Malaria No More charity. I gave out packs of sweets and leaflets about the cause, wore a dress made of a mosquito net, and even did a little bit of crafting, sewing the words Malaria No More onto a large blue mosquito net. Mostly, I felt utterly terrified, and had horrendous stage fright, more so than I had ever imagined I would have.

Malaria No More, amongst other things, aim to distribute insecticide-treated bed nets (ITNs), eventually with a view to eradicate malaria entirely. According to them:

"£10 can transport 150 life-saving nets to a community in rural Ghana; enough to protect 300 people."

 Blimey, that sounds far too good to be true, doesn't it? But luckily, there is good, robust, independent evidence that impregnated mosquito nets really do prevent deaths from malaria:

"About 5.5 lives (95% CI 3.39 to 7.67) can be saved each year for every 1000 children protected with ITNs...ITNs are highly effective in reducing childhood mortality and morbidity from malaria. Widespread access to ITNs is currently being advocated by Roll Back Malaria, but universal deployment will require major financial, technical, and operational inputs.." -Cochrane Database Syst Rev. 2000;(2):CD000363.

So the idea is that two people can sleep under one net, but because of the insecticide, there is an area outside the nets which is also protected. If there are enough nets in a household, or even a village, then the whole area could be protected, even when people are out and about and not just when they are sleeping under the net. The available evidence seems to back this up-the little extract I have copied above only refers to deaths, but the results are even better when it comes to reducing the incidence of malaria illness- a reduction of 62% in areas of unstable malaria, for example. 

This got me thinking a bit. With the news today that Gareth Bale, a man that I have never heard of, who runs about on a bit of grass after an inflatable round thing is apparently worth a record £85.3 million, I can't help but do some little calculations. Obviously these are all estimates, but it makes for an interesting thought experiment.

  • £10= 150 mosquito nets


 

  • £85,300,000/10=8,530,000 mosquito nets

  • As each of those 8,530,000 nets can protect two people= 17,060,000 people could be protected.

  • 5.5 lives can be saved for every 1000 children protected with ITNs. If we assume all the people protected are children:

    • 17,060,000/1000= 17,060

    • 17.060*5.5=93,830 children could be saved.


The WHO estimates that there were 660 000 malaria deaths in 2010. So that amount of mosquito nets, could, in actual fact, prevent a large chunk of those deaths (we dont know how many adult deaths it could prevent, either) meaning that over a few years, malaria could potentially be eradicated. 

Now, I'm sure this Bale chap is very good and all, but I do wonder whether, in the context of all the World's problems, this sort of amount is appropriate. Personally, I would rather opt for reducing the massive morbidity and mortality caused by a disease that is potentially eradicable given the right resources, but then what do I know?

Before anyone complains, yes I know this is terribly simplistic, and its not as easy as that, and all of that sort of hoohah. I just want to make a bit of a point about how vast sums of money need a context, and in my humble opinion, I don't think it is particularly appropriate or such sums to exchange hands when there are still people dying of hunger or preventable diseases.  I'm sure some men doing footballing makes some people happy and all, but come on. I'm not even convinced that Christian Bale is worth that much, despite that scene of him running around naked, bloodstained, and with chainsaw in hand in American Pyscho.

Hxxx

To self-monitor blood glucose, or not?

Today's news greets us with a story about "rationing" of diabetes glucose test strips. Diabetes UK, in a survey of about 2,200 people, found that 39% of people with diabetes have had their prescriptions refused or restricted. Meanwhile, politicians are wading in stating that restrictions are unacceptable. 

Now, this sounds bad. But when you start applying some skeptical principles to this area, it all becomes slightly less clear. Here are some brief points to consider about self monitoring of blood glucose (SMBG) to put today's news into context:
 

Test strips are expensive. 

Spending on test strips in the UK is pretty high, and has been rising year on year since 2008. In 2010/2011, a whopping £158.4 million was spent on testing in England alone. These things are expensive, and a lot of them are being prescribed. Historically, they have been over-prescribed, and this has been a priority area for the NHS to attempt to prescribe more rationally. (NB: rationally does not necessarily mean rationing, it just means using resources more effectively.)

The UK Guidelines are clear that SMBG has an established place in the management of diabetes controlled by insulin, whether this is type one or type two. Its also accepted in the guidelines that it is useful for patients with type 2 diabetes who are at risk of hypoglycaemia. Reports such as this one from the NHS Diabetes Working Group are also clear that rationing should not be undertaken in patients who are deriving benefit from SMBG. 
 

SMBG doesn't actually do anything to control diabetes.

 It isn't an intervention, it's a testing tool. The only way it can have a positive impact on diabetes treatment is if the results are used to guide treatment or behavioural choices. So its useful for insulin dosing, for example, as it is variable and needs to be responsive to what you have eaten that day. However, if you take a twice daily dose of metformin 500mg, say, SMBG isn't going to really help anything. I think this point isn't quite as clear as it should be to some patients, carers, and even healthcare professionals.  

It only gives you a result for one pinpoint in time. It doesn't tell you anything at all about more long term control. This limits how useful it is in assessing lifestyle changes, such as exercise and longer term changes in diet.


Studies have found that some patients are not using SMBG to guide treatment changes or choices

...so they are essentially testing for no gain at all. If this is the case, then it is clear that the SMBG can be discontinued with no impact on the patient's overall care- in fact its an all-round win situation, as the NHS saves some cash and the patient no longer has to bother doing a painful test.

Its not a no risk option. Apart from the obvious discomfort of testing, there is some (although limited) evidence that some patients can feel more depressed, anxious, and even obsessive if they are using SMBG.
 

The evidence that SMBG works is very limited, 

and is confounded by lots of different factors. You can find more detailed information on the evidence base in this Medicines Q&A. The technology of SMBG was welcomed with open arms by patients and healthcare professionals alike, and it was widely accepted before there was robust evidence that it worked to improve outcomes. In these sorts of situations, where people are used to using a technology or drug etc, it becomes quite difficult to start being rational about it, without people feeling that they are having something taken away from them. If you really want to have a good look at the evidence, you can have a look at this Health Technology Asessment by Clar et al. It's only 156 pages long (!) but it is a really good quality summary of the evidence. 
 

The evidence that SMBG is cost effective is even more limited.

We simply don't know if it represents good value for money for the NHS. Meanwhile, there are interventions which we do know are cost-effective. So doesn't it make sense to limit spending on the unknown, and to put funds into the interventions that we know work instead?

Its a real shame if these sorts of issues have been ignored in favour of rationing. Rationing test strips for patients who are insulin treated isn't rational prescribing, its just daft. But there is a serious issue of overuse and over dependence on SMBG, which blanket rationing makes more difficult to address. The UK guidance makes a lot of sense given the state of the evidence we have access to at the moment, and I would be very sorry to see it being misused in some patients, whilst others are fruitlessly undertaking a needless task at a potential cost to their quality of life and the NHS. 

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 

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

The Vaper Verdict

I seem to have gotten myself a bit of a reputation as a Vaper-hater. In truth, I'm actually really not.

I even once owned a disposable e-cigar. It was a good few years back now. Although I consider myself a non-smoker, I do smoke the odd cigar, but about one a week and only when the weather is nice (so about 4 days a year then) and only when someone has brought me some back from their holidays probably does not constitute a habit, or would be considered the world's most pathetic addiction. I would never dream of smoking indoors, and somebody thought it would make a nice stocking filler for me one year.

I used it a few times, and it was alright, in the same way that a Pot Noodle is mildly enjoyable in its own right, but bears no resemblance to a steaming hot bowl of freshly cooked spicy Szechuan chicken in udon noodles (no 69. on the menu at Nudo, my favourite restaurant in Newcastle. Its always giggle-worthy ordering it). E-cigarettes are the Smash mashed potato of the smoking world, a Cup-A-Soup to a home-made broth.

I can see how it would be good to have something vaguely resembling a cigarette if you're trying to give up smoking, and I can certainly see how a nicotine delivery method that avoids all the tar, chemicals and other gunk that smoking dumps in your lungs is more healthy.

My reservations are thus:

  1. If they're unregulated, you have no idea what's in them. It might say on the pack that it contains x mg of nicotine and chemicals y and z but there is no guarantee of this. Some have been found to contain toxic chemicals like ethylene glycol, for example. Its undoubtedly likely that they still contain less dangerous chemicals that cigarettes, but it would be very nice to have that guaranteed.

  2. There's no long term safety data. We literally don't know what the long term effects of these things are. For all we know, the seemingly safe-at-first ingredients could actually prove to be carcinogenic, say, when inhaled in this way in the long term. Admittedly its unlikely the products would be as bad or worse than smoking, but without the studies we just don't know. Theoretically they may seem like they're going to be harmless, but without the data there to back it up we just cannot make that assumption- its that sort of reasoning that lead to the thalidomide disaster, for instance. Unknown does not mean safe.

  3. There's evidence that products are often do not contain what it says on the label (if they even have a label at all). A study in the BMJ's Tobacco Control found that products contained variable and potentially dangerous amounts of nicotine- most often the product contained less than was stated. Now, if I'm paying for a product that says it contains 72mg/ml of nicotine, I expect that product to contain 72mg/ml of nicotine, just as I would expect a 500mg paracetamol tablet to contain 500mg paracetamol. If it contains less than this, I'm essentially being ripped off. The other available nicotine replacement products- patches, gums, inhalators etc- all have a license, and I don't really see why these electronic cigarettes should be any different.

  4. In smoking cessation, using a product which looks like a cigarette might be helpful in the short term, but it doesn't help to address the habits of smoking rituals, and in my experience of helping people quit, that's half the battle.

  5. The risk of serious accidental nicotine poisoning in both adults and children. 

  6. There is a risk that the ease of use of the products and ability to use them indoors might actually increase nicotine intake in some people.

  7. Even if nicotine itself were entirely safe (which it isn't), its still an addictive substance. Any addiction can lead to harmful effects in a person. For evidence of this, try speaking to me on a day when I have not had any caffeine. If I added up all the time and money I have spent in my life engaging in drug-seeking behaviour to feed my addiction (mainly desperately trying to find the nearest kettle or coffee shop), I suspect it would be very upsetting.

Today there has been, in my opinion, some good news. The MHRA have decided to start . This decision essentially eliminates concerns number 1, 3 and 5 and starts us on the road to also ruling out concerns 2,4 and 6. The BMA have responded enthusiastically to the news, stating:

“We can now build on this and press for good research which looks at the efficacy and health implications of e-cigarettes. It’s really important that we find out if the hand to mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We need to know if e-cigarettes actually help smokers quit."


I'm also enthusiastic about this step. Whilst it may lead to decreased availability and choice of these products, it will hopefully lead to a smaller number of better quality products being legitimized and incorporated more formally into smoking cessation or harm reduction schemes- if they are proven to work in robust clinical trials. This is yet another case where, instead of waiting until we have good, robust data that a product works and is safe, it has been widely sold and adopted by users in lieu of risk or efficacy information. There will no doubt be an outcry from users and manufacturers, and wails that the MHRA have banned e-cigarette sales, that its a Big Pharma conspiracy to give everyone cancer so they can sell more drugs, that big evil corporations are trying to trample the little guys down, when all they are trying to do is save some lives. But none of this regulation means that.

All a manufacturer of e-cigarettes would need to do to continue selling their product is to prove its safety, efficacy and quality. It will take money and time, but if they have been already producing their wares safely and in accordance with Good Manufacturing Practice guidelines, they're already some of the way there. Gaining a license will of course cost time and money, but if these manufacturers are genuinely interested in saving lives- and not just unscrupulously making profit- they would see the value in the licensing process, and the opportunities available for a licensed product in the long run.

So here's to what could be start of a new dawn of smoking cessation or harm reduction. I really hope so, but will reserve judgement until the evidence starts piling in.

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?

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.

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.

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.

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"
  • "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.

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 moisturising 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. Isimply 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.
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 theInternational 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 tell-tale 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. 

Nose gunk strikes again: Nasalguard AllergieBLOCK

What is it with people trying to produce "Revolutionary" new versions of rubbing vaseline on your nose whilst charging vastly over the odds for the privilege? Someone, somewhere has obviously decided that our noses just aren't greasy enough. Thanks to my friend Paul for bringing this to my attention.

Enter the new kid on the over-the-counter hayfever market block (see what I did there?): Nasalguard AllergieBLOCK. Firstly, how am I supposed to trust a product that can't even manage to spell allergy properly? Secondly, is that Comic Sans font that I spy on the packaging?! Okay, so it seems like the UK packaging is different, but that doesn't matter. The damage is done, and the use of Comic Sans is an unforgivable crime.

Font against humanity.&nbsp;

Font against humanity. 


Thirdly, on trying to find the UK site, it seems that this is yet another company who has taken to giving free stuff to people so that they will say on their personal blogs how very marvellous it is. This sort of publicity just doesn't wash with me. It feels grimy and seedy and smells faintly of desperation. I therefore imagine this is also what Allergieblock gel smells of.

Let's have a look at what the manufacturer's say:

"NasalGuard AllergieBLOCK® Regular is a revolutionary topical gel based upon patented technology containing cosmetic grade ingredients. The FDA-approved gel creates a positive charge which blocks negatively charged allergens on contact before they enter the nasal passages."

Right, it's really not revolutionary, is it? It's hardly going to free the downtrodden masses from the grips of the evil dictatorship of pollen. It's exactly the same principle as Prevalin and Haymax, and of course good old Vaseline. I've said it before in the Prevalin post, but the idea of putting vaseline on your nostrils to reduce hayfever symptoms is as old as the hills. There's nothing revolutionary about this. This positive charge thing is new, however. It sounds like something that a bunch of marketers sat in an office having a "thinkstorm" session would come up with as being suitably science-y to wow the masses. 

But surely this can't possibly be the case, not when there is a heart-warming "Inventor's Story" on the website:


"About 20 years ago, New Jersey Professional Engineer Ashok Wahi's daughter Aikta frequently suffered from allergies after exposure to her friend's cat. He wanted her to be relieved from the constant sneezing, runny nose and congestion without taking drugs.  The conventional over-the-counter remedies made her sleepy at school, he got motivated to create a drug-free solution for his daughter that wouldn’t cause drowsiness, dry mouth and similar side effects.

The project's goal was to prevent the inhalation of allergens rather than treating the allergy symptoms after the fact.

With this in mind, Wahi put his engineering skills to work and developed a unique gel that blocks allergens on contact, therefore alleviating allergy symptoms. Hence the birth of NasalGuard® technology."


So its taken this dude 20 years to reinvent the wheel and come up with a fancy version of Vaseline. Shame really, he could have saved himself the effort if he had only spoken to a decent pharmacist or GP. Whilst I'm sure being a "Professional Engineer" is awesome and all, I'd really rather like it if people who are trying to improve my health have some sort of background or training in healthcare, thank you very much. 

Anyway, all of this is by-the-by, because of course there is going to be a wealth of good quality clinical trial evidence to say that it works, right? Dear readers, you probably know the drill by now. There's some testimonial videos on the website, a grand total of 4 of them. With Prevalin, the manufacturers tried to pass off two methodologically poor trials about products that bore no relation to Prevalin at all off as clinical proof that it works. These guys don't even bother going to that amount of effort. There is no mention anywhere on the website about any trials at all. They don't even bother cursorily referencing the Principles and Technology bit:

 "NasalGuard AllergieBLOCK® uses patented technology that works on a simple principle of electrostatic charges: opposite charges attract each other.
AllergieBLOCK gel has a slight positive charge which attracts negatively charged allergens. Allergens like pollen, ragwort/ragweed, hay, dust mites, pet dander and house dust all carry a slightly negative charge. The allergens are blocked on contact. You do not inhale allergens, which means you don’t suffer from allergic reactions"

Now, it does seem to be the case from this PLoS One study that allergens are negatively charged whereas non-allergens are more likely to be postively charged. But until there's some evidence that a mixture of "Dl Water, Polyquats, Propylene Glycol, Octoxynol-9, Glycerin, other cosmetic grade ingredients and preservatives" can definitely produce some sort of nasal forcefield against the nasty pollen, and the manufatcurers can demonstrate an ability to spell properly, I'm not interested.

I'd also rather not apply something to my face which is going to actually attract the very things I am expressly trying to keep away it, thank you very much. Without evidence to the contrary, there is nothing to say that all of those positively-charged allergens which are supposedly now attracted to the gunk on your nose will get stuck on the gunk. A few allergens with probably make it through, given that nostrils are relatively big holes in comparison to how small the allergens are. So if anything, there is a potential that you end up with more allergens than you would have done had you not bothered applying it in the first place. Imagine Justin Bieber in a young girl's school, with only one or two bouncers for protection. a fair proportion of the screaming pre-pubescent youngsters are likely to get through the bouncers to plant a kiss or two on the fresh-faced child-adonis. (If I'm honest, I have only a vague knowledge of who Justin Bieber is, but I understand he's the Jason Donovan of modern time)

How much does it cost? oh, only the princely sum of £11.99 for 3g at Boots. ELEVEN POUNDS AND NINETY NINE PENCE for THREE GRAMS!!! Think of all the other things you could buy for £11.99.

Save your money, people.

Wake up and smell the (green) coffee

The media is raving about it. Waif-like celebrities like Demi Moore are swallowing it like there's no tomorrow. Any internet search results in a tidal wave of websites and blogposts screaming that its the new "100% safe and natural!" weight-loss secret. In short, the world seems to be falling over itself to get its soon-to-be-no-longer-chubby hands on a green coffee extract supplement. We'll all be size zeros in a matter of days.

Just one of the many hyperbolic stories appearing in the media.&nbsp;

Just one of the many hyperbolic stories appearing in the media. 

Green coffee beans are normal, every day coffee beans before they have been roasted. The roasting process decreases the amounts of chlorogenic acid contained in the products. Chlorogenic acid is thought to moderate effects of glucose metabolism and inhibit fat accumulation- sounds brilliant, right? Well, before I go off, burger in hand, to eat lots of cake safe in the knowledge that I'll be shopping in the size 8 section in no time thanks to green coffee, lets have a look at the evidence.

Green coffee beans. Just like brown coffee beans, only, well... green.&nbsp;

Green coffee beans. Just like brown coffee beans, only, well... green. 

First things first: does it work?

The short answer is it might do, a little bit, but we don't really know yet. There are a couple of little trials here and there, but they're limited by their size and trial design, so the results could just be fluke. There's one systematic review, which found that overall the data from the better quality trials suggested that green coffee extract could lead to modest weight loss differences (about 2.47kg (95% CI -4.23 to -0.072kg) over about 12 weeks. That's hardly enough to transform my size 16 lumpen frame into a lithe size 8 overnight, or indeed over a year, despite what all the before and after pictures on the manufacturer's websites say.

And what of its safety?

Well, in short we have no idea. I've done loads of research into this and have been unable to find any good, reliable information on its safety. Green coffee contains a similar amount of caffeine as normal coffee beans, so we can assume that all of the nasty side effects from drinking too much coffee could also happen with a green coffee extract. Palpitations, anxiety, insomnia, diarrhoea, and heart problems may result, and even anaphylaxis in the worst cases. Some products claim to be decaffeinated, but as none of these products are regulated, there is no guarantee. 

There is nothing out there on the safety of chlorogenic acid. It seems to have been used in chinese medicine injections, and seemed to be thought to cause allergies. However it seems that there is some debate about this. One study in dogs seems to suggest that it could have an effect on the liver and kidneys, but whether it could damage human kidneys or livers is unknown.

So there we have it.

We basically know very little about green coffee extracts, despite what the websites that are selling it will tell you. It might work a bit, but its certainly not a miracle cure, and we don't really know whether or not its safe yet. It may well be safe, but we just can't say for certain yet. Instead of waiting until more evidence is known, however, it seems that manufacturers are gleefully happy to sell it far and wide.

What's particularly uncomfortable is that the sellers of green coffee extracts are taking the more and more common approach of marketing their products. Google "Green coffee extract safety" and instead of finding reliable sites or those actually looking at the safety of the product, the search is flooded with marketing sites masquerading as genuine safety sites. This sort of marketing feels really icky, and I don't like it at all.

Its yet another opportunity for unscrupulous people to make money from our insecurities. I'm overweight myself, and I know that I have to struggle against the urge to throw my skepticism to the wind and throw money at anything that claims it will help. The simple fact is that there wont be a miracle cure, and losing weight takes time, effort, patience and willpower, not to mention the fact that the desperation to be unhealthily skinny is dangerous in itself.

Hxxx