skepticism

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

 

Isn't homeopathy the same as herbal medicines?

A lot of the posts on this blog are looking at homeopathy and its harms.  I've been working on the basis that most people that read this blog have a knowledge of what it is and how it differs from, say, herbal medicines. However, on speaking to a lot of people, it would seem that it is worth reiterating what it actually is, as this really helps to put into context the sort of harms that might be caused by it. 

The ingredients of a homeopathic medicine are beyond a 12 C or 24 X dilution are as follows:

  • Sugar

  • Water

That's it. That's all it is. Homeopathic medicines are so highly diluted that by the time the pills are made, there is essentially no probability of it having any molecules of the "active" ingredient in it at all.

So, although homeopathic medicines are made from all sorts of things- plant materials, heavy metals, conventional medicines, dolphin sonar,  body part, tumours, ducks, exhaust fumes, the light reflected from Saturn etc, none of these ingredients are actually present in the final formulation- the pill or tincture that you take. It probably hasn't even been within a mile of the remedy listed on the pack.

If you didn't know this already, you're now probably thinking 'Eh? What are they playing at? How on earth is that supposed to work?!" Well this website is probably the best one to tell you that: How Does Homeopathy Work?

Herbal medicines are different. They are made from plants or plant extracts, and they haven't been subjected to the dilution process- in other words, there are high enough levels of pharmacologically active component  in them to mean that they could-at least theoretically- work

Lake Superior as a homeopathic solution

A good way to illustrate what I mean about homeopathy is to use Lake Superior as an example.

At its longest, Lake Superior is 360 miles, and it is 160 miles at its widest point. Let's say we filled Lake Superior with a 30C Nat Mur (salt) solution.

  • Lake Superior holds 12,000 square km of water.
  • In this volume of a 30C solution, there would be 40080 molecules of sodium chloride (salt).
  • 40080 molecules = 0.000,000,000,000,000,003,89 grams of salt.
  • 1 grain of salt weighs approx 0.064799 grams

If Lake Superior were a 30C Nat Mur solution, it would a teeny, tiny fraction of one grain of salt. That's how dilute a homeopathic solution is. It makes no sense whatsoever for it to possibly work, and indeed all good quality evidence suggests that it doesn't. 

An award nomination and a shiny new look blog, oh my!

Hello and welcome to this new shiny home for my ramblings. It's much prettier, right? 

I really wanted something that looks a bit less like it has been cobbled together by an idiot in a few hours, even if that is, ultimately, what it is. Because I listen to a lot of podcasts, and pretty much every one in existence is sponsored by Squarespace, I started to feel like they were sponsoring my brain. It seemed natural (or simply the inevitable effect of subliminal marketing) to give them a try, and it turns out that I really like it as a platform.  It meant I even finally got round to sorting out a proper domain name and everything. Hurrah!

I'm still getting to grips with it so far, so its likely that there will be a few bits and pieces that don't work or problems that need ironing out. Do bear with me, and do let me know if you come across anything that isn't working yet. If you nip over to the About This Blog bit in the menu in the top corner, you can find a contact form or more details about how to give me a shout.

In other news, I was really pleasantly surprised to find out a while ago that I had been shortlisted for a Ockham award. Although I didn't win, I've found it a real honour to be recognised in this way, amongst really important skeptical activism campaigns like Stop The Saatchi Bill. The shortlist is determined by nominations, so its really wonderful to know that many of you thought my little blog worthy. I'm truly lucky that so many people like what I do. The evening of the awards ceremony was good fun too- it was held at the QED conference, and it just felt great to hear the title of my blog read out, the rowdy whooping it got in response, and to see excerpts of it being shown on the big screens. 

So I just wanted to say a big ole' thank you to all of my readers. I know I'm not the most consistent of posters, thanks to the mundane realities of daily life, but hopefully having a lovely new slick website might spur me on to post more regularly. Remember to change your bookmarks and all of that other stuff.

Hxxx

Vicks, Feet, and a whole load of nonsense.

Vicks Vaporub. It's a staple of our medicine cabinet, and we all reach for it at the first sign of sniffles. You may have seen (usually on a poorly made image posted on Facebook) or heard (from a friend who heard from their friend who heard from their aunt's sister's niece's dogsitter) that actually we've all be using it all wrong. 

It's logical to use Vaporub on your chest, pillow, in a steam inhalation. It makes sense, because the vapours will end up in or around your nostrils, which is where it acts. But no- according to this particular internet fraud, it is only by smearing our tootsies with it that we will get the full benefit. 

I'm going to pick apart the standard Facebook post, piece by piece, so you can see my thought processes and logical reasons why I don't believe a word. Even if you do think this works, stick with me and see whether or not you agree with any of my individual points, or if you can come up with a more robust argument for using it on your feet. 

"Some of us have used Vicks Vaporub for years for everything from chapped lips to sore toes and many body parts in between."

 Wait, What? Who uses Vicks Vaporub for chapped lips? I've never heard of anyone do this, ever. Firstly, it would sting lots, and secondly it could be highly toxic, given its essential oil content, and aspiration risk when swallowed due to petroleum. I wouldn't put the stuff anywhere near my mouth.

But I’ve never heard of this. And don’t laugh, it works 100% of the time

100% of the time? Nothing in medicine works 100% of the time, so alarm bells are ringing loudly, unless this is the single most important medical discovery that's ever happened. If a medicine had been truly found to be 100% effective for anything, it would have been ground-breaking, world-changing news- probably not something that's just shared by your cousin on FB. 

 In the interests of research, I actually tried this when I had a troublesome post-infective cough. Needless to say, it did nothing to the frequency of my cough, so we've already disproved that number straight away. Whether or not it works, it most certainly does not work 100% of the time, and if that number isn't true, then why on earth should we believe anything else in this post?

...although the scientists who discovered it aren’t sure why.

 What scientists? What were their names? Where were they working? Where did they receive their funding from? Why aren't their details given? If they aren't sure, do they have any working theories? 

The lack of detail here is really telling. It really suggests that this is a whole load of hokum, especially given that a search (see below) shows no formal records of any "scientists" or research.

To stop night time coughing in a child (or adult as we found out personally), put Vicks Vaporub generously on the bottom of the feet at bedtime, then cover with socks.

Ahh, feet. Feet really are a favourite for peddlers of quackery. I'm not sure why, but from reflexology to detox foot patches, the alt med world seems to be obsessed with them. Any time feet are suggested as therapy for anything going on elsewhere in the body, loud alarm bells start going off. 

The ironic thing is that feet are probably the worst place to apply any medicine. The skin on your feet is miles thicker that elsewhere. Absorption through the skin tends to be low and erratic at the best of times, but if you apply something onto your feet, the chances of absorbing anything useful from it are very low indeed. 

Additionally, your feet, when lying down, are very far away from your airways. The post requests that you put socks on over it. Therefore there is certainly no way that vapour could get to your airways in any clinically relevant amounts.

Even persistent, heavy, deep coughing will stop in about 5 minutes and stay stopped for many, many hours of relief. 

Coughing fits are just that- fits. They're acute- you cough a lot for a little while, then stop, then it all starts again. A more chronic cough will still follow this pattern or stopping and starting. So yes, persistent, heavy deep coughing will usually stop- albeit temporarily- in probably much less than 5 minutes. If you're coughing for longer than that, it's likely you're going to be having severe problems breathing, and you'll need urgent medical care- you wouldn't really be thinking about smearing goo on your feet. You may find that you put Vicks on your feet and your coughing stops shortly after, but the likelihood is that the coughing would have stopped even if you hadn't. This is called regression to the mean, and its one reason why we can't rely on anecdotes for deciding whether a medicine works. We need to scale up and look at robust clinical trials instead.

Works 100% of the time and is more effective in children than even very strong prescription cough medicines. 

That 100% claim raises its improbable head again. To claim that something is more effective than other medicines would suggest the existence of comparative trials, which-spoiler alert- don't actually exist. This is rather a strawman anyway, as there are very few prescription cough medicines on the whole. Even conventional cough medicines don't really work to any great degree, and are based on very shakey evidence. It would be a very, very rare occasion indeed that a doctor would prescribe a cough medicine on prescription for a child. 

 In addition it is extremely soothing and comforting and they will sleep soundly.

I can see how that tingly, cold sort of feeling you get from menthol could be pleasant, though I don't think I'd go as far as to call it soothing. To be honest, you'd have to have perfectly soft skin on your feet to feel anything at all- when I tried it I didn't even feel a tiny tingle, especially since it was covered over with socks. 

Just happened to tune in A.M. Radio and picked up this guy talking about why cough medicines in kids often do more harm than good, due to the chemical makeup of these strong drugs so, I listened.

What guy, and on which radio station? What qualifications does this guy have for making medical recommendations?  Who is even meant to be narrating this post? The only medicines now available for coughs in children in the UK are glycerol and simple linctus paediatric. Both of these essentially work on the basis of being sugary, slightly gloopy water. There's no "strong drugs" here, just some soothing "demulcents" that taste nice and are supposed to leave a soothing lining on the throat, making a cough feel less raw. They're mainly placebos. 

It was a surprise finding and found to be more effective than prescribed medicines for children at bedtime, in addition to have a soothing and calming effect on sick children who then went on to sleep soundly.

 Where is this finding published? What sort of a study was it and how was it designed? How many participants were there? Was there a control group, or a comparator group and if so, what was the comparator? As it happens, all of this is irrelevant really, as no studies exist. These statements come from the head of an internet fraudster, rather than actually being grounded in reality. 

My wife tried it on herself when she had a very deep constant and persistent cough a few weeks ago and it worked 100%! She said that it felt like a warm blanket had enveloped her, coughing stopped in a few minutes and believe me, this was a deep, (incredibly annoying!) every few seconds uncontrollable cough, and she slept cough-free for hours every night that she used it.

 We don't even know who is narrating this thing in the first place, let alone their wife. As I've explained above, this is an anecdote, and we can't derive anything from it. A person, who may or may not be mythical, had a cough, and it went away after they did a thing. It might have gone away anyway, we just can't tell. 

A warm blanket?  far from it. It actually just feels like you have some oily gunk on your feet. At best it might feel a little cold, but for most of us, it'll feel no different at all thanks to our thick skin. 

If you have grandchildren, pass this on. If you end up sick, try it yourself and you will be absolutely amazed at how it works!

Well that's just bizarre. Presumably you don't need to bother if you're simply a parent, only if you're a grandparent? What a load of nonsense. I wasn't left amazed, I was just left feeling a little silly. And I had minty-smelling feet.

So of course I have done a search for the evidence and claims included in the post and have found a grand total of Nothing At All. I will say this though: If I was the manufacturer of Vicks, and someone had done some studies which found my product to be 100% effective, I would sing it loudly from every rooftop I could find. I would be the manufacturer of The Number One Most Effective Medical Product In The World Ever, and I would make sure that I made my millions on the back of that fact, as well as collecting my Nobel prize for Medicine and probably world peace as well. What I probably wouldn't do is ignore the claims, and continue on selling my product and advising that its used in a way which has a less than 100% chance of it working. 

Direct harms from following this advice could include dermatitis and skin reactions. Indirect harms? Well, you've slathered some slippery, oily unguent onto the bottom of your feet. When you take your socks off, you may be slip-sliding all over the place.

The moral of the story is: Very rarely should you believe anything posted on Facebook. Unless its me, posting a link to my blog, of course ;)

Hxxx
 

The beauty of disagreement

If this skepticism lark has taught me anything, its that disagreeing is a beautiful thing. Disagreeing with someone is a hard thing to do, in any context. Yet as humans, health care professionals, and as skeptics, its one of our keenest tools. Its only by being able to step into disagreement that we can understand our topic, our audience, and hopefully steer hearts and minds away from those willing to mislead.

I recently attended a panel about daring to disagree, which mainly focused on religious debates over Twitter and the like. I'm guilty of wiling away hours of my life arguing with homeopaths over twitter, and I'm often asked why, as I'm never going to change their minds. The short, and most noble answer is that someone undecided might spectate, and I might be able to make some impact into how they think about the subject. The more self-serving version is that its good practice to hone my skills in identifying fallacies and flaws, finding workarounds and ways of wording things, and to understand an argument in advance of the next time. In these types of arguments, the people who you are speaking to are removed from yourself, perhaps not anonymous as such but they tend to be used to arguing. Their position is usually on the defensive in the first place because their chosen subject has usually been the butt of skeptical inquiry for years.

But what of those closer to home? Sticking out heads up above the parapet in other situations is one of the hardest things in life to do. Most of us instinctively see disagreement as a threat and a personal attack, and we react accordingly. Even now, despite all I've learnt about constructing arguments and debates, with all of this practice, I certainly still get physical reactions when someone disagrees with me. My heart will pound, my mouth with become dry, and I'll want to curl up in fear because my body and brain immediately leap to the conclusion that no one likes me, that I'm so insignificant that I must automatically be wrong. I'm thankful to skepticism in that I'm able to take a deep breath and overcome those initial few moments, then can try to reassess my position. Am I actually right, but there are some good points to take away from the other stance? Or actually, is my reasoning flawed? In which case, why? Where could I have found more information, what is the other person bringing to it? Whichever way it goes, I, and the other person, end up learning more. Ultimately, we're not here to be right or wrong- we're hear to learn more, and that's the important bit.

Problems arise though because often our instincts take hold. I can't describe the number of times its all gone tits up. I can spend ages agonising over whether or not to disagree. Once I've decided to do so, I write and rewrite my argument so that it is as objective as possible, structured clearly, evidence based etc., only to have the response be “Eurgh why are you being so mean?! I thought we were friends!” or similar. I've tried all sorts of ways to word things, and I haven't quite come up with an answer on how best to avoid this response. Its not just Facebook etc. where this is a problem- we all hear in the news about irrevocable breakdowns in the doctor-patient relationship (Ashya King, as an example). We've all encountered the patient at the pharmacy counter who believes a random person waiting in the queue over our own expert advice. No one learns anything from these sort of exchanges, and that's a real missed opportunity.

So the question is, how do we go about promoting disagreement as a positive thing that we all need in our lives? How do we turn the tables on the thousands of years of evolution that make us shut down arguments as soon as they begin? Well I think the answer has to initially come from example. I believe the skeptical movement is extremely well placed to start this tidal change in thought, but we all have to practise the heck out of it every single day if we're ever going to get anywhere. We have to start being known synonymously as folk who are really, really good at disagreeing respectfully, and that has to start from within. Its clear that the skeptical community in the UK and beyond occasionally falls short in this regard, and that's a real shame as it appears to be driving good people away.

We need to recognise that we might agree with someone on one thing, but not the other. We can't see a person as synonymous with one of their opinions, and put people in good or bad boxes based on that. We shouldn't be labelling people as anti-this, or anti-that, and then refusing to engage further. We should be experts at digging deeper than that, looking behind the headlines to search for shared humanity underneath. We need to lead the way in disagreeing without bullying, and we should never, ever let up on that. We put ourselves in a position that could so easily be mashed up together with bullying by the general population when we dare to disagree, and we need to be relentlessly exemplary in our behaviour to prove that we aren't. We need to be the type of people who, even if faced with a mutant hybrid of Nigel Farage and Piers Morgan, would manage to keep their cool and be polite.

But then again, feel free to disagree ;)

Hxxx

 

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.

It's thyme to Bronchostop this nonsense

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

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

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

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

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

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

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

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

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

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

Hxxx

In memory of Rachel

I didn’t know Rachel at all. But I was told her story last night, and all of today I have been thinking about her. I don’t know how old she was, what her life was like, the colour of her hair, whether she spelt her name with just an 'e' or if there was an 'a' in there too. 

It sounded like Rachel was a nice person. It sounded like she was enthusiastic (I think she met the teller of her story whilst volunteering for something).

Rachel was diagnosed with bipolar disorder. She was encouraged to try homeopathic treatment for it, and to stop her conventional medicines.

Several days after stopping her medicines, Rachel took her own life.

Many of you might remember that I blogged about a homeopath’s response to my good friend’s request for help for her own bipolar disorder. At the time, I theorised that, had my friend followed this homeopath’s advice, she would have destabilised and it would have killed her. 

I’m so, so sad that this happened to Rachel. I often get questioned about why I do what I do, why I rant on about homeopathy and alternative medicine so much. If other people want to use it, I’m told, then just leave them be. But how can I sit back and not do anything, when there are other people out there just like Rachel? If I can make any difference at all, even a tiny one, then I will do. If I can make even just a couple of people raise their eyebrows and wonder why homeopathy is still used in this day and age in place of effective treatments, then I’ll keep doing what I’m doing.

Sorry, Rachel. I’m really sorry that this happened to you. I didn’t know you, but I’m sorry that you went through all of that, and I’m sorry that your friends and family and the world lost you.

Hxxx

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


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


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

Facebook, breasts, and why the combination of both has been annoying me

"I like it on the living room floor!"
"I like it on the kitchen counter!" 


Blah blah blah. These are the sorts of bawdy Facebook statuses that surface every year. They're then followed up with a message along the lines of "hey, let's not tell the MENwhat we're doing, but according to this arbitrary nonsense below, put something attention seeking as your status update to help raise awareness of breast cancer".

There's always the inevitable guilt trip of "most of you wont bother with this, and you're all terrible, terrible, evil people who don't care about people with cancer and you will all go to hell"

These sorts of statuses/ messages have always bothererd me. The whole Carry On Breast Cancer vibe is just uncomfortable, for starters. They are infused with the same sort of superstitious, guilt-ridden nonsense as the old chain letters you used to get back in the late 80s. And people seem to go to great lengths to defend them, and any even remotely negative comments about them are batted straight back with an unthinking "why wouldn't you want to raise awareness of breast cancer? are you some sort of EVIL PERSON?!"  I have raised the point on my own Facebook and have also seen some friends take flack for daring to question these games. 

There is a great piece of writing about exactly this subject that you can find about this subject here. You'll also find a piece from Skepchick here. However, there are a couple of other points that I want to raise in addition and to compliment the points raised in that piece, and some of the arguments used to defend the game that I have seen used on Facebook. These points are in no particular
 

How much awareness are these "games" raising? 

Given that the messages contain no information on the symptoms or how to check for breast cancer, or any links to good quality information sources, I'm not convinced that it is raising awareness. There have already been huge campaigns to raise awareness of breast cancer- people in the main already know that the disease exists. Therefore this campaign needs to add something specific to that: how best to check for signs of breast cancer, practical tips, or signposting to other good quality sources of information. Furthermore, actively excluding an entire gender or other large group of people from your awareness campaign seems like a very odd tactic indeed. The messages include how the "bra game" made it to the press- this appears to be the case, although not in the way the message would like to imply. But have any of the other campaigns that surface regularly made it to the press? I certainly haven't seen so.

Who has started these campaigns, and what charity etc are they raising money for? its not clear, and it would seem that no one knows who or why they originated. So what sort of awareness are they really raising?
 

Cold, hard cash

These games aren't asking for money to be donated to any particular charity. Yet, when it comes to cancer research, it is cold hard cash that makes the difference. There is a risk that people may feel that by taking part in the game, they have done their bit already in helping to raise awareness, which might discourage any further action. In actual fact, if you want to help, donate some money to a cancer research charity.Is there any evidence that this sort of bid to raise awareness translate into money being donated? No, of course there isn't, so we should all be focusing our efforts elsewhere. 
 

Dignity

Really people, are we that unimaginative that we require this arbitrary nonsense to put something titilling as a status? Do we so desperately want to feel a part of something that we will lower ourselves to this sort of bawdy crap? Can we really not think up any better innuendos to grab male attention as we appear to be so desperately doing here? These sorts of statuses sit on the same level of annoyance as the ones that are simply an unhappy face so that many people will reply with "what's up hun?" and the original poster will get lots of attention. If you want to be tacky and attention seeking, go right ahead, but do so with a bit of imagination and personality, not according to some formulaic crap involving handbags.

Exclusion

In 2010, breast cancer rates in men were approximately 1 per 100,000. Just imagine how emasculating, shocking, and devastating this diagnosis may be. The fact that bright pink is constantly associated with this disease can't help matters. That awareness campaigns like this one actively exclude men is frankly unforgivable. Campaigns that raise awareness of testicular or prostate cancer are often very inclusive of women (I'm thinking of the Movember campaign in particular, problematic as it may be for other reasons), despite the fact that for obvious reasons the likelihood of women getting these types of cancers is zero. 

In addition, as a good friend of mine pointed out, it may be men who notice or feel changes in their partner's breasts before they do. Why would they therefore be excluded from any awareness campaign? It just doesnt make sense.
 

Humour

"Oh but its just a bit of a laugh isn't it?". I've seen this used as a defence for these games. No actually, no its not a bit of a laugh- its breast cancer, for crying out loud. Humour is undoubtedly a powerful tool in coping with such a diagnosis, but this is going to be different for everyone and needs to be treated as such. some people might find this funny whilst others might find it plain offensive. No Facebook chain message is going to be able to deal with the complexities of when and how to use humour in the face of a potentially devastating diagnosis.

So there is some thoughts to be going on with. I may or may not add to them as time goes on. In the meantime, if you'd like to do your bit, you could always donate a few pennies here. Meanwhile, for information on how to check your breasts, try this Breakthrough Breast Cancer page.

Hxxx

Homeopathic Harms 3.1 Addendum: C's Story

Imagine you're twelve years old.

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


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


What's this got to do with homeopathy?

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

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

C's story

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

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

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

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

C was:

  • not allowed to stay at school for lunchtime, but instead had to go home.

  • not allowed to stay at school after the school day had finished.

  • not allowed to cross the local footbridge over the motorway, which cut him off from the majority of his peers.

  • not allowed to go down the street of the one classmate who lived on his side of the motorway.

  • allowed and encouraged to socialise with one boy who was two years his junior.

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

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

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

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

Limitations

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

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

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


Thankyou to C
 

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


H xxx

I ain't afraid of no ghosts... oh hang on.

"Girls, come over here. You'll be safe from the evil spirit on this side of the vault. A lady came in today and blessed it- you can see how she left healing flowers as part of the ritual."

This sentence would appear at first glance to be the sort of thing that would send me into an apoplectic rage. There is so much woo encapsulated in that one little sentence: ghosts (which don't exist), sexism (the men were left on the un-blessed side), god (who doesn't exist) healing flowers (medicinal woo) and rituals (spiritual nonsense which makes no difference). 

However, standing in the pitch black, musty cold of one of Edinburgh's vaults, clinging onto my friend Hesther and a complete stranger for dear life, I found myself repeating in my head 'its alright, I'm safe. A lady has been in and blessed it. Nothing bad is going to happen' over and over again in a desperate and unsuccessful bid to stave off hysteria.

This was just over a year ago. Every year, my friends and I take a trip over the border to take in the Edinburgh Fringe Festival. In amongst the sight-seeing, drinking, burning of the candle at both ends, and stand-up comedy binging, we always tend to do something ghostie-related. Edinburgh is a very charismatically historical and spooky city. The first year, we went to Mary King's Close, then last year was a vaults tour. Each time, I have shown myself up as a pathetic, borderline hysterical scaredy-cat.

In another vault during last year's tour, we were told how a coven of Wiccan witches had tried to use a particular vault as a meeting room (I suspect meeting room isn't the correct terminology, to be honest, but never mind.). They had moved some stones to form a protective circle in the middle of the vault, but found that terrible things happened when they were inside the circle, including the appearance of a terrifying, animalistic evil demon which trapped them in the vault, stalking the corridor murderously so they couldn't get out. The tour guide very dramatically informed us of how no one had set foot inside the circle in her presence, but how she would leave us alone for a while and we could do so if we wished, before swooping out theatrically. Now, you and I know that this was just a room, and a tourist putting a toe into a circle of inert stones is not going to make a non-existent demon turn up.

However, as one chap went to put his foot within the circle, an inhuman sound emanated from the corner of the vault. It could only be described as a guttural shriek, and went something like:

"DONTEVENFUCKINGDAREORIWILLKILLYOUWITHMYBAREHANDS"

Something like that, anyway. I can't quire remember the exact words I used. Here I was, an atheist who believes firmly in science, screeching violent threats at a complete stranger all because he had moved his foot vaguely in the direction of the stone circle. I was, to say the least, utterly terrified, and it was only after a good few vodkas in the bar afterwards that I started to calm down.

But this was before I started to get really interested and involved in skepticism. I've since found myself being a whole lot more rational about many aspects of my life, and applying skeptical principles, critical thinking, and rationality has become a lot more second nature to me. This year's tour, which took in some supposedly more active vaults, as well as a graveyard and mausoleum, home of Edinburgh's most active and evil poltergeist, would be a breeze. After all, I would be able to calmly rationalise all aspects of it and see it for what it really is: pure entertainment. Skeptical pharmacist extraordinaire that I am, I would be serenely smirking at all of my friends and the rest of the tour group as they clung onto one another and shrieked.

Umm, well...

As it happened, I was marginally less hysterical than last time. I would love to say that this was due to my skepticism, but in actual fact is due to the fact that there was a bigger group of people, the tour guide was more comedic than dramatic, and that I had imbibed some gin beforehand.  But I do mean marginally. I was still clinging onto whoever was near me for comfort, (whimpering "don't leave me, please don't leave me"). I used up the last vestiges of my phone's battery for light because I was so terrified of the darkness. In the graveyard, I was telling myself that ghosts were less powerful in the open air, rather than that ghosts do not exist. In the mausoleum, I consoled myself with the fact that the Mackenzie poltergeist would probably like me because I'm an atheist and not a catholic, rather than that it is merely a tall tale made up to appease tourists and that there was a perfectly rational explanation for everything. Barely a rational thought crossed my mind for the whole sodding one and a half hours of the tour.  

It would seem then, based on this n=1 social experiment, that one is perfectly able to be paralyzingly frightened of something that you don't believe in, given the right circumstances. In the dark, having to listen to stories of ghostly hands grabbing at ankles, i can confirm that there is a minority part of my brain that not only takes over the rational, skeptical majority, but beats it into a pulpy submission then stamps on it repeatedly.

Hxxx

P.S. Spirits almost definitely did have something to do with the fact that I randomly fell over just before the tour even started.

 

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

Nelson's: Suggesting that your kids need mood stabilisers from two years old.

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

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

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

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

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

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

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

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

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


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

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

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

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

Icky, right?

Hxxx

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

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

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


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

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

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

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

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

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


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

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

Hxxx