critical thinking

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. 

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

 

"I do my own research"

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

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

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

Even in the last two weeks, I've been revisiting my critical appraisal skills to make sure they are up to date. I've done some in-house work, three on-line courses, and a one to one training session. Yet I still find myself sat here at my desk for several hours, if not days, looking over the same study with a furrowed brow, desperately trying to make the numbers and statistics tell me their story.  If I find it so hard, then how on earth is someone without any medical background or critical appraisal training supposed to do any of it? 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hxxx

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

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

When real science gets left out in the Coldzyme

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

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

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

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

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

Medicine vs. Medical Device

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

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

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

The Evidence

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

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

The practicalities

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

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

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

To Summarise

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

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

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

Hxxx


A Miracle Migraine Machine?

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

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

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

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


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

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

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

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

There was no significant difference in severity of migraine.

Although some of the results in this trial are encouraging, it is limited by its very small size. It is worth noting that the authors and manufacturers claim that this trial proves that the product is effective at preventing migraine, despite the lack of a significant between-group difference in the primary outcome of migraine days.
Other papers have been published in the literature regarding this product, and the manufacturers try their best on their website to make them look like they are real trials. However, these range from letters, conference abstracts, experiments in healthy adults, and case studies- not robust clinical trials.

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

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

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

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

Hxxx
 

Why it's okay to question a charitable cause

I wrote last year about how I dislike Facebook “Games” that “Raise cancer awareness” in a vague and most probably pretty useless manner.



There’s another one doing the rounds – that of taking selfies without makeup on the raise awareness of cancer. The specifics of where it arose are shadowy and exceptionally vague. Some people state that it is for breast cancer awareness, some just for cancer.



It actually seems to have arisen from a well-meaning but very misguided campaign by some friends of a girl who recently hit the headlines after dying from cervical cancer – yet not one selfie post which I have seen mentions this particular type of cancer.



This appears completely random. There’s no connection between wearing makeup and “being aware” of breast cancer. The posts do not on the whole give information and advice on how to check your breasts for signs or what symptoms to look out for.



I’ve questioned it on Facebook, as have others. The response has been… defensive. Of course people who are posting selfies and who are supporting them are doing so in good faith, and I have no problem with this. What I do have a problem with is the vagueness of these campaigns, of the fact that adding “for cancer” on the end of any old nonsense seems to be a code for “Do not question this or else everyone will think that you’re a meanie and will get all offended with you.” This leads us down a dangerous path, which in rare cases leads to real, tangible harm. Those cases - though rare - should be enough to make us stop for a moment and question.


I drew a little cartoon to explain this. I’d like to point out that it’s generalised, and simplified, and is no way aimed at well meaning people who take part in potentially questionable campaigns. Its just the process that I go through, and what many other people do, and I would love it if more and more people understood it, and why it is perfectly okay to question any charity campaign.

Scenario One:
 

Scenario Two:

A healthy dose of skepticism can make any campaign worth its salt even stronger in the end. Being open and honest when questioned only serves to strengthen a cause. Defensiveness doesn't help anyone.

Hxxx

Postscript: This selfie craze ended up making a lot of money for breast cancer charities, which is great. No one has ever denied that making money for charities is wonderful. I'd argue that donations started for this- as well as the ALS ice bucket challenge that followed- not instead of, but because of, healthy skepticism about the purpose of the craze. 

A comparison between medical and homeopathic information sources

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

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

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

Up To Date?

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

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

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

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

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

Political Correctness

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

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

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

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

Clarity

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

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

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

In Conclusion

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

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

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

 

Evidence-Based Ambridge

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

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

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

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

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

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

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

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

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

And as for herbal arnica? there's also no evidence that it works, although there is a little bit of prior plausibility, in that some of the chemicals in the arnica plant have an anti-inflammatory and anti-platelet action. There is, however, no information on how clinically significant these actions are, and whether rubbing a bit of cream into an area would get these potentially useful chemicals to the right place in any meaningful amounts.

Let's not forget that bruises are self-limiting. They go away of their own accord (and probably at the same pace), regardless of whether or not you rub some gunk into them. herbal arnica isn't risk free: the cream can cause  contact itchiness, dry skin, and rash. Orally, arnica can be pretty nasty stuff, even causing coma and death in extreme cases. 

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

Blowing a raspberry

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

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

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

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

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

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

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

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

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

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

Do you step through the door? 

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

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

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

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

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

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

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

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

Hxxx


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

Is Gareth Bale worth more than eradicating malaria?

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

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

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

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

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

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

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

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

  • £10= 150 mosquito nets


 

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

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

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

    • 17,060,000/1000= 17,060

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


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

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

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

Hxxx

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

Self Selecting P-meds: searching for the evidence

The other week, the lovely folks at The Pharmacy Show Community (they are really lovely, my flattery of them is nothing whatsoever to do with the fact that they are linking to and publishing bits of my blog) held a tweet chat all about the self-selection of P meds, led by the mysterious and always entertaining @MrDispenser.

There are a few concerns that I- and it seems many other pharmacists share about the self-selection of P-meds. I've covered some of my concerns here, but the tweet chat threw up many others too. Other pharmacists have also shared their concerns, and you can find some of them in the links below:

Right now I want to look at the evidence that self-selection works. The theory is that allowing patients to choose their own medicines leads to greater adherence. As the patient feels they have more ownership over their healthcare decisions, they might use the drugs more effectively for a better outcome. But is there any cold, hard evidence that this is the case when it comes to over the counter medicines? 

As a skeptic, the words "Where's the evidence?" are often found escaping from my mouth. Sometimes the need for evidence is countered by the risk averse pharmacist side of me, where the theoretical likelihood of a risk outweighs the need for evidence. As with all things in healthcare, a balance needs to be taken into account: what are the risks vs what are the benefits?  In this case of self selection, I can see there being a real risk of fatalities. Any evidence of benefit to patients needs to be robust in order to outweigh the risks, in my opinion.

So I've made a start by looking at Embase and Medline. I've also had a look at NHS Evidence and have even googled. And I've been able to find very, very little on the subject. I found one Dutch paper about self-selection in the pharmacy, but that has no abstract.

I found this World Self-Medication Industry website which states:

"A study done in the United Kingdom showed that consumers welcome the opportunity to self-select medicines in that country's pharmacy class. Three out of four of the British consumers in the study felt that re-configured pharmacies with easier access to non-prescription medicines was a good idea, half because it would save their own time or that of their doctor, and the remainder because it offered greater choice."

But this doesn't appear to be referenced, so I can't find the study to see how reliable it is.

Have I missed anything? If you're aware of any evidence for the efficacy of self-selection of P-meds, please do let me know by dropping me an e-mail at healthydoseofskepticism@gmail.com. I would be particularly interested in any evidence that could be provided by the GPhC, and might drop them a line to see what they have to say on the matter. 

In contrast, I stumbled across a study from New Zealand, which concludes that, when purchasing a pharmacy medicine for the first time, in 62.2% of cases the sale was influence by pharmacy staff. This study has its limitations of course, but if true (and from my personal experience of many years of community pharmacy work it would appear about right), it would seem a shame to eliminate this from the medicines buying experience. 

There is also some evidence that patients who approach the pharmacy counter with a specific product in mind are given poorer advice than those who ask for a recommendation based on their symptoms- again something I have experienced both as a pharmacist and a customer. 

Of course patients can still ask for the expertise of pharmacy staff, but how many of them will know to ask, and how many will simply pick the nearest thing and hope for the best?

I'm going to hopefully write another post about my concerns about how the patient experience will be affected. If you have any thoughts on this, again do get in touch. If you're a customer in a pharmacy, I would love to know whether you think self-selection of Over-The-Counter medicines would be good for you. 

The Society of Homeopaths and what they pass off as evidence

So today has seen some great news for rationality, science, and above all patients. The ASA has announced this ruling, leading to the Society of Homepaths taking down a rather large chunk of their website- the bit about what homeopathy can be used for.

However, using their search function, you can still find some of the nonsense they are promoting. I stumbled across this article, for example, entitled "Homeopathy Offers Alternative Relief for hay fever sufferers". I'd be very surprised if this article doesn't get taken down soon also, to be honest. It really should, given part of the ASA's ruling relates to their claims over the efficacy of homeopathy for hay fever. 

That use of the word alternative (as opposed to complementary) is interesting. That in itself suggests that the Society of Homeopaths are advocating patients not using conventional medicines in favour of their homeopathic products.

One thing that I have learnt about homeopaths is that, despite the fact that they often claim that randomised controlled trials (and indeed science in general) can't explain their wondrous treatment because of its individualised nature and quantum nanoparticles blah blah all the other words that they're clinging onto, they like to cite trials. A lot.

Homeopaths will often spout names of trials and provide links to PubMed abstracts with abandon, even when the trials say little about the clinical use of homeopathy in humans. In vitro or animal trials are favourites, and on the odd occasion where I have been sent a human trial, the result usually show that homeopathy is no better than placebo, and in some cases actually worse than placebo. At best, I'm guessing this is just ignorance- maybe they have misread the results of the trial? At worst (and more realistically), its a pretty obvious and petty method of obfuscation, and a pretty rubbish one at that. Presumably they think I will be so vowed by the fact that a trial exists that I wont bother to check the actual results of what the trial is saying.

This hayfever page overs a great example of this:

"A number of research trials have shown that homeopathic treatment can produce a significant improvement in hay fever symptoms,(4-7) but what does this involve?"

 Let's have a look at the "number of research trials", shall we?  

  • Reilly DT, Taylor MA, McSharry C, Aitchison T. Is homeopathy a placebo response?  Controlled trial of homeopathic potency, with pollen in hayfever as a model. Lancet,1986;2: 881-6.

This is a trial from 1986. Really, that's the best they can do, in 2013? The abstract of this trial appears impressive: "The homoeopathically treated patients showed a significant reduction in patient and doctor assessed symptom scores", but neglects to mention the most important part of a study like this: blinding. How can we assess the placebo effect in a study that isn't blinded? especially when the results rely on only reported outcomes. We can tick this one off the list as being a pretty rubbish effort at a trial. Must try harder. 

  •  Kleijnen J, Knipschild P, ter Riet G. Clinical trials of Homeopathy. Br Med J, 1991; 302:316-22.

Ahh, the early nineties. We're getting thoroughly modern and hip now, eh? This is a meta-analysis. hay fever isn't mentioned in the abstract at all, and the conclusion of the paper is that studies performed in homeopathy are rubbish, and better ones need to be done. Hardly a conclusive statement that homeopathy works for hay fever. We can tick this one off the list too.

We're now left with two trials to back up that statement above. To me, two trials is not "a number" of trials, even at this point. Even if these two trials were massive, robust, good quality randomised controlled trials, I still wouldn't be entirely convinced: I'd want to see the result replicated in as many different trials as possible. Anyway, we shalll soldier on, in the hopes of being dazzled by the brilliance of these two references. 

  • Launsø L, Kimby CK, Henningsen I, Fønnebø V. An exploratory retrospective study of people suffering from hypersensitivity illness who attend medical or classical homeopathic treatment. Homeopathy, 2006; 95: 73-80.

Oh dear. A retrospective study. So not a controlled trial at all then? The results? "The two groups of patients were similar in respect of their health at the start of the treatment, 57% of the patients who consulted a CH experienced an improvement of their state of health compared to 24% of the GP patients." well, that's all very well and good, but there is no blinding here whatsoever, and only 88 patients completed the study. means nothing at all, except for- as even the authors put it- as an exploratory study, maybe to try to find ways of how to conduct as more robust actual trial in the future.

That's it, down to the final trial. I'm expecting great things.  

  • Kim LS, Riedlinger JE, Baldwin CM, Hilli L, Khalsa SV, Messer SA, Waters RF. Treatment of Seasonal Allergic Rhinitis Using Homeopathic Preparation of Common Allergens in the Southwest Region of the US: A Randomized, Controlled Clinical Trial. Ann Pharmacother, 2005; 39(4): 617-24.

HURRAH!!! It's double-blind! We've gotten there! We've gotten some good, robust evidence tha- oh hang on, its only got 40 participants in it. It's just a wee ickle study that's far too small to draw any conclusions from.

So there you have it. This page is still up there on their website, using crappy references that don't back up their claims. The Society of Homeopaths- and quacks in general- need to realise that, no matter how hard they try, just trying to shoehorn poor excuses for studies in wherever they like isn't good enough.

Here's how it should go: you look at the evidence, you evaluate the evidence, and you make your claim on the basis of that evidence. Not: "I shall claim this, then try desperately to find something that vaguely looks like it backs me up, and I'll just hope for the best that no-one else bothers reading it. It seems the Society of Homeopaths are going in for the latter, and good on the ASA for pulling them up on it.

"We told the Society of Homeopaths not to discourage essential treatment for conditions for which medical supervision should be sought, including offering specific advice on or treatment for such conditions. We also told them not to make health claims for homeopathy unless they held sufficiently robust evidence of efficacy." -ASA ruling


Hxxx

Antidepressants in pregnancy

This morning BBC News are running with this rather terrifying looking story about the dangers of antidepressants in pregnancy. This is an area that I deal with pretty commonly, so I thought you may be interested in my assessment of the situation. 

First thing to note: things can go wrong in even a normal, healthy pregnancy. There is always a risk of malformations or miscarriage, and unfortunately these things can happen for reasons that we dont understand. The risks are usually low, but are increased by things like increased age, obesity, illnesses etc.

One of those illnesses can be uncontrolled depression. "But how can feeling a bit sad harm an unborn baby?" I hear you ask. Well firstly, depression can be a very serious illness which should be taken seriously. It may even be terminal. Pregnancy is a time of massive changes, and as a consequence is a high risk time where someone's mental health can destabilise. If you have depression, you may not be looking after yourself properly: you might not be eating well, you might be avoiding exercise etc. In the worst, most tragic cases, suicide attempts might happen. We don't have enough data to put figures on how much of an increase in risk this all adds up to, but we do know that it can increase risks in a pregnancy if not sufficiently controlled.

Of course, this doesn't even take into account the more nebulous risks to both the child and mother- how will having a depressed mum impact psychologically on the child, how will the bond be affected, and what are the long term effects of this?  

So what of the SSRIs, the most commonly used type of antidepressants in pregnancy? Looking at the risk of cardiac malformations,, the BBC article claims that:

"Currently, prescription guidelines for doctors only warn specifically against taking the SSRI, paroxetine, in early pregnancy."

 It used to be the case that we were aware of the possibility of a cardiac malformation risk with paroxetine. Up until, oh, about 2010, when a large review was published whichsuggested that the increase in risk, if it exists, may be a class effect. The UK Teratology Information Service's Guidance was changed accordingly to be more practical, to remove a heirachy of one particular SSRI, and to make the drug of choice that which is the best for the individual patient (please note that UKTIS are a service for healthcare professionals only, and pateints should not ring them directly). The fact that NICE guidelines haven't yet been updated probably says more about NICE's workload and update schedule than any evil big pharma cover up. 

As an aside, you will notice that there are a lot of words in this post which suggest uncertainty. That is because there is a lot of uncertainty in teratology: because we cant do large robust trials on pregnant women because of ethical concerns, we have to scrape together what we can and make the best of it. There are few certainties in this area.

Strange then, that the BBC are quoting a Prof Pilling from NICE:

"He says the risk of any baby being born with a heart defect is around two in 100; but the evidence suggests if the mother took an SSRI in early pregnancy that risk increases to around four in 100."

I'd love to know where these figures came from. The current status of data on the risks of SSRIs is pregnancy is as follows:

  • There is lots of data, which has had various statistical analysis methods applied to it. 

  • Some of this data suggests no increase in risk

  • Some of it suggests a small increase in risk.

So, with some data saying there isn't an increase and with some saying there is, it is virtually impossible to say for certain if there is an increase. The only thing we can say for certain at this point is that we can't say anything for certain. But given that we have lots of data, and SSRIs are commonly taken in pregnancy, I think we can say that if there is a large increase in risk, we would have known about it by now. So any increase in risk, if it is there, will be low.

Of course the BBC are reporting the relative risk, which sounds more impressive: a doubled risk sounds much more sensational than a small absolute risk. But I'm not even sure where this figure has come from, given the conflicting state of the evidence at the moment. Needless to say, research is oretty much constantly ongoing. 

All of this is a very long winded way of saying: we dont know at the moment. But the fact that we don't know, in the face of how commonly used these drugs are in pregnancy, could be seen as reassuring.

As with all things in healthcare, this is a balance. A balance between the risks of uncontrolled depression and destabilising a mother's mental health during pregnancy, compared with the -as yet unknown but likely to be small- risks of SSRI antidepressants. Of course some women with minor depression might be taking antidepressants unnecessarily, but in cases where it is required, we need to look at the bigger picture. Just focusing on a drug's teratogenic potential is not enough: we need to consider the teratogenic potential of the illness itself, and the impact on everyone's lives that might happen if treatment is withheld. 


The bottom line is, if women are thinking of becoming pregnant or are already pregnant whilst taking an SSRI, and they are worried, they shouldn't stop it of their own accord, but should make an appointment with their GP to have a discussion about their concerns. 

Hxxx

UPDATE: I've been thinking about this 4 in 100 figure for cardiac malformations, and last night tried to find the reference source from it.

I've tweeted @bbcpanorama asking to know where this figure has come from, as have a few others. I've also tweeted @shelleyjofre, the journalist who has mad ethe programme, and have been met with a stony silence. This is really unfortunate, given that to be able to deal effectively with any enquiries from patients relating to this programme, I -and all the other health care professionals dealing with worried mums to be- need to be able to see and appraise the evidence for ourselves.

I have managed to find this document from the MHRA, which does mention a 4 in 100 figure. However, I sincerely hope that this isn't the source in question, given that:

  • The document refers to paroxetine alone, not the whole class of SSRIs

  • There is no date on the document, meaning we have no way of knowing how up to date these figures are.

  • the 4 in 100 figure cited refers to the risk of ALL malformations, not just cardiac ones.

  • the risk cited for cardiac malformations is 2 in 100. Half that which the BBC and Professor Pilling are quoting.

  • The background risk of all malformations cited is 3 in 100, and the background rate of cardiac malformations is 1 in 100. So yes, the relative risk is doubled, but the overal risk remains very low. 

As I say, I really do hope that this isn't the source, and that @bbpanorama or @shelleyjofre are able to provide me with the reference soon.  

Needless to say, I never heard back.

 

My Fantasy Pharmacy

People are allowed fantasy football teams, so why shouldn't I be allowed my own little fantasy pharmacy?

Now people, I want you to contribute to this post. So let me know if I haven't included your desert Island drug and why you think my pharmacy should stock it, and I shall put it on the shelves if I deem it worthy. Tweet me @SparkleWildfire, leave a comment, or drop me an email at inthecityofthefuture@gmail.com. I'm going to start off small with this post, and add to it gradually.

With all this talk of pharmacy as a quack trade, and the lack of evidence base for many OTC products, my pharmacy is going to have the bare minimum. Only the drugs I want to sell, ad that I think are necessary, with none of the extraneous, shiny combination packs that are purely there for profit. 

So, welcome into my emporium of evidence-base, and help yourself to some expert advice, a healthy dose of skepticism, and a pinch of thriftiness.

Shelf One: Pain Relief

  • Paracetamol: because it is an effective painkiller and antipyretic with few side effects. 
  • Ibuprofen: again, an effective painkiller and antipyretic. Needs more caution because of side effects, but still useful to have over the counter.
  • Sumatriptan: a good shout, thanks for your comment, Joanne. This is actually a really useful product to have OTC, in my opinion- its for migraines, so its great for regular sufferers to have easy access to if they don't have their usual meds to hand. But it does needs to be sold very carefully, with good questioning and counselling. 

Shelf Two: Coughs and Colds

  • Sudafed: just the plain old pseudoephedrine variety. Its the most effective decongestant over the counter (phenylephrine has much less of an effect orally) and can be combined with paracetamol or ibuprofen if there is pain associated with blocked sinuses.
  • Lemons and Honey: for combining with hot water for soothing throats and coughs. About as effective as any other cough mixture.
  • Glycerin, Lemon and Honey Mixture: as above, but ready made for when you don't have access to a kettle. Also: its quite delicious. 
  • I would include a night time product too, but I'm not sure which one yet. I don't want to include Night Nurse because its got far too many ingredients in it, and no one should have to take medicines they don't need. My product would just have diphenhydramine and paracetamol in it, probably, just something to help you sleep when you have that awful achey can't breathe feeling that comes with colds. 
  • Menthol crystals: for adding to steam inhalations. Inhaling the vapours of a  couple of those bad boys in boiling water will have your mucus cowering and crying in a corner. 
  • Xylometazoline nasal spray: an option for people with bad congestion who can't take pseudoephedrine.
  • Pholcodine cough medicine: As voted for by Kev. Its cheap enough, and acts to suppress a dry, tickly cough. Shouldn't be used in chesty coughs though. 

Shelf Three: Ear problems

  • Olive oil: there is no reason whatsoever for any of the other products to exist. Plain old cheap olive oil will do the job just as well as anything else.
  • Dropper: for administering the olive oil. 

Shelf Four: Allergies

  • Generic beclomethasone nasal spray: cheap, works if used in advance of the hayfever season.
  • Antihistamine tablets (generic): Chlorphenamine, loratadine, and cetirizine. Exactly the same as the hugely expensive branded varieties. chlorphenamine can cause drowsiness, the other two tend to be much of a muchness- some people find one works for them, some the other.
  • Cheap anti-allergy eye drops: great for people that have predominantly eye symptoms. 

  •  

That's a little start, and I shall add to it when I think of anything else or get a chance.

Hxxx