Allergy Relievers: Red Light Nonsense

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

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

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

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

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

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

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

Hxxx

Medical and Homeopathic information sources: A comparison

My friend Nancy and I are doing another Skeptics In The Pub talk this Thursday, and as a result, 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. http://homeoint.org/books/kentrep/kentpref.htm. 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.  

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. 

Postscript: Homeopathic Harms 3.1: C's Story

Imagine you're twelve years old.

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


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


What's this got to do with homeopathy?

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

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

C's story

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

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

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

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

C was:

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

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

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

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

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

Limitations

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

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

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

Thankyou to C

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


H xxx

Nelsons- suggesting kids need mood stabilisers from 2 years+

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

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

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

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

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

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

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

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

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

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

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

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

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

Icky, right?

Hxxx

The Society of Homeopaths and what passes for 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 little 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

Making Clinical Trials Sexy

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

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

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

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

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

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

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

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

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

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

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

Hxxx

The Magic Blankie

When its cold and dark outside, I like nothing more than snuggling on the sofa under my blanket with a good book or a film. Some would even say its medicinal. No, really, they would. They'd go on to claim that its excellent for treating chronic diseases and that everyone should have a Magic Blankie of their very own at home.

Enter the healing blanket TMB-01, which stands for Treatment Multilayer Blanket. I prefer The Magic Blankie, though to be honest. Or Truly Mad Bollocks, that would also work. I love how they think also assigning it a number will make it more scientific sounding. Mind you, coming from SCENAR (Self-Controlled Energo Neuro Adaptive Regulation), we can be fairly confident that they have a robust, experienced Department Of Shoehorning Random And Sceince-y Words Into Acronyms (DoSRASWIA) on the case.

NO Kermit! Don't you know that by saying bye bye blankie you are denying yourself the health benefits of Magic Russian Technology?!

They're all the rage in Russia apparently. And I suppose, given how cold their winters are, it's only natural that every household would have a cosy blanket lying around. At only $325 a pop, why wouldn't you?

So what can the healing blanket actually heal? Lets see what Scenar have to say about it:

"The healing blanket TMB-01 can be combined with other therapies for a treatment of a wide range of diseases as well as stand alone independent treatment for psycho-emotional regulation, insomnia, stress and reduction of muscular spasm. The TMB blanket also helps to regulate psychosomatic conditions, relieves constant tiredness, and improves feelings of well being."

Insomnia, stress, tiredness, psycho-emotional stuff. Well we all have problems with those, don't we. Lets have a look at how we should use the blanket: 

"Maximum effects are achieved when the patient is wrapped completely and sleeps... One procedure takes around 40 minutes and could be repeated 2 – 3 times a day. The course of treatment is between 15 – 20 days 9 up to 1 – 3 procedures a day)".

Right, so to make yourself feel less sleepy, or to stop insomnia, what you should do is get cosy in your Blankie and sleep. Yep, seems perfectly plausible to me that the effects on conditions caused by lack of sleep are purely down to the blanket itself and nothing to do with sleeping, or just having a bit of a relax. Although frankly, having a 40 minute nap three times a day for 20 days is unlikely to help my stress levels as I'd have time to get sod all done in the rest of the day. 

How is The Magic Blankie supposed to work? Similarly to a tin foil hat, it would seem. It's made of layers of metal, which apparently shields the body from all external electromagnetic fields and radiation. Except, presumably, your head, which you'd probably not be covering with the blanket to avoid the minor inconvenience of suffocating. Its a reverse tin foil hat, I suppose.

"No, no its fine. We don't care if any electromagnetic evil rays of death  get into their angelic little heads,. It's not like there's any useful organs in there that might need protection. What's a brain ever done for us?"- SCENAR Department of Making Excuses (DoME) Spokesperson. Probably. 

Physicists, forgive me if I'm wrong here, but aren't there some forms of electromagnetic radiation that even several feet of lead won't stop? But those clever Russians have found a way to stop all of it. Makes you wonder why X-ray departments aren't simply tents made of these blankets held up with curtain poles. They could be renamed X-ray dens.  

Anyway, what about evidence? There is some, of course. It's just been blown away by the electromagnetic fields of reality.

Hxxx

P.S.I hope the sarcasm is clear enough in this post. Don't want to end up with quotes being used as testimonials or anything. "AT $325 A POP, WHY WOULDN'T YOU?"- H-Jo, Skeptic Pharmacist 

Wake up and smell the (green) coffee

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

Of course you know where this story is from. But its also being advertised in stories in glossy magazines and other newspapers too.

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

Coffee beans. Just more green than usual ones.

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

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

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

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

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

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

Hxxx

Homeopathic Harms Vol 6: Self-awareness & self-criticism

This post is a taster of the the next in our series of blogposts following on from our SITP talk about the harms of homeopathy It's written by the marvellous @Skanky_fish

You can find the full blog post over at her blog, Evidence-Based Skepticism

One of the most important mechanisms that people have for regulating their own behaviour is feedback from other people.  This happens from the day we’re born – babies learn that some behaviours earn a smile so they repeat them; toddlers learn that other behaviours get attention, so they repeat them.  As adults we do exactly the same thing – we learn behaviours that make us successful friends, partners or parents based on how people react to us.


This carries over into professional life too, and in some professions is even put into words as codes of conduct, or ethics.  We learn what is and is not acceptable by seeing how people respond to our actions.

Homeopathic Harms Vol 5: Interactions

In February 2013, my friend Nancy and I delivered a Newcastle Skeptics in the Pub talk entitled Homeopathy: Where's The Harm? As a follow up to this, we've decided to write a series of blog posts about a number of points we covered in the talk: 

In the next installment of our series on the harms of homeopathy, I want to talk about interactions. I've covered this a bit in the past, but let's have a look at this area in a bit more detail.

We all hopefully know by now that homeopathic medicines pretty much have no trace of active ingredient in them by now. Do we need to worry about drug interactions with homeopathic remedies?

Can homeopathic medicines interact with conventional medicines?
The obvious answer is no. Magic Sugar Water Pills are highly unlikely to affect any conventional medicines. There's a lack of actual evidence to prove this, but I think it's pretty safe to rely on a theoretical basis here. So that's great, right, blog post over and see you later. If only it were that simple.

Can homeopathic practitioners interact with conventional medicines?
Unfortunately, yes. very much so. It's pretty well known that homeopathic practitioners step over (and in some cases stomp over, then jump up and down repeatedly on) the boundaries between conventional and homeopathic medicines, just by the advice they give. One example would be vaccines- many homeopathic practitioners are against vaccines and therefore advise their patients to avoid them- Just look at the emails sent by pharmacist (and embarrassment to the profession) Tony Pinkus to an undercover BBC reporter. Little offhand remarks about the toxicity of conventional medicines, or big pharma conspiracies, or how conventional medicines might not work, all add up to the effect of harming the patient's relationship with their actual doctor. And how about the spectacular example of inappropriate advice in my previous post?

Can conventional medicines interact with homeopathic medicines?
I'd like to say no here, because of course homeopathic medicines are inert and don't actually contain any medicine. It is the case, however, that homeopathic practitioners unfortunately think otherwise, which can lead to a huge amount of harm as patients discontinue their conventional medicine in favour of homeopathy.

I have in front of me a book called "Homeopathic Pharmacy", by Stephen Kayne. This is a book aimed at healthcare professionals, and indeed is a  recommended resource for medicines information pharmacists in the UK. And yet, even this source, which we could consider to be one of the more balanced tomes (despite the ominous mention of Dana Ullman in the acknowledgments), contains a wealth of dangerous nonsense. This book tells me that, for example, "potent topical steroids are thought to negate the use of  homeopathy in the treatment of eczema and psoriasis" Now I know more than some that skin conditions such as this can be horrifically uncomfortable, not to mention their effects on your self-esteem. Stopping treatment that works in favour of a placebo is not, in my opinion, acceptable in any shape or form, especially given how vulnerable and desperate people can be because of skin conditions- don't forget that in some cases, dermatological conditions are terminal, as they can drive sufferers to suicide. 

There can, apparently, be interactions between oral steroids and homeopathy too. "the patient's symptoms tend to be masked, however, making an accurate choice of remedy much more difficult", we are told on page 205 of Homeopathic Pharmacy. Well, you could call it a masking of symptoms, or you could- as I prefer, refer to it as "working". So what is the average homeopath to do then, when presented with a patient who is taking steroids but seeking their help? It would seem that the obvious (but sadly not the ethical) solution would be to ask them to discontinue their steroids so that that the symptoms are "unmasked". This will obviously lead to an increase in symptoms for the patient, and lead to unnecessary suffering, but it can also precipitate acute adrenocortical insufficiency, which can in the worst case scenario be fatal. Patients should "ideally" discontinue their steroids for 6 weeks prior to initiating a homeopathic remedy- this is more than enough time to result in loss of control in their condition. 

It's not just drugs themselves that can be a problem, but the excipients (inactive ingredients used in the formulation of a medicine) too. Strong flavours used in syrups, for example. This could potentially discourage patients to take- or to give their child- antibiotic syrups, with the potential to worsen or prolong a patient's condition.


Can foodstuffs interact with homeopathic medicines? 
Yes, apparently so, though again there is no hard study evidence for this- why would there be, when there's no good hard study evidence that homeopathy works in the first place? Coffee, tea, cocoa, chocolate, and spicy foods are all to be avoided. Aside from being unnecessarily restrictive, and potentially causing a patient anxiety, this idea fills me with horror. Imagine a life without tea, chocolate, or spicy foods. I rely on all of these three things to get me through my daily life, and would inevitably become depressed if I had to avoid any of them.

Can homeopathy interact with homeopathy?
I know, right? What a bizarre question, given that homeopathic remedies are sugar with specially shaken water sprinkled on. Can sugar interact with sugar? Well it seems that someone has decided that they can, based on a grand total of no evidence. Aromatic preparations, such as camphor, menthol, and peppermint, are supposed to inactivate other homeopathic medicines. Remember, though, that homeopathic camphor, menthol  or peppermint is highly unlikely to actually contain any molecules of camphor, menthol or peppermint, and we're left in a bit of a ridiculous situation based on nothing at all.

It would seem that homeopaths utilize certain foods or remedies as "antidotes". Apparently, if a remedy isn't working, and they want to try something else, they might ask a patient to drink a cup of coffee, or take a remedy like camphor to "wash out" the previous remedy so that they can start again. I'll refer you again to "Homopathic Pharmacy"- with a reminder that this is one of the more reasonable texts:

"It is certainly not dangerous in life-threatening terms, but used injudiciously will interfere with the vibrational pattern of the vital force.

Vital force, vibrational energy, sugar as an antidote to sugar, and none of it- not a scrap- based on science, evidence, or even basic logic.

See you again soon for the next episode :)

Hxxx

Homeopathic Harms Vol 3: Poor Advice

And so begins the third installment in our Homeopathic Harms series, a collaboration between myself and @Skanky_Fish of the Evidence Based Skepticism blog. For this post, I have my lovely, wonderful friend @shandymarbles to thank for the idea and the action. 

Indirect harms due to homeopathy can, as we're trying to cover in these posts, come in various different guises. In my opinion, there is none more dangerous than this: poor advice from homeopathic practitioners. 

To set yourself up as a homeopath in the UK, you don't need any medical background. You also don't need to register with any regulatory bodies or undergo any standardized training. Medical homeopaths, i.e. doctors who practice it on the side, are of course regulated by the GMC, but your common or garden variety homeopaths could basically be anyone.

And yet, they claim to practice medicine and give advice on your health. Scary stuff, in my eyes. And I can give you a specific example of how harmful this can be, because one of my good friends contacted a UK homeopath recently. This homeopath is, as is proudly declared on his website, an engineer by trade.

Under the pseudonym Stacey Slater (which apparently didn't appear to ring any alarm bells with the homeopath in question), my friend asked for help in treating bipolar disorder. She said she had stopped taking the medication prescribed for it because she was getting horrible side effects, and asked if there was anyway that homeopathic treatments could help her stay stable and avoid psychosis. There are a few things to note here: the question was very specifically asking if homeopathy could be used instead of conventional medicines, and was asking about avoiding psychosis- we're talking about serious symptoms here, not a vague sort of "could it help with me feeling a bit down" sort of question. The description of "horrible side effects" would immediately ring alarm bells to me- what sort of side effects, and how is she feeling at that time.

Here's the response I would have liked to have seen in a dream world filled with responsible homeopaths (actually, in my dream world there would be no homeopaths at all, but you know what I mean):

"Dear Stacey,

Thank you for your enquiry. I'm sorry that you've stopped talking your medication for bipolar disorder, and would like to advise you in the first place to speak to your GP first of all about the side effects you have been experiencing. You should also discuss with them your decision to discontinue your medicines, as stopping them suddenly may cause your symptoms to worsen.

Homeopathy may be a useful option to help treat some of your symptoms. However, I wouldn't recommend that it is used instead of your usual medicines, unless this is done with the agreement of your medical team. Once you have spoken to them, please do contact me again and I will be happy to discuss any homeopathic treatment with you then."

This response covers all bases. It makes sure that the primary outcome of patient safety is covered by referring them to their own healthcare provider, however its also helpful and leaves open the possibility of some homeopathic treatment as an adjunctive, complementary treatment. It does not suggest that homeopathy can be used instead of her usual medication.

Here, however, is the real-life response:

"To,
Dear Stacey Slater,
Yes I am happy to help you for your Bipolar Disorder and will try to restore your previous health. 

Recently, my grandmother has been treated for her 15 years long Bipolar disorder with only two weeks of homeopathic treatment. Now, my father-in law (Himself Medical Practishner) says she is 100% okay with homeopathic remedy and need not take any other medications.
To help you, I need some more information, like; your physical, mental and spiritual condition.
1. Any skin diseases are you suffering from?
2. Do you have problem of thyroid dysfunction? hyper or hypo?
3. Diabetes?
4.High or low blood pressure?
5. Since how long are you suffering from Bipolar disorder?
6. Your family history, if any one in your blood relation have tuberculosis, diabetes, cancer or high blood pressure?
7. Your liking and disliking? Food,Drink, time and weather
8. Your family life, etc..
Your detail will help me to prescribe best remedy.
Looking forward to your reply,"

There are a few things to note here, as I'm sure you can tell. This homeopath claims that they will "try to restore to previous health"- in other words, he is offering a cure to bipolar disorder. We've got some anecdotes in there, in lieu of actual clinical evidence, and an extraordinary claim that longstanding bipolar disorder can be cured with only two weeks of magic woo water therapy. Now, given that bipolar is, by its very nature (and name!) a relapsing-remitting disease of two extremes, there is no way that an anecdote could be used as evidence of successful treatment. Who’s to say his grandmother wasn't just going through a good period that just happened to coincide with taking a couple of week’s worth of homeopathic medicines. How do we know she wasn't using effective conventional medicines at the same time? Who's to say she even exists? I can't help but wonder about his grandmother's right to confidentiality as well- has she given consent to be used as an anecdote in his consultations with other patients?

Who is this father-in-law mentioned? If he is so happy with the treatment, why isn't he happy to be named, and why is he even commenting on the grandmother's treatment? What relevance does this have to this homeopath's practice? The advice given that she "need not take any other medications" is a clear indication that this homeopath thinks that the homeopathy he advises can be used to "cure" bipolar disorder on its own, as an alternative to conventional medicine. By trying to make it seem like the advice has come from an actual medical practitioner, the homeopath is clearly trying to give this advice more credibility.

Lets have a think about the consequences of this advice: Our Stacey Slater is reassured that she doesn't have to continue on with her conventional medicines. She responds to the email above, goes on to have a consultation with the homeopath online (which costs £50 by the way- we're not talking pennies here. £50 for an email exchange!) She slips into psychosis, or mania, or a deep, deep depression. Eventually, she can't take anymore and she commits suicide. This homeopath has directly contributed to her death by not advising that she sees her medical team before discontinuing her medicines, and by claiming that she can be cured by inert sugar pills instead of continuing on with effective, evidence-based medication

The problem is, we can't gather robust evidence on this sort of thing, as it would be too unethical to do good, clinical studies. Maybe Stacey hasn't mentioned to anyone that she stopped taking her medicines and she was under the "care" of a homeopath- how would anyone know that the death was caused by him? And even if they did know, they're probably too upset and shocked at that point in time to think about raising a complaint. Who would write up a case report to publish in the medical literature? Certainly not the homeopath in question, he's not going to incriminate himself, and her medical team have probably had little contact with her since she's been advised not to bother with them anymore. And so homeopaths can continue to claim that their treatment is "safe", because we just don't know the scale of these sorts of cases. 

The only bright side here is that, of course, my friend will most definitely not be taking this shoddy advice. She's well aware that homeopathy is a whole load of nonsense and just contacted this guy to see what the response would be. However, we have to wonder how many other emails he's getting, from people who are genuinely seeking help. And we have to wonder what's happening to them, and whether they are safe.As an interesting, and rather creepy, aside the homeopath started following my friend on Google plus and Twitter a couple of hours after responding to her. This is at best weird and unprofessional, and at worst, really quite frightening. I can't think of any healthcare professionals who would do such a thing, just randomly looking up a patient on social media and then following them after one consultation- what about confidentiality? 

Homeopathic Harms Vol 2: Where's The Evidence?

Here's the next in our series of blogposts following on from our SITP talk about the harms of homeopathy. This is a guest post written by the marvellous @Skanky_fish of Evidence-Based Skepticism fame. Now, I'm going to be a bit bossy here and insist that, if you haven't already bookmarked her blog, you do so right this minute. Future blogposts in this series will just be posted on our respective blogs, but we'll be sure to post links to all of them so you don't miss any installments. so, without further ado, I shall hand you over to Nancy:
 
We often harp on about the evidence for homeopathy working or otherwise, and I’m not going to touch on that here, because it’s been covered beautifully by many more eloquent writers than me.  What you don’t often see though, is comment on the evidence for homeopathy doing harm.  In the last post in this series the lovely @SparkleWildfire touched on medicalisation, an indirect harm that’s very real but tough to quantify; but what about direct harms?  I’m glad you asked…

In conventional medicine, randomised controlled trials are the best kind of study we can do of a drug to see if it works and if it it’s safe.  What maybe doesn’t mentioned quite so often is that there’s an even *better* form of evidence – the systematic review.  These are produced when someone sits down to do the very tough but remarkably important job of finding every single scrap of evidence they can on a given topic, and pooling it all together to try and get closer to the definitive answer.  The result is a document that represents the best evidence possible for how well a drug (or anything else, for that matter) works, and how safe it is.

One of the biggest and most respected sources of these systematic reviews is the Cochrane Collaboration, who cover all areas of medicine.  Happily, they also have a few reviews related to homeopathy, and that seems as good a place to start as any.  The most recently published is:

Homeopathic Oscillococcinum^® for preventing and treating influenza and influenza-like illness

The authors searched multiple databases of medical literature, covering a time period dating back to the mid-60s and all the way up until August 2012.  That’s a lot of literature.  Out of all the results they found six randomised, placebo-controlled trials of Oscillococcinum that were similar enough to be directly compared.  Since we’re not really interested in efficacy in this review, I’ll skip straight to the safety part: out of these six trials, including a total 1,523 people, there was one reported adverse event.  One. It happened to be a headache. Let’s stop and think about that for a moment.

A good quality randomised controlled trial collects every single adverse event that happens to every single patient.  And the use of the term “adverse event” is very deliberate, because it includes absolutely everything unexpected and unwelcome that happens (and here’s the key part) whether or not it’s likely to be related to taking the drug.  That might sound counter-intuitive, but the reason is simple – we want to pick up every possible side effect of drugs, and sometimes side effects are…weird.  So it might sound odd to include as an adverse event that someone got hit by a bus, but what if the drug they were taking made them dizzy, or confused, or clumsy?  It’s not unreasonable to suggest that any one of those things could end up in getting you involved in a traffic accident.  So every single little thing is recorded, and once the trials is over you do some sums to work out the key question – are these things *more likely to happen in the people who took the drug*? If 20 people broke a leg but they were equally spread out among the trial groups then nothing further needs to be said; if 19 of them were on the drug being studied then there might be something to worry about.  The flip side of that of course is that if 19 were in the placebo group, you might want to wonder if the drug is (perhaps unintentionally) promoting better balance and co-ordination, for example (or if everyone in the placebo group was a keen but inept snowboarder).

Is that one single adverse event out of over 1,500 people taking Oscillococcinum starting to look fishy yet?  What about if I drop in the snippet that some of the people involved (327, to be precise) took the remedy every day for four weeks, to see if it stopped them from getting flu in the first place?  How many times in four weeks would an average, healthy person experience something that you could call an adverse event – a headache, a tummy upset, indigestion, a strained ankle, a touch of insomnia?  I’ve had three of those things in the last 24 hours, and I wouldn’t say I’m a particularly remarkable individual.
So hopefully you can see from this that there’s simply a huge, yawning hole in the evidence about safety in homeopathy.  There are ways and means to address this (though they’re far from perfect), and I’ll address one of those in my next post in this series.

Homeopathic Harms Vol 1: Medicalisation

In February 2013, my friend Nancy and I delivered a Newcastle Skeptics in the Pub talk entitled Homeopathy: Where's The Harm? As a follow up to this, we've decided to write a series of blog posts about a number of points we covered in the talk. Here is the first:  

Doctor's appointments: often you feel like you're in and out before you know it, and they can't get you out the door quick enough. They have a target number of minutes to spend with each patient, and sometimes you can feel like they don't have as much time as you'd like to discuss all the things you want to with them.

There is, then, one aspect of homeopathic practice which can be superior to that of conventional medicine: the consultation. A homeopath might spend an hour or more assessing each individual, not just asking about particular symptoms but about their personality as well, how they think and feel about the world. I've never been to see a homeopath, but I'd imagine this is really valuable to a patient, particularly those with minor mental health complaints. I know myself that when I've been to see a good GP who I feel has really listened to me, I leave feeling a bit better already.

I suspect that the consultation itself may be part of what provides benefit to patients, rather than the sugar pills that are given out at the end of it. I'm not aware of any evidence that compared individualised homeopathic treatment to the OTC stuff though, which would be the only way to tease out and quantify any benefit from the consultation.

So what's the problem here? If a consultation with someone who appears to listen to you and care makes you feel better, where's the harm in that? The sort of subtle, indirect harms that we'll be discussing in this series of posts are often theoretical and would be very, very difficult to assess via hard, clinical evidence, so you'll have to bear with me while I discuss them with you and see if they make sense at the end of it. Consider the following story:

Imagine I'm quite an anxious person (in actual fact I am, so it doesn't take that much imagining to those who know me). Imagine I'm particularly anxious at the moment because I maybe have a public speaking event (something like Skeptics In The Pub, say!) to deliver in a few week's time. I might be finding it hard to sleep, I find I'm worrying about it quite often, and getting some physical symptoms- my heart is beating quite fast at times, say, and my stomach hurts at times, but it's nothing too serious.

I go to visit a homeopath (admittedly, this would be an unlikely thing to do if I was actually talking about myself) who takes time to discuss with me my problems. I get on well with them, and feel like they are really listening to me. During the discussion, I find that vocalising my anxieties helps me to rationalise them and my fears are allayed somewhat. Just the act of talking about it makes me feel better- in other words, the homeopath is delivering a talking therapy service to me. By the end of the consultation, I'm already feeling more in control of my anxieties, yet I'm still given some tablets to take home, and I dutifully follow the instructions I'm given.

As I've discussed elsewhere, there is a stigma about mental health issues. This also, unfortunately, extends to talking therapies too. Its quite likely that some people would be happier to declare "I'm seeing a homeopath" than "I'm seeing a counsellor" in front of their friends or acquaintances. The handing over of the sugar pills at the end of the consultation will no doubt suggest the talking bit is more "justified", and they can convince themselves that they're not mad, or the sort of weak person who would have to resort to a talking therapy. And thus, the stigma is reinforced. Talking therapies shouldn't be something to be ashamed of. You don't need some inert sugar pills to justify and hide the fact that, now and then, you just need to be able to talk to someone about your problems or feelings.

There are wider issues with this kind of thing too. The visit to the homeopath has made me feel better. I've been to see someone, left with some pills in my hand, and I've improved, reinforcing the fact that I feel better when given something to take. Let's say that in the next few months, I feel a bit rubbish because I've had a bit of a cold and I'm left with a cough that's been there for a couple of weeks. I go to see my Dr, who tells me that my chest is clear, and the cough should clear up of its own accord. However, I've expected to get something out of the visit- I don't want to leave the surgery with no pills in my hand, as I know that last time I left a consultation about my health I was given pills at the end of it and I felt better. It's left to the Dr to explain to me that I don't need antibiotics, and this can be a notoriously difficult thing to do. Some Drs might relent and give me a prescription for an antibiotic, contributing to the catastrophic situation we're in now with antibiotic resistance. If the Dr doesn't give me a prescription, I'm left with a bad taste in my mouth and a bit of mistrust in the conventional health care system. 'Next time I'm feeling ill', I think, 'I'll go back to that homeopath. They take me seriously because they gave me pills'.

And so the cycle goes on.... 

H Jo

Cherry-picking the evidence?

A good friend of mine is really into running, and has many half-marathons, kilomathons, and marathons under his belt (at least one of which was in a very hungover state). He is taking a sour cherry supplement, which has led to some heated debate about whether or not it works.

He eagerly googled, to bring up some small studies of the effects of sour cherry juice on pain after a marathon. More animated discussion took place. He seemed to think that the very existence of some studies meant that the stuff would definitely work:  So I thought this would be the perfect place to assess what evidence there is for sour cherry.

It would seem that there are several different types of cherry, sweet and sour. It is the sour, tart varieties which appear to be of interest in exercise products such as this. And these things are pretty expensive.

My first point: the evidence appears to be looking at juice, not tablets. There is nothing to say that any benefits you might get from a juice will also be present in a tablet- think of garlic, for example, where allicin, the active ingredient, is mainly lost during the processing required to make a garlic supplement.

My search strategy begins with my old friend Embase. eagerly, I find sour cherry in the database and search it, only to get 9 results. When I limit it to humans, I get 1 result, and that is assessing its effects on sleep quality, so is nothing to do with exercising.

And so, I move onto Medline, in which I find a grand total of 2 studies looking at the effects of sour cherry juice in recovery following exercise.

The first study has 20 recreational marathon runners in it, so its tiny, and far too small to be able to draw any reliable conclusions from. Whilst it seems to show some positive results, with significant reductions in isometric stress, inflammation, and oxidative stress, there is no indication of how relevant this is clinically.1. Would I actually feel better after a marathon as a result of this? Is this increase in recovery of muscle function actually going to make a difference?

The second study has a grand total of 14 male students in it. It's randomised and placebo controlled, but again, to small to be of any interest. This study found that strength loss and pain were reduced in the cherry group, but relaxed elbow angle and muscle tenderness were no different. 2

There are a couple of other little trials dotted here and there are well. But they're all too small to suggest that there is any definite effect. Moreover, there is no information on the safety of such products. Any trials only apply to cherry juice, and can't as yet be extrapolated to cherry supplements such as tablets or capsules.

Whilst the preliminary evidence looks juicy, it's certainly not enticing enough to tempt me to pop my marathon cherry.

I'll stick to my favourite types of cherries, if you don't mind, namely those that are steeped in sugar and  encased in pastry.

Search strategy:
Embase:*sour cherry [Limit to: humans]
Medline: (sour AND cherry).af OR (tart AND cherry).af [limit to: humans]
References: 
1. Howatson G et al. Influence of tart cherry juice on indices of recovery following marathon running. Scandinavian Journal of Medicine & Science in Sports, 12 2010, vol./is. 20/6(843-52), 0905-7188;1600-0838
2. Connolly D et al. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med 2006; 40: 679-683

Big Pharma & Big Homeo. Titans will clash, and ducks will die.

There has been much talk of homeopathy in the media in the past few days. I want to pick up on one point that is being brought up by homeopathy believers everywhere at the moment in response to any criticism.

"But Big Pharma has many problems! Just read Bad Pharma by Ben Goldacre!"

There are a few reasons why this is an utterly terrible argument.

The Logical Fallacy
This is not a two option scenario, so this is a false dilemma. homeopathic supporters are attempting to suggest that because Big Pharma has its problems, homeopathy is a better alternative. But here's the problem: These are not the only options in the world. Big Pharma does have massive, endemic problems, but that bears no resemblance to whether or not homeopathy works. Even if there were no evidence that any conventional medicine works ever, there still wouldn't be any evidence that homeopathy works either.

There's definitely an element of a "You too!" fallacy here as well. Big Pharma has its problems, but this is no reason to expect anything less than impeccable ethics from any other sector.

The Misleading Rustic Image
Homeopathic manufacturers would very much like us to have a fluffy, warm, reassuring image in our heads of some nice, compassionate people making a tincture from plants, shaking it in a special way, and making a nice, safe medicine from it. In actual fact, the image is rather more grubby, with diseased body parts, conventional medicines, and limbs being used in the manufacture. Oscillococciinum, supposedly the most popular homeopathic remedy for flu, involves killling a muscovy duck and using its heart and liver to produce a mother tincture. I wonder if folks who are against animal testing and the likes in the pharmaceutical industry are aware of this fact? For the purposes of this blog post, lets call our duck Dave.

A Muscovy Duck, who i have decided is called Dave.

Homeopathy is not usually made by ethical practitioners in their kitchens. And frankly, if it were, i'd be pretty concerned about hygeine etc and would be wanting inspectors to go round to check it. Its mainly made by large companies who are ultimately concerned with profits. In fact, until very recently, New Era homeopathic products (ooh, sounds all new agey and nice and hopeful, doesn't it?) were made by Merck (Sounds-and indeed is- a pretty damn large corporate pharmaceutical company).

We also know from the FDA that homeopathic manufacturers can be less than meticulous to say the least in their standards. Broken glass? That's not a problem, just leave it there on the production line, no one will mind. More info on this story can be found at The Quackometer

The Massive Mark Up Margins
Pharmaceutical companies spend a HUGE amount on research and development of new drugs. First they have to employ people to find a new chemical entity, whether that be in the rainforest or in the lab. Then they have to find out if it works, which involves a huge amount of lab work. If that seems postive, they then have to do trials, which is hugely expensive. At any of these stages, there is a huge likelihood of failure and it is a very, very small minority of new chemical entities that actually get through to a stage where they can be marketed. At that point, price margins can be pretty damn high, which is in part to cover all of those R&D costs. Yes, there are also huge profits that are made in the pharmaceutical industry, and there are all the associated problems covered in Bad Pharma. This is certainly not an ideal scenario, but at least at the end of the day we are left with some drugs that work.

Big Homeo, on the other hand, puts little-if any- funds into research and development. If it did, we would have a load more trials than we do now. The work in drug discovery has been done for them, by Hahnemann et al who have written Materia Medica and the likes. So not many outgoings there then.

What about the costs of the ingredients? Well sugar is cheap, as is water. And even if your mother tincture comes from a valuable substance, you can make a hell of a lot of homeopathic medicine from it. Here is the recipe for Boiron's Oscillococcinum (according to Wikipedia)

• Active ingredient: Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy Duck liver and heart) 200CK HPUS 1×10⁻⁴⁰⁰ g^[9]
• Inactive ingredient: 0.85 g sucrose, 0.15 g lactose (100% sugar.^[10])

So to make 1 gram of oscillococcinum, you only need 1×10⁻⁴⁰⁰g of extract of poor Dave's heart and liver. This is a ridiculously tiny amount, and as you will hopefully now know, there will be VERY VERY VERY little chance of any of Dave's molecules remaining in the resulting solution. 

I have no idea how much the heart and liver of Wor Duckie Dave would weigh. I also have no idea how much an extract made from him would cost. I'm guessing, however, that the number of packs of homeopathic pills I could make from his unfortunate organs would mean it is very, very lucrative, and I would be laughing all the way to the bank with my profits were I a company with few scruples about selling nonsense to vulnerable people.


The Pointlessness Of It All

Poor Dave. Dave has been killed to make a medicine. However, none of Dave's molecules actually make it into that medicine in the end, because it has been diluted to such extremes. There's no memory of Dave in the water or sugar left in the medicine, only in the minds of his little duckie friends and his family who miss him dearly. There are huge outcries about bear bile being collected for use in chinese traditional medicines- why is no one speaking out for Dave?

At the end of the day, evidence suggests that after all the sacrificing, succussing, potentization, and all the other fancy words they use for magic rituals, what we are left with is an inert sugar pill.We could have saved ourselves all the bother, and saved Dave's life, if we just made an inert sugar pill in the first place and didn't bother with all the pretending.

Won't anyone think of the ducks?