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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

Homeopathic Harms Vol 5: Interactions

In February 2013, my friend @EBMScientist 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 expanding on a number of points we covered in the talk.

In the next instalment 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. (EDIT: This book no longer appears as a recommended source.) 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 acknowledgements), 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