St John's Wort and why it scares me, despite the fact that it works.

Hi all,

It's lovely for once to be able to write about something that works, instead of something which has little to no evidence of it working. However, I wanted to share with you some reasons why I would tend to steer people away from a "natural" remedy, despite the evidence being positive. Why St John's Wort today? Well, my RSS feed today popped up with:

31/12/2012
Daily Telegraph
By: Presswatch
GPs prefer herbal remedies to Prozac, says survey
A survey by Schwabe Pharma found that GPs are increasingly likely to prescribe herbal remedies such as St John's wort for depression rather than Prozac.	(

(http://www.presswatch.com/health/index.php?d=2012-12-31#3)

I haven't been able to find the actual story, or the press release from Schwabe Pharma (who, incidentally, produce St John's Wort, so wouldn't be without bias), but it got me thinking anyway.

Is it because of a big pharma conspiracy? Is it because I'm in cahoots with the evil drug companies and all I want is money? Is it because I'm just too close-minded to be able to accept anything other than conventional medicines? Is it because I love seeing patients suffer? Well, in short no.

I find herbal medicines really interesting. Unlike homeopathy, which has no theoretical possibility of working, herbal medicines contain plant material with high enough levels of chemical constituents to cause a pharmacological effect. There's something quite beautiful about the concept of using plants for medicinal purposes. The problem with them lies in the fact that there just aren't enough studies done for us to be able to say whether they work, or more importantly, whether they harm. Whilst herbal remedies have enough "medicine" in them to make them work, this also means they have enough in them to cause adverse reactions, to interact with other herbs, medication, illnesses and so on. Without Big Pharma funding, though, its not that likely that large, well designed trials will be undertaken on them, so using herbal medicines can be a bit like shooting in the dark. Even if we don't find any documented issues with a herb, this doesn't mean none exist, it may just mean that nobody has looked at (or published) any issues yet.

St John's Wort is different. There is now a pretty large body of evidence to suggest that it works, and that it works better than placebo and as well as conventional antidepressants like the SSRIs. We also know a fair bit about its interactions and its adverse drug reactions... So that's great then, yes? That means healthcare professionals should all consider it as a better choice than the conventional medicines, with all their nasty side effects etc, right?

Well, in my opinion: not always. Whilst we know a fair amount about it, the problem here lies with production, and the inherent variability in herbal medicines. Because they're made from plant materials, there can be a huge amount of variability in what each tablet contains.. Even if you're using a product licensed under the Traditional Herbal Registration scheme, there can still be variability between each batch, depending on where the plant was grown, the time of year/ day it was harvested, and what it was treated after it was harvested. So, if you get stabilised on one batch of medicine, the next batch may contain differing amounts of active ingredients, which could mean a whole host of things might happen: it might work better, it might start interacting with your other meds, it might trigger a side effect etc. Then, just when you're getting used to that batch, the next one is different too, etc etc.

I've come across a few enquiries where a patient wants to use St John's Wort as add-on therapy along with their antidepressants. It maybe doesn't occur to the patient or their GP/pharmacist etc that it actually works in a very similar way to a conventional antidepressant. Combinations of antidepressants are usually only done under specialist care (with a few exceptions) because combining them increases the risk of some very severe side effects such as serotonin syndrome- the same applies to St John's Wort. The fact it's "natural" seems to blindside people into forgetting the usual principles of how medicines work.

This is before we even get into the territory of risks associated with self-treatment of what can be a very, very serious disease. Would I exclude use of St John's Wort entirely, for everyone? No, because it does appear to work. But do I treat it with as much (if not more) caution than I would an SSRI? Yes, because there's still not that much information about its safety in the grand scheme of things. So this sort of negates the point of it, to be honest.

Hopefully that explains a bit about why I'm cautious about herbal medicines.

Have a lovely New Year's Eve folks, see you again in 2013. 

Halotherapy: the return

Ages and ages and ages ago I wrote an initial blog post on halotherapy (salt cave therapy), and i promised you a follow up once I have looked at the available data for it.

In short, I always meant to get round to following it up, but kept forgetting or getting embroiled in something else instead. So here, dear friends, is the follow up post.

As you may recall, www.saltcave.co.uk were claiming their clinically tested, drug free treatment meant that many of their patients stopped taking their medications becuase they because symptom free. They claimed it would work for asthma, COPD, and sinusitis. So, I thought I'd test their claim for COPD, particularly since this illness can be particularly devastating and debilitating.

So here's what I did: had a look at their website, which attempts to helpfully provide a list of published studies. I the proceeded to ignore this entirely, and did my own search of Medline and Embase, the two leading medical literature databases in the world. If there was going to be any robust evidence, I would find it in those.

Now I'm interested in human clinical studies mainly as a starting point, because these are the ones that can actually tell us best whether or not something works. So I limited the searches to human trials: after all, The Salt Cave are claiming that it's a clinically tested therapy, right? I then combined the results for halotherapy, with results for chronic obstructive pulmonary disease, to see what would come up.

In Embase, I found one study. Unfortunately, it was in Russian, so I have to rely on the abstract. The study included 29 patients, and that's pretty much all that we know. The authors claim a significant positive effect, with no other information or data reported in the abstract. But frankly, a study with 29 patients in is neither here nor there- it's far too small to use to make any claims of benefit.It's worth noting, by the way, that these patients were in a "sanatorium" setting, which is likely to be a rather different setting to the middle-class-Ikea-£35 a go-UK based version that is being sold here. What other treatments would be given in a Russian sanatorium setting? How would any of this affect the patient's condition? How has this been controlled for in this study? Unfortunately, there's no way of knowing given how badly presented the abstract is.  

Okay, so what did I find in Medline? Well, in short, nothing. No results at all.

So then I went back to the references provided by www.saltcave.co.uk and found very little to add. Another Russian-based sanatorium study, in abstract only, providing no data at al. Likewise, the study that they use on the "results" page of their website only include 26 patientswith COPD: again, too limited to draw any secure conclusions from.

So my conclusion? The evidence for the use of salt cave therapy in COPD is far too limited to claim any benefit at this point in time. More research needs to be done in this area to be able to claim that it works. And this evidence base certainly doesn't justify £35 per hour. They can put as many testimonials as they like on their website but it still doesn't add up to good, robust clinical evidence.

Hopefully this is a step to debunking some of the claims they are making on this website. Whilst there is a possibility that it might work, at the moment we just don't have enough information to justify the claims- and the cost.

Further reading on halotherapy can be found at The 21st Floor and Sceptical Letter Writer

For transparency, here's my search terms:
EMBASE: halotherapy.ti.ab AND Chronic obstructive ling disease/ 
MEDLINE: halotherapy.ti.ab AND Pulmonary disease, chronic obstructive

Christmas Dinner Conversation: An Anecdote

Hi all,

Hope you all had a lovely festive period, whatever religion (or lack of) you may follow.

I spent christmas day with my parents and remaining grandparents, and thought I'd regale you with the tale of part of our christmas dinner conversation.

Having been asked what I was doing in life at the moment, one of the things that was mentioned was the Newcastle Skeptics in the Pub talk that my good friend and Helper Dog Nancy and I are doing in February. This prompted Mum to state that she thought that homeopathy might work, after all plants had been used for many years in medicine. Now, I have written before about the case of the magic crystals, and do remember mum trying homeopathic remedies on me as a child (out of desperation due to my awful car sickness. Out of interest, I also remember them not working) when I was a bit older, so this stopped me short. I do have a suspicion that the majority of users of homeopathy have little knowledge of how it is made, and therefore no idea how unreasonable it is to expect it to work. And here was living proof that this was, indeed the case. Dad was aware of the like-cures-like principle, but they had no idea at all of the serial dilutions used in homeopathy.

Cue a demonstration (involving wine), and an explanation that beyond 12C there is virtually no likelihood of any molecules of the "active" ingredient appearing, and the general consensus was that they were amazed at this turn of events, and couldn't understand how on earth it could work and how anyone could possibly be taken in by such nonsense.

And so it seems to me that a general lack of good information about what homeopathy is, and what the principles of it are, may well be responsible for the majority of people who may believe it still works.

What do you think? I wonder if there is any way to measure this? If you have any ideas, do give me a shout.

H x

A Call To Arms: Pharmacists should call for Open Data

Pharmacists of the world, unite and take over.

Pharmacy has been hit hard over the past few weeks. We've had MPs accusing us of being smartie counters, and a badly written BBC News expose implying that we are all merrily dealing benzo's to make a quick buck. (I may attempt another blog post on this at some point)

I believe that historically, pharmacy has drawn the short straw. In my opinion. our professional body, the Royal Pharmaceutical Society, seems to lag behind other bodies when it comes to media savviness, and it often feels like we have very little impact or voice when it comes to the healthcare profession as a whole. Even now, its still a rare occastion that a pharmacy-related story will actually have a pharmacist commenting on it in the news- GPs, doctors and nurses are simply much more vocal and recognisable to an audience.

But here is an opportunity, and it has been handed to us on a silver platter by Ben Goldacre and the BMJ. I'm sure you may have heard by now, but there is a pretty large campaign on the go to allow for more transparent reporting of clinical trial data. This has been prompted by the case of Roche's Tamiflu, but its wider implications on patient safety and care are huge.

All the information you need about the BMJ's Open Data campaign can be found here. 

Today I tweeted Ben Goldacre to ask what involvement there has been from the pharmacy bodies. The answer? A big fat zero. There has been no involvement at all, from any of them.

So here is my call to arms. If you are a pharmacist, or if you are affiliated with the pharmacy profession, lets contact the RPS, the GPhC, NPA, PSNC, and anyone else who will listen. Lets tell them how important this is to us and how we want them to represent us and get our voice heard.

After all, to be experts in medicine, we need to have access to information about medicine. And that information has to be accurate, reliable, accessible, and unbiased. Without open data, we simply cannot do our jobs properly or with the degree of safety that we would like to. It may seem like a trial not being published is far removed from handing over a prescription to a patient over the counter, but the fact of the matter is that patients are dying due to the lack of transparency. How can we counsel a patient on side effects, for example, when patient level data from trials has been withheld? How can a patient be prescribed the best medicine for their condition when most of the trials involving the drug haven't been published?

Moreover, what a great way to represent ourselves as a profession who, more than anything, care about the health- and safety- of our patients, and who are willing to speak up when it counts. What a fantastic opportunity for our professional bodies to prove what they can do.

H xxx