it's Thyme to Bronchostop this nonsense

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

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

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

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

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

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

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

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

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

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

Hxxx

In memory of Rachel

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

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

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

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

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

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

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

Hxxx

to study pharmacy, or not to study pharmacy?

I always wanted to be an archaeologist, growing up. I knew, however, that this was probably a pipedream- partly because I dislike creepy crawlies, but mostly because I was pretty sure in my childhood brain that everything interesting would have been dug up already by the time I was old enough to work.

Turns out I was wrong about that, but I’m still really proud of the profession I ended up in. I remember wandering up to the local shops with my Mum when I was little. We were talking vaguely about the future, when we had a little nose around the local chemist’s shop, cooing at the colourful bubblebaths and hairgrips that they had in stock.

“I know”, Mum said. “Why don’t you become a pharmacist?”

“What’s one of those?”, I asked. As far as I was concerned, the chemist’s shop was a place to buy cheap make-up and bath salts.

“Well, they stand in the back and mix up the medicines”. That’s it, I was hooked. I had images of brewing potions, mixing up gloopy ointments, and all sorts of stuff that, it turns out, in real life you only actually get to do for a couple of hours as an undergraduate. But my decision was made, and all the rest of my life I knew I was going to be a pharmacist.

As I got older, and I started telling people what I wanted to do, I used to hear nothing but positive things. I worked as a counter assistant in my local super market, and locums always used to tell me “You’ll never be out of work. Everyone is always desperate for pharmacists.”

At the time I graduated (2006), it still hadn’t been that long since the Great Pharmacist Shortage. This happened because the old style three year degree now became a four year Masters degree- so there was one year where no newly qualified pharmacists came on the scene. Everywhere you looked, people were crying out for a full time pharmacist to work for them. Whatever happened, you always knew that you could locum as a back up, and earn a good wage doing so.

As university went on, and I started applying for pre-reg places, I got worried. Not because I didn’t think I would get a place- in actual fact I was being courted by several companies, all of whom were clamouring to fill their pre-reg spots. I think I did maybe 10 interviews, and I got job offers from every one of them (and believe me, some of those interviews I was really quite atrocious in). No, I was worried, because I wanted to do my pre-reg in hospital, and I knew that pre-reg places really were limited in my local area- only 7 for the whole city.

I was lucky, and I got in. My year was really lucky, as it turns out there were enough jobs going for each of us pre-regs- though I actually went elsewhere. Whilst community pharmacy jobs were plentiful, hospital pharmacy was a lot more difficult to get a job in.

Nowadays, it has changed so much. I don’t think I can ever really hear myself saying the sort of things I was told to an enthusiastic school child now. “You’ll never be out of a job” would just simply be a massive lie.

When I was choosing universities, there were only a handful that actually offered pharmacy as a degree. In recent years there has been a proliferation of universities offering it now though, and as a result, the number of graduates is increasing year on year. I’m sure this isn’t the whole reason, but we have now reached a point where pre-registration places are becoming really hard to come by. There is a group of potential pharmacists, year on year, who will simply never be able to get a place anywhere.

So what does that mean? Well, you can’t register as a pharmacist, so you can’t work in your chosen profession. You’ve still got a Masters degree- but you’re actually pretty limited as to what you can do with it. Sure, its equivalent or better than a pharmacology degree, but you’ll always have a question hanging over your career, whatever you choose to do: “If you’ve got a pharmacy degree, why aren’t you a pharmacist?”. There’ll always be a slight, unfair, cloud of suspicion there. It means, even for those lucky enough to get pre-reg places, that jobs are more and ore difficult to come by, wages are being lowered despite responsibilities and workloads being higher, and locum shifts are both hard to get and pay an awful lot less.

Several places that I do locum shifts for have an email alert system for new shifts. On several occasions, I have received an email, checked my diary for my availability, then rang back immediately only to be told that all the shifts have gone already. The good thing that comes out of this is that, once you get your foot in the door, there is an incentive to work hard and become known as one of the best, most hardworking locums, because then you will get offered shifts first. The bad thing is that its now really hard to get that first step on the ladder.

How do we fix it? I have no idea, as it’s a multifactorial problem. A cap on the number of students studying pharmacy does seem logical, but that’s already been stamped upon by the Minister for Universities, science and cities Greg Clark MP, who has said:

“Having considered the evidence I have decided that it is not necessary to introduce a specific student number control for pharmacy. The government's objectives for pharmacy can best be achieved outside of a number control system. It is the government's policy to remove student number controls wherever possible to enable students to have greater choice and to encourage universities to offer better quality courses to attract students. I believe pharmacy students can and should benefit from this reform and not be restricted. Therefore there is no need to consider further options for a pharmacy number control.”

It seems to me that the one thing that Mr Clark isn’t considering is those students. Yes, they might have greater choice, but I wonder, if asked, where their priorities lie- would they rather have more choice, or would they rather have some security in their future. I wonder if it has occurred to him to ask them directly.

So it is that I, and a number of other pharmacists, are sadly starting to discourage students from looking at pharmacy as a profession. Its through no fault of their own, and its brilliant that so many young people want to be pharmacists- but its hard out there, and its only going to get harder. Our bright young potential pharmacists might be better off opting for a less focused, vocational degree.

Hxxx

Coldzyme: a result of real science being left out in the cold

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

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

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

Image source: http://www.sourcewire.com/news/84612/by-cod-now-your-plate-of-fish-chips-could-stop

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

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

Medicine vs. Medical Device

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

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

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

The Evidence

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

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

The practicalities

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

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

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

To Summarise

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

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

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

Hxxx

A Miracle Migraine Machine?

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



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



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



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



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



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



There was no significant difference in severity of migraine.



Although some of the results in this trial are encouraging, it is limited by its very small size. It is worth noting that the authors and manufacturers claim that this trial proves that the product is effective at preventing migraine, despite the lack of a significant between-group difference in the primary outcome of migraine days.



Other papers have been published in the literature regarding this product, and the manufacturers try their best on their website to make them look like they are real trials. However, these range from letters, conference abstracts, experiments in healthy adults, and case studies- not robust clinical trials.



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


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



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



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



Hxxx