Il n'est pas evidence for Salonpas

Firstly, forgive that truly horrific use of French in the title. I'm truly sorry.

Okay, so today I've been having a more in-depth look at the evidence that Salonpas works. And, as predicted, the bottom line is that there seems to be very little. I'm going to tell you where I've looked, in what order, and what I've found and you can see if you agree with this conclusion.

Firstly, the manufacturer's info, the Summary of Product Characteristics. This tells me how it works- it contains methylsalicylate which is converted into salicylic acid (an anti-inflammatory which also irritates the skin), and levomenthol, which causes a local cooling effect and also causes irritation. You might think including ingredients that cause irritation might be weird, but in fact this is partly how most topical rubs and sprays-and even just plain heat- works. Such things are called rubefacients. The irritation basically detracts from the pain and is supposed to distract you from noticing it- replacing one type of  pain with another, almost.

So now we know that we can try to find some proper evidence that this particular product works. So I've done a Medline and Embase search, freetext searching using the brand name. the results? zip. not a sausage. So I tried searching methylsalicylate, and again I found nothing of use. Hmmm.

Eventually I've managed to dig out one study by the manufacturers of Salonpas. I can only get it in abstract form, so I can't really appraise it properly, but its pretty small (n=208) and is limited to patients with mild to moderate muscle strain. Now, if you've ever done any exercise ever, you'll probably know that muscle strain is a self-limiting condition anyway which may well get better itself after a few hours. I also don't know from the abstract whether they controlled the amount of activity in the patients- as you'll know, keeping moving can really help with muscle strain, whereas keeping still can mean you seize up and hurt more. I'm wondering about the blinding of the study as well: what did the placebo contain, because with levomenthol in the active patch it would be easy to distinguish by smell which was which. The results do seem to find a significant difference in pain, but are mainly reported as a per-protocol analysis, so don't account for any patients who have dropped out of the study.

So one study suggests some benefit, but may have some flaws that mean we can't quite accept the results yet.

What about topical rubefacient and anti inflammatory agents as a whole? Well, a Cochrane review in 2004 found that the available studies are limited by poor design, that rubefacients are pretty rubbish in acute pain, but they might work for 1 in 6 patients above those that respond due to placebo effect with chronic pain. The same review reveals that topical NSAIDs might benefit 1 in 3 patients with chronic pain.

Part of the reason these topical preparations work for some people actually has little to do with the drug content of them and a lot to do with application technique: rubbing the product into the area itself can increase blood flow and soothe the area. These patches eliminate that effect, which I think is a really problem in justifying their use. The side effects look pretty innocuous for Salonpas, but I would postulate that having irritants in constant contact with the skin for 8-12 hours, rather than acutely rubbing a small amount of cream into the area, would lead to more local skin irritation.

I have emailed the manufacturers to see if they have any more evidence in their favour. I guess we'll have to wait and see what they come back with, but in the meantime: Will I be recommending this product to patients? Definitely not. There's limited evidence that they work, and no evidence to suggest they are better than the existing (cheaper) products on the market. In short, its yet another gimmick to fill up the shelves in a pharmacy and yet another way to get people to part with their money with little justification. Would you agree?

Hxxx

Salonpas in the firing line

I feel like I've recently been bombarded with slightly cringe-worthy adverts for pharmaceutical products. And no adverts annoy me more than those for painkillers which claim to be delivered "direct to the source of pain" or similar. 

When I was a wee bairn, I remember being interminably confused by how one particular glug of Calpol will know that this time I have a headache, so it has to go to my head, whilst the next dose knows that it is required to report for painkilling duties in my ear because I have an earache at that particular time. Now of course, I have a more thorough understanding of pharmacokinetics (or at least I should have, but most of it has probably been pushed out of my brain by less useful, but inordinately more entertaining things), and I know that this is all total nonsense. A drug is distributed around the body depending on its properties, and whether it needs to go "direct to the site of action" depends on how it works, and whether it acts centrally or not.

I now spend a percentage of my time on locum shifts advising people that topical painkillers like Ibuleve and Voltarol are probably no better than taking tablets, and attempting to steer them towards the more effective-and cheaper- option of ibuprofen tablets, with advice to just rub the area if that makes it feel better, as that's what makes topical preparations work. So I'm already set to default to cynical mode with topical pain preparations. 

Enter the newest shiny painkilling gimmick onto our screens: Salonpas, a patch which, according to the US website allows absorption of the active ingredients through the skin to "go directly to the pain site"

So my skeptical ears are already pricked up. A quick glance at the website offers me a video to tell me how it works, which also makes me suspicious. I also can't find any particularly robust evidence on the website with a cursory look. 

The other thing that's worrying me is that these patches are rather expensive. they appear to retail at £4.99 for 3 plasters, with the maximum dose being 1 patch twice daily. That would be a whopping £23.29 per week.

So I'm going to start having a bit of a dig about to see what evidence there is on this new product and i shall, of course, let you know the results. It could well be that these patches are worth every penny, and are the holy grail in pain relief. However I suspect they're just another way to get money from people who are pretty desperate. But, I will remain open minded in my quest for evidence-based information.

Salonpas, be warned. I'm after your evidence.

Lets have some honesty, shall we?

Stigmas. They're stubborn things aren't they?

I've seen a few folk tweeting this article: Hooked on Happy Pills? in The Independent this week about the sort of language used to describe medication for mental illness, and this has started me thinking a bit about one of the seemingly most stubborn stigmas: mental health. When you've worked as a community pharmacist for a while, you sort of start to see the sort of numbers of people who are taking mental health drugs, and you start not really thinking twice about them, so its interesting to see how pervasive the stigmatisation of mental health issues even in this day and age.

Now I'm a pretty normal person, to be honest. I'm not particularly exciting in any way shape or form, I have a stable, loving family background, and a truly wonderful circle of friends. I'm not rich, nor am I completely destitute. I work a 9-5, five days a week job which I rather enjoy. I function pretty well in daily life, to be honest, despite living up to my nickname of Simple Dog. I've been subjected to few major traumas in life, and whilst I've been certainly affected by my divorce, even that went pretty smoothly to be honest.

So what am I doing writing about mental health then, eh? Well, like pretty much everyone else in the world, I'm affected by it. And I'm tired of this stigma, and I think its becoming time to just start talking. I know that my contribution to the party is going to be very, very tiny, but I'm also naive enough to think that very, very tiny bits all add up to a change. Lately, I've just started being honest about myself with other people. It started imperceptively, but seems to have grown to the point where I'm merrily discussing my anxiety issues with colleagues that I would never have dreamed talking to about such things with.

I'm generally of a pretty anxious constitution, and I think I always have been. When I was much younger, maybe 12-13-ish I started having panic attacks which led to a period of bulimia, which had nothing to do with my weight but was to do with a fear of vomiting in public. It seemed logical at the time (and to be entirely honest, I still think its a bit logical now). Anyway, I overcame all that, and am left with a sort of residual anxiety which raises its head now and then, but most of the time is fairly easily kept in check. In recent months its resurfaced a fair bit, and its not being helped by my increasingly monstrous appearance of late as my guttate psoriasis continues. What helps? telling people about it. If I'm getting palpitations, I'll tell people that I'm getting them, and that in itself makes me feel a bit better. If I wake up early in the morning filled with vague, formless fears, I'll tweet about it, and there's an instant bit of relief, and usually someone there to say something practical or funny about it.

I'm surrounded by people who also have mental health issues of varying degrees, from some of my nearest, dearly loved and oldest friends to momentary acquaintances. There are people I have never met, but who have been some of the greatest pillars of support to me in less than 140 characters. There are people who I hope I've helped a bit, and some I wish I could help more. And guess what, everyone else is surrounded too. The more open I've been, the more open people have been with me, and I think this is a privilege and a right that everyone should have. There's been some  who haven't handled these things as sensitively as they could have done, but I figure the more I bleat on about things, the more normalised it becomes.

At our Skeptics In The Pub talk the other night, there was one lone voice in the crowd that believed and spoke up for homeopathy. I'm reminded of him when writing this because he was getting a pretty thorough grilling from myself and other folk who were there, and was being asked about his particular experience with homeopaths and he had little hesitation in talking openly about his depression, and how he felt it was helped by having a homeopath with whom he felt he could talk to. His bravery is quite staggering really, given he was in a room full of people who disagreed heartily with him, and yet he still told us all.

I know this has been said already in bigger and better ways, but this is my tiny contribution. I guess what I'm trying to say is lets be rational about this whole thing, accept that these issues are everywhere and everyone has them to some degree or another, and just be honest about it. The more matter of fact we are, every day, even in the tiniest of ways, the more difference we can make to everyone. I sort of feel like its the people like myself, the "normal, functioning" folk who can maybe make the most amount of difference here. I'm guessing people with milder mental health issues may be more able to mask it, and more reluctant to be open about it lest something terrible happens. But they key thing here is that we have to be open, so that the something-terrible-that-might-happen-if-we-do-let-on doesn't exist anymore.

Hope this makes sense,

Hxxx

Red wine as painkiller... In babies?!

A couple of years ago, I was working a locum shift in a supermarket pharmacy. It was quite late at night, and a man came up to the counter to ask me if I did circumcisions. I assumed I had heard incorrectly, but no. "I thought you would be able to do circumcisions, since you can do healthcare services and you have a private room" he said, pointing at the extremely small and flimsy consulting "room" and the end of the counter. I couldn't help but notice the small boy cowering behind him as I politely explained that no, circumcision certainly wasn't a pharmacy service.

At the time, I remember being amazed that it would occur to someone to take their child to a supermarket for what is a surgical procedure. Whilst it may be considered minor surgery, I'm sure to the young boy himself it didn't seem all that minor, and I'm pretty sure he wouldn't be wanting a pharmacist to do it in the middle of a supermarket with only some thin plastic walls between him and the vegetable aisle.

Anyway, I shall leave aside the ethics of circumcision for now, and consider a tweet I saw this morning by Andy Lewis. One particular Doctor, on his website, is advising pain relief options for babies who are about to be circumcised. He advises loading the child up on red wine as a preferred option. Now hold on here, this is a GMC registered Dr advising on giving babies alcohol. Whilst he doesn't give any information about how much wine to give, i'm assuming it would have to be enough to get the child at least slightly intoxicated to have any painkilling effect. A quick google search suggests the 8th day after birth is a usual time for the circumcision to take place.

"1. To give the baby sweet, red wine prior to the procedure. (Kiddush wine is ideal). This is very effective in calming the baby. Ideally it is given about 15 minutes before the circumcision and I will give it on arrival if you wish. You will need to provide the wine."

At this point, let us consult TOXbase.org, the database of the National Poisons Information Service (NPIS). They advise that any children under the age of 10 who are symptomatic due to an alcohol ingestion (i.e. intoxicated) are taken into hospital for medical assessment.

Why is it dangerous to advise wine as a painkiller in a child of this age? Well, alcohol in children can be very nasty. It can cause hypoglycaemia, particularly in children, and a seemingly well child can sometimes suddenly and quickly go downhill fast- that's why NPIS recommend that they are observed in hospital.

Such advice, coming from a trusted Doctor, is very concerning indeed. It appears from the website that he expects the baby to be "prepared" prior to his arrival, so he is expecting the parents to administer and provide the wine (whilst he says he can give it "if they wish", to me this implies that its more usual for the parents to give it). He also recommends Emla cream, which he says the parents can buy from a pharmacy. This is an off-label use that he is openly promoting.

I have emailled the GMC to ask what their stance on such advice is:

"To whom it may concern,

I have happened upon the following website, which promotes the work of a GMC registered doctor, Dr Howard Cohen GMC number 3057256, and wish to clarify with yourselves whether I would be able to make a complaint against the advice he gives on his website:
www.mohel-circumcision.co.uk

I am particularly concerned about the advice regarding pain relief that Dr Cohen is giving. He recommends giving babies "sweet red wine prior to the procedure". It is my understanding that children should not be given alcohol, particularly on the advice of a healthcare professional. I regularly use Toxbase in my daily work and note that children who have ingested notable amounts of alcohol should be observed in hospital due to the risk of hypoglycaemia and other issues. A Dr recommending that a child is given presumably enough wine to be intoxicated as pain relief is highly dangerous advice.

He also advises purchasing Emla cream from a pharmacy for use prior to circumcision. It is my understanding that, although Emla cream is licensed in children, its use on the skin of male genital organs is only licensed in adults. Dr Cohen is therefore promoting off-label use of a drug on his website, without giving sufficient dosing advice or guidance.

I look forward to hearing from yourselves if this would be grounds for a complaint, or if promoting such advice is reasonable from your point of view.

Kind regards,"

Let's hope I get a decisive reply back. 

Hxxx

Update: As of 25th Feb I still haven't heard back from the GMC.

Skepticism in practice

The difference between skepticism and cynicism, so we skeptics often say, is that skeptics are willing to accept scientific evidence and adjust behaviour accordingly.

Today, I grudgingly put this principle into practice in one of the most important areas of my life. I have used science to change my behaviour.

I am a passionate lover of tea. It is my life force, and runs through me, sustaining my body and soul, much in the same way some people would say qi does. And my whole life, I have been making tea in what I considered to be "the right way". Teabag in, pour water over, leave for a few minutes, put milk in. Any suggestion of a variation from this pattern would usually be enough to send to turn me into an angry, spluttering whirlwind of fury. I love tea so much that I even devoted hours of my life to school physics projects investigating the diffusion properties of differently shaped teabags. FYI, pyramid >> round=square

It seems, however, that science disagrees with me, so today I accepted this fact and have been making tea as recommended by science. In 2003, the Royal Society of Chemistry produced a press release, which states:

"Milk should be added before the tea, because denaturation (degradation) of milk proteins
is liable to occur if milk encounters temperatures above 75°C. If milk is poured into hot tea,
individual drops separate from the bulk of the milk and come into contact with the high
temperatures of the tea for enough time for significant denaturation to occur. This is much
less likely to happen if hot water is added to the milk." Now that I am finally aware of this scientific basis, I have realised the error of my ways.

The office tea run. Doing it right, as per Science.

So this is me accepting the evidence, and accepting that, when it comes to making tea, I am wrong and have been all my life. I hereby follow science, and have joined the Milk In First brigade.

Hxxx

Skin deep: a lesson on empathy

For the past few weeks, I have been suffering from guttate psoriasis. My poor dear friends and twitter followers will be very aware of this by now, as it has led to much wailing and complaining.

Guttate psoriasis appears a few weeks after a strep throat infection in most cases, as it did with me. It appeared pretty suddenly on my face and chest, then got worse and worse until I basically now resemble a small pox victim with Ebola in the midst of turning into a zombie, with some added bubonic plague thrown in.

The treatment? Well it tends to go away of its own accord after a few week or months. It's not helped by stress, so it's good to chill out. Usually treatment with topical steroids, emollients, and reassurance are all that's required.

A few weeks ago I would have read that sentence with ease, accepting that reassurance and time would be enough for a patient. Slap on a bit of cream, and away you go.

A small section of my thigh at the moment. Imagine this rash, all over. And this is after vigorous application of topical steroids and has gone down slightly.

You learn in university and in various courses that dermatological conditions can have a huge impact on a patient's life. You learn about all the creams an emollients, and how we should advise they're used. You know in the back of your mind that its probably horrible for the sufferer but you don't really give it a second thought. I know I've even been felt vague consternation at having to dispense and check huge, bulky prescriptions for various and many unguents, with my main thought being "how am I going to fit this damn prescription on that shelf?!"

Well, what a lesson in empathy these past few weeks have been. Nothing could have prepared me for the impact a rash would have on my life. Aside from the panic about what it was, the constant feeling that everyone was looking at me and feeling disgusted is utterly wearing. And of course you know deep down that they're not looking at you, but it makes no difference at all. I know I need to be calm about the whole situation because stress makes it worse, and that makes me even more stressed because I'm not destressed enough. I feel like all I want to do is hide in a darkened room, so I don't have to inflict my grotesque features on anyone else.

And my goodness, the treatment. I get in the bath, which is already suffused with an oily emollient bath additive. I then apply some gunk, and wash it off with the oily water. I then get out the bath (which is made more interesting due to the added element of slippery danger) and proceed to apply more oily gunk, in various combinations of layers, then have to wait for it to dry sufficiently to be able to put on my most high-necked, low hemmed, least transparent clothing I can find. I haven't felt clean for weeks. You know on holiday, that awful sticky feeling you get from the sun lotion? That, all the time. In February.

All I've been able to think about is my rash. I'm struggling with conversations because my head is consumed only by thoughts of what bits of skin are visible and to whom. It's crossed my mind that converting to Islam might be an idea because then I could feasibly wear a burkha. Honestly, I have thought this. I've been turned into a hysterical drama queen all because of some spots.

In short, I have a whole newfound empathy for anyone who suffers from a skin condition. I can just about imagine the sort of impacts a longer term condition might have on your life. I can see how desperation can creep in, and how you could be tempted to try anything.

It's no co-incidence that so many quacks target people with skin conditions, nor that so many preparations are so expensive.

Hxxx

P.S. I'd very much like to thank everyone who has been supportive. You're all total darlings.

The Burzynski Connection

There's an event coming up in Newcastle that I'm really looking forward to. There's a lot of excitement about Street Spice, a street food festival coming up at the end of February, dedicated to celebrating world spices and food. And, to make it even better, its being held to raise money for charity- Brain Tumour UK.

So how does this fantastic event cross over into the murky realms of Dr Burzynski's work? Many others have covered the Burzynski debacle much better than I would ever be able to do. If you do want to know more about it, I recommend starting at Josephine Jones' blog, as she has a pretty extensive list of her own blogposts, along with those written by many others in the skeptical community.

The event is being held in memory of Kuly Ral, who died of a brain tumour. I know very, very little of this chap, except for the information given on the Street  Spice website:

"Kuly Ral made up one third of super Urban-Bhangra group RDB when his devoted family and Three Records label colleagues discovered that he had a terminal brain tumour. Although Kuly sought to get treatment in America for this, it was not to be:"

It's a very sad fact that my heart sinks every time I read or hear the words "treatment in America" for cancer. I can't help but dread that it means Burzynski's clinic, and with a bit of digging, it seems that in this case it was indeed Burzynski's clinic that Kuly was receiving treatment from when he died. I know nothing of the circumstances of his treatment, or how he died, but given that Burzynski supporters have been known to use the names of dead patients as testimonials for successful cancer treatment, showing no respect whatsoever to the deceased or their loved ones, I'm frankly amazed that Burzynski and his cronies aren't shouting from the rooftops about how they were treating such a high profile Bhangra personality. (In the past I have emailled the Burzynski Patients Group to ask if they were going to take down the name of a patient who had been dead for months. Unsurprisingly, I received no reply.)

I'm making no judgement here on anyone who would choose to go to Burzynski. I'm also still really happy to be going to any supporting the event, as it's raising money for Brain Tumour UK rather than for Burzynski himself. The person who I judge the most in this situation is Burzynski himself, who seems rather happy to be making his millions providing unproven treatments, deceiving patients, making shoddy movies, and claiming an FDA conspiracy, when he could quite easily silence his critics-and the FDA- by simply publishing the results of his "clinical trials". If he spent half the time he spends on shameless self-promotion by sitting at his desk and actually writing up some results, then at least he could back up all of his miraculous claims, and all of us who are critical of him would have to sit down, shut up, and happily accept that there is a cure for cancer on the market. 

So here is my own tiny little memorial to Kuly Ral. It takes the shape of a simple plea, and goes thus:

"Dear Dr Burzynski,

Please publish the results of your trials.

Its the least you could do"

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