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

Dear Kate

I’ve still not quite been able to come up with an adequate phrase to describe having social anxiety. Sometimes the old clichés are the best, and so I go with the duck- calmly floating above the water, but paddling like mad beneath.

I can be so good at hiding the furious paddling that even my closest friends have doubts that it exists. But if I were to invite you under the water, you’d see constant, frantic movement. You'd experience my physiological reactions going mad for no reason, reacting to the unforeseen horror of merely having a pleasant conversation with someone.  You'd be hit with tidal waves of thoughts, rushing over and over in a jumble. You'd hear that nasty, mean little internal monologue of mine telling you what other people are thinking (although they are probably not), how stupid you look (although you probably don’t), how boring you are (although you’re probably not). Then you'd feel the confusion and shame of cutting all these thoughts up with a knife of rationality. You'd see how that knife then turns on yourself because you just can't keep up with all of the mean thoughts, and you feel so weak for letting them take over you. 

Eventually, this state becomes your norm. It becomes background noise, and the peaks of it get even higher in moments where you feel threatened. Our metaphorical duck spends his days thrashing relentlessly under the water every second of everyday, and the tiniest of waves sends him into free-fall. Of course, Kate, you probably know how this feels already to a degree: it is stage fright that kept you away from touring for so long.

Moments of true calm are few and far between when you reach this point. When they do occur, you start worrying about them- internal silence starts to feel alien. Constant anxiety becomes your default position, and the otherworldliness of calm feels dangerous somehow.

That’s how I was this time last year. Things have now improved somewhat- thanks to the CBT, thanks to those around me, and in no small part thanks to my own stubbornness. I’m now at a point where the peaks are still there, but they’re not quite as insurmountable. My default position is no longer fight or flight, and I'm more able to quell the thought onslaught. True moments of stillness are, however, still relatively rare.

I’m never usually able to lose myself in a moment, as this stupid anxiety makes me constantly self-aware. The other night though, I experienced several blissful hours of basically forgetting that I existed. All thanks to you, Kate.

You’ve always been able to lift me out of terrible moods. One of the joys of living on my own is that I can get home, and crank up your music as loud as I like. I can sing, I can let go, and I can dance about with the cat without anyone laughing at me. I often find that you’re able to lift me out of an approaching mist. You've been the manufacturer of one of my most reliable coping mechanisms.

I saw Before The Dawn the other night. I was scared of going in alone, but within minutes I was chatting away with other people. We couldn't believe our luck. I've honestly never seen so many utterly excited people in one place before.

I know that everyone else has loved it. I've read the reviews, and I've seen the tweets. I expected it to be good, but what I didn't expect was to be completely enraptured- with you, with the story of a woman in the water, of a dawning day, with the detail. I had expected a couple of tears, perhaps a couple of whoops if I was feeling brave. What I hadn't expected was to realise that I was so taken in by it all that I was no longer self aware. I sort of came to, whilst dancing madly away to Cloudbusting, and realised that the waves had stopped for me for 3.5 hours. Here I was, on my own, in a situation that would usually scare me, completely and utterly swept up in the world of your making.

Thank you, Kate. Thank you for that gift.

Hxxx

It's time to reclaim holism

Holistic. It's one of those words that's sure to set any skeptic’s teeth on edge. It's basically a codename for woo, bandied about by supporters and pushers of all sorts of magic, unicorn tears, and snake oil.

But should it be? Is it time for the medical profession to reclaim the label holistic as its own, and start shouting from the rooftops about how we are holistic practitioners? I think it is, and here’s why.

holistic

həʊˈlɪstɪk,hɒ-/

adjective

Philosophy

adjective: holistic

1. characterized by the belief that the parts of something are intimately interconnected and explicable only by reference to the whole.

o    Medicine

characterized by the treatment of the whole person, taking into account mental and social factors, rather than just the symptoms of a disease.

There is a general perception, gleefully pushed by proponents of alternative healthcare,  that somehow conventional healthcare and holism are at odds with each other. The image of an uncaring, white-coated medical professionals hell-bent on simply treating that one particular symptom, with no regard for the fact that a patient is attached to that symptom seems pervasive.

We don’t help ourselves, I suppose. With a limited time on GP appointments, for example, its easy to feel like you’re being rushed through the system. Some surgeries ask that you book one appointment per ailment. Our health care professionals tend to specialise in one particular type of illness, and you can start to get the impression that they only care about that particular bit of your life, despite the fact that it’s very often all interconnected. You can feel passed from pillar to post, one day an appointment with a diabetes nurse, the next day an appointment with someone else for your arthritis, and two days later an appointment with a mental health specialist. So I do understand that it can seem like, as healthcare professional, we only care about your symptoms. 

But, even at the most basic level, it is impossible and really quite dangerous  to practice healthcare without looking at the patient as a whole. We’re all trained to do it, and its become so second nature to us that we have all sort of forgotten to be proud of it. As a result, we've lost control of the word holistic and we’re allowing unscrupulous charlatans to creep in to the public’s consciousness on the back of it. Of course, there are improvements to be made, but I think on the whole we do bloody well in the NHS, given the knowledge, funding and time constraints we’re lumbered with.

Now, in my day job as a medicines information pharmacist, I actually have no direct contact with patients. But I still, fundamentally, operate as a holistic practitioner. Here’s a basic example of what I mean:

GP: “Ah, hi there, I’m just wondering if there are any interactions between Champix and CellCept?”

In this sort of seemingly simple interaction enquiry, it is imperative that I look at the patient as a whole, rather than simply as two drugs out there on their own. 

• Champix®▼(varenicline) is a drug used to help patients stop smoking
• CellCept® (mycophenolate mofetil) is an immunosuppressive drug used to stop organ rejection in transplant patients. 

If I were to look at interactions of these two drugs,  I wouldn't find any,So fine, we’re good to go, right? I mean, I’ve answered the question, done my job, and all is well, yes? 

No, not at all. If I’m going to safely answer this question, I need to look at the patient as a whole. I need to acknowledge that they’re not simply a smoking machine that needs to stop but they’re a living, breathing complicated human.  I need to look at the patient holistically, not just as some isolated drugs.

So our patient is in his mid-forties, using the mycophenolate mofetil because he has previously had a heart transplant. He has a history of depression (understandable really, given how ill he has been in the past), and takes a couple of other medicines too (no major interactions on checking). He wants to stop smoking, which is great, a really positive step for him, but he’s failed a few attempts already whilst using nicotine replacement therapies. He's found these failed attempts frustrating in the past,which has then triggered bouts of depression. His liver and kidneys are working just fine.

So, looking at the patient as a whole, I need to think about how using varenicline will impact him as a person. Some of my thoughts go thus:

• Stopping smoking itself might affect some drugs, as there are chemicals in cigarette smoke which can affect the enzymes that metabolise some drugs. Is this the case with any of these drugs?
• Quitting smoking itself can be a trigger for depression or suicidal ideation. 
• There is also an association between varenicline and changes in behaviour and thinking, including depression and suicidal ideation. Given this patient’s history, this will need to be discussed with him and he’ll need to be monitored carefully.
• Certain cardiovascular events were reported more frequently with varenicline than placebo in trials: we need to bear that in mind and monitor him for any adverse reactions, especially given his heart transplant
• Not succeeding in giving up smoking has made him depressed in the past. Continuing to smoke increases his cardiovascular risks. A good old risk vs benefit decision needs to be made.

So I discuss all this with the Dr, and her response is:

“Ah that's great. Yep, I knew about the depression stuff but to be honest I hadn't really thought about the cardiovascular risks. I'll discuss it all with him, and I think we'll go ahead and prescribe it but I'll make sure to keep him closely monitored”

By looking at the patient holistically, his Dr and I have made sure that he will know to look out for any cardiac effects and to report it as soon as possible if he does experience any side effects. We can make sure that he's also prepared for the fact that his mood might change, and knows to report any of that too. He’s willing to take these risks for the sake of stopping smoking, so we’re helping him to take a really positive step in his life, aimed with all the information he needs to do it safely.

That’s just a small example of how I practice holistic medicine in my daily life. All over the NHS, at every level, other healthcare professionals are doing the same thing in their practice. We don’t declare ourselves to be holistic, because its such second nature that we don’t even realise we’re doing it. Maybe its time to start reminding people-and ourselves- that conventional medicine does, fundamentally, mean holistic medicine. 

Hxxx

Album Review: Lychnobite by Simma

There is a particular pub in Gatesheadwhich I rather like. It’s called The Central Bar and it holds good memories for me. It’s a traditional haunt for my good friends and I on Christmas Eve, it has an excellent range of beers, and does some good nosh too.

And so it was that on one particular Sunday afternoon just before Christmas, three friends and I were in there. We were suitably adorned in tacky, sparkly Christmas attire and were festively tipsy, when a chap started playing his acoustic guitar and singing in the corner of the pub.

Given our rather jolly state at the time, we showed our appreciation of this man’s lovely voice by bellowing along to some of the songs and inventing new interpretive dance routines to others (And thus, the great Gateshead Sit Down dance was born). We were a source of amusement for the singer, who declared that he’d never had anyone invent dances for him before and patiently explained that no magic was at play when we had loudly declared that we wanted him to play Fairytale Of New York then he actually did, prompting us to look drunkenly confused. “Girls, I’m not on the radio you know. I can actually hear you.” It was a really fun afternoon, and we left giggling hysterically and wondering if we could ever show our faces in there again.

The singer in question was Simma, and I’ve since seen him play several times. He fairly recently released his new album, Lychnobite, so I snapped up a copy of it and thought I would review it for you dear people.

On first listen, it’s on the whole a cheery affair, with upbeat tunes perfect for having on in the background while you do something else. Subsequent listens via headphones reveal a more melancholic, complex side to the album.

A particular highlight for me is “Black Dog”, a song about depression which combines a nifty little toe-tapping rhythm with an almost monotonous melody. This makes for an atmospheric juxtaposition, much like the illness itself. Next up is the joyous “Sing”, a marching, uplifting little song that I tend to happily belt out when I have it on at home.

Other songs are more calmly folky, all with a touch of cleverness to the songwriting that I find really pleasing. There is a clever use of vocals throughout the album (see Whisky Highway as an example), something which I find quite pleasingly different, given my previous experience of Simma is limited to him and one guitar in the corner of the Central Bar

“The Drink” is gorgeous, plaintive, and full of feeling. Meanwhile, “Sixteen Tons” is bluesy and pleasingly cynical, managing to blend together a very American sound with tales of Benwell woe. “Happy New Year” is likely to make its way onto my Christmas Songs For The Existentially Wounded list this year, with its mix of optimism and sadness for times gone by.

The other thing that I really like about Simma is how his Geordie accent creeps into the edges of his songs, lending them a little bit of added personality. All in all, this is a lovely, complicated album which is likely to be on heavy rotation in my household, nestled in nicely between Great Lakes by John Smith and Under Mountains by Rachel Sermanni. 

Hxxx