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Signing up for a drug trial after a stroke really helped me – even though I may have had a placebo, writes test patient MOIRA PETTY
Befuddled and shocked, I sat in the chair by my hospital bed as two more medics approached.
It was December 2020 and the previous day I’d spent more than ten hours in A&E in a blur of tests, examinations and pill-popping after a suspected stroke.
I’d been speaking to a friend on the phone when, without warning, I felt extreme dizziness and mounting nausea. Then I couldn’t control my right hand any more, my right leg was wobbly and I was overwhelmed by fatigue.
I was admitted in the early hours, and that day was filled with scans and tests, with me still in disbelief that I’d gone from apparent good health to having a stroke.
It was December 2020 and the previous day I’d spent more than ten hours in A&E in a blur of tests, ciprofloxacina calox 500mg examinations and pill-popping after a suspected stroke
The two figures who introduced themselves as hospital researchers had something in mind that I could help with. They wanted to enrol me on a clinical trial studying the effect of a new anticoagulant, a drug to prevent blood clots, the cause of the most common type of stroke — an ischaemic attack, which I’d had.
This is when a blood vessel supplying the brain becomes blocked — brain cells and tissue can start to die off within minutes, which explains the sudden onset of catastrophic symptoms.
Anticoagulants help by reducing the formation of fibrin, a protein which would otherwise form a fibrous mesh over a cut or injury to reduce the flow of blood.
It was explained that I’d be taking two pills daily for a year, and I had a 25 per cent chance of it being a placebo or the drug (known as Bay 2433334) in one of three doses — 10 mg, 20 mg or 50 mg.
Because the trial was ‘double blind’ neither researcher nor participant knew who got what.
Being on the trial would involve five visits to the hospital (Charing Cross, London, part of the Imperial Healthcare Trust) for various tests, and in the seven other months a researcher would phone to check on my health.
Throughout the year, I would have up to four ECGs to check how my heart was working and up to three MRI scans of my brain. I was handed a 15-page information sheet to read, which told me that in all, there would be about 1,900 participants in 24 countries.
Because the trial was ‘double blind’ neither researcher nor participant knew who got what. A stock image is used above
The information did not promise any direct advantage, but said those in the study might benefit from all the extra health checks.
Of course, as a health journalist I couldn’t help but think of the catastrophic Elephant Man drugs trial of 2006, which left six fit young men in intensive care. The trial, at a private wing of the Northwick Park Hospital in London, was the first in humans, with a drug designed to treat leukaemia and chronic inflammatory conditions.
The drug worked by manipulating the immune system, and it sent the young men’s systems into overdrive. Five of them spent three weeks in hospital, the sixth, whose face swelled hugely, was there for four months.
The dizziness I’d experienced at the start of the stroke had largely gone and my thinking was beginning to feel clearer. I still felt stunned by the events, but was surprised by how rationally I assessed the option of going on the trial.
I was able to ask questions and found that increased safety measures had been introduced after the Elephant Man disaster.
The drug I was being asked to take had already been tried in humans in previous smaller trials, I was told, so I reasoned that the safety risk was much smaller.
Unfortunately, doctors aren’t able to say what caused my stroke, although my blood pressure was very high on admission.
I’d had Covid-19 badly and as the virus makes blood stickier, it could have been caused by that, but no one could confirm the link.
Without any known cause, the chance of having a second stroke, always more disabling, within two years is a terrifying 30 per cent.
This was enough to reel me in to the drugs trial, but the experience perked me up at a difficult time.
My stroke was in the cerebellum, the part of the brain responsible for balance, coordination and posture, as well as helping with eye movement and vision.
So in addition to balance and co-ordination problems on my right-hand side, I’d lost fine motor skills in that hand, including handwriting, something integral to my life and work. Anything that might prevent worse happening was worth it, I thought, as I signed my consent to the trial with a scrawl — all I could manage.
Looking around me on the hyper acute stroke ward, sadly I could see several patients severely affected who didn’t appear to move, talk or eat. When I was discharged a day later, I felt a real zeal about doing my little bit to help improve medication for others — also giving me a sense of purpose at a time when I couldn’t even write a Christmas card.
A year on, my lost functions have gradually returned, with exercises to improve balance and coordination and practice writing and typing. I have also just finished the drug trial. There is no doubt that the regular monitoring was reassuring, not least when the two ECGs I had done in June and December, as well as an MRI in June, as part of the trial, showed that there had been no silent strokes and my heart was fine.
I was petrified about the risk of a second stroke, especially as I didn’t smoke and already ate a Mediterranean diet — two of the suggested methods for avoiding further events — so all that was left to me to do was take my newly prescribed pills with alacrity.
The MRI, though not pleasant, was a huge bonus and relief. My blood pressure checks almost every other month (I had five in total) were also reassuringly normal.
It’s not yet clear when the findings of this trial are due — and, of course, I don’t know if I was taking the trial drug or a placebo. I was the first patient recruited at Charing Cross and, being an optimist, I like to think I’d been allocated the drug and it was doing me good.
This will only ever be revealed if I have a medical emergency and a doctor needs to find out what I have been taking. But there is no doubt that I gained much from taking part.
One of the difficulties facing those recruiting patients for such trials is whether the patients will be well enough to see it through. Another is that, for instance in stroke medicine, patients can arrive at night or on weekends when the recruiters may not be on duty. There is also patients’ fear of the unknown at a time when they’re already dealing with a new health scare — and the ‘reputation’ of trials themselves.
Jane Armitage, a professor of clinical trials and epidemiology at Oxford University, was running a trial on statins at the time of the Northwick Park trial in 2006, which ‘impacted our ability to recruit’, she says. But she believes Covid vaccines and the work of the Recovery trial, to establish which treatments do and do not work on Covid patients, ‘has restored some of that confidence’.
Dr Dheeraj Kalladka, a consultant neurologist and stroke physician at Charing Cross Hospital, who is involved in the stroke trial, adds: ‘Clinical trials are not experiments that doctors randomly dream up, and patients should not think of themselves as guinea pigs.
‘A lot of thought goes into developing clinical trials. And the more patients get involved and see trials as positive, the more we can improve care and tailor medicines.’
Interestingly, Professor Armitage notes that people on trials, even those given a dummy treatment, have been shown to do better healthwise than those with the same condition outside the trial.
‘Some of that is because health problems might be picked up earlier because the participants are being monitored.’
She adds: ‘Drugs trials are vitally important to make sure the medicines prescribed by our doctors are safe and effective. We don’t get a huge response rate, but we’d like people to consider it carefully.’
To find out more about taking part in a UK trial, check the websites of relevant medical charities, and the Be Part of Research website: bepartofresearch.nihr.ac.uk
History case notes
Old medical practices still relevant today. This week: Honey for wounds
Today, the NHS uses dressings impregnated with medicinal honey to keep wounds clean, something for which we can thank a long history of medics, including Dioscorides, a doctor from Ancient Greece (who lived about AD 40 to 90).
He wrote that ‘honey is cleansing, opens pores and draws out fluids’ — and he was pretty much spot on. ‘Honey contains hydrogen peroxide, which is antibacterial,’ says Dr Maninder Ahluwalia, a lecturer in biomedical sciences at Cardiff Metropolitan University.
‘It is hygroscopic, which means it can draw moisture out of the wound, dehydrating bacteria so they die off. It also reduces inflammation, increases new blood vessel formation and assists removal of dead tissues.’
But you can’t just use any honey. ‘Medical honey has to be free from contaminants and organic matter, sterilised using gamma radiation and have followed strict production and storage standards,’ says Dr Ahluwalia. ‘Table honey may have contamination with pollen or microbial spores that mean it’s not safe to use.’
If you want to try medicinal honey, Medihoney dressings are available in pharmacies — but speak to your GP first.
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