A device that sends magnetic pulses through the skull to combat severe headaches has received qualified approval from Britain’s health guidance authority for the treatment of migraine, a debilitating condition that is estimated to cost the economy about £2.25bn a year in absenteeism.
The National Institute for Health and Care Excellence (Nice) said that there is enough scientific evidence to support the use of transcranial magnetic stimulation (TMS) for the treatment and prevention of migraine, and that it can now be used by NHS patients under the care of specialist clinicians.
However, Nice emphasised that the clinical evidence for TMS is still “limited” and that the treatment, which involves delivering a brief pulse of magnetic energy to the back of the head via a hand-held device, is not likely to benefit most of the six million people who suffer the acute and chronic migraine attacks.
“Patients should be informed that TMS is not intended to provide a cure for migraine and that reduction in symptoms may be modest,” warns the Nice guidance.
“Evidence on the efficacy of TMS for the treatment of migraine is limited in quantity and for the prevention of migraine is limited in both quality and quantity. Evidence on its safety in the short and medium term is adequate but there is uncertainty about the safety of long-term or frequency use of TMS,” Nice says.
However, the Migraine Trust said that the Nice guidance will mean that many migraine sufferers who cannot take conventional anti-migraine therapies – such as the triptan drugs – may now be able to benefit from a relatively safe, non-invasive procedure that can also be used by women during pregnancy and breast-feeding.
“Huge numbers of sufferers find their lives blighted by migraine. We welcome Nice guidance that may help to deliver brighter futures to many people for whom other treatments have not worked,” said Wendy Thomas, chief executive of the Migraine Trust.
“This is a non-invasive, non-drug therapy based on a device. It is the first such therapy of its kind and it means that migraine sufferers have another treatment option. We tend to get quite excited about anything that adds to the armoury of migraine treatment,” Ms Thomas said.
A handful of small-scale clinical trials has shown that some patients benefit from using TMS either to reduce the frequency or diminish the intensity of migraine attacks. One trial on 164 patients treated with a single magnetic stimulation for at least one attack of migraine with visual disturbance produced 39 per cent pain-free levels for at least two hours.
In a separate study, three quarters of patients with migraine who were treated repeatedly with the TMS device experienced a significant reduction in headache frequency – even those patients who suffer from severe, chronic attacks lasting several days.
Many migraine sufferers will benefit from the device, which costs £150 a month to rent from its California-based manufacturers, according to Professor Peter Goadsby, chair of the British Association for the Study of Headaches and director of the national headache centre at King’s College London.
“Single pulse transcranial magnetic stimulation is a wonderful example of clinical and laboratory research delivering a real improvement in migraine treatment that is both effective and extremely well tolerated,” Professor Goadsby said.
It is estimated that about 190,000 migraine attacks occur every day in Britain and that some 25 million days are lost from work and school each year as a result of severely incapacitating headaches.
Dr Fayyaz Ahmed, a consultant neurologist and a trustee of the Migraine Trust, said: “This is a breakthrough treatment for those who cannot tolerate or do not respond to current treatment, and opens the door for a new era in treating migraine headaches. We welcome Nice guidance and very much hope this treatment is made available to those in need.”
The Nice guidance concerns “interventional procedures” and is intended solely for safety and efficacy. As such, it does not cover whether the NHS must fund the procedure – funding decisions are the responsibility of clinical commissioning groups.
Migraine results in recurrent, pulsating headaches that may last between several hours to days and are often accompanied by nausea and sensitivity to light and sound. An attack can also be preceded by an “aura”, which can include disturbances in vision, the sense of smell, or difficulties with speech.
Sufferers report that the onset of symptoms can be prompted by a wide range of triggers, but the best treatments are usually those that are taken in the earliest stages of an attack. Apart from pain killers and triptan drugs, botox injections are also thought to work on some people.
Rebecca Armstrong, the features editor of The Independent, has been a migraine sufferer for 20 years
It looked as though I was seeing a snowstorm, but only in my right eye. This fuzziness signalled my first migraine 20 years ago. Then, it merely disrupted a geography lesson. In the next two decades, however, migraines disrupted my finals and laid me low on my wedding day.
The usual run of events is fuzzy vision, a stiff neck, then a headache and extreme nausea. A day and night in bed usually does the trick, but I’ve had migraines last 48 hours. I get only a handful each year and I respond well to Sumatriptan. Still, it doesn’t always work for me.
The idea of using a device to prevent the pain isn’t new to me – a friend has trained as a light therapist after her migraines diminished using the technique. I have yet to try it, but for most sufferers, any relief has got to be worth a shot.”