Can female sex hormones beat brain damage Doctors believe progesterone may have protective effect
Treating brain injuries costs the NHS 1.2 billion a year
A major new trial has begun in the UK using the sex hormone progesterone to treat brain injuries.
Doctors believe the chemical — usually thought of as a female hormone — may have a protective effect on the brain, reducing swelling and improving mental recovery.
Five hospitals are now testing the new approach on patients with traumatic brain injuries caused by road accidents, sports injuries, falls and assaults.
More than 1,200 patients aged 17 to
70 will be enrolled worldwide on the trial known as SyNAPSe, and each
will be randomly given either a five-day intravenous infusion of
progesterone or a placebo, also an infusion, but with no medical
effects, so the treatments look identical.
of the trial will be available within two to three years, and
researchers believe they could transform the recovery of thousands of
patients with serious head injuries.
Belli, a consultant neurosurgeon at Southampton General Hospital and
the trial’s chief investigator in the UK, explains: ‘Although we have to
be cautious, the rewards of this trial could be phenomenal — the
results have the potential to significantly improve the outcome for
patients with traumatic brain injuries.’
advances in surgery and intensive care, traumatic brain injury remains
the leading cause of death in people below the age of 45, and a major
cause of disability.
Inflammation of the brain caused by a severe blow to the head can cause the blood supply to the brain to be cut off as the brain swells within the rigid skull, causing cells to die and permanent damage to occur.
Of those who make it to a hospital A&E department, between 20 and 50 per cent will die.
Treating brain injuries costs the NHS 1.2 billion a year, yet there is currently no effective drug treatment.
The new progesterone approach is the result of research in the mid-Eighties by American doctors who became intrigued by reports that women with a brain injury tended to recover better than men.
While progesterone is most commonly known for regulating a woman’s menstrual cycle and playing a key role in pregnancy, it is present in men but at lower levels.
Despite advances in surgery and intensive care, traumatic brain injury remains the leading cause of death in people below the age of 45
In men, it influences the production of sperm cells and testosterone, and in both sexes it has a role in sleep and mood.
The form of progesterone used in this trial is extracted from plants of the yam family. It is cheap to produce and has no feminising effects.
Studies on rats, published in 2008, suggested progesterone had a ‘remarkable’ protective effect on the brain — when progesterone levels were highest, the brain injury outcomes were improved with much less swelling and better functional recovery.
One recent trial involving 100 patients in the U.S. showed that while 30 per cent of patients given a placebo died within 30 days of injury, the death rate in the progesterone group was 13 per cent.
Progesterone seems to protect the brain by reducing swelling, allowing a healthy blood supply to the brain to be maintained and reducing cell death. Exactly how it does this is still unclear.
More than 100 hospitals in Europe, America, South America, Israel and Asia are involved in the new study, funded by U.S. research and development company BHR Pharma, and each centre is expected to recruit between ten and 15 patients.
The UK centres are Leeds General Infirmary, Royal Preston Hospital, Southampton General Hospital, The Royal London Hospital and University Hospital Coventry (Queen Elizabeth Hospital, Birmingham in the future) and the first patients are currently being recruited. A similar study called ProTect started in the U.S. last year.
However, carrying out such a trial is not without its difficulties. The progesterone infusion has to be given to the patient within eight hours of sustaining the injury for it to be effective.
Mr Belli explains: ‘Many patients don’t arrive at a neurosurgical unit until four or five hours after sustaining the injury, then they need to undergo tests to make sure they are suitable for progesterone treatment — for example, it can’t be given to pregnant women — and then consent has to be gained from the patient or relatives.
‘To start the treatment within eight hours is a real challenge.’
To determine whether the progesterone has had any effect, patients will be followed up after six months to see how well they have recovered from their injury.
They will be assessed on whether they are back at work, can live independently, what quality of life they have and the extent of any disabilities.
Commenting on the research, Luke Griggs, of brain injury charity Headway, says: ‘This is very exciting news and could have a significant impact on the number of people living with the long-term effects of traumatic brain injury.
‘There are obvious challenges, such as the eight-hour window of opportunity to administer the progesterone, and we have to remain slightly cautious until the results of this trial are clear, but the possibilities for reducing the number of deaths and severe disability as a result of brain injury are clear and have to be warmly welcomed.’