Revolutionary drug to shrink fibroids could spare women hysterectomies
WAKING up in agony, Katherine Hill knew instantly what was causing the pain in her lower abdomen. The 43-year-old children’s nurse, like 40 per cent of women, had fibroids.
These are benign growths that develop in or around the uterus, and Katherine was unfortunately familiar with the symptoms — five years earlier she’d undergone surgery to have a large fibroid removed. She’d initially been referred to a gynaecologist after blood tests showed she was iron deficient, which her GP had put down to heavy periods.
‘I’d always presumed my heavy periods were normal, but at that time they seemed to last longer and were heavier than before,’ says Katherine, who lives with her husband Graham, 43, a shop owner.
Fibroids can make the surface area of the womb l i ning, the endometrium, increase — when this is shed each month, this causes heavier bleeding. After her surgery, Katherine’s symptoms dramatically improved. Then, two years ago, she started experiencing pain so bad it woke her at night. Initially, Katherine tried to manage the pain, which occurred during the first three days of each period, with painkillers and hot-water bottles, to little avail. She was also experiencing heavy bleeding again, causing embarrassing leaks.
After six months of symptoms she saw her gynaecologist. An ultrasound revealed a large 6cm fibroid, and one smaller fibroid. She was prescribed tranexamic acid, commonly used to tackle heavy periods — it promotes blood clotting. When this didn’t work, he suggested a new daily pill, Esmya. The drug was licensed in 2012 as a three-month treatment for fibroids before surgery to remove them — it reduces their size.
Research showed that Esmya quickly controlled bleeding in 90 per cent of patients and significantly reduced fibroid size; in patients who didn’t later have the fibroids removed, this reduction lasted up to six
THE drug has now been approved for use for a further three months, if the woman needs it, with a gap of two menstrual cycles between. Researchers are assessing whether Esmya can be used longer term.
After starting on the drug last spring, Katherine found that the bleeding and pain she had suffered quickly stopped. ‘Not waking in the middle of the night with pain was a godsend. I felt confident doing everyday activities,’ she says.
While the exact cause of fibroids i s unknown, t he hormones oestrogen and progesterone are thought to sustain them once they start growing.
Esmya effectively blocks the progesterone receptors in fibroids and the endometrium. As well as stopping the fibroids growing, this causes them to shrink, stopping heavy bleeding and pain. In many women, periods get much lighter or stop; they return around six weeks after treatment stops. ‘Esmya is a significant breakthrough,’ says Professor Ellis Downes, a consultant gynaecologist. ‘From my experimonths. ence, and published studies, after t hree months on Esmya, fibroids shrink by an average of 50 per cent, it gets rid of symptoms and serious side- effects are uncommon.’
Treatment i s only necessary if women experience symptoms from fibroids, as many have them without realising and there is no risk if symptomless fibroids remain in the body, he explains.
Symptoms include heavy periods and anaemia, pelvic pain, infertility and discomfort during sex.
If the fibroids grow towards the abdomen, they become big lumps and can make women look pregnant, and press on the bladder or bowel causing them to need the loo more. They can also lead to women suffering back pain. Some patients need an operation even if the fi- broid has shrunk if symptoms return, but Professor Downes says fewer than 25 per cent of his patients needed surgery.
‘Those who did still benefited from Esmya; they lost less blood and the fibroid was smaller and therefore easier to remove.’ Indeed, a few weeks after Katherine stopped taking Esmya, her heavy periods returned so her largest fibroid was removed. It had shrunk by a third, so the operation was more straightforward.
Fibroids naturally have a rich blood supply, so there can be too much bleeding to carry out surgery accurately and operations may need to be stopped prematurely, says Martin Powell, Katherine’s a consultant gynaecologist (who is part of a multi- centre European study looking into the drug).
Esmya has potential side-effects, however. It can thicken the womb lining — a condition known as endometrial hyperplasia, which is associated with a slightly higher risk of womb cancer.
Studies suggest this returns to normal after the three- month course. Other side- effects may include bleeding, ovarian cysts, pel- vic pain and breast tenderness. The main risk factor for fibroids is a family history. Women of Afro-Caribbean descent are also more likely to develop them, says Mr Powell. Typically, women aged 30 to 50 are affected.
Because fibroids are linked to oestrogen, some women choose not to have them surgically removed and wait until they reach the menopause, when oestrogen f all s naturally and the fibroids slowly shrink. But many sufferers seek a faster solution. An alternative drug to Esmya is gonadotrophin-releasing hormone (GnRH) agonists, which reduce oestrogen and progesterone levels to achieve a temporary post-menopausal state.
Given as monthly injections, these stop the pituitary gland in the brain releasing luteinising hormone and follicle- stimulating hormone, which make the ovaries produce oestrogen and progesterone. However, this treatment can be used for only six months as it can cause loss of bone density (oestrogen helps bone strength).
‘Patients don’t like these drugs because they go on to cause unpleasant menopausal symptoms such as hot flushes and when stopped, the fibroid problem returns,’ says Dr Woodruff Walker, a consultant diagnostic and inter- ventional radiologist. Esmya treats fibroids without surgery ‘equally well, but without the side- effects associated with reduced oestrogen’, adds Professor Downes. ‘Rate of regrowth is less than after the conventional injection treatment.’
There is little difference in cost — Esmya costs €350 for three months, while the injections would be €300 in that time-frame.
However, Dr Walker believes that rather than being a long-term treatment, Esmya may only have a role in temporarily relieving symptoms before more definitive measures are required, and says it doesn’t work in all women.
He believes fibroid embolisation, in which he specialises, is superior to drug treatments and open surgery such as hysterectomy.
This minimally invasive procedure uses X-ray to guide a tube inserted via the groin to the arteries in the uterus.
Tiny plastic balls are then injected to block the blood supply to the fibroids, killing them.
The dead fibroids shrinks over three to six months. ‘This works in more than 90 per cent of cases,’ he says. However, embolisation is difficult for fibroids inside the uterus.
Another treatment uses MRI to focus ultrasound beams on to the fibroid, encouraging it to shrink, but this is not widely available due to expense. Despite these options, it’s thought thousands of Irish women with fibroids still have hysterectomies — a complete removal of the womb — each year.
Experts feel this is unwarranted major surgery, which ultimately leaves women infertile.
‘In nearly all cases, hysterectomy is unnecessary,’ says Dr Walker.