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What a groundbreaking new clinical trial could do for women with PCOS

One in five women in the UK suffer from PCOS, and there is currently no known treatment – although that could be about to change. Stylist goes behind the scenes of a groundbreaking new clinical trial to find out how

When Claire was 14, she had a period that lasted an agonising six weeks. After bleeding heavily for the entire school summer holiday she ended up in hospital, where she spent seven days undergoing invasive medical tests as doctors tried to stop the bleeding. It wasn’t until she was 15, and offered a laparoscopy in another hospital, that she was finally diagnosed with polycystic ovary syndrome (PCOS) – a condition she had never heard of before.

PCOS is defined by the NHS as a “common condition that affects how a woman’s ovaries work”. The main symptoms include irregular periods, as the ovaries don’t release eggs regularly; excessive facial or body hair, due to an increase of testosterone or ‘male hormones’ released into the body; and polycystic ovaries, in which the ovaries swell and become filled with fluid-filled sacs called follicles.

While exact numbers are unknown, PCOS is thought to affect around one in every five women in the UK. Despite this huge number, the condition has no cure, and little is known about its causes.

PCOS is thought to affect around one in every five women in the UK

PCOS is thought to affect around one in every five women in the UK

Having been diagnosed at such a young age, PCOS is something that Claire, now 36, simply had to learn to live with. “I resigned myself to always having it,” she tells Stylist.

But the impact of the condition on her life has been far from insignificant. As well as irregular periods, which arrive every couple of weeks and then vanish for up to nine months at a time, Claire also suffers from excessive hair growth, including on her face and arms.

“That was the worst part, especially when I was at school,” she says. “I’ve always had to shave my arms.”

But Claire is hoping her condition might soon become easier to manage, as she has been accepted onto a revolutionary new clinical trial that is hoping to reduce the symptoms of PCOS – using little more than a tiny silicon balloon and some hot water.

The trial is being run by Imperial College London and Imperial College Healthcare NHS Trust at the Hammersmith Hospital NIHR Imperial Clinical Research Facility in London. It involves a quick, non-invasive procedure that researchers hope will transform the body’s reaction to insulin, a hormone produced by the pancreas that works to control blood sugar levels. If someone becomes resistant to insulin, then the body has to create more to compensate.

However, this increased level of insulin causes the ovaries to produce too much testosterone in women with PCOS. This prevents normal ovulation which can, in turn, lead to the development of polycystic ovaries. In fact, the majority of PCOS cases (around 70%) are thought to be caused by insulin resistance – and this is where the trial, and the mini balloon, come in.

70% of PCOS cases are thought to be caused by insulin resistance

70% of PCOS cases are thought to be caused by insulin resistance

Patients will undergo a procedure in which the deflated balloon, attached to a thin tube, is threaded down their throats to reach their duodenum, which is part of the intestine. Hot water is then flushed into the balloon, causing it to inflate to the size of a small plum and pushing it against the wall of the duodenum, where it will burn off the insulin resistant cells. 

This causes the body to produce new, non-insulin-resistant cells, hopefully lowering the overall amount of insulin in the body and encouraging normal ovulation – meaning that PCOS sufferers can, at last, enjoy regular periods. The whole thing takes less than an hour from start to finish.

The procedure and the balloon, which is part of a device called Revita, is already being used by doctors to lower insulin resistance in people with type 2 diabetes. But this is the first time the device will be used to treat PCOS.

The Revita device can be used to help PCOS

Part of the Revita device. The deflated silicon balloon can be seen towards the bottom of the tube

Researchers on the trial, which kicked off in May this year, are recruiting 30 women with significant insulin resistance to take part in the procedure. Half of these women will receive the intervention and half will act as a control. The trial is blind, meaning that neither the women nor the researchers know who has had the intervention – although the women in the control group will be offered the procedure for real after the trial has finished.

And if the intervention is successful, what benefits can the women expect?

“The first thing we are interested in is fertility,” Dr Alex Miras, the endocrinologist who is running the trial, tells Stylist. “We want to see the women become more sensitive to insulin, and start producing eggs and having more regular periods. This means they are more likely to be fertile than before the trial.

“Putting a number to those things will be difficult, but we will be measuring insulin secretion and sensitivity, along with hormone levels. We will also be doing ultrasounds of the women’s ovaries,” he adds.

One caveat to the trial is that the results are unlikely to last a lifetime, as the lining of the intestine takes around five years or so to grow back after the procedure.

“From what we can understand, the lining grows back healthier than it was before, so the results could last longer than expected,” Dr Miras explains. “For women with PCOS who are struggling to get pregnant, the procedure could give them enough time to have a baby while the lining is growing back. Then they will have achieved the goal of getting pregnant without needing any medication or having any permanent changes made.”

Claire was told she might struggle to get pregnant as part of her PCOS, and this was something that “always concerned” her as she grew up. Indeed, when she and her husband first tried for a baby, they faced difficulties and enlisted the help of a fertility clinic. They now have two children, so Claire is hoping the procedure will help alleviate her other PCOS symptoms.

Claire has not yet had the intervention but Nikita, 34, who has suffered from PCOS for five years, underwent the procedure in August. While she doesn’t know if she had the intervention or the placebo (all patients are put under general anaesthetic), she has already noticed a difference in her symptoms.

“I feel better than I did before, so I’m hoping it’s not all psychological!” she tells Stylist.

With PCOS, Nikita has battled irregular periods, weight gain and hair growth, especially on her face and underarms. She was diagnosed with the condition in 2013 after giving birth to her son, and gained around 30 kilos in the following two years. She also had to start shaving her face every day.

“I didn’t recognise myself in photos, and I started looking in the mirror constantly,” she says. “I had depression before my diagnosis but the symptoms made it worse, and I’ve had to increase my medication to deal with it. I’m a single mum working full time and I’m constantly exhausted.

“It was hard making the effort to go out and I became a social hermit. My confidence was really low.” 

PCOS can cause symptoms such as excessive hair growth

“I had depression before my PCOS diagnosis but the symptoms made it worse, and I’ve had to increase my medication to deal with it”: Nikita, 34

Now, less than a month after the procedure, Nikita has lost two kilos and her energy levels are more stable throughout the day, which she hopes is due to an increased sensitivity to insulin after having the intervention. “I don’t know if it’s just my mentality, but I feel prettier,” she says. “I can appreciate myself a bit more now.”

Next, Nikita is hoping that her periods will become more regular (tampons “don’t agree” with her, meaning that if she books a holiday and then suddenly comes on her period, she can’t swim as she has to use pads). She also hopes her hormones will level out and reduce her PMT; she had her implant removed in order to take part in the trial, and says her hormones have been “all over the shop” since then.

“When I’m due my period, the hormones combined with my depression make me feel like I wish I didn’t exist,” she says. “I get very tearful, angry and snappy.”

PCOS can affect a woman's periods

“When I’m due my period, the hormones combined with my depression make me feel like I wish I didn’t exist.”

This time next year, her goal is to have lost another 10 kilos and be shaving less.

“It’s been a nightmare, but I feel like I’m on the right track,” she adds.

The trial is recruiting women until the end of the year, and results are expected as soon as June 2019. Dr Miras predicts the procedure will be available privately within the next year, although it could be a while before it’s available on the NHS, as it’s an expensive treatment to provide.

But with the condition affecting so many women, and having potentially devastating consequences for their day-to-day lives, here’s hoping the trial is successful – and that it’s rolled out across the UK as soon as possible.

Images: Getty, Unsplash

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