Despite heavy menstrual bleeding, or HMB, affecting many women worldwide, studies into HMB and effective primary care measures remain scarce.
Professor Joe Kai and a multi-disciplinary team at the University of Nottingham and the University of Birmingham, UK, have provided invaluable insight into treatments for HMB, and the critical role of the primary care physician, revolutionising understandings of HMB and effective treatment options.
Read the Research Outreach article: https://researchoutreach.org/articles/valuable-insights-caring-women-heavy-menstrual-bleeding-hmb/
Read the original research: https://bjgp.org/content/73/729/e294
Image source: Adobe Stock Images / KPMZZ
Transcript:
Hello and welcome to Research Pod! Thank you for listening and joining us today.
It’s estimated that as many as one in four premenopausal women suffer from Heavy menstrual bleeding, or HMB, making it a common problem for women. In this episode, we will be looking at the work of Professor Joe Kai and a multi-disciplinary team at the University of Nottingham and the University of Birmingham, UK, who have provided invaluable insight into treatments for HMB, and the critical role of the primary care physician.
Also known as menorrhagia, HMB is a chronic condition characterised by abnormally heavy or prolonged bleeding. While some cases have a physical cause, such as fibroids, known as benign uterine tumours, most do not. Common though the condition may be, that doesn’t make it necessarily bearable. HMB not only poses a significant health risk but also interferes with a woman’s physical, emotional, social, and material quality of life. Unfortunately, given cultural sensitivities around menstruation in general, little has been done to make women aware of the condition and that treatments are available. With this in mind, one might wonder: why are studies into HMB and primary care so scarce?
Dr Joe Kai is a primary care physician and professor of primary care at the University of Nottingham. He recently led the university in its third successful application to be part of the National Institute for Health Research School for Primary Care – a partnership between the UK’s leading primary care units to enhance research capacity and deliver high-quality research evidence in the field of primary care. Kai knew that some small-scale studies had shown that a specific intrauterine contraceptive – the levonorgestrel releasing intrauterine system, or LNG-IUS – reduced menstrual blood loss, but more extensive studies were needed to explore this. In consequence, Kai helped to design one!
The result is the ECLIPSE trial, referring to the effectiveness and cost-effectiveness of levonorgestrel containing intrauterine system in primary care against standard treatment for menorrhagia. It has fundamentally changed our understanding of HMB and how women deal with it. Moreover, it has also provided clarity on what GPs can do to help them. Importantly, ten years after the initiation of the trial, Kai and his team are still learning from it.
The LNG-IUS is a T-shaped plastic device containing levonorgestrel, a hormone similar to progesterone. Levonorgestrel works by thickening the mucus at the cervix to prevent sperm from entering the uterus; it also thins the lining of the uterus to prevent pregnancy from developing. Importantly for the research, an LNG-IUS can be fitted by a primary health care physician and, depending on the brand, can be left in place for up five to eight years.
To test its effectiveness, the ECLIPSE trial randomly assigned 571 women who presented to their GP with HMB, for over a minimum of three cycles, to treatment with the LNG-IUS or standard medical intervention – selected oral medications, contraceptives, or injections known to reduce menstrual blood loss. This was the largest trial of medical treatments for HMB and was designed to last five years. Throughout the trial, the women assessed the impact their periods had on their daily life.
What emerged was that all the participants found that whatever treatment they were using did reduce – to varying degrees – the effects of HMB on their daily quality of life. However, those fitted with an LNG-IUS showed an overall more significant improvement in their condition at two years. This improvement was more than a reduced menstrual blood flow. HMB often carries additional symptoms beyond excessive blood loss, including significant cramping and tiredness and the anxiety associated with the threat of menstrual leakage. At five years, the greater benefit of LNGIUS was reduced, but there were still large improvements in symptom relief whichever trial treatments women had used.
The treatments also helped boost the women’s confidence and general psychological and physical wellbeing. For Kai and his team, the results of the ECLIPSE trial strengthened the case for using the LNG-IUS to reduce HMB, but also showed the benefits of other available treatments. However, the full value of the research was yet to be realised.
Ten years after the initiation of the ECLIPSE trial, Kai led a team of researchers from the University of Nottingham, including Professor Jane Daniels, Dr Yana Vinogradova, Brittany Dutton, and Nicholas Hilken, and Professor Janesh Gupta of the University of Birmingham, in a follow-up study. Of the 571 original trial participants, 424 completed the full five years. From this, 206 agreed to provide further data on their condition via a series of postal and online questionnaires. Ten years is a long time, and much has happened in the lives of the women who responded to the request. Some had entered their menopause, some had had surgery to secure a longer-term addressing of their condition – either endometrial ablation or a hysterectomy, and two had died.
The so-called ‘responders’ agreed that, overall, they felt their quality of life had improved thanks to the treatments they received. No significant statistical difference existed between those who used the LNG-IUS and those given other treatments. However, those initially treated with the LNG-IUS were slightly less likely to need surgical intervention than those on standard medical treatments. 30% of those treated with the LNG-IUS were still using one after ten years.
The follow-up questionnaires produced reams of valuable data, but some of the most profound insights came when the researchers also sat down to talk with some of the participants about their long-term experiences with HMB and the treatment they used. Through semistructured interviews with a sample of 36 responders, the interviews all spoke of the harmful effects HMB had on their lives. What stood out for Kai and his team, however, was how prior to the trial the respondents had normalised their experience – a probable outcome of societal taboos about menstruation and a general lack of awareness about the condition. As a result, they just dealt with HMB, largely unaware that treatments existed.
The qualitative study helped shine a light on just how debilitating HMB can be. The respondents described the flooding and unpleasant release of blood clots and the lengths they would go to manage or conceal their blood loss, even avoiding any forms of social interaction. They explained HMB’s significant impacts on intimate relationships – the decreased libido and prolonged bleeding preventing sexual activity, sometimes permanently damaging relationships.
Beyond the physical disruption to their lives were HMB’s psychological and emotional impacts – this was largely unrealised before the study. The effects on their working lives could be far-reaching. Respondents spoke of the embarrassment and stigma of the condition and feeling the pressure to conceal their menstruation, the inability to explain and discuss the condition to work colleagues and senior management.
Kai identified the essential role of the primary care physician in framing the respondents’ experiences. Those whose GPs were informed and supportive helped women understand the condition; some had GPs who were more dismissive, suggesting HMB was normal, ‘nothing to worry about’ or not a legitimate problem, or who failed to understand the emotional and psychological impact HMB had on their lives. The study showed the importance of sharing information and the value of joint decision-making with patients – of evaluating what would be best for them as individuals.
The study participants also had valuable recommendations for future primary care: the importance of raising awareness of HMB. They suggested more comprehensive initiatives to get people talking about the condition – at schools, in the media, and in the workplace. This would not only reduce stigma, but also encourage women to seek help.
The initial five-year ECLIPSE study, the ten-year follow-up data study, and the qualitative assessment of the participants’ experiences have produced invaluable insight into the impacts of a common and debilitating condition that affects so many women around the world. HMB is a condition where the primary care physician is at the frontline. Whilst we now know that a range of effective treatments exist, more importantly, we must also show that compassion, understanding, and the freedom to share information are critical components of their care, and essential for the future wellbeing of sufferers of HMB.
That’s all for this episode – thanks for listening. Be sure to check out Professor Kai and his team’s original research in the show notes below. And, as always, stay subscribed to Research Pod for more of the latest science.
See you again soon.
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