Heavy periods, endometriosis, fibroids, and other women’s health conditions are a huge burden to many. Symptoms can continue for many years, make everyday life a challenge, and have a negative impact on work, school, relationships, social life, self-esteem and emotional wellbeing. Stigma and misinformation mean many women suffer in silence.
Heavy periods: Women may have to change sanitary products every 1 – 2 hours, use both a pad and a tampon, bleed through to clothes or have periods that last 7 days or more.
Endometriosis: Cells similar to the lining of the womb grow elsewhere in the body. They may break down and bleed during a period, which can cause severe pain.
Fibroids: Growths of muscle and fibrous tissue develop in or around the womb. Not all cause symptoms.
Treatments are available, but clinicians and women need sufficient information to make shared decisions about care. High quality evidence comparing the benefits and risks of different treatments, alongside women’s preferences, values and beliefs, can help women receive the care that is right for them.
“Shared decision-making is the principal mechanism for ensuring that patients get the care they need and no less, the care they want, and no more…”
- Making Shared Decision Making a Reality: No Decision About Me, Without Me (2011)
At the NIHR Evidence webinar (November 2024), researchers presented their findings on the long-term effects of treatments for heavy periods, endometriosis and fibroids. Attendees included clinicians, members of the public, and NHS decision makers, highlighting broad interest in women’s health, and the need for information. The webinar asked:
- how do treatments for heavy periods compare after 10 years?
- which hormonal treatment best prevents pain 3 years after endometriosis surgery?
- which fibroid procedure has better outcomes after 4 years?
This Collection summarises the 3 research projects presented at the webinar and includes video clips from the speakers.
1. Heavy periods: the coil and oral medicines are similarly effective over 10 years
“Many women and girls don't like talking about their periods, or they believe nothing can be done… Whilst attitudes are changing, there is an unmet need for treatments for heavy periods.”
- Jane Daniels, Professor of Clinical Trials, University of Nottingham
Up to 1 in 3 women have heavy periods. The original ECLIPSE randomised controlled trial (2005 - 2009) investigated whether the coil or oral medicines (tranexamic acid, mefenamic acid, combined oestrogen-progestogen, or progestogen alone) are more effective at reducing the impact of heavy periods. The study included 571 women from 63 UK general practices. Their average age was 42 and most (82%) were white.
Both treatments were effective. At 2 years, the impact of heavy menstrual bleeding was less for women who received the coil, compared with the oral medicines, but by 5 years, the impact was similarly reduced in both groups.
At the webinar, Jane Daniels, Professor of Clinical Trials, University of Nottingham, presented 10 year outcomes of the ECLIPSE trial. The original participants were asked to complete a questionnaire; 206 women answered questions about their periods, symptoms and quality of life. 36 women were interviewed in depth.
Ongoing treatment and outcomes at 10 years
Among 206 women at 10 years:
- half (106) had reached the menopause
- 60 had had surgery
- 88 were using the coil; either alone (67) or in combination with oral treatments (21)
- 89 had stopped all treatments for heavy periods.
Some women retained their coil after the menopause because they were concerned that their bleeding would return, or because they wanted its ongoing hormonal effects. None of those who were through the menopause continued to take oral treatments.
Surgery was similarly likely, whether women initially had the coil or oral treatment. But both treatments remained effective for many women.
Women’s decisions about treatment were influenced by changes in their personal and working lives, and their requirements for contraception. They were concerned about the impact of treatment on their fertility, health, and as a cause of early menopause.
Quality-of-life improvements were maintained up to 10 years for the 88 women still using the coil or oral treatments. Improvements in pain, discomfort and mental health continued (compared to before treatment).
What impact do heavy periods have on everyday life?
Women in the study described the anxiety, embarrassment, and disruption to their lives caused by heavy periods, before they started treatment. Several bled through products onto clothes and bedding. One said: “[I would have to] throw clothes away because there was so much blood on them.”
Heavy bleeding could affect relationships, work and mental health, often leading to anxiety and a lack of confidence: “it always made me really anxious, I would get very tearful.”
More than half the women interviewed had positive interactions with clinicians, even if they had to try multiple treatments. They felt informed and knew what to expect from treatment. But some said they were ‘fobbed off’ and told that the bleeding was normal.
Clinicians can support women to make informed decisions
Treatments prescribed by GPs improved quality of life for most women over the long-term. These findings could help doctors and women make shared decisions about managing heavy periods.
The research stressed that women need a clear explanation in the initial consultation when there is no obvious cause for the problem, or if tests would help. They need to know that treatment may need to be changed over time. After starting treatment, contact points with healthcare professionals such as when the coil needs to be changed or for cervical screening, are ideal opportunities to discuss progress.
2. Endometriosis: long-acting progestogens and the contraceptive pill similarly reduce pain after surgery
Around 1 in 10 women have endometriosis. Surgery for endometriosis can improve symptoms, but recurrence of pain is common. National Institute for Health and Care Excellence (NICE) guidelines recommend the contraceptive pill and progestogens to treat endometriosis-related pain.
At the webinar, Justin Clark, Consultant Gynaecologist, Birmingham Women's Hospital and Honorary Professor, University of Birmingham, presented data from the PRE-EMPT randomised controlled trial. It explored whether the contraceptive pill or long-acting progestogens are better at preventing pain 3 years after surgery for endometriosis.
The randomised controlled trial included women who had surgery for endometriosis: 205 were randomised to long-acting progestogens (a long-acting injection of medroxyprogesterone acetate every three months or a coil) and 200 to the contraceptive pill. Most women (91%) were white and their average age was 29.
Both treatments improved endometriosis-related pain at 3 years
Both groups saw approximately a 40% reduction in endometriosis-related pain after 3 years compared to before surgery (the main outcome); there was no significant difference between groups. Results were the same across subgroups, including type of progestogen.
The Endometriosis Health Profile-30 questionnaire assesses the impact of endometriosis on women’s lives. Both groups had improved scores for most aspects of life, including emotional wellbeing and work life, compared with before surgery. There were no consistent differences between groups.
Neither fatigue nor quality of life were significantly improved by either treatment at 3 years.
Fewer women on long-acting progestogens required additional treatment
Use of long-acting progestogens reduced the risk of additional treatments and further surgery compared with the contraceptive pill. Women in the long-acting progestogen group had fewer (73) additional treatments or procedures than those in the contraceptive pill group (97).
Uncertainty remains over which treatment is more cost-effective
The contraceptive pill was associated with higher costs per woman (£2,470) but slightly more quality adjusted life years (equivalent to 1 year in perfect health; 1.98) than long-acting progestogens (£1,937, 1.94, respectively). A cost-effectiveness analysis suggested only a 61% chance that the contraceptive pill was more cost-effective; uncertainty remains over which treatment offers more value for money.
Outcomes for long-acting progestogens and the contraceptive pill are similar
The findings support current guidance to prescribe hormonal treatment after surgery for endometriosis.
“This trial suggests we should be offering women either type of hormonal treatment to prevent symptomatic recurrence of endometriosis. The findings should hopefully help shared decision making.”
- Justin Clark
Clinicians could share these findings with women to improve shared decision making. Further research could compare these treatments with newer ones, such as dienogest. In the Q&A, Justin Clark said that relatively few women in the study were from ethnic minorities and that more research is needed in this group.
For women unable to tolerate hormonal medications, Justin Clark said that surgery alone may be an option, though evidence suggests that hormonal medications improve pain symptoms further. Women could be referred to a pain clinic or use other pain relieving drugs, he said.
3. Fibroids: myomectomy and uterine artery embolisation have similar long-term outcomes
2 in 3 women will have a fibroid in their lifetime (not all of which cause symptoms). Hysterectomies are the most common treatment for removing fibroids but many women opt for womb-preserving procedures. These include myomectomy (surgical removal of fibroids) and uterine artery embolisation (UAE; blocking the blood vessels that supply fibroids).
The original FEMME randomised controlled trial (2012 - 2015) compared outcomes for myomectomy or UAE among 254 premenopausal women with symptomatic fibroids. Their average age was 41 and a similar proportion of women were white (46%) or black (40%).
At 2 years, both treatments improved quality of life, but myomectomy was significantly better than UAE. At the webinar, Jane Daniels presented outcomes for the 81 women in the myomectomy group and 67 in the UAE group who provided data at year 4.
Both treatments improved quality of life, symptoms and satisfaction
At 4 years, both procedures improved health-related quality of life but myomectomy was no longer significantly better (as it was at year 2). Most women (76%) were happy with the procedure they had and if they could go back in time, would make the same choice again. Menstrual bleeding scores were similar in both groups; most menstruating women reported regular or fairly regular periods (77% for myomectomy and 75% for UAE). Further procedures were more common in the UAE group (22) than in the myomectomy group (13) .
Myomectomy is slightly more cost-effective than UAE
The mean total cost to the NHS was £8,010 for the myomectomy group and £8,362 for the UAE group (based on 2018/19 costs). Quality adjusted life years were higher for myomectomy (0.82) than UAE (0.73). Myomectomy was therefore more cost-effective over 4 years. Nevertheless, the total differences in costs and quality adjusted life years were small.
Outcomes for myomectomy and UAE are similar over 4 years
“It's important that GPs, gynaecologists and other health care professionals discuss both procedures as an alternative to a hysterectomy, and allow women a choice, where both are viable options.”
- Jane Daniels
Clinicians could discuss both treatments with women considering surgery for fibroids. The differences between treatments in effectiveness and cost-effectiveness were small.
In the Q&A, several attendees raised the difficulty of being diagnosed with fibroids, endometriosis, and heavy periods. The panellists said that both women and clinicians can consult NICE guidelines to understand what treatments and support are recommended, and when. Women can be assured that their views matter in choosing the right treatment for them; they are encouraged to share their preferences with clinicians.
Conclusion
“In the absence of a clear difference in clinical outcomes, listening to patients and respecting their preferences is really important.”
- Justin Clark
In these 3 studies, the long-term outcomes of different treatments for heavy periods, endometriosis, and fibroids were similar. Clinicians need to listen to women and ask about their priorities and preferences to help them make informed decisions about their care.
Shared decision making is the starting point for delivering high-quality care. This Collection provides high-quality evidence to underpin discussions between women and their clinicians about overlooked and undertreated conditions: heavy periods, endometriosis, and fibroids.
Resources
Women’s Health: Why do women feel unheard?
NICE guidance on heavy periods
Support and information from Wellbeing of Women, Endometriosis UK, The Endometriosis Foundation, The British Fibroid Trust and the Menstrual Health Project
Guidance from the Royal College of Obstetricians and Gynaecologists
Menstrual Cycle Support - a free online course to help women them manage their menstrual cycle
How to cite this Collection: NIHR Evidence; Endometriosis, fibroids and heavy periods: long-term research supports treatment decisions; November 2024; doi: 10.3310/nihrevidence_64953
Disclaimer: This publication is not a substitute for professional healthcare advice. It provides information about research which is funded or supported by the NIHR. Please note that views expressed are those of the author(s) and reviewer(s) at the time of publication. They do not necessarily reflect the views of the NHS, the NIHR or the Department of Health and Social Care.
NIHR Evidence is covered by the creative commons, CC-BY licence. Written content and infographics may be freely reproduced provided that suitable acknowledgement is made. Note, this licence excludes comments and images made by third parties, audiovisual content, and linked content on other websites.
