Title: Medical treatment of heavy menstrual bleeding in primary care: Long term follow up of ECLIPSE trial cohort
Funder: Department of Health and Social Care

Abstract: Introduction Heavy menstrual bleeding (HMB) is a debilitating problem that can affect women’s physical, emotional and social quality of life. With an annual incidence of 25% among women aged 18-54 years, HMB is a common reason for general practice consultation. HMB accounts for 12% of all gynaecological referrals with up to 40% having surgical intervention within a year, creating substantial burden for women and health care. Addressing a lack of longer-term evidence on treatment, the ECLIPSE trial has shown women with HMB can be effectively helped in primary care. This trial found that two years after initiating either usual (largely oral) medical treatments or levonorgestrel contraceptive intrauterine system (LNG-IUS) in general practice, both approaches significantly reduced the effect of HMB of women’s quality of life, though LNG-IUS was more effective. Only 10% of women had surgical intervention. After five years, women in either treatment group had experienced similar and significant improvement, but with LNG-IUS no longer superior. The proportion of women having surgery remained modest but increased to 20% in both groups. HMB can be a chronic and episodic problem, with women commonly discontinuing or changing treatments. This may reflect differing preferences for, and responses to oral treatments or insertion of an LNG-IUS left in situ, and changing needs for contraception or fertility over time. The current observational study now seeks to follow up patients to 10 years, when it is expected over half the cohort will have reached the menopause. The study aims to: (1) assess further patterns of treatment use and surgical intervention rates, and (2) explore and understand women’s decisions in choosing or stopping treatments for HMB and their experiences of using them over time. Methods Multi-centre observational study involving patient questionnaire and/or interviews, supplemented by data collection from general practice medical records, to determine treatment use and surgical intervention rates (data for a minimum of 66% women [n=276 of 571 original participants] will be sought); with nested qualitative interview study involving purposeful sample of 30-40 women. Outcomes Ten- year outcome data on HMB medical treatment type and duration, progression to surgical interventions (hysterectomy, endometrial ablation); qualitative data on treatment choices and experience over time. These should provide information for women and general practitioners on what to expect in the long term from initiating or choosing differing medical treatments for HMB. This will include whether women presenting with HMB and treated in primary care continue to experience low surgical intervention rates after 10 years.

Lay abstract: Heavy menstrual bleeding is a common problem experienced by around 25% of women during the lifespan of their menstrual cycle: from teenage years until the menopause. It can affect not only physical health, but also women’s emotional and social wellbeing, work and relationships. Some women will seek medical help for this problem - usually from their GP, and it is also a common reason for referral to a gynaecologist when surgical treatments may be offered. The ECLIPSE trial compared the success of women starting two different treatment approaches when they saw their GP for this problem. Women agreed to be randomly allocated to either taking ‘standard’ medical treatments (such as oral mefenamic acid, tranexamic acid tablets or the contraceptive pill) or having a contraceptive ‘coil’ inserted, called levonorgesterel intrauterine system or ‘LNG-IUS.’ By offering questionnaires to women, at 2 years and 5 years after starting treatment, the trial found both types of treatment approach significantly helped reduce the effects of heavy menstrual bleeding on women’s lives. This included reducing practical difficulties with sanitary care and on their family, work and social lives. At two years, although on average the coil was more effective, 36% of women had had it removed because it wasn’t working or caused unpredictable bleeding, while around 40% of women were still using standard medical treatments. Only 10% of women had had surgery. At five years, about 50% of women still had the coil in place, while only 15% of women were still using standard treatments; and 20% of women in both groups had gone on to have surgery. Heavy menstrual bleeding and its effects on women’s lives can be intermittent and occur over several years up to the menopause, when menstrual bleeding stops naturally. Therefore this ‘follow up’ study will try to collect information from those women who participated in the trial 10 years after they started - when their average age was 42 years. As the menopause usually starts around the age of 52, most will be approaching natural menopause, making it timely to find out how many women continued treatments, and whether more women still had to have surgery. With women’s consent, we will seek this information by questionnaire and from their GP records. We will also interview a smaller sample of women in more detail. We will ask about their experiences of using or deciding to stop or change treatments for this problem, and how these decisions may have changed over time (such as changing need for contraception or wanting to conceive later in life). The results of the study will provide very useful long-term information on what happens to women who seek help and are treated for heavy menstrual bleeding in general practice. This information could help women and health professionals to make more informed choices about help for this condition at its outset. This might include taking account of women’s differing preferences and circumstances, what to expect from different treatments, or knowing what proportion of women may still require surgery over time.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH