Discontinuing HRT; How and why do women decide and experience stopping HRT, why do women decide to restart and is a clinical trial comparing stopping methods feasible?
Around 40% of women who stop hormone replacement therapy (HRT) find their menopausal symptoms return, and one in four restart HRT, often cycling on and off the treatment. This matters because there is no evidence on the best way to stop—whether tapering the dose or stopping abruptly leads to fewer symptoms, lower NHS costs, and less repeated prescribing. The research will interview women and GPs, review existing studies, and use a survey to measure what women value when deciding whether to restart. The core of the project is a feasibility study in GP practices, testing three different tapering schedules (long, medium, short) in 60 women to see whether a full clinical trial comparing stopping methods is possible. If the feasibility study works, it could lead to a definitive trial that gives women and clinicians clear, evidence-based guidance on how to stop HRT without triggering a cycle of restarting. That would reduce unnecessary NHS prescribing and improve quality of life for women navigating menopause.
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Research question Discontinuing HRT; How and why do women decide and experience stopping HRT, why do women decide to restart and is a clinical trial comparing stopping methods feasible? Background Hormone replacement therapy (HRT) is an effective treatment for symptoms of the menopause. HRT prescribing has increased in England, likely due to media attention and campaigners. Most menopause care (including prescribing of HRT) happens in primary care. At some point most women stop HRT, often concerned about longer term health risks associated with duration of use. However, around 40% of women have resurgent symptoms when stopping HRT and 1-in-4 who stop will restart HRT, potentially leading to a cycle of stopping/starting. The longer-term consequences are a likely increase in morbidity and NHS costs. It is not known how best to stop HRT and whether tapering or stopping abruptly affects health outcomes and care costs. Objectives Explore the experiences of women who have stopped/are stopping HRT and Health Care Professionals (HCPs) that care for them using semi-structured interviews. Conduct a systematic review and meta-analysis of qualitative studies on stopping/restarting HRT. Establish what women value when considering restarting HRT using a discrete choice experiment. Design a non-randomised feasibility study looking at tapering of HRT Undertake a feasibility study to determine if a future definitive trial of abrupt stopping vs tapering HRT is possible. Methods WP1 (month 1-14) Findings from a synthesis of existing data and experiences of a PPI panel and Project Research Group (PRG) will inform an interview schedule for semi-structured interviews with women who have stopped / are stopping HRT and HCPs caring for them. WP2 (month 6-17) I will perform a systematic review and meta-analysis of qualitative studies looking at stopping HRT +/- restarting including the results from WP1. This will inform attributes (variables) of most importance for WP3 (Discrete choice experiment DCE) and priority outcomes for WP4. WP3(month 15-33) After establishing the attributes (variables) of most importance (WP1/2), supported by a health economist, I will undertake a DCE within a survey to compare the trade-offs in health states when women consider restarting HRT. WP4 (month 23-47) I will use the results of WP1/2/3 and work with key stakeholder groups (women, GPs, pharmacists, third sector organisations, trial methodologists) to design a feasibility study and collect data, including those relevant to supporting the need for a future definitive trial comparing methods of stopping HRT. Design recruitment materials (with a PPI panel) and obtain ethical approval for WP5. WP5 (month 48-72) undertake a non-randomised feasibility study in general practices serving a diverse population comparing three different tapering regimes for stopping HRT (long, medium, short taper) in 60 women to inform the design of a definitive trial. Anticipated impact and dissemination Findings will be disseminated in ways that have immediate impact, highlighting resurgent symptoms on HRT discontinuation to women and HCPs. Findings from WP1/2/3/5 will be published and presented, and if appropriate lead to full trial funding. Dissemination will involve women, GPs, commissioners, professional bodies, and policy makers.
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