Potential new medical treatment for problematic menstrual bleeding
DexFEM study provides the first evidence of therapeutic benefit of dexamethasone in heavy menstrual bleeding.
This study built on previous laboratory research showing that a deficiency in the inner lining of the uterus, of steroid hormones known as glucocorticoids, may contribute to the symptom of heavy menstrual bleeding. Dexamethasone is a glucocorticoid already in common use for a wide range of health conditions.
In the UK heavy menstrual bleeding affects one in four women aged around 18 to 50 years of age, and it can have severe adverse impact on quality of life, often persisting for years. Yet there has been no new medical treatment for heavy menstrual bleeding for over two decades.
The study team aimed to demonstrate that giving women who experience heavy menstrual bleeding a low dose of dexamethasone for 5 days in the later part of the menstrual cycle would reverse the glucocorticoid deficiency in the lining of the uterus and as a result reduce menstrual blood loss.
After a 4 year, dose-finding, response adaptive randomised controlled trial - they were pleased to announce that it did just that.
Our adaptive trial in heavy menstrual bleeding showed that dexamethasone 1·8 mg daily reduced menstrual blood loss. The role of dexamethasone in heavy menstrual bleeding management deserves further investigation.
DexFEM (Dexamethasone For Excessive Menstruation) was led by Professor Hilary Critchley (Centre for Reproductive Health) supported by Dr Pamela Warner (Usher Institute) and Professor Chris Weir (Usher Institute/ Edinburgh Clinical Trials Unit (ECTU)). Other Usher/ECTU staff who played a key role in trial design, and management, and in analyses, were Ms Anne Douglas and Drs Christian Hansen and Richard Parker, with additional support from other ECTU staff for the adaptive randomisation, database programming and data management. The research was funded by an MRC Developmental Clinical Studies research grant.
The journal EBioMedicine from The Lancet, published a commentary to accompany the main paper. The commentary praised the team for the study design and implementation.
The multidisciplinary DexFEM study team is ... to be congratulated for their triumphant efforts: methodological contributors for producing an excellent case study that will be gleefully received and much cited in the medical statistics literature; and clinical collaborators for successfully implementing the design after consulting the statisticians long before the first patient was randomised. This was so much better than deferring statistical input until after harvesting final data endpoints, a sadly common characteristic of poor medical research.
Full paper published in EBioMedicine, July 2021
Extensive supplementary material is provided online with the paper, including: 3 papers already published from the research; full protocol; statistics analysis plan; an introduction to Bayesian methods and adaptive design; and a report of the proof-of-concept research.