Skip to main content

Research Repository

Advanced Search

A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial

Gupta, Janesh K.; Daniels, Jane P.; Middleton, Lee J.; Pattison, Helen M.; Prileszky, Gail; Roberts, Tracy E.; Sanghera, Sabina; Barton, Pelham; Gray, Richard; Kai, Joe

A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial Thumbnail


Authors

Janesh K. Gupta

Jane P. Daniels

Lee J. Middleton

Helen M. Pattison

Gail Prileszky

Tracy E. Roberts

Sabina Sanghera

Pelham Barton

Richard Gray



Abstract

Background: Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited.

Objectives: To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women’s perspectives on treatment.

Design: A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study.

Setting: Women who presented in primary care.

Participants: A total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment.

Interventions: LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen–progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment.

Outcome measures: The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost–utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses.

Results: The MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points; p < 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI –0.6 to 8.3 points; p = 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women’s experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments.

Conclusions: The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women’s assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.

Trial registration: Current Controlled Trials ISRCTN86566246.

Citation

Gupta, J. K., Daniels, J. P., Middleton, L. J., Pattison, H. M., Prileszky, G., Roberts, T. E., Sanghera, S., Barton, P., Gray, R., & Kai, J. (2015). A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial. Health Technology Assessment, 19(88), 1-118. https://doi.org/10.3310/hta19880

Journal Article Type Article
Acceptance Date May 1, 2015
Publication Date Oct 1, 2015
Deposit Date Oct 27, 2017
Publicly Available Date Oct 27, 2017
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 2046-4924
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 19
Issue 88
Pages 1-118
DOI https://doi.org/10.3310/hta19880
Keywords Clinical Effectiveness; Cost-Effectiveness; levonorgestrel-releasing intrauterine system; Menorrhagia; Randomised Controlled Trial; ECLIPSE trial; Primary Care
Public URL https://nottingham-repository.worktribe.com/output/759858
Publisher URL https://www.journalslibrary.nihr.ac.uk/hta/hta19880#/abstract
Contract Date Oct 27, 2017

Files





You might also like



Downloadable Citations