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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

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 

Journal Article Type Article
Publication Date Oct 1, 2015
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 1366-5278
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 19
Issue 88
APA6 Citation Gupta, J. K., Daniels, J. P., Middleton, L. J., Pattison, H. M., Prileszky, G., Roberts, T. E., …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), https://doi.org/10.3310/hta19880
DOI https://doi.org/10.3310/hta19880
Keywords Clinical Effectiveness; Cost-Effectiveness; levonorgestrel-releasing intrauterine system; Menorrhagia; Randomised Controlled Trial; ECLIPSE trial; Primary Care
Publisher URL https://www.journalslibrary.nihr.ac.uk/hta/hta19880#/abstract
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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